BUBENDORF, Switzerland [04th June 2025] – CARBOGEN AMCIS, a Switzerland-based pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, is pleased to announce a strategic co-investment of more than CHF 25 million with a long-standing Japanese customer to expand manufacturing capabilities at its sites in Aarau and Neuland, Switzerland.

The investment will support the production of a drug linker for a commercial antibody-drug conjugate (ADC), enabling CARBOGEN AMCIS to meet rising global demand. As part of the agreement, both facilities will see significant equipment and infrastructure enhancements, including:

• Aarau site: installation of 850-litre reactors and 0.4 m² agitated filter dryers with supporting equipment. Completion is expected by Q1 2027.
• Neuland site: installation of 850-litre reactors and 0.4 m² agitated filter dryers with auxiliary systems. Completion is anticipated by Q3 2027.

This project builds on a previous joint funding agreement between CARBOGEN AMCIS and the same customer in April 2021 to develop a site extension at the Bubendorf site in Switzerland, reinforcing the strength of the relationship and their shared commitment to long-term growth.

“This expansion demonstrates our ability to scale alongside our customers, responding to the increasing demand for complex and high-value compounds such as ADC drug linkers,” said Stephan Fritschi, CEO at CARBOGEN AMCIS. “We’re proud to continue building on our strong trust and technical collaboration foundation.”

CARBOGEN AMCIS is recognised for its robust capabilities in handling highly potent compounds, offering end-to-end support from process development to commercial supply. The new investments will further strengthen the company’s infrastructure to deliver high-quality manufacturing services in line with cGMP and global regulatory expectations.

“By investing in both Aarau and Neuland, we’re ensuring that our infrastructure keeps pace with our customers’ ambitions,” said Carl Baker, Vice President Business Unit Drug Substance. “These upgrades will allow us to seamlessly manage increased volumes while maintaining the operational excellence and containment controls required for highly potent APIs and advanced therapies.”

With facilities across Switzerland, France, the UK, the Netherlands, and China, CARBOGEN AMCIS continues to expand its global footprint while delivering flexible, integrated CDMO solutions to pharmaceutical and biopharmaceutical innovators worldwide. 

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CARBOGEN AMCIS AG (carbogen-amcis.com) is a leading service provider, offering a portfolio of drug-development and commercialization services to the pharmaceutical and biopharmaceutical industry at all stages of drug development. The integrated services provide innovative chemistry solutions to support timely and safe drug development, allowing customers to make the best use of available resources. CARBOGEN AMCIS AG is owned by Dishman Carbogen Amcis Limited., Ahmedabad, India.

Dishman Carbogen Amcis Limited (www.imdcal.com) is a global outsourcing partner for the pharmaceutical industry, offering a portfolio of development, scale-up and manufacturing services. Dishman Carbogen Amcis group improves its customers’ businesses by providing a range of development and manufacturing solutions at locations in Europe and in India.

BUBENDORF, Switzerland – [22^d April 2025] – CARBOGEN AMCIS, a Switzerland-based pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company is pleased to announce that its Shanghai facility has successfully obtained its first Drug Manufacturing License (DML) from China’s National Medical Products Administration (NMPA).

The NMPA approval followed a rigorous review focused on GMP compliance and operational readiness. The Shanghai site successfully met all regulatory expectations, reflecting the maturing of its operations and the strength of its quality systems. This milestone marks a pivotal step in CARBOGEN AMCIS’ expansion in China and reinforces its commitment to customers in the region.

Located in the Shanghai Chemical Industry Park (SCIP), the 40,000m² site is a fully self-supporting facility equipped for early-phase research and development, pilot scale production and commercial GMP manufacture. Its services range from raw materials to APIs, including high potency material handling and micronization. With equipment in four segregated units and reactor capacities from 50 to 6,300 litres, the facility is built for flexibility, efficiency and scalability. The site employs over 140 people and brings together an international team of specialists whose expertise, combined with advanced infrastructure, enables the delivery of tailored, scalable solutions to customers worldwide.

“This achievement underscores our team's commitment, disciplined execution, and the robustness of our Quality Management System, which has been rigorously aligned with both corporate and Chinese regulatory requirements,” said Simone Maggi, Quality Head - CARBOGEN AMCIS Shanghai site.

“In addition to our core manufacturing capabilities, we’re proud that the Shanghai site is equipped to handle highly potent compounds up to category 3 and provide full GMP product release and analytical support,” said Harry Wong, Country Manager, CARBOGEN AMCIS Shanghai. “This license is a testament to the strength of our team and demonstrates our ability to execute seamless technology transfers and align with the highest quality standards across CARBOGEN AMCIS’ global network.”

Stephan Fritschi, CEO at CARBOGEN AMCIS, stated: “Securing the Drug Manufacturing License not only demonstrates the operational readiness of our Shanghai site but also reflects the strength of our global quality culture. This achievement strengthens our long-term goal of becoming a trusted partner in the Chinese pharmaceutical market.” He added, “I would like to take this opportunity to express my gratitude to every member of our site team for their dedication and to the Executive Team for their continuous support and trust throughout this journey.”

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CARBOGEN AMCIS AG (carbogen-amcis.com) is a leading service provider, offering a portfolio of drug-development and commercialization services to the pharmaceutical and biopharmaceutical industry at all stages of drug development. The integrated services provide innovative chemistry solutions to support timely and safe drug development, allowing customers to make the best use of available resources. CARBOGEN AMCIS AG is owned by Dishman Carbogen Amcis Limited., Ahmedabad, India.

Dishman Carbogen Amcis Limited (www.imdcal.com) is a global outsourcing partner for the pharmaceutical industry, offering a portfolio of development, scale-up and manufacturing services. Dishman Carbogen Amcis group improves its customers’ businesses by providing a range of development and manufacturing solutions at locations in Europe and in India.

Bubendorf, Switzerland (March 24, 2025) – Switzerland-based CARBOGEN AMCIS, a leading pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, is pleased to announce the successful completion of the first inspection by the French regulatory authority, ANSM (Agence nationale de sécurité du médicament et des produits de santé), at its state-of-the-art sterile drug product manufacturing site in Saint-Beauzire, France.

The inspection, conducted from January, 20th to January, 24th, follows the site’s opening in February 2023. This is the first inspection of a routine process by ANSM to ensure compliance with Good Manufacturing Practices (GMP). As a result, CARBOGEN AMCIS has been granted a GMP certificate for the Saint-Beauzire facility, marking a significant milestone in the site's successful start-up. The certificate allows for the manufacture and release of clinical and commercial sterile drug products. The site received authorization from the ANSM to manufacture, test and release drug products from February 2023 and since then has been working under this authorization with the first clinical batch released in January 2024.

“This achievement reflects our team's dedication and hard work” said Angie Stevens, Vice President, Drug Product Business Unit. “I am incredibly proud of the commitment and motivation every Saint-Beauzire employee shows. With this certification, we look forward to actively supporting our customers in bringing new drugs to market and shaping a bright future together.”

A State-of-the-Art Facility

Opened in early 2023, the Saint-Beauzire facility represents a major investment by CARBOGEN AMCIS (60 million euros). It underscores the company’s commitment to enhancing sterile drug product manufacturing capabilities. The 9,500m² site features two fully automated production lines for liquid and lyophilized drug products, supporting a wide range of therapeutic areas, including highly potent compounds and advanced therapies such as antibody-drug conjugates. The flexible and versatile setup is unique within Europe and fully compliant with the latest EU GMP Annex 1 standards for sterile medicinal products.

With over 15 years of expertise developing injectable and liquid pharmaceutical forms, CARBOGEN AMCIS’ Saint-Beauzire site provides tailored solutions for pre-clinical and clinical trials and small-scale commercial manufacturing. It also creates significant job opportunities, employing approximately 130 highly skilled professionals

A Growing Portfolio of Services

“The successful ANSM inspection reaffirms CARBOGEN AMCIS as a reliable partner in the drug product manufacturing market,” said Helen Caddy-Leach, Head of Business Development, Drug Product. “With our extensive expertise and a state-of-the-art GMP-certified facility, we are well-positioned to support customers’ drug product projects with excellence.”

This new site complements CARBOGEN AMCIS’ existing capabilities as a renowned API manufacturer. “Having a cutting-edge facility dedicated to the development and manufacture sterile drug products, including to a commercial scale, strengthens our ability to offer comprehensive end-to-end services, from drug substance to drug product,” said Stephan Fritschi, CEO of CARBOGEN AMCIS. “This integrated approach is a significant advantage in today’s competitive pharmaceutical landscape and provides added value for our clients.”

Supporting Global Pharmaceutical Innovation

CARBOGEN AMCIS’ eight sites across Switzerland, France, the United Kingdom, China, and the Netherlands deliver cGMP-compliant, innovative technologies that enable pharmaceutical and biopharmaceutical companies to bring next-generation medicines to market. The Saint-Beauzire site completes the CARBOGEN AMCIS group portfolio and is integral to the company's production chain. The site plays a critical role in this mission by enhancing the group’s capacity to develop and manufacture advanced sterile drug products.

To learn more about our GMP certified site: watch our dedicated video.

CARBOGEN AMCIS AG (www.carbogen-amcis.com) is a leading service provider, offering a portfolio of drug-development and commercialization services to the pharmaceutical and biopharmaceutical industry at all stages of drug development. The integrated services provide innovative chemistry solutions to support timely and safe drug development, allowing customers to make the best use of available resources. CARBOGEN AMCIS AG is a wholly owned subsidiary of Dishman Carbogen Amcis Limited., Ahmedabad, India 

Dishman Carbogen Amcis Limited (www.imdcal.com) is a global outsourcing partner for the pharmaceutical industry, offering a portfolio of development, scale-up and manufacturing services. Dishman Carbogen Amcis group improves its customers’ businesses by providing a range of development and manufacturing solutions at locations in Europe and in India. 

BUBENDORF, Switzerland (February 3, 2025) — Switzerland-based CARBOGEN AMCIS, a leading pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, has announced the departure of its current CEO, Pascal Villemagne as of March 31 and the appointment of his replacement, Stephan Fritschi.

After thirteen years with CARBOGEN AMCIS, the last three thereof as Chief Executive Officer (CEO), Pascal Villemagne has announced his intent to step down at the end of March 2025, to take on a new challenge in his professional career. He will remain in his role until March 31, 2025, and facilitate the handover to the new CEO.

“We thank Pascal for his dedication and leadership during a transformational period for CARBOGEN AMCIS,” said Arpit Vyas, Global Managing Director. “Pascal has been instrumental in the turnaround of CARBOGEN AMCIS. During his tenure, Pascal successfully implemented structural changes in the company organization and supported our digital transformation. He paved the way for a bright future for our company, securing CARBOGEN AMCIS’ position as a world leader in the pharmaceutical industry.”

The company is pleased to announce that Stephan Fritschi, currently serving as Chief Alliance Officer and deputy CEO, will assume the role of CEO, effective as of April 1, 2025. “With more than 25 years at CARBOGEN AMCIS, a perfect knowledge of the company and extensive experience in the pharmaceutical market, Stephan Fritschi brings a deep understanding of the company’s operations, values, and strategic direction, he assures continuity in growing the business” stated Christian Eich, Chairman of CARBOGEN AMCIS.

“It has been a privilege to lead CARBOGEN AMCIS. I am incredibly proud of what we have accomplished together, not only during my three years as CEO, but also over the past thirteen years within the company. I have full confidence in Stephan’s ability to steer the company toward even greater success. We will be working together over the coming weeks to ensure a smooth transition.” Said Pascal Villemagne.

“I am honored to take on this role and lead CARBOGEN AMCIS into the future. I look forward to collaborating with the team to continue the progress we have made and to build on the foundations laid by my predecessor, ensuring we continue to deliver value to our customers, employees, and stakeholders.” Commented Stephan Fritschi

The Board of Directors expressed its gratitude to Pascal Villemagne for his outstanding contributions and commitment to the company, as well as its confidence in Stephan Fritschi to lead CARBOGEN AMCIS into its next phase of growth.

CARBOGEN AMCIS AG (www.carbogen-amcis.com) is a leading service provider, offering a portfolio of drug-development and commercialization services to the pharmaceutical and biopharmaceutical industry at all stages of drug development. The integrated services provide innovative chemistry solutions to support timely and safe drug development, allowing customers to make the best use of available resources. CARBOGEN AMCIS AG is a wholly owned subsidiary of Dishman Carbogen Amcis Limited., Ahmedabad, India 

Dishman Carbogen Amcis Limited (www.imdcal.com) is a global outsourcing partner for the pharmaceutical industry, offering a portfolio of development, scale-up and manufacturing services. Dishman Carbogen Amcis group improves its customers’ businesses by providing a range of development and manufacturing solutions at locations in Europe and in India. 

BUBENDORF, Switzerland (January 13, 2025) — Switzerland-based CARBOGEN AMCIS, a leading pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, is pleased to announce the successful completion of a Swissmedic inspection of its Vionnaz facility, reaffirming the site’s compliance with high regulatory standards.

Swissmedic, the Swiss Agency for Therapeutic Products, conducted a routine two-day inspection at the company’s Vionnaz site in Switzerland from 13 to 14 November 2024. Led by an inspector from the Regional Medicines Inspectorate of Western Switzerland (ISOPTh), the inspection focused on the Quality Management System compliance for the development and manufacture of highly potent APIs, including analytical and quality control processes. The site’s GMP Certification has been successfully renewed.

Hélène Mazuel, Quality Director - Drug Substance CARBOGEN AMCIS, Switzerland, said: “This successful inspection underscores our track record of delivering high-quality development and manufacturing services. It reflects the unwavering commitment of our team to consistently meet the highest quality standards required for the site.

I am immensely proud of the Vionnaz team for this achievement, supported by our expert groups across Switzerland. Demonstrating our ability to meet all aspects of quality to Swissmedic is a significant milestone that further strengthens our reputation.”

This continues a series of successful inspections in Vionnaz, starting with the first in 2015 and followed by subsequent inspections in 2016, 2017, 2020, and 2022. It reinforces CARBOGEN AMCIS’s strong history of compliance with Swissmedic requirements.

Acquired by CARBOGEN AMCIS in 2014, the Vionnaz facility specializes in the development and small-scale production of Highly Potent APIs (up to category 5), including the capability to produce highly potent warheads and linkers for antibody-drug conjugates (ADC).  The site features three process development laboratories, a dedicated QC laboratory, three production units with reactors up to 30 L, preparative chromatography systems and freeze dryers up to pilot scale.

CARBOGEN AMCIS AG (www.carbogen-amcis.com) is a leading service provider, offering a portfolio of drug-development and commercialization services to the pharmaceutical and biopharmaceutical industry at all stages of drug development. The integrated services provide innovative chemistry solutions to support timely and safe drug development, allowing customers to make the best use of available resources. CARBOGEN AMCIS AG is a wholly owned subsidiary of Dishman Carbogen Amcis Limited., Ahmedabad, India 

Dishman Carbogen Amcis Limited (www.imdcal.com) is a global outsourcing partner for the pharmaceutical industry, offering a portfolio of development, scale-up and manufacturing services. Dishman Carbogen Amcis group improves its customers’ businesses by providing a range of development and manufacturing solutions at locations in Europe and in India. 

BUBENDORF, Switzerland (July 22, 2024) —Switzerland-based CARBOGEN AMCIS, a leading pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, is pleased to announce the successful completion of U.S. Food and Drug Administration (FDA) inspections at its Neuland and Aarau sites. 

The FDA conducted routine inspections over five days in Neuland from June 17-21, 2024, and three days in Aarau from June 24-26, 2024. The inspections concluded with no Form 483 observations or significant critical findings, affirming that No Actions Indicated (NAIs) were identified.

“The successful inspections at our Aarau and Neuland sites highlight CARBOGEN AMCIS’s consistent track record of high-quality development and manufacturing. This achievement reinforces our commitment to delivering the superior quality our customers expect,” said Pascal Villemagne, CEO of CARBOGEN AMCIS. “Our Quality Team collaborates closely with every CARBOGEN AMCIS facility to uphold a robust and reliable quality policy across the company.”

“I am delighted about these positive reports from the FDA,” said Mr Arpit Vyas, Global Managing Director of the Dishman CARBOGEN AMCIS Group. “This accomplishment reflects years of dedication and hard work by our team, maintaining the highest standards of quality and building on our extensive record of successful regulatory audits and inspections.”

About the Neuland Facility

Opened in 2000, the Neuland facility, located in Hunzenschwil, specializes in drug development and small to medium-scale cGMP manufacturing. It is CARBOGEN AMCIS’s second site dedicated to laboratories for developing highly potent compounds. The facility is equipped to handle analytical services, API and intermediate stability studies, API process research and development, and small-scale commercial API supply.

About the Aarau Facility

Established in 1994, the Aarau facility focuses on drug substance development and small to medium-scale cGMP manufacturing. Centrally located in Switzerland, it offers a wide array of technology tools, including solid-state analysis, chromatography separation, isolation, and analytical capabilities. The primary activities include API process research and development, small-scale commercial API supply, and chromatography services.

The Neuland and Aarau facilities are designed to be flexible, accommodating various projects, whether API or analytical. Situated just 10km apart, they employ over 300 professionals and are fully cGMP-compliant and Swiss Medic-approved. Together, they operate 30 vessels ranging from 10L to 640L.

CARBOGEN AMCIS AG (www.carbogen-amcis.com) is a leading service provider, offering a portfolio of drug-development and commercialization services to the pharmaceutical and biopharmaceutical industry at all stages of drug development. The integrated services provide innovative chemistry solutions to support timely and safe drug development, allowing customers to make the best use of available resources. CARBOGEN AMCIS AG is a wholly owned subsidiary of Dishman Carbogen Amcis Limited., Ahmedabad, India 

Dishman Carbogen Amcis Limited (www.imdcal.com) is a global outsourcing partner for the pharmaceutical industry, offering a portfolio of development, scale-up and manufacturing services. Dishman Carbogen Amcis group improves its customers’ businesses by providing a range of development and manufacturing solutions at locations in Europe and in India. 

BUBENDORF, Switzerland (19 March 2024) – Switzerland-based CARBOGEN AMCIS, a pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, announces the successful completion of its first Brazilian Regulatory Authority Agency (ANVISA) routine inspection of its facility in Shanghai.

Between 6-10th November 2023, a five-day inspection was undertaken, which concluded successfully with no critical and no major observations raised. A Good Manufacturing Practice (GMP) certificate has been granted to the site by the authority.

Pascal Villemagne, CEO of CARBOGEN AMCIS, said: “I want to congratulate the Shanghai team on their first successful independent regulatory inspection, and for being commended by the inspectors for their transparent and open approach. The GMP certification is a reflection of our high-quality standards and the commitment of our teams at this important site.”

CARBOGEN AMCIS’ Shanghai site employs 140 people and specializes in large-scale manufacturing of raw materials, intermediates and API; manufacturing of highly potent chemicals up to category III; GMP product release and analytical support for development activities.

The ANVISA audit was focused on areas including utilities, maintenance and calibration, production, quality control and assurance.

Harry Wong, General Manager of CARBOGEN AMCIS’ Shanghai site, said: “We are delighted to establish ourselves as a crucial part of the CARBOGEN AMICS CDMO network, meeting the same high standards our clients expect globally. We are an integral part of the company supply chain, offering the group great possibilities in terms of capacity and geographical flexibility”

Martin Schneider, Vice President Quality & ESH of CARBOGEN AMCIS, said: “I was pleased to support the Shanghai site through their first international authority inspection and impressed by how professional the inspection was prepared and hosted. This success adds to our history of positive global inspections at our facilities around the world, which we are, and the local team can be very proud of.”

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CARBOGEN AMCIS AG (carbogen-amcis.com) is a leading service provider, offering a portfolio of drug-development and commercialization services to the pharmaceutical and biopharmaceutical industry at all stages of drug development. The integrated services provide innovative chemistry solutions to support timely and safe drug development, allowing customers to make the best use of available resources. CARBOGEN AMCIS AG is owned by Dishman Carbogen Amcis Limited., Ahmedabad, India.

Dishman Carbogen Amcis Limited (www.imdcal.com) is a global outsourcing partner for the pharmaceutical industry, offering a portfolio of development, scale-up and manufacturing services. Dishman Carbogen Amcis group improves its customers’ businesses by providing a range of development and manufacturing solutions at locations in Europe and in India.

Manchester, UK (20 June 2023) – CARBOGEN AMCIS Manchester, a member of the Switzerland-based CARBOGEN AMCIS Group, a pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, won the Manufacturing and Resource Efficiency Award at the prestigious Chemistry Industry Awards last week.

CARBOGEN AMCIS Manchester won the industry award in recognition of its efficiency improvement program implemented in response to increased demand for its products. The two-year award-winning program resulted in a 75% productivity increase and a step change in its approach to sustainability. Productivity benefits were reinvested back into the business to support the health and wellbeing of the over ninety-employee strong team, leading to a 20% increase in employee retention.

The Chemical Industry Awards, held at Kimpton Clocktower Hotel in Manchester, are the premier accolades for the UK chemical industry to highlight and promote excellent performance. Hosted by comedian Justin Moorhouse, CARBOGEN AMCIS took home the award for demonstrating significant recycling and production process improvements.

Carl Baker, Site Director of CARBOGEN AMCIS Manchester, said: “We are proud to win recognition for our best in class manufacturing performance, demonstrating significant improvements to resource efficiency within the last two years.

“The award further highlights the full commitment of our team to deliver world class services and I would like to congratulate everyone at CARBOGEN AMCIS Manchester for their contributions.”

CARBOGEN AMCIS Manchester is home to appropriate-GMP technologies that support the pharmaceutical, cosmetic and fine chemical industries. The facility focuses on the development of robust, efficient and safe processes for the manufacture of commercial quantities of high quality goods.

CARBOGEN AMCIS AG (www.carbogen-amcis.com) is a leading service provider, offering a portfolio of drug-development and commercialization services to the pharmaceutical and biopharmaceutical industry at all stages of drug development. The integrated services provide innovative chemistry solutions to support timely and safe drug development, allowing customers to make the best use of available resources. CARBOGEN AMCIS AG is a wholly owned subsidiary of Dishman Carbogen Amcis Limited., Ahmedabad, India 

Dishman Carbogen Amcis Limited (www.imdcal.com) is a global outsourcing partner for the pharmaceutical industry, offering a portfolio of development, scale-up and manufacturing services. Dishman Carbogen Amcis group improves its customers’ businesses by providing a range of development and manufacturing solutions at locations in Europe and in India. 

BUBENDORF, Switzerland (02 june 2023) – Switzerland-based CARBOGEN AMCIS, a pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, announces the completion of a U.S. Food and Drug Administration (FDA) inspection at its headquarters in Bubendorf, Switzerland and a Swissmedic routine inspection at Bubendorf, Aarau and Neuland, Switzerland.

From December 8th - 16th 2022, a seven-day surveillance inspection was undertaken by the U.S. FDA at its facility in Bubendorf, Switzerland. The inspection concluded with a Form 483 listing two observations. CARBOGEN AMCIS has initiated measures to correct the observations, which the FDA has accepted.

In January 2023, The Swiss Agency for Therapeutic Products, Swissmedic, successfully concluded their routine inspection of CARBOGEN AMCIS’ Bubendorf, Aarau and Neuland sites with no critical observations. The inspection included Bubendorf’s newly enhanced manufacturing division. Swissmedic validated CARBOGEN AMCIS’ existing GMP manufacturing authorization of all three sites for an unlimited period without restrictions.

Pascal Villemagne, CEO of CARBOGEN AMCIS in Europe, said: “The outcome of these inspections further highlights the full commitment of our team to deliver quality products and services to our clients.

I would like to congratulate everyone for their contributions to our success and the continuous support from our customers to deliver high value solutions to patients around the world.”

CARBOGEN AMCIS’ Swiss-based facilities focus on the development, process optimization and commercial supply of API products. They also accommodate bioconjugation manufacturing, highly potent manufacturing, intermediate-scale production, chromatography and freeze-drying.

Martin Schneider, Director Quality & ESH and Chief Quality Officer of CARBOGEN AMCIS, said: “The result of these new inspections adds to the series of positive inspections across our facilities and reinforces our successful history of FDA and Swissmedic inspections.”

All four Swiss-based CARBOGEN AMCIS’ facilities manufacture products according to cGMP standards and are routinely inspected by legal and regulatory authorities. The facilities underwent successful Swissmedic inspections in 2015, 2017, 2018, 2020 and 2022, and the Bubendorf facility underwent successful FDA inspections in 1997, 2002, 2008, 2011, 2014 and 2017.

CARBOGEN AMCIS AG (www.carbogen-amcis.com) is a leading service provider, offering a portfolio of drug-development and commercialization services to the pharmaceutical and biopharmaceutical industry at all stages of drug development. The integrated services provide innovative chemistry solutions to support timely and safe drug development, allowing customers to make the best use of available resources. CARBOGEN AMCIS AG is a wholly owned subsidiary of Dishman Carbogen Amcis Limited., Ahmedabad, India 

Dishman Carbogen Amcis Limited (www.imdcal.com) is a global outsourcing partner for the pharmaceutical industry, offering a portfolio of development, scale-up and manufacturing services. Dishman Carbogen Amcis group improves its customers’ businesses by providing a range of development and manufacturing solutions at locations in Europe and in India. 

Bubendorf, Switzerland (3 February 2023) – Switzerland-based CARBOGEN AMCIS, a pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, has opened a state-of-the-art facility in Saint-Beauzire, France.

The new site is dedicated to the custom development and production of sterile injectable drug products. Built on newly acquired land located 7km from an existing CARBOGEN AMCIS site in Riom, the new facility increases product development and manufacturing capacity for liquid and freeze-dried products for pre-clinical and clinical trials as well as small scale commercial use.

CARBOGEN AMCIS has over 15 years’ experience of developing safe injectable and liquid pharmaceutical forms for a wide range of disease areas. Construction started on the new site in January 2021. The facility forms two new fully-automated production lines for liquid and freeze-dried drug products, including highly potent compounds and advanced therapies such as antibody drug conjugates enabling increased customer access. The lines offer a flexible and versatile set up, which is unique within Europe and comes at a time when securing fill finish capacity can be a challenge for many pharmaceutical companies.

Pascal Villemagne, CEO of CARBOGEN AMCIS Group, said: “Over the last six years, CARBOGEN AMCIS has continued to expand our facilities and grow our capacity, enabling us to support more customers and increase access to new and diverse technologies and services.

“Our new site will enable us to fully synergize our world-class chemistry skills and continue to bring our customers’ science to life, helping us play our part in the roll-out of new and better treatments, which help improve patients’ quality of life or treat otherwise terminal illness.”

The 9,500m² facility will be home to approximately 100 highly-skilled employees and create 50 new jobs throughout 2023.

François Baduel, Vice President of Business Development, Sales & Marketing of CARBOGEN AMCIS Group, said: “The opening of our new site in France signals an exciting time for us as we enhance our capacity to provide seamless drug product development and commercialization services for leading pharmaceutical and biopharmaceutical companies on a global scale.

“Applying state-of-the-art containment technologies, our new site in France cements us as the partner of choice for development and manufacture of drug products.”

CARBOGEN AMCIS’ nine sites across Switzerland, France, the United Kingdom, China and The Netherlands are home to cGMP-compliant, innovative technologies that enable the pharmaceutical and biopharmaceutical industries to bring new generation medicines to market.

Videos of the new facility being constructed can be found here and here.  

CARBOGEN AMCIS AG (www.carbogen-amcis.com) is a leading service provider, offering a portfolio of drug-development and commercialization services to the pharmaceutical and biopharmaceutical industry at all stages of drug development. The integrated services provide innovative chemistry solutions to support timely and safe drug development, allowing customers to make the best use of available resources. CARBOGEN AMCIS AG is a wholly owned subsidiary of Dishman Carbogen Amcis Limited., Ahmedabad, India 

Dishman Carbogen Amcis Limited (www.imdcal.com) is a global outsourcing partner for the pharmaceutical industry, offering a portfolio of development, scale-up and manufacturing services. Dishman Carbogen Amcis group improves its customers’ businesses by providing a range of development and manufacturing solutions at locations in Europe and in India. 

Bubendorf, Switzerland (Septembre 29, 2022) – Switzerland-based CARBOGEN AMCIS AG, a pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, announced that its site in Vionnaz, Switzerland has successfully completed a Swissmedic inspection performed by Regional Medicines Inspectorate of Western Switzerland (ISOPTh).

The two-day inspection took place from September 20th to 21th, 2022 and was undertaken by an inspector of Regional Medicines Inspectorate of Western Switzerland (ISOPTh) at the Vionnaz, Switzerland, site. The routine inspection covered the Quality Management System compliance and no critical deviation were raised.

This inspection continues a series of successful inspections by Swissmedic in Vionnaz with the first inspection in 2015 followed by 2016, 2017 and 2020.

“I am very pleased by the positive outcome of the inspection,” said Pascal Villemagne, CEO of CARBOGEN AMCIS. “It’s a great achievement for our Vionnaz site and rewards the constant excellent work and commitment to quality of our dedicated team, maintaining our successful audit history.”

The facility was acquired by CARBOGEN AMCIS in 2014 and is designed to develop and manufacture highly potent active pharmaceutical ingredients (API) including the capability to produce highly potent warheads and linkers for antibody drug conjugates (ADC).

CARBOGEN AMCIS (www.carbogen-amcis.com) is a leading service provider offering a portfolio of drug development and commercialization services to the pharmaceutical and biopharmaceutical industries across all stages of clinical development and product life cycle. Our integrated services and innovative chemistry solutions support timely and safe drug development, allowing customers to better optimize available resources. CARBOGEN AMCIS is a wholly owned subsidiary of Dishman Carbogen Amcis Limited, Ahmedabad, India. 

Dishman Carbogen Amcis Limited (www.imdcal.com) is a global outsourcing partner for the pharmaceutical industry, offering a portfolio of development, scale-up and manufacturing services. Dishman Carbogen Amcis group improves its customers’ businesses by providing a range of development and manufacturing solutions at locations in Europe and in India. 

Ahmedabad, India (December 9th, 2021) — Dishman Carbogen Amcis Limited, a global outsourcing partner for the pharmaceutical industry, welcomes the results of a new Clinical Research Study which shows that oral 25-Hydroxyvitamin D3 (Calcifediol) was able to correct vitamin D deficiency/insufficiency in patients with COVID-19 and that it resulted in improved immune function by increasing blood lymphocyte percentages. The research was supervised by Tehran University of Medical Sciences and Boston University School of Medicine and supported in part by a grant from Dishman Carbogen Amcis Ltd’s wholly owned subsidiary CARBOGEN AMCIS B.V.

Dishman Carbogen Amcis Ltd (DCAL) is a leading global manufacturer of vitamin D plus its analogs and related APIs with over 70 years of experience in the field. DCAL partnered with Dr. Michael Holick, MD, PhD, professor of medicine, physiology and biophysics and molecular medicine at Boston University School of Medicine and its team for the Clinical Research Study to be run by the Tehran University of Medical Sciences on treatment with 25-Hydroxyvitamin D3 (Calcifediol) of hospitalized patients with COVID-19.

The study showed that patients receiving the 25-hydroxy metabolite had, in comparison to those receiving a placebo, a demonstrably more favorable development of their immunological defense against COVID-19. Thus, dosing the metabolite significantly increased the blood levels as well as the comparative percentage of lymphocytes in blood, i.e. a reduced Blood Neutrophil-to-Lymphocyte Ratio.

“A person’s vitamin D status is defined as the person’s blood level of the vitamin’s 25-hydroxy metabolite (Calcifediol), i.e. the vitamin’s natural form in circulation which the body can quickly access and finally activate. Therefore, Dishman Carbogen Amcis Ltd has for years studied the effects of dosing either the vitamin and/or the metabolite. Said Dr. Scott Miller, Sr. Scientific Advisor at DCAL, “Our support of this study of Calcifediol in the context of COVID-19 was motivated by the fact that the blood level of the metabolite can be increased more rapidly and more distinctly, if supplemented directly.”

To support the Clinical Research Study CARBOGEN AMCIS B.V. (Netherlands) provided the Active Pharmaceutical Ingredient (Calcifediol) and the capsules and placebo were made at Dishman Carbogen Amcis Ltd’s plant in Bavla, India, specifically for this study.

“There are several studies that have reported that a good vitamin D status i.e. a healthy blood level of 25-hydroxyvitamin D, can not only dramatically reduce the risk of being infected by this deadly virus but also a higher vitamin D status reduced risk for serious symptoms and death caused by the virus.” Commented Dr. Michael Holick. “This controlled study similar to the one conducted in Spain recently ^[1] demonstrate that the rapid improvement in vitamin D status can improve positive outcomes for patients infected with COVID 19.”

“The COVID-19 pandemic hitting the world in early 2020 resulted in unprecedented global focus of R&D efforts and of solidarity in coping with the sudden and unexpected high need for intensive care beds, which didn’t hit all countries to the same degree.” Said Arpit Vyas, Global Managing Director of Dishman Carbogen Amcis Limited: “It is important for us to play a role in this new challenge, not only for our corporate interests but to contribute to the possible future of the fight against COVID-19. Therefore, to follow up with this Clinical Research Study, Dishman Carbogen Amcis Ltd is currently conducting a second round of study in a larger scale in India.”

For more information about the study supported by Dishman Carbogen Amcis Limited:
https://www.sciencedirect.com/science/article/pii/S1530891X21012593

^[1] “Effect of Calcifediol treatment and best available therapy versus best available therapy on intensive care unit admission and mortality among patients hospitalized for COVID-19: A pilot randomized clinical study”
https://www.sciencedirect.com/science/article/pii/S0960076020302764

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CARBOGEN AMCIS AG (www.carbogen-amcis.com) is a leading service provider, offering a portfolio of drug-development and commercialization services to the pharmaceutical and biopharmaceutical industry at all stages of drug development. The integrated services provide innovative chemistry solutions to support timely and safe drug development, allowing customers to make the best use of available resources. CARBOGEN AMCIS AG is owned by Dishman Carbogen Amcis Limited., Ahmedabad, India.

Dishman Carbogen Amcis Limited (www.imdcal.com) is a global outsourcing partner for the pharmaceutical industry, offering a portfolio of development, scale-up and manufacturing services. Dishman Carbogen Amcis group improves its customers’ businesses by providing a range of development and manufacturing solutions at locations in Europe and in India.

MEYLAN, France, BUBENDORF, Switzerland, (November 3rd, 2021) - NH TherAguix, a clinical stage company developing innovative nanomedicine for the treatment of cancer, and CARBOGEN AMCIS, a pharmaceutical process development and Active Pharmaceutical Ingredient (API) and Drug Products manufacturing company, announced today the release of a new batch of AGuIX Drug Product for clinical trials.

CARBOGEN AMCIS just released the fifth batch of AGuIX Drug Product since inception of the company. The release of this 3.7 kg batch added to previous available batches will secure the supply for hospitals and cancer centers that are involved in the clinical trials managed by the company. At present, 4 Phase1b/2 studies are recruiting (brain metastasis, cervix cancer, pancreatic cancer and lung cancer) and 3 are foreseen to start on other indications since already authorized by health authorities.

AGuIX combines three essential assets to fight tumors without changing the patient care. It has the potential to target, image (magnetic resonance imaging) and treat (radiosensitizing effect) cancer after intravenous injection. Its pharmacological potential is related to its innovative design that combines both a metal containing hybrid composition and a nanoscale structure.

The manufacturing of the fifth clinical batch of AGuIX Drug Product was performed at CARBOGEN AMCIS’ French site in Riom:
“We’ve manufactured several clinical batches of AGuIX Drug Product for NH TherAguix at our Riom site and we are delighted with the collaboration between our two companies on this exciting product that could make significant positive impact on patients.” said Mark Griffiths, Dishman Carbogen Amcis Global CEO. “NH TherAguix has a bright future, and we are very proud to be a part of their innovation journey. We hope to be able to support them for many years to come, especially by offering them more production capacity at our new French state-of-the-art facility localised 7km away from our current Riom site and dedicated to custom development and commercial manufacturing of parenteral drug products, which will open its doors in early 2023.”

The two companies have been collaborating on product development for seven years in the past. “CARBOGEN AMCIS was our first service partner for the production of the AGuIX Active Pharmaceutical Ingredient back in 2014 at their Swiss sites for a total of three successful campaigns. In 2019 the manufacturing of AGuIX API was transferred to Sanofi for scale-up purposes. However, we are very happy to work with CARBOGEN AMCIS from the inception of the project in 2015 on the Drug Product manufacturing at Riom site,” said Michel Julien, head of CMC at NH TherAguix. “It has been and it is still a very structuring partnership for a rapidly growing young company like NH TherAguix to be backed by a manufacturer like CARBOGEN AMCIS”.

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About AGuIX
The drug candidate AGuIX, whose potential efficacy is based on nanoscale structuring, is administered by intravenous injection. It combines three essential assets to fight tumors and accessible from the same injection: target, image and treat. AGuIX technology is therefore part of the theranostic concept which corresponds to a combination of therapy (radiosensitizing effect) and diagnosis (visible in MRI), and more broadly in the personalized medicine of tomorrow, without changing the patient's care path. Due to its biodistribution and mode of action, the nanomedicine AGuIX has a broad spectrum of action against solid tumors, 60% of which are treated by radiotherapy.

About the company NH TherAguix (www.nhtheraguix.com)
NH TherAguix is a French biotech start-up based in Grenoble and created in 2015 by two co-founding scientists, Prof Olivier Tillement (Scientific advisor of NH TherAguix and Director of the Fennec team, Institute Lumière Matière, University of Lyon 1) and Géraldine Le Duc (CEO of NH TherAguix), after 10 years of preclinical research. The technology of the drug candidate AGuIX is supported by 14 patent families and more than 70 scientific publications. The production of AGuIX is handled by partners such as Sanofi and Carbogen. The team currently consists of 16 people and its board of directors is chaired by Hervé Brailly (Co-founder and current chairman of the supervisory board of Innate Pharma). The company is pursuing its strategy ambitiously as it is currently focused on its clinical development in the USA and on the preclinical development of a second generation drug.
Contact: Géraldine Le Duc contact@nhtheraguix.com

About the company CARBOGEN AMCIS (www.carbogen-amcis.com)
Carbogen Amcis is a leading service provider offering a portfolio of drug development and commercialization services to the pharmaceutical and biopharmaceutical industries across all stages of clinical development and product life cycle. Our integrated services and innovative chemistry solutions support timely and safe drug development, allowing customers to better optimize available resources. CARBOGEN AMCIS is a wholly owned subsidiary of Dishman Carbogen Amcis Limited, Ahmedabad, India.

Dishman Carbogen Amcis Limited (www.imdcal.com) is a global outsourcing partner for the pharmaceutical industry, offering a portfolio of development, scale-up and manufacturing services. Dishman Carbogen Amcis group improves its customers’ businesses by providing a range of development and manufacturing solutions at locations in Europe and in India.
Contact: press@carbogen-amcis.com

BUBENDORF, Switzerland (May 22nd, 2019) — Switzerland-based CARBOGEN AMCIS AG, a pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, announced today that its Manchester site successfully passed the accreditation for the ISO22716 Cosmetics GMP standard. 

CARBOGEN AMCIS Ltd (Manchester) successfully passed two stages of audit in December 2018 and in March 2019 by a third-party certification body conducted by Lloyd's Register Quality Assurance Limited. The audit sessions were to assess the compliance of the Quality Management System of CARBOGEN AMCIS Ltd against ISO 22716:2007.

The new accreditation solidifies the Manchester site capabilities for cosmetic ingredient development and production, allowing for production, control, storage and shipment of active ingredients for skin cream cosmetic products.

“CARBOGEN AMCIS Ltd has been developing and manufacturing cosmetic ingredients for over 20 years. We have a dozen cosmetic ingredients in development and/or production,” said Mark Griffiths, CEO, Dishman Group. “CARBOGEN AMCIS Ltd has a portfolio of cosmetic ingredients and the decision to implement the standard was to provide a Quality Management System to support the current and future cosmetic ingredients portfolio. Moreover, it will provide the basis for all of the products manufactured at the Manchester site and is not restricted to only cosmetic ingredients.”

“Our team was fully committed to successfully achieving this accreditation. The work involved the co-ordination of all departments across the site to implement the requirements of the standard,” said Ian Burley, Director ESQ. “We took a number of steps to meet the accreditation standard’s requirements, such as: gap analysis audits from external companies including CARBOGEN AMCIS AG Switzerland (Mother Company), training for key personnel and workshops. In addition, we have arranged specific external training for staff to ensure internal audits are conducted correctly and in a consistent manner,” added Ian Burley.

“This certification process is integrated in our commitment for continuous quality made by CARBOGEN AMCIS group in order to provide full customer satisfaction and safety by ensuring the quality of the production, storage and shipment of products,” said Robert Rhodes, Manchester Site Director/Director Technical Operations. “In order to maintain the standard, we will be audited every 6 months to ensure compliance is met.”

Manchester’s facility is fully integrated into the in-house supply chain for complex APIs. With over 30 years of experience, the site employs approximately 80 people. Site information at-a-glance:

• Process research and custom synthesis of pharmaceutical intermediates, cosmetic ingredients and fine chemicals
• 30 L to 4500 L reactors, cryogenic up to 3000 L
• Production of early-phase APIs and large-scale intermediates
• 50% of technical staff hold Ph.D. qualifications
• > 100 projects per annum
• In-house technologies to support different types of chemistry
• Analytical laboratories and safety lab

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CARBOGEN AMCIS AG (www.carbogen-amcis.com) is a leading service provider, offering a portfolio of drug-development and commercialization services to the pharmaceutical and biopharmaceutical industry at all stages of drug development. The integrated services provide innovative chemistry solutions to support timely and safe drug development, allowing customers to make the best use of available resources. CARBOGEN AMCIS AG is owned by Dishman Carbogen Amcis Limited, Ahmedabad, India.       

Dishman Carbogen Amcis Limited (www.imdcal.com) is a global outsourcing partner for the pharmaceutical industry, offering a portfolio of development, scale-up and manufacturing services. Dishman Carbogen Amcis group improves its customers’ businesses by providing a range of development and manufacturing solutions at locations in Europe and in India.

BUBENDORF, Switzerland (February 16, 2018) — Switzerland-based CARBOGEN AMCIS AG, a pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, announced today that its Vionnaz site has successfully completed a Swissmedic inspection.

Swissmedic conducted the inspection (general surveillance audits) over two days, on December 12-13, 2017 at CARBOGEN AMCIS’ Vionnaz site. The inspection covered the Quality System related to the development and manufacture of highly potent APIs, including Analytical and Quality Control. No significant concerns were discovered during the inspection, which will result in the renewal of the GMP-certificates for the site.

The high potency facility in Vionnaz is designed to operate at an occupational exposure limit (OEL) level down to 0.05μg/m³. CARBOGEN AMCIS acquired the facility in August 2014 to significantly increase the development and manufacturing capacity of highly potent APIs. This site has already demonstrated the capability to produce highly potent warheads and linkers, which can be transferred to our bio conjugation facility in Switzerland to create Antibody Drug conjugates (ADC) for cancer treatment therapy.

 “This inspection follows the first audit by Swissmedic in 2016 for the cGMP certification after we acquired this site,” said Martin Schneider, Chief Quality Officer at CARBOGEN AMCIS. “This successful inspection underscores CARBOGEN AMICS’ track record of high quality development and manufacturing. Our other facilities in Switzerland also successfully passed a series of audits last year; FDA audit in October 2017 for the Bubendorf (Headquarters) and Swissmedic inspections for the sites in Bubendorf, Neuland and Aarau in July 2017. This proves our commitment to consistently fulfill the highest quality requirements for all of our sites”.

 “I am proud of what the Vionnaz team has been able to achieve with support by our expert groups in Switzerland. Demonstrating to Swissmedic its capacity to meet all aspects of quality is a significant accomplishment,” said Mark Griffiths, CEO, Dishman Carbogen Amcis group. “This facility was acquired more than 3 years ago to extend our Antibody Drug Conjugate Services and increase the development and manufacturing capacity of highly potent APIs. I am delighted of this successful integration that meets the constantly growing demand of our customers.”

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 CARBOGEN AMCIS AG (www.carbogen-amcis.com) is a leading service provider, offering a portfolio of drug-development and commercialization services to the pharmaceutical and biopharmaceutical industry at all stages of drug development. The integrated services provide innovative chemistry solutions to support timely and safe drug development, allowing customers to make the best use of available resources. CARBOGEN AMCIS AG is owned by Dishman Carbogen Amcis Limited., Ahmedabad, India.  

Dishman Carbogen Amcis Limited (www.dishmangroup.com) is a global outsourcing partner for the pharmaceutical industry, offering a portfolio of development, scale-up and manufacturing services. Dishman Carbogen Amcis group improves its customers’ businesses by providing a range of development and manufacturing solutions at locations in Europe and in India. 

To meet rising demand for highly potent active pharmaceutical ingredients (APIs) spurred by the growing targeted therapy approach in the treatment of diseases, in particular oncology, Switzerland-based CARBOGEN AMCIS AG today announced that it has completed a capital investment project to upgrade its high potency capabilities. An industry leader in the production of high potency APIs, CARBOGEN AMCIS offers drug developers the full range of high potency services, from development, manufacturing and chromatography, to antibody drug conjugates (ADCs), fill & finish, lyophilization, and life-cycle management.

The enhancements will include: 

• A dedicated chromatography suite for Category 3 and 4 compounds at its niche-scale commercial facility for highly potent APIs in Bubendorf, Switzerland. The 55-sqm grade D area features three walk-in barrier hoods for safe handling of highly potent material and a 15 cm ID high performance liquid chromatography (HPLC) column for the purification of highly potent APIs in the range of 50 - 500 g/day.
• A new Class 100,000 High Potency Kilo-lab with 110-sqm of floor space at its large-scale commercial facility for highly potent APIs in Bavla, India. The Kilo-lab features multiple glass-lined and stainless steel reactors and agitated nutsche filter driers (ANFDs) equipped with charging/discharging isolators. A negative pressure cascade and the high-efficiency particulate air (HEPA) filters allow the safe production of highly potent APIs at exposure limit values (OELs) between 1 μg/m³ and 50 ng/m³ at 8-hour time weighted average.

“The expansions in India and Switzerland continue CARBOGEN AMCIS’ investment in building out a global, high potency platform to meet the growing demand for high potency APIs for oncology applications. This move, along with parallel investments in the ADC arena in France and Switzerland, is a reflection of CARBOGEN AMCIS’ continued commitment to providing a broad range of personalized, expert services, capabilities and geographic choices to our clients to help them develop the next-generation cancer treatments,” commented Mark C. Griffiths, CEO, CARBOGEN AMCIS and the Dishman Group.

Choosing the right outsourcing partner for the development and manufacture of high potency APIs is a critical consideration for pharmaceutical companies who seek partners with expertise in chemistry, cutting-edge containment engineering technology and risk reduction in the handling of highly potent cytotoxic drugs. Since 2003, high potency APIs have been a core specialization for CARBOGEN AMCIS and the recent investments underscore the company’s commitment to offering strong technical expertise in the development and commercialization of New Chemical Entities (NCEs) and APIs, which resulted in the launch of more than 12 commercial products worldwide.

Thanks to its state-of-the-art R&D and manufacturing infrastructure and expertise in high potency APIs, CARBOGEN AMCIS is well positioned to contribute to the development of next-generation cancer treatments and other therapies.

About CARBOGEN AMCIS High Potency Facilities:

The Bubendorf facility was opened in 1987 and has seen a number of additions in its more than 20-year history. The manufacturing building was commissioned in 1996 and the lab, administration and containment facilities were opened in 2005. The site now supports over 180 employees, who focus on process optimization and supply of late-phase and commercial API supplies. 

The Bavla facility complements the Bubendorf high potency facility. The plant is one of the largest, extensive and flexible custom-manufacture high potency facilities in the world and enables customers to work with CARBOGEN AMCIS from early-stage route development to market supply without volume limitations. The Bavla facility caters to both cytotoxic and non-cytotoxic highly active substances in dedicated areas.

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Profile

CARBOGEN AMCIS AG (www.carbogen-amcis.com) is a leading service provider, offering a portfolio of drug-development and commercialization services to the pharmaceutical and biopharmaceutical industry at all stages of drug development. The integrated services provide innovative chemistry solutions to support timely and safe drug development allowing customers to make the best use of available resources. CARBOGEN AMCIS AG is a member of the Dishman Group based in Ahmedabad, India.

Dishman Group (www.imdcal.com) is a global outsourcing partner for the pharmaceutical industry, offering a portfolio of development, scale-up and manufacturing services. Dishman Group improves its customers’ businesses by providing a range of development and manufacturing solutions at locations in Europe, China and India.

Source: CARBOGEN AMCIS AG, Bubendorf, Switzerland

Switzerland-based CARBOGEN AMCIS AG announces a series of significant investments aimed at enhancing its antibody drug conjugate (ADC) capabilities to better respond to increasing demand for ADCs in the development of highly targeted cancer treatments. The investments include a $4 million USD clean room clinical supply facility at the Bubendorf, Switzerland site and a $950,000 USD upgrade of the sterile manufacturing area at the facility in Riom, France. By adding on to the current High Potency facility, CARBOGEN AMCIS is well positioned to offer its partners seamless development and manufacturing services for ADCs.

“The new targeted cancer treatments, such as Adcetris, Kadcyla and Mylotarg, have fueled a growing demand for ADCs and we made the decision to expand our ADC service offer to support customers in the development of next-generation cancer treatments. We have taken into account customer feedback and market dynamics and are confident that our enhanced infrastructure will enable us to provide our partners in the pharmaceutical industry a needed resource in drug development,” said Mark C. Griffiths, CEO, CARBOGEN AMCIS and the Dishman Group.

The Bubendorf facility now features a new 100-sqm ADC clean room suite dedicated to the development and production of ADC clinical material under current good manufacturing practices (cGMP), and contains grade D and grade C areas to allow aseptic and safe handling of highly potent material at occupational exposure limit values (OELs) below 1 µg/m³ at 8-hour time weighted average (8h-TWA). A system of pressure cascade and air locks for material and personnel fully segregates both areas of the clean room from the rest of the building and ensures sterile operations within both compartments.

The grade D area of the lab is dedicated to operations such as the preparation of reagents and buffers as well as the sterilization of production equipment by dry oven or autoclave. The segregated grade C area is exclusively used for the conjugation, the purification, and the packaging of ADC material under cGMP and features (a) an isolator for the preparation of toxin solutions, (b) a barrier system for aseptic filtration, (c) a walk-in fume hood for handling of organic solvents, and (d) a bio-safety cabinet (classified grade C) for antibodies and ADCs.

The upgrades at our Riom, France location include the implementation of a new vaporized hydrogen peroxide (VHP) disinfection system and the installation of two new aseptic filling isolators operating under nitrogen atmosphere and at regulated temperature, which will expand the Grade A (ISO 5) manufacturing capability at OELs below 1 µg/m³ 8h-TWA, allowing a maximum batch size up to 5’000 units (2 mL vials).

“In addition to strengthening our ADC capabilities, over the past 12 months, we have built a cross-functional team with expertise in chemistry, biochemistry and biology that is well equipped to support our customers’ cancer drug development programmes,” added Griffiths. Dr. Scott Miller, head of special projects, a chemist with over 19 years industry experience in the commercialization of oncology drugs, will lead CARBOGEN AMCIS ADC team and will support customers involved in ADC projects.

As major oncology players focus on ADCs as a high-potential opportunity in the development of targeted cancer therapies, CARBOGEN AMCIS offers a valuable outsourcing solution for the complex process of ADC development.

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Profile
CARBOGEN AMCIS AG (www.carbogen-amcis.com) is a leading service provider, offering a portfolio of drug-development and commercialization services to the pharmaceutical and biopharmaceutical industry at all stages of drug development. The integrated services provide innovative chemistry solutions to support timely and safe drug development allowing customers to make the best use of available resources. CARBOGEN AMCIS AG is a member of the Dishman Group based in Ahmedabad,India.

Dishman Group (www.dishmangroup.com) is a global outsourcing partner for the pharmaceutical industry, offering a portfolio of development, scale-up and manufacturing services. Dishman Group improves its customers’ businesses by providing a range of development and manufacturing solutions at locations in Europe, China and India.

Source: CARBOGEN AMCIS AG,Bubendorf,>Switzerland

CARBOGEN AMCIS, the Swiss-based pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, has announced plans to take over operations of a high-containment facility located in Vionnaz, Switzerland, 70 kilometers East of Geneva:

CARBOGEN AMCIS │ Route du Simplon 24 │ CH-1895 Vionnaz │ Switzerland

The high potency facility in Vionnaz opened in December 2005 and was formerly managed by Bachem AG as an integrated part of their site in Vionnaz. Designed to operate at OEL < 0.1μg/m³ 8h-TWA, the unit is cGMP-compliant and inspected by Swissmedic and by the U.S. Food and Drug Administration (FDA). Effective today, CARBOGEN AMCIS has signed an agreement to officially take over control of this unit. Operations are slated to start later this fall.

“We are facing a significant increase in the demand for high potency services, spurred by the fast-paced growth of the Antibody Drug Conjugates (ADCs) market. The expansion in Vionnaz will ensure we can continue to fulfill customer needs and expectations while our company continues to grow and expand.” commented Mark Griffiths, CEO CARBOGEN AMCIS. “Our partners will benefit from additional high potency capabilities available at the Vionnaz facility such as high potency laboratories, cGMP kilo-scale manufacturing, as well as larger scale lyophilisation.”

The Vionnaz unit is dedicated to the development and manufacture of highly potent APIs and can accommodate projects from gram to multi-kilo scale. The facility is completely independent and features a process development laboratory, a dedicated QC laboratory and two production units fitted with reactors up to 30 L, as well as a freeze dryer for lyophilisation and chromatography. Operations involving cytotoxic compounds are performed under containment conditions in line with CARBOGEN AMCIS’ standards of safety and quality. The building is self-contained and segregated from the outside. All laboratories from gram to kilo-scale production are cGMP compliant.

The substantial increase in development capabilities and manufacturing space for highly potent drugs in Vionnaz, along with the recent construction of a clean room dedicated to conjugation projects in Bubendorf, positions CARBOGEN AMCIS as industry leader and outsourcing partner for complex highly potent APIs and ADCs. In the near future, the company plans to introduce additional capability for highly potent drugs at the Neuland (Hunzenschwil) site to meet customer needs in chemical development and niche commercial manufacturing.

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CARBOGEN AMCIS AG (www.carbogen-amcis.com) is a leading service provider, offering a portfolio of drug-development and commercialization services to the pharmaceutical and biopharmaceutical industry at all stages of drug development. The integrated services provide innovative chemistry solutions to support timely and safe drug development allowing customers to make the best use of available resources. CARBOGEN AMCIS AG is owned by Dishman Pharmaceuticals and Chemicals Ltd., Ahmedabad, India. 

Dishman Group (www.dishmangroup.com) is a global outsourcing partner for the pharmaceutical industry, offering a portfolio of development, scale-up and manufacturing services. Dishman Group improves its customers’ businesses by providing a range of development and manufacturing solutions at locations in Europe, China and India.

CARBOGEN AMCIS, the Swiss-based pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, announced that Mark C. Griffiths, global chief executive officer of Dishman and CARBOGEN AMCIS, has joined the board of directors of Dishman Pharmaceuticals and Chemicals Ltd.

The appointment was made public by Shri Arpit J. Vyas, managing director,Dishman Pharmaceuticals and Chemicals Ltd.“We are excited to welcome Mark to the board of Dishman. Mark’s leadership at the helm of CARBOGEN AMCIS has turned the company into a success story in the pharmaceutical industry, leading to an increase in business from 63 to 100 million CHF since his appointment. We look forward to a path of continued success together,” said Vyas. Griffiths has served as chief executive officer since 2011 and has been associated with CARBOGEN AMCIS as director of operations and chief executive officer for almost ten years. He also worked for the Dishman Group as operations advisor overseeing the design and construction of the group’s large-scale manufacturing facilities for commercial supply of Highly Potent APIs (HPAPIs) in Shanghai, China, and Ahmedabad, India.

Griffiths has over 31 years of relevant industrial experience delivering high added value technical and operational solutions within the pharmaceutical and fine chemical industry. Qualified as an engineer and having gained significant experience in the management of complex, multi-task, multi-input projects, he brings a cross-functional ability to anticipate and optimize technical, operational and management issues. Griffiths has designed, built and managed facilities ranging in function from research and development to manufacturing. Griffiths holds a Master of Science in engineering from Bristol University, UK.

Dishman is a leading global outsourcing partner for the pharmaceutical industry, offering a rich portfolio of development, scale-up and manufacturing services that straddle the entire pharmaceutical value chain. The company offers cost-effective, high-quality research, development and manufacturing services that include production and supply of tailor-made, high-quality Intermediates and generic APIs to the global pharmaceutical industry. Its global presence includes multiple manufacturing sites in Europe, India, and China – making it one of the most geographically diversified players in the industry.

The Dishman board of directors consists of Shri Janmejay R. Vyas, Chairman & Managing Director; Mrs. Deohooti J. Vyas, Whole-Time Director; Shri Arpit J. Vyas, Managing Director; Shri Yagneshkumar B. Desai, Director; Shri Sanjay S. Majmudar, Director; and Shri Ashok C. Gandhi, Director.

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CARBOGEN AMCIS AG (www.carbogen-amcis.com) is a leading service provider, offering a portfolio of drug-development and commercialization services to the pharmaceutical and biopharmaceutical industry at all stages of drug development. The integrated services provide innovative chemistry solutions to support timely and safe drug development allowing customers to make the best use of available resources. CARBOGEN AMCIS AG is owned by Dishman Pharmaceuticals and Chemicals Ltd., Ahmedabad, India. 

Dishman Group (www.dishmangroup.com) is a global outsourcing partner for the pharmaceutical industry, offering a portfolio of development, scale-up and manufacturing services. Dishman Group improves its customers’ businesses by providing a range of development and manufacturing solutions at locations in Europe, China and India.

CARBOGEN AMCIS, the Swiss-based pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, has announced a successful inspection by Swissmedic of its recently acquired site in Vionnaz, Switzerland.

The site has been inspected by Swissmedic and by the U.S. Food and Drug Administration (FDA) in the past and the re-audit is due to the change of ownership. The two-and-a-half-day audit covered the Quality System related to development and manufacture of highly potent APIs at the Vionnaz facility, including Analytical and Quality Control. This is the first stage in the facility’s cGMP certification process, which should be completed in the next two months.

The high potency facility in Vionnaz is designed to operate at an occupational exposure limit (OEL) level down to 0.05μg/m3. CARBOGEN AMCIS acquired the facility in August 2014 to significantly increase the development and manufacturing capacity of highly potent APIs. This site has already demonstrated the capability to produce highly potent warheads and linkers, which can be transferred to our bio conjugation facility in Switzerland to create Antibody Drug conjugates (ADC) for cancer treatment therapy.

"The positive conclusion of this inspection demonstrates our commitment to the highest standards of quality across all of CARBOGEN AMCIS’ facilities,” said Martin Schneider, Chief Quality Officer at CARBOGEN AMCIS. "We acquired this site last year and, with the support of our expert groups in Switzerland, the Vionnaz team has been able to demonstrate to Swissmedic that CARBOGEN AMCIS meets all aspects of quality to supply our customers with GMP API’s from the facility. This continues our long track record of successful regulatory audits.”

“My team on-site is highly qualified with more than 10 years of experience in manufacturing highly potent APIs. Combined with our 15 years of expertise at CARBOGEN AMCIS, we managed to create really attractive synergies,” said Rolf Tunnemann, Director of CARBOGEN AMCIS Vionnaz facility. “As we move forward, we will continue to pursue opportunities to improve quality. We now have to follow the process and validate cGMP certification in the next few months.”

“I am proud of what our team has achieved in such a short length of time and delighted that we will be able to continue to support our clients growing needs,” commented Mark Griffiths, CEO, CARBOGEN AMCIS and the Dishman Group.