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CARBOGEN AMCIS AG Opens New High-Potency Manufacturing Unit

New Facility will be the Company’s First in India
27 January 2010

 

BUBENDORF, Switzerland (Jan. 27, 2010) — CARBOGEN AMCIS AG today inaugurated its new High-Potency Active Pharmaceutical Ingredient (API) facility. Located on the site of its parent company, Dishman Pharmaceuticals and Chemicals Ltd., in Ahmedabad, India, the new facility is the first of its kind to be opened in India, and one of only a few such facilities worldwide.

 

The inaugural event, hosted on Jan. 27, 2010, was attended by 200 people, including customers, staff and members of the local business community. The facility was opened with the help of Dr. Nigel Courtenay-Luck, a leading oncology researcher, co-founder of Antisoma, senior lecturer at Hammersmith Hospital, London, and founder of Saturn Biosciences.

 

The facility’s large-scale capacity (currently up to 1,600 L) will be capable of producing multi-tonne quantities of highly potent APIs (down to < 1 µg/m3 OEL). It is expected that most of the products will be in support of the growing demand for large volume oncology products, although there has been considerable interest in cardiovascular and central nervous system-related production.

 

“Combining CARBOGEN AMCIS’ experience in the High-Potency area with the established infrastructure and support systems on the Dishman Bavla site make this a truly unique offering for customers,” said Jay Vyas, managing director, Dishman Pharmaceuticals and Chemicals Ltd.

 

“This is a very exciting time for us,” said Charlie Johnson, High-Potency business manager for CARBOGEN AMCIS. “We are now able to offer customers first-class, engineering-controlled, Highly Potent API production across two continents. CARBOGEN AMCIS’ customers will benefit from economies of scale as their API demands grow. We also will be able to offer competitive production of API to support life-cycle management.”

 

The new facility extends the capacity of CARBOGEN AMCIS’ existing High-Potency API facilities in Bubendorf, Switzerland.

 

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CARBOGEN AMCIS AG 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.

 

Source: CARBOGEN AMCIS AG, Bubendorf, Switzerland
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CARBOGEN AMCIS AG announces company restructure

Refocused activities will emphasize high potency, late phase offerings and drug product services
3 November 2009

BUBENDORF, Switzerland (November 3, 2009) -- CARBOGEN AMCIS AG has today announced its intention to restructure its Swiss operations.  The early phase services, currently provided by its facilities in canton Aargau, will be consolidated at the Aarau site.  The Hunzenschwil site will focus on new technologies, such as micro-reactors, crystallisation and the using the unique assets of the site.  In addition, the late phase and high potency (HiPo) service groups, business at the Bubendorf facility, will be expanded, due to increased market demand.

 

The company presently employs 400 people at its Swiss facilities.  The proposed changes would result in the loss of up to 40 positions across the Swiss operations. 

 

The past 18 months has seen some significant changes to the markets CARBOGEN AMCIS serves. While the company has seen a significant increase in the number and rate of progress associated with later phase projects, there has been a substantial decline in the number of early phase projects being generated.  “CARBOGEN AMCIS has taken the opportunity to review the business and is making these changes to provide the foundation of a future-oriented business,” said Gaudenz von Capeller, managing director, CARBOGEN AMCIS.

 

“In the last year, we’ve tried our best to keep all jobs intact,” said von Capeller.  “Thus far, due to decisions we’ve made, we’ve been able to weather the economy better than most in our industry. As we make the shift, we will continue to ensure that we meet customer demands and provide the same level of customer service.  By making these changes we believe that CARBOGEN AMCIS, continues to be a robust and profitable business and a key part of the Dishman group.”

 

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CARBOGEN AMCIS AG 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.

 

Source: CARBOGEN AMCIS AG, Bubendorf, Switzerland

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CARBOGEN AMCIS AG Partners with NextPharma Technologies

Agreement combines production and drug product services for highly potent APIs
6 October 2009

BUBENDORF, Switzerland (Oct. 06, 2009) — Switzerland-based CARBOGEN AMCIS AG, a pharmaceutical process development and active pharmaceutical ingredient (API) manufacturing company, recently partnered with NextPharma to provide customers with seamless development services covering highly potent (HiPo) APIs and drug products. NextPharma is a leading European provider of product development, contract manufacturing, and cold chain and logistics outsourcing services to the pharmaceutical and biotech industries.

The alliance offers a complete range of services to customers for both the API and drug product, to provide material for pre-clinical and clinical trials. The joint services will result in reduced cycle times and risks, related to the delivery of customers’ development projects.

"This alliance offers considerable added value to CARBOGEN AMCIS customers," said Charlie Johnson, CARBOGEN AMCIS, High Potency business manager. "It’s difficult to find reliable API production and drug product service companies in the HiPo arena; this agreement eliminates that challenge for customers."

CARBOGEN AMCIS will focus on API support with categorization, assessment, development, validation, manufacturing, scale-up and regulatory assistance. NextPharma will provide drug product development services for pre-formulation, formulation design and optimization, validation, manufacturing, scale-up, stability studies, clinical trial services, release and regulatory support.

"Our customers continuously look for ways to speed up development and reduce costs; this alliance moves customers one step closer to achieving these goals," said Sean Marett, managing director, NextPharma Technologies, Product Development Services.

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CARBOGEN AMCIS AG 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.

NextPharma Technologies, headquartered in the UK and founded in 2000, is a world class outsourcing partner to the pharmaceutical and biotechnology industry. The company offers a full range of services, from early phase product development to clinical trial packaging to high volume commercial manufacturing. NextPharma is a world leader in lyophilization, sterile fill finish and pellet technologies. The company also specializes in product manufacturing, including cytotoxics, hormones, penicillins, cephalosporins and narcotics.

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CARBOGEN AMCIS AG Appoints Johnson as HiPo Business Manager

Industry leader Charlie Johnson to lead high potency business
26 January 2009

BUBENDORF, Switzerland (Jan. 23, 2009) — Switzerland-based CARBOGEN AMCIS AG, a pharmaceutical process development and active pharmaceutical ingredient (API) manufacturing company, recently announced the addition of its new High Potency Business Manager, Charlie Johnson.

“This key new appointment demonstrates CARBOGEN AMCIS’ commitment to maintain its position as a leading provider of high potency services to the pharma and biotech sectors.  Charlie Johnson will continue the momentum CARBOGEN AMCIS has gained in the provision of HiPo services.  He will also be a valuable addition to the internal project team, helping to shape customer strategy in the highly potent area,” said Rhona McIntyre, commercial director for CARBOGEN AMCIS AG. 

Johnson’s expertise is built on more than 16 years working within the pharmaceutical industry. During this time, he has been based in Italy and England, while holding positions with UQUIFA and Avecia Pharmaceuticals (now Piramal Healthcare), and Zeneca (now AstraZeneca).

Johnson will lead the commercial roll-out of the new 4,300m2 large scale high potency facility in Bavla, India which is due for completion mid-2009.  He will also play a pivotal role in expanding the company’s high potency offer through exploring new technology platforms and other business opportunities. Johnson’s experience combines both commercial and operational roles in the high potency and contract manufacturing arenas. This extends to both conventional highly potent chemistry and antibody drug conjugation offerings.

“I was attracted to CARBOGEN AMCIS because of its ability to provide the full continuum of HiPo services, from bench to large-scale manufacturing,” said Johnson. “Once the Bavla facility is completed, CARBOGEN AMCIS’ unmatched production capabilities and end-to-end API operations will present significant advantages for customers.”

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CARBOGEN AMCIS AG 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.

Source: CARBOGEN AMCIS AG, Bubendorf, Switzerland

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CARBOGEN AMCIS AG Makes Capital Investments

Facility expansions and enhancements benefit HiPo customers
26 September 2008

BUBENDORF, Switzerland - Switzerland-based CARBOGEN AMCIS AG has made a number of capital investments this year, with the support of its parent company, Dish-man Pharmaceuticals & Chemicals Ltd. Capital expenditures will total $25 million by the end of the fiscal year in April 2009.

As announced earlier this year, the company’s Indian subsidiary, CARBOGEN AMCIS INDIA Limited, is building a high-potency facility at Dishman’s headquarters near Ahmedabad, India. The facility, a state-of-the-art, 4,300-square-meter plant catering to cytotoxic and non-cytotoxic highly active substances, will be one of the largest and most flexible custom-manufacturing high-potency facilities in the world.

“The addition of the plant in India offers customers a seamless approach to high-potency re-search and development, process optimization and commercial manufacturing,” said Rhona McIntyre, commercial director, CARBOGEN AMCIS AG. “The different locations and infrastruc-ture provide options to maximize speed, flexibility and cost advantages with the same safety and quality standards throughout. The new facility in India will enable customers to solely col-laborate with CARBOGEN AMCIS as a technical partner from early stage route development to market supply without volume limitations.”
 
With an operational floor space of 4,300 square meters, the Bavla facility will have its own dedicated utilities. Designed using the established principals at the company’s existing Buben-dorf facility in Switzerland, the Bavla complex will exercise the same advanced safety and envi-ronmental protection. The facility in India will operate as category 3 (OEL<10?g/m3) and cate-gory 4 (OEL<0.1µg/m3) facilities. Four segregated high-potency cells will each be fitted with three reactors and a filter dryer. Reactor sizes will range from 630 to 1,600 L and will comple-ment the existing category 3 and 4 facilities in Bubendorf. The facility will also house a number of contained laboratories, and significant additional space is available within the current building for subsequent fit-out of further high-potency manufacturing cells.

The facility is expected to be operational by mid-year 2009.

In Bubendorf, the company’s main manufacturing plant has increased flexibility with an ex-pansion of low temperature reaction capacity, along with an upgrade of the category 3 con-tainment area. More vessels are now available to perform low temperature reactions, thereby freeing capacity from the low temperature/high pressure vessels in the category 3 contain-ment area.
 
In addition, a 30 cm chromatography column has been installed and will be operational in Octo-ber 2008, providing a long-term solution for processes, which include chromatography. To sup-port the newly installed chromatography infrastructure, the capacity of the tank farm has been expanded, assuring safe and efficient solvent handling in a dedicated area outside the main building. This also minimizes the likelihood of environmental hazards.

At the company’s Manchester, England, facility, CARBOGEN AMCIS has invested in a new kilo-lab, affording 2 x 30 L glass vessels and a new 46 cm diameter chromatography column holding 100 kg of silica gel. Both enhancements have been installed and are operational, en-hancing CARBOGEN AMCIS’ ability to rapidly deliver small-scale non-GMP material to support pre-clinical studies.

Profile
CARBOGEN AMCIS AG 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.

Source: CARBOGEN AMCIS AG, Bubendorf, Switzerland

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CARBOGEN AMCIS AG Announces New Scientific Specialities

Company’s Continued Growth Creates New Position
28 January 2008

BUBENDORF, Switzerland  – Switzerland-based CARBOGEN AMCIS AG an-nounced today that Patrick Jeger, manager of R&D at the Bubendorf facility, has been ap-pointed as manager, Scientific Specialities for the company. In recognition of the increasing importance of a diverse technology base, CARBOGEN AMCIS created the position to manage responsibility for the ongoing implementation of company’s micro-reactors, lab automation, crystallization, supercritical fluid technologies and further additions to the technology portfolio.

“Patrick has been with CARBOGEN AMCIS since 1999, and his accomplishments as a key part of the company’s development group make him the ideal choice for this role,” said Mark Griffiths, CEO, CARBOGEN AMCIS AG. “Our industry has an ever-expanding reliance on the efficient management and deployment of technology resources to support the ever more complex and time-pressured goals of our customers. Therefore, we are pleased to appoint such a highly skilled and experienced team member to oversee that critical component of our business.”

In 2007 CARBOGEN AMCIS experienced another year of growth. In 2008, in addition to contin-ued organic growth, CARBOGEN AMCIS expects to grow through acquisition. These acquisitions will be in synergistic areas that enhance the company’s existing technology platform. The ac-quisition team will be led by Mark Griffiths and commercial director Steve Cracknell.

Profile
CARBOGEN AMCIS AG 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.

Source: CARBOGEN AMCIS AG, Bubendorf, Switzerland

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CARBOGEN AMCIS AG Announces Upgrades, Expansions for Facilities

Manchester and Bubendorf Locations to Improve and Increase Capabilities
18 September 2007

BUBENDORF, Switzerland  - Switzerland-based CARBOGEN AMCIS AG announces a 2.4 M EUR enhancement to its production and analytics capabilities at its Manchester, England facility. The upgraded site features a new pan dryer in production; replacement overheads on reactors; and an upgraded steam raising apparatus and a vacuum system. A 2500l reactor and additional filtration have already been added to the plant. Additional Liquid Chromatography-Mass Spectrometry and High Performance Liquid Chromatography will supplement analytical capabilities by the end of 2007, and later in the year the Kilo Lab will be rebuilt.

Further, CARBOGEN AMCIS will enhance the Bubendorf laboratories by expanding its chromatography services with a new 30-centimeter column. The new unit will be designed and installed within the cGMP and FDA-inspected manufacturing unit.

In parallel to these investments in capability CARBOGEN AMCIS has also been adding personnel to support the enhanced operations. The Bubendorf site now operates a 24 hours a day, seven days a week system and operation at the Aarau and Neuland sites has been extended to two shifts. This combination of investments will allow CARBOGEN AMCIS to accelerate customer projects, to be more flexible in finding solutions to complex chemistry issues and to more efficiently use the company’s assets.

“We are committed to maintaining the highest-quality facilities possible, as our company continues to grow and expand,” said Mark Griffiths, CEO, CARBOGEN AMCIS AG. “This substantial investment in our capabilities, along with the recent incorporation of CARBOGEN AMCIS LTD, and our addition of a High Containment Analytical Laboratory anticipates and ensures CARBOGEN AMCIS’ future growth and position as industry leader.”

Profile
CARBOGEN AMCIS AG 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.

Source: CARBOGEN AMCIS AG, Bubendorf, Switzerland

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CARBOGEN AMCIS AG Adds Analytical Enhancements

New Capabilities at Aarau and Bubendorf Facilities Benefit Customers
12 April 2007

BUBENDORF, Switzerland - The new CARBOGEN AMCIS AG High Containment Analytical Laboratory is commencing operations this month.  It has been designed to support analytics of Highly Potent compounds down to an OEL of 0.3ų g/m3 with staff wearing standard lab protective dress to provide a pleasant and safe working environment. The laboratory in-cludes nine easily cleanable hoods which house a range of analytical equipment to support the majority of standard processes.

CARBOGEN AMCIS has also added powder X-ray diffraction capability to its Aarau, Switzerland site. Powder X-ray technique provides an effective method of monitoring polymorphic proper-ties, an in-demand industry capability. 

“We have experienced increased requirements for the identification of morphic forms from our customers,” said Mark Griffiths, CEO, CARBOGEN AMCIS AG. “It is our objective to apply inno-vative chemistry solutions; the introduction of powder X-ray capabilities is an example of our flexibility and proactive attitude toward applying the best tools to achieve results for our cus-tomers.”

In addition, the Laboratory Information Management System (LIMS) has been introduced at the Bubendorf, Switzerland site. CARBOGEN AMCIS already has a fully compliant LIMS system op-erating at its Aarau and Hunzeschwil sites (both in Switzerland). The extension of the LIMS system to the Bubendorf site will mean that analytical data can be shared throughout the entire CARBOGEN AMCIS organization and directly with the customer in real time through secure por-tals at all sites.
 
“LIMS is a powerful and effective tool for our customers, providing improved management of laboratory data and allowing quick decision making,” said Griffiths. “LIMS allows CARBOGEN AMCIS to integrate and harmonize our lab processes and enables more effective scheduling of work and allocation of resources, including quality management, validation and regulatory compliance requirements.” 

Profile
CARBOGEN AMCIS AG 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.

Source: CARBOGEN AMCIS AG, Bubendorf, Switzerland

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CARBOGEN AMCIS AG Adds Operational Enhancements

2006 Growth Spurs Expansion
7 February 2007

BUBENDORF, Switzerland - CARBOGEN AMCIS AG has announced plans for a number of operational enhancements in response to positive results in the 12 months ending December 2006.

"We are extremely pleased with our growth in 2006," said Mark Griffiths CEO, CARBOGEN AMCIS. "It is the result of the hard work and dedication of our employees. Our growth is also an indication that our customers are confident Dishman’s acquisition of CARBOGEN AMCIS will enhance the business."

The company was acquired in Q3, 2006, by Dishman Pharmaceuticals and Chemicals Ltd., which is headquartered in Ahmedabad, India.

"By executing our strategies of key account management and expansion of our customer base in the U.S. and Europe, revenue for the period saw substantial double-digit growth over our strong 2005 results," added Steve Cracknell, commercial director, CARBOGEN AMCIS.

Chief among the number of key changes to support continued growth in 2007/08 is the introduction of 24/7 operation at the manufacturing unit at Bubendorf. In addition, the company will add production capacity with the introduction of a third shift in the High Potency Kilo Plant at Bubendorf, and institute full two-shift operations at the manufacturing units in Aarau and Neuland, Switzerland. These changes are in direct response to increased customer demand.

Coupled with these additions, CARBOGEN AMCIS will continue to deploy technology enhancing its ability to meet customer needs in chemical development and niche manufacturing. Microreactors will be introduced to the Neuland site, and the new High Potency Analytical and QC laboratory in Bubendorf will be put into operation in Q1 2007. Additional capability will also be introduced into the chromatography group at Aarau where CARBOGEN AMCIS maintains a center of chromatography expertise. Further analytical tools will also be implemented to assist in providing data to speed up the chemical development cycle.

Profile
CARBOGEN AMCIS AG is the supplier of choice for the pharmaceutical industry for technical development and niche scale production of active pharmaceutical ingredients. Innovative solutions for customers and application of new technology differentiate CARBOGEN AMCIS from its competition.

CARBOGEN AMCIS AG is owned by Dishman Pharmaceuticals and Chemicals Ltd., Ahmedabad, India.

Source: CARBOGEN AMCIS AG, Bubendorf, Switzerland

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Solutia Reaches Agreement to Sell Pharmaceutical Services Business

St Louis
24 May 2006

ST. LOUIS - Solutia Inc. (OTCBB: SOLUQ), today announced that its subsidiary, Solutia Europe SA/NV (“SESA”), has reached a definitive agreement to sell its Pharmaceutical Services business, comprised of CarboGen AG and AMCIS AG.  Under the terms of the agreement, Dishman Pharmaceuticals & Chemicals Ltd. will purchase 100 percent of the stock of CarboGen and AMCIS, as well as certain other assets used in the Pharmaceutical Services business, for $74.5 million, subject to working capital adjustment.  This transaction is subject to removal of the restrictions related to the sale under SESA’s Euronotes, authorization by the bankruptcy court overseeing Solutia’s reorganization, and government and regulatory approvals, which are expected by August 31, 2006.

CarboGen and AMCIS (http://www.carbogen-amcis.com) provide seamless drug development and commercialization services for leading pharmaceutical and biotechnology companies.  During the year 2005, the business had sales of approximately CHF 80 million. The Pharmaceutical Services business has world-class research and development facilities at three sites in Switzerland: Aarau, Bubendorf, and Neuland.  All intellectual property, patents and trademarks, customer contracts, as well as employees of the Pharmaceutical Services business are included in the transaction.

Dishman Pharmaceuticals & Chemicals Ltd. (http://www.dishmangroup.com) is a globally focused company, involved in the manufacture of APIs (active pharmaceutical ingredients), API intermediates, quaternary compounds and fine chemicals.  Headquartered in Ahmedabad, India, Dishman has exports spanning all continents.

Profile
Solutia (http://www.Solutia.com) uses world-class skills in applied chemistry to create value-added solutions for customers, whose products improve the lives of consumers every day.  Solutia is a world leader in performance films for laminated safety glass and after-market applications; process development and scale-up services for pharmaceutical fine chemicals; specialties such as water treatment chemicals, heat transfer fluids and aviation hydraulic fluid and an integrated family of nylon products including high-performance polymers and fibers.
Solutia ... Solutions for a Better Life.

Source: Solutia Inc., St. Louis

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CarboGen and AMCIS Create Senior Scientist Team

Expand and Support Sales Teams in Europe and U.S.
17 February 2006

BUBENDORF, Switzerland - Feb. 17, 2006 – CarboGen and AMCIS have developed an internal consulting team to provide project leaders with direct access to the combined experience and expertise of senior scientists.  Leading this consulting team are senior scientists Peter Mueller, Ph.D., and Bruno Schaub, Ph.D.  “The creation of this team means that CarboGen and AMCIS customers and project teams will benefit from the considerable expertise contributed by Drs. Schaub and Mueller in resolving challenging chemical development issues and project requirements,” said Mark Griffiths, CEO and director of operations, CarboGen and AMCIS. “This is another example of the way that CarboGen and AMCIS are actively working to provide the best possible service and products for our customers.”
 
Mueller has been working with AMCIS since 1997, previously spending time with Hoffmann-La Roche, Givaudan (since 1992, Givaudan-Roure) and Pentapharm, gaining a total of 22 years experience in the industry. He has been named head of research in different fields of activities: chemistry, analgesic chemistry (Roche); aromatic, odoriferous and cosmetic substances (Givaudan); and diagnostics, therapy and cosmetics (Pentapharm). He has authored more than 20 publications and articles. Mueller will continue to consult on the development of highly potent materials and evaluation of their toxicological profiles.  He also will provide invaluable guidance on adapting development strategies for active pharmaceutical ingredients, regulatory requirements and commercial opportunities and needs.

Schaub has spent 11 years at AMCIS having previously worked 16 years for Ciba-Geigy. His work has involved central research activities in Basel and Manchester (U.K.) as well as pharmaceutical process research and development.  At Ciba-Geigy, Schaub’s main focus was on organometallic chemistry, organo-fluorine and phosphorus chemistry. He is a frequent guest lecturer on the topic of organometallic chemistry at universities, congresses and companies such as Bayer and Merck. He assists as an expert on Ph.D. examinations at the University of Lausanne. He has written more than 20 publications.

In addition, CarboGen and AMCIS have increased their sales teams in both Europe and the U.S. to provide a higher level of local service for existing customers and additional resources to cover key growth areas. Joining the team are Jim Whiteaker (Eastern U.S.), Angela Phuc (Western U.S.), Suae-chen Chang (Northwestern U.S.), who will focus on emerging and medium-sized pharmaceutical companies, and Thomas Schlatterer (Central Europe).

Profile
CarboGen and AMCIS combine world-class chemistry skills to provide seamless drug substance development and commercialization services for leading pharmaceutical and biotechnology companies. We offer an array of integrated services to support faster, safer drug development with improved cost efficiency. This commitment helps our clients make decisions more quickly and progress more candidates through the pipeline in a shorter period of time.
CarboGen and AMCIS are owned by Solutia Inc., St. Louis, Missouri.

Source: CarboGen and AMCIS, Bubendorf, Switzerland

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CarboGen and AMCIS Announce Strategic Expansion of LIMS and Chromatographic Data Management System

Bubendorf
10 February 2006

BUBENDORF, Switzerland - Feb. 10, 2006 – CarboGen and AMCIS will extend the application of their state-of-the-art Laboratory Information Management System (LIMS) to include late-phase clinical and commercial projects at their site in Bubendorf, Switzerland. The pharmaceutical services provider will also install a Chromatographic Data Management System (CDS) at the Bubendorf site.

As part of the upgrade, the system will be configured to manage all stages of analytical work from early development through the release of commercial products. It will allow customers real-time access to release data for each of their active pharmaceutical ingredients (APIs) and intermediates and complementary regulatory analytical measurements, such as stability studies.

“The expansion of LIMS and CDS technology will provide greater automation, improved lab data management and seamless analytical knowledge management throughout all of the sites in our system,”   said Franz Breitfield, manager of analytical development for CarboGen and AMCIS. “The increased productivity, efficiency and quality that result will improve our ability to help customers get new drugs to market with reduced time, cost and risk.”

The upgraded system will offer expanded usability with more intuitive navigation of LIMS and greater ability to access analytical and release data via a customer portal. “Since implementing LIMS in 2002, we have been extremely pleased with the paper-free work processes that have resulted,” said Alan Fischer, divisional head of information technology for CarboGen and AMCIS. “A secure internet portal allows customers to access their projects, from raw HPLC data, to the release information of their shipped API products.”

In 2002, CarboGen and AMCIS implemented LIMS at two other sites, Aarau and Neuland, so the Bubendorf upgrade means LIMS will be active throughout the entire organization. LIMS complies in full with 21 CFR part 11 requirements. The upgrade is scheduled to run throughout 2006 into 2007.

Profile
CarboGen and AMCIS combine world-class chemistry skills to provide seamless drug substance development and commercialization services for leading pharmaceutical and biotechnology companies. We offer an array of integrated services to support faster, safer drug development with improved cost efficiency. This commitment helps our clients make decisions more quickly and progress more candidates through the pipeline in a shorter period of time.
CarboGen and AMCIS are owned by Solutia Inc., St. Louis, Missouri.

Source: CarboGen and AMCIS, Bubendorf, Switzerland

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CarboGen and AMCIS Plan Early Expansion for Swiss Containment Facility

Bubendorf
6 February 2006

BUBENDORF, Switzerland - Exceeding goals set in the planning stages of their new containment facility, CarboGen and AMCIS announced the successful completion of 16 projects since the facility began operations in July 2004. Based on increased customer demand for cytotoxic/highly potent custom synthesis development, the Swiss-based manufacturer of active pharmaceutical ingredients (APIs) has already begun expanding capacity a full year earlier than predicted.

“We have been delighted with the industry’s reception of the facility, which has allowed us to complete 16 projects in 18 months. Growth in the demand for oncology drugs has significantly exceeded our expectations. As a result, we will be expanding our capacity sooner than we originally planned in order to assure we can continue to fulfill customer needs,” said Mark Griffiths, CEO and director of operations, CarboGen and AMCIS.

CarboGen and AMCIS have experienced a steady increase in the demand for oncology drugs, which they expect to continue. “Recent industry reports tell us that with 545 drugs in the pipeline, cancer continues to be the leading area of therapeutic advancement. In our business, CarboGen and AMCIS are seeing no indications that this trend will slow down, and it is expected to increase faster than most other therapeutic areas,” said Jason Bertola, new business development director.

“The decision to expand is driven by the market as well as feedback received from customers. To enable CarboGen and AMCIS to continue growing our capabilities and to meet future customer project requirements, we will add a quality control laboratory and expand into two additional building areas, adding a total of approximately 250 square meters to our overall capacity,” added Griffiths.
The facility passed full inspections by Swiss Medic in 2005.  Although the expansion isn’t slated to be operational until later this year, Bertola states that CarboGen and AMCIS have already adjusted their capacity to meet customer needs. “We now have a steady flow of projects through the facility, and a second shift has been added to accommodate the increased demand. Thanks to our initial projections for growth in this area of service, we have significant space available for quick expansion. In addition, we are actively pursuing the opportunity to offer our customers greater access to services such as formulation, chromatography, downstream processing and drug substance handling,” said Bertola. 

“The future looks bright for the industry and for our facilities. We fully expect that in 2006 we will continue to see progress at an increased rate over last year,” said Griffiths.

Profile
CarboGen and AMCIS combine world-class chemistry skills to provide seamless drug substance development and commercialization services for leading pharmaceutical and biotechnology companies. We offer an array of integrated services to support faster, safer drug development with improved cost efficiency. This commitment helps our clients make decisions more quickly and progress more candidates through the pipeline in a shorter period of time.
CarboGen and AMCIS are owned by Solutia Inc., St. Louis, Missouri.

Source: CarboGen and AMCIS, Bubendorf, Switzerland

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