Enhancements in High Potency Chromatography & Kilo-Lab15 October 2013
BUBENDORF, Switzerland (October 15, 2013) — 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.
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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.
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
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,
Source: CARBOGEN AMCIS AG, Bubendorf, Switzerland