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 has 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 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.