To meet rising demand for high potency active pharmaceutical ingredients (HPAPIs) spurred by the growing targeted therapy approach in the treatment of diseases, in particular oncology, Switzerland-based CARBOGEN AMCIS has completed a capital investment project to upgrade its high potency capabilities. An industry leader in the production of HPAPIs, CARBOGEN AMCIS offers drug developers the full range of high potency services, from development, manufacturing and chromatography, to antibody drug conjugates (ADCs), fill and finish, lyophilisation and lifecycle 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 m2 grade D area features three walk-in barrier hoods for safe handling of highly potent material and a 15 cm internal diameter (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 m2 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 eight-hour time weighted average (TWA).
“The expansions in India and Switzerland continue CARBOGEN AMCIS’s 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 personalised 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 that 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 specialisation for CARBOGEN AMCIS and the recent investments underscore the company’s commitment to offering strong technical expertise in the development and commercialixation 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.
CARBOGEN AMCIS AG, +41 61 935 53 53, www.carbogen-amcis.com.