Carbogen Amcis AG has expanded its high potency capabilities with a dedicated chromatography suite for Category 3 and 4 compounds at its niche-scale commercial facility for APIs in Bubendorf, Switzerland, and a new 110-m2 Class 100,000 High Potency Kilo-lab at its large-scale commercial facility in Bavla, India.
The Bubendorf 55-m2 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. The kilo-lab in Bavla features multiple glass-lined and stainless steel reactors and agitated nutsche filter driers (ANFDs) equipped with charging/discharging isolators. Also, a negative pressure cascade and the HEPA filters allow the safe production of highly potent APIs at exposure limit values between 1 μg/m³ and 50 ng/m³ at eight-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,” said Mark C. Griffiths, chief executive officer, Carbogen Amcis and the Dishman Group.
Carbogen Amcis Expands High Potency Capabilities
Published October 16, 2013
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