High therapeutic activity (potency) - low dosage compounds require product handling in containment facilities which provide the necessary protection for our personnel, for the environment and, last but not least, for the product itself.
Helsinn’s expertise and reputation in this highly specialized area has been recognized world-wide in recent years.
With over 10 years of experience handling highly potent compounds (from 2 microgram up to 350 microgram per dose) the team working in the dedicated area has produced numerous HPAI’s without any containment failures. The therapeutic areas of these compounds include: CNS, cardiovascular, cancer supportive therapy, pulmonary and dermatology.
Helsinn Advanced Synthesis SA has two different small scale production plants for HPAI manufacturing:
- HPAI plant 1 in operation since 1999 for clinical and commercial batches of 1-7 kgs / batch
- HPAI plant 2 in operation since 2006 for small clinical and registration batches of 50 – 500 grams / batch
In addition, in the larger containment bays of Helsinn Advanced Synthesis SA, Helsinn can manufacture HPAIs up to 100s of kilograms batches and has room for the addition of extra large scale capacity also.
Several HPAIs have already been successfully produced in our multi-purpose, single campaign production plant.
In the summer of 2003, the HPAI plant also passed the first FDA Pre-Approval Inspection with No-483.
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