Sai opens HPAPI facility
In response to an increasing number of projects, notably in oncology, Indian CRDMO Sai Life Sciences, has opened a 1,485 m2 high potency API (HPAPI) facility at its cGMP API campus in Bidar. This follows on from the opening of an HPAPI development facility at the Hyderabad R&D campus.
The company said that this expands its expertise “across HPAPI development and manufacturing, providing its customers with a streamlined pathway for NCE development”. It will now be able to handle all aspects of the product life cycle.
The facility is designed and validated to handle high potent molecules to <1 ug/m3 containment. Other key features include:
* A warehouse to store key starting materials, intermediates and finished goods
* A dedicated sampling and dispensing area containing isolators with three independent streams to handle commercial-scale batches
* Reactors to handle multiple unit operations, equipped with isolators and split butterfly valves (SBVs)
* A powder processing and packing area with isolators; dedicated isolator train for quality control testing
* A deactivation facility
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