Sai Life Sciences unveils high-potency API manufacturing facility at Bidar Campus
The facility is spread across 16000 sq ft HPAPI block
Sai Life Sciences announced the opening of a new high-potency API (HPAPI) manufacturing facility at its cGMP API Manufacturing campus in Bidar. The addition of this new facility expands the company’s expertise across HPAPI development and manufacturing, providing its customers with a streamlined pathway for NCE development.
Krishna Kanumuri, CEO and MD, Sai Life Sciences said, “In recent years, we have been seeing an increase in projects involving oncology drugs, thus creating a need for high-potency APIs. To better serve this growing need and leverage recent advancements in technology related to HPAPI manufacturing, we have created this new facility. The addition of the latest generation HPAPI manufacturing to our facilities expands our capacity to serve the diverse needs of our customers.”
The new 16000 sq ft HPAPI block, located in the Bidar Manufacturing Campus of the company, has the following features:
- Designed and validated to handle highly potent molecules less than 1 μg/m3 containment
- Inbuilt warehouse to store KSMs, intermediates and finished goods
- Dedicated sampling / dispensing area with isolators with three independent streams to handle commercial scale batches
- Reactors to handle multiple unit operations equipped with isolators and split butterfly valves (SBVs)
- Powder processing and packing area with isolators; dedicated isolator train for Quality Control testing
- Deactivation facility
