- Designed and validated to handle high potent molecules less than 1 µg/m3 containment
- First commercial production batch has commenced
HYDERABAD, India, Jan. 17, 2023 /PRNewswire/ -- Sai Life Sciences, one of India's fastest growing Contract Research, Development & Manufacturing Organizations (CRO-CDMO), today announced the opening of a new High-Potency API (HPAPI) manufacturing facility at its cGMP API Manufacturing campus in Bidar, India. 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.
Making the announcement, Krishna Kanumuri, CEO & Managing Director of 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 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 high 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
Earlier in 2022, the company had opened its HPAPI Development facility at its Hyderabad R&D campus. Now, with the addition of the new HPAPI production facility in Bidar, the company is capable of handling of all aspects of the project life cycle spanning process development, analytical development, particle engineering, warehousing, pilot, scale up, sampling, QC, powder processing, effluent treatment, packing, transportation and stability services.
Over the past couple of years, the company has undergone an intense phase of transformation as part of its Sai Nxt initiative, executing investments of over US$120M in its capacity and operations, expanding into new geographies, growing its scientific talent base, and raising the overall bar for quality, compliance and performance.
About Sai Life Sciences
Sai Life Sciences is a full-service CRO-CDMO that works with innovator pharma and biotech companies globally, to accelerate the discovery, development and commercialisation of small molecules. It takes a nimble and creative approach to deliver high-quality, cost-effective solutions for its clients that accelerate their time to market. Backed by global investors, TPG Capital and HBM Healthcare Investments, the company today works with over 200 innovator companies globally and has over 2500 employees across its facilities in India, UK and USA. https://www.sailife.com/
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