Sai Life Sciences recently opened a new High-Potency API (HPAPI) manufacturing facility in Bidar, India, according to a press release.
"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,” Krishna Kanumuri, CEO and managing director of Sai Life Sciences said. “The addition of latest generation HPAPI manufacturing to our facilities expands our capacity to serve the diverse needs of our customers."
With existing operations in Massachusetts, the fast-growing Indian contract research, development and manufacturing organizations platform’s new addition will leverage its HPAPI development and manufacturing abilities across HPAPI development and manufacturing, and make way for clients to access stream-way global NCE development.
Spanning a 16,000-square-foot HPAPI block, the new facility is located in the Bidar Manufacturing Campus of the company. The new venture includes an inbuilt warehouse to store KSMs, intermediates and finished goods. Additionally, there is a dedicated sampling and dispensing area equipped with isolators featuring three independent streams to handle commercial scale batches.
To accommodate multiple unit operations, the company equipped the new establishment with reactors that contain isolators and split butterfly valves (SBVs), and to include a deactivation facility to ensure the safe handling and disposal of any hazardous materials.
The expansion follows the company’s HPAPI development facility opening at its Hyderabad R&D campus. With this addition, the company will now be capable of offering “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 $120 million in its capacity and operations, expanding into new geographies, growing its scientific talent base and raising the overall bar for quality, compliance and performance,” a recent press release notes.