Sai Life Sciences, one of India’s fastest growing contract research, development and manufacturing organizations (CRO-CDMO), has opened 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.

“In recent years, we have been seeing an increase in projects involving oncology drugs, thus creating a need for high-potency APIs,” said Krishna Kanumuri, CEO and managing director of Sai Life Sciences. “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 square foot 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 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 $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.