The new GMP Kilo Lab will enable Sai Life Sciences to offer drug substances and intermediates supplies ranging from gram to kilogram quantities to meet customer clinical requirements at an accelerated pace
Sai Life Sciences, a leading global Contract Research, Development & Manufacturing Organization (CRO-CDMO), announced the setting up of a GMP Kilo Lab at its facility in Alderley Park, Manchester, UK. The new GMP Kilo Lab will enable Sai Life Sciences to offer drug substances and intermediates supplies ranging from gram to kilogram quantities to meet customer clinical requirements at an accelerated pace.
Making the announcement, Sauri Gudlavalleti, COO, Sai Life Sciences, said, “The new lab, located closer to our customers, has been set up with comprehensive cGMP controls and world-class infrastructure. The facility will combine with our expertise in route scouting, process chemistry and scale-up, to help our partners accelerate their drug discovery and development journeys by reducing time to first-in-human clinical trials.”
Being offered both, as a standalone facility as well as part of an integrated service together with its capabilities in India, the lab consists of one process stream including two vessels of up to 35 L capacity with provision to add more streams in future. It is supported with associated contained filtration & drying equipment and is engineered to provide a containment level of 1μg/m3. The lab also offers analytical method validation and analytical services to support batch release, in addition to stability studies to enable rapid regulatory filing.
Earlier, in July 2020, the company had opened a new Centre of Excellence (CoE) in Process Chemistry R&D in Alderley Park, Manchester, to help accelerate the NCE development programmes of global innovator customers. This centre has since grown to become a reliable partner to many innovator companies across the world, providing high-quality chemistry, non-GMP delivery, and successful technology transfer to our sites in India for scale-up.
Over the past three years, the company has made investments of over $120 M as part of its SaiNxt initiative, to augment capacity, scale up operations, expand into new geographies, grow its scientific talent base, and raise the overall bar for quality, compliance, and performance.