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Sai Life Sciences, a leading global Contract Research, Development & Manufacturing Organisation (CRO-CDMO) based out of Hyderabad, has 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 substance and intermediates supplies ranging from gram to kilogram quantities to meet customer clinical requirements at an accelerated pace.
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 containment level of 1μg/m3. The lab also offers analytical method validation and analytical services to support batch release, in additional to stability studies to enable rapid regulatory filing.
Over the past three years, the company has made investments of over $120 million 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.
