Sai Life Sciences, a global Contract Research, Development & Manufacturing Organisation (CRO-CDMO), announced on Wednesday that it has established a GMP Kilo Lab at its facility in Alderley Park, Manchester, UK.
The GMP Kilo Lab is to allow the company to provide drug substance and intermediates supplies ranging from gram to kilogram quantities to more rapidly meet customer clinical requirements.
The lab includes one process stream that covers two vessels of up to 35 litre capacity with provision to add more streams in future, and is supported with associated contained filtration and drying equipment. It provides analytical method validation and analytical services to support batch release, in additional to stability studies to allow rapid regulatory filing.
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