การพัฒนากระบวนการและการเพิ่มขนาดการผลิต
A variety of large bioreactor scales have been utilized ranging from pilot-scale 50L and production scale 200L and 1000L. The downstream process optimizations including chromatography, virus inactivation, tangential flow filtration and normal flow filtration are performed in parallel with upstream process optimization to expedite the timeline for the best benefit for Thai patients.
CBRD pilot plant with 50L bioreactor is set up as clean room for mammalian cell culture production facility, which can be used to produce non-sterile bulk active pharmaceutical ingredient (API) of recombinant protein materials. The facility design is GMP compliant for the production of biological drugs to be used in human. For a larger production scale, CBRD production plant is a facility with clean room grade C and grade D for mammalian cell culture production, which can accommodate the biologics production process with 200- and 1000-L bioreactor. Both facilities utilize single-use technology to reduce cross contamination, lower cleanroom and facility footprint, reduce waste water generation, reduce upfront investment and product change over time as well as increase facility flexibility.
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