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A Pichia process for a recombinant protein was transferred from 10 L (Lab) to 12,000 L
(GMP). Outcome: Catastrophic failure. Titer dropped 60%, and product quality degraded due to
proteolysis.
By prasad ernalaA Pichia process for a recombinant protein was transferred from 10 L (Lab) to 12,000 L
(GMP). Outcome: Catastrophic failure. Titer dropped 60%, and product quality degraded due to
proteolysis.