Following unexpected observation of higher levels of process impurities upon scale-up of two recombinant proteins, it was desired to improve the primary recovery and purification processes to deliver two drug substances of improved purity with respect to host cell protein (HCP) removal. The team was given 10 weeks to develop the processes prior to scale-up for GMP production. This required a high level of collaboration between different research & development and pilot manufacturing groups. This presentation will cover the technical solutions developed by the team as well as lessons learned for future process development under critical timelines.

Aggressive development of two recombinant protein production processes to generate a bivalent vaccine

251st National Meeting (2016)

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