Optimizing Production and Accelerating the Timeline from Cell Line Development to CGMP ProductionOptimizing Production and Accelerating the Timeline from Cell Line Development to CGMP Production

This case study highlights how Avid Bioservices, a contract development and manufacturing organization (CDMO), collaborated with an emerging biotechnology company to address complex biomanufacturing challenges within an ambitious 12-month timeline. The client aimed to transition a difficult-to-express bispecific fusion protein from human embryonic kidney (HEK) cells to Chinese hamster ovary (CHO) cells, a shift critical for industrial scalability and regulatory approval. Avid’s proficiency in cell line development (CLD) resulted in a CHO-cell clone achieving more than a 10-fold improvement in productivity. To accommodate the tight timeline, Avid began process development earlier than usual, leveraging stable pools to accelerate purification and analytical evaluations. The bispecific molecule’s sensitivity to pH required innovative purification strategies, incorporating mixed-mode chromatography and high-throughput techniques to ensure product stability and quality. Through expertise and a collaborative approach, Avid successfully laid the groundwork for the client’s manufacturing capabilities, enabling a seamless transition from early development to CGMP production. This case demonstrates Avid’s ability to deliver customized solutions that foster long-term success for emerging biopharma innovators.

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