Outsourcing GMP Biologicals

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Selection of a CMO is critical to biologic drug development; and the primary selection criterion is experience. How do biotech companies measure experience? CMO experience can be measured in many ways — primary metrics include (1) total number of GMP processes developed by a CMO; (2) number of projects involving your strain; (3) number of projects involving your product type; (4) GMP production success rate; (5) total number of GMP lots produced; and (6) number of quality audits.”

Eurogentec’s biologics division is specialized in the manufacturing of biopharmaceuticals from microbial sources: bacteria, yeast, and biosafety level 2 (BSl-2) organisms. Eurogentec has manufactured according to GMP since 1994.

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Host Cell Experience: Microbial Experts

Eurogentec has expertise with E. coli, P. pastoris, H. polymorpha, S. cerevisiae, and numerous BSl-2 organisms.

Chemistry Experience: Conjugation Experts

Product Family Experience

GMp Infrastructure

Process Development Strategies

About the Author

Author Details
Dr. Pascal Bolon is biologics sales and marketing manager at Eurogentec SA, Rue du Bois Saint-Jean 5, 4102 Seraing, Belgium; +32 4- 366-6116; [email protected].