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 GMPprocesses 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."
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