Scaling a Monoclonal Antibody Program: From Bench to GMP
Understand the operational and strategic decisions required to transition a biologics manufacturing process from research scale to clinical and commercial production, including CMO partnerships, quality systems, and supply chain resilience.
Context: MedBio Therapeutics, a 12-person biotech startup in Cambridge, Massachusetts, developing a monoclonal antibody (mAb) for an orphan autoimmune indication. The company has completed preclinical studies and secured $8M in Series A funding to support IND-enabling studies and early clinical manufacture. Problem: MedBio's research team produces mAb in small shake-flask cultures (500 mL) achieving 1.2 g/L titer in a university collaborator's lab. The company now needs 50 kg of drug substance for Phase 1 trials within 18 months and must decide: (1) whether to hire a CMO or build internal manufacturing capacity; (2) which cell line and bioreactor platform to…
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