Scaling Biologics With Confidence

If you're navigating the transition from late-stage clinical supply to commercial biologics manufacturing, you already know the stakes. Technology transfers fail quietly, scale-up assumptions don't hold, and regulatory timelines compress faster than anticipated. These four case studies show what that journey actually looks like in practice, with real data, real constraints, and real solutions.

Case Study 1 details an Fc-fusion protein tech transfer from Brisbane, Australia, where a five-stage Ambr screening and optimization strategy lifted titer from under 0.8 g/L to over 1.0 g/L within a 14-day process, ahead of a Biologics License Application (BLA) filing target. Case Study 2 covers a bispecific antibody scale-up to 2,000 L XDR to meet rising Phase 1a clinical demand, achieving greater than 95% product recovery on the first execution. Case Study 3 shows a simultaneous scale change and bioreactor system switch (HyPerforma S.U.B. to XDR) within a single batch, maintaining titer throughout. Case Study 4 documents a biosimilar IgG2/4k monoclonal antibody program that has cleared pre-approval inspections from the US FDA, Korea MFDS, and Brazil ANVISA, with more than 30 commercial-scale batches executed to date.

Access the full case studies to evaluate which scale-up and tech transfer approaches apply to your current program stage.