From Data to Scale: How Workplace Silos Break Bioprocessing Models

In this episode of Method Made, host Nicholas Crudele sits down with digital bioprocessing expert Dr. Moritz von Stosch to uncover why even the most sophisticated bioprocessing models fail when workplace silos disconnect the people who run experiments from those who analyze the data.

What You'll Learn:

• Why analytical variations of 10-20% still plague new modalities in cell and gene therapy
• How separation between operators, sample analyzers, and modelers introduces dangerous assumptions
• Why standardization gaps across sites and raw material lots sabotage process development
• The hidden scaling challenges that have persisted since 2002 and continue to impact gene therapy manufacturing

Key Insights:Dr. von Stosch reveals how the separation of tasks between people who run processes, analyze samples, and model data creates a cascade of documentation errors and missed assumptions. From transfection efficiency challenges to capsid filling ratios, he explains why "if we didn't document it, if we didn't measure it, then we'll have a hard time with the modeling."

Critical Takeaway: Process development should focus on answering specific questions, not modeling for modeling's sake. As Moritz emphasizes: "If you have a model which is good enough to answer the question at hand, that model is good enough."

Perfect for: Cell and gene therapy process development engineers, manufacturers, operations and technical leaders wrestling with scale-up challenges.

Guest: Dr. Moritz von Stosch brings 20+ years of digital bioprocessing expertise from academia and industry, including leadership roles at GSK and as Chief Innovation Officer at Dathera, specializing in hybrid modeling for bioprocess optimization.

Method Made explores operational challenges in bioprocessing with a focus on cell and gene therapy manufacturing.