CMC, Bioprocessing & Scale-Up Blog - Smart Biotech Scientist

Innovation

When Your Delivery Vehicle Contains a Membrane Protein: CMC Decisions With No Regulatory Precedent – Part 2

Biopharma faces mounting pressure to develop safer, more efficient platforms for delivering nucleic acid therapies, especially as regulatory agencies scrutinize novel formulations and excipients.

Innovation

When Your Delivery Vehicle Contains a Membrane Protein: CMC Decisions With No Regulatory Precedent – Part 2

Biopharma faces mounting pressure to develop safer, more efficient platforms for delivering nucleic acid therapies, especially as regulatory agencies scrutinize novel formulations and excipients.

Innovation

When Your Delivery Vehicle Contains a Membrane Protein: CMC Decisions With No Regulatory Precedent – Part 2

Biopharma faces mounting pressure to develop safer, more efficient platforms for delivering nucleic acid therapies, especially as regulatory agencies scrutinize novel formulations and excipients.

CMC and Bioprocess Blog

Execution-focused articles on CMC strategy, bioprocess scale-up, tech transfer, CDMO selection, and GMP readiness for process development scientists and manufacturing leaders scaling biologics into regulatory-ready therapies.

Bioprocessing

Why Regulatory Affairs Belongs in Drug Design: 30 Years of CMC Lessons from Discovery to GMP Manufacturing – Part 2

What happens between scientific discovery and clinical trials?

Bioprocessing

Why Regulatory Affairs Belongs in Drug Design: 30 Years of CMC Lessons from Discovery to GMP Manufacturing – Part 1

Picture the difference between a “drug” and a true “product”.

Bioprocessing

Is Bioprocess Education Keeping Up With New Tech? The Training Gap Industry Cannot Afford to Ignore – Part 2

What if the biggest advancement in bioprocessing isn’t a new AI algorithm or cutting-edge bioreactor, but a renewed focus on the foundational skills that drive innovation—and a clear-eyed look at what AI can (and can’t) really do for the industry right now?

Bioprocessing

Is Bioprocess Education Keeping Up With New Tech? The Training Gap Industry Cannot Afford to Ignore – Part 1

How do you bridge the gap between cutting-edge industrial bioprocessing and the academic world tasked with training the next generation?

Innovation

How to Source, Manufacture, and Scale the Earliest Stem Cells for Allogeneic Cell Therapy Without Ethical Barriers – Part 2

Can aging be fundamentally slowed or even reversed—not by science fiction, but by harnessing the unassuming power of super-early stem cells?

Innovation

How to Source, Manufacture, and Scale the Earliest Stem Cells for Allogeneic Cell Therapy Without Ethical Barriers – Part 1

What if the secret to healthier, longer lives is quietly discarded in hospital operating rooms every day?

Bioprocessing

How to Use Media Supplements to Tailor Biosimilar Glycan Quality to Your Reference Product in Two Rounds

Today we’re talking about one of the most frustrating bottlenecks in biosimilar development: how to screen efficiently a long list of quality-modulating compounds when your standard tools

Bioprocessing

Why a Single Large DoE Fails Biosimilar Glycan Optimization — And the Parallel Screening Method That Actually Works

Today we’re talking about one of the most frustrating bottlenecks in biosimilar development: how to screen efficiently a long list of quality-modulating compounds when your standard tool

Bioprocessing

Nitrosamine Risk Assessment and CRO Selection: The $6 Million Mistake CMC Teams Must Avoid – Part 2

Getting an NDA signed shouldn’t feel like waiting for FDA approval. If your CRO needs weeks just to kickstart paperwork…

Bioprocessing

Nitrosamine Risk Assessment and CRO Selection: The $6 Million Mistake CMC Teams Must Avoid – Part 1

When drug safety fails, patients—and entire markets—pay the price. Understanding your CMC isn’t just compliance; it’s the line between therapeutic promise and product recall.

Bioprocessing

Why Your Shake Flask Culture Doesn’t Scale: OTR, Shaking Diameter, and How to Fix It – Part 2

What’s the real difference between a shake flask, a microtiter plate, and a full-scale bioreactor—and why do so many experiments go sideways, even when the SOP looks perfect?

Bioprocessing

Why Your Shake Flask Culture Doesn’t Scale: OTR, Shaking Diameter, and How to Fix It – Part 1

In bioprocess development, orbital-shaken bioreactors—shake flasks, spin tubes, and microtiter plates—are the unsung backbone powering industry decisions about production strains and media.

Innovation

Engineering iPSC Neurons for Parkinson’s: From 3% Survival to Durable Graft – Part 2

What does it actually take to turn a cell therapy idea into a viable therapeutic—especially when the hurdles are higher than ever and every experiment carries real consequences for your runway?

Innovation

Engineering iPSC Neurons for Parkinson’s: From 3% Survival to Durable Graft – Part 1

When it comes to neurodegenerative disease, few diagnoses evoke as much dread as Parkinson’s.

Innovation

From Static Scaffolds to Dynamic Matrices: Hydrogels for Animal-Free 3D Cell Culture – Part 2

How much of your research lives and dies on the bench—not because the idea isn’t sound, but because building reproducible, scalable biomaterials remains an unsolved puzzle?

Innovation

From Static Scaffolds to Dynamic Matrices: Hydrogels for Animal-Free 3D Cell Culture – Part 1

What if the real obstacle in 3D cell culture and tissue engineering isn’t the cells, but the very ground they grow on?

Innovation

How to Turn Mesenchymal Stem Cells into Programmable Cancer Delivery Vehicles – Part 2

The world of oncology constantly searches for breakthroughs, but few cancers present such stubborn challenges as glioblastoma (GBM).

Innovation

How to Turn Mesenchymal Stem Cells into Programmable Cancer Delivery Vehicles – Part 1

What if the answer to solid tumor therapy isn’t about making immune cells smarter—but about rethinking what a therapeutic cell can do?

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Enjoying what you're reading? Get the next deep-dive and digest in your inbox.

The Bioprocess Brief — biweekly digests, deep-dives, and field notes on biologics, cell and gene therapies, and AI-driven bioprocessing, written by a CMC practitioner.

No spam. Unsubscribe anytime.

Innovation

Dr. David Brühlmann

Innovation

Dr. David Brühlmann

Innovation

Dr. David Brühlmann

CMC and Bioprocess Blog

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