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

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?

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?

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?

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 CHO Is Still Winning (and the 5 Platforms That Beat It in Specific Contexts)

Is CHO still the host of choice?

Biotech Success

Why Strong Science Isn’t Enough to Get Funded: What Investors Actually Look For – Part 2

Securing capital for biotech innovation has never been more challenging—or more crucial.

Biotech Success

Why Strong Science Isn’t Enough to Get Funded: What Investors Actually Look For – Part 1

Strong science alone won’t get your biotech startup funded—investors are sizing up much more than just your molecule.

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

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.

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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.

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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

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

Dr. David Brühlmann

Innovation

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

Dr. David Brühlmann

Innovation

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

Dr. David Brühlmann

CMC and Bioprocess Blog

Bioprocessing

Why CHO Is Still Winning (and the 5 Platforms That Beat It in Specific Contexts)

Biotech Success

Why Strong Science Isn’t Enough to Get Funded: What Investors Actually Look For – Part 2

Biotech Success

Why Strong Science Isn’t Enough to Get Funded: What Investors Actually Look For – Part 1

Bioprocessing

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

Bioprocessing

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

Bioprocessing

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

Bioprocessing

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

Bioprocessing

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

Bioprocessing

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

Bioprocessing

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

Bioprocessing

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

Bioprocessing

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

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

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