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

Innovation

Neither Small Molecule nor Biologic: The Cyclodextrin Dimer CMC Challenge – Part 1

What if the boldest therapeutic breakthroughs begin with questioning the very boxes we use to define drugs?

Innovation

Neither Small Molecule nor Biologic: The Cyclodextrin Dimer CMC Challenge – Part 1

What if the boldest therapeutic breakthroughs begin with questioning the very boxes we use to define drugs?

Innovation

Neither Small Molecule nor Biologic: The Cyclodextrin Dimer CMC Challenge – Part 1

What if the boldest therapeutic breakthroughs begin with questioning the very boxes we use to define drugs?

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.

Innovation

Neither Small Molecule nor Biologic: The Cyclodextrin Dimer CMC Challenge – Part 1

What if the boldest therapeutic breakthroughs begin with questioning the very boxes we use to define drugs?

Bioprocessing

Is CFD Overkill for Your Scale-Up? Why It Belongs in Every Biotech Scientist’s Toolkit – Part 2

Bioreactor scale-up failures are still one of the top reasons promising cell therapies never reach the clinic. Traditional “power per volume” scale-up is often just a best guess—putting product quality and timelines at risk.

Bioprocessing

Is CFD Overkill for Your Scale-Up? Why It Belongs in Every Biotech Scientist’s Toolkit – Part 1

Can computational fluid dynamics (CFD) join the ranks of everyday tools in bioprocess engineering—right alongside spreadsheets and pH meters?

Biotech Success

The Fool’s Game That Became Standard Practice: Perfusion, the ATF, and What Changed – Part 2

How do you know when your biotech startup is ready to sell—before the product is “perfect”?

Biotech Success

The Fool’s Game That Became Standard Practice: Perfusion, the ATF, and What Changed – Part 1

Most bioprocess innovation is dismissed as a “fool’s game”—until the skeptics are proven wrong.

Innovation

Batch-to-Batch Variability Is a Design Failure, Not the Norm – Part 2

Biotech startups face a labyrinth of decisions when it comes to manufacturing strategy.

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?

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

Data & Analytics

From 10,000 Structures to 1.8 Billion Interactions: Breaking the Data Bottleneck to Engineer Efficacious Therapeutics – Part 2

For years, protein engineering has struggled with a fundamental bottleneck: machine learning models, powerful as they are, have been starved of meaningful data.

Data & Analytics

From 10,000 Structures to 1.8 Billion Interactions: Breaking the Data Bottleneck to Engineer Efficacious Therapeutics – Part 1

Antibody therapeutics have transformed modern medicine, but for many scientists, developing new candidates still feels like searching for a needle in a haystack—a slow, expensive, and unpredictable process.

Data & Analytics

From Data Silos to Autonomous Biomanufacturing: Digital Twins and AI-Driven Scale-Up – Part 2

AI won’t replace your bioprocessing team—but it will make them more indispensable than ever.

Data & Analytics

From Data Silos to Autonomous Biomanufacturing: Digital Twins and AI-Driven Scale-Up – Part 1

What if the secret to reliable, real-time bioprocessing isn’t buried in another wet-lab experiment, but hiding inside your data—waiting for the right digital ally?

Data & Analytics

From Developability to Formulation: How In Silico Methods Predict Stability Issues Before the Lab – Part 2

If you could run an experiment in your computer instead of the lab—and it actually gave you answers worth acting on—would you try it?

Data & Analytics

From Developability to Formulation: How In Silico Methods Predict Stability Issues Before the Lab – Part 1

Imagine trimming years off biologics development—and catching problematic formulations long before the first pipette is even picked up.

Biotech Success

The Fool’s Game That Became Standard Practice: Perfusion, the ATF, and What Changed – Part 2

How do you know when your biotech startup is ready to sell—before the product is “perfect”?

Biotech Success

The Fool’s Game That Became Standard Practice: Perfusion, the ATF, and What Changed – Part 1

Most bioprocess innovation is dismissed as a “fool’s game”—until the skeptics are proven wrong.

Biotech Success

Why Affordable Insulin Is a Money Problem, Not a Science Problem – Part 2

What happens when the solution to America’s insulin crisis isn’t a new molecule or fancy delivery device—but a new way of thinking about biotech itself?

Biotech Success

Why Affordable Insulin Is a Money Problem, Not a Science Problem – Part 1

What if affordable insulin isn’t a scientific hurdle—but a financial and distribution puzzle no one’s been motivated to solve?

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.

Innovation

Neither Small Molecule nor Biologic: The Cyclodextrin Dimer CMC Challenge – Part 1

What if the boldest therapeutic breakthroughs begin with questioning the very boxes we use to define drugs?

Innovation

Batch-to-Batch Variability Is a Design Failure, Not the Norm – Part 2

Biotech startups face a labyrinth of decisions when it comes to manufacturing strategy.

Innovation

Batch-to-Batch Variability Is a Design Failure, Not the Norm – Part 1

What if batch-to-batch variability was no longer just “part of the job” in tissue engineering and in vitro biology?

Innovation

Detecting 1 in 100,000 Cells: DNA Barcoding for Smarter Clone Selection – Part 2

Cell line development in biotech is a race against time and complexity, with innovators constantly seeking solutions that provide robust and scalable data for manufacturability and regulatory demands.

Innovation

Detecting 1 in 100,000 Cells: DNA Barcoding for Smarter Clone Selection – Part 1

Cloning workflows have long relied on brute force: screen more cells, automate harder, and hope that small-scale performance predicts manufacturability.

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.

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.

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

Innovation

Bioprocessing

Bioprocessing

Biotech Success

Biotech Success

Innovation

Bioprocessing

Bioprocessing

Bioprocessing

Bioprocessing

Bioprocessing

Bioprocessing

Data & Analytics

Data & Analytics

Data & Analytics

Data & Analytics

Data & Analytics

Data & Analytics

Biotech Success

Biotech Success

Biotech Success

Biotech Success

Biotech Success

Biotech Success

Innovation

Innovation

Innovation

Innovation

Innovation

Innovation

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.