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

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.

Bioprocessing

Prevent the Delays That Derail Biologics Tech Transfer: 12-Week Protocol for CMC

What if the difference between a seamless tech transfer and a costly setback isn’t your process, but how you orchestrate the people and details behind the scenes?

Bioprocessing

Turn Tech Transfer from a Gamble into a Managed Process: The 6-Pillar Biologics Scale-Up Framework

Tech transfer in biotech can feel like a high-stakes gamble, balancing regulatory shifts, incomplete data, and mounting stakeholder pressure—all with timelines breathing down your neck.

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

Why Your Funding Pitches Fail Despite Brilliant Science (And How to Fix It) – Part 2

Ever watched judges’ faces light up during your pitch?

Biotech Success

Why Your Funding Pitches Fail Despite Brilliant Science (And How to Fix It) – Part 1

Ever stood in front of a room full of executives, your heart pounding, wondering why your brilliant science isn’t connecting?

Biotech Success

When the Innovator Becomes the Patient: Manufacturing Reality vs. Patient Urgency – Part 2

What happens when therapeutic innovation meets real patient urgency?

Biotech Success

When the Innovator Becomes the Patient: Manufacturing Reality vs. Patient Urgency – Part 1

Real urgency in healthcare means balancing safety, impact, and accessibility—not just speeding to market.

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

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.