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

High-Throughput Microbial Screening: Avoiding Early Mistakes That Derail Scale-Up – Part 2

For many biotech innovators, high throughput screening platforms promise faster discoveries and streamlined workflows.

Bioprocessing

High-Throughput Microbial Screening: Avoiding Early Mistakes That Derail Scale-Up – Part 1

Why do so many promising biotech ideas stall—long before they reach the clinic or marketplace?

Bioprocessing

From Cultivated Meat to Chocolate: Rethinking Cellular Agriculture Scale-Up – Part 2

Our food systems face a monumental challenge: by 2050, the global population could reach 10 billion, demanding at least 60% more food than we produce today.

Bioprocessing

From Cultivated Meat to Chocolate: Rethinking Cellular Agriculture Scale-Up – Part 1

What if your daily chocolate or coffee could be brewed without farms—or deforestation—but straight from a bioreactor?

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 Most Bioprocess Automation Projects Fail Before the Robot Is Even Ordered – Part 2

Complex automation often arrives wrapped in hype, but the reality is more nuanced.

Biotech Success

Why Most Bioprocess Automation Projects Fail Before the Robot Is Even Ordered – Part 1

Are you struggling with automation projects that spiral into unnecessary complexity or fail to solve the real problem in bioprocessing?

Biotech Success

From IND to BLA: The Biologics CMC Decisions That Determine Regulatory Success – Part 2

Biologics manufacturing success is built—not salvaged—from day one. Overlook CMC fundamentals, and you’re architecting your own failure.

Biotech Success

From IND to BLA: The Biologics CMC Decisions That Determine Regulatory Success – Part 1

How solid is your CMC foundation—and what happens if it cracks under pressure?

Biotech Success

Media-Based Glycan Engineering for Biosimilars: Your Rapid Implementation Guide

When raffinose works, when it doesn’t, and a 3-experiment protocol to validate it for your process in 8 weeks.

Biotech Success

Media-Based Glycan Engineering for Biosimilars: Achieving Reference Product Match

Why pistachios sabotaged cyclists’ performance — and the raffinose mechanism behind it.

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

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.