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

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?

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?

Innovation

From Human Variability to Automated Precision: Accelerating Cell and Gene Therapy Manufacturing Scale-Out – Part 2

Are you struggling with the complexities of cell and gene therapy manufacturing and wondering how automation and digital solutions can truly make these life-saving therapies accessible to more people?

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?

Bioprocessing

Why the Cell Line Is the CMC Decision You Don’t Get to Undo – Part 2

Is your next blockbuster biologic doomed before your team even steps into a lab?

Bioprocessing

Why the Cell Line Is the CMC Decision You Don’t Get to Undo – Part 1

What if your blockbuster biologic stumbled—not because the science wasn’t there, but because no one asked if it could actually be manufactured at scale?

Bioprocessing

How to Stop Defaulting to CHO: An Evidence-Based Host Selection Framework for Biologics

“Will this novel host replace CHO?” I hear this question often — and I want to be direct with you: I think it’s the wrong question.

Bioprocessing

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

Is CHO still the host of choice?

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.

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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.

No spam. Unsubscribe anytime.

Innovation

Dr. David Brühlmann

Innovation

Dr. David Brühlmann

Innovation

Dr. David Brühlmann

CMC and Bioprocess Blog

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