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

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.

Innovation

When Your Delivery Vehicle Contains a Membrane Protein: CMC Decisions With No Regulatory Precedent – Part 1

Imagine a delivery system that can slip straight into a cell’s membrane, bypassing the barriers that stop most genetic medicines in their tracks. While AAVs and lipid nanoparticles have charted the way for gene therapies, a new contender is emerging: proteolipid vehicles powered by viral fusion proteins.

Innovation

Why Nanovesicles Outperform Exosomes: Scalable Drug Delivery Beyond Injectable Vaccines – Part 2

Manufacturing under GMP with no established playbook isn’t for the faint-hearted—especially when your therapeutic platform is first-in-class and the regulatory template hasn’t been written yet.

Innovation

Why Nanovesicles Outperform Exosomes: Scalable Drug Delivery Beyond Injectable Vaccines – Part 1

What if the best way to unlock durable, broad-spectrum immunity is to rethink the very vessels delivering our vaccines?

Data & Analytics

Your Bioprocess Data Already Holds 35% More Yield: From End-to-End Models to Digital Twins – Part 2

Leveraging digital models and AI-powered tools can make all the difference for both R&D and manufacturing, but finding the right starting point—and justifying the investment—can feel overwhelming.

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

Why Your Dormant Omics Data Is Worth More Than the Data You’ll Generate Next – Part 2

What does it take to crack the code of protein production—and why do some proteins stubbornly refuse to cooperate, despite the best efforts of scientists and engineers?

Data & Analytics

Why Your Dormant Omics Data Is Worth More Than the Data You’ll Generate Next – Part 1

Somewhere in your lab, a hard drive is quietly storing omics data that hasn’t seen the light of day in years—genome sequences, metabolomics runs, scribbled notes in aging ELNs.

Data & Analytics

Your Bioprocess Data Already Holds 35% More Yield: From End-to-End Models to Digital Twins – Part 2

Data & Analytics

Your Bioprocess Data Already Holds 35% More Yield: From End-to-End Models to Digital Twins – Part 1

Is your bioprocess development stacked with siloed data, endless spreadsheets, and a constant battle to identify where to start your digital transformation?

Data & Analytics

Why AI and Automation Tools Won’t Deliver Until Your Lab’s Data Is Connected – Part 2

What separates labs with truly connected, AI-ready data from those drowning in digital chaos?

Data & Analytics

Why AI and Automation Tools Won’t Deliver Until Your Lab’s Data Is Connected – Part 1

What if the real bottleneck in biotech labs isn’t equipment, talent, or even funding—but a silent issue lurking in plain sight: fragmented data?

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.

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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

Dr. David Brühlmann

Innovation

Dr. David Brühlmann

Innovation

Dr. David Brühlmann

CMC and Bioprocess Blog

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Bioprocessing

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Biotech Success

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Innovation

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