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

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

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

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.

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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

Innovation

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Data & Analytics

Bioprocessing

Bioprocessing

Bioprocessing

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Data & Analytics

Data & Analytics

Data & Analytics

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Biotech Success

Biotech Success

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Biotech Success

Biotech Success

Biotech Success

Innovation

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