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

Why Regulatory Affairs Belongs in Drug Design: 30 Years of CMC Lessons from Discovery to GMP Manufacturing – Part 2

What happens between scientific discovery and clinical trials?

Bioprocessing

Why Regulatory Affairs Belongs in Drug Design: 30 Years of CMC Lessons from Discovery to GMP Manufacturing – Part 1

Picture the difference between a “drug” and a true “product”.

Bioprocessing

Is Bioprocess Education Keeping Up With New Tech? The Training Gap Industry Cannot Afford to Ignore – Part 2

What if the biggest advancement in bioprocessing isn’t a new AI algorithm or cutting-edge bioreactor, but a renewed focus on the foundational skills that drive innovation—and a clear-eyed look at what AI can (and can’t) really do for the industry right now?

Bioprocessing

Is Bioprocess Education Keeping Up With New Tech? The Training Gap Industry Cannot Afford to Ignore – Part 1

How do you bridge the gap between cutting-edge industrial bioprocessing and the academic world tasked with training the next generation?

Bioprocessing

How to Use Media Supplements to Tailor Biosimilar Glycan Quality to Your Reference Product in Two Rounds

Today we’re talking about one of the most frustrating bottlenecks in biosimilar development: how to screen efficiently a long list of quality-modulating compounds when your standard tools

Bioprocessing

Why a Single Large DoE Fails Biosimilar Glycan Optimization — And the Parallel Screening Method That Actually Works

Today we’re talking about one of the most frustrating bottlenecks in biosimilar development: how to screen efficiently a long list of quality-modulating compounds when your standard tool

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 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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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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