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Can a biotech create a CDMO market? GeoVax, an infectious disease/oncology biotech, may have just done so. David Dodd, CEO, believes we should all concentrate more on whether the outsourcing model can align with evolving technology platforms. Both sponsors and CDMOs may need to change things up.

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EDITOR'S DESK

What If The U.S. Government Stopped Funding Biotech?
It sets off a real tension – ideological, economic, even personal. But what would happen if the U.S. government cut direct financial support for “biotechnology research,” leaving it entirely to investors, private and public markets, and bigger pharma? "Our industry’s mind-meld says with no government largesse our biotech industry collapses," writes Chief Editor Louis Garguilo. It's an "outlandish hypothetical," but he asks for a few minutes to go through this. And he has help in making his case.

Advising The Biotech C-Suite To Reconsider Quality

“I assist C-suite executives to transfer quality from a painful cost center to a competitive asset." It's the type of bold statement that draws one's attention. Chief Editor Louis Garguilo asked David Grote on what his assertion means materially – and how that’s applied to working with CDMOs. Here's their discussion that focuses on a transformation that moves executives from regarding quality as ‘overhead’ to recognizing quality as “an operational element for business advantage.”

A Biotech Business Model That's Investor-Friendly

For biotechs meeting with current and potential investors, says Edward Ahn, CEO, Medipost Inc., “it should be about demonstrating your business continuity more than anything else.” Investors know, he says, “any supply chain may be fragile.” Indeed, Ahn’s organization has put in place an intriguing business model to address such concerns. It includes owning part of a CDMO.

From Biology Grad To Manufacturing Guru

Stephanie Wimberly graduated from Howard University in 2012 with a degree in biology. What was next? An online search turned up an intriguing area – pharmaceutical manufacturing. “It was manufacturing,” she thought, “but I could still help patients." It was a fortuitous start. This young female professional with a penchant for helping others started a manufacturing career that has wound through GSK, and leadership roles at Shire/Takeda. Now as a manufacturing consultant, here is her advice for manufacturing outsourcing, and careers.

Taking The First Steps Towards Digitalizing Biopharma Development

AbbVie's head of biologics purification development and digitization teams, Moiz Diwan, Ph.D., and independent technology consultant Kat Kozyrytska share their thoughts on AI and smart technology adoption in this recap of the Bioprocess Online Live event, “How Digital Tools Are Accelerating Biopharma Development.”

GUEST COLUMNISTS

Why Your MES RFP Is Failing Before It Starts
Many manufacturing execution system requests for proposals fail. Not because vendors cannot deliver or the tech is immature, but because the requirements are written backward.
Here's How FDA's Accelerated Approval Pathway Has Evolved Since '24
FDA's accelerated approval guidance kicked off a rebalancing of new drug approval pathways. Since its 2024 release, the agency has been building on it in a few key areas.
Why Dilution Gets Tricky: The Role Of Measurement Variability
Dilution's effects on downstream processes and final formulation is often understated. A statistical framework can quantify measurement uncertainty's impacts.
Gaining An Edge In GLP-1 Production
The shortage-driven production of GLP-1 drugs of the past few years is giving way to a long-term operation model characterized by digital enablement and supply chain resilience.
Inside March Biosciences' CD5-Targeting CAR-T Approach
Fratricide is one of the key reasons T-cell therapies targeting T-cell malignancies have faltered. March's approach aims to solve that with its MB-105 candidate.
Causal Mechanism And Effect Analysis (CMEA): FMEA's Simpler, Effective Alternative
This article describes causal mechanism and effect analysis (CMEA) as an alternative to failure mode and effect analysis (FMEA) for analyzing and managing the industry’s risks.
The Stepwise Path Lilly Mapped From Paper To Digital Logbooks
Eli Lilly and Company started at the front lines, on the shop floor gathering operator input, when switching from paper to digital logbooks.
Minimizing Regulatory Risk For Biologics Manufacturing Changes
Any manufacturing process change for a biologic can raise comparability questions. Here’s a practical, action-oriented strategy to ensure health authorities are satisfied.

BIOPROCESSING WHITE PAPERS

The Role Of Extractables Data In The Adoption Of Single-Use Systems
Explore guidance for evaluating single-use systems for extractables and leachables, and learn how supplier-provided single-use system extractables data can save both time and resources.

Oligonucleotide Synthesis: Scale-Up Made Simple
10/16/2024

Scaling oligonucleotide synthesis isn't as straightforward as it seems. Explore key challenges, critical process parameters, and solutions for a smooth scale-up.
A Toolbox For An Effective Tech Transfer
7/23/2025

As drug development costs rise, companies are embracing digital-first strategies and Pharma 4.0 principles to streamline operations, enhance tech transfer, and accelerate time-to-market through innovation.
Achieving Rapid, High-Titer Expression For Next-Generation Biologics
3/5/2025

This advanced cell line development technology overcomes production challenges related to the expression and scalability of complex biologics.
Physiologix Serum Replacement Performance On T Cells
9/16/2024

A serum replacement for promoting T cell growth and functionality in cell therapy development shows comparable or superior performance to traditional human serum supplements.
Improving Gene Therapy Development With Organ-On-A-Chip Technology
8/7/2024

Explore the current challenges of developing gene therapies, the potential of Organ-on-a-Chip technology, the future of gene therapy, and more.

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BIOPROCESSING APP NOTES & CASE STUDIES

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BIOPROCESS ONLINE CONTENT COLLECTIONS

This collection of articles digs into the industry’s growing focus on knowledge management as an indispensable facet of biomanufacturing and pharmaceutical development, exploring how it plays into risk management, quality, vendor relationships, and supply chain resilience.