Bioprocess Online for bioanalytics, biopurification, bioproduction

CDMO Capacity Crunch: Are Biotechs Wasting Time On The Wrong CDMO?

Biotechs often default to one of two flawed instincts: pursue the biggest name in the space or go with the lowest bidder. To avoid misalignment, look at these less visible factors.

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EDITOR'S DESK

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.”

Bioprocess Online's 2025 Editorial Reflections

Bioprocess Online's chief editor, Tyler Menichiello, reflects on the year and provides a preview of what to expect in 2026.

GUEST COLUMNISTS

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.
Selecting The Right eQMS To Maximize Quality Maturity
Let's take a closer look at the current electronic quality management system (eQMS) landscape in pharma/biotech and what a future-ready eQMS must enable to support continuous improvement.

BIOPROCESSING WHITE PAPERS

Molecular Approaches To Streamline Cell Therapy Product Analytical Testing
Learn how rapid molecular methods of cell therapy testing like qPCR for mycoplasma, sterility, and lentiviral quantification are key to accelerating product release and timely treatment delivery.

Guide To Seeding, Expanding, And Harvesting Stem Cells
6/18/2025

Investigate important considerations for working with three different stem cell types: mesenchymal stem/stromal cells, induced pluripotent stem cells, and neural stem cells.
Business Continuity Management: The Benzonase® Endonuclease Success Story
8/21/2024

Business continuity management is a key success contributor to the pharma industry. Explore best practices for a robust supply chain and how they can translate into success stories.
Accelerating ADC Clinical Development Timelines
8/28/2024

For ADC developers, obtaining the desired payload can be a challenge, as their synthesis is more complex than most other small molecules. Learn about a more efficient approach to payload synthesis.
Improving API Solubility
3/3/2025

Ensuring adequate solubility is crucial for small molecule drugs' effectiveness. Find out how poor solubility remains a significant challenge, potentially hindering medications from reaching the market.
Safely Scaling High Potency API Manufacturing
4/13/2026

Scaling HPAPI production demands disciplined containment and exposure control. Integrated operating models help manage risk while enabling compliant, reliable scale‑up.

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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.