Bioprocess Online for bioanalytics, biopurification, bioproduction

Will FDA's One-Day Inspection Pilot Stand The Test Of Time?

FDA's complementary pilot could help weed through a persistent examination backlog, but uncertainty and upheaval in leadership at the top puts its future in question.

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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

Repeating Sanofi's Ballroom Design On Two Continents
Moveable walls and a stunning number of robotics at its sites in France and Singapore, among other features, has earned Sanofi international recognition for innovation.
Closing The MES Value Gap: Why Technology Isn't The Problem
Manufacturing execution system (MES) technical maturity is rising, but adoption across manufacturing sites is uneven. Organizational readiness may hold the key.
Why Are Life Science Companies So Poorly Prepared For RIM's Future?
Most organizations have modernized their global regulatory information management (RIM) systems and improved data quality. Yet modernization and readiness are not the same thing.
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.
April 2026 — CDMO Opportunities And Threats Report
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
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.

BIOPROCESSING WHITE PAPERS

Driving Operational Excellence Using Machine Learning
Explore how advanced machine learning and data analytics are revolutionizing biopharmaceutical manufacturing and driving operational excellence.

Late‑Stage Progress In Excipients For Precision Nanomedicine
5/6/2026

View late‑stage development and GMP manufacturing of novel excipients for nanomedicines, emphasizing regulatory rigor, process optimization, analytics, and scale‑up for lipid‑based delivery systems.
The Evolution Of Antibody-Drug Manufacturing
6/3/2024

Explore how ADC chemistry and manufacturing have evolved, the challenges this dynamic growth has created, and how CDMOs are adapting to these changes to meet customer needs, now and in the future.
Alleviate Compliance Risks With Your EAM/CMMS
3/2/2026

Discover how unified asset management enhances audit readiness by connecting maintenance, calibration, and quality insights, as well as how integrated workflows reduce compliance risk.
Quality Assurance In IVT RNA Vaccine Development Using Electrophoresis
2/20/2025

Discover advanced solutions for IVT RNA synthesis, focusing on enhancing fidelity in throughput, innovative technologies, and methodologies to optimize your RNA research and development processes.
Using Client Centricity As Fuel For Innovative Biologics Development And Manufacturing Solutions
4/23/2026

Complex biologics require flexible development, advanced analytics, and quality by design. Learn how collaborative bioprocessing reduces risk, enables efficient scale‑up, and supports clinical success.

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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.