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What Reliance, Annex 1, And AI Mean For The Future Of GMP

EMA’s Brendan Cuddy explains how regulators are adapting oversight to global supply chains, new technologies, and growing operational complexity.

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EDITOR'S DESK

On The Ground At NextGen Biomed 2026
Bioprocess Online caught up with Tiffany D. Rau, Ph.D., CMC consultant and adjunct professor of biochemistry and cell biology at the University College Cork in Ireland, at Oxford Global's 2026 NextGen Biomed conference.

Integrate Upstream/Downstream To Reduce Development Risks And Costs

Coordinating unit operations can help reduce costs and mitigate challenges in process development. Check out these key takeaways from the Bioprocess Online Live event “Optimizing Process Development Through Upstream and Downstream Integration.”

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.

GUEST COLUMNISTS

Field Notes: Freeing Process Data For Automation At Kivi Bio AI Summit
The missing link between data generation and unleashing it to power automation often lies in well-governed cloud infrastructure.
Rethinking CQV In A Digital, Agile Manufacturing Landscape
While commissioning, qualification, and validation (CQV) remains foundational, the way it is planned and executed must evolve to keep pace with modern manufacturing realities.
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.
A Multi-Agent Audit Intelligence Framework For CDMO Quality Oversight
A Takeda quality executive demonstrates how a team of AI agents uses synthetic data to provide decision support ahead of CDMO audits.
Why Contamination Control By Design Should Matter To Your CDMO
EU GMP Annex 1 mandates a documented contamination control strategy, and FDA expectations are substantively equivalent. Let's look at why CDMOs are disproportionately exposed.
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.

BIOPROCESSING WHITE PAPERS

Performance Characteristics Of The Mobius® ADC Reactor For Conjugation
Explore results from a series of studies evaluating the mixing performance of an innovative ADC reactor during the conjugation step utilizing a model fluid.

Setting The Standard For Plasmid DNA Production
10/16/2024

Discover how Boehringer Ingelheim’s expertise in plasmid DNA manufacturing can propel your innovative therapies forward and transform patient care.
Expanding The Capabilities Of Targeted Integration
5/1/2026

See the demonstration of precise, site‑specific integration of a 50 kb multi‑gene construct into human iPSCs, overcoming size limits of traditional genome‑engineering approaches.
Seasonal Vaccine Manufacturing: 3 Areas To Evaluate When Selecting A Partner
10/16/2024

Experienced outsourcing partners will have the right facility and technical capabilities, a culture of speed and execution, and shared expectations and commitment to continuous improvement.
Incremental Adoption Of A Modular Operations Platform
1/31/2025

Discover the potential of a modular operations platform that scales the benefits of digitalization and aids organizations in implementing a unified data strategy to realize the full potential of smart manufacturing.
2024 Global Biopharma Sustainability Review
9/3/2024

What steps is the biopharma industry taking to enhance sustainability? What challenges does biopharma encounter? And how can the entire industry draw lessons from the companies setting the standard?

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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.