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Use Of AI In FDA Inspection Activities: Strategies For Effective Preparation

Are you ready? FDA has begun to implement the use of artificial intelligence in its operations, particularly during inspection activities.

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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

Affinity Membranes Are Moving Closer To Commercial Reality
A recent review shows advances in surface chemistry and ligand engineering are moving the needle for next-generation affinity membranes.
Mastering Temperature Control And Advanced Therapy Logistics In Global Clinical Supply Chains
Cold chain failures can derail patient dosing in global trials. Real-time visibility and predictive logistics are becoming mission critical.
AI Has Arrived In Biotech CMC Amid Patchwork Governance
AI is surfacing within regulatory and CMC workflows at a vigorous pace. Unfortunately, in small and midsize biotechs, it's happening faster than governance can keep up.
Avoiding Common Pitfalls In CDMO–Sponsor Relationships Through Integrated Execution Models
Let's delve into the key pitfalls to avoid when working with a CDMO and the integrated execution model that solves or mitigates these pitfalls before they occur.
The Future Of Continuous Is Integrated Manufacturing: The 4 Misconceptions About A Lean Process
Pharmaceutical continuous manufacturing is an enabler of better manufacturing, but only when implemented with intention.
CDMO Selection: Start With The Relationship, Not The RFP
Friction often comes from unspoken expectations. Before production begins, treat the combined sponsor-CDMO group as one extended team and intentionally make “how we work together” visible.
Why FAT Should Confirm Alignment, Not Reveal Its Absence
In many aseptic fill/finish projects, the factory acceptance test (FAT) has become the first true integration test of the entire project. That is a problem. Here's how to flip that mindset.
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.

BIOPROCESSING WHITE PAPERS

Advancing Drug Safety And Improving R&D Productivity With The Liver-Chip S1
Explore how the Emulate Liver-Chip S1 revolutionizes predictive toxicology by mimicking human liver biology, achieving superior sensitivity and specificity.

Rapid Discovery And Characterization Of Monoclonal Antibodies Against The SARS-CoV-2 Delta Spike Protein
4/23/2025

Delve into the intricate workflow employed for the discovery and characterization of monoclonal antibodies (mAbs) targeting the Delta spike protein.
Digital Solutions Enhance Pharmaceutical Manufacturing Performance
2/6/2026

Personalised therapies and advanced technologies are reshaping manufacturing. Explore how intelligent automation can improve flexibility, strengthen data integrity, and accelerate production.
Onshoring Advantage: 7 Forces Reshaping Global Biologics Manufacturing
10/27/2025

Policy, trade, and security pressures are fundamentally reshaping global biologics manufacturing. Forward-looking companies are onshoring critical programs to mitigate risks to supply chains, IP, and regulatory timelines.
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.
How Integration Is Redefining Speed, Scale, And Sustainability
5/13/2026

Integrated manufacturing ecosystems help biologics programs adapt to changing demand across the product lifecycle. Discover flexible scaling strategies that improve speed, efficiency, and sustainability.

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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.