Bioprocess Online for bioanalytics, biopurification, bioproduction

FDA's Guidance On Cell And Gene CMC Codifies Flexibility

The final guidance articulates common practices around validation, stability data, and reserve samples that, up until now, had been applied on a case-by-case basis.

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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

A Comparison Of 6 Analytical Validation Guidelines Using Data Envelopment Analysis
This is the first published application of data envelopment analysis to six major pharmaceutical analytical validation guidelines, including ICH Q2(R2), USP, ChP, and Brazil's ANVISA.
Inside AstraZeneca's Fully Electrified Cell Therapy Facility
The company won an ISPE FOYA for its Rockville, Maryland, manufacturing site that boasts 100% uptime and flexible capacity to produce thousands of batches annually.
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.

BIOPROCESSING WHITE PAPERS

A Supplier-Manufacturer Approach To Mitigating Nitrosamine Risk
Learn about how nitrosamines are formed, their prevalence and chemical precursors in pharmaceuticals, techniques for quantification, and approaches for managing nitrite impurities.

Is Sustainability The Key To Agile Biopharma Manufacturing?
3/18/2025

In biologics manufacturing, change is constant. Discover how new innovations and a focus on sustainability have gotten 62% of executives to prioritize eco-friendly practices, which reflects a commitment to long-term viability.
The Complete Flow Cytometry Guide
9/24/2024

This guide covers the fundamentals of flow cytometry, aiming to help you better understand how it works, when it is most valuable, and how to conduct an experiment.
Systematic Strategy To Reduce The Cost Of Goods Sold
3/26/2026

Learn key ways to cut biologics manufacturing costs through smarter process design, material choices, and supply resilience — driving more efficient, reliable, and commercially sustainable production.
Opportunities In Preclinical Development
11/4/2024

Every domain produces critical data and this data and contexual information should be captured and managed in the most effective and robust manner.
Antibody-Based Drug Discovery At The Speed Of Light
5/23/2025

Review this end-to-end workflow, including First-to-Human antibody development strategies, the use of the PentaMice® platform for targeted immunization, and the precision of single B cell screening.

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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.