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Hormuz Deal Brings Cautious Relief To Pharma Packaging Supply Chains

Restrictions and fear on the Hormuz Strait have fractured supply chains, especially for primary materials used in pharmaceutical packaging.

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EDITOR'S DESK

Can A Biotech Create A CDMO Market?
Can a biotech create a CDMO market? GeoVax, an infectious disease/oncology biotech, may have just done so. David Dodd, CEO, believes we should all concentrate more on whether the outsourcing model can align with evolving technology platforms. Both sponsors and CDMOs may need to change things up.

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.”

GUEST COLUMNISTS

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.
Where Does 3D-Printed Single-Use Tech Fit In The Development Pipeline?
Additive manufacturing in early-phase process development is growing more common, but the practice comes with important considerations.
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.
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.

BIOPROCESSING WHITE PAPERS

A Guide To Process Transparency In Custom Lab Automation Development
Discover a practical guide to building custom automation systems with clarity and confidence, as well as how transparent processes reduce risk, prevent misalignment, and support reliable testing.

Tool Enzymes For Antibody-Drug Conjugate Development And Manufacturing
3/26/2026

See how modern tool enzymes enable cleaner, more consistent ADC conjugation, sharper analytics, and a smoother path from research to clinical development — practical guidance for manufacturing.
A Comparative Analysis Between Liquid Nitrogen And Mechanical Freezers
9/23/2025

Explore the differences between liquid nitrogen and mechanical cryogenic freezers, and learn how each method supports scientific, medical, and industrial storage needs.
Super Short Activated CAR-T Process
1/17/2025

Experience the benefits of faster, more effective CAR-T cell production with this innovative three-day short-cycle process, designed to enhance patient treatment outcomes while reducing costs.
AAV-Based Gene Editing For Huntington's Disease
10/28/2025

LETI-101 uses AAV5 to deliver a compact CRISPR system for allele-selective editing of mutant HTT, showing promise as a one-time treatment for Huntington’s disease with strong preclinical safety and efficacy.
Reducing Costs & Risks: A Pharma Guide To FTZ Subzones For U.S. Drug Manufacturing
2/11/2025

Utilized wisely, FTZs and subzones can be tools for cost savings and can enable pharma companies to leverage the benefits of American manufacturing.

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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.