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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

Improving Gene Therapy Development With Organ-On-A-Chip Technology
Explore the current challenges of developing gene therapies, the potential of Organ-on-a-Chip technology, the future of gene therapy, and more.

Bispecific Antibodies Unleashed
2/4/2026

Explore how leveraging expert CDMO partnerships can streamline the development process and enhance the efficacy of your bispecific antibody therapies.
Quality: The Link Between Platform, Processes, And Patients
2/18/2025

Quality management in healthcare and life sciences is crucial for optimizing patient health. Learn how modern quality management systems optimize patient outcomes, enhance safety, and drive operational efficiency.
Non-Viral Genetic Modification Using The 4D-Nucleofector LV Unit In CGT
11/21/2024

This paper underscores the 4D-Nucleofector® LV Unit as a pivotal tool for translating genetic modification technologies into scalable, safe, and effective therapeutic solutions.
The Key To Viral Vector Success
11/11/2024

Establishing a robust and scalable viral vector process requires a multidisciplinary approach that incorporates expertise in foundational science, analytics, and biomanufacturing.
Overcoming Challenges To High-Concentration Formulation Development
3/25/2025

Explore how the S-HiCon™ platform optimizes high-concentration therapeutic antibody formulations, overcoming stability and manufacturability challenges to deliver safe, effective therapies.

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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.