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Achieving Annex 1 Compliance In Sterile Manufacturing, Part 3: Building A Compliant Program

In this third and final article of this series, let's take a closer look at what a well-constructed Annex 1-compliant program looks like at each stage, from gap assessment through governance.

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EDITOR'S DESK

Insufficient Vendor Data Is Hamstringing Single-Use Adoption
Audience polls and expert insights reveal insufficient vendor data as the main bottleneck stalling advanced single-use technology adoption. Explore that and other key takeaways in this recap of the Bioprocess Online Live event on "Closing The Adoption Gap For Advanced Single-Use Materials."

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.

GUEST COLUMNISTS

Achieving Annex 1 Compliance In Sterile Manufacturing, Part 2: Objective Measurement Tools
Let's examine the objective measurement tools that directly address each of the gaps between Annex 1 expectations and what drug manufacturing facilities can currently demonstrate in practice.
FDA Explains How To Respond To Form 483 Observations In New Draft Guidance
In March 2026, the FDA issued a new draft guidance titled Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection Guidance for Industry. Let's take a closer look.
Solving Glycoengineering Challenges Could Begin At The Cell Line
Researchers produced a panel of platform cell lines illustrating how glycoform selection can be made experimentally visible earlier in biologics development.
What Biopharma Often Overlooks In A Scheduled Shutdown
Shutting down an operating biologics facility upsets systems often designed for continuous operation. One expert shares his tips for preventing unnecessary problems.
Organizing Digital Systems Around Novel Modalities
Cell therapies represent an important advancement in our ability to treat difficult cancers, but continued exploration of this new modality will require new digital tools and equipment.
Achieving Annex 1 Compliance In Sterile Manufacturing, Part 1: Common Compliance Failures
A persistent gap remains between what Annex 1 requires and what facilities can demonstrate. Let's take a closer look at four common compliance failures.
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.
Is Your AI Model Trustworthy And Credible In GMP Processes?
Credibility and trustworthiness in AI models are related but distinct attributes. If you're using them in GMP manufacturing, you should understand the difference.

BIOPROCESSING WHITE PAPERS

The Key To Viral Vector Success
Establishing a robust and scalable viral vector process requires a multidisciplinary approach that incorporates expertise in foundational science, analytics, and biomanufacturing.

Handle Single-Use Technology Biopharma Waste: Data Sharing, Collaboration
7/7/2025

Learn more about data sharing and collaboration to enable a better environmental impact of single-use technologies (SUTs) and quantifying the single-use plastic waste generated when manufacturing mAbs.
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.
Economic Advantage Of Robotic Gloveless Pharmaceutical Isolators
4/28/2025

Are robotic gloveless isolators the key to smarter, safer, scalable solutions? Discover how they can revolutionize aseptic filling by reducing contamination, minimizing waste, and enhancing manufacturing flexibility.
Delivering Critical Therapies With Speed And Safety
6/26/2026

Faster approvals depend on treating regulation as part of development, not the finish line. See how early quality planning and strong agency communication can move therapies toward patients sooner.
ADCs As Biological Missiles For Targeted Therapies
6/15/2026

Antibody-drug conjugates are reshaping cancer treatment. Learn how monoclonal antibody targeting, linker design, and next-gen payloads are defining the future of precision oncology.

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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.