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Essential CMC Elements For A Therapeutic Secretome

Noveome Biotherapeutics's Larry Brown, Sc.D., explains the regulatory and CMC challenges behind the company's novel secretome therapy, ST266.

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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

FDA Explains How To Respond To Form 483 Observations In New Draft Guidance
In March 2026, the FDA issued a new draft guidance titled Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection Guidance for Industry.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.
May 2026 — CDMO Opportunities And Threats Report
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

BIOPROCESSING WHITE PAPERS

Context-First Data For Trustworthy AI In Biopharma
Bridge the gap between AI experimentation and enterprise value. Learn how capturing structured, semantically rich data at the point of origin builds regulator-credible AI pipelines.

Tailoring Viral Clearance Study Design
3/4/2026

Viral‑clearance studies need phase‑appropriate design, strong virus stocks, modality‑specific risk assessment, and alignment with evolving regulations for reliable safety outcomes.
Standardized Extraction Protocol Per USP <665>: Bridging Regulatory Expectations And Industry Best Practices
4/29/2026

View how to implement USP <665> extractables testing, align with global E&L standards, and apply risk-based strategies to ensure regulatory compliance and patient safety.
Rethinking Peptones As First-Line Optimization Tools
11/14/2025

Peptones enhance CHO cell growth, viability, and yield, offering a fast, low-risk way to improve bioprocess performance without major process changes.
Why Strategic Outsourcing In Biologics Is No Longer Optional
5/26/2026
Exploring Perfusion Technology For Virus Manufacturing Process Intensification
1/23/2026

Perfusion cell culture technology supports high cell densities and product yields for viral vaccine manufacturing, offering a reliable way to produce high-quality cells at a commercial scale.

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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.