Bioprocess Online for bioanalytics, biopurification, bioproduction

On The Ground At BIO 2026: Johanna Kaufmann, Ph.D., On The Oncology Modality Puzzle

At the 2026 BIO International Convention, Bioprocess Online caught up with Johanna Kaufmann, Ph.D., CSO at Deck Bio, a company developing multi-targeted T-cell engagers for solid tumors.

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EDITOR'S DESK

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.

Midyear Pulse Check: What's Shaping Biopharma In 2026?

This article summarizes the major developments and industry pressures highlighted by Life Science Connect editors in the "Better Biopharma" midyear editorial roundtable.

Reflecting On Continued Turbulence At The FDA

Bioprocess Online's Editorial Advisory Board responds to former FDA commissioner Marty Makary’s resignation amid a prolonged period of instability at the agency.

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.

GUEST COLUMNISTS

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.
An Open-Source Modeling Tool For Suspended Continuous Lyophilization
Building on a continuous suspended-vial lyophilization workflow, process developers can model critical variables before doing physical experiments.
Mapping Early-Phase Supply Chain Bottlenecks That Doom Pipelines
Many sponsors miscast preclinical development as an unglamorous step between discovery and the clinic. Here's how the consequences may lead to irrevocable losses.
How To Avoid The Biggest USP <665> Compliance Trap
U.S. Pharmacopeia General Chapter <665> went into effect May 1. One expert explains why complex bioprocessing equipment trains present a greater obstacle than you might think.
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.

BIOPROCESSING WHITE PAPERS

Stabilizing Your Supply Chain In Times Of Global Volatility
Discover how a proactive, risk-based supply chain strategy can help strengthen resilience, mitigate disruption, and ensure continuity across your biotech and pharmaceutical operations.

Handling Protocols: Key Considerations In The Highly Potent API Market
5/12/2025

Explore the growing role of highly potent active pharmaceutical ingredients in oncology and Antibody-Drug Conjugates to highlight manufacturing challenges, safety protocols, and opportunities for CDMOs.
Time To Intensify: Taking mAb Manufacturing To The Next Level
8/19/2025

Explore how process intensification can revolutionize monoclonal antibody manufacturing to boost productivity, cut costs, and enhance sustainability with scalable strategies and real-world results.
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.
Enhancing Biopharmaceutical Production Through Advanced Mixing
6/30/2026

Eliminate particulate contamination and product degradation in downstream bioprocessing. Learn how frictionless, levitating impeller technology ensures low-shear mixing and high yields.
Perspectives On Performance, Scalability, And Regulatory Compliance
10/28/2024

Here, we discuss the challenges and solutions for cell and gene therapies, focusing on performance, scalability, and regulatory compliance to accelerate commercialization and improve patient access.

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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.