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

Driving Operational Excellence Using Machine Learning
Explore how advanced machine learning and data analytics are revolutionizing biopharmaceutical manufacturing and driving operational excellence.

Smart Manufacturing: A Strategic Imperative For Pharma's Future
1/15/2026

Pharmaceutical manufacturing is evolving rapidly. Find out how digital technologies like AI, digital twins, and software-defined automation are driving smarter, more agile production.
Generate CHO-K1 GFP-Expressing Cells For Cell Line Development Workflow
11/7/2025

Discover a high-efficiency workflow for generating GFP-expressing CHO-K1 clones using automated single-cell dispensing to achieve 93% isolation success and stable expression in under five weeks.
A Comprehensive Solution For Adventitious Agent Testing
2/13/2026

Modern sequencing methods offer sensitive detection of adventitious and species‑specific viruses. Learn how targeted and non‑targeted NGS approaches improve confidence in cell bank characterization.
Producing MSC-Derived Cell Therapies From Isolation To Large-Scale Expansion
8/4/2025

Explore the journey of producing MSC-derived cell therapies, from initial isolation and expansion to final product formulation and storage, and learn how to optimize each step.
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.

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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.