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Addressing The Particulate Challenge In Cell Therapy Products

Cell therapy products challenge traditional particulate controls. One expert explains detection, mitigation, and contamination prevention.

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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

Top 5 Challenges In Antibody-Oligonucleotide Manufacturing
AOC manufacturing breaks programs in five predictable ways. Learn where antibody-oligonucleotide conjugate development stalls, from synthesis impurities to conjugation chemistry, and what preparation actually looks like.
Transforming Computer System Validation In The Life Sciences Industry
Regulators acknowledge how traditional CSV methods fail to meet modern demands for speed and flexibility. The scene is changing in favor of smarter, leaner validation.
Analyzing And Managing CDMO Project Risks Using Causal Mechanism & Effect Analysis
Since every sponsor–CDMO relationship can have widely different scopes, requirements, and procedures, this article focuses on the basic principles for analyzing and managing the risks of not achieving the relationship’s objectives.
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.

BIOPROCESSING WHITE PAPERS

A Guide To Process Transparency In Custom Lab Automation Development
Discover a practical guide to building custom automation systems with clarity and confidence, as well as how transparent processes reduce risk, prevent misalignment, and support reliable testing.

Tool Enzymes For Antibody-Drug Conjugate Development And Manufacturing
3/26/2026

See how modern tool enzymes enable cleaner, more consistent ADC conjugation, sharper analytics, and a smoother path from research to clinical development — practical guidance for manufacturing.
Perfusion Cell Line Development For Intensified Processes
5/5/2025

The biopharmaceutical industry is transforming by shifting to continuous and intensified upstream bioprocesses, which are driven by evolving demands. Discover the key goals and innovations shaping this transition for modern healthcare.
Reducing Costs & Risks: A Pharma Guide To FTZ Subzones For U.S. Drug Manufacturing
2/11/2025

Utilized wisely, FTZs and subzones can be tools for cost savings and can enable pharma companies to leverage the benefits of American manufacturing.
Cell Based Potency Assays: De-Risk Your Path With An Experienced CDMO
4/21/2026

Thorough characterization is key to unlocking the potential of antibody-based therapeutics. Leveraging a CDMO's extensive capabilities and expertise can allow you to navigate the biopharmaceutical development landscape.
Navigating Digital Transformation For Pharmaceutical CDMOs
10/31/2025

Discover how CDMOs can modernize operations, safeguard data integrity, and improve audit readiness with practical strategies for connecting systems and reducing validation burdens.

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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.