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Manufacturing is a critical factor in ADC success. Discover how to align CDMO capabilities with molecule complexity, mitigate risks, and navigate capacity limits.

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EDITOR'S DESK

BIO 2026: Modernizing The FDA And Bolstering The Workforce
Bioprocess Online's chief editor, Tyler Menichiello, shares his key takeaways from the 2026 BIO International Convention in San Diego.

BIO 2026: Crowley On Competing With China And Modernizing The FDA

Exclusive coverage from John Crowley's press conference at the 2026 BIO International Convention in San Diego.

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.

GUEST COLUMNISTS

The Complex Anatomy Of An ADC Tech Transfer
Unlike traditional biologics tech transfer, antibody-drug conjugates have many more moving parts. Here are some of the unique challenges that require close attention.
What Goes Into Restarting A Shelved Orphan Drug Candidate?
The Orphan Therapeutics Accelerator wants to help viable clinical-phase products reach patients. Its cofounder describes the complexity of rebooting a shelved candidate.
A Much-Improved Approach For Understanding And Managing Safety Risks
Learn how causal mechanism and effect analysis (CMEA) and its principles can be used to develop and maintain safer working environments in the pharma/biotech and medical device industries.
CSV Assumes The AI System Sits Still — It Doesn't.
The computer system validation playbook was written for software that holds its shape. AI doesn't. Validating it has to become an act of governance.
July Update — U.S. Generic Drug Tariffs: Implications For Pharma And Outsourcing
Mathini Ilancheran updates us on how delayed U.S. tariffs on generic drug imports could reshape supply, sourcing, and trial planning.
In Bioprocessing, Trusted Data Is A Process Variable
As digital systems become increasingly interconnected, digital validation ensures systems generating and managing GxP data remain accurate, consistent, and trustworthy.
Combination Cell Therapy's Clinical Success Hinges On Manufacturability
Cell therapy could help unlock checkpoint inhibitors’ potential in solid tumors, but combination regimens raise the bar for manufacturing consistency and scalability.
Are Biopharma Companies Outsourcing Their Ability To Think?
Amid gaining immediate access to external manufacturing capabilities, sponsor companies can lose the foundational understanding required to govern that capability.

BIOPROCESSING WHITE PAPERS

Optimizing Poloxamer 188
Poloxamer 188 stabilizes proteins in liquid formulations and protects cells from shear stress. Molecular weight and hydrophobicity variations influence its effectiveness in different biopharmaceutical applications.

Oligonucleotide Synthesis: Scale-Up Made Simple
10/16/2024

Scaling oligonucleotide synthesis isn't as straightforward as it seems. Explore key challenges, critical process parameters, and solutions for a smooth scale-up.
Activate Advanced Contamination Control Technology To Safeguard Your Cell Therapy
2/6/2026

The most common contamination risks in cell therapy manufacturing are open processes that leverage different products, inflexible instruments, labor intensive workflows, lack of in-line monitoring, and zero failure tolerance.
Cell Line Development For Bispecific Antibodies
8/18/2025

See how the recently described cell line development paradigm shift, enabled by the Leap-In transposon platform, can extend to the development of bispecific monoclonal antibody-producing cell substrates.
Enabling Digital Twins With Computational Fluid Dynamics Modeling
1/16/2025

Embrace the transformative power of predictive modeling and digital twin technology to optimize bioprocess efficiency, ensure product quality, and drive innovation in biopharmaceutical manufacturing.
The Proven, Practical Gateway To Upstream Process Intensification
11/18/2025

N-1 perfusion enables higher inoculum densities, faster production, and reduced costs without altering fed-batch processes. Explore a practical path to intensification for biologics manufacturers.

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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.