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Bioprocess Online's 2025 Editorial Reflections

Bioprocess Online's chief editor, Tyler Menichiello, reflects on the year and provides a preview of what to expect in 2026.

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EDITOR'S DESK

Supporting The Next Generation Of ADCs
Experts discuss innovation in antibody-drug conjugate (ADC) technology and how these impact CMC strategy. This summary captures key takeaways from the Bioprocess Online Live event "Evolving CMC Strategies To Enable Next-Gen ADCs."

The 9 Fastest-Growing Outsourcing Segments

Capacity isn’t the choke point—capability is; this piece ranks nine fast-growing outsourcing segments and shows sponsors how to win by locking in modality-proven partners early.

AbbVie And Amgen's Blueprint To Digitalize Biomanufacturing

At BioProcess International 2025, leaders from AbbVie and Amgen gave keynote presentations about how their companies are advancing product development through digital tools.

On The Ground At BPI: Kat Kozyrytska On Ethical AI And Collaboration

AI consultant Kat Kozyrytska advocates for ethical AI adoption and explains its potential to foster collaboration across the industry.

On The Ground At BPI: Takeda's Amy Shaw On Scaling Cell Therapy Manufacturing

Takeda head of process development, Amy Shaw, explains what factors to consider when scaling up or scaling out cell therapy manufacturing.

GUEST COLUMNISTS

Contamination Control Strategies In Low Bioburden Biologic Drug Substance Manufacturing
How do manufacturers apply a contamination control strategy in a non-sterile world, particularly at a low bioburden biologic drug substance manufacturing site? How can Annex 1 apply?
What 2025 FDA Warning Letters Tell Us About GMP Compliance
This analysis identifies key compliance trends and regional disparities by examining the 2025 U.S. FDA warning letters issued to drug product manufacturers posted between Jan. 1 and Dec. 9, 2025.
Unpacking The EU's Mutual Recognition Agreements For Pharma
MRAs can save resources for regulators and drug makers by, among other things, reducing the number of inspections and waiving retesting requirements.
The Module Type Package Wants All Your Equipment To Start Talking
A forthcoming ISPE guide uses case studies to aid in the design of plug-and-play process skids with implications for every step in the manufacturing process continuum.
Four Reasons You Should Choose Lyophilization for Your Next Project
Lyophilization ensures product stability, extends shelf life, supports sensitive formulations, and simplifies storage and transport, making it a critical choice for modern drug development projects.
Why Your MVP And Its Evolution Matters To Manufacturing
Minimum viable product is one of the most important inputs to developing a manufacturing process. It defines essentials that matter to the people who make the product.
TFF Offers Ideal Anaerobic, GMP Conditions For LBP Concentration
When configured correctly, TFF provides the gentle processing environment and oxygen protection required for strict anaerobes.
Biotech Wasn't Ready For AI's Speed; Here's How We Catch Up
Computational success is no stand-in for therapeutic readiness. Innovators must learn to discern between models rooted in science and those that speculate.

BIOPROCESSING WHITE PAPERS

Opportunities In Preclinical Development
Every domain produces critical data and this data and contexual information should be captured and managed in the most effective and robust manner.

A Supplier-Manufacturer Approach To Mitigating Nitrosamine Risk
10/10/2024

Learn about how nitrosamines are formed, their prevalence and chemical precursors in pharmaceuticals, techniques for quantification, and approaches for managing nitrite impurities.
The Effect Of Mixing Homogeneity In Retentate Vessel
8/5/2025

Discover a novel analytical method enhancing TFF diafiltration insights that deliver superior mixing, reliable scale-up, and breakthrough interpretation of diavolume performance.
Set Your Cell And Gene Therapy Program Up For Success From Day One
9/25/2024

Partner with a specialized CDMO early in your CGT development to ensure a streamlined path from discovery to successful commercialization, avoiding costly pitfalls and delays.
Digital Innovation And Sustainability Are Redefining Biomanufacturing
12/8/2025

Next Generation Manufacturing (NGM) integrates advanced process design, digital innovation, and strategic facility planning to facilitate agile, efficient, and sustainable biopharmaceutical production.
Impact Of Immunogenicity On Efficacy And Safety Of Biosimilars
2/9/2024

The presence of ADAs can affect the effectiveness and safety of biologic drugs. Read why regulatory agencies emphasize the need for extensive immunogenicity evaluation in biosimilar development.

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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.