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The Real Reason We Haven't Fully Automated Cell Therapy Yet

Manual cell therapy workflows often set the tone for automation. This discussion suggests the approach is flawed and presents automation as a chance to innovate.

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EDITOR'S DESK

FDA Releases Draft Guidance To Accelerate Biosimilar Development
New FDA draft guidance aims to reduce the timeline and cost of developing biosimilars.

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.

GUEST COLUMNISTS

Process Engineering's Key Role In Sterile Injectable Facility Design
Quality requirements for parenteral drugs complicate facility design like few other regulated products. If you're developing injectables, be aware of these key issues.
What To Know About — And How To Apply For — FDA's PreCheck Pilot
FDA has now provided specific eligibility and selection criteria for the PreCheck Pilot Program and a timeline for next steps.
MES Is Still In The CD ROM Era But The Data Architecture Has Moved On
Many manufacturing execution system (MES) deployments still operate like it is 2005: a big install, disruptive upgrades, etc. Here's a clearer path forward.
A Novel In Vitro Glycosylation Approach For Difficult PTMs
Post-translational modifications of membrane proteins have been historically challenging. Research shows how an in vitro approach brings stability and predictability.
Field Notes: Reducing Risk At Kivi Bio's Interchangeability Conference
Risk and fitness for use of interchangeable single-use parts were key themes at the conference. The event exposed communication gaps between suppliers and end-users.
Using Carbon Nanotubes To Pinpoint Optimal Harvest Time in Bioprocessing
Cell-free expression systems confound the moment of peak expression. These nanosensors signal through crude lysate for process optimization and endpoint monitoring.
U.S. Pharma Tariffs And MFN In 2026: Manufacturing And Procurement Impact
Beroe Inc.'s Mathini Ilancheran discusses the 2025 U.S. pharma tariff framework and translates it into actionable procurement and outsourcing responses.
A Peek Into Novo Nordisk's Sustainable Facility Construction Mindset
Fill/finish operations are famously resource-heavy. Nonetheless, Novo set out to achieve ambitious environmental goals with its $4.1 billion project in North Carolina.

BIOPROCESSING WHITE PAPERS

Optimal Microbial Sampling Criteria
Microbiological sampling ensures sterile conditions through surface, passive, and active air methods. The EU GMP Annex 1 emphasizes integrating these for comprehensive environmental monitoring.

The Current And Future Value Of mRNA Vaccines And Therapeutics
2/4/2026

Discover how decades of research have propelled mRNA technology to the forefront of therapeutic development and learn how our expertise is advancing mRNA drug development.
Cell Collection Basics For The Transplant And CGT Industries
6/3/2025

Breakthroughs in CAR T-cell and stem cell therapies depend on mastering cellular collection. Understanding these fundamentals is vital for advancing treatment efficacy and patient outcomes.
Improving Safety And Efficacy With Charged Variant Characterization
5/14/2024

Discover how a CDMO with extensive experience in protein variant characterization, CQA analytics, and patient-centric product development can ensure the safety and efficacy of your biotherapeutic.
ATMP Cryopreservation Done Right - Best Practice In Small Volume Cryo-Freezing
3/11/2025

Explore best practices for cryopreserving small-volume advanced therapy medicinal products (ATMPs), emphasizing sterility, cell viability, and efficiency using innovative single-use systems and aseptic connectors.
Avoiding The Pitfalls Of PQR
10/9/2024

Explore the fundamentals of Product Quality Reviews (PQRs), common challenges manufacturers face, strategies for streamlining PQRs, and solutions that aim to unlock the potential of a "real-time PQR."

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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.