Contamination control gaps arise when two dynamics merge — when processes become familiar and workloads increase. Here's how to spot them before they spin out of control.
- Accelerating Technology Diffusion In Cell And Gene Therapy
- 5 QMS Blind Spots You Should Know About
- New MIT Consortium Links Innovation With Real-World Biomanufacturing
- A Biotech Business Model That's Investor-Friendly
- Dynamic Flux Analysis Offers Faster Metabolic Modeling Than DOE
- Green Supply Chains Rarely Start With A Pledge; Target Waste Instead
- The Real Reason We Haven't Fully Automated Cell Therapy Yet
EDITOR'S DESK
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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.
Chief Editor Louis Garguilo says he's sure some readers will smirk at our headline. CDMOs are running a business; they may attempt to treat all customers equally, but they focus where the most financial gain is. That's usually with bigger clients. Nonetheless, according to a very experienced outsourcing professional, there's nothing humorous here at all.
New FDA draft guidance aims to reduce the timeline and cost of developing biosimilars.
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."
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.
GUEST COLUMNISTS
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Accelerating Technology Diffusion In Cell And Gene Therapy
Unlike most other drugs, advanced therapies require complex, purpose-built supply chain networks. Making them requires cross-sector collaboration.
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5 QMS Blind Spots You Should Know About
Companies often underestimate the complexity of standing up an eQMS. These are five of the most common issues that lead to regulatory and GMP exposure risk.
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New MIT Consortium Links Innovation With Real-World Biomanufacturing
In one area, the Initiative for New Manufacturing is exploring whether microfactories, championed by the EV industry, can help biopharma iterate facility design faster.
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Dynamic Flux Analysis Offers Faster Metabolic Modeling Than DOE
By continuously analyzing spent media, researchers can estimate reaction rates at regular time points, providing a granular view of cell metabolism.
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Green Supply Chains Rarely Start With A Pledge; Target Waste Instead
Effective sustainability strategies in pharma supply chains reduce rework and overage. Three leakage points offer the most practical starting point for rooting out waste.
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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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The Hidden Engineering Behind Successful Upstream Bioprocessing
In upstream biopharmaceutical production, manufacturing is inseparable from biology, engineering, contamination control, and quality science.
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A Practical Look At Modern Downstream Processing For Biologics
Part 2 in a series about current bioprocessing practices explores the latest in separation, purification, sterile filtration and aseptic filling.
BIOPROCESSING WHITE PAPERS
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A Comprehensive Solution For Adventitious Agent Testing
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.
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Quality By Design In The Pharmaceutical Industry12/12/2025
Real-time release and digital quality management, powered by PAT, are driving efficiency and compliance, reshaping how manufacturers achieve speed, consistency, and competitive advantage.
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Reducing ADC Timelines With Integrated Development And Manufacturing4/8/2024
ADCs have proven to be highly effective in cancer treatment, but their manufacturing poses challenges. Learn how a CDMO partner can help bring these treatments to patients safely and efficiently.
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Why Biopharma Breakthroughs Aren't Moving The Market10/20/2025
Biopharma is innovating fast but falling short commercially. Reveal key ecosystem gaps and five strategic actions to help strengthen resilience, accelerate performance, and futureproof organizations.
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The Evolution Of Antibody-Drug Manufacturing6/3/2024
Explore how ADC chemistry and manufacturing have evolved, the challenges this dynamic growth has created, and how CDMOs are adapting to these changes to meet customer needs, now and in the future.
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Rapid, Seamless Upstream Process Development And Scale-Up For CHO-K1 Cells6/28/2024
Accelerate your biotech company's scale-up process while delivering consistent and strong cell growth, productivity, and product quality.
BIOPROCESSING APP NOTES & CASE STUDIES
- Taking The First Steps Towards Digitalizing Biopharma Development
- Bioprocess Online's 2025 Editorial Reflections
- FDA Releases Draft Guidance To Accelerate Biosimilar Development
- Supporting The Next Generation Of ADCs
- AbbVie And Amgen's Blueprint To Digitalize Biomanufacturing
- On The Ground At BPI: Kat Kozyrytska On Ethical AI And Collaboration
- On The Ground At BPI: Takeda's Amy Shaw On Scaling Cell Therapy Manufacturing
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.
More Content CollectionsFEATURED PRODUCTS AND SERVICES
ON-DEMAND WEBINARS
- Strategies For Robust Process Characterization And Validation To Accelerate Biologics Manufacturing
- Innovating Upstream Manufacturing For The Next Wave Of Gene Therapies
- Where Biologic Stability Programs Fail—and How ICH Q1 Can Help You Get It Right
- USP <665> Compliance Guidance
- Practical Considerations For Aseptic Gowning In Contamination Control Strategies
INDUSTRY NEWS
NEWSLETTER ARCHIVE
- 03.14.26 -- Bioprocess Online Best Of February
- 03.13.26 -- STREAM Edition: Making Biologics Orally Available With Vivtex's Thomas von Erlach, Ph.D.
- 03.13.26 -- Field Notes: Reducing Risk At Kivi Bio's Interchangeability Conference
- 03.12.26 -- Rapidly Generate High-Producing, Stable & Scalable Cell Lines
- 03.12.26 -- Supporting The Bioprocessing Workforce In The AI Era With Sanofi