Siren Biotechnology's SVP of vector development, Nathalie Clément, Ph.D., explains the challenge of purifying AAV capsids and the ways developers are optimizing vector recovery.
- Choosing Analytical Technologies At The Right Stage Of Development
- The Complex Anatomy Of An ADC Tech Transfer
- Preserving Tacit Knowledge In ADC Tech Transfers
- What Goes Into Restarting A Shelved Orphan Drug Candidate?
- A Much-Improved Approach For Understanding And Managing Safety Risks
- CSV Assumes The AI System Sits Still — It Doesn't.
- July Update — U.S. Generic Drug Tariffs: Implications For Pharma And Outsourcing
EDITOR'S DESK
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![IMG_7262]( "On The Ground At BIO 2026: Johanna Kaufmann, Ph.D., On The Oncology Modality Puzzle")
On The Ground At BIO 2026: Johanna Kaufmann, Ph.D., On The Oncology Modality PuzzleAt the 2026 BIO International Convention, Bioprocess Online caught up with Johanna Kaufmann, Ph.D., CSO at Deck Bio, a company developing multi-targeted T-cell engagers for solid tumors.
Bioprocess Online's chief editor, Tyler Menichiello, shares his key takeaways from the 2026 BIO International Convention in San Diego.
Exclusive coverage from John Crowley's press conference at the 2026 BIO International Convention in San Diego.
Noveome Biotherapeutics's Larry Brown, Sc.D., explains the regulatory and CMC challenges behind the company's novel secretome therapy, ST266.
This article summarizes the major developments and industry pressures highlighted by Life Science Connect editors in the "Better Biopharma" midyear editorial roundtable.
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![Multicolored antibodies immunoglobulin protein structures-GettyImages-1301300910]( "The Complex Anatomy Of An ADC Tech Transfer")
The Complex Anatomy Of An ADC Tech TransferUnlike traditional biologics tech transfer, antibody-drug conjugates have many more moving parts. Here are some of the unique challenges that require close attention.
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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.
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A Much-Improved Approach For Understanding And Managing Safety RisksLearn 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.
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![artificial intelligence innovation, digital data analysis, modern technology-GettyImages-2203258173]( "CSV Assumes The AI System Sits Still — It Doesn't.")
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.
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![pills spill on 100 dollar bill-GettyImages-826130422]( "July Update — U.S. Generic Drug Tariffs: Implications For Pharma And Outsourcing")
July Update — U.S. Generic Drug Tariffs: Implications For Pharma And OutsourcingMathini Ilancheran updates us on how delayed U.S. tariffs on generic drug imports could reshape supply, sourcing, and trial planning.
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In Bioprocessing, Trusted Data Is A Process VariableAs digital systems become increasingly interconnected, digital validation ensures systems generating and managing GxP data remain accurate, consistent, and trustworthy.
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![security safe-GettyImages-2203734514]( "Combination Cell Therapy's Clinical Success Hinges On Manufacturability")
Combination Cell Therapy's Clinical Success Hinges On ManufacturabilityCell therapy could help unlock checkpoint inhibitors’ potential in solid tumors, but combination regimens raise the bar for manufacturing consistency and scalability.
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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.
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![Global logistics supply chain-GettyImages-2256982707]( "An Innovative, Modular Approach To Flexible Supply Chain Management")
An Innovative, Modular Approach To Flexible Supply Chain ManagementLearn how modular strategies, global coordination, and data-driven decisions help maintain continuity, compliance, and speed amid constant uncertainty.
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Digital Biomanufacturing, Now: From Digital Dreamer To Digital Doer3/24/2025
Discover how digital biomanufacturing is revolutionizing drug production by exploring strategies for integrating digital technologies to enhance efficiency and innovation in bioprocessing workflows.
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Assuring Multipotency Of Human Mesenchymal Stem Cells (hMSCs)4/4/2025
Stem cell research has revolutionized tissue repair and regenerative medicine. Discover how mesenchymal stem cells play a key role and offer insights into connective tissue repair, immune response, and inflammatory diseases.
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Late‑Stage Progress In Excipients For Precision Nanomedicine5/6/2026
View late‑stage development and GMP manufacturing of novel excipients for nanomedicines, emphasizing regulatory rigor, process optimization, analytics, and scale‑up for lipid‑based delivery systems.
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Build An AAV8 Platform: Lessons From A Collaborative Development Journey11/5/2025
Explore how a modular AAV8 platform enables scalable, GMP-ready gene therapy manufacturing with reproducible outcomes, streamlined tech transfer, and adaptability across serotypes.
BIOPROCESSING APP NOTES & CASE STUDIES
- Overcoming Recovery Challenges In AAV Production
- Preserving Tacit Knowledge In ADC Tech Transfers
- Multispecific Manufacturability Starts With Molecular Design
- On The Ground At BIO 2026: Johanna Kaufmann, Ph.D., On The Oncology Modality Puzzle
- BIO 2026: Modernizing The FDA And Bolstering The Workforce
- BIO 2026: Crowley On Competing With China And Modernizing The FDA
- Essential CMC Elements For A Therapeutic Secretome
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.
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- 08.26.26 -- De-Risking Combination Product Development For Complex Biologics
- 08.26.26 -- New Resources to Strengthen Your Contamination Control Strategy
- 08.26.26 -- Where Should Development Teams Focus To Simplify Downstream Processes?
- 08.25.26 -- Smarter Purification Solutions For Today's Downstream Challenges
- 08.25.26 -- The Challenge Transferring Proprietary ADC Technology