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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On The Ground At BIO 2026: Johanna Kaufmann, Ph.D., On The Oncology Modality Puzzle
At 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.
GUEST COLUMNISTS
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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.
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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 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.
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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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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.
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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.
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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.
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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.
BIOPROCESSING WHITE PAPERS
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Perspectives On Performance, Scalability, And Regulatory Compliance
Here, we discuss the challenges and solutions for cell and gene therapies, focusing on performance, scalability, and regulatory compliance to accelerate commercialization and improve patient access.
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Unlocking The Full Potential Of Antibody-Drug Conjugates (ADCs)6/15/2026
ADCs are evolving rapidly. Gain insight into how success now hinges on managing complexity, delivery, and scalability to turn promising designs into viable therapeutic products.
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Optimizing Charge And N-glycan Profiles For CHO-Derived Fusion Proteins9/24/2025
Discover how structured design-of-experiment approaches can optimize charge variants and glycosylation to enhance biologics quality and therapeutic performance.
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Onshoring Advantage: 7 Forces Reshaping Global Biologics Manufacturing10/27/2025
Policy, trade, and security pressures are fundamentally reshaping global biologics manufacturing. Forward-looking companies are onshoring critical programs to mitigate risks to supply chains, IP, and regulatory timelines.
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An Overview Of 2026 Life Sciences Industry Trends6/3/2026
Explore the paradigm shift reshaping life sciences. Learn how connecting data streams across the product lifecycle drives predictive compliance and operational excellence.
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The Effect Of Conventional Cooling Versus Controlled Ice Nucleation On Primary Drying Time4/1/2026
See how controlled ice nucleation shortens lyophilization cycles, supports higher drying temperatures, and reduces complexity for amorphous and mixed formulations without sacrificing quality.
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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NEWSLETTER ARCHIVE
- 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