European nations offer a welcoming environment for clinical-phase cell and gene therapies. Don't assume the same flexibility carries through to commercialization.
- Enzyme Activity As A Surrogate Potency Marker In Cell Therapy
- Implementing And Optimizing Your eQMS
- 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
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.
GUEST COLUMNISTS
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![Automation, engineering-GettyImages-2192972387]( "Implementing And Optimizing Your eQMS")
Implementing And Optimizing Your eQMSThis article addresses everything that follows the signed contract for an eQMS: how a system is configured, validated, adopted, and maintained.
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![DNA amplification, Reverse transcription PCR, RNA, scientist-GettyImages-1163127104]( "Choosing Analytical Technologies At The Right Stage Of Development")
Choosing Analytical Technologies At The Right Stage Of DevelopmentTake a beat before investing in the latest analytical tools. Capability and sensitivity come at a cost. Depending on your phase, you might not need it just yet.
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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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![uniqueness, expertise, differently abled, inclusiveness, diversity-GettyImages-2261212848]( "What Goes Into Restarting A Shelved Orphan Drug Candidate?")
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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![Work safety, risk management-GettyImages-2221147512]( "A Much-Improved Approach For Understanding And Managing Safety Risks")
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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![cybersecurity, AI validation-GettyImages-2209954431]( "In Bioprocessing, Trusted Data Is A Process Variable")
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.
BIOPROCESSING WHITE PAPERS
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![GettyImages-1327977864-lab-science]( "Delivering Critical Therapies With Speed And Safety")
Delivering Critical Therapies With Speed And SafetyFaster approvals depend on treating regulation as part of development, not the finish line. See how early quality planning and strong agency communication can move therapies toward patients sooner.
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Pushing The Boundaries Of Chromatographic Separation7/29/2026
Metal-sensitive analytes often suffer from poor recovery and distorted peak shapes. Learn how inert hardware improves sensitivity and chromatographic performance for challenging analyses.
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Achieving Rapid, High-Titer Expression For Next-Generation Biologics3/5/2025
This advanced cell line development technology overcomes production challenges related to the expression and scalability of complex biologics.
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Is Sustainability The Key To Agile Biopharma Manufacturing?3/18/2025
In biologics manufacturing, change is constant. Discover how new innovations and a focus on sustainability have gotten 62% of executives to prioritize eco-friendly practices, which reflects a commitment to long-term viability.
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Manufacturing Of Cytotoxic And Non-Cytotoxic Drugs In A Multiproduct Facility10/16/2024
The experience and expertise of the CMO is crucial to avoid the risk of cross-contamination of the drug product, as failures or weaknesses in this process can pose risk to the end-user.
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Process Intensification And Other Ways To Adapt To Changing Needs7/20/2026
As biologics manufacturing evolves, gain insight into why productivity depends on smarter investments, flexible production strategies, and supplier support that can address shifting modalities.
BIOPROCESSING APP NOTES & CASE STUDIES
- Validating VH2O2 Decontamination Cycles For Product And Personnel Safety
- Microbial Recovery And Flow Performance With Membranes
- Optimizing Bispecific Antibody Expression Via Multi-Omics Analysis And Vector Redesign
- Characterization Of Antibody-Drug Conjugate Critical Quality Attributes
- Enhancing Viral Clearance Prediction And Process Optimization
- 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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- 08.27.26 -- In Bioprocessing, Trusted Data Is A Process Variable
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