Using AI for CSV might feel like the students are grading their own papers. One consultant explains why it's not the same, namely, there are no subjective judgment calls.
- CDMO Quality Oversight: How FDA And Pharma Leaders Are Rethinking Data, AI, And Culture
- A QMS That Anticipates Cell And Gene Therapy Quality Challenges
- Using Digital Platforms To Find Your CDMO
- Controls For Retrieval-Augmented Generation In GxP
- July 2026 — CDMO Opportunities And Threats Report
- ADC CDMO Selection For Small Biotech
- Evaluating The Levers Driving Productivity In Bioprocessing
EDITOR'S DESK
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![GettyImages-1490925234]( "Multispecific Manufacturability Starts With Molecular Design")
Multispecific Manufacturability Starts With Molecular DesignAP Biosciences’ VP of antibody discovery, Jhong-Jhe You, Ph.D., explains the key design elements of multispecific antibodies and how they affect product developability.
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.
GUEST COLUMNISTS
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![GettyImages-2234439798-AI-Medicine-Trials-Drug-Development]( "CDMO Quality Oversight: How FDA And Pharma Leaders Are Rethinking Data, AI, And Culture")
CDMO Quality Oversight: How FDA And Pharma Leaders Are Rethinking Data, AI, And CultureDiscover strategies for risk-based governance, AI-enabled quality management, stronger collaboration, and fostering a culture that supports long-term operational excellence.
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![Asian man typing on laptop-GettyImages-1371907414]( "Using Digital Platforms To Find Your CDMO")
Using Digital Platforms To Find Your CDMOIn recent years, digital platforms have emerged to help pharma/biotech companies discover, evaluate, and connect with CDMOs more efficiently. These resources have different functions and limitations.
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![Medical research-GettyImages-1287846309]( "A QMS That Anticipates Cell And Gene Therapy Quality Challenges")
A QMS That Anticipates Cell And Gene Therapy Quality ChallengesSome quality system elements are non-negotiable in Phase 1 cell and gene therapy. For the rest, a risk matrix can help define flexible, defensible specifications.
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![data search, information discovery, file management, digital analysis, and advanced data retrieval systems-GettyImages-2284270263]( "Controls For Retrieval-Augmented Generation In GxP")
Controls For Retrieval-Augmented Generation In GxPValidation teams deal with inherent variability all the time. The same principles for GMP — think visual inspection — can apply to probabilistic AI systems.
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![July CDMO]( "July 2026 — CDMO Opportunities And Threats Report")
July 2026 — CDMO Opportunities And Threats ReportEach month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
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![paylinker-cdmo-GettyImages-1287846309]( "ADC CDMO Selection For Small Biotech")
ADC CDMO Selection For Small BiotechManufacturing is a critical factor in ADC success. Discover how to align CDMO capabilities with molecule complexity, mitigate risks, and navigate capacity limits.
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![digital research, biotech, scientific innovation-GettyImages-2223712673]( "Implementing AI Solutions In GMP While Managing Risk")
Implementing AI Solutions In GMP While Managing RiskWhen using artificial intelligence in GMP settings, risk management extends far beyond validation. This discussion explores moving AI solutions out of the pilot phase.
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![innovation, technology, future science-GettyImages-2272380557]( "Europe's ATMP Opportunity Still Requires Local Navigation")
Europe's ATMP Opportunity Still Requires Local NavigationEuropean nations offer a welcoming environment for clinical-phase cell and gene therapies. Don't assume the same flexibility carries through to commercialization.
BIOPROCESSING WHITE PAPERS
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![Lipid Nanoparticles GettyImages-1437855772]( "How Lipid Nanoparticles Enable Next-Gen Delivery")
How Lipid Nanoparticles Enable Next-Gen DeliveryCell therapy’s future depends on smarter gene delivery. Learn how lipid nanoparticles offer a scalable, cell-friendly alternative to electroporation and viral vectors for manufacturing efficiency.
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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.
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Optimizing DSP Development: Faster Timelines, Lower Costs, And High-Quality Processes4/8/2025
The biopharmaceutical industry faces growing downstream processing challenges in purifying complex biologics efficiently and at scale.
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Context-First Data For Trustworthy AI In Biopharma6/26/2026
Bridge the gap between AI experimentation and enterprise value. Learn how capturing structured, semantically rich data at the point of origin builds regulator-credible AI pipelines.
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ADC Development Grows More Complex — SPR Insights Bring Clarity4/14/2026
Explore how real-time kinetic analysis reveals how conjugation, linker chemistry, and drug loading influence antibody–antigen interactions, while enabling sensitive detection of anti-drug antibodies.
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Small Volume ATMP Cryo-Freezing Strategies3/11/2025
Discover best practices for cryopreserving small-volume ATMPs, focusing on sterility, viability, and efficiency with advanced containers and packaging.
BIOPROCESSING APP NOTES & CASE STUDIES
- Rapid And Sensitive Detection Of Replication-Competent Lentivirus (RCL)
- Development Of Separation Methods For GLP-1 Synthetic Peptides
- Pharmaceutical Requirements For Portable Monitoring In Cleanrooms
- Assessing Particle Generation In A Single-Use Mixing System
- Risk Assessment Services Align With FDA Guidance For Gene-Edited Human Gene Therapy Products
- Evaluating The Levers Driving Productivity In Bioprocessing
- 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
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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- 09.04.26 -- New Podcast Episodes: Fixing AAV Recovery, Cell Therapy Advances, Reimagining Solid Tumor Immunotherapy
- 09.04.26 -- Developing Multi-Targeted T-Cell Engagers With Deck Bio's Johanna Kaufmann
- 09.04.26 -- What Goes Into Restarting A Shelved Orphan Drug Candidate?
- 09.03.26 -- Real-Time Visibility Is Reshaping Outsourced Gene Therapy
- 09.03.26 -- CDMO Live Europe 2026: Partnerships For An Uncertain World