When analytical capability and process understanding fail to keep pace with a drug candidate, the technical uncertainty creates debt that's difficult to pay down.
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- Risk Managing Through The Void Of ATMP Visible Particle Guidance
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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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![CAPA effectiveness-GettyImages-2283083181]( "You Can't CAPA What You Can't Classify")
You Can't CAPA What You Can't ClassifyAn LLM or agentic error can occur with no component broken in any way the QMS recognizes. Classifying it takes two fields: the error type and the error origination point.
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![complex messy management, bureaucracy,red tape,organization, communication problems,business disruption-GettyImages-2262947509]( "6 Modeling Approaches That Make Complex Bioprocess Data Useful")
6 Modeling Approaches That Make Complex Bioprocess Data UsefulAI algorithms can reduce data dimensionality more faithfully by interpreting multivariate features relevant to prediction or control.
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![molecular biology, DNA analysis-GettyImages-2270602865]( "Bringing Next-Gen Sequencing To GMP Scale")
Bringing Next-Gen Sequencing To GMP ScaleNGS enables broad detection of known and novel viruses in a single assay. Its high sensitivity, specificity, and scalability can meet GMP throughput levels.
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![Bubbles-GettyImages-1028675986]( "Risk Managing Through The Void Of ATMP Visible Particle Guidance")
Risk Managing Through The Void Of ATMP Visible Particle GuidanceRegulators expect cell therapy manufacturers to prove they control for visible particles, but guidance remains notably quiet on the matter. Companies must get creative or risk clinical holds.
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![Artifical intelligence, future concept-GettyImages-1166228181]( "Building Trust In AI For Computerized System Validation")
Building Trust In AI For Computerized System ValidationUsing 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.
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![GettyImages-1295693748-mRNA-strand]( "A Gentler Cell Line Selection Method Using microRNA")
A Gentler Cell Line Selection Method Using microRNATraditional selection stresses surviving cells. New research shows how structurally interacting RNA may use endogenous microRNA for a faster, nontoxic selection process.
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![developing secure code, risk mitigation-GettyImages-2261595149]( "When To Trust And When To Verify AI-Enabled Validation Systems")
When To Trust And When To Verify AI-Enabled Validation SystemsComputer software assurance, coupled with AI, can help validation teams reduce redundant work and spend more time on patient-centric issues.
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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.
BIOPROCESSING WHITE PAPERS
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![GettyImages-1790844511-assay-laboratory-machine-plate]( "Three Key Actions To Minimize Dead Volumes")
Three Key Actions To Minimize Dead VolumesMinimizing liquid dead volume helps labs conserve costly reagents and scarce samples while boosting assay throughput. Learn how advanced liquid level detection technologies are driving efficiency.
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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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Flexibility In Drug Development: From Tactical Response To Strategic Imperative4/6/2026
Build flexibility into your drug development strategy to navigate change effectively, maintain momentum, and drive successful outcomes across every stage of the lifecycle.
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Manufacturing Readiness: Why Compliance Is Won Or Lost On The Floor8/6/2026
Achieve continuous regulatory readiness by embedding ALCOA++ compliance directly into manufacturing workflows to eliminate paper-based documentation risks.
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Optimizing Bioprocess Design And Workflow Orchestration7/30/2026
Disconnected systems can slow development by making data harder to coordinate. Learn how workflow orchestration and structured experimental design can help labs reduce friction and improve efficiency.
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Innovation And Evolution Of Affinity Chromatography Resins For Monoclonal Antibody Purification9/30/2025
Discover how innovations in ligand design and resin manufacturing have improved monoclonal antibody purification by enhancing selectivity, stability, and process economics.
BIOPROCESSING APP NOTES & CASE STUDIES
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- Evaluating The Levers Driving Productivity In Bioprocessing
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- 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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ON-DEMAND WEBINARS
- Scaling AAV Manufacturing To 1000 L: Strategies For Robust Production
- Driving Productivity Across The Antibody Manufacturing Workflow
- De-Risking Cell Culture Media Scale-Up For Late-Stage Manufacturing
- Reducing Timelines And Development Costs Through Scale Up
- Scaling AAV Purification: UF/DF Technologies That Deliver
INDUSTRY NEWS
NEWSLETTER ARCHIVE
- 09.17.26 -- Scale Bioprocesses With Greater Confidence
- 09.17.26 -- July 2026 — CDMO Opportunities And Threats Report
- 09.16.26 -- Antibody Purification: Practical Pathways To Stronger Processes
- 09.16.26 -- Could Open-Source Modeling Accelerate Continuous Lyophilization?
- 09.15.26 -- CLD & The Cost of Scale-Up Delays