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.
- New USP Guidelines, Standards Address Lentivirus Characterization
- 6 Modeling Approaches That Make Complex Bioprocess Data Useful
- Bringing Next-Gen Sequencing To GMP Scale
- Risk Managing Through The Void Of ATMP Visible Particle Guidance
- Building Trust In AI For Computerized System Validation
- A Gentler Cell Line Selection Method Using microRNA
- When To Trust And When To Verify AI-Enabled Validation Systems
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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![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.
BIOPROCESSING WHITE PAPERS
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![mAb, monoclonal antibody, antigen, vaccine-GettyImages-2245122166]( "Optimizing mAb Production: Upstream Process Intensification Strategies")
Optimizing mAb Production: Upstream Process Intensification StrategiesSee how integrated upstream and downstream intensification strategies can increase monoclonal antibody yield, streamline workflows, improve facility utilization, and reduce manufacturing costs.
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Unlocking ROI And Capacity In Monoclonal Antibody Manufacturing11/5/2025
Perfusion-based upstream production offers up to 24% lower cost and significantly higher productivity than fed-batch, enabling faster timelines, better facility utilization, and improved quality.
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Advances In Regulations For Viable Environmental Monitoring2/21/2025
Viable air monitoring is critical for environmental monitoring programs in pharmaceutical manufacturing. Explore current regulatory standards as well as the impact of the EU GMP Annex 1 revisions.
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Fast Path To Market: Going From GMP1 To PPQ In Just 12 Months4/30/2026
Learn how focused optimization and coordinated execution helped overcome technical uncertainty and enable faster progression to market readiness.
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Ready To Demystify Organoids?7/1/2025
Organoids are transforming biomedical research. Explore their top applications, research workflows, key challenges, and dissociation techniques in this comprehensive guide to personalized medicine.
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Support Of Scale-Up And Technical Transfer Through Understanding Equipment10/16/2024
See how our expertise in formulation and process development can ensure a seamless scale-up from laboratory to full-scale production of lyophilized injectable products.
BIOPROCESSING APP NOTES & CASE STUDIES
- 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.
More Content CollectionsFEATURED PRODUCTS AND SERVICES
ON-DEMAND WEBINARS
- Improving Clinical Translation For ADCs And Immuno-Oncology With Human-Relevant Tumor Models
- A Smarter Microbial Approach To Therapeutic Peptide Manufacturing
- 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
INDUSTRY NEWS
NEWSLETTER ARCHIVE
- 09.21.26 -- A Gentler Cell Line Selection Method Using microRNA
- 09.18.26 -- Annex 1 Is Just The Beginning: Compliance, Innovation, And The Future Of Sterile Manufacturing
- 09.18.26 -- The Risk Of Losing Tacit Knowledge In An ADC Tech Transfer
- 09.18.26 -- Focusing On Quality Unit Independence With Tatyana Matveeva, Ph.D.
- 09.17.26 -- Scale Bioprocesses With Greater Confidence