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
-
![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
-
![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.
-
![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.
-
![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.
-
![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.
-
![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.
-
![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.
-
![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.
-
![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
-
![GettyImages-2152031133-atom-hand-gear-wrench-automation]( "The AI-Ready Factory: How IT/OT Integration Transforms Manufacturing Data")
The AI-Ready Factory: How IT/OT Integration Transforms Manufacturing DataPharmaceutical manufacturers need more than raw production data to scale AI. Learn how contextualized, governed IT/OT integration can turn disconnected shop-floor signals into real-time decisions.
-
Cell Based Potency Assays: De-Risk Your Path With An Experienced CDMO4/21/2026
Thorough characterization is key to unlocking the potential of antibody-based therapeutics. Leveraging a CDMO's extensive capabilities and expertise can allow you to navigate the biopharmaceutical development landscape.
-
Where Speed Meets Complexity In Bioprocess Development6/18/2026
Bioprocessing faces mounting pressure to compress timelines, especially for mAbs, while complex modalities like bispecifics and gene therapies introduce technical challenges. Process intensification, scale-up translation, and comparability risks remain critical hurdles.
-
Smart Scaling For Cell And Gene Therapies2/5/2026
To meet patient demand, advanced therapy manufacturing processes must be commercial ready. CGT sponsors can mitigate risk and protect viability by partnering with a CDMO that prioritizes scalability.
-
How To Take Your Process To A Closed System4/22/2025
Understand the critical considerations for implementing closed systems in bioproduction, from vessel selection to workflow customization for optimal efficiency and safety.
-
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 Process Development For Cell Line Optimization Using Protein A
- Measuring ADC Positional Isomers Using Nonreduced CE-SDS And HIC
- A Paperless Lab Simplifies, Accelerates Full Sample Lifecycle Data Management
- Digital Transformation Optimizes Production, Quality, And Compliance
- Enable Low Volume Delivery Of Proteins In Aqueous Solutions
- 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
- 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