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
-
![AugustBio_Hiring_Fixed]( "Strategic Hiring For Scalable Success")
Strategic Hiring For Scalable SuccessDiscover how a people-first talent strategy, purpose-driven culture, and cross-functional collaboration come together to support scalable growth and operational excellence in commercial manufacturing.
-
Advancements In Microbial Manufacturing Of Biopharmaceuticals9/26/2024
Dive into the evolution and future potential of microbial manufacturing in the biopharmaceutical industry to discover how digital tools can revolutionize development and production processes.
-
Better, Safer Science Through Proper Detergent Selection And Cleaning6/22/2026
Enforce reliable lab results by improving washer performance, detergent selection, and rinsing to prevent residues, cross-contamination, and spotting—supporting reproducibility and compliance.
-
Handling Protocols: Key Considerations In The Highly Potent API Market5/12/2025
Explore the growing role of highly potent active pharmaceutical ingredients in oncology and Antibody-Drug Conjugates to highlight manufacturing challenges, safety protocols, and opportunities for CDMOs.
-
Oligonucleotide Synthesis: Scale-Up Made Simple10/16/2024
Scaling oligonucleotide synthesis isn't as straightforward as it seems. Explore key challenges, critical process parameters, and solutions for a smooth scale-up.
-
Advancing Nanomedicine Production With Flow Manufacturing5/6/2026
Learn how flow manufacturing enables scalable, reproducible nanomedicine production with tighter control, consistent particle quality, and smooth lab-to-commercial scale‑up.
BIOPROCESSING APP NOTES & CASE STUDIES
- LC-UV-Based Synthetic Peptide Impurity Tracking And Reporting
- Monitoring Of A pH Optimization Approach For CHO Cell Cultivation
- Automating Mass Spectrometry Analysis To Accelerate Oligonucleotide Drug Development
- Discover A System That Can Be Used With Various Cell Culture Media
- Improved T Cell Expansion Using Closed, Automated Stirred-Tank Bioreactors
- 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
- 09.18.26 -- 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
- 09.17.26 -- July 2026 — CDMO Opportunities And Threats Report