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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- Bringing Next-Gen Sequencing To GMP Scale
- Risk Managing Through The Void Of ATMP Visible Particle Guidance
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- 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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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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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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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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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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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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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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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.
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A Risk-Based Approach To Plasmid DNA And mRNA Process DevelopmentBalancing robust analytics and clinical readiness is key for early-phase pDNA and mRNA therapeutics amid structural complexity and regulatory challenges.
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Innovations In API Manufacturing Of Small Molecule Drugs5/6/2026
Read how advances in people, processes, technology, materials, analytics, and sustainability are reshaping small‑molecule API manufacturing to reduce costs, scale efficiently, and meet future demand.
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Strategic Hiring For Scalable Success1/22/2026
Discover 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.
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Best Practices In Formulation And Lyophilization Development: Proteins, mAbs And ADCs10/16/2024
Discover how advancements in pharmaceutical freeze-drying are reshaping the process through better product understanding, precise process control, and innovations in equipment efficiency.
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Peptides: A Scientific Revolution In Modern Medicine7/21/2026
GLP-1 peptides are transforming metabolic care. Discover how structural modifications extend half-lives, enable multi-receptor targeting, and expand into heart, kidney, and brain health.
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Automated Validation And Centralized Data7/23/2025
Discover how intelligent CPV, powered by automation and real-time analytics, is transforming manufacturing by driving quality, compliance, and innovation in a rapidly evolving regulatory landscape.
BIOPROCESSING APP NOTES & CASE STUDIES
- Optimizing TFF And SPTFF For High-Concentration mAb Formulations
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- CLD Case Study: Complex Biologics – Bispecific Fusion Nanobody
- Fab-Oligo Conjugation
- Enhanced mAb Production With High-Intensity Perfusion CHO Medium
- 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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ON-DEMAND WEBINARS
- Improving Clinical Translation For ADCs And Immuno-Oncology With Human-Relevant Tumor Models
- A Smarter Microbial Approach To Therapeutic Peptide Manufacturing
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INDUSTRY NEWS
NEWSLETTER ARCHIVE
- 09.22.26 -- From Bench To Batch: Modernizing CMC For Faster Decisions
- 09.22.26 -- Using Digital Platforms To Find Your CDMO
- 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