NGS enables broad detection of known and novel viruses in a single assay. Its high sensitivity, specificity, and scalability can meet GMP throughput levels.
- A Gentler Cell Line Selection Method Using microRNA
- When To Trust And When To Verify AI-Enabled Validation Systems
- CDMO Quality Oversight: How FDA And Pharma Leaders Are Rethinking Data, AI, And Culture
- A QMS That Anticipates Cell And Gene Therapy Quality Challenges
- Using Digital Platforms To Find Your CDMO
- Controls For Retrieval-Augmented Generation In GxP
- July 2026 — CDMO Opportunities And Threats Report
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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![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.
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![Asian man typing on laptop-GettyImages-1371907414]( "Using Digital Platforms To Find Your CDMO")
Using Digital Platforms To Find Your CDMOIn recent years, digital platforms have emerged to help pharma/biotech companies discover, evaluate, and connect with CDMOs more efficiently. These resources have different functions and limitations.
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![Medical research-GettyImages-1287846309]( "A QMS That Anticipates Cell And Gene Therapy Quality Challenges")
A QMS That Anticipates Cell And Gene Therapy Quality ChallengesSome quality system elements are non-negotiable in Phase 1 cell and gene therapy. For the rest, a risk matrix can help define flexible, defensible specifications.
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![data search, information discovery, file management, digital analysis, and advanced data retrieval systems-GettyImages-2284270263]( "Controls For Retrieval-Augmented Generation In GxP")
Controls For Retrieval-Augmented Generation In GxPValidation teams deal with inherent variability all the time. The same principles for GMP — think visual inspection — can apply to probabilistic AI systems.
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![July CDMO]( "July 2026 — CDMO Opportunities And Threats Report")
July 2026 — CDMO Opportunities And Threats ReportEach month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
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![paylinker-cdmo-GettyImages-1287846309]( "ADC CDMO Selection For Small Biotech")
ADC CDMO Selection For Small BiotechManufacturing is a critical factor in ADC success. Discover how to align CDMO capabilities with molecule complexity, mitigate risks, and navigate capacity limits.
BIOPROCESSING WHITE PAPERS
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![GettyImages-597971944-viral-vector-AAV-adeno-associated-virus]( "The Key To Viral Vector Success")
The Key To Viral Vector SuccessEstablishing a robust and scalable viral vector process requires a multidisciplinary approach that incorporates expertise in foundational science, analytics, and biomanufacturing.
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Drug Substance For Early Clinical Phase Initiation5/6/2026
Explore how proactive nitrosamine impurity risk assessment protects early clinical drug supply, minimizes development delays, and enables confident progression to first‑in‑human studies.
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Bio-Based Polymers Towards Net Zero In Single-Use Bioprocessing6/13/2025
Decarbonizing healthcare and pharmaceuticals is vital to meet climate goals and safeguard public health. Learn why these energy-intensive sectors must act swiftly to reduce emissions and navigate complex global supply chains.
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For Greater Transparency And Efficiency7/21/2026
Paper-heavy production can slow decisions and limit flexibility. See how IT/OT integration connects shop-floor and enterprise data to support real-time visibility and more resilient operations.
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Cell Line Development For Bispecific Antibodies8/18/2025
See how the recently described cell line development paradigm shift, enabled by the Leap-In transposon platform, can extend to the development of bispecific monoclonal antibody-producing cell substrates.
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Digital CMC Maturity: Rethinking QTTP And Control Strategy9/2/2026
Digital CMC maturity depends on structured, science- and risk-based knowledge. Learn how connecting development, validation, regulatory, and lifecycle information can accelerate timelines.
BIOPROCESSING APP NOTES & CASE STUDIES
- CQA Assessment Of LNP-Encapsulated IVT mRNA
- A Universal Workflow Approach For Single Cell Mass Spectrometry Based Proteomics
- Lyophilization Process Development For Antibody Drug Conjugates
- Can Your Biopharma Team Keep Unplanned Downtime At Bay?
- Biotech Firm Streamlines Maintenance, Calibration & Validation With RAM
- 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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