By treating distinct validation guidelines as decision-making units, data envelopment analysis (DEA) allows for the mathematical evaluation of their resource efficiency.
- Engineering Better ADCs, Part 2: Characterization, CMC, And More
- AstraZeneca's Focus On Predictive Control, Semi-Autonomous Processing
- CDMO Selection Beyond Capabilities And Price
- August 2026 — CDMO Opportunities And Threats Report
- ICH M4Q(R2) And M16 Modernize The CTD For Digital Submissions
- Prioritizing Quality Over Everything
- Building Sustainable Biopharma Supply Chains Starts With Procurement
EDITOR'S DESK
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![growth chart-GettyImages-1491553346]( "Overcoming Recovery Challenges In AAV Production")
Overcoming Recovery Challenges In AAV ProductionSiren Biotechnology's SVP of vector development, Nathalie Clément, Ph.D., explains the challenge of purifying AAV capsids and the ways developers are optimizing vector recovery.
ADCs built on proprietary platforms risk losing process-specific knowledge during a tech transfer. See what advice panelists from the Bioprocess Online Live event "Ensuring Successful Technology Transfer In ADC Development" shared with the audience on preserving this implicit knowledge.
AP 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.
GUEST COLUMNISTS
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![health hands icon symbol logo-GettyImages-893252564]( "Engineering Better ADCs, Part 2: Characterization, CMC, And More")
Engineering Better ADCs, Part 2: Characterization, CMC, And MoreLet's take a closer look at antigen selection and tumor biology, PK and PD, analytical characterization, CMC, toxicity, and more.
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CDMO Selection Beyond Capabilities And PriceSome of the most useful information relevant to CDMO selection is also the hardest to obtain. Here are suggestions for uncovering data that tells the whole capability story.
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![CDMO August]( "August 2026 — CDMO Opportunities And Threats Report")
August 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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![reminder, update-GettyImages-1830311745]( "ICH M4Q(R2) And M16 Modernize The CTD For Digital Submissions")
ICH M4Q(R2) And M16 Modernize The CTD For Digital SubmissionsA former FDA assessor explains how recent changes to the common technical document bring long-overdue updates to the submission process, accounting for greater data demands.
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Engineering Better ADCs, Part 1: MoA, Conjugation Chemistry, And MoreThe field has evolved considerably in antibody–drug conjugate (ADC) science. In this first article of a two-part series, let's discuss how to engineer better ADCs, covering MoA, conjugation chemistry, and more.
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Building Sustainable Biopharma Supply Chains Starts With ProcurementNearly all the industry's emissions happen upstream from core manufacturing functions. This puts sustainability almost entirely on the shoulders of purchasing.
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![Bayer Facility-GettyImages-1918555070]( "Sustainable Facility Design Brings Bayer Instant Savings")
Sustainable Facility Design Brings Bayer Instant SavingsROI for sustainability initiatives often come later as lower maintenance and utility costs. Bayer's pursuit of LEED certification led to substantial savings up front.
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![past due envelopes-GettyImages-917638506]( "Why You Should Measure Comparability Debt Before Ever Starting A Study")
Why You Should Measure Comparability Debt Before Ever Starting A StudyWhen analytical capability and process understanding fail to keep pace with a drug candidate, the technical uncertainty creates debt that's difficult to pay down.
BIOPROCESSING WHITE PAPERS
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![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.
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The Connectivity Crisis Blocking AI Deployment6/30/2026
Disconnected systems and siloed data block analytics in life sciences manufacturing. Learn to bridge the infrastructure gap and build a connected foundation for scalable intelligence.
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Selecting A CDMO For Custom Activated PEGs1/27/2026
Custom-activated PEGs require thoughtful planning and precise analytical control. Discover key considerations for selecting a partner capable of supporting scalable, compliant PEGylation.
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A Shift Towards Biofluorescent Particle Counters In Manufacturing5/12/2025
Sterility in injectable drug manufacturing is vital for patient safety and efficiency. Discover how biofluorescent particle counters revolutionize contamination control, regulatory compliance, and operational excellence in modern pharma.
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Innovation In Filtration3/18/2025
Filtration removes contaminants to ensure safety and is essential in various applications, from lab-scale tasks to GMP production. Explore how its simplicity and reliability make it indispensable.
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Tech Transfer At Risk: The Imperative For Digital Maturity, Modernization12/2/2024
Tech transfer is critical for biopharmaceutical production, but outdated tools can hinder the process. Discover how digital maturity can streamline operations, reduce risks, and accelerate time to market.
BIOPROCESSING APP NOTES & CASE STUDIES
- Comparison Of Constant- And PulsedField Electrophoresis
- 3X Bispecific Antibody Output, 98.5% Purity In 7 Months
- Bioconversion Of Babassu Mesocarp Flour Into Single-Cell Protein In A Controlled Bioreactor System
- Mechanochemistry- Enabled Solid-State Stress Testing
- Benchmarking Filtration Performance Of TFF Cassettes
- AstraZeneca's Focus On Predictive Control, Semi-Autonomous Processing
- Prioritizing Quality Over Everything
- 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
EDITORIAL COLLECTIONS KNOWLEDGE CENTER
Editorial Collections are subscriber-only, curated resources that combine expert interviews, feature articles, and industry analysis to help readers better understand emerging trends, operational challenges, regulatory developments, and best practices shaping the biopharma industry.
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ON-DEMAND WEBINARS
- Beyond Fed-Batch: Choosing The Right Path To Process Intensification
- Accelerating CHO Media Development: From Screening To AI Design
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- Advancing The Human Liver-Chip Toward FDA Qualification
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INDUSTRY NEWS
NEWSLETTER ARCHIVE
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