The 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.
- Why You Should Measure Comparability Debt Before Ever Starting A Study
- What FDA Inspectors Want From Your OOS File
- You Can't CAPA What You Can't Classify
- 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
EDITOR'S DESK
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Multispecific Manufacturability Starts With Molecular Design
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.
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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Why You Should Measure Comparability Debt Before Ever Starting A Study
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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What FDA Inspectors Want From Your OOS File
Read enough FDA warning letters and a pattern emerges: Investigators rarely cite a retest that was performed badly. They cite a retest that nobody justified in writing. Let's take a closer look.
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New USP Guidelines, Standards Address Lentivirus Characterization
The United States Pharmacopeia is rolling out new standards and tools to help manufacturers characterize fragile, complex lentiviral vectors.
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You Can't CAPA What You Can't Classify
An 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 Useful
AI 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 Scale
NGS 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 Guidance
Regulators 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 Validation
Using 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.
BIOPROCESSING WHITE PAPERS
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Optimizing Poloxamer 188
Poloxamer 188 stabilizes proteins in liquid formulations and protects cells from shear stress. Molecular weight and hydrophobicity variations influence its effectiveness in different biopharmaceutical applications.
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Tablet Manufacturing Technologies For Solid Drug Formulation4/2/2025
Compressed tablets are common oral solid dosages that contain the API and various excipients. Learn about the critical steps in selecting manufacturing methods and excipients to achieve the desired therapeutic effects and stability.
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Digital Solutions Enhance Pharmaceutical Manufacturing Performance2/6/2026
Personalised therapies and advanced technologies are reshaping manufacturing. Explore how intelligent automation can improve flexibility, strengthen data integrity, and accelerate production.
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Why Biopharma Breakthroughs Aren't Moving The Market10/20/2025
Biopharma is innovating fast but falling short commercially. Reveal key ecosystem gaps and five strategic actions to help strengthen resilience, accelerate performance, and futureproof organizations.
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Pave The Way To High Productivity With Continuous Manufacturing For Pharma12/12/2025
Continuous manufacturing delivers agility and precision for pharma, combining automation, reduced manual steps, and quality control to meet regulatory and cost pressures while accelerating development.
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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
- 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
- How Sodium Hydroxide CIP Affects Column Performance And Resin Lifetime
- Annex 1 In Practice: Turning CCS Into Cleanroom Design
- De-Risking The Path To GMP Manufacturing At Another Organization
- Challenges And Opportunities For MSC Expansion Workflows
- Breaking The AAV Titer Barrier: A 9x Manufacturing Breakthrough
INDUSTRY NEWS
NEWSLETTER ARCHIVE
- 09.25.26 -- What Really Drives CDMO Success?
- 09.25.26 -- Shaping Drug Development By Starting With The Disease With Roche's Sylke Poehling, Ph.D.
- 09.25.26 -- Evaluating The Levers Driving Productivity In Bioprocessing
- 09.24.26 -- How Top CDMOs Are Accelerating Speed To IND
- 09.24.26 -- Transforming Computer System Validation In The Life Sciences Industry