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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Using Client Centricity As Fuel For Innovative Biologics Development And Manufacturing Solutions
Complex biologics require flexible development, advanced analytics, and quality by design. Learn how collaborative bioprocessing reduces risk, enables efficient scale‑up, and supports clinical success.
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Enhancing Biopharmaceutical Production Through Advanced Mixing6/30/2026
Eliminate particulate contamination and product degradation in downstream bioprocessing. Learn how frictionless, levitating impeller technology ensures low-shear mixing and high yields.
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Assessing A Targeted Molecular Method Against Traditional In Vitro Testing For Adventitious Virus Detection10/3/2024
Discover a CHO AOF panel that provides rapid detection of relevant adventitious viral contaminants in bulk harvest material, and explore data showing equivalent sensitivity to the in vitro assay.
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Assuring Multipotency Of Human Mesenchymal Stem Cells (hMSCs)4/4/2025
Stem cell research has revolutionized tissue repair and regenerative medicine. Discover how mesenchymal stem cells play a key role and offer insights into connective tissue repair, immune response, and inflammatory diseases.
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A Comprehensive Solution For Adventitious Agent Testing2/13/2026
Modern sequencing methods offer sensitive detection of adventitious and species‑specific viruses. Learn how targeted and non‑targeted NGS approaches improve confidence in cell bank characterization.
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A Comparative Analysis Between Liquid Nitrogen And Mechanical Freezers9/23/2025
Explore the differences between liquid nitrogen and mechanical cryogenic freezers, and learn how each method supports scientific, medical, and industrial storage needs.
BIOPROCESSING APP NOTES & CASE STUDIES
- mRNA Manufacturing With Fed-Batch In Vitro Transcription
- Boston Scientific: Strengthening Asset Control And Operational Visibility
- Contamination Control Strategies For Innovation And Regulatory Compliance
- End-To-End Workflow Integration For Antibody Development
- A High-Throughput Platform For Fast And Reliable Clone Screening
- 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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NEWSLETTER ARCHIVE
- 09.24.26 -- How Top CDMOs Are Accelerating Speed To IND
- 09.24.26 -- Transforming Computer System Validation In The Life Sciences Industry
- 09.23.26 -- From Development Strategy To Market Entry
- 09.23.26 -- Reducing Risk Across The Pharma Supply Chain
- 09.23.26 -- Risk Managing Through The Void Of ATMP Visible Particle Guidance