This article captures key takeaways from a BioProcess International keynote by Preeya Boppana, director of MSAT process analytics and laboratories at AstraZeneca, titled “Transforming Biologics Manufacturing: Leveraging Predictive Analytics and Advanced Process Control for Next-Generation Operations.”
- ICH M4Q(R2) And M16 Modernize The CTD For Digital Submissions
- Prioritizing Quality Over Everything
- Building Sustainable Biopharma Supply Chains Starts With Procurement
- Engineering Better ADCs, Part 1: MoA, Conjugation Chemistry, And More
- Sustainable Facility Design Brings Bayer Instant Savings
- Why You Should Measure Comparability Debt Before Ever Starting A Study
- What FDA Inspectors Want From Your OOS File
EDITOR'S DESK
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Overcoming Recovery Challenges In AAV Production
Siren 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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Engineering Better ADCs, Part 1: MoA, Conjugation Chemistry, And More
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.
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Building Sustainable Biopharma Supply Chains Starts With Procurement
Nearly 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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Sustainable Facility Design Brings Bayer Instant Savings
ROI 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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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.
BIOPROCESSING WHITE PAPERS
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Biomanufacturing Readiness: A Validation Model For Multiproduct Facilities
Optimize your validation strategy to meet evolving regulatory demands and product complexities with a scalable, efficient framework that accelerates facility readiness and ensures consistent quality.
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Aseptic Process Design And Simulation Under Annex 1 Guidelines1/9/2026
Gain insight into how Annex 1 reshapes aseptic process validation, as well as into risk reduction by design and why isolators are redefining modern sterile manufacturing standards.
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The Current And Future Value Of mRNA Vaccines And Therapeutics2/4/2026
Discover how decades of research have propelled mRNA technology to the forefront of therapeutic development and learn how our expertise is advancing mRNA drug development.
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Challenges, Methods, And Solutions For Obtaining Optimal Starting Material6/3/2025
For innovative treatments like CAR-T and stem cell transplants, optimal starting material is key. Understanding collection challenges and new solutions helps ensure the best foundation for these therapies.
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Isolate Bright GFP-Expressing HEK293 Cells For Cell Line Development Workflow11/7/2025
Explore a high-efficiency workflow for isolating and expanding GFP-expressing HEK293 cells that enables stable, bright clones ideal for imaging and tracking to simplify clonal development.
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A Guide To Accelerating Cell Line Development For Commercial Production7/11/2025
Explore the challenges associated with cell line development in the production of biologics, and solutions that can help biotech developers evade the pitfalls of misinformed decision-making.
BIOPROCESSING APP NOTES & CASE STUDIES
- 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
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
- Lessons In Building Connected Lab Operations Across Development And GMP
- Advancing The Human Liver-Chip Toward FDA Qualification
- Evaluating Modular CAR T Manufacturing Workflows
- IND In As Little As 6 Months: Now Beyond mAbs - Accelerating Bispecifics, Fc-Fusions And High-Concentration Biologics To The Clinic
- Scaling Cell And Gene Therapy Manufacturing
INDUSTRY NEWS
NEWSLETTER ARCHIVE
- 09.30.26 -- From Nanomedicine To Manufacturing: New Insights From Ardena
- 09.30.26 -- Fill/Finish Robotics Are Reshaping Aseptic Manufacturing
- 09.30.26 -- The Levers And Tradeoffs That Drive Process Productivity
- 09.29.26 -- Modularity And Flexibility For Single-Use Biopharma Assemblies
- 09.29.26 -- Why You Should Measure Comparability Debt Before Ever Starting A Study