Downloads
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Recombinant Erwinia Asparaginase Production
9/16/2026
When E. coli-derived asparaginase supply failed patients with hypersensitivity, a recombinant Erwinia alternative went from project kick-off to FDA approval in approximately five years.
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What FDA Inspectors Want From Your OOS File
9/16/2026
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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You Can't CAPA What You Can't Classify
9/16/2026
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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New USP Guidelines, Standards Address Lentivirus Characterization
9/16/2026
The United States Pharmacopeia is rolling out new standards and tools to help manufacturers characterize fragile, complex lentiviral vectors.
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Viral Vector Services
9/15/2026
Fast-track your Gene Therapies from cutting-edge process development to commercial success with advanced viral vector manufacturing solutions!
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Scaling AAV Manufacturing To 1000 L: Strategies For Robust Production
9/15/2026
Learn how integrated cell line, media, and process design can support consistent AAV production at larger volumes while maintaining productivity and quality, as well as reducing scale-up risk.
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Driving Productivity Across The Antibody Manufacturing Workflow
9/14/2026
Learn how integrated upstream and downstream strategies can reduce harvest bottlenecks, improve purification efficiency, and support scalable therapeutic antibody manufacturing.
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6 Modeling Approaches That Make Complex Bioprocess Data Useful
9/14/2026
AI algorithms can reduce data dimensionality more faithfully by interpreting multivariate features relevant to prediction or control.
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De-Risking Cell Culture Media Scale-Up For Late-Stage Manufacturing
9/11/2026
Explore practical approaches to scaling cell culture media manufacturing, from supply assurance to evolving quality requirements, digital formulation tools, and strategies for controlling costs.
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Reducing Timelines And Development Costs Through Scale Up
9/11/2026
See how an engineering-based approach to bioreactor scale-up delivered comparable cell growth, metabolic profiles, and product performance across cell lines and vessel sizes, helping reduce risks.