When using artificial intelligence in GMP settings, risk management extends far beyond validation. This discussion explores moving AI solutions out of the pilot phase.
- The Unspoken Truth About Cell Therapy Product Understanding
- Overcoming Recovery Challenges In AAV Production
- In Vivo CAR T Needs More Than Better Cell Engineering
- Enzyme Activity As A Surrogate Potency Marker In Cell Therapy
- Implementing And Optimizing Your eQMS
- Novel Approach To Cancer Explores Severing Its Genetic Supply Line
- Choosing Analytical Technologies At The Right Stage Of Development
- Reimagining Solid Tumor Immunotherapy With SRC-3-Edited Tregs
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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What Is Size Exclusion Chromatography (SEC)?Aggregation can compromise mAb quality at many stages of development. Learn why size exclusion chromatography is a trusted approach for detecting aggregates and supporting confident characterization.
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CDMO Live Europe 2026: Partnerships For An Uncertain World112 pages of executive insight from CDMO Live Europe 2026: tariffs, geopolitics, supply resilience, AI in manufacturing, and why strategic partnerships remain aspirational for most.
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A Toolkit For Unraveling Protein Expression PatternsLearn about a method that utilizes monoclonal antibodies and flow cytometry to analyze the metabolic state of individual immune cells, advancing immune research and immunotherapy.
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How To Effectively Manage Local Affiliate Pharmacovigilance OutsourcingManaging PV across dozens of markets strains even experienced safety teams. Learn about a framework that helps you maintain compliance, reduce risk, and scale confidently into new markets.
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Key Selection Criteria For Cell & Gene Therapy CDMOsChoosing the right CDMO requires early internal assessment plus strong technical capability, agility, advocacy, clear communication, and long‑term alignment to meet evolving cell and gene therapy needs.
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A Risk-Based Approach To Plasmid DNA And mRNA Process DevelopmentBalancing robust analytics and clinical readiness is key for early-phase pDNA and mRNA therapeutics amid structural complexity and regulatory challenges.
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IVT mRNA Encapsulation Efficiency AssessmentIn vitro transcribed mRNA revolutionizes biotherapeutics, which necessitates thorough quality assessments. See how an analyzer system enhances encapsulation efficiency and CQAs in IVT mRNA workflows.
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Efficient Protein Purification StrategiesExamine two rapid, high‑throughput strategies for small‑scale protein separation, using either multimodal resins or ion exchange membranes to achieve efficient, low‑volume purification.
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Demonstration Of Scalability For A Novel Fixed Bed Reactor PlatformDesigned to enable efficient scalability, a new FBR platform allows operators to use one technology, with a standardized workflow, for their process development, scale-up, and manufacturing processes.
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History Of Peptides In Medicine: From Early Chemistry To The GLP-1 EraPeptide therapeutics from early chemical breakthroughs to today’s metabolic drugs, highlighting scientific, clinical, and manufacturing advances shaping modern drug development.
NEWSLETTER ARCHIVE
- 08.28.26 -- OPCU: Scaling Your Program Without Creating New CDMO Risks
- 08.28.26 -- What Goes Into Restarting A Shelved Orphan Drug Candidate?
- 08.27.26 -- Meeting Modern Challenges In Ophthalmic Drug Delivery
- 08.26.26 -- Optimizing Cold Chain & Cryo Logistics
- 08.26.26 -- Clinical Success Of Combination Cell Therapy Hinges On Manufacturability
- Why Celcuity's REVTORPYK Creates A New Path For Precision Oncology
- In Vivo CAR T Needs More Than Better Cell Engineering
- Reimagining Solid Tumor Immunotherapy With SRC-3-Edited Tregs
- Building Antigen-Specific Immune Tolerance For Autoimmune Disease
- Solving Vector Yield Challenges Starts Long Before Manufacturing
CELL AND GENE CONTENT COLLECTIONS
While there are opportunities to scale, there are also manufacturing gaps, capacity issues, and production timelines that require improvement to do so. And then, of course, there’s cost. Because scale up and scale out are significant to everyone in the sector, we’ve curated insightful editorial that addresses the most important aspects of scalability.
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