I review 10 of the FDA’s guidances spanning the last 12 months, all of which aid cell and gene therapy companies to assure safety and efficacy of these medicines.
- You Can't CAPA What You Can't Classify
- New USP Guidelines, Standards Address Lentivirus Characterization
- Inside Kyverna's Autoimmune CAR T Platform Beyond SPS
- Bringing Next-Gen Sequencing To GMP Scale
- Risk Managing Through The Void Of ATMP Visible Particle Guidance
- Engineering CAR T Cells With mRNA-LNPs: Applying Oncology Learnings To Allergic Diseases
- The Promise Of MRD-Guided CAR-T Treatment
- CDMO Quality Oversight: How FDA And Pharma Leaders Are Rethinking Data, AI, And Culture
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1091167386-virus-cell]( "Virus Reduction And Impurity Removal")
Virus Reduction And Impurity RemovalExamine a DOE-based study that reveals how buffer conditions impact virus and impurity clearance using a mixed-mode resin, as well as gain practical guidance for optimizing downstream purification.
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![antibody molecules-GettyImages-2165626333]( "Building A Smarter Potency Strategy For Bispecific Antibodies")
Building A Smarter Potency Strategy For Bispecific AntibodiesA biotech company needed a regulatory-ready potency strategy for a bispecific antibody. This organization combined orthogonal analytics with functional assays.
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![GettyImages-2153976466-protein-3d-model-render]( "Measure And Control In-Line Protein Concentration")
Measure And Control In-Line Protein ConcentrationStreamline protein and antibody purification with an automated TFF system featuring real-time, in-line concentration measurement for enhanced accuracy, reliability, and cGMP compliance.
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![Scientist, laboratory, microscope analysis-GettyImages-1530246394]( "Human Platelet Lysate (hPL) Improves Expansion Of MSCs")
Human Platelet Lysate (hPL) Improves Expansion Of MSCsLearn how human platelet lysate significantly improves mesenchymal stromal/stem cell expansion and eliminates the need for plate coating, boosting yield without altering cell phenotype.
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![GettyImages-1186871650 PCR]( "Analysis Of Partial Capsids Using Empty-Full Capsid Kit")
Analysis Of Partial Capsids Using Empty-Full Capsid KitDiscover how to assess AAV genome integrity beyond ITR-2 using an extended ddPCR method for precise quantification of empty and full capsids with various genomic targets.
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![GettyImages-1354172647-scientist-in-lab-with-flasks-pipette]( "Engineering The Future Of Antibody-Drug Conjugates")
Engineering The Future Of Antibody-Drug ConjugatesAs ADCs expand into broader use, upstream process design is becoming a competitive advantage. Discover how smarter media strategies and data-driven decision-making are helping teams reduce risk.
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![GettyImages-1434627610 lab, manufacturing]( "Handle Your Large-Scale Buffer Preparation Efficiently")
Handle Your Large-Scale Buffer Preparation EfficientlyDiscover how to prepare 10x PBS using an innovative system to ensure scalable, efficient, and consistent buffer preparation for large-scale workflows.
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![Multi ethnic lab team-GettyImages-1255978257]( "Evaluating Carryover When Using A TOC Analyzer")
Evaluating Carryover When Using A TOC AnalyzerAccurate TOC results shouldn’t depend on sample order. See how low-level measurements remain reliable even after high-TOC analysis, helping reduce false positives and streamline decisions.
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![GettyImages-1069264194-syringe-filter-vial-lab]( "Protect Your Columns And Your Peaks")
Protect Your Columns And Your PeaksLearn how thoughtful filter selection can protect LC systems, improve protein recovery, and support reliable chromatographic results with key performance data and solvent compatibility insights.
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![GettyImages-1472832232 cleanroom]( "Activate Advanced Contamination Control Technology To Safeguard Your Cell Therapy")
Activate Advanced Contamination Control Technology To Safeguard Your Cell TherapyThe most common contamination risks in cell therapy manufacturing are open processes that leverage different products, inflexible instruments, labor intensive workflows, lack of in-line monitoring, and zero failure tolerance.
NEWSLETTER ARCHIVE
- 09.22.26 -- How Regeneron Navigates Early Cell And Gene Therapy Quality Risks
- 09.22.26 -- Balancing Innovation With Manufacturability When Designing Next Generation Vectors
- 09.21.26 -- CDMO Market Risk Report: Tracking Client M&A, Approvals, And FDA Rejections
- 09.18.26 -- Autoimmune CAR T Has Hit A Critical Moment. Are We Asking The Right Questions?
- 09.17.26 -- Navigating Digital Platforms For Smarter CDMO Selection
- Inside Kyverna's Autoimmune CAR T Platform Beyond SPS
- Autoimmune CAR T Has Hit A Critical Moment. Are We Asking The Right Questions?
- 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
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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