NGS enables broad detection of known and novel viruses in a single assay. Its high sensitivity, specificity, and scalability can meet GMP throughput levels.
- The Promise Of MRD-Guided CAR-T Treatment
- CDMO Quality Oversight: How FDA And Pharma Leaders Are Rethinking Data, AI, And Culture
- Autoimmune CAR T Has Hit A Critical Moment. Are We Asking The Right Questions?
- A QMS That Anticipates Cell And Gene Therapy Quality Challenges
- Using Digital Platforms To Find Your CDMO
- July 2026 — CDMO Opportunities And Threats Report
- ADC CDMO Selection For Small Biotech
- Implementing AI Solutions In GMP While Managing Risk
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1181392775 lab, research]( "Navigating The Cell And Gene Regulatory Landscape")
Navigating The Cell And Gene Regulatory LandscapeNavigating the complex regulatory landscape is essential for cell and gene therapy success. Explore key considerations, challenges, and best practices for companies operating in this space.
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![Emergent BioSolutions]( "Aseptic Filling Solution Enhances Sterility Assurance for Pharma Manufacturer")
Aseptic Filling Solution Enhances Sterility Assurance for Pharma ManufacturerEmergent BioSolutions upgraded its Winnipeg site with the Cytiva SA25 aseptic filling workcell to improve sterility assurance, product flexibility, and regulatory compliance for CGT manufacturing.
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![GettyImages-597971944-viral-vector-AAV-adeno-associated-virus]( "The Key To Viral Vector Success")
The Key To Viral Vector SuccessEstablishing a robust and scalable viral vector process requires a multidisciplinary approach that incorporates expertise in foundational science, analytics, and biomanufacturing.
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![Doctor checking patients skin-GettyImages-1094162454]( "Use Of Epiontis ID In A Phase 2 Psoriasis Trial")
Use Of Epiontis ID In A Phase 2 Psoriasis TrialMirikizumab’s Phase 2 trial explores IL-23 inhibition in psoriasis, measuring immune cell changes to assess its potential for long-term disease control and flare-up prevention.
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![GettyImages-1354172647-scientist-in-lab-with-flasks-pipette]( "Where Speed Meets Complexity In Bioprocess Development")
Where Speed Meets Complexity In Bioprocess DevelopmentBioprocessing faces mounting pressure to compress timelines, especially for mAbs, while complex modalities like bispecifics and gene therapies introduce technical challenges. Process intensification, scale-up translation, and comparability risks remain critical hurdles.
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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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![scientist in lab microscope-GettyImages-1867575565]( "Advancing IHC Assays From RUO To Clinical Trials And CDx")
Advancing IHC Assays From RUO To Clinical Trials And CDxExamine how an exploratory IHC assay evolved into a multi-indication clinical program through integrated assay development, validation, regulatory strategy, and scientific collaboration.
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![GettyImages-1181392775 lab, research]( "Predicting Antibody-Dependent Cell-Mediated Cytotoxicity")
Predicting Antibody-Dependent Cell-Mediated CytotoxicityWe developed and validated a dual screening procedure (genotype and phenotype) for Lonza human peripheral blood mononuclear cells (PBMCs) to identify donors with high ADCC potential.
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![GettyImages-1339300422 CAR T-Cell Immunotherapy]( "How To Successfully Isolate Your T Cells")
How To Successfully Isolate Your T CellsExplore the results of a study focusing on the early stages of the CAR T cell workflow, specifically the initial washing of leukapheresis followed by the isolation of T cells.
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![iStock-1213713667-viral-vector-virus]( "Smart Scale-Up: Expanding Viral Vectors With Microcarrier Bead Technology")
Smart Scale-Up: Expanding Viral Vectors With Microcarrier Bead TechnologyScale up your manufacturing of adherent cell cultures used for viral vector-based treatments with the novel technologies needed to facilitate safe, rapid production.
NEWSLETTER ARCHIVE
- 09.12.26 -- Cell & Gene Newsletter - Best Of August
- 09.11.26 -- Why Autoimmune CAR T Needs A New Patient-Centered Playbook — With Dr. Panteli Theocharous
- 09.10.26 -- Is Your Fill/Finish Strategy Ready To Scale?
- 09.10.26 -- In Vivo CAR T Needs More Than Better Cell Engineering
- 09.09.26 -- Smarter Ways To Reduce Risk, Downtime, And Lifecycle Surprises
- 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
- Building Antigen-Specific Immune Tolerance For Autoimmune Disease
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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