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-1396008671 RNA, DNA sequencing]( "Epigenetics Application Guide: RNA Modifications")
Epigenetics Application Guide: RNA ModificationsLearn about the rapidly evolving field of RNA modifications, including innovative techniques like miCLIP and RIP for mapping chemical modifications and understanding RNA’s role in cellular processes.
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![GettyImages-1426756188-scientists-in-lab-with-computer-analyzing]( "Scaling Investigational Drug Services: A Case Study in Overcoming Operational Bottlenecks")
Scaling Investigational Drug Services: A Case Study in Overcoming Operational BottlenecksAre operational bottlenecks holding back your research site? Explore a blueprint for automating investigational product workflows and giving staff time back for patient care.
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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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![GettyImages-2148703252-DNA-helix-blue]( "Automated Library Prep For Nanopore Human Whole Genome Sequencing")
Automated Library Prep For Nanopore Human Whole Genome SequencingGain insight into an automated high‑input workflow that streamlines long‑read whole‑genome library prep, supporting large DNA fragments while reducing reagent use.
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![GettyImages-1225652892-amino-acid-chain-3d-render]( "Surveying Amino Acid Variability Among CHO Media")
Surveying Amino Acid Variability Among CHO MediaVariability in amino acid levels across CHO media can affect growth and product quality. Learn why real-time monitoring and proactive control strategies are key to improving process consistency.
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![GettyImages-2187764040-cell-culture-testing-manufacturing-in-lab]( "A Comprehensive Solution For Adventitious Agent Testing")
A Comprehensive Solution For Adventitious Agent TestingModern sequencing methods offer sensitive detection of adventitious and species‑specific viruses. Learn how targeted and non‑targeted NGS approaches improve confidence in cell bank characterization.
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![GettyImages-2148703240 DNA]( "Single-Use Innovation For The Future Of Therapeutic Manufacturing")
Single-Use Innovation For The Future Of Therapeutic ManufacturingGain insight into these end-to-end plasmid DNA solutions, leveraging robust cGMP-compliant processes and single-use manufacturing platforms to accelerate your cell and gene therapy programs.
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![GettyImages-1293879301-scientists-inspecting-analyzing-lab]( "Sample Clean-Up After N-Linked Glycan Release And Labeling")
Sample Clean-Up After N-Linked Glycan Release And LabelingGlycan profiling starts with effective clean-up. See how comparable recovery across key labeled glycans and sialylated glycan groups can support confident analysis while helping labs manage costs.
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![GettyImages-1987435635 research, planning]( "Rescuing A Global Program For NDA Success")
Rescuing A Global Program For NDA SuccessExplore the collaboration that enabled FDA approval of a novel chronic-condition therapy, rescued a high-risk program, and demonstrated a unified “one-team” approach by reworking the sponsor's SAP.
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![Proconnex]( "Control pH Adjustment And Reduce Complexity")
Control pH Adjustment And Reduce ComplexityLearn how automated, banded pH control uses dose-and-wait logic to limit overshoot, account for mixing and buffer effects, and maintain stable setpoints across changing fill volumes.
NEWSLETTER ARCHIVE
- 09.17.26 -- Navigating Digital Platforms For Smarter CDMO Selection
- 09.16.26 -- Strategies To Boost Yield, Speed IND Timelines, And Scale AAV Manufacturing
- 09.16.26 -- Novel Approach To Cancer Explores Severing Its Genetic Supply Line
- 09.15.26 -- Consequences Of Environmental Residues In Cleanrooms
- 09.15.26 -- Fixing AAV Recovery With Siren Biotechnology's Nathalie Clément, Ph.D.
- 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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