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
-
Enhanced Validation Data Anti-EGFRvIII Recombinant Antibody
Select the right antibody clone by exploring enhanced validation data for top recombinant antibody clones that offer comprehensive specificity and sensitivity insights tailored to your project's unique requirements.
-
Drug Development Plan Explained: DPP Templates And Examples
Only 6.7% of Phase 1 drugs reach approval. A well-structured Drug Development Plan (DDP) can meaningfully improve your odds — learn exactly how to build one.
-
CDMO Selection For Small Biotech: Amit Jain On Avoiding Costly Transfers
Make smarter outsourcing decisions early. Reduce the risk of costly tech transfers, evaluate capacity needs, speed development timelines, and strengthen manufacturing partnerships.
-
Matrigel Dome Assay And Drug Screening Of Colorectal Cancer Organoids
Using CRC organoids and bioprinting, explore the automation of dome assays to evaluate drug responses and delve into the insights from image-based end-point assays on the efficacy of anti-cancer treatments.
-
Overcome Patient-Level Access Barriers For New Medicine
Explore market access from the patient’s perspective and identify five aspects of how people get hold of medicine that should inform commercialization.
-
Microbial Recovery And Flow Performance With Membranes
Compare membrane materials and pore sizes to assess their impact on flow rate and microbial recovery. See how fast filtration and ≥90% organism recovery offer guidance for selecting reliable membranes.
-
Decoding AAV: Navigating Critical Quality Attributes And Their Analytics
For groundbreaking genetic treatments, stringent quality control is non-negotiable. This exploration delves into defining essential attributes and the analytical tools that safeguard their consistent production.
-
Standardizing Cryopreservation For Cell Therapy Supply Chains
Explore how a standardized cryopreservation process is transforming leukapheresis handling by reducing risk and improving quality across the cell therapy supply chain.
-
Risk Assessment Services Align With FDA Guidance For Gene-Edited Human Gene Therapy Products
Navigate the FDA's gene therapy guidelines with advanced risk assessment strategies. Optimize gene editing and ensure regulatory alignment for safer, more effective therapies.
-
A Comparison To Traditional Clone Screening Platforms
See how 46 CHO clones performed across automated, deep-well, and microbioreactor fed-batch cultures, using cell density, viability, and IgG concentration to evaluate clone performance.
NEWSLETTER ARCHIVE
- 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
- 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
- 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.
More Content Collections