Sana Biotechnology and Mayo Clinic are partnering to standardize delivery of a one-time hypoimmune cell therapy, aiming to scale access and redefine care for type 1 diabetes.
- FDA's First cGMP Enforcement Action On AI Misuse In Drug Manufacturing
- Validating Candel's BLA-Ready Analytics Profile
- Mapping Candel Therapeutics' Sprint To The BLA Finish Line
- Why Cell And Gene Therapies Break After Early Success
- AI, Digitalization, And In Vivo Programming Redefine Cell And Gene Therapy
- Lilly's Unified Mindset For A Global Parenteral and Device Manufacturing Network
- Reprogramming T-Cell Access To Solid Tumors Through Improved Trafficking And Entry
- Why A Cell Therapy CEO Waited Until Phase III To Outsource
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
-
Automation Of 3D Intestinal Organoids Culture
Gain insight into how 3D organoids promise better disease modeling and drug screening and how challenges like assay complexity, reproducibility, and scalability hinder their widespread adoption in drug discovery.
-
Revolutionizing Drug Discovery From "Undruggables" To AI
Explore four current trends in drug discovery, how each trend addresses some of the most crucial challenges in drug discovery, and the obstacles to their widespread adoption.
-
Maintain Control Of Pharmaceutical Water Systems
Early TOC excursions often reveal hidden risks in water systems. Capturing samples at the moment of deviation helps teams confirm root causes faster, reduce uncertainty, and maintain control.
-
Handle Single-Use Technology Biopharma Waste: Data Sharing, Collaboration
Learn more about data sharing and collaboration to enable a better environmental impact of single-use technologies (SUTs) and quantifying the single-use plastic waste generated when manufacturing mAbs.
-
Streamline Your mAb Manufacturing With Strategic Development And CDMO Compatibility
Though the journey to mAb development begins at lab scale, for clinical trials and commercial distribution, a production process must be streamlined and scalable to 2,000 L production and above.
-
Automated Cell Washing And Formulation In CAR T Cell Therapy Manufacturing
Explore data collected from a study utilizing healthy donors in a typical CAR T cell processing workflow without a transduction step from a cross-site validation study.
-
Best Practices For Regulatory Excellence In Clinical Research
Observe how GCLP can integrate ethical and technical standards to ensure reliable, compliant clinical trial data and optimize laboratory operations across sponsors, CROs, and partners.
-
Ensuring Product Safety And Purity With Mycoplasma And Sterility Testing
Discover how the Applied Biosystems™ MycoSEQ™ Plus system and Applied Biosystems™ SteriSEQ™ Rapid Sterility Testing System can help accelerate your cell therapy manufacturing process.
-
TFF Cassettes With 100 kDa Membranes For RNA And LNP Applications
This study showcases the performance of regenerated cellulose flat sheet membranes with a 100 kDa molecular weight cutoff for UF/DF of RNA molecules by TFF.
-
Next-Generation CRISPR Approaches
By providing essential components like nucleases, gRNAs, and HDR templates, a reliable CDMO facilitates a seamless transition from discovery research to clinical trials and beyond.
NEWSLETTER ARCHIVE
- 04.27.26 -- March 2026 — CDMO Opportunities And Threats Report
- 04.25.26 -- Why A Cell Therapy CEO Waited Until Phase III To Outsource
- 04.24.26 -- U.S. Pharma Tariffs And MFN Become Law After April 2 Update
- 04.23.26 -- Mastering Biotech's Insourcing/Outsourcing Trade-Offs
- 04.22.26 -- Building Resilient Biomanufacturing From Media To Market
- Sana, Mayo Clinic Advance A New Model For Cell Therapy Delivery In T1D
- Reprogramming T-Cell Access To Solid Tumors Through Improved Trafficking And Entry
- Target Selection Drives The Future Of CAR T Therapy In Solid Tumors
- Mitigating Challenges In Solid Tumor Delivery
- Ensuring Quality Of CGT Materials
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