Newsletter | February 26, 2024

02.26.24 -- Paving The Way For India's First Domestic CAR-T Approval

FROM THE EDITOR

Paving The Way For India’s First Domestic CAR-T Approval

India recently saw the approval of its first domestic CAR T cell therapy, NexCAR19, marking a significant achievement for the country and the CGT industry as a whole. To learn more about this journey to approval, I met with ImmunoACT, the pioneer behind NexCAR19.

FEATURED EDITORIAL

Accelerating Future Approvals

Dr. Peter Marks shares what he and his team have learned from current gene therapy approvals to accelerate future approvals.

INDUSTRY INSIGHTS

Choosing A CDMO: Top 10 Intangibles Biotech Firms Should Consider

Selecting a CDMO isn't just a transactional relationship. Consider this when forming a long-term partnership and how it can impact the success of your current product and benefit future manufacturing.

Earning RMAT Designation - What Developers Need To Know

Explore a high-level overview of the Regenerative Medicine Advanced Therapy designation and how to ensure success and accelerate advanced therapy products toward commercialization.

Create The Correct Checklist To Land The Best CDMO

Discover how to construct an agreement between partners that favors fluid communication and alignment of business objectives — crucial for a fruitful CDMO relationship to diminish risk for both.

Scale Up Allogeneic Cell Therapies To Large Patient Populations

Achieve your therapeutic and commercial goals by utilizing a tried-and-tested standardized approach combined with the latest technology and reliable analytics.

Monitoring Cord Blood Inventory Reliability By Key Quality Indicators

Validated processing methods and storage conditions are the first steps toward providing a safe and effective product for transplant. Review a retrospective analysis of a final verification process.

SOLUTIONS

Cell And Gene Therapies – Changing The Healthcare Landscape

Leveraging Expertise For Plasmid Production Success

Scalable, cGMP-Ready AAV And LV Platform Processes

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