Newsletter | June 10, 2024

06.10.24 -- Understanding FDA's Draft Guidance On Human- And Animal-Derived Materials In The Manufacture Of CGT Products


With additional cell therapy approvals on the horizon, a diverse array of products and platforms are needed to ensure safety and efficacy in manufacturing, increase speed to market, and decrease overall COGS. Join Cell & Gene Live for a digital discussion on the next generation of platforms and innovative technologies. Registration is free thanks to the support of Invetech.


The Next Frontier: Industrializing Cell Therapy Manufacturing

Uncover how leveraging platform processes can enable flexible service at each level – pre-clinical through commercial – and reduce development timelines and costs on the path to market.

Improving iPSC Allogeneic Cell Therapy Precision Via Advanced Gene Editing

Learn how researchers are leveraging CRISPR nucleases, employing single cell cloning techniques, optimizing delivery methods, and refining guide RNA design to enhance the safety and efficacy of iPSCs.

Top Tips For Taming CRO Turnover

Employee turnover, even during complex clinical trials, should never be the breaking point of a project. Avoid these instances and keep studies on track by developing proactive employee retention strategies.

Innovations In ADC Technologies

Examine the drivers behind the recent successes in the clinic, current challenges with development and manufacturing, and what the future might hold for the ADC industry.

The Landscape, Modalities, And Logistics Of CGTs

Explore the latest market trends and the nuances of various cell and gene therapy modalities, along with the logistical considerations necessary to safeguard product quality and safety.

Championing Change: Optimizing Plasmid Production Strategies

As you search for a supplier best suited to help manufacture your product, prioritize the CDMO with previous plasmid production experience needed to avoid common manufacturing obstacles.


Understanding FDA's Draft Guidance On Human- And Animal-Derived Materials In The Manufacture Of Cell And Gene Therapy Products

Here, the authors provide a summary of the new draft guidance, Considerations for the Use of Human- and Animal-Derived Materials in the Manufacture of Cellular and Gene Therapy and Tissue-Engineered Medical Products — and learn what's shocking about it.

Best Practices For Effective Donor Management

Starting with high quality donor material is critical for allogeneic cell therapy drug manufacturing, and this requires laying the groundwork for a high-touch, end-to-end donor pool management strategy.


Analytical Testing Capabilities

Sonexus Access And Patient Support: Supporting Patients At Every Step

A New Horizon In AAV cGMP Gene Therapy Manufacturing

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