Newsletter | August 12, 2024

08.12.24 -- Working With EMA/FDA To Develop Hemgenix Potency Assays

SPONSOR

Don't miss the next Cell & Gene Live discussion on how CAR-T manufacturing has advanced recently and where it's going. Host Tyler Menichiello welcomes CTMC's Jason Bock, Ph.D., Cartesian Therapeutics' Emily English, Ph.D., and former FDA-turned Dark Horse consultant and CMC Expert, Tal Salz, Ph.D., for this digital event happening Tuesday, August 27, at 11 AM ET. Registration is free thanks to the support of CPC.

FEATURED EDITORIAL

Working With EMA/FDA To Develop Hemgenix Potency Assays

Gene therapy products are complicated, and knowing at which step to measure potency can be challenging. Here, we explore how CSL Behring addressed this issue for Hemgenix.

INDUSTRY INSIGHTS

A CDMO's Checklist For Prospective Clients: Part 2

In continuing from Part 1 of our series, we delve deeper into the crucial elements of transparency that prospective clients should consider when partnering with a CDMO.

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.

Optimizing Plasmid Production Strategies And Partnerships

To find the plasmid manufacturer with the appropriate knowledge and experience to manufacture your plasmid with quality and efficiency, you’ll need to recognize the offerings of a seasoned supplier.

Optimizing Scale-Up Of AAV Gene Therapy In Upstream Processing

Gain insight on how to achieve a 2000L scale-up by observing studies optimized through process characterization and other experimental approaches to better understand key process steps.

The Synergistic Role Of Drug Safety In Clinical Trial Operations

Delve into the significance of adept interpersonal leadership within your drug safety program, shedding light on the operational and financial benefits that stem from fostering a collaborative environment.

Building The Next Therapeutic Modality With End-To-End Product Support

Extracellular vesicles hold immense potential for treating diseases, owing to their natural biocompatibility and ability to carry a diverse arsenal of therapeutic molecules.

Secure And Industrialize Your CGT Process Towards cGMP Manufacturing

Learn the principles of commercialization readiness and guidance to address them in process development as well as the best time to implement automation and minimize commercialization risks.

SOLUTIONS

Accelerating The Customer Journey: From Discovery To Commercial Release

WuXi Advanced Therapies Capacity Update May 2024: CGT

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