02.14.23 -- 8 Key Takeaways From FDORA

Disruptive technologies and advances in analytics are needed to enable wider application of gene therapies in a cost effective and sustainable way.

Learn the key benefits of a proprietary cryopreservation media intended for preserving cell and gene therapies for regenerative medicine applications.

Find out why the commercialization of cell and gene therapies raises several complex conversations and questions for employers and payers.

Explore the advantages and disadvantages of transient transfection and the reasons many viral vector (VV) developers are moving toward using stable producer cell lines for lentiviral vector (LV) development.

Gain a more thorough understanding of single-use technology, security of supply, and business continuity management and the need to take action to benefit from multi-site manufacturing.

Discover why CAR T cell therapy is so exciting and note some common hurdles in development and manufacturing and how ddPCR is a solution for some of these issues.

No single CDMO strategy or outsourcing model is appropriate for every project. Outsourcers can and should evaluate a strategy and partner(s) on a case-by-case basis.

This guide explores the regulatory strategy considerations sponsors should bear in mind when working with global regulation agencies, with a focus on the development of drug and biologic products.

A rationale-based methodology to address T cell manufacturing challenges, based on the intended final manufacturing process, proposes a robust, scalable, cost-effective, and sustainable allogeneic platform.

We demonstrate a turnkey solution to the complex challenge of characterizing genome-edited systems. Learn how to make genome-editing system optimization significantly easier.

Early identification of a robust, commercially available, optimized platform medium and cell line-specific feed could be the key to achieving strong productivity and delivering product to market more rapidly.

Lipid nanoparticles (LNPs) function as a drug delivery system (DDS) for nucleic acids. Learn about biomedical applications of LNPs, anatomy of LNPs, formulation optimization, and LNP safety.

There are two types of cell therapies in development: autologous and allogeneic. Each provides distinct clinical and production advantages and challenges, and therapeutic capabilities.

Explore each intertwined step in the mRNA manufacturing process and how a flexible approach can get your mRNA product to clinic and market faster.

The Nanoplasmid vector is a high-performance <500 bp antibiotic-free bacterial backbone designed to replace antiquated bacterial backbones that have for decades been the industry standard.