10.15.24 -- When Should You Select Your Supply Partner?

Chemistry, manufacturing, and controls (CMC) source documents are the foundation for module 3 of a cell/gene therapy FDA regulatory submission.

Acumen Pharmaceuticals, a clinical-stage biopharmaceutical developing a novel therapeutic for the treatment of Alzheimer’s, selected its manufacturing partner early on, and told the world about it. Chief Editor Louis Garguilo asked the chief development officer about that strategy.

Chief Editor Louis Garguilo instigates a bit of philosophic thought in panelists Sriram Naganathan, REVOLUTION Biologics, and Kirsteen Keith, Immunocore, when it comes to strategic alliances with CDMOs.

We report on the use of a novel lipid nanoparticle (LNP) reagent in a validated protocol to achieve successful complex gene editing in primary T cells with high efficiency while maintaining high cell viability.

There are a number of technology solutions that, when applied to a cell and gene therapy workflow, can streamline development and improve workflow integration.

See how a next-generation rAAV production platform delivers high yields and superior product quality across various serotypes and genome lengths through innovative process optimization.

A robust pharmaceutical quality system is pivotal in achieving safe and efficient drug manufacturing. Learn more about its importance and the optimal methods for implementation. 

The integrity of your master cell bank (MCB) is paramount key in the production of advanced therapies. Selecting a provider with specialized expertise, optimal storage facilities, and meticulous record-keeping is crucial.

The integrity of your master cell bank (MCB) is crucial for advanced therapy production. Choosing a provider with specialized expertise, top-tier storage, and precise record-keeping is essential.

Discover a ready-to-use, suspension-based platform technology for transient transfection of LVVs that eliminates the need to transition from small-scale adherent processes.

Partner Week is back this October! From 10/21 through 10/25, hear from CDMOs across Fill/Finish, Large Molecule, Small Molecule, Cell & Gene, and our newest addition: ADC. Bring your questions and requirements, skip the small talk, and get right down to the business of finding the best-fit partner for your short- and longer-term drug development needs. Register for free at this link.

This revolutionary enzyme delivers enhanced safety, cost-effectiveness, and performance, empowering researchers to unlock the full potential of mRNA therapeutics.

Examine our platform analytical and process technologies designed to accelerate the development of your cell therapy, gene therapy, or vaccine drug product.

Discover comprehensive genomics solutions to advance your clinical trials, with tailored support from expert teams, state-of-the-art technologies, and a focus on oncology and beyond.