Transition to GMP

Raw and Ancillary Materials Selection Strategy

The success of cell therapy products, including CAR-T cell therapy, is significantly dependent upon the process and material-selection strategies set in the early stages of development. To facilitate the translation into clinical trials, an ancillary (i.e. raw) material selection strategy that considers the end goal is critical. Most long-term strategies emphasize the use of the highest grade of raw materials available as early as possible; however, this may not always be feasible. Accounting for material grade transitions can help balance both performance and costs when moving onto the next stage. Since these raw materials have a significant impact on both the quality and safety of the final products, it is also important to source them from companies that can provide them at a standard that adheres to both local and international regulations.

We understand the complexity of developing an appropriate raw material selection strategy. Regardless of where you are in your cell therapy development, you can rely on us to provide high-quality and cost-effective materials of the appropriate grade that fit your process.

Why consider our GMP products?

GMP products are manufactured under a stringent quality management system that monitors the production process and quality control, while providing a comprehensive set of documentation. To support our customers with high-quality and guaranteed safe GMP products, we are fully committed to upholding the guidelines in GMP manufacturing. We extensively evaluate our products for use as ancillary materials in ex vivo manufacturing including comprehensive viral residue testing and animal in vivo safety experiments. Our strict adherence to GMP helps us bolster your IND application without disrupting your development process.