Key Raw Materials for Cell and Gene Therapy

Category: Cell Therapy and Regenerative Medicine

Booth No: M1033

Characteristic

Seamlessly transition from preclinical to clinical research

To facilitate the transition of your cell therapy product into clinical trials and beyond, developing a raw material strategy that considers the end goal is critical. For early-stage research and development of cell therapy, research-use only (RUO) materials are most commonly used. However, as the development progresses into the preclinical or clinical phases, RUO materials that may have been sufficient before do not meet the criteria required to proceed. Most strategies emphasize the use of the highest grades 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.

ACROBiosystems offers several different grades of materials for different development stages in your cell therapy product. Premium grade materials are produced under our rigorous quality control system that incorporates a comprehensive set of tests including sterility and endotoxin tests. Product performance is carefully validated and tested for compatibility for cell culture use or any other applications in the early preclinical stage. When ready to transition into later clinical phases, we also offer a custom GMP protein service that tailors to your needs. GMP grade materials are developed using our GMP-grade quality management system platform. These products are produced with strict quality management and drug-level release testing standards. Since our premium grade components are similar to our GMP products, the transition between grades can be easily performed without further comparability studies.