Taking Care of Cell Therapy Quality Control

T cells play a big role in bringing cell and gene therapies to patients. Despite this clinical potential, scientists developing T cell therapies such as chimeric antigen receptor (CAR)-T cells, tumor-infiltrating lymphocytes (TILs), and regulatory T cells (Tregs) are often hindered by the need to scale up while meeting stringent quality control requirements.¹ Optimized chemistry, manufacturing, and control (CMC) production processes are key to addressing these challenges.

Developing effective T cell-based therapeutics involves multiple intricate cell culture manufacturing steps, including ex vivo activation, expansion, and genetic modification.² Additionally, scientists must safeguard against introducing exogenous contaminants such as bacteria, fungi, mycoplasma, and viruses into raw materials, cell substrates, and production products across all steps of a workflow.

Taking careful quality control steps into account early and often helps reduce the risk of exogenous factor contamination in final therapeutic products and improves production throughput and process robustness. Optimizing and standardizing CMC processes with the right reagents supports consistent production of high-quality, therapeutically effective T cells.

For instance, regulatory agencies across the globe have established standardized safety requirements and recommendations. This includes the use of GMP-grade materials and reagents in cell therapy production, such as the materials for CMC production processes from ACROBiosystems. These high-quality solutions encompass reagents for T cell culturing, activation, and engineering, CMC process purification, and residue detection. They are designed to support innovation, grow alongside therapeutic manufacturing, and scale-up when entering commercialization, starting from discovery and development and to the adoption of cells in the clinic.

Learn more about materials for CMC production processes.