Comprehensive CMC-QC Solutions For Cell Therapy

Cell therapy quality control is critical for ensuring the safety and efficacy of treatments, spanning research to clinical applications. It involves rigorous processes to maintain preparation stability, validate multiple batches, and adhere to strict standard operating procedures (SOPs). ​Key areas include CAR/TCR detection, residual testing, and potency assays, which are essential for maintaining high-quality standards.

Solutions such as fluorescent-labeled proteins, residual DNA/RNA detection kits, enzyme activity assays, and cytokine release assays provide robust tools for monitoring and optimizing cell therapy processes. These tools help detect residual host cell materials, antibiotics, and endotoxins while assessing therapeutic potency through cytokine release and activation assays. ​By leveraging these advanced solutions, researchers and clinicians can ensure the reliability and consistency of cell therapy products.

Discover the full range of solutions and learn how they can enhance your cell therapy quality control processes.