Cell Therapy Lot Release Package

A complete, cGMP-compliant solution for cell therapy lot release is essential to meet strict regulatory standards and accelerate therapeutic delivery. This testing package covers all critical aspects of product evaluation, including identity confirmation through STR analysis and flow cytometry, cell morphology, viability, and vector copy number assessment. Potency assays and population analysis ensure functional integrity, while safety testing addresses sterility, mycoplasma, endotoxin levels, and viral contamination. Additional risk-based evaluations include species-specific virus detection, replication-competent virus screening, and residual process impurity checks. General characteristics such as color, pH, and osmolality are also measured to maintain consistency and quality.

Beyond lot release, services extend to full cell line characterization and cGMP manufacturing of working and master cell banks, supporting the entire development lifecycle. With decades of bioanalytical expertise and proven regulatory success across global health authorities, this testing framework ensures reliability, compliance, and patient safety. Designed for precision and speed, it enables advanced therapy developers to confidently move products from manufacturing to market.