Molecular Approaches To Streamline Cell Therapy Product Analytical Testing

Cell therapies face a unique challenge: the need for urgent treatment delivery is often at odds with the lengthy turnaround times of traditional compendial safety and impurity tests, which can take days or weeks. However, to satisfy regulatory guidelines and ensure patient safety, data from these tests are essential. The rapid pace of innovation in cell therapy demands new analytical solutions that provide reliable information quickly to help meet production needs and expedite treatment.

Regulatory agencies, including the FDA and EMA, are addressing this by increasingly accepting rapid PCR or nucleic acid-based assays for critical quality attributes, provided they demonstrate results equivalent to or better than standard methods. This shift allows developers to leverage the high sensitivity of technologies like quantitative PCR (qPCR) to quickly and cost-effectively screen for microbial contaminants.

Molecular approaches offer a path to actionable results, often within five hours, without sacrificing accuracy or speed. These methods are particularly well-suited for mycoplasma contamination testing, in-process sterility testing for bacteria and fungi, and lentiviral vector quantification—three primary molecular analyses crucial for demonstrating cell therapy safety and potency. Discover how rapid molecular testing can help you maintain product integrity, avoid costly delays, and support the speedy delivery of safe, effective therapeutics. Download the full white paper.