Cell Therapy Analytical Testing Solutions

Successful approval of cell therapies depends on robust product characterization, requiring high-quality analysis for safety, quality, purity, and potency. Traditional, growth-based methods can lead to lengthy turnaround times—up to 28 days for mycoplasma detection and 5 days for sterility testing.

Applied Biosystems SEQ analytical testing solutions offer a rapid, sensitive alternative, leveraging digital PCR (dPCR) and quantitative PCR (qPCR) platforms to deliver same-day results, often in under 5 hours. These off-the-shelf molecular methods accelerate key stages of the cell therapy workflow, offering reliable performance designed to support regulatory compliance for in-process and lot-release testing.

For product safety, the MycoSEQ Plus Mycoplasma Detection Kits and SteriSEQ Rapid Sterility Testing Kits provide rapid contaminant detection. For product quality, the resDNASEQ Quantitative HEK293 DNA Kits and resDNASEQ Quantitative Plasmid DNA - Kanamycin Resistance Gene Kits allow for impurity analysis. Furthermore, the ViralSEQ Lentivirus Physical Titer Kits and ViralSEQ Lentivirus Proviral Titer Kits are available for product potency and viral vector characterization.

The full range of SEQ analytical testing solutions, complemented by automated sample preparation options, offers the scalability needed to address diverse throughput demands. Download this brochure to explore comprehensive solutions for your cell therapy analytical testing needs.