The development and qualification of robust analytical assays is essential to ensure the success of cell and gene therapy (CGT) products. We have developed a wide variety of analytical assays, technologies, and protocols that have been successfully implemented in our cell processing sites.
Using a wide range of analytical technologies, we develop in-process control (IPC) and final product release tests, including identity, purity, and potency assays. These often include complex and product-specific biological assays, requiring sound scientific understanding and principles.
Selection of our in-house analytical assays
|Identity||Presence of transgene (e.g., CAR Detection Reagent) by flow cytometry|
|Cell composition analysis by flow cytometry|
|Purity||Analysis of unique surface markers using flow cytometry|
|Cell count and viability assays|
|Potency||CAR T and CAR NK cell quantification|
|Cell phenotype characterization by flow cytometry|
|Cytotoxicity / cell killing assays (ELISA)|
|Cytokine secretion analysis (MACSPlex assays)|
|RCL type assays (e.g., MACS® LentiCheck)|
|Lentiviral transduction efficiency|
|Colony Forming Unit (CFU) assays|
|Vector copy number (VCN) determination (e.g., qPCR, ddPCR)|
|Stability||Incoming and intermediate material stability|
|In-use drug product stability|
|Final drug product storage stability|
If existing analytical methods are a requirement, we are happy to transfer your protocols to our process development space for further development and characterization. Once the testing methods meet your requirements, our Manufacturing Science and Technology (MSAT) team works closely in exchange with your teams for the creation of analytical method qualification protocols, standard operating procedures (SOPs), and training sessions. Upon qualification, the methods and assays are ready to be used.
Flow cytometric analysis is central to analytical assay development, and grants evaluation of various characteristics of a CGT product during the manufacturing process, including cell viability, identity, purity, and potency. We build on decades of experience with specialized flow cytometry instruments, such as the MACSQuant Analyzer with ready-to-use flow panels for consistent and reliable analytics. Our software offers an ‘Express Mode’ module, which allows fully automated sample acquisition, data analysis, and reporting. We streamline analytical features, such as calibration, compensation, staining, and even harmonized instrument settings, across multiple devices and sites, irrespective of equipment or operator. Build your analytics on a platform that meets your requirements, from process development to commercialization.