Leveraging Instrumentation to Accelerate Release Testing & Minimize Human Input

Presented by Therese Choquette, Head of Analytical and Translational Sciences at Tigen Pharma This talk will focus on the analytical testing needed for the release of cell and gene therapy products. A lot of focus has been on improvements and automation of equipment used in manufacturing of cell therapies such as bioreactors. However, to improve and speed up the release testing, this needs to be done also on the analytical side. Today, in most Quality Control labs, the instruments and methods that are used for in-process and release testing are high throughput (bigger sized instruments) and require experienced analysts for the execution of the test, for example in flow cytometry. The preparation of the sample involves manual manipulation, such as for the potency assay, sometimes very extensive and lengthy before ready to be tested. Once the test is performed, the data needs to be analyzed and calculated for the reportable results, it may for example be from an ELISA for cytokines or the genetic transduction by PCR. The entire procedure from the sample preparation to the data analysis for the results provides opportunities for errors, and the manipulation of the samples can have an impact on the cells. This may decrease the precision of the assay and potentially cause Out Of Specification and delay of product release. Depending on each specific product, different analytical tests and assays are required for the release of the product. However, safety tests for determination of absence of mycoplasma, endotoxin, and bacterial and fungal contamination are mandatory for all products. No matter the type of tests or assays, there is a need for faster and less hands-on technology. Using automated instruments and methods with less manipulation of the sample and automated data analysis, offers opportunities to reduce time and costs for the release testing, as well as providing assays with improved performance and less prone for errors.