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Product hub: How can CGT manufacturers ensure product safety with Microbial Solutions QC test methods?

Posted: 31 August 2022 | | No comments yet

Innovation forms the basis of every emerging technology. That is certainly the case with cell and gene therapies (CGTs), and the search for efficient quality control (QC) test methods continues to grow in this pharmaceutical sector. One of the most important factors to consider while deciding on a QC method for CGTs is the time to release a high-quality product, given that developing and manufacturing these therapies is already time consuming and complex.

QC testing validation is a mandatory step to meet strict regulatory requirements and routine inspections. Given the complex nature of cell and gene therapies (CGTs) and their unique manufacturing processes, certain challenges arise which require identifying the best QC testing support options available.

Charles River Microbial Solutions offers an extensive portfolio of products and services that are compliant with the current advanced therapy medicinal products (ATMPs) regulations. The following sections provide an understanding of the critical role these products and technologies play in reducing the time constraints and quality issues that may arise during and after manufacturing.