Cell and gene therapies are quickly becoming a promising area of medicine, with the potential to revolutionize how we treat a variety of diseases. However, the production process for these therapies is complex and requires precise monitoring to ensure efficacy and safety. Commercially available analytical assay kits have emerged as a crucial tool in this process, providing researchers and manufacturers with the ability to measure critical parameters such as purity.
This presentation will explore the various analytical solutions that are available for cell and gene therapy production. We will discuss the types of assays that are commonly used, and how these techniques can be applied to different stages of the production process. We will focus on a new, internally controlled multiplex TaqManTM-based Real-time PCRMycoplasma detection assay that enables rapid and reliable testing for lot-release testing as per regulatory guidance.
Ultimately, this presentation aims to provide attendees with a comprehensive understanding of the importance of analytical kits in cell and gene therapy production, and how they can be leveraged to improve the development and manufacturing of these life-changing therapies.