Technology digest: Mitigating cell culture variability with robust screening of raw materials
Advanced therapies, including cell and gene therapies, are complex biological products that are strongly impacted by the characteristics of the materials and processes involved in their manufacture. Good manufacturing practice guidelines cover key considerations around manufacturing, including eliminating the risk of cross-contamination and potential presence of disease agents, as terminal sterilization is impossible.
Given the inherent variability in biological materials, quality and regulatory requirements for advanced therapies manufacturing necessitate consistency and reliability in documented supply chains and processes.
In association with
