This playbook explores biologics safety, regulatory compliance, NGS innovations, virus detection, and advanced therapy quality assurance.
Biologics and cell- and gene-based therapies are already benefitting many patients around the globe. But for innovative new treatments to reach their potential to improve patient lives they must be proven safe and adhere to a variety of regulations.
Biologics and cell- and gene-based therapies pose the risk of contamination because they are manufactured using viral vectors, genetic material, and living cells. Fortunately, innovations in next-generation sequencing (NGS) are evolving quickly to help ensure the safety of advanced therapies. Download this playbook to understand:
- How regulations such as CFR 21 Part 11 and ICH Q5A(R2) apply to biologics and cell- and gene-based therapies.
- The limits of polymerase chain reaction (PCR) and cytopathic effect (CPE) tests to detect adventitious viruses in biologics and cell- and gene-based therapies
- The efficiency and flexibility of NGS-based approaches to adventitious virus detection.
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