eBook: analytical methods for viral vector development and manufacturing in gene therapy
Gene therapy is one of the most innovative therapies in the world. By the end of 2022, there were 24 gene therapies approved (five of which happened in 2022) and more than 2000 clinical trials being conducted worldwide, including genetically-modified cell therapies.
As with any other therapeutic product, the development and manufacturing of viral vectors for gene therapy must follow Good Practice (GxP) regulations. A Good Manufacturing Practice (GMP)-compliant process for viral vectors must ensure consistent quality in the vector’s potency (biological activity), purity (absence of contaminants or impurities) and safety (absence of potentially harmful substances). To achieve this, various Critical Quality Attributes (CQAs) are monitored during the manufacturing process by measuring key properties and ensuring that they are within the appropriate levels. Quick, reliable and high-throughput analytical methods to assess these CQAs are essential in process development and later GMP-compliant testing for batch release during quality control. Given that automated liquid handlers dramatically improve the reproducibility of results and the traceability of samples, they are inherently suitable for high-level regulatory compliance.
Chapters included in this eBook:
- Review of the gene therapy field
- Automation of analytical assays during viral vector development and manufacturing
- What Hamilton can offer
In association with
