Testing Solutions For Viral Vector-Based Products

Gene therapy holds immense promise for treating a vast array of diseases, from inherited conditions to cancers. But a critical hurdle lies in effectively delivering the necessary genetic material into cells. Viral vectors — engineered viruses that act as microscopic couriers, carrying therapeutic genes directly into targeted cells — are a promising method for effective delivery.

The development of viral vector therapies is a rigorous process, with stringent regulations ensuring patient safety and product efficacy. This technical fact sheet outlines the various tests performed on materials such as transgene plasmids, viral vectors, isolated cells, and more. These evaluations are conducted at different stages, including raw materials testing, in-process testing, and final product testing. The goal is to confirm the presence and characteristics of the materials, ensure their purity and consistency, and verify their safety and potency.

SGS, a leading provider of analytical testing services, specializes in drug substance release assays for viral vector-based drug products. These assays encompass a wide range of tests, including physicochemical parameters, RNA sequence, purity, safety, residual plasmid and protein, and more. SGS's expertise in analytical testing ensures that these viral vector-based drug products meet regulatory standards. They offer method feasibility, development, validation, routine testing, and stability testing to ensure the quality, safety, and stability of these crucial therapies.

Stay informed about the latest advancements in gene therapy and learn how SGS can help ensure the effectiveness and safety of viral vector-based drug products.