Viral Vectors in Vogue
We must collaborate to address stability challenges in viral vector manufacturing
Arvind Srivastava | | Opinion
Rapid advances in cell and gene therapy development have led to new approvals, but commercialization has introduced a whole raft of new challenges. How do we produce these therapies safely, cost-effectively, and in time to meet growing global health needs? Stable, safe workflows for viral vector processes are critical; after all, the vector is the delivery mechanism for the therapy. The vector manufacturing process includes vector amplification, expansion and purification steps, followed by fill and finish.
Over time, vectors may undergo undesirable changes, such as aggregation, unfolding, surface absorption, oxidation and deamidation during storage, shipping and handling, which can cause the vector to fail in properly delivering the therapeutic (1, 2). Manufacturers – and the companies that supply critical raw materials to them – must examine how viral vector stability can be affected, and then consider how to solve these challenges to ultimately improve the end product delivered to the patient.
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