Guidance for Vaccine Licensure may Speed Modifications

May 1, 2013 — 

The USDA Animal and Plant Health Inspection Service Veterinary Service has issued a memorandum providing guidance to licensees, permittees, and applicants, regarding the licensure of Production Platforms used for recombinant, non-replicating, nonviable constructs, intended for use as biological products.

Advances in molecular biology have resulted in the development of manufacturing processes of genetic recombinant constructs varying only with respect to the inclusion of one or a few specific gene inserts utilizing essentially identical procedures and components. This type of manufacturing process referred to as a Production Platform offers a consistent manufacturing process for incorporating gene inserts of contemporary microorganisms into biological products, resulting in a finished product that is available more rapidly than a product that is developed by conventional approaches. In addition, the process is well defined and expected to be consistent with respect to the product safety profile, testing methods, and manufacturing equipment and reagents.

This approach will allow a more rapid response to emerging diseases resulting from antigenic shift and drift and/or may be used in cases where the culture requirements for an infectious organism are difficult to reproduce in vitro and/or culture of the live organism poses a human or animal health hazard.

The CVB will consider conditional license applications for products based on Production Platform technology that result in a recombinant, non-replicating, nonviable construct intended for use as biological products in which the Master Sequence for the protective gene or genes may be exchanged post-licensure without requiring additional field safety studies or reevaluation for compliance with the National Environmental Policy Act (NEPA).

This policy is applicable to all biological products; however, a determination will be made by the CVB regarding the appropriateness of the proposed Production Platform and its use. The CVB will base its consideration on the disease agent, animal and public health concerns, as well as the impact on the environment, disease surveillance, and commerce. Product applications are limited to non-replicating, nonviable recombinant constructs that result in biological products. Each product will be limited to a single disease agent and specific gene or set of genes, the sequences of which are to be provided to the CVB.

Source: USDA VS Memorandum 460