Assay Development: Vaccines
Lab Manager Magazine
Vaccine development is a long, intensive process that begins with the determination of public health needs and priorities. Several organizations have compiled priorities for research and development, including the World Health Organization/United Nations Development Program for Vaccine Development. There are several stages of vaccine development and testing, beginning with an exploratory stage to identify natural or synthetic antigens. Next, pre-clinical work begins and cell culture and animal models are used to determine the immunogenicity and safety of a vaccine candidate. Following the approval of an Investigational New Drug application to the US Food and Drug Administration, clinical trials may begin. Specialized assays are developed in the pre-clinical and early clinical trial phases, and are validated in later clinical trial phases. Prior to lot release, assays have well-characterized parameters and criteria, although the assay development process is not without challenges. The immune system is highly complex; however, new technologies and techniques offer solutions. Eventually, a successful vaccine candidate will progress through to Phase III trials and be licensed. The entire rigorous process can take upwards of 15 years to complete.