Merck is developing a 15-valent Pneumococcal Conjugate Vaccine. Vaccine licensure requires a highly tailored bioanalytical strategy and custom clinical assays. These bioanalytical assays can be the basis of licensure when immunobridging to a previously licensed vaccine. This session will detail two validated assays to support licensure: (1) Multiplex, electrochemiluminescence (ECL)-based detection assay for quantitation of IgG serotype-specific antibodies (Pn ECL) and (2) Multiplex Opsonophagocytic Assay (MOPA) for measuring the protective capacity of antibodies to pneumococci. The challenges and benefits of multiplexing will be discussed.
Upon completion, participant will be able to identify the types of bioanalytical assays needed to license a pneumococcal conjugate vaccine (PCV).
Upon completion, participant will be able to understand the rationale for the development of the IgG and MOPA assays.
Upon completion, participant will be able to recognize the challenges in clinical assay development for a PCV.