Successful development of vaccines and biologics poses some unique challenges: they are not as well defined as small molecules. Hence the process of making them needs to be well characterized and controlled by meaningful biological measures. This in turn requires the development of clinical and biological measures that link product characterization and release with clinical outcomes. Vaccines and biologics also require sterile manufacturing and substantial early capital investment, because the lack of a complete definition of the product emphasizes the importance of the production process and increases the need for establishment of a final manufacturing process before phase III, which is sometimes before clinical proof of concept. Therefore and because phase III studies can be large and costly, early markers or predictors of clinical success are particularly important. Vaccines are mostly used to prevent, not treat diseases, in otherwise healthy populations - requiring a high safety standard and a well thought through benefit risk assessment. In addition, they are often licensed based on correlates or surrogates of protection rather than based on direct controlled clinical efficacy data. The assays and clinical trials to support such indications therefore have unique requirements as well.
Vaccines and biologics development - for the reasons listed above - is a highly collaborative process between several disciplines.
Philimmune provides expertise in medicine, clinical and regulatory development and analytical sciences to support successful development and registration of vaccines and biologics.
