Method Development to Monitor Adjuvant Levels in a Vaccine

Situation: Our client needed a method developed to monitor the levels of a key component of an adjuvant in their vaccine product. The adjuvant component was a high molecular weight polymeric compound with no UV chromophore. The polymer contained both strongly hydrophobic and strongly hydrophilic groups and was present in very low levels in the adjuvant matrix.

Task: Develop the new analytical method that can satisfy FDA requirements in the face of the challenges posed by the hydrophilic/hydrophobic emulsion and high ionic strength of the adjuvant matrix. AAIPharma was required to be fully prepared to justify the analytical methodology in anticipation of an FDA response.

Action: AAIPharma utilized unconventional HPLC column chemistries, and meticulous scientifically-driven solvent(s) selection which led to a successful and very efficient method development. The method is simple and robust and fully satisfies FDA and GMP requirements.

Result: The client was pleased with the analytical methodology which fully satisfied the FDA requirements. It has provided the client with reliable data and characterization of the adjuvant purity and levels in the various steps of production and final product.