Our EU client — an established manufacturer of vaccines that are supplied globally — developed a vaccine against Hepatitis B that they had demonstrated to be clinically superior to the existing vaccines.
This was due mainly to its improved genetics enabling the viruses S, pre-S1 and pre-S2 proteins to be expressed and purified to provide an efficacious vaccine with greater than 75% seroconversion.
Our experience with a wide range of vaccines, including live, attenuated, virus vector, mRNA, etc., for a wide range of virus infections made us the client’s first choice in guiding their regulatory activities — from data collation, regulatory interactions and licence applications.
Our team managed and delivered all aspects of the clients dossier preparation, including drafting key parts of the clinical and CMC sections, BLA submission, responses of questions, and receipt of licence approval.
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