Applying quality by design to vaccine development - BioProcess ...

Next Step: Target Product Profile (TPP) from A-VAX Case StudyParameterMechanism of ActionIndicationPrimary EndpointsKey ClaimsSecondary EndpointsFormulation/DosingApprovals andRecommendationsDescriptionA‐VAX is a pentavalent vaccines containing the capsularpolysaccharide (Ps) of 5 serotypes, each linked to a recombinant noninfectiousvirus‐like particle (VLP) and adjuvanted with Al salt.Expected to produced enhanced cellular and humoral antigen specificprotective immunityActive immunization of 2‐60‐month old infants and children forprevention of disease related illnesses due to causative agent70% reduction of confirmed disease within 1 year after dosing in thetarget population, Safe and tolerableFavorable risk‐benefit ration, can be dosed with other pediatricvaccines, achieves WHO stability requirementsReduction of disease specific hospitalizations and ER visits, reductionof causitive agent specific disease, duration of protection > 1 yearAntigen/Adjuvant in pre‐filled syringe or single dose vial, containerspre‐mixed prior to injection, 3 doses administered 2 months apart –preferably on standard pediatric vaccine scheduleExpecting Advisory Committee on Immunization Practices and otheruniversal recommendations23 From Clone to Clinic®