Formulation, stability, and delivery of live attenuated vaccines for humanuse

The successful use of live attenuated viral and bacterial vaccines depends not only on the proper choice and delivery of the microorganisms, but also on maintaining the sufficient potency required for an immune response. The inherent lability of live organisms presents a particular formulation chall enge in terms of stabilizing and preserving vaccine viability during manufa cturing, storage, and administration. This review examines pharmaceutical a pproaches to the stabilization, formulation, and lyophilization of biologic al macromolecules in general, as well as the specific applicability of thes e principles to live attenuated viral and bacterial vaccines . Several form ulation development case studies with live vaccines are presented. In addit ion, comparative stability data are summarized for many other live viral an d bacterial preparations. Various pharmaceutical issues with conventional a nd novel delivery systems for administration of parenteral and oral live va ccines are also discussed.