摘要 : Although aluminum-containing adjuvants have been used in vaccine formulations to potentiate immune responses since 1926, their properties and interactions with antigens have been poorly understood until recently. This lack of info... 展开 Although aluminum-containing adjuvants have been used in vaccine formulations to potentiate immune responses since 1926, their properties and interactions with antigens have been poorly understood until recently. This lack of information has historically led to a trial and error approach to the development of vaccine dosage forms using aluminum-containing adjuvants. Based on an improved understanding of the chemistry and immunopotentiation properties of aluminum-containing adjuvants, amore rational approach to optimizing vaccine formulation in terms of potency and stability is now possible. An essential element in modern vaccine formulation development is the identification of key properties of the antigen and aluminum-containing adjuvant in advance of the actual formulation and stability studies. The information gathered in these studies can provide important physicochemical data to guide in the systematic design of stable and efficacious vaccine formulations. The small molecule drug industry realized the need to fully characterize the drug and excipients prior to the formulation process long ago and termed this function “preformulation”. More recently, preformulation studies have become an increasingly common step in the development of biopharmaceutical drugs such as monoclonal antibodies. We believe that it is time to invest in more extensive preformulation studies as presented in Table 1 to develop the most effective aluminum adjuvantcontaining vaccines. 收起