Excipient Provides Improved Performance And Stability In Vaccine Development And Final Formulations

Human serum albumin (HSA) has been used in various parts of biopharmaceutical manufacturing for its well known attributes and properties.

Of particular interest here is the stability and preservation effect that albumin has on viral vaccines. A key aspect of vaccine production is maintaining stability and function of the final product, including sustained potency and viral titer. Indeed, this knowledge has driven various preservation strategies, such as lyophilization, temperature control, and localized constitution for use. However, these are only partial solutions these strategies introduce their own challenges to vaccine stability and potency. There are chemical stabilizers and excipients formulated for vaccines, but none have been shown to be as effective as those containing HSA in combination with other excipients (e.g. sugars). HSA’s ability to serve as a preservative, protect biologics from both physical and chemical stresses, and the other advantages listed above remain unparalleled.

The objective of this poster is to demonstrate the performance and stability improvements that an rHSA Exbumin ® has on viral vaccines. Furthermore, this FDA and EMA approved excipient should be preferred in future vaccine, cell therapy, and gene therapy formulations.