Enhanced Stability and Improved Manufacturability of High Value Adenovirus Vaccines using a Proven Proprietary Formulation Technology

Adenovirus (AdV) vectors are used as a viral based delivery system and are currently in 24% of gene therapy clinical trials that are on-going, as well as being under development in areas such as HIV vaccine development. AdV vectors have poor stability meaning that storage conditions are restricted to a frozen or a lyophilised state with significant implications relating to cost and convenience. As the use of AdV vectors increases it is becoming more of a necessity to develop stable liquid AdV formulations. This will allow ease of transport worldwide, ease of administration and a significant reduction in cost. The key deliverable of this project is to develop stable liquid formulations of AdV vectors with critical quality attributes acceptable for use in injectable products. We will use two AdV vectors as models for formulation development, which will use FDA approved excipients, using Arestat™ stabilisation technologies. Arestat™ is a proprietary formulation technology allowing the design of novel liquid formulations of biologics with superior stability. The technology has been validated on a wide range of recombinant proteins and other biologics in collaboration with major pharma companies, but application to more complex biological systems, such as AdV vectors, is yet to be validated and poses various risks due to the increased complexity. The key objective will be to develop a formulation that would ideally have =2 years shelf-life at 2-8°C, sufficient stability at ambient temperatures, with a minimum of 3 month stability at 25°C to allow for short term storage and handling temperature excursion in the field without refrigeration and to be stable following multiple freeze/thaw cycles. The development of this formulation will significantly enhance the utility of AdV as a vector for human gene therapy, creating significant value in this rapidly developing therapeutic area.