This document outlines the scope of work and details necessary to provide a proposal for transfer of the current procedures for producing and testing research supplies, manufacture, and qualification of master cell banks (MCB) and viral stocks (MVSS), analytical methods development and qualification, production of reference standard, process development and scale-up, cGMP manufacturing of vHCA8*, and drug substance and drug product stability testing. It is important to note that, due to the nature of the vector, sterile filtration of the drug product is not possible and all manufacturing steps – upstream, downstream, and formulation/fill of drug product – must be performed under aseptic processing conditions.