Re-cloning, strain development and antigen presentation
During the re-cloning, strain development and antigen presentation stage of pre-clinical development lead candidate vaccines will be refined and optimised in order to provide optimal responses within in-vitro and in-vivo vaccine screening studies. This will involve manipulation of the lead candidate vaccine to ensure that it is presented to the immune system in an appropriate manner in order to elicit a protective immune response following immunisation. The correct presentation and 3D structure of the vaccine antigen will be critical to the quality of the response elicited within the host. The time required to complete this step will be dependent on level of work required but it is likely to take a minimum of 6-12 months.
The critical steps will include the re-cloning of the vaccine antigen to ensure that it is delivered in the correct manner when inoculated into a host, the development of the vaccine stain to ensure that it can be produced optimally in vitro and the study of the configuration in which the vaccine antigen is presented to the immune system.
There are not likely to be any bottlenecks within this process apart from having sufficient resources to conduct the laboratory work.
No rate limiting capacity issues.