Early Process Development
In order to alleviate some of the process development challenges later in the map, many organisations may attempt to engage in early process development. The purpose of this step is to down select from several clones/candidates a number of candidates that may be easier to manufacture at scale. Antigens can be subject to shear-intensive processing environments that mean their yields and robustness is unsuitable for large-scale manufacturing. By engaging in some early stage process development it may be possible to identify problems early in order to mitigate them – or if required, to go back to re-cloning, strain development, and antigen presentation to generate better candidates.