Fill / finish
- It is not uncommon that a GMP manufacturer does not have fill finish on site. Instead, it is common practise that the bulk drug substance is made at one manufacturer and shipped to a second site, sometimes a contractor, to fill the final drug product. Depending on the type of vaccine being filled and the number of doses required; identifying a suitable fill finish site could be a bottleneck that adds delays to the manufacturing process.
- Furthermore, once a suitable fill finish site has been identified, finding a suitable production slot within the site’s production calendar can also become limiting. Therefore, early consultation and booking is required to minimise delays.