SWAT Team Description: Provide cross-cutting support to COVID-19 vaccine developers in the area of Drug Substance (DS) and Drug Product (DP) scale-up and scale-out, supply chain and release assays.
Co-Leads: Ingrid Kromann and Nicolas Havelange (CEPI), Gavi, and BMGF
The manufacturing SWAT will like to make attention to the updated list of OMCLs with capabilities that are considered to be relevant for the different categories for COVID-19 vaccine candidates PA/PH/OMCL (20) 96 R2.
This update replaces the previous version which was in force from 15/09/2020 and includes updates regarding the technique of affinity characterisation by Fortebio and the e-mail address of the ANSM contact.
The list was created by the EU OCABR network together with EDQM in order to help organise EU Official Control Authority Batch Release for candidate COVID-19 vaccines as smoothly as possible. It is intended to help manufacturers identify potential partners to set up OCABR arrangements and begin test transfer. The list will in addition be available to involved manufacturers on request from EDQM at email@example.com.
Please note that the list is not exhaustive and is intended only to provide a snapshot of capabilities. OMCLs have been surveyed based on current knowledge of potential control strategies for different vaccine platforms as communicated from manufacturers or authorities. Additional updates may be relevant as more information is received from manufacturers regarding their testing strategies.