AWERB Minutes - 15 February 2022

Minutes of a Special meeting held on Tuesday 15^th February 2022 at 2:00 pm via MS Teams

2.      AWERB Review of PPL on Control of Biological Medicines and Vaccines

The PPL Holder went through the list of comments from the AWERB review and explained how the PPL was revised to address the comments.

The suitability of title of the PPL was discussed since “control” is often associated with control testing within the institute. The PPL does not cover any protocols for control testing and the committee agreed that the title of the PPL should be changed.

The PPL includes a protocol for bleeding of NHP. The additional establishment queried whether or not blood sampling under anaesthesia was still considered mild for NHP. The NVS confirmed that this procedure was indeed considered mild. Furthermore, the committee discussed how the information for individual NHP which are moved on and off different PPLs is captured and used to ensure that individual NHP do not undergo too many procedures in a short period of time. The committee was reassured by the NVS and the NACWO that each NHP has an individual life time record which is used to discuss their future use during pre-study meetings of BSD and the PPL Holders.

There also was a discussion on whether the table listing general humane endpoints should only list the limits for moderate severity or should also include the limits for mild severity. In a previous licence (Novel Biologics for Tumour Immunotherapy), both severity limit criteria were listed whereas for this licence BSD staff felt that only the moderate severity limits should be listed. The committee again discussed how best to make sure to harmonise the wording in different PPLs.

Once all the discussed revisions are implemented on ASPeL and the additional establishment agrees to these revisions, the PPL will be ready for submission to the Home Office.

3.      Lead time for processing of PPL application by the ASRU

The NVS brought up recent communications by the ASRU informing institutes/PEL Holders that the lead time for processing of PPL applications will be up to 9 months rather than up to 3 months under the new system. This may potentially affect several PPL applications to be submitted in 2022 and the HOLC will inform the affected PPL Holders. There is a risk that it may not be possible to renew some PPLs in time before the old PPLs expire and that work under these PPLs may have to be paused for some time.

The ASRU also informed institutes/PEL Holders that establishments holding NHPs will undergo a full systems audit during 2022.

The meeting concluded at 3.34 pm.

END

These Minutes have been viewed and approved by the Establishment Licence Holder (Director of NIBSC).

Signature: REDACTED

Date: 29^th March 2022