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- Laura hook (Deactivated)
- Bryan Jones (Deactivated)
- Chris Lloyd (Deactivated)
- Abhinandan Raghavan (Deactivated)
- Kieran Todd (Deactivated)
Apologies
Discussion items
| Time | Item | Who |
|---|
Action items
| Output | |||
|---|---|---|---|
| 17:00 - 19:00 (120 mins) | >Populate assay table: -Gather information for all assays highlighted (based on the required pre-work) -Go through the table to agree information, check for accuracy and address gaps -Definitions less important at this stage | >Richard/All | >Correlate and establish common and uncommon assays used across organisations >Agreed level of assay 'comparability' and 'production process' dependency >Agreement on which data needs to be shared to meet our objectives |
Minutes
Assay table
>Impact of production process;
-Decision to use Likely or Unlikely categories for impact of production process.
-If impact of production process is Likely, a statement which captures the cause of the impact should be added - this approach will cover eventualities associated with change in the production process from early to later stages.
-We have to assume that the process used delivers antibodies with a 'minimum' level of purity. Post-meeting note: need to define what this purity cut-off is for each of the 3 phases.
>Likelihood of comparability;
-Decision to use High, Medium, Low data 'comparability' categories as defined.
-Reproducibility is a pre-requisite for comparability of data from an individual assay within the same organisation. Reproducibility will depend on the assay type i.e. quantitative data will be directly comparable and qualitative data will be associated to standards with numerous replicate data on the standards. Despite the likely lack of data within organisations confirming reproducibility, our underlying assumption is that individual assays within the same organisation are reproducible and thus data is comparable.
>Accelerated stability (AS);
-Decision not to focus on assays used to measure AS properties in the first instance. The type and length of stress applied to each molecule could have a significant impact on the molecule and the readout of each AS assay. As such, we predict challenges with data 'comparability' as a result of the large variability in stress conditions used at each organisation. Assays and stress conditions used for AS studies will be revisited once we have established a way forward with the assays (and data) which measure intrinsic molecular properties. Post-meeting note: check any Objectives which cannot be met due to this approach.
-Some 'standard' stress conditions exist which could form the basis for initial comparability during the Early Selection phase e.g. use of PBS as buffer and 40 Celsius up to 4 weeks. Conditions during Final Profiling and Endpoint Data phases are likely to be significantly diverse and thus comparability will be low.
>Need to define what a 'standard' glycosylation pattern is and how this is linked to immunogenicity.