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Highlighting requirements of the "Laboratory Evaluation" stage in order for successful biologics translation.
RESEARCH GRADE BIOLOGIC:
Align form of biologic(proteins, antibodies (appropriate IgG backbone) or derivatives, peptide, oligonucleotides, vaccines) to indication/route of administration/immune response needs.
Considerations should include:
- Production and selecting of “clones/cell lines”
- Mammalian or bacterial production
LABORATORY EVALUATION:
Laboratory evaluation is a crucially important step to develop early Proof-of-Concept and secure follow-on funding. This includes:
- Humanisation
- ‘In-house’ development and target validation
- Consider which PoC animal models are appropriate for target and biologic modality
UCL Support:
The Translational Research Group (TRG) and the Biologics TIN have extensive knowledge of early stage biologics development and can provide advice to guide development, as well as longer-term considerations for future translation.
FINANCE:
Regardless of altruistic drivers, development of biologics has significant costs that must be met and VAT needs to be added for manufacturing and/or services not resulting in a medicinal product.
UCL Support:
The TRG supports UCL researchers in attracting and managing public, commercial, investor and philanthropic funding for the development of biologics, pre-clinical studies and ultimately clinical studies. Clinical studies need to be appropriately costed in partnership with the JRO or appropriate CTU.