WP1: Expression optimisation of lead monoclonal antibodies

The first phase of pre-clinical development of our lead monoclonals will be expression optimisation in readiness for transfer to GMP production, and also to use the process-optimised cultures to produce sufficient GLP antibody for the biological validation and also toxicology and PK studies. Therefore the objectives will be to:

  • Establish regulatory approved mammalian cell lines expressing target antibody at yields of at least 500 mg/L

  • Define an antibody purification process yielding  antibody at sufficient concentration and purity for GLP studies and suitable for transfer to GMP production

  • Perform pharmaceutical-standard stability tests on each antibody

Culture flasks