Development of a novel robust clone for the manufacturing of AVID100 biosimilar
AVID100 is an antibody-drug conjugate (ADC) against a validated cancer target that is undergoing IND-enabling studies. Phase I clinical trials are scheduled for late 2016. The monoclonal antibody (mAb) portion of the ADC is currently manufactured using a recombinant CHO clone that fails to meet industrial production yield standards. In order to support clinical phases II and III as well as commercial supply a higher-expressing cell line must be developed. MAb product characteristics will need to be similar to the current clone, namely with regards to the N-glycan composition. We will thus develop an accelerated clone selection process using a fluorescence activated cell sorter combined with a high-resolution imaging system for monoclonality demonstration. A micro-bioreactor system will be used to rapidly compare multiple clones to select for stability, productivity and N-glycan profile. Manufacturing cost reductions and improved clinical supply risk mitigation are the partner’s intended benefits.
Voir la description complète du projetYves Durocher
Formation Biologics Inc
Life Sciences
Manufacturing
Université de Montréal
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