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.