Ajinomoto Bio-Pharma Services has developed a phase appropriate cGMP process for the production of materials suitable for use in early development and GLP pre-clinical studies. Producing these GLP-ready materials with solid documentation packages will enable the filing of investigational new drug applications (INDs) and eventually new drug applications (NDA). This process was developed using guidance from multiple regulatory agencies to adapt traditional GMP production for site specific ADC synthesis. Using this strategy, site-specific ADCs were produced on gram-scale and synthesized utilizing AJICAP™ technology.
Promising results from early technology development studies necessitated further investigation of AJICAP™ ADC materials to obtain a “homogenous DAR” ADC. Here we report our current efforts to propose site-specific conjugation followed by a preparative HIC purification strategy to obtain “DAR = 1.0” and “DAR = 2.0” AJICAP™ ADC materials respectively.
AJICAP™ technology is a novel platform for the site-selective conjugation of antibodies through the use of a class of Fc-affinity compounds to install payload-compatible linkers to well-defined amino acid residue(s).
In this poster, we present six comparative analytical methods for drug-antibody ratio (DAR) determination to apply to sitespecific ADCs, using an AJICAP™ ADC. We are also able to confirm the site-selectivity of the AJICAP™-ADCs by MS/MS peptide mapping.