One-stop antibody & bioconjugation CMC platform
9 months from Sequence to ADC Tox batch completion
ADCs are formed by connecting an antibody (Ab) to a cytotoxic payload drug using a small molecular linker. The development of ADCs is a complex, multi-faceted process requiring diverse expertise, technologies, and approaches.
With extensive experience in handling antibody and protein CMC projects, GenScript ProBio integrates its expertise in antibody fast CMC and its experience in conjugation process development and analytical development to build up a one-stop ADC CMC solution for ADC and AXC projects.
Bioconjugation Process Development
AXC Project Experience
The laboratories of ADC conjugation process development and formulation development are equipped with OEB-5 level isolators, which support the conjugation of multiple types of payloads.
GenScript ProBio established platform methods for structure confirmation, physiochemical properties, bioactivity, and impurity analysis of naked antibody and ADC. We will evaluate the impact of bioconjugation to antibody primary structure and its bioactivity, define the conjugation site(s), DAR values, and payload distribution, as well as conduct qualitative and quantitative evaluation for impurities (e.g., residual payload, residual solvents and heavy metals) introduced from bioconjugation process.
A variety of instruments and equipment and a dedicated cell engineering team are in place to support ADC method development and qualification, as well as extended characterization.
Single-use Conjugation Reactor
Automatic Filling Machine