The analytical development team has advanced instruments and holds extensive experience in pCQA analysis for monoclonal antibodies, bispecific antibodies, and recombinant proteins. We provide analytical method development for biotherapeutic proteins and one-stop solutions for IND/BLA submission.

Developability Study

Protein structure and activity characterization

Quality specification & SOP establishment; Method validation, verification and transfer

Quality attributes monitoring for CMC process and formulation development

Materials and documents preparation for IND/BLA filing