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Analysis Methods Development

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

Services Offered

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