Formosa Laboratories (Formosa Labs) provides one-stop solution for Antibody-Drug Conjugates (ADCs) manufacturing from antibody production through domestic alliance, to in-house toxin-linker CMC services and antibody bioconjugation for drug substance (DS), and finally through to cytotoxic fill-finish drug product (DP) manufacturing. To demonstrate our capability, Formosa Labs is developing a biosimilar of ado-trastuzumab emtansine (biosimilar Kadcyla), which is available for co-development or out-licensing. Integrated ADC CMC Service Ability and Capability Process Experience Expertise with more than 10 ADCs conjugated lysine, cysteine, and proprietary linkage technologies Post-conjugation ADC purification and characterization:  ÄKTA AVANT 150 mg to g scale   Full Characterization UV-Vis analysis (Nanodrop 2000) LC: & HIC / SEC / PLRP (Waters Bio-UPLC, Agilent) CE-SDS & cIEF assay (Beckman PA800) ELISA reader (Biotek Synergy H1) TOF MS (Waters Vion IMS QTOF)

Process Research

Analytical Support

Regulatory Service