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Offering End-to-End Solutions
At WuXi XDC, we leverage in-house expertise and state-of-the-art analytical equipment to characterize the distinct intermediates (e.g., protein/mAb, payload and linker) and the bioconjugate or antibody drug conjugate (ADC) therapeutic candidates at various stages of development. Methods utilized to assess and characterize these complex bioconjugated molecules include UV/VIS, HPLC, cIEF, LC-MS and analytical assessment of drug-to-antibody ratio, free-drug content, ADC affinity, protein concentration, aggregation, PI, peptide mapping and potency tests.
Methods utilized to assess and characterize these complex bioconjugated molecules include (but are not limited too):
Additional Bioconjugate Characterization Capabilities:
Formulation and Drug Product Development
We offer extensive end-to-end services for formulation/process development for a wide variety of bioconjugates. Our team assists from early-stage molecular assessments to development of First-in-Human (FIH) formulations to enable clinical trial starts. Additionally, we further provide commercial formulations lock and process/device development in preparation for product launches.
We are experts in developing liquid, frozen or lyophilized dosage forms filled into vials as well as special dosage forms for products containing nanoparticles and other advanced molecular complexes.
Our services include, but are not limited to:
A partial list of key, cutting-edge equipment used in formulation development includes: