Biologics Services

WuXi AppTec provides a comprehensive range of analytical testing services to ensure product quality and consistency during all stages of pharmaceutical and biopharmaceutical development. For biotechnology derived products as well as synthetic peptides and oligonucleotides, WuXi AppTec's testing services provide the analysis required to ensure product quality and consistency during Pre-IND; Phases I, II, and III clinical trials; and post-BLA/NDA stages of pharmaceutical development. Assays can be verified, qualified or validated at WuXi AppTec and can be run under GMP or GLP conditions.

Services Include:

  • Reference Standard Characterization
    A battery of regulatory-compliant tests needed to characterize primary and secondary reference standards are available, including methods for molecular weight and extinction coefficient determinations.
  • Detection and Estimation of Process-Related Impurities
    Includes: • Protein A • Antibiotics • Insulin / Growth Factors • Host Cell Protein and DNA (e.g., human, hamster, murine, e. coli, simian and canine)
  • Safety Tests
    The necessary safety tests that are part of any product characterization program are also available from WuXi AppTec. Safety test methods include sterility, bioburden, endotoxin (LAL), as well as mycoplasma and virus detection assays. WuXi AppTec also maintains a state-of-the-art molecular biology laboratory for the detection of viruses, mycoplasma, host cell DNA, gene/construct copy number and genetic stability studies.

Methods Available:

• HPLC (SEC, RP and IEX) • SDS PAGE • Western Blotting • Flow Cytometry • ELISA / Immunoassays • PCR and qPCR • FTIR • Karl Fischer Moisture Determination • Capillary Gel Electrophoresis (CGE) • IEF • UV Spectrophotometry • Osmolality • Amino Acid Analysis • Particulates • Mass Spectometry • Carbohydrate Analysis • Cell-Based Potency Assays • in vitro and in vivo methodologies