Safety, Identity, Strength, Quality and Purity Assessment

Specialized expertise. End-to-end solutions.

Throughout the development and release of a commercial product, a critical part of Chemistry, Manufacturing and Controls (CMC) is to establish the safety, identity, strength, quality and purity of your biologic. While we offer a complete range of CMC analytical capabilities to successfully support your biologic program, we specialize in the following:

  • Safety testing
    • Adventitious virus identification ─ Next Generation Sequencing (NGS) and bioinformatics
    • Viral clearance testing
  • Identity determination
    • High-resolution MS
    • Edman sequence analysis
    • Amino acid analysis (AAA)
    • Circular dichroism
  • Strength/potency assessment
    • Platform and custom assays─ ADCC, CDC  and more
    • In vivo USP hormone assays
  • Quality testing
    • GMP and non-GMP stability and release testing
  • Purity determination
    • Charge heterogeneity (CZE, IEX-HPLC, cIEF)
    • Size heterogeneity (CE-SDS, SDS Page, SEC-HPLC)
CMC safety testing specimen inside a bottle at a Covance lab.