Safety, Identity, Strength, Purity and Quality (SISPQ)

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)