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SPECIALIZED EXPERTISE. END-TO-END SOLUTIONS

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 biological 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)