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Developability &
Analytics

Industry-leading risk assessment data to enable effective
clinical strategies.

Our developability assessment expertise helps identify the physical and chemical properties of drug candidates, such as aggregation, post-translational modifications, stability, and solubility, that can negatively impact the safety, efficacy, manufacturability and ultimately the success of clinical candidates. Our approach combines in silico modeling, stress, stability and concentration tests. Our clients can enter the preclinical space with the knowledge of process parameters to mitigate liabilities that cannot be engineered out of the molecule, to help avoid costly and time-consuming formulation development efforts, and clinical failures with appropriate control strategies.

With a broad range of analytical services and capabilities, we provide our clients the tools and understanding to achieve successful biologics characterization and process development in a phase-appropriate manner. The analytics team collaborates with other teams and external partners to ensure the seamless transfer of knowledge.

We offer:

Protein
Activity

  • Binding affinity (FortéBio Octet® RED96 System, GE Biacore™ 3000)
  • Enzyme activity
  • Cell-based assays
  • In vivo testing

Protein Titer/Concentration

  • Protein A HPLC
  • ELISA
  • A280

Protein Integrity & Structure

  • Size variants by SEC-HPLC
  • Size variants by SEC-MALS
  • Size variants by CE-SDS (reduced and non-reduced)
  • Hydrophobic variants by RP-HPLC/UPLC or HIC
  • Protein purity by SDS-PAGE
  • N-glycan analysis by HILIC-FLD
  • N-glycan analysis by CE
  • Sialic acid content by DMB RP
  • Free thiol content by SEC-FLD
  • Charge variants by cIEF
  • Western Blot
  • HCP titer by ELISA
  • Residual Protein A, Protein G, Protein L by ELISA or Octet
  • Endotoxin levels by LAL

Protein Stability (Unchained Labs: Uncle)

  • Tm and Tagg
  • △G
  • Isothermal stability
  • Thermal recovery
  • Sizing and polydispersity
  • Sizing with thermal ramp
  • B22 and kD
  • Viscosity

Protein mass (Agilent HPLC- CHIP/QTOF)

  • Accurate mass: proteins, protein-drug conjugates
  • Peptide and Glycan mapping
  • Determination of post-translation modifications either in known or unknown samples
  • Standard COAs