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Antibody Drug Conjugates

Technologies & Platforms

We provide a comprehensive range of high-quality analytical assays to characterize protein therapeutics. Whether characterizing the original or subsequent reference standards, evaluating production lots to those standards or performing comparability studies of biosimilars or biobetters, we have the full-range of methodologies (Table 1) available to provide the detailed analysis required to pass scientific and worldwide regulatory standards.

Full in-house Analytical Methodologies

Table 1
Quantity
  • Protein concentration by UV280, etc.
Potency by bioassay and biological characterization
  • Cell-based or binding ELISA assays
  • Fc Functional assays
Physiochemical property
  • Aggregation (SEC)
  • Fragmentation (CE-SDS)
  • Charge variants (IEX, cIEF) and pI determination (cIEF)
  • Appearance, pH, osmolality
Biochemical and biophysical characterization
  • Intact mass analysis (LC/MS)
  • Primary sequence analysis and PTMs (Peptide map HPLC/MS/MS)
  • Glycan profiling (HPLC or UPLC)
  • CD, DLS, DSC, SEC-MALS

Product Biochemical and Biophysical Characterization Capabilities

Mass Analysis
  • Intact Mass
  • Reduced Mass
  • Deglycosylated Mass
Peptide Mapping
  • Amino acid sequence coverage analysis
  • Degradation pathways: oxidation, deamidation, fragmentation, etc.
  • Disulfide bond analysis
  • Peptide mapping for ID
  • Peptide mapping for product and impurity characterization
  • Stability Study
Glycosylation/Carbohydrate
  • Quick N-Glycan analysis
  • N-glycosylation ID and analysis by FL and HILIC-MS
  • N and O-glycosylation ID and analysis by glycopeptides using RPLC-MS
  • N-glycosylation sites
  • O-glycosylation sites
  • Monosaccharides
  • Sialic acids
  • M6P
Higher order structures
  • CD
  • Far UV for 2⁰ Structure
  • Near UV for 3⁰ Structure
  • Fluorescence
  • DSC
  • SEC-MALS
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