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Product Quality

The cornerstone of any product development and manufacturing effort is the analytical characterization of the product and testing of all raw materials, bulk solutions, in-process materials, and finished product.

Our well-designed analytical programs satisfy regulatory requirements to assure the success of the clinical program. Our dedicated analytical scientists customize phase-appropriate analytical programs to the specific needs of your unique molecule, delivering a comprehensive understanding and characterization of the molecule for each stage of development and commercialization.

Reference lots or standards are incorporated throughout the analytical program and are utilized as controls for assays used during the development and characterization of your product. Every time your drug product is manufactured, we compare your drug product against the standard to ensure it has comparable quality, purity, strength, and consistency.

Analytical Capabilities Our on-site laboratories are equipped with sophisticated analytical instrumentation, enabling scientists to employ a full range of methodologies and techniques to characterize your product and develop test methods that will validate your product’s integrity throughout its life cycle.

Primary Structure Analysis

  • Peptide mapping via UV-HPLC or LC/MS/MS (QTOF, Ion Trap)
  • Peptide sequencing via LC/MS/MS (QTOF, Ion Trap)

Biophysical Characterization

  • Multi-angle light scattering (MALS)
  • Circular dichroism (CD)
  • Fourier-Transform infrared spectroscopy (FTIR)
  • Differential scanning calorimetry (DSC)
  • Dynamic light scattering (DLS)
  • Second-derivative UV spectroscopy
  • UV/VIS spectroscopy
  • Electrophoretic mobility (Zeta-potential)

Glycan Analysis

  • Monosaccharide composition
  • Oligosaccharide mapping
  • Sialic acid quantitation

HPLC

  • Size-exclusion chromatography
  • Ion-exchange chromatography
  • Affinity-based chromatography
  • Reversed-phase chromatography

Capillary and Conventional Gel Electrophoresis

  • Capillary isoelectric focusing (cIEF)
  • SDS-PAGE
  • Western blot

Process Residuals

  • ELISA
  • qPCR
  • HPLC (antibiotics, IPTG, surfactants, etc.)

Potency Assays

  • Enzymatic activity assays

Particulate Analysis, Including Sub-10 Micron Particle Characterization

  • Microscopic-flow imaging (MFI)
  • Asymmetric-flow field flow fractionation (A4F)
  • Sub-10 micron particle characterization

Mass Spectrometry (QTOF, ION TRAP)

  • Intact mass mapping
  • Disulfide mapping
  • PEGylation site identification
  • Peptide mapping with LC/MS or LC/MS/MS
  • Identify post translational modifications (oxidation, deamidation)
  • Glycan characterization & linkage-site identification