Analytical Development

 Analytical Development And Validation Services

Synergy Bioscience offers analytical development consulting services integrated as part of a comprehensive development and manufacturing consulting program, but also as standalone services. Synergy Bioscience has experience developing analytical methods for a wide range of drug products, including small synthetic molecules and large protein molecules like enzymes, growth factors, complex glycoproteins, and novel recombinant constructs.

Services offered
  • Development of analytical methods for release testing.
  • Development and execution of characterization methods
  • Comparability studies
  • Purification and characterization of isomers, impurities, and degradants
  • In-process support during process development
Analytical Methods

Purity

  • SDS-PAGE or capillary electrophoresis-SDS
  • Isoelectric focusing (gel-based cIEF or imaged cIEF)
  • Ion-exchange HPLC
  • Size-exclusion HPLC
  • Reversed-phase or hydrophobic interaction HPLC
  • Host cell protein (HCP) ELISA
  • Residual DNA
  • Endotoxin

Primary Structure

  • Western blot
  • N-terminal Amino Acids sequencing
  • Peptide mapping for detailed primary sequence analysis by LC-MS/MS
  • Characterization of post-translational modifications by LC-MS/MS

Carbohydrate Analysis

  • Monosaccharide composition analysis
  • Sialic acid quantitation
  • N-linked glycan profiling (fluorescent HPLC and CE-LIF
  • Detailed glycan structural analysis by MALDI-TOF-MS and ESI-MS/MS

Functional Assays

  • Cell-based bioassay
  • Binding ELISA
  • Surface plasmon resonance (BIAcore) and isothermal titration calorimetry (ITC)

Protein Mass

  • High-resolution intact protein mass measurement by LC-ESI-MS
  • Intact protein mass measurement by MALDI-TOF-MS

Conformational Analysis

  • Circular dichroism (CD)
  • Fluorescence
  • Fourier transform infrared spectroscopy (FTIR)

Aggregation Analysis

  • Dynamic light-scattering (DLS)
  • Size-exclusion chromatography with multiangle laser light scattering (SEC-MALLS)
  • HIAC liquid particle counting system

Physical Properties

  • PH
  • Osmolality
  • Residual moisture by Karl Fischer

Process Residuals

  • Process residual analysis by spectrophotometric assay
  • HPLC, ELISA, or LC-MS/MS, including surfactants, methotrexate
  • Host cell protein (HCP)
  • Residual DNA (qPCR)
  • Endotoxin

To discuss how Synergy Bioscience can help you, please contact us.

Contact Us

Phone
888 – 588 – 6704

408 – 228 – 7193

469 – 304 – 9272

Email Us
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