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CBS has established and has strong expertise in utilizing orthogonal analytical techniques to characterize the structural, physicochemical, and bioactivity properties of therapeutic proteins.


Higher Order Structure analysis
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CBS has established higher order structure analysis of proteins, including secondary, tertiary, and quaternary structural and conformational profiles.

  • Secondary structure analysis by FT-IR

  • Secondary tertiary structure by far and near-UV Circular Dichroism Spectrometer (CD)

  • Higher order structure stability analysis by intrinsic fluorescence

  • Conformational and thermal stability by nano Differential Scanning Calorimetry (DSC)

  • Analysis of homogeneity and hydrodynamic radius by Dynamic Light Scattering (DLS)

  • Determination of aggregation, conformation, and shape of proteins by Analytical Ultra Centrifugation (AUC)

  • Analysis of aggregates by Size Exclusion Chromatography (SEC)

Primary Structure Analysis
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Primary structure analysis of proteins are achieved by liquid chromatography with different separation and detection techniques, including high-resolution mass spectrometer, UV, and fluorescence detection.

  • Intact mass analysis of untreated, reduced, deglycosylated, reduced and deglycosylated proteins

  • Amino acid sequence by peptide mapping

  • Amino acid composition

  • Glycosylation analysis (N-Glycan profiling and carbohydrate structure)

  • N/C-terminal sequencing

  • Disulfide bond mapping

  • Free Thiol Groups


Product Purity analysis
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CBS has implemented the separation techniques that are essential to the determination and holistic profiling of product-related substances and process-related impurities of proteins.

  • Purity and size analysis by Capillary Electrophoresis (CE-SDS), reduced and non-reduced

  • Analysis of monomer, aggregates, and fragments by Size Exclusion Chromatograph (SEC)

  • Charge purity analysis by Ion Exchange Chromatography (IEX)

  • Analysis of isoelectric point (pI) and charge purity by Imaged Capillary Isoelectric Focusing (iCIEF)

  • Purity analysis by Hydrophobic Interaction Chromatography (HIC)

  • Purity analysis by Reversed Phase Chromatography (RP-HPLC)

  • Determination of protein quantity and concentration by UV

Bioactivity analysis
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The following ligand-binding and cell-based techniques have been established to determine the bioactivity and potency of prote”ns.

  • Receptor binding assay by ELISA

  • Antibody binding assay by ELISA

  • Cell-based bioactivity assays by ELISA, including

  • Antibody-dependent cellular cytotoxicity (ADCC)

  • Complement-mediated cytotoxicity (CDC)

  • Antibody-dependent cellular phagocytosis (ADCP)

Process Impurity analysis
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CBS offers the analytical services to assess the process impurities and to facilitate the GMP manufacturing of your drug products.

  • Residual Protein A by ELISA

  • Residual host cell proteins (HCP) by ELISA

  • Residual host cell DNA by PCR

  • Endotoxins testing per USP <85>

  • Bioburden test per USP <61>

  • Sterility test per USP <71>

Related Updates in Crystal Pharmatech

Contact Us
bd_global@crystalpharmatech.com +1-609-604-8303
U.S
Suite 500-B, 3000 Eastpark Blvd, Cranbury, New Jersey 08512, USA
Canada
6800 Kitimat Rd, Unit 1, Mississauga, Ontario, Canada L5N 5M1
China
Suite B4-101, Biobay, 218 Xinghu Street, Suzhou Industrial Park, Suzhou, China, 215123
Suite 500-B, 3000 Eastpark Blvd, Cranbury, New Jersey 08512, USA
bd_global@crystalpharmatech.com +1-609-604-8303