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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

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

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

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

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

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>

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Contact Us
bd_global@crystalpharmatech.com +1-609-604-8303
Suite 500-B, 3000 Eastpark Blvd, Cranbury, New Jersey 08512, USA
6800 Kitimat Rd, Unit 1, Mississauga, Ontario, Canada L5N 5M1
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