Structure Characterization

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Structure Characterization

BOC Sciences provides comprehensive services in the drug development phase, using our perfect testing technology platform, as well as years of accumulated pharmaceutical testing experience in the industry, to provide high-quality and high-standard structural characterization services for your concerned biological macromolecules such as monoclonal antibody drugs, recombinant proteins and antibody-drug conjugate to customers around the world. 

At present, biological innovative drugs are the focus of new drug development, different from small molecular drugs, large molecular biological pharmaceuticals have large molecular weight, heterogeneity of structure and rich types of a post-translational modification. These changes may have an unpredictable impact on therapeutic efficacy and safety, so the structural characterization of biopharmaceuticals is the key and difficult point in the process of drug development.

Our structural characterization services include but not limited to the following:

  • Amino acid composition
  • Primary sequence analysis including N- and C-terminal truncation (peptide mapping by proteolytic digestion and LC-MS/MS, Edman degradation)
  • Peptide mapping
  • Amino acid misincorporation analysis
  • Free sulfhydryl group and disulphide bridge analysis (mis-matched bridges)
  • Carbohydrate structure determination: carbohydrate content (neutral, amino sugars, sialic acid), glycosylation site determination, antennary profile, glycan composition analysis
  • Post translational modification analysis by HRMS (Orbitrab): Deamidation, Oxidation,
  • Glycation, Glycosylation, Phosphorylation, Scrambled disulfide bridges, Truncation, N- and C-terminal modifications
  • Drug antibody ratio (DAR)

Below is a list of ourStructure Characterization Technique (include but not limited to the following):

Mass Spectrometry

Mass spectrometry (MS) is the preferred technique to determine molecular weight and fragmentation data to support structure elucidation. The use of LC-MS enables the collection of structural data for many components in a complex mixture. The mass spectrometry data can be used for both quantitative and qualitative purposes.

These NMR techniques are used to determine the assignments of all resonances for a molecule, and knowledge of the relative position of each nucleus permits the determination of the molecular conformation in solution. Quantitative and qualitative data can be obtained using NMR spectroscopy.

Scanning electron microscopy (SEM) is a microscopic morphology observation method between transmission electron microscope and optical microscope.

AFM is a type of scanning probe microscopy (SPM), with demonstrated resolution on the order of fractions of a nanometer. The information is gathered by “feeling” or “touching” the surface with a mechanical probe. Piezoelectric elements that facilitate tiny but accurate and precise movements on (electronic) command enable precise scanning.

FTIR is a technique used to obtain an infrared spectrum of absorption or emission of a solid, liquid or gas. An FTIR spectrometer simultaneously collects high-spectral-resolution data over a wide spectral range. This confers a significant advantage over a dispersive spectrometer, which measures intensity over a narrow range of wavelengths at a time.

This technique includes Debye powder photographic analysis, high temperature, normal temperature, low-temperature diffractometer, back reflection, and transmission Laue photography, quadruple diffractometer for measuring single crystal structure, and the like.

This technique can be used to:

  • Confirm the chemical structure of an API
  • Unambiguously determine the absolute configuration of all stereocenters in a molecule
  • Determine if the crystalline phase is a neat phase (pure API) or if it is a multicomponent crystal such as a hydrate or solvate
  • Determine the stoichiometric ratio of components for salts, cocrystals, hydrates and solvates
  • Uniquely identify forms and unravel the form landscape of polymorphic compounds

Why choose BOC Sciences?

BOC Sciences can provide structure characterization with high quality and short period. We have a professional pharmaceutical analysis team and advanced equipment to provide one-stop structural characterization services for drug development in preclinical research. BOC Sciences is committed to becoming the preferred partner for your drug structural characterization analysis, to help you solve the problems encountered in structural characterization, please feel free to contact us!

Process-of-Structure-Characterization

References

  1. Yıldırım, G., & Tokalıoğlu, Ş. (2016). Heavy metal speciation in various grain sizes of industrially contaminated street dust using multivariate statistical analysis. Ecotoxicol Environ Saf, 128, 266-266.
  2. Karkra, R., Kumar, P., Bansod, B. K. S., & Krishna, C. R. (2016). Analysis of heavy metal ions in potable water using soft computing technique ☆. Procedia Computer Science, 93, 988-994.
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