Structure Characterization

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Structure Characterization

BOC Sciences provides comprehensive and high-quality services for each step in drug development, using our technology platform, as well as years of testing experience. We help to characterize your biological macromolecules such as monoclonal antibody drugs, recombinant proteins and antibody-drug conjugate.

At present, innovative biologics are the focus of new drug development. Different from small molecules, large molecule biologics have heterogenous structure and different forms of a post-translational modifications, which could potentially impact the efficacy and safety of the therapeutics. To minimize this impact, it is important to perform structure characterization for each large molecular drug during 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 disulfide 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 our Structure Characterization Techniques (include but not limited to):

Mass Spectrometry

Mass spectrometry (MS) is the preferred technique to determine molecular weight and fragmentation. The use of LC-MS enables the collection of structural data for many components in a complex mixture. Data obtained by mass spectrometry 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 high-quality structure information of a compound within a short period of time. Our team of analysts uses advanced instruments to help your drug development efforts. BOC Sciences is committed to become a preferred partner for your drug structural characterization analysis. 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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