According to the ICH-Q6B guidelines, proteins or peptides should be characterized in terms of their visual appearance, molecular weight, isoelectric point, pH in solution, amino acid content, primary structure, and the presence of disulfide bridges.
With more than 30 years of experience in the synthesis, purification, and characterization of biochemicals, Cayman Chemical has become a leader in the field of designer drugs by providing high-purity reference standards to federally licensed laboratories.
A large number of biologics are proteins and based on the established classification of protein-structure we provide following analysis of biological products: Primary Structure Analysis, Secondary Structure Analysis & Tertiary Structure Analysis.
We provide analysis of Glycoforms and other modifications like Phosphorylation, acetylation, myrsitoylation, PEGylation, esterification using varieties of methods such as HPLC & LC-ESI-MS / MALDI-TOF, charge variants by Iso-electric focusing and N-terminal and C-Terminal sequence Analysis.
Host and process related impurities are analyzed by confirming absence or presence of host-Cell DNA and Protein by electrophoresis and mass-spectrometry based analysis. Pyrogen contents are also analyzed similarly.
Based on the formulation protein Content, Appearance, pH, Osmolarity, Composition of Key excipient including stabilizer and visible and sub-visible particles in the samples are analyzed by variety of methods.
For the purpose of efficacy and also purity and batch-to-batch consistency analysis of lipid and carbohydrate is essential in completing the characterization of biologics. We utilize variety of techniques including TLC, LC-MS, GC-MS, FACS for characterization of biologics on case by case basis.
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