Being able to measure the protein concentration of your product will allow you to demonstrate consistency between different batches and control over your manufacturing process. BioPharmaSpec can provide both an estimation and a determination of extinction coefficient and our scientists are on hand to discuss the right solution for your biopharmaceutical and stage of development.
Estimation of Extinction Coefficient
BioPharmaSpec uses OPA/FMOC pre column derivatisation chemistry to analyze amino acids hydrolyzed from proteins and glycoproteins. The derivatized products are analyzed by UPLC with fluorescence detection. The data obtained can be used to assess amino acid molar ratio (against expected) and estimate the protein concentration and extinction coefficient.
Determination of Extinction Coefficient
An accurate determination of the extinction coefficient becomes essential when you start to consider the dosage of your product. BioPharmaSpec scientists can help you understand when a determination of the extinction coefficient of your product, rather than an experimental estimation, is required. We will use our working knowledge of ICH guideline ICH Q2(R1) to perform a qualification of the UV spectrophotometry and amino acid analysis for the product.