Determination of the theoretical (!) molar extinction coefficient by the amino acid sequence of a biomolecule is i.a. well known in pharmaceutical industry. However, according to ICHQ6 guidelines the theoretical value ought to be supported by an empirically (!) determined value for the drug product at least once.
At ProJect Pharmaceutics, we are able to determine the extinction coefficient experimentally using an absolute gravimetric determination approach. Thereby, we are able to consider not only the protein primary sequence but also glycosylation as part of the overall protein mass.
If you also need support determining the molar extinction coefficient of your biological product empirically, contact us.
