US immunogenicity specialist EpiVax Inc and not-for-profit scientific corporation CUBRC Inc announced on Thursday that they have received a contract from the Office of Generic Drugs (OGD) of the US Food and Drug Administration (FDA) to develop standardised controls for T cell assays performed to evaluate the immunogenicity risk of generic drugs in support of abbreviated new drug applications (ANDAs).

This contract is valued at USD2m and is for a period of two years. It is intended to establish new standards that may be used to improve specificity and sensitivity across industry assay methods.

The new FDA-funded collaboration is based on research conducted by EpiVax during two previous FDA contracts that assessed the immunogenicity risk of generic drug impurities. As part of the first contract, EpiVax demonstrated the value of in silico and in vitro methods for immunogenicity risk evaluation of two well-known generic peptide drugs. In the second contract, EpiVax developed the What-if Machine (WhIM), an algorithm engineered to conduct iterative modifications to the amino acid sequence of a synthetic peptide drug (in silico), generating a comprehensive list of impurities for that sequence, and prospectively identifying high and low risk impurities to enable the de-risking of drug products.