Evaluating immunogenicity risk of complex peptide products

As a developer of complex peptide drugs (such as glucagon, liraglutide, semaglutide, teriparatide, teduglutide, nesiritide etc.), you are required to demonstrate that:

1. for each peptide-related impurity found in both the Reference Listed Drug (RLD) and the generic peptide, the level of impurity in the synthetic peptide is not higher than in the RLD;

2. the generic peptide does not contain any new impurities more than 0.5% of drug substance;

3. for such impurities present, a justification can be provided as to why the that impurity would not be expected to affect the safety of the generic peptide compared to the RLD including with respect to immunogenicity.

This can be a daunting prospect as the technical capabilities required to provide this evidence are not typically available in-house. With the regulatory requirements constantly evolving as our knowledge deepens, you need to work with a trusted partner. ProImmune has more than 10 years of experience in this specific area and we will deliver high-quality reliable data for you in a rapid timeframe and in a format that is routinely reviewed by global regulatory authorities.