A question we often get asked is when do I need cGMP peptides? Here is a guideline:
Preclinical studies: research grade peptide (nonGMP) is sufficient for nearly all cases.
Toxicology (tox) batch: If there are no plans for use of the batch in Phase I studies, research grade (nonGMP) material is acceptable, though batch records and additional release testing are recommended. If the tox batch will also be used in later clinical studies, cGMP grade is required. There are advantages and disadvantages to each scenario.
While not a “requirement”, it is recommended to use lower purity material for tox as the related substances from the tox batch will become the basis for related substance limits in subsequent cGMP batches (related substances limits that are set tight due to the constraints of an overly pure tox batch can reduce yield and drive up costs of the subsequent cGMP batches).
Phase I and beyond: cGMP peptide is required.
Have more questions? Our experienced staff would be happy to help you determine the type of synthesis that your project needs. Contact us here.