What synthesis approach should be taken for a toxicology (tox) and Phase I batch?

There are typically 2 approaches for a tox and Phase I batch. Here are a few guidelines:

Two batch approach:
A tox batch (nonGMP with batch records, additional release testing, and purposefully targets a lower purity) for a GLP tox study, followed by a cGMP clinical batch for a Phase 1 clinical trial (that has a higher purity than the tox batch & sets individual related substance limits based on the tox lot).

One batch approach:
A single cGMP batch to be used for both tox and Phase 1 that will have identical impurity profiles.
There are advantages and disadvantages to be considered for each scenario.

Have more questions? Our experienced staff would be happy to help you determine the type of strategy that your project needs. Contact us here.

Additional Resources:

When do I need cGMP peptides?

What does cGMP mean?

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