From Low Purity to GMP: Rescuing a Challenging Orphan Drug

After multiple major development partners failed to scale its challenging compound to GMP standards, the client, a developer of an orphan drug for donor‑heart preservation, turned to Wilmington PharmaTech to rescue its program. By applying its disciplined, stepwise process‑chemistry strategy that combines deep synthetic expertise, carefully targeted analytical testing, and close cross‑functional alignment, Wilmington PharmaTech was able to rescue the candidate so that it could progress to the next development milestone on time, ensuring that it reliably met all quality expectations when scaled within GMP conditions. In downstream evaluation, the candidate went on to show excellent efficacy.