Mastering Complexity: Turning a Challenging API Into a Fully Validated GMP Process
Over the past ten years, Seqens has partnered with a rapidly growing European biotech to transform a highly challenging small‑molecule candidate, from an immature laboratory route with low yields and impurity risks, into a fully industrialized, validated GMP process now running at up to 2.5 tons.
What you will learn in this article is:
- How we redesign the API route with impurity profile control
- QbD‑driven process and analytical development
- Robust scale‑up from grams to tons
- Seamless multi‑site technology transfer
- Dedicated CMC project management and global regulatory support
Early solid‑state studies secured the API form, and data‑driven scale‑up, supported by DoE, kinetic modelling, and statistical tools, ensured scale-up from gram to industrial production. The outcome is a validated, industrial‑grade, five‑step isolated GMP process delivering high‑purity API at ton scale, demonstrating Seqens’ capability to solve complex chemistry challenges, industrialize routes, and deliver secure, inspection‑ready clinical and pre‑commercial supply.
