The increasing complexity of new chemical entities (NCEs) entering the drug pipeline has seen a greater demand for highly potent active pharmaceutical ingredients (HPAPI). Sterling has invested in its capability to stay ahead of the demand for the development and manufacture of these molecules. Sterling’s Germantown, US facility offers state of the art solutions in containment and process risk mitigation in order for its customers to safely and efficiently develop and manufacture Highly Potent API.

Highly Potent API facility

Capabilities:

Our Germantown facility contains two state-of-the-art Highly Potent API manufacturing suites which meet global cGMP regulatory requirements and are FDA approved.

  • Two fully qualified cGMP suites up to 10 Kg batch size:
    • Primary containment and engineering controls for nanogram-level containment
    • Dedicated utility and support systems for superior reliance and control
    • Distillation, cryogenic and hydrogenation capabilities
    • Aurora filter isolation, drying and packaging
  • Expert support in areas of quality and hazard risk assessment along with mitigation
  • Full development and QC support