API Manufacturing

Case study

API manufacturing at Axplora

Optimizing production of a high-volume multi-step oncology API through a multi-site strategy

Axplora is an expert in API (Active Pharmaceutical Ingredient) manufacturing with over 30 years’ experience and offers services from process development to commercial manufacturing in full regulatory compliance and secure supply chain.

Following the FDA approval, a global pharmaceutical company requested Axplora to manufacture the API at multi-tons scale for commercial needs and build up safety stocks.

Highlights:

  • Successful multi-site strategy
  • Increase batch size
  • Validation of each step transferred