Process Development

Process Development for API and Intermediates

Leonides Life Sciences is an ideal contract partner for global pharmaceutical companies and offers a full range of integrated services to support the development and production of high-quality products (API and Advanced Intermediates).
We have over 20 years of extensive professional experience in developing a cost-effective, commercially viable and robust process. We have fully integrated solutions for the delivery of quality, speed, and flexibility. We have creative solutions for challenging products across all major therapeutic areas.​
We support our clients throughout all phases of API Process Development and manufacturing, including analytical R&D, stability studies, impurity/degradant profiles, and vendor qualification.
We have successfully integrated our capabilities and capacities to deliver a wide product portfolio in APIs, Advanced Intermediates, and Fine chemicals.

Our Process Development Services include but is not limited to :

  • Route scouting
  • Development of FTO (freedom to operate) or IP Protected synthetic routes
  • Development of GMP friendly Process
  • Feasibility of Route of synthesis
  • Optimization of existing/novel synthetic route
  • Optimization of process parameters using Design of Experiments (DoE)
  • Development and optimization of purification and isolation methods
  • Polymorphism study
  • Identifying the Critical process parameters
  • Impuritiy and Metabolite synthesis
  • Spike and Purge studies
  • Fate and Control
  • Genotoxic impurities evaluation /assessment
  • Validation of Process
  • Preparation of Process development report
  • Custom Synthesis from mg to multi-kilogram scale
  • Troubleshooting
  • Transfer of process into GMP
  • Isolation of active ingredients from natural sources
Our Reaction Capabilities

We take great care to make sure our products are of high quality and meet regulatory requirements. We also employ strict quality control measures to maintain product quality

To maintain our competitive edge in the production of key starting materials and intermediates, we are committed to innovation and the adoption of new technologies. By continually seeking ways to improve efficiency and embracing backward integration, we are able to gain strategic advantages over our competitors and lower costs. This allows us to stay ahead of the curve and provide our customers with the highest quality products at competitive prices.