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Small Molecule API and Intermediates CDMO Services

To Build the World’s leading Pharma Solutions Platform

Small Molecule API and Intermediates CDMO Services

Process Route Design, Development And Optimization.

With industry-leading expertise and a highly experienced pool of scientists, Porton has helped clients develop more than 1,200 Active Pharmaceutical Ingredients (API) and advanced intermediates, among which more than 200 New Chemical Entities (NCEs) have been approved in global markets. Operating with rigorous precision and speed, we take a “Fit for Purpose”, phase-appropriate approach to drug development.

Route Design and Scouting

  • Design and explore a new route of synthesis
  • Develop a route of synthesis with a benchmark of 2~3 steps/week for route scouting. Our process chemists have ready access to LC-MS, GC-MS and NMR
  • Quickly develop and optimize key steps using parallel reactors and high throughput screening platforms
  • Evaluate new technologies for quick feasibility impact studies of recalcitrant chemical steps
  • Safely handle and scale hazardous reactions

Process Development and Optimization

  • Develop a Fit-for-Purpose process development and control strategy
  • Perform process development and synthesis of API to support GLP TOX and clinical studies
  • Develop final process suitable for commercial production and supply
  • Optimize process to improve robustness and output while reducing cost
  • Screen and optimize any high-cost catalysts using high throughput
  • Perform salt screening, polymorph screening, polymorph characterization, salt selection and process development
  • Develop API recrystallization process and optimize crystallization process
  • Conduct impurity profile analysis, impurity characterization, synthesis and specifications setting
  • Apply Process Analysis Technology (PAT) to support process development, e.g. online IR, online HPLC and FBRM
  • Apply Quality by Design (QbD) principles for process development, e.g. to utilize Statistical Design of Experiments (DOE) to study the Design Space
  • Handle high potency compounds with OEL<0.1ug/ m³
  • Process safety test and evaluation with RC1, DSC, TGA, ARC, TSU, etc.
  • Support process development with chemical engineering simulation (e.g. filtration rate simulation, O2 content control evaluation) and project transfer equipment risk evaluation (e.g. selection of reactor and agitator, rectification parameters and azeotropy efficiency simulation)

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