Process Development Research

Avista Pharma’s process chemists have extensive experience in pharmaceutical process development (PD) research. Investment in PD research often reduces the cost of goods associated with an API through optimization or replacement of expensive and/or inefficient synthetic operations. If necessary, re-design of an entire manufacturing route can be executed in order to facilitate material throughput in support of a development program. Avista Pharma strives to rapidly deliver innovative technologies to solve PD challenges and advance development programs. Our process research team works closely with the analytical research and development (ARD) team to integrate chemistry and analytical controls into the process at an early stage of the project.

 

Avista Pharma’s best-in-class services for Process Development Research include:

  • Discovery chemistry intermediates and analogs preparation from milligram to kilogram scale
  • Custom synthesis
  • Route discovery, selection and definition
  • Process improvement and optimization
  • Robustness and process limits testing
  • Synthesis of analytical reference standards
  • Metabolite, degradant and impurity synthesis
  • Reference standards and impurity qualification
  • Impurity isolation, identification and structure elucidation
  • Preparative chiral and achiral chromatography (LC, SFC)
  • pGTI identification and method development
  • Quality by Design (QbD) process evaluation
  • Statistical Design of Experiments (DOE)
  • Determination of critical process parameters (CPP) and critical quality attributes (CQA)
  • Process scale-up and demonstration
  • Solid state chemistry –salt selection, polymorph screening, amorphous dispersions, crystallization development
  • Hazard evaluation
  • Phase appropriate analytical method development