Process Chemistry Services

Avista Pharma Solutions is driven by an established, committed and innovative team with specific strengths in custom synthesis, route scouting, process optimization, solid state chemistry, analytical development and cGMP manufacturing.

 

Avista Pharma Solutions provides research and process chemistry services to the chemical community to support development programs from preclinical through commercial manufacturing. Avista Pharma has a proven track record of confronting and resolving challenges associated with the development of complex synthetic organic chemistry projects as well as providing process optimization expertise for challenging API development programs. Our multi-disciplinary team of scientists includes experienced personnel from a variety of big pharma research organizations. Expertise in cGMP manufacturing, together with operations out of a fully equipped, state-of-the-art laboratory, ensure that all projects are delivered in-full, on-time and with a high degree of quality. A dedicated project manager ensures execution of the full scope of work in each contract and full client satisfaction in all aspects of the project(s).

 

Avista Pharma’s best-in-class areas of synthetic expertise include:

 

  • Terpenoid glycosides
  • Carbohydrates
  • Glycolipids
  • Cyclic peptides
  • Biopolymers
  • Oxaboroles
  • Macrolides
  • Heterocycles

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

Process Optimization

Avista Pharma’s process optimization strategy involves phase-appropriate process optimization to ensure that the API laboratory and manufacturing process is developed in a safe, robust and cost-effective manner as possible.  During early phases of work, process optimization centers on improving the yield and purity of each stage to deliver API of suitable quality for its intended use.  As the program matures, attention turns to developing the design space, identifying quality-critical parameters and building a data package to support quality-by-design filings and technology transfers to manufacturing.