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.