Formulation Development,Analytical Development

R & D

The Kirk A. Copanos R&D Laboratory is composed of two units:

Formulation Development
  • Initial formulas for new products and product improvement
  • Production of initial quantities of product used for trials and obtaining
    stability data
  • Scale-up of products through clinical-sized and production-sized lots
Analytical Development
  • Full release and stability test methods for new materials and products
  • Method validation and qualification as required by cGMPs
  • Method transfers, as required
  • Laboratory investigations as required by CAPAs, RCAs and cGMPs
  • Detailed testing for improved accuracy and reduced costs