Expedite Development While Ensuring Successful Commercial Outcomes
White Paper Jan 23, 2013
As regulatory expectations continue to evolve in the area of pharmaceutical development, working with contract research and manufacturing organizations (CRMOs) that couple execution experience with high-end technical capabilities and contemporary quality systems will ensure the most value from strategic partnerships and enhance a project’s progress on its path toward commercialization.
Pharmaceutical and biotechnology companies reap the most benefit from their strategic collaborations by working with CRMOs whose strategic and operational practices aim to combine and apply the comprehensive knowledge gained during the entire development process. The best strategies include a greater focus on process knowledge compared to a conventional milestone driven and three-batch validation strategy. This focus should be coupled with a design space framework that focuses on a true technical understanding of operations, as well as an establishment of critical process parameters, quality attributes and controls.