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.
Related White Papers
8 Reasons why it’s Time to Upgrade to Automated ImagingWhite Paper
Why automated image analysis is rapidly replacing manual microscopy for characterizing particle shape and how combining it with Raman spectroscopy adds chemical identification.READ MORE
7 Key Factors When Considering a Benchtop X-ray DiffractometerWhite Paper
In this white paper, our marketing director of the America’s Kathy Macchiarola outlines the important decisions factors that are key requirements and help you select a benchtop system ideal for your situation and your needs.READ MORE
Supporting the Pharmaceutical Industry with 21 CFR Part 11 Compliance ReadinessWhite Paper
The purpose of this document is to describe how PANalytical systems support system owners meeting the requirements of the 21 CFR Part 11 regulations issued by the United States’ FDA.READ MORE
World Congress on Bio-organic and Medicinal Chemistry
Nov 12 - Nov 13, 2018