After a small molecule has been identified as a viable drug candidate, substantial testing is required to assure that chemical and structural integrity are preserved throughout the drug development process to maintain its functionality. To keep a balance between quality and manufacturability, time-consuming and labor-intensive testing and analysis are required to demonstrate that chemical integrity is intact. Among the techniques used to study changes in chemical integrity are infrared and Raman spectroscopy.
This webcast will discuss where efficiencies can be made in data collection, regulatory compliance, instrument qualification, method validation, and data integrity all along the drug development pipeline up to final quality control (QC) testing. Learn how to quickly identify changes in polymorphic structure, monitor API to excipient distribution, and troubleshoot out-of-specification (OOS) product lots, while preserving data integrity needed for audits.
Key Learning Objectives
- Where along the drug development path can FTIR, NIR and Raman techniques be used and what knowledge is gained
- How to minimize the number of laborious steps in analytical method validation, verification, and transfer to QC and manufacturing
- What to look for in a hardware-software platform to not only assure drug formulation integrity but also data integrity
- Mike Bradley, Sr. Product Manager – Raman Spectroscopy, Thermo Fisher Scientific
- Katherine Paulsen, Product Manager – FTIR Spectroscopy, Thermo Fisher Scientific
- Mike Garry, Sr. Product Manager – NIR Spectroscopy, Thermo Fisher Scientific