All drugs, however they are developed, must meet stringent quality and regulatory requirements. This webinar provides insights into how UV-Visible spectroscopy supports research & development work and also shows how the technique enables quality control and regulatory compliance throughout the drug formulation, development, and manufacturing processes.
Another common use of spectrophotometric analysis is to quantify nucleic acid concentrations and to examine sample quality. The technique can identify the presence of contaminants such as phenol or chloroform, and provide critical information to enable the success of polymerase chain reactions (PCR) and next-generation sequencing (NGS) techniques. This video will review qPCR/RT-qPCR and NGS methodologies; present best practices for the determination of sample quantity and quality; and offer tips to mitigate downstream issues and ensure compliance with the 21 CFR Part 11 regulation.
Key learnings:
- Explore the complex biopharma pathway and review opportunities for enhancement with UV-Vis spectroscopic technology.
- Improve sampling process efficiency and effectiveness through essential insights into sample contamination.
- Take away key software management recommendations to safeguard data integrity and security and comply with 21 CFR Part 11 requirements.
About the speaker:
Justin Shaffer, Product Marketing Specialist
Justin Shaffer is a Product Specialist with Thermo Fisher Scientific where he provides support for both Thermo Scientific™ NanoDrop™ UV-Visible Microvolume Spectrophotometers and standard cuvette-based UV-Visible spectrophotometers. Prior to this position, he worked as a technical support member supporting NanoDrop products and before that worked as a forensic biologist. Justin has both a master’s degree in forensic science and law and a bachelor’s degree in biology from Duquesne University. Justin has extensive experience working in highly regulated environments and utilizing various techniques such as PCR, qPCR, and capillary electrophoresis.