Optimizing drug development involves employing key tools to assess and maintain quality. Cambrex, a contract development and manufacturing organization (CDMO), utilizes its expertise in analytical services and process development to help clients navigate the complexities of nitrosamine risk management in pharmaceutical development. Join our experts – Todd Sprouse, Associate Director, Analytical Services and Benjamin Foust, Senior Manager, Process Chemistry – at NC Biotech as they share practical, phase-appropriate strategies and real-world examples to help you safeguard product quality and compliance.

What You’ll Learn:

• Phase-appropriate assessment and control strategies for nitrosamines
• Preliminary process reviews and risk assessments to identify and mitigate nitrosamine formation pathways
• Small-molecule nitrosamine formation and Nitrosamine Drug Substance-Related Impurities (NDSRIs)
• Advanced characterization and quantification techniques for sensitive detection of nitrosamines
• Best practices for the synthesis and qualification of reference materials to support robust analytical method development

Date and Time: Thursday, December 11^th, 11:30am – 1:00pm

• 11:30am – 12:00pm: Networking and Seating
• 12:00pm – 1:00pm: Presentation and Lunch

Location: NC Biotech Center – 15 TW Alexander Drive, Durham, NC 27713

Lunch will be provided. Please let us know in the registration form of any dietary requirements.