N-nitrosamines are a growing challenge in pharmaceutical development. This class of mutagenic impurity has been responsible for multiple rounds of recalls that have hit several major pharmaceutical companies.
Watch Joe DiMartino, the Luminata Solutions Manager present on “Using CMC Decision Support to Enhance Control Strategies” at the Scientific Update N-Nitrosamines Event.
Topics include:
- Developing a data-driven control strategy
- Component identification lifecycle
- How Luminata can be used to manage n-nitrosamine impurities
Joe is joined by Dr. Andrew Teasdale for the question-and-answer period. Dr. Teasdale is the Senior Principal Scientist of Impurity Management and External Advocacy at Astra Zeneca. He is the author of over 50 peer reviewed scientific papers as well as three books. Watch Dr. Teasdale’s presentation.
Questions addressed:
- Is Luminata developing integrations with other software?
- How can one control n-nitrosamines in continuous manufacturing?
- What are practices in formulation for avoiding n-nitrosamines?