Discussing industry-wide challenges among industry peers is the best way to share information and take key learnings from the experiences of others. We all live and work in the same set of evolving regulations and complex scientific problems, and analytical tools are always improving to keep up with industry demand.
Three key questions always come up when I’m talking with like-minded colleagues and customers:
How to achieve cutting-edge extractable and leachable (E&L) studies?
How to ensure I am effectively testing for genotoxic impurities such as nitrosamines?
How to transfer HPLC method transfer across platforms or across labs?
Throughout May 2022 we bring you three pharma-focused webinars with guest speakers from within the pharma industry to talk about their own approaches to some seriously hot topics, just in time for the summer sunshine.
Extractable and leachables (E&L)
Accurate identification of extractable and leachable (E&L) compounds is vital to ensure that there are no potentially harmful chemicals being absorbed into a finished drug product or medical device when it is manufactured, packaged or stored. Identifying trace levels of unknown E&L compounds in matrices, sometimes relatively complex, is a challenging task.
Join Paulina Pinedo-Gonzalez, Ph.D., E&L Chemist II, SGS Health Sciences, as she shares strategies that will demonstrate the practical steps followed for structural elucidation of unknown non-volatile and semi-volatile organic compounds based on their LC-MS spectra. This stepwise approach in structure identification has proven useful for the effective identification and quantification of E&L compounds in a variety of pharmaceutical and medical products.
Nitrosamine exchange – a USP’s knowledge community for all-things nitrosamine
The nitrosamine impurities crisis prompted regulators around the world to increase their scrutiny of drug manufacturing processes even further. In the future, this greater scrutiny may lead to the discovery of nitrosamine impurities in other medicines. For this reason, manufacturers need to understand which medicines are likely to form nitrosamines, how and at what levels nitrosamine impurities are forming, and how to control nitrosamines.
In the following seminar, Naiffer Romero, MSc, MPH, Senior Scientific Affairs Manager, United States Pharmacopeia will explore how USP responded to the nitrosamine impurities crisis not only with a proposed general chapter on nitrosamine impurities but also non-compendial resources and tools that provides a risk assessment strategy, and methods for detecting and measuring nitrosamine impurities. In that effort, USP built a knowledge community dedicated to all things nitrosamines.
We transfer methods across platforms and labs all the time, and something always seems to go wrong. Implementing the right strategy with the right analytical tools can help save time, effort and re-work, making sure key criteria are kept for legacy methods while utilizing advanced tools for development of new methods. And what do you do if the you need to use technology from one manufacturer and validated software from another?
Join Nolan Dean, Staff R&D Mfg Scientist, and Blake Bailey, Supervisor R&D Mfg Scientist, Patheon, as they share key learnings, feedback and best practices for transferring methods from across instrument and developing new ones onto advanced liquid chromatography platforms.