“The meeting provided an opportunity to share our common difficulties and discuss solutions to establish robust and accurate methods for analysing nitrites in excipients.”
We recently welcomed members of the Lhasa Nitrites data sharing consortium and IPEC Europe – European Excipients Association for the first face-to-face Nitrites meeting at the Lhasa Head Office. Hosted in partnership with IPEC Europe, this one-day event provided a platform for insightful discussions and presentations aimed at advancing understanding of nitrosamine impurities formation in drug products. The event focused on how excipient manufacturers can address risk mitigation. Experts from both pharma and excipient manufactures shared their experience and research on the challenge of nitrite in excipient analytical testing.
Perspectives from attendees
The theme of the meeting emphasised the integral role of collaboration, bringing together 34 organisations to share knowledge and advance science on nitrosamines. We spoke to some of the attendees to get their thoughts…
Anamarija Vajs and Miha Mrzlikar from Krka, d.d., Novo mesto, valued the diversity of the expertise:
“Thanks for bringing together people from different backgrounds. The meeting was very productive, and it was very interesting to hear about different perspectives from the experts regarding nitrite in excipients.”
Marie-Odlile from Roquette, discussed the importance of developing robust methods of nitrites analysis through collaboration:
“The meeting provided an opportunity to share our common difficulties and discuss solutions to establish robust and accurate methods for analysing nitrites in excipients. Excipients and drug manufacturers must work together, as solutions can be found on both sides to reduce nitrosamines formation. IPEC, European Directorate for the Quality of Medicines & Healthcare (EDQM), and United States Pharmacopeia (USP) authorities, who were part of the seminar, can benefit from this work to establish official methods for nitrite analysis, which is a key point for manufacturers.”
Dr. Jessica Mueller-Albers from Evonik Operations, GmbH, expressed her appreciation for the collaborative nature of the event:
“I enjoyed meeting with all these experts, especially discussing the analytical challenges we all face when analysing our excipients.”
For more details, read the Lhasa and IPEC Europe collaborative meeting report on our website.
Nitrites data sharing initiative
The Vitic Nitrites data sharing initiative is a key part of our global response to the nitrosamine crisis and is one of several pre-competitive data sharing initiatives undertaken by Lhasa.
Grace Kocks, Senior Global Alliances Manager at Lhasa, and the organiser of the meeting, outlines the goals of the Lhasa Nitrites consortium: “The Nitrites consortium was established to foster collaboration in the testing and analysis of nitrite in excipients, as well as to facilitate the sharing of scientific knowledge and data. Through collaboration between the consortium, IPEC Europe and excipient manufacturers, we aim to harmonise testing methods and standards for nitrite, convey a consistent message to regulators and pharmacopoeias, and ensure the quality and safety of drug products.”
Together with the 29 members of the Nitrites consortium, we continue to positively impact the wider scientific community by making new knowledge more accessible.
If you’d like to join the Nitrites data sharing initiative, please get in touch.
