Hello 2025!

Welcome to the first edition of The latest from Lhasa, a monthly newsletter dedicated to sharing knowledge, updates and advancements on chemical safety and toxicology.

Sharing updates

Reflecting on an incredible 2024

Last year was a landmark year for Lhasa, and we couldn’t have done it without you — our community of members, collaborators and advocates. Here’s a quick recap of the highlights:

?? Building global connections

We hosted symposia in more regions than ever, connecting with regulatory experts, our members and the wider scientific community in Brazil, India, Mexico, South Korea, Japan and China.

?? Partnering with leading pharmaceutical organisations

We are proud to now count the top 20 pharmaceutical companies as part of our 680 members (and counting), demonstrating the growing trust in our innovative solutions.

??Advancing in silico innovation

• Acrostic launch: Supporting acceptable intake limit setting for novel nitrosamines through read-across.
• Zeneth 10: Enhanced structure-based and nitrosamine risk assessments, enabling early identification of degradation issues and potential nitrosamine formation.
• Sarah Nexus: Facilitating comprehensive genotoxicity assessments with the addition of a major endpoint; chromosome damage.
• Kaptis 2: Bridging the gap between non-animal studies and confident safety assessments.

?? Collaborating to share knowledge

We authored and co-authored 11 publications in prestigious journals such as Organic Process Research & Development, Regulatory Toxicology and Pharmacology, and Computational Toxicology. We also proudly showcased our research internationally, presenting posters and vendor-hosted sessions at conferences like Society of Toxicology (SOT), European Toxicology (EUROTOX), Genetic Toxicology Association (GTA), and the American College of Toxicology (ACT).

?? Celebrating award nominations

We were finalists in three Leeds Digital Festival Awards, celebrating our exceptional team, culture and commitment to equality, diversity and inclusion.

Have you seen our new company values video? It’s a celebration of the core principles that drive everything we do:

Sharing knowledge

Did you vote within the Lhasa Publication Awards? ??

We asked our scientific community to vote for their favourite 2024 publication across three categories: Toxicology (excluding nitrosamines), Toxicology (specifically nitrosamines) and Chemistry.

The results are in! Check out our first blog of 2025 to discover the winning publications.

Sharing advancements

Nitrosamine news

In the latest EMA nitrosamine limits update, a number of N-nitrosoureas, guanidines, indoles and similar compounds were included. These are out of scope of the CPCA - so the potential acceptable intake was the class-specific 18 ng/day for the ureas/guanidines - but limits for several have been set by read-across. These compounds have always been in the cohort of concern, but regulatory concern is now increasing. To address this, we offer a robust workflow for nitrosamine impurity risk - read our blog to find out more.

Consult Lhasa, a wholly owned subsidiary of Lhasa which launched last year can help with selecting and justifying a suitable surrogate for a N-nitroso compound, whether in scope of the CPCA or beyond.

For more insight on the place of N-nitroso compounds in the Cohort of Concern, including a discussion of whether the N-nitrosoindoles should be, check out this paper by Dr David Ponting and Dr Robert Foster.

What’s next for Lhasa in 2025?

?? Organic Process Research and Development, Charleston (March 10-12): This conference provides a great opportunity to learn how we can help with managing potentially mutagenic impurities in your drug development workflow.

?? Society of Toxicology, Orlando (March 16–20): Join us for our session on transforming carcinogenicity assessments with new approach methodologies (NAMs) and guided expert review.

??? Science of Stability Conference, Philadelphia (May 19–21): We’re thrilled to co-host this event again with FreeThink Technologies as it returns for the 9th year running!

Thank you for joining us in our introductory edition of The latest from Lhasa!

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