The Lhasa Intermediates Data Sharing Initiative celebrates a significant milestone, its 20th anniversary, along with twenty consecutive years of collated industry donated Ames mutagenicity records.
Lhasa Limited is pleased to share the release of the Intermediates 2026.1 dataset which has reached a new total of over 43,974 data records for production intermediates.
Across the two decades, members of the consortium and annual donators of proprietary, precompetitive data, have used this exclusive dataset to refine their formulations and enhance risk assessments.
The sharing of data regarding common intermediates can act as an early predictor for genotoxicity, as Lhasa Limited prioritises compounds which can improve understanding of structure-activity relationships (SARs).
Newly added Ames mutagenicity data from top pharmaceutical organisations
United by shared industry progression, the Intermediates consortium continues to facilitate the development of in silico modelling, a New Approach Methodology (NAM) for chemical toxicity assessment.
As stewards of high-quality pharmaceutical data, and market-leaders in managing data sharing across the pharmaceutical, life science and biotechnology industries, Lhasa Limited is committed to assisting the UK NAMs roadmap.
The Intermediates 2026.1 release from the Lhasa data sharing initiative expands the database for another year, to now include:
- 2199 new data records, bringing the total to 43,974.
- 118 new substances, bringing the total to 2,371.
- There are now specifically >41,000 in vitro genetic toxicity records.
- 60% of the single experiment records contain dose-response data.
This extensive dataset is strengthened by 20 years of active participation from members of the Lhasa Intermediates consortium, motivated by:
- Reducing the duplication of costly experiments, redirecting resources towards high quality data access and in silico methodologies to accelerate discovery.
- Strengthening safety decisions and enhancing risk assessments, enabling earlier identification of potential risks and streamlining development programs.
- Unlocking improved structure activity relationships, to enhance predictive toxicology models, including the refinement of Derek mutagenicity alerts to support more informed decision making.
Access to the dataset is available through Vitic Intermediates. All new data records are automatically available to consortium members.
Shared data, shared knowledge, shared progress
Recognising that pharmaceutical organisations worldwide were duplicating costly analytical experiments to produce Ames mutagenicity data, the Intermediates data sharing initiative launched.
In 2006, Lhasa Scientists began the movement towards achieving more through industry collaboration and collated results for common intermediates and compounds containing functional groups of interest donated by members.
For over 20 years, Lhasa Limited has continued to facilitate the anonymous sharing of genetic toxicity data.
Lhasa Limited data sharing has expanded to cover excipients, aromatic amines, AI/PDE, and several more initiatives in response to critical toxicity data gaps in the pharmaceutical landscape, as well as to harmonise the efforts of siloed organisations.
Unified by a single, overarching objective, Lhasa data sharing initiatives, including the Intermediates 2026.1 release, are positioned to advance scientific understanding and improve predictive toxicology.
Lhasa Limited offers data stewardship to align with the regulatory guidelines and future ambitions of the UK, US and beyond.
New Approach Methodologies (NAMs) for mutagenic impurities
The mutagenic status of process intermediates is of paramount importance under the ICH M7 guideline.
The Lhasa intermediates data sharing initiative lends itself to the ICH M7 workflow, allowing efficient retrieval of relevant shared information whilst mitigating the need for costly experiments.
Powered and housed by the Vitic database, the Lhasa Intermediates dataset provides structure, substructure and similarity searching to innovatively identify the most relevant data to assist in ICH M7 classification.
ICH M7 risks being an expensive process for pharmaceutical organisations working in silo. With collaborative data sharing, consortium members can support the required in silico analyses to identify potentially mutagenic impurities while maintaining data anonymity.
Data sharing has proven to improve risk assessment capabilities and validation of in silico toxicology prediction systems. For over two decades, the market-leading data sharing initiatives from Lhasa Limited have driven NAMs and enhanced in silico software such as Derek Nexus and Sarah Nexus and the ability to perform read-across with Acrostic.
Ready to access 40,000 Ames mutagenicity data records donated by leading pharmaceutical organisations? Join the Lhasa Intermediates data sharing initiative.
Share your data, facilitate industry progression.