Lhasa Limited announces the immediate release of Mirabilis 4.4.2, an update that significantly expands the knowledge base and introduces new features to streamline impurity assessment throughout the drug development lifecycle. The release is highlighted by the addition of early-phase and late-phase assessment modes, and a substantial increase in research data.
When carrying out impurity assessments in Mirabilis, the alert functionality developed in Mirabilis 4 removes human error by ensuring potentially formed impurities are flagged and must be de-risked. However, for scientists in late-phase development only, spending time on de-risking impurity formation alerts is unnecessary. The new early-phase/late-phase functionality enables chemists to tailor their assessment to review impurity formation alerts (early-phase) if needed, or allows them to bypass alerts (late-phase). The alerts are still shown in late-phase, but it is not a requirement to address them. This optimisation ensures scientists can speed up assessments when appropriate, while maintaining full documentation and compliance tracking as they approach commercialisation.
Identifying potential impurity formation often relies on manually assessing the synthetic route, requiring robust knowledge that is liable to oversight. Knowing the synthetic process to ensure any potential formation, and therefore carryover is controlled, is essential. Mirabilis 4.4 includes almost a 20% increase in impurity purge coverage on the previous release. This data expansion, which focuses on key potentially mutagenic impurities (PMIs) such as Michael acceptors and sulfonate esters, is supported by thousands of examples and references, ensuring chemists have confidence to justify their assessments to regulators.
The update also introduces a category risk level for the PMI formation alerts (154), based on the reactivity of impurity generation and the distance to the current synthesis stage. This prioritisation allows chemists to immediately focus on the most impactful risks, reducing overall project cycle time. New functionality allows scientists to archive full reaction routes – including comments and assessments – for simplified record-keeping and collaboration across teams.
For current Mirabilis members, book in for training to ensure you are familiar with the new features.
Alternatively, book a personalised demonstration of how the Lhasa team can support confident impurity assessment.