Lhasa Limited shared knowledge shared progress

Mirabilis Features and Benefits

 

 

 

 

Organisations involved in the discovery and development of new drugs will benefit from using Mirabilis by:

 

Consistent Industry Standard Approach: A common methodology and reporting framework provides standardisation for the management of PMIs and subsequent inclusion of purge-based arguments in submissions to regulators.
Greater Efficiency: Eliminates the need to set up costly and time consuming analytical methods to measure impurities that are unlikely to be present in the final drug product.
Targeted Testing: Impurities only need to be assessed and controlled if they are both expected to be mutagenic and not be purged during synthesis. Effort can therefore be focussed on PMIs that pose more of a risk.
Expert ICH M7 Support: Section 8, Control Option 4 of the ICH M7 Guideline specifically allows for a control strategy that relies on an understanding of process controls in lieu of analytical testing and that such an approach may be based on scientific principles alone provided that an appropriate risk assessment has been undertaken. This risk assessment can be presented as an estimated purge factor for the clearance of the impurity by the process.
Chemical Intelligence: Automatic recognition of the structural class of impurities and transformation types in synthetic steps delivers rapid calculations of purge factors.
Shared Knowledge, Shared Progress: Using the combined knowledge of leading process chemistry experts, Mirabilis provides more accurate, justifiable and scientifically robust purge-based arguments.
Improved Knowledge Visibility: This web-based software can act as the corporate repository of synthetics schemes, reactions and purge factors facilitating internal collaboration and retention of corporate knowledge.
Transparency: Provides expert commentary and detailed supporting information for calculated purge factors, enabling improved and justifiable decision making.
Aiding Submission to Regulators: Mirabilis provides a report which includes the purge calculation, scientific rationale and supporting evidence to aid in the submission to regulators.

 

Contact Us

© 2017 Lhasa Limited | Registered office: Granary Wharf House, 2 Canal Wharf, Leeds, LS11 5PS, UK Tel: +44 (0)113 394 6020
VAT number 396 8737 77 | Lhasa Limited is registered as a charity (290866)| Company Registration Number 01765239 (England and Wales).

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