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.
Impurities only need to be assessed and controlled if they are expected to be both mutagenic and not 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.
Once an API dose, initial impurity concentration, and daily control limit have been added by the user, Mirabilis automatically calculates a Purge Ratio for the impurities which can be used to justify a Control Option 4 approach.
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.
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.
To find out more about how Mirabilis can help you, please get in touch.