Method qualification
Ensure your method performs at the highest quality.
Why is method qualification important?
Method qualification shows that a method is scientifically accurate and suitable for its intended use. Qualification of a method provides a number of benefits, including:
- Improved data quality: Ensure that the analytical data generated is reliable and accurate
- Reduced risk: Help to reduce the risk by providing evidence that the method was properly developed and validated
- Regulatory compliance: Provide evidence that the method is suitable for its intended use
Understanding our method qualification capabilities
Our method qualification, a pivotal process conducted within state-of-the-art research and development laboratories, adheres to the rigorous guidelines outlined in ICHQ2R1. This qualification provides understanding of each method’s capabilities through a comprehensive evaluation. Parameters assessed include:
- Specificity
- Precision
- Linearity
- Accuracy
- Range
- Limit of detection
The results of the qualification exercise are summarized in a method qualification report. These insights are instrumental in deriving appropriate acceptance criteria for subsequent method validation activities.
Why partner with Enzene for method qualification?
We are a CDMO and biosimilar developer driven by the vision of positively impacting the global healthcare landscape by bringing trusted and affordable medicines to market at speed.
Committed to progression, our CDMO capabilities are designed to support you at every stage of your development and manufacturing journey. Along with our proprietary continuous bioprocess manufacturing platform, EnzeneX™, we can provide everything you need in a partner.
Through a passionately progressive approach, our cutting-edge services and method qualification capabilities are designed to cater to your project’s every need.
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Fueled by our continuous innovation and armed with EnzeneX™, our fully-integrated CDMO solutions and our biosimilars pipeline are designed to help bring your biologics innovations to life.