The life cycle management of analytical methods shall be followed as per USP<1220>.
Method Development & Qualification
We follow ICH Q14 guidelines for method development and ICH Q2R2 standards for method qualification, ensuring that every method is robust and meant for intended usage.
- Method Development approach as per ICH Q14
- Analytical Method Qualification as per ICH Q2R2
Method Transfer
Our method transfer services ensure seamless transitions between development lab, GMP facilities, client sites and external laboratories while maintaining consistency and compliance.
- Transfer from Development to GMP facility as per USP <1224>
- Transfer of Methods to External Laboratories as per USP <1224>
Method Validation & Performance Monitoring
Once methods are developed and qualified, validation ensures that they perform consistently during commercial production. We also monitor method performance to guarantee quality across the biologic’s lifecycle.
- Validation of Methods for Commercial Production as per ICH Q2R2
- Method Performance Monitoring
- Re-Development/ Re-validation as required
At Aragen, our comprehensive Method Life Cycle Management services ensure that your analytical methods remain consistent, reliable, and compliant throughout your biologic’s development journey. From initial development and qualification to seamless transfers and ongoing performance monitoring, we provide the expertise to maintain regulatory compliance and scientific rigor at every stage. Collaborate with Aragen to leverage our method life cycle management solutions to support your biologic’s path to commercialization.