QBD STRATEGY FOR LC METHOD DEVELOPMENT
Abstract: As part of Quality by Design (QbD) principle, new tools allow pharmaceutical industry to develop more robust analytical methods from the earlier stages of drug development. With a QbD strategy, the method will be close to its optimum and more robust in comparison with “traditional†approach. This strategy has been implemented at Amatsigroup after several months of training and in- depth testing in order to use the software in an expert mode. One of our method development is presented in the poster.
Description: For HPLC method development, the traditional approach is based on One-Factor-At-a-Time (OFAT) development, whereas QbD approach is based on development using design of Experiments (DoE).
To apply DoE, Fusion LC Method Development® software can be used. Fusion is aligned with QbD principles and regulatory guidance.
Thanks to Fusion QbD software, method development is performed in two steps: screening and optimisation.
During first step of screening, 4 chromatographic parameters, which are considered to have the more impact on the separation are screened (CMP = Critical Method Parameters). Following this first step, best conditions are given (based on CMA = Critical Method Attributes). These conditions are then optimised during the 2nd step of development to obtain the Method Operable Design Region (MODR).
For our method development presented in the poster, a simulated robustness study was also performed afterward (using Robustness Simulator® module) to check if the developed method was considered as robust. The MODR was adjusted with regard to results obtained during this simulation to have a final MODR with robust zones.
Category: Drug Product
Type: Small Molecules
Contact: Nicolas Leroy ([email protected])