Analytical tests that have to be specifically developed: WB, RP-, SE- & IEx-HPLC, HCP, rDNA, restriction mapping, ELISA, activity…
- Development of the In Process Controls (IPC) selected to monitor the efficiency of each step of the production / purification process in terms of recovery yield and quality improvement.
- Development of the Quality Controls (QC) selected to characterize the purified material in terms of physical state, identity, content, purity / impurity, safety and potency.
- Evaluation of the specificity, linearity, accuracy and precision of the analytical methods.
- Report including a description of all the analytical methods (IPC & QC) developed.