Once a lead compound has been identified, the biopharmaceutical development is a long process including preclinical phases and clinical trials before to obtain regulatory marketing approval. During this development a variety of analytical technologies are used to assess the characteristics of the product. Validated methods are necessary for full compliance with Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP) regulations.
During those early stages, GenoSafe can work on development, qualification and validation of analytical methods in accordance with ICH Q2R1 or the EMA/ FDA guidelines.
We follow an Analytical Procedure allowing to define different criteria:
Specificity (identification and impurity)
Precision (repeatability, reproducibility, intermediate precision)
LoD (Limit of detection)
LoQ (Limit of Quantitation)
This approach anticipate and control the key quality criteria to be applied ensuring the method will reach the optimized level of qualification and validation in the later phases of development of your product.
Moreover, the development of those customized analytical methods may then be implemented during the preclinical studies, the clinical phase or for Quality Control batch release testing.