Once a lead compound has been identified, the biopharmaceutical development is a long process including preclinical phases and clinical trials to obtain regulatory marketing approval. During this development a variety of analytical technologies are used to assess the characteristics of the product. Many of these methods must evolve into assays that will require validation for their final intended use. Validated test methods are necessary for full compliance with cGMP and GLP regulations.
During those early stages, we work on development, qualification and validation of analytical methods which are validated in accordance with ICH Q2R1 or the EMA/ FDA guidelines:
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.