Analytical development

Analytical development is the stage of drug development establishing proper methods to characterize pharmaceutical substances and ensure that they are safe and/or efficient for its intended use in patients. In particular, attributes such as physicochemical properties, biosafety, purity, identity and potency are evaluated.

Analytical method development consists in the development and finally the validation of suitable methods to evaluate if a drug product meets its specifications. Thus, it requires a strict application of relevant guidelines, particularly those issued by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH Q2R2). As mentioned above, analytical development includes method validation which ensures that the developed assay is conform to key parameters: specificity, linearity, accuracy, repeatability intermediate precision and has the proper range of detection (LOD: limit pf detection) or quantification (LOQ: limit of quantification).

Support to analytical method development includes de novo development, optimization, suitability evaluation and consulting with regards to regulatory expectations. Analytical method qualification and validation support can range from in-house method transfer to initial qualification to full cGMP validation. These methods  will be therefore used either to optimize the process development steps or to allow the release of the drug product at the end the pharmaceutical manufacturing.