Extractables & Leachables Analysis

covering a range of drug product types (e.g. Inhalation, Biologics, ADCs, Cell & Gene Therapies)

Since its inception the topic of extractables and leachables has grown continuously. It has expanded into different dose forms and heighted regulatory expectations. Analytical requirements still remain a challenge to effectively detect, identify and quantify, and this area if not addressed correctly can add costly delays to the development of new and existing medicines. We now finally have a draft ICH guideline, but E&L is still a complex area to navigate successfully.

The key to successfully negotiating its potential pitfalls is an understanding of E&L core concepts and requirements. This course sets out to provides that detail.