AnalyticalDevelopment and validation of analytical methods
Clean Biologics has more than 35 years of cumulated experience in analytical development and validation for the evaluation of biopharmaceuticals between companies Clean Cells and Naobios. These methods may be used for quality control testing of starting material, intermediates (cell and virus banks, harvests and drug substances) and to perform in-process controls.
Developing compendial or customized assays
Methods developed by our companies are further used to check the manufactured substance for various quality attributes including physicochemical properties, biosafety, purity, identity and potency. Our extensive experience handling thousands of biologics in our laboratories provides us with an in-depth technical and regulatory expertise across all types of assays at pre-clinical, clinical and commercials steps, and according to multiple Pharmacopoeias guidelines and specific customers’ expectations.
Validating methods according to international standards
Validation of assays needs to be planned according to their ultimate purpose: in-process controls, intermediate substance testing or release testing. Our validation process includes strict specifications based on international guidelines such as ICH Q2R1. This procedure must also take into account the accuracy, specificity, sensitivity, precision, detection (or quantitation) limit, range criteria while including repeatability and robustness elements.
Once validated, these methods may be transferred to customers or incorporated into our portfolio of assays to be used routinely under the scope of the GMP certifications held by Clean Cells and Naobios.
The methods may undergo development and validation in accordance with GMP expectations or in a non-GMP format. They may be developed along our process development or bioproduction services or independently.