Labcorp Biopharmaceutical CMC Analytical Development Services

The underlying principle for biopharmaceutical development and manufacturing is to provide a drug product that is both safe and efficacious for the patient. Therefore, manufacturing of any drug substance and drug product must demonstrate consistent production of a quality product, which must be shown to be stable over its intended shelf life. To achieve these goals, a manufacturing process needs appropriate and often product-specific analytical techniques that are reproducible, robust and able to operate in a Current Good Manufacturing Practice (cGMP) environment. Consequently, analytical development is a crucial component in any drug development program. In the following, we will address the basic principles of analytical development for cGMP assays, highlighting how International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q14 (Analytical Procedure Development, adoption planned for 2022) will change the analytical development approach. Additionally, we will evaluate the assays that are generally relevant to major biopharmaceutical modalities.