Analytical Development Services

Ensuring patient safety and drug efficacy is the foundational principle of biopharmaceutical development and manufacturing. Consequently, the consistent production of a quality drug substance and product with demonstrated stability throughout its shelf life is paramount. Achieving these objectives necessitates reproducible and robust analytical techniques, often product-specific, that can function within a Current Good Manufacturing Practice (cGMP) environment. Therefore, analytical development forms a critical element of any drug development program. This discussion will cover the fundamental principles of analytical development for cGMP assays, emphasizing the anticipated impact of the International Council for Harmonisation (ICH) Q14 guideline (Analytical Procedure Development, adoption planned for 2022). Furthermore, we will assess the assays commonly relevant to major biopharmaceutical modalities.