By Jeffrey R. Mazzeo, Ph.D., Biopharmaceutical Business Director, Waters Corporation
Nearly every process conducted by a biopharmaceutical company requires a tremendous amount of analytical characterization to support the development of biotherapeutic products. Due to the inherent complexity of biotherapeutics, characterization is significantly more difficult than it is for small molecules. Therefore, numerous analytical methods are applied to fully characterize these high-molecular-weight products for regulatory approval, intellectual property protection, or comparability studies during manufacturing changes.
Used with permission from Life Science Leader magazine.