COLUMBUS, Ohio, Dec. 18, 2023 /PRNewswire/ -- Andelyn Biosciences, Inc., a pioneering and patient-focused cell and gene therapy Contract Development and Manufacturing Organization (CDMO), announced ...
CLN2, a form of Batten disease caused by TPP1 protein deficiency, is a pediatric neurodegenerative disorder with an estimated incidence of 0.5 per 100,000 live births. Most affected children begin ...
Utilising extensive knowledge of ICH guidelines, this course will outline and define best practice in the approach and requirements for Process Characterisation and Qualification (Validation) studies, ...
Pharmaceutical manufacturing requires defining quality target product profiles and critical quality attributes (CQAs) to ensure desired product quality. Process development identifies critical process ...