| Autor: |
Borman P; Product Development and Supply, GSK, Medicines Research Centre, Gunnels Wood Road, Stevenage SG1 2NY, U.K., Campa C; Technical Research & Development, Vaccines, GSK, Via Fiorentina 1, 53100 Siena, Italy., Delpierre G; Analytical Research and Development, GSK, 1330 Rixensart, Belgium., Hook E; Global Pharma Analytical Science and Technology, Pharma Supply Chain, GSK, Priory Street, Ware, SG12 0DJ, U.K., Jackson P; Product Development and Supply, GSK, Medicines Research Centre, Gunnels Wood Road, Stevenage SG1 2NY, U.K., Kelley W; Product Development and Supply, GSK, King of Prussia, Pennsylvania 19406, United States., Protz M; Analytical Research and Development, GSK, 1330 Rixensart, Belgium., Vandeputte O; Analytical Research and Development, GSK, 1330 Rixensart, Belgium. |
| Abstrakt: |
A structured approach to method development can help to ensure an analytical procedure is robust across the lifecycle of its use. The analytical target profile (ATP), which describes the required quality of the reportable value to be produced by the analytical procedure, enables the analytical scientist to select the best analytical technology on which to develop their procedure(s). Once the technology has been identified, screening of potentially fit for purpose analytical procedures should take place. Analytical procedures that have been demonstrated to meet the ATP should be evaluated against business drivers (e.g., operational constraints) to determine the most suitable analytical procedure. Three case studies are covered from across small molecules, vaccines, and biotherapeutics. The case studies cover different aspects of the analytical procedure selection process, such as the use of platform method development processes and procedures, the development of multiattribute analytical procedures, and the use of analytical technologies to provide product characterization knowledge in order to define or redefine the ATP. Challenges associated with method selection are discussed such as where existing pharmacopoeial monographs link acceptance criteria to specific types of analytical technology. |
