Lecturer: Prof. Dr.-Ing. Jørgen Magnus (RWTH Aachen) and Prof. Dr. Sven Stegemann (CEO Leibniz JointLab)
The first part of this lecture describes the design and operation of a production facility for adeno associated viral vectors used for in-vivo gene therapy. Starting with the basic calculations to size the facility, the lecture continues to describe the necessary equipment, the layout of the building, the personnel and material flows in the building as well as cost calculations and the time schedule for the facility construction. The second part will provide an introduction into the “Good Manufacturing Practice” framework covering the entire pharmaceutical product manufacturing cycle to ensure the reproducibility and traceability of the targeted quality characteristics of products for human and veterinary use.
Principles of Good Manufacturing Practice (GMP) GMP is a set of guidelines for the manufacture of medical-pharmaceutical products that are administered in or on humans. The aim is to ensure the defined quality and safety of a product in a reproducible and consistent manner for an approved therapy or a therapy under development. The regulations consist of nine different areas that cover all aspects of production. GMP is a global standard that is certified and continuously monitored by authorities on a product-specific basis. Each manufacturer and its management is and remains responsible for compliance with GMP standards and the manufactured product. GMP is a continuous process that also contributes to the continuous improvement of the quality and efficiency of manufacturing.
GMP Guidelines