Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Biotechnology: Regulatory Requirements On Continuous Manufacturing for (glycosylated) Monoclonal Antibodies ***

Dr. Gritt Schäfer (Abschlußjahr: 2017)

Summary
Language: English
This master thesis provides an overview on the current debate on continuous manufacturing of biopharmaceuticals. Continuous manufacturing promises several major advantages in terms of efficiency, stability and flexibility at the same time. Regulatory authorities as well as the industry recognize that modern continuous manufacturing could be an efficient solution for biopharmaceutical manufacturing and could solve or reduce current problems like drug supply disruption. Using continuous manufacturing the industry could react faster to drug amount changes, increase the productivity and decrease the costs of production.
The thesis explains the regulatory requirements for continuous manufacturing of (glycosylated) monoclonal antibodies and examines the advantages and disadvantages of these production form compared to standard batch manufacturing. Glycosylated mABs are used in various therapeutic fields, like cancer or autoimmune disease therapies. Glycosylation, a post-translational protein modification, is recognized as one of the most critical attributes for the function of therapeutic proteins and must therefore be analysed and controlled adequately during biopharmaceutical production.
In this work different manufacturing approaches of pharmaceutical companies are compared and discussed. The regulatory basis for continuous manufacturing is analysed by comparing the different positions of ICH, EMA and FDA. The potential possibilities for a switchover from batch to continuous manufacturing process are examined. Pharmaceutical manufacturing companies can use this thesis as an overview and strategic decision guidance.
Pages: 66, Annexes: 5, pages: 6