Biotechnologie
Key Words single-use technology | continuous manufacturing | biopharmaceutical facilities | flexible facilities | biotech manufacturing
Abstract
The pharmaceutical industry is changing. From being a stable and predictable industry it is facing the challenge of becoming agile and flexible. The challenge of smaller product volumes and smaller batches is to combine agile and flexible manufacturing solutions with cost-effectiveness.
It is a new pharma reality and it calls for innovative approaches with new technologies, which dramatically will impact the design and operation of the future pharmaceutical facilities in order to meet current and future challenges. The last decade has changed the manufacturing landscape for biopharmaceuticals due to the rapid development of single-use technology.
This article elaborates on the possibilities of the single-use technology and addresses how the biopharma production can benefit from the implementation of continuous manufacturing like other industries did before. These approaches play an important role in agile and flexible biopharma productions.
Korrespondenz:
Gert Moelgaard, NNE Pharmaplan GmbH, Siemensstr. 21, 61352 Bad Homburg;
e-mail: GTM@nnepharmaplan.com
Morten Munk Morten Munk joined NNE Pharmaplan as Senior Technology Partner in 2015. In 2001 he co-founded CMC Biologics A/S, where he held a position as Vice President for Business Development. Prior to founding CMC Biologics, he held a position as principal scientist at Novo Nordisk A/S in which he was responsible for the CMC part of several projects. He has authored or co-authored a number of technical articles and guidelines. Moreover, he is frequently invited to give scientific and technical |