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European Biopharmaceutical Review

Vaccine Production: Preparing for the Worst

The challenges posed by vaccine development and manufacture are similar to those faced in the production of other biopharmaceuticals. There are, for example, increasing demands for greater speed in the transition from R&D to clinical trials, increased cost-effectiveness of the manufacturing process and reduced time to market.

The production of vaccines, however, presents additional issues: the need to produce high volumes of vaccine in short timelines; the need for improved safety measures when working with pathogens and pathogenic antigens; as well as meeting FDA and European regulatory standards. This article focuses on a number of these challenges and considers some of the developments being designed to support vaccine developers and manufacturers.

TURN UP THE VOLUME

In order to effectively protect a target population, a vaccine must be developed in such a way that it can be produced and delivered in large volumes. For example, when faced with the threat of seasonal and pandemic influenza, vaccine manufacturers face the challenge of scaling up production to deliver large batches of vaccine dose in the shortest possible timeframe.


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Björn Lundgren is the Marketing Manager for the vaccine and microcarrier product portfolio at GE Healthcare, with a special focus on vaccine applications. In previous positions at Pharmacia Biotech and Amersham Biosciences, Björn was instrumental in the development of microcarriers and in application work to support scale-up issues, process development, high cell-density culture and training course materials. Björn’s extensive experience with cell culture includes MAb production, whole cell in vitro testing, comparative evaluations of culture systems and the development of an automated cell harvesting and concentration system. He has a BSc in Microbiology from Uppsala University.
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Björn Lundgren
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