| 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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