Biotech Industrial Process : How Science, Technology and Market Demand meet
Alain Bernard, Vice President, UCB Pharma SA
Biotechnology industrial process design and development has been one of the
cornerstones of the successes of biotech products on the market. In recent
years, the pharmaceutical industry has evolved swiftly and adapted in order to
cope with the rapid changes in the market demands, the upcoming technologies
and the constant need to lower production costs. It has also developed novel
strategies to improve quality and to respond to increasing regulatory
expectations. We will illustrate some strategies that have enabled
to improve manufacturing processes. In particular we will focus on how process
changes can be safely implemented whilst respecting product quality and
comparability. We will explain how, thanks to the implementation of these
strategies the earlier concerns of lack of capacities have more or less
disappeared and we will also discuss the new challenges now facing the industry
with novel product formats and/or novel therapy paradigms.
|
|