Abstract

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.