Biopharmaceuticals has become a main pillar in the pharmaceutical industry, with significant transformation in the development, strategy, technology and operations. This transformation is a continuous process, which is impacted by other developments in digitalisation amongst other factors.
Entirely new concepts, such as gene — and cell therapy, are being brought to market, which offer even more possibilities to regenerative medicine or disease remission. However, there are still operational and technological challenges.
Reproducing large molecules reliably at an industrial scale requires manufacturing capabilities of a previously unknown complexity and sophistication. The starting material that produce recombinant therapeutics are genetically modified living cells that must be frozen for storage, thawed without damage, and made to grow in a reaction vessel. The molecules must then be separated from the cells that cultivated them and the media in which they were produced, all without destroying their complex, fragile structures. This process requires new technologies and capabilities and will be explored at our conference.
Similarly, in GMP and Quality there are challenges, for instance working with a non-sterile starting material in a sterile and aseptic manufacturing process, where it is needed to prove that the micro-organisms are from starting material only and not from processing. Challenges that need new and innovative approaches.
The 2019 ISPE Europe Biotechnology Conference will address these topics with industry case studies and plant tours. Most important, the conference will allow for collaborative dialogue with presenters, regulators, industry, peer groups and top managers in an interactive forum.
Professionals at all levels of the industry from young professionals to the most senior executives, Communities of Practice, special interest groups, pharmaceutical industry equipment and services suppliers, and regulatory professionals.