The ISPE 2018 Europe Aseptic Conference will focus on manufacturing technologies and supporting systems for the most relevant dosage forms for innovative drugs to come in the next years, which need to be produced in sterile and aseptic environment.
The globally relevant Regulation, the EC Guide Annex 1, drafted by the European Medicines Agency and widely commented by a number of industry stakeholders will be one major focus. The common understanding of the right approach in Quality Risk Management has become a hot topic in the conversation with the regulators. Data science workflows will lead to different ways to come to good management decisions in Quality Management.
Innovation in technology of aseptic processing, such as isolators, barriers and robotics will eliminate operators impact on process and product and also protect operators from product as more and higher toxic compounds need to be handled.
Aging facilities will create more and more questions about the right decision making to build new factories or update the existing ones. As always the answer is „it depends“. There will be industry business cases presented for both ways to cope with the challenges of investment and delivering fast to the market needs.
Technical challenges for decontamination, sterilisation, all kinds of transfers from materials between various hygienic zones will be addressed as well. Where „Ready-To-Use“ equipment or spare parts are advantageous, where not? What can automation support to keep good environmental conditions during production?