Single-Use Systems in Sterile & Biomanufacturing
Objectives
The aim of the event is to bring you up to date with the latest developments and possible applications of SU Systems. One important aspect besides overcoming technical issues is ensuring the quality of single-use systems.
Registration
Register as a congress delegate for just 690 EUR/day!
This special offer is only valid until 31 December 2024!
Background
Single-use systems have become established in biotechnology and are increasingly used in sterile pharmaceutical manufacturing. Reasons include significantly lower costs compared to stainless steel systems, and reduced expenses for cleaning and cleaning validation. Additionally, time-to-market can be shortened due to the elimination of construction activities and faster scale-up. For ‘small batch products’ and ATMPs, there are sometimes no other solutions available. SUS is also increasingly being used in the production of clinical material.
Regulatory requirements for single-use systems are becoming more defined, but true harmonization is still lacking despite industry efforts. Challenges beyond GMPs include extended delivery times for single-use equipment, reduced raw material availability, and high dependence on suppliers. These and other topics will be addressed at the Single-Use Systems Conference and discussed with experts from authorities, pharmaceutical manufacturing, single-use suppliers and universities.
Detailed Programme
Single-Use Systems – GMP Inspector's View
Dr Daniel Müller, Local Government Baden-Württemberg, Germany
Single-Use Technology in biopharmaceutical Production: An Overview from USP to Fill&Finish Technologies
Prof Dr Regine Eibl, Zurich University of Applied Sciences
Quality Approach in Manufacturing of Single-Use Systems: How to assure Performance, Robustness, and Sterility of Single-Use System
Dr Simone Biel, Merck
Pharma QA/QC when using Single-Use Equipment
Dr Alicja Sobantka, Octapharma
Case Study Merck: Single-Use Technology in Aseptic Drug Product Manufacturing
Nicola Rutigliani, Merck
Case Study BioNTech: CCS for Processing Frozen Sterile Drug Products in a Single-Use Assembly
Angus Liu, BioNTech
Case Study Sanofi: Optimization of Single-Use Systems for Fill-Finish Manufacturing Operations to the new Requirements
Dr Rebecca Geyer, Sanofi
E&L Testing of Process Materials used in Bioproduction – Case Studies on Study Design and showing the practical Hurdles when performing E&L Studies
Dr Koen Smets, Nelson Labs
Particle Cleanliness Assessment of SUS
Gerald Dallmann, SGS INSTITUT FRESENIUS GmbH
Case Study: Manufacturing of a Monoclonal Antibody with SUT
Jyotsna Agnihotry, Flavine Europe