The European Microbiology Conference 2022 from 03-05 May offers three different tracks on 2.5 days which focus on a variety of topics from strategies for gene therapy products to implementation experiences with robotic isolators:
- Microbiological Control of Cell- and Gene-Based Products/ATMPs
- Current Trends in Endotoxin and Pyrogen Testing
- Robotic Isolators – Challenges and Modern Monitoring Systems
Learn more about the conferences below.
03 May 2022
The number of cell-, tissue- or gene-based advanced therapy medicinal products (ATMPs) in research, development and production is steadily increasing. Due to the very different characteristics of the biological materials, the often small batches, the limited shelf life or the bio-safety requirements of the manufacturing environment, conventional control methods can often only be used to a limited extent. Alternative approaches for microbiological control, independent whether we are talking about sterility testing, endotoxin detection or others, are often necessary for such products.
The following conference will provide insight into how pharmacopoeias deal with this, the experiences and expectations of regulatory authorities and how microbiological control and testing strategies and methods are implemented in industry and laboratories. During the Q&A-session you will also have the opportunity to ask the speakers your individual questions.
- Current Pharmacopoeial Thinking
- Bacterial Safety Aspects
- Viral Safety Aspects
- Strategy for a mRNA Product
- Alternative Sterility Testing
- Strategy for Gene Therapy Products
04 May 2022
For several years now, the field of endotoxin and pyrogen testing has been subject to a high pressure of change. Especially in Europe, also as a consequence of the 3R strategy of the European Union, alternative test methods have found their way into pharmacopoeias. The comparison of existing methods and alternative test methods, the experiences with pitfalls and possibilities but also limitations still leads to a lively discussion.
Learn about the latest trends and developments in this conference. International experts from industry and laboratories as well as representatives from EDQM will report on current requirements, implementation in practice, establishment of new methods and where these can also be a challenge.
- Pharmacopoeial Background
- Endotoxin Removal
- Detecion in Novel Products
- Assessing Performance with Real Contamination
- Analyzing Endotoxin in Complex Samples
- MAT Experiences
05 May 2022
Aseptic production has always been complex and cost-intensive and the risk of contamination high. To minimise the risks, the techniques used have become increasingly sophisticated, from simple cleanrooms, sterile workbenches and RABS to the classic isloators. With the new possibilities of automation, digitalisation and rapid microbiological methods, there are currently even more opportunities to minimise contamination risks and optimise processes. This also, or especially, plays a role in the production of novel therapies with biological starting materials, which often have small batch sizes.
One possible method is the use of modern isolators, without gloves, automated and in combination with modern real time or online monitoring systems. However, when establishing such systems, the user is faced with the challenge that the currently valid regulatory requirements were often oriented towards the previous systems and are difficult to apply across the board for modern systems, either because given limits were derived from the less sensitive systems or because comparability of the results is difficult or impossible to achieve due to the different methodologies.
This workshop will provide an insight into the view of a GMP inspector, an introduction to available techniques and systems, as well as industry experience in implementation and the hurdles that may be encountered in regulatory acceptance.
- Technical Principles of Robotic/Gloveless Isolators
- Challenges of Modern Monitoring
- Implementation Experiences
- Inspectors Point of View
- Perspective and Experience of Recent Inspections