Celsis International Ltd. hosted the first user group meeting for customers in the pharmaceutical industry at its offices in Brussels, Belgium. The full-day meeting included presentations from two of Celsis’ pharmaceutical customers, representing Janssen Pharmaceutica and Schering-Plough (Merck), who both discussed and answered questions about their experiences using the Celsis Advance™ system. Attendees also benefited from presentations covering topics from the European Medicines Agency (EMA) validation pathways to available regulatory tools, as well as a scientific presentation on rapid sterility testing using the Celsis AKuScreen™ system. "We presented a case study about our experiences in validating and implementing a rapid microbial method. For the user group, we described the benefits we have received by introducing Celsis Rapid Detection products - specifically in achieving shorter cycle times," said Miek Van Loon, Janssen Pharmaceutica. Dr. Geert Verdonk, of Schering-Plough (Merck) stated that they "discussed and provided information proving that a statistical model is suitable for the implementation and validation of new technologies."
- Scientific Principles
- _Growth-based Methods
- _Viability Staining and Laser Excitation
- _Detection of Cellular Components
- _Optical Spectroscopy
- _Nucleic Acid Amplification
- _MEMs
- Product Matrix
- How to Validate
- Regulatory
- _Annex 1 Revision
- _Rapid Sterility Testing of ATMPs
- _Changing Acceptance Levels
- _US Food and Drug Administration (FDA)
- _European Medicines Agency (EMA)
- _Australia TGA
- _Japan PMDA