Regulatory & methodological trends in the lab
Despite the ongoing pandemic situation, PharmaLab will be taking place on 22-26 November 2021 - with a new structure: Over five days, the congress will offer important and new information on analytics, bioanalytics and microbiology in four consecutive tracks:
- Optimisation and Automation
- Validation of Analytical Methods and Life Cycle Management of Analytical Procedures
- Alternative and Rapid Microbiological Methods
- Endotoxin and Pyrogen Testing.
A whole range of topics will be addressed that are important for those responsible and staff in the labs for quality and in-process control, but certainly also in the area of quality assurance and R&D. On the first conference day, the focus will be on the area of automation and optimisation of laboratories, the methods used and the requirements in the accompanying digitalisation. Continuous improvement (CIP) and the Idea management process (IMP) are as important as the establishment of computer systems and the optimisation of methods and techniques.
On the following day, the contributions will be dedicated to another topic that has become increasingly important over the last three years, the validation of analytical methods and the life cycle management of analytical processes. While the corresponding ICH chapters Q2(R1) and Q14 are still under development or revision, the USP has currently published its General Information Chapter <1220> Analytical Procedure Lifecycle, which will become effective in May 2022
On the third day, microbiology will be at the centre of attention. One of the most important topics in connection with the growing importance of cell- and tissue-based, as well as gene therapies – some of which have only short shelf lives or small batch sizes –, is the establishment of alternative and preferably faster microbiological control and detection methods. Real-time or online systems are also gaining importance in the field of monitoring rooms and media. Accordingly, the third conference track is dedicated to alternative microbiological rapid methods.
The last two days of Pharmalab will focus on testing for endotoxins and pyrogens, a field that has been characterised by major changes in recent years. Starting with the initiatives to reduce the use of animal testing (rabbit test), through the knowledge gained in masking and thus low endotoxin recovery, to the inclusion of recombinant test systems in the European Pharmacopoeias. Accordingly, the Endotoxin and Pyrogen Conference is divided into different sections dealing with the LAL test as well as the rFC and MAT. This is particularly important for companies operating internationally, as the use of alternative test methods and recombinant factors is dealt with differently by the authorities.
With more than 40 speakers and around 50 presentations, Pharmalab provides a unique opportunity to get familiar with the current state of regulations, science and technology.
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This article was originally published in Autumn Edition European Biotechnology Magazine 2021.