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In the last years, the LAL test has become the preferred system to test for endotoxins – for the in process control as well as in the final inspection – and it is anchored in the pharmacopoeias.
However, in the recent past, the problem of low endotoxin recovery employs the pharmaceutical microbiology. Masking – or not? Evidence gaps? And how can I close them? And how to evaluate?
But although the question about alternative methods like MAT or Recombinant Factors is frequently asked – what is the status of these methods in the Pharmacopoeias? What is the authorities thinking on their use.
These are the questions the pharmaceutical microbiologists as well as those responsible for the release have to deal with.
Understanding conflictive results
Optimization of current detection methods
Development in Pharmacopoeias
Laboratory management and staff of pharmaceutical microbiology
Microbiologists and laboratory assistants from contract laboratories
Authority representatives involved in the topic
Scientific staff from the area Pyrogen and/or Endotoxin testing
QA staff who has to evaluate endotoxin data and handle deviations
Dr Johannes Reich, Microcoat Biotechnologie GmbH, Germany
Johannes Reich studied business administration and chemistry in Regensburg. His doctoral thesis was on “function-structure relationship of Lipopolysaccharide with recombinant factor C test systems” at the Institute for physical and theoretical chemistry. He deals with the problems of modern endotoxin detection methods and with the problem of low endotoxin recovery. In the meantime he worked for Profos. Currently he is Managing Director at Microcoat Biotechnologie GmbH with focus on the Endotoxin and Pyrogen testing.