Cell and tissue based therapies require stringent quality controls to rule out any contaminations with pathogenic agents. How can rapid and reliable test methods transferred into the routine procedures in a timely manner? This was the subject discussed by experts of the Paul-Ehrlich-Institut (PEI) and the ECA Foundation with representatives of industry at a workshop that took place at the PEI on 13 February 2019.
Salmonella enterica on blood agar
Source: PEI
The use of innovative therapeutical methods based on biolgocial substances – cells and tissues – are increasing steadily. At the same time, we have to face up to ever increasing challenges, since freedom from contaminations with pathogenic agents must be ensured for these cells or tissues. Strict microbiological quality controls are therefore necessary. At the same time, it must be ensured that such tests require only a short period of time, due to the very short stability of the biological material.
Although a fair number of suitable test methods are available in the meantime, many of them are not yet included in the European Pharmacopoeia which forms the basis for the test methods. On 13 February, Professor Isabelle Bekeredjian-Ding, head of Division Microbiology and her co-workers at the PEI, and Dr Oleg Krut, head of Section Microbiological Safety as well as Dr Sven Deutschmann, Roche Diagnostics GmbH, as the representative of the ECA Foundation, scheduled a workshop to find ways and means to make these test methods available for routine use as soon as possible.
Participants in this event included experts of the ECA foundation, the pharmaceutical industry, regulatory agencies of the European Union, contract laboratories for microbiology, as well as manufacturers of microbiology methods.
The ECA Foundation is the leading European organisation whose tasks, among other things, include quality assurance in manufacturing processes.
Updated: 13.02.2019
