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Lykiri

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Lykiri

Re: flipper44 post# 189369

Thursday, 09/13/2018 7:25:56 PM

Thursday, September 13, 2018 7:25:56 PM

Post# of 704620
Flipper44,

It seems like the Fraunhofer production process is(was) not 100% identical to the American.


The therapeutic agent already has been and is being successfully used in clinical trials in the USA. As part of the project, the existing GMP manufacturing process, including quality controls, was transferred to Leipzig by the American manufacturing company Cognate BioServices Inc., where it was also adapted to the European legal foundations which are stricter in some respects.



https://www.izi.fraunhofer.de/content/dam/izi/en/documents/Publications/Annual_Report_IZI_2012.pdf
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