Allogenic and autologous nondiluted serum eye drops—validation strategy compliant with good manufacturing practice

URN to cite this document:: urn:nbn:de:bvb:355-epub-588515
DOI to cite this document:: 10.5283/epub.58851

Dormann, Frauke ; Hähnel, Viola

; Müller, Viktoria ; Burkhardt, Ralph

; Offner, Robert

License: Creative Commons Attribution 4.0
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Date of publication of this fulltext: 19 Aug 2024 09:33

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Abstract

Background and aims Serum eye drops alleviate ocular symptoms of diseases such as sicca syndrome, or chronic graft-versus-host disease. This study was designed for good manufacturing practice validation of our standard manufacturing, storage and transport processes for both autologous and allogenic SEDs. Specifications of quality parameters are lacking and were aimed to be ...