SPECIFICITY OF MANUFACTURING PROCESS VALIDATION FOR DIAGNOSTIC SEROLOGICAL DEVICES

The aim of this research was to analyze recent scientific literature, as well as national and international legislature on manufacturing process validation of biopharmaceutical production, in particular devices for serological diagnostics. Technology validation in the field of medical devices for se...

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Veröffentlicht in:	Biotechnologia acta 2018-01, Vol.11 (1), p.25-38
Hauptverfasser:	Galkin, O Yu, Komar, A G, Pys'Menna, M O
Format:	Artikel
Sprache:	eng
Schlagworte:	Antibodies Antigens Biopharmaceuticals Biosafety Diagnostic systems Immunoassay Immunosorbents Manufacturing Medical device industry Medical devices Medical electronics Medical equipment Organic chemistry Pharmacology Polyclonal antibodies Process parameters Proteins Quality management Raw materials Reagents Risk management
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