Quality assurance for biopharmaceuticals: An overview of regulations, methods and problems

Pharmaceutica Acta Helvetiae

Volumn 71, Issue 6, 1996, Pages 421-438

  Müller, Kristian M ^a   Gempeler, Mathias R ^b   Scheiwe, Max Werner ^c   Zeugin, B Tatjana ^d  

^a UNIVERSITY OF ZURICH   (Switzerland)

^b Pentapharm Ltd   (Switzerland)

^c Mepha Ltd   (Switzerland)

^d Regionale Fachstelle fur H   (Switzerland)

Author keywords

Biopharmaceuticals; Fermentation; Formulation; GMP; Guidelines; Lyophilization; Purification; Quality assurance

Indexed keywords

BIOLOGICAL PRODUCT; DRUG;

ARTICLE; DRUG FORMULATION; DRUG LEGISLATION; DRUG SAFETY; EUROPEAN UNION; FREEZE DRYING; GOOD LABORATORY PRACTICE; GOOD MANUFACTURING PRACTICE; PRACTICE GUIDELINE; PURIFICATION; QUALITY CONTROL; SWITZERLAND; TECHNIQUE; UNITED STATES;

EID: 0030482250     PISSN: 00316865     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0031-6865(96)00050-7     Document Type: Article

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