Validation of Biopharmaceutical Purification Processes for Virus Clearance Evaluation
نویسندگان
چکیده
منابع مشابه
Viral clearance for biopharmaceutical downstream processes
2015 Viral clearance studies are mandated prior to entering clinical trials and for commercial launch of biopharmaceuticals. These studies are a key component of risk mitigation to reduce the potential for iatrogenic transmission of pathogenic viruses. This paper reviews regulatory guidance and practical strategies for designing viral clearance studies. Essential elements of a developmental pha...
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© 2009 Microbac Laboratories, Inc. Page 1 of 7 The purpose of Viral Clearance evaluation is to assess the capability of a manufacturing production process to inactivate and/or remove potential viral contaminants. Experience and knowledge in selecting the most relevant target viruses, appropriate purification steps, and viral clearing agents are critical in the design and implementation of a cos...
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Protein separation and purification technologies play an essential role in various industries including but not limited to pharmaceuticals, dairy as well as the food sector. Accordingly, a wide variety of techniques such as chromatography and electrophoresis has been developed and utilized extensively over the years for this purpose. Despite their widespread acceptance, conventiona...
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attempts have been made to study the thermodynamic behavior of 1,3 butadiene purification columns with the aim of retrofitting those columns to more energy efficient separation schemes. 1,3 butadiene is purified in two columns in series through being separated from methyl acetylene and 1,2 butadiene in the first and second column respectively. comparisons have been made among different therm...
Herpes Simplex Virus Clearance during Purification of a Recombinant Adeno-associated Virus Serotype 1 Vector.
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ژورنال
عنوان ژورنال: Molecular Biotechnology
سال: 2002
ISSN: 1073-6085
DOI: 10.1385/mb:21:1:057