Viral Safety

Viral safety assurance strategies

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SA Johnson,MR Brown,SC Lute,KA Brorson
Biotechnology and bioengineering 2017-12-16
M Plavsic,K Shick,KF Bergmann,L Mallet
Biologicals : journal of the International Association of Biological Standardization 2017-01-23
Vesivirus 2117 (VV-2117) has been recently described as a contaminant of cell culture operations in several biologics manufacturing facilities. VV-2117 has been poorly studied and little information exists about its biology, pathogenicity and infectivity range in cell culture settings. In this study we evaluated the potential inRead More
SA Johnson,MR Brown,SC Lute,KA Brorson
Biotechnology and bioengineering 2017-12-16
There has been a recent drive in commercial large-scale production of biotechnology products to convert current batch mode processing to continuous processing manufacturing. There have been reports of model systems capable of adapting and linking upstream and downstream technologies into a continuous manufacturing pipeline. HoweRead More
E Cabannes,C Hébert,M Eloit
PDA journal of pharmaceutical science and technology 2016-10-21
The availability of next-generation sequencing techniques is about to strongly modify the strategies of control of the viral safety of biologicals products. It is now possible to use the tools of metagenomics, which is the study of the microbial genetic sequences recovered directly from a given sample. In this setting, the sequeRead More
J Blümel
PDA journal of pharmaceutical science and technology 2016-10-21
L Xu,SB Lee,C Fuchs,KC Hyams,K Brorson,P Swann
PDA journal of pharmaceutical science and technology 2016-10-21
J Stuckey,D Strauss,A Venkiteshwaran,J Gao,W Luo,M Quertinmont,S O'Donnell,D Chen
Biotechnology progress 2014-02-07
Viral filtration is routinely incorporated into the downstream purification processes for the production of biologics produced in mammalian cell cultures (MCC) to remove potential viral contaminants. In recent years, the use of retentive filters designed for retaining parvovirus (~20 nm) has become an industry standard in a consRead More
M Zhang,GR Miesegaes,M Lee,D Coleman,B Yang,M Trexler-Schmidt,L Norling,P Lester,KA Brorson,Q Chen
Biotechnology and bioengineering 2015-04-23
Protein A chromatography is widely used as a capture step in monoclonal antibody (mAb) purification processes. Antibodies and Fc fusion proteins can be efficiently purified from the majority of other complex components in harvested cell culture fluid (HCCF). Protein A chromatography is also capable of removing modest levels of vRead More
K Brorson,H Willkommen
PDA journal of pharmaceutical science and technology 2016-10-21
IJ Kljavin
PDA journal of pharmaceutical science and technology 2016-10-21
CONFERENCE PROCEEDING Proceedings of the PDA/FDA Adventitious Viruses in Biologics: Detection and Mitigation Strategies Workshop in Bethesda, MD, USA; December 1-3, 2010 Guest Editors: Arifa Khan (Bethesda, MD), Patricia Hughes (Bethesda, MD) and Michael Wiebe (San Francisco, CA) The production of biotechnology products using maRead More
JP Gregersen
PDA journal of pharmaceutical science and technology 2016-10-21
CONFERENCE PROCEEDING Proceedings of the PDA/FDA Adventitious Viruses in Biologics: Detection and Mitigation Strategies Workshop in Bethesda, MD, USA; December 1-3, 2010 Guest Editors: Arifa Khan (Bethesda, MD), Patricia Hughes (Bethesda, MD) and Michael Wiebe (San Francisco, CA) For decades conventional tests in cell cultures aRead More
AS Lubiniecki
PDA journal of pharmaceutical science and technology 2016-10-21
CONFERENCE PROCEEDING Proceedings of the PDA/FDA Adventitious Viruses in Biologics: Detection and Mitigation Strategies Workshop in Bethesda, MD, USA; December 1-3, 2010 Guest Editors: Arifa Khan (Bethesda, MD), Patricia Hughes (Bethesda, MD) and Michael Wiebe (San Francisco, CA) Approaches to viral safety issues for biological Read More
A Kerr,R Nims
PDA journal of pharmaceutical science and technology 2016-10-21
While viral safety is a major concern for biologics manufactured using mammalian cells, the numbers of viral contamination events reported in the literature are quite low. During a 10-year period during which biologics derived from a variety of mammalian cell culture processes were evaluated using the in vitro virus screening asRead More
F Barin
Annales pharmaceutiques francaises 2013-11-21
The viral safety of biologicals, either human blood derivatives or animal products or recombinant proteins issued from biotechnology, relies on the quality of the starting material, the manufacturing process and, if necessary, the control of the final product. The quality of the starting material is highly guaranteed for blood dRead More
JS Robertson
Developments in biologicals 2016-11-24
For many years users of bovine serum in the manufacture of human and veterinary biological medicinal products have relied upon USDA 9CFR to ensure the viral safety of their serum. Recently, EU regulators have formalised their position by issuing guidelines on the use of bovine serum during manufacture. Additionally, the EuropeanRead More
K Brorson,L Norling,E Hamilton,S Lute,K Lee,S Curtis,Y Xu
Developments in biologicals 2013-11-21
JS Robertson
Developments in biologicals 2013-11-21
J Descotes,G Ravel,T Vial
Therapie 2006-11-15
Biotechnology-derived products represent a class of increasingly numerous drugs. One of their major characteristics is extreme diversity, which requires specific approaches for the preclinical evaluation of their safety. The selection of relevant animal species is not easy, as most of these products are human-specific. Thus, onlRead More
M Dinowitz
Developments in biologicals 2013-11-21
A key component in the development of safe cell-based biologicals is the incorporation of procedures to ensure virological safety using a three-pronged approach--raw material testing, including testing of the cell banks; incorporation of virus clearance steps in the production process; and lot-by-lot virus testing of culture harRead More
H Brandwein,H Aranha-Creado
Developments in biologicals 2013-11-21
Incorporation of adequate clearance methodologies for viral safety assurance constitutes an integral part of the manufacturing process for plasma-derived biologicals. Filtration, being non-invasive, non-destructive and a mechanism for virus removal is often the method of choice. This paper discusses the virus filter perRead More
D Larzul
Developments in biological standardization 2013-11-21
In many cases, the viral safety evaluation of biological products does not derive solely from direct testing for the presence of contaminants, but also from the demonstration that the manufacturing process is able to inactivate/eliminate them. This is achieved by the voluntary addition of a virus load at various steps of the proRead More
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Federal register 2013-11-21
The Food and Drug Administration (FDA) is publishing a guidance entitled "Q5A Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of PharmaceutRead More
DW Trent
Developments in biological standardization 2013-11-21
F Horaud
Developments in biological standardization 2013-11-21
T Hayakawa
Developments in biological standardization 2013-11-21
The current situation concerning the development of an internationally harmonized document on the technical requirements for the viral safety of biotechnology drugs (ICH viral safety document) is described. Major issues relating to harmonization of testing requirements for viral safety include: (i) clarification of scientific raRead More
PR McAllister,PJ Shadle,TM Smith,RG Scott,AS Lubiniecki
Developments in biological standardization 2013-11-21
F Horaud
Developments in biological standardization 2013-11-21
VP Grachev
Developments in biological standardization 2013-11-21
The production and quality control of biological products are regulated by the different national and international requirements. One of the many functions of WHO is to develop an international consensus on basic criteria for the acceptability of biological products. These include general and international requirements for the pRead More
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