Viral Inactivation Papers

Reduce the level of infectious viruses in your mAb process

Read the most recent papers in viral inactivation


Nazari, et al.
Scientific reports 2017-09-26
Femtosecond (fs) pulsed laser irradiation techniques have attracted interest as a photonic approach for the selective inactivation of virus contaminations in biological samples. Conventional pulsed laser approaches require, however, relatively long irradiation times to achieve a significant inactivation of virus. In this study, Read More
Orozco, et al.
Biotechnology progress 2017-08-23
We designed, built or 3D printed, and screened tubular reactors that minimize axial dispersion to serve as incubation chambers for continuous virus inactivation of biological products. Empirical residence time distribution data were used to derive each tubular design's volume equivalent to a theoretical plate (VETP) values at a Read More
Conley, et al.
Biotechnology and bioengineering 2017-10-10
Inclusion of a detergent in protein biotherapeutic purification processes is a simple and very robust method for inactivating enveloped viruses. The detergent Triton X-100 has been used for many years and is part of the production process of several commercial therapeutic proteins. However, recent ecological studies have suggestRead More
Nims, et al.
Biologicals : journal of the International Association of Biological Standardization 2017-01-23
The use of specific model viruses for validating viral purification process steps and for assessing the efficacies of viral disinfectants is based, in part, on the assumption that viral susceptibilities to such treatments will be similar for different members, including different genera, within a given viral family. This assumptRead More
Hume, et al.
Viruses 2017-11-30
Effective inactivation of biosafety level 4 (BSL-4) pathogens is vital in order to study these agents safely. Gamma irradiation is a commonly used method for the inactivation of BSL-4 viruses, which among other advantages, facilitates the study of inactivated yet morphologically intact virions. The reported values for susceptibiRead More
Kateja, et al.
Biotechnology journal 2017-01-19
Coiled Flow Inverter Reactor (CFIR) has recently been explored for facilitating continuous operation of several unit operations involved in downstream processing of biopharmaceuticals such as viral inactivation and protein refolding. The application of CFIR for continuous precipitation of clarified cell culture supernatant has bRead More
Mattila, et al.
PDA journal of pharmaceutical science and technology 2017-10-16
Considerable resources are spent within the biopharmaceutical industry to perform viral clearance studies, which are conducted for widely used unit operations that are known to have robust and effective retrovirus clearance capability. The collaborative analysis from the members of the BioPhorum Development Group Viral ClearanceRead More
Tai, et al.
Journal of visualized experiments : JoVE 2017-10-29
Cell-based systems are useful for discovering antiviral agents. Dissecting the viral life cycle, particularly the early entry stages, allows a mechanistic approach to identify and evaluate antiviral agents that target specific steps of the viral entry. In this report, the methods of examining viral inactivation, viral attachmentRead More
Chinniah, et al.
Biotechnology progress 2016-12-30
To ensure the viral safety of protein therapeutics made in mammalian cells, purification processes include dedicated viral clearance steps to remove or inactivate adventitious and endogenous viruses. One such dedicated step is low pH treatment, a robust and effective method commonly used in monoclonal antibody production to inacRead More
Mazzer, et al.
Journal of chromatography. A 2016-10-19
Protein A chromatography is a near-ubiquitous method of mAb capture in bioprocesses. The use of low pH buffer for elution from protein A is known to contribute to product aggregation. Yet, a more limited set of evidence suggests that low pH may not be the sole cause of aggregation in protein A chromatography, rather, other facetRead More
Chollangi, et al.
Biotechnology and bioengineering 2015-09-29
To be administered to patients, therapeutic monoclonal antibodies must have very high purity, with process related impurities like host-cell proteins (HCPs) and DNA reduced to <100 ppm and <10 ppb, respectively, relative to desired product. Traditionally, Protein-A chromatography as a capture step has been the work horse for cleRead More
Durno, et al.
PDA journal of pharmaceutical science and technology 2017-08-17
Bolton, et al.
Biotechnology progress 2015-04-23
Low pH viral inactivation is typically performed in the eluate pool following the protein A capture step during the manufacturing of monoclonal antibodies and Fc-fusion proteins. However, exposure to low pH has the potential to alter protein quality. To avoid these difficulties, novel wash buffers capable of inactivating virusesRead More
Ma, et al.
Journal of the Chinese Medical Association : JCMA 2014-01-10
Murine xenotropic leukemia virus-related virus (XMulV) is used as a model virus in the evaluation of viral inactivation in Chinese hamster ovary (CHO) cell-derived pharmaceutical proteins. Mus dunni cells and mink lung cells are used to produce XMulV particles. In consideration of the characteristics of XMulV, we tried to propagRead More
Kljavin, et al.
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
Rosenberg, et al.
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) Viral contamination of biotech product facilitiesRead More
Fang, et al.
Journal of chromatography. B, Analytical technologies in the biomedical and life sciences 2013-11-21
Yeastolates, triton X-100 (TX-100) and methotrexate (MTX) are common process-related impurities (PRI) in cell-based bioproduction of many active biopharmaceuticals. In this study, a reverse phase high performance liquid chromatography (RP-HPLC) method coupled with ultraviolet (UV) detection was developed for simultaneous determiRead More
Murphy, et al.
Biologicals : journal of the International Association of Biological Standardization 2015-11-19
Viral contamination of mammalian cell cultures in GMP manufacturing facility represents a serious safety threat to biopharmaceutical industry. Such adverse events usually require facility shutdown for cleaning/decontamination, and thus result in significant loss of production and/or delay of product development. High temperatureRead More
Nims, et al.
Biologicals : journal of the International Association of Biological Standardization 2011-11-01
Animal-derived materials such as animal sera represent a low, but finite, risk for introduction of an adventitious agent (virus or mollicute) into a biological bulk harvest during upstream manufacturing processes involving mammalian cell substrates. Viral and mollicute (Mycoplasma sp. and Acholeplasma sp.) contamination events hRead More
Lorenz, et al.
Biotechnology progress 2013-11-21
As part of an investigation to identify potential new viral reduction strategies, ultraviolet-C (UV-C) light was examined. Although this technology has been known for decades to possess excellent virus inactivation capabilities, UV-C light can also introduce significant unwanted damage to proteins. To study the effect on monocloRead More
Robertson, et al.
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
Qin, et al.
Acta biochimica et biophysica Sinica 2006-11-15
To explore the potential application of capsid-targeted viral inactivation (CTVI) strategy in prophylactic model against dengue virus (DV) infection, here we fused a Ca(2+)-dependent nuclease, staphylococcal nuclease (SN), to the capsid protein of dengue 2 virus (D2C) at the carboxyl terminal, and constructed the desired expressRead More
Valdés, et al.
Journal of biotechnology 2008-11-21
The virus removal of protein A affinity chromatography, inactivation capacity, acid pH and a combination of high temperature with a chaotropic agent was determined in this work. The model viruses studied were sendaivirus, human immunodeficency virus (HIV-IIIb), human poliovirus type-II, human herpesvirus I and canine parvovirus.Read More
Lowy, et al.
Antiviral research 2011-11-17
Radiation inactivation of viral pathogens has potential application in sterilization and in the manufacture of biological reagents, including the production of non-infectious viral antigens. Viral inactivation by gamma radiation has been extensively investigated, but few direct comparisons to other qualities of radiation have beRead More
Uemura, et al.
Biologicals : journal of the International Association of Biological Standardization 2004-11-17
Control sera are an essential component of in-vitro clinical diagnostic reagents. We have developed a control serum for HBsAg, anti-HCV, anti-HIV and anti- Treponema pallidum testing. Since this control serum is prepared from human plasma, we paid special attention to viral safety. We incorporated three viral inactivation methodRead More
Lau, et al.
Journal of biotechnology 2005-11-17
Chinese hamster ovary cells used for pharmaceutical protein production express non-infectious retrovirus-like particles. To assure the safety of pharmaceutical proteins, validation of the ability of manufacturing process to clear retrovirus-like particles is required for product registration. Xenotropic murine leukemia virus (X-Read More
Smales, et al.
Biotechnology and bioengineering 2008-11-21
Heat treatment is routinely used in the preparation of therapeutic protein biopharmaceuticals as a means of viral inactivation. However, in undertaking virucidal heat treatments, a balance must be found between the bioprocessing conditions, virus kill, and the maintenance of protein integrity. In this study, we utilize a simple Read More
Larzul, et al.
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
Burstyn, et al.
Developments in biological standardization 2017-11-16
This paper provides an overview of the fundamentals of viral inactivation and clearance studies required for mammalian cell culture-derived biotechnological products. Strategies and considerations for evaluating the potential of purification processes to inactivate or remove adventitious or endogenous viruses are also discussed.Read More
Stoltz, et al.
Annales pharmaceutiques francaises 2014-11-20
Affinity and/or immunoaffinity chromatography is one of the less commonly method used for large scale separation purposes. As this technic is greatly selective and gives high yields, it allows in vivo removal, in an extracorporeal circulation, of harmful substances in patient plasma as well as purification of molecules for bioloRead More
Vicari, et al.
Developments in biological standardization 2013-11-21
Viruses represent a main concern as a potential risk associated with the use of both classical biologicals and new biotechnological products. The objective of validation is to estimate quantitatively the overall level of virus clearance obtained during the various stages of purification and viral inactivation procedures. The desRead More
Aronson, et al.
Progress in clinical and biological research 2013-11-21
Tolbert, et al.
Developments in biological standardization 2003-11-14
Murine monoclonal antibodies are now routinely produced from highly expressing hybridoma cell lines for human clinical applications. Epstein Barr Virus transformed human lymphocytes are used to produce human monoclonal antibodies but these cells have generally exhibited low expression and poor stability in culture when compared Read More
K Brorson,S Krejci,K Lee,E Hamilton,K Stein,Y Xu
Biotechnology and bioengineering 2006-11-15
Viral safety is a predominant concern for monoclonal antibodies (mAbs) and other recombinant proteins (RPs) with pharmaceutical applications. Certain commercial purification modules, such as nanofiltration and low-pH inactivation, have been observed to reliably clear greater than 4 log(10) of large enveloped viruses, including eRead More