Tag: <span>viral inactivation</span>

The Pervasiveness of Bovine Viral Diarrhea Virus in Commercial Bovine Serum

The procurement of lots of bovine serum that are free of infectious bovine viral diarrhea virus (BVDV) and of neutralizing antibodies to BVDV can still be problematic for manufacturers of biologics. For cell-culture based applications requiring the use of bovine serum as a cell culture medium supplement, the BVDV issue has plagued the industry for decades. Has there been any improvement over the years? The literature from the past four decades has been reviewed to answer this question. There is some evidence that the frequency of detection of infectious BVDV in commercial bovine serum lots has decreased in recent years. There are, however, insufficient data for making conclusions in the case for neutralizing antibodies to BVDV. There are several complementary approaches for mitigating the risk of introducing infectious BVDV into a manufacturing process. These include eliminating the use of serum, pre-treatment of the serum by the vendor or end-user, or treatment of media formulated with the serum to inactivate any BVDV that might be present.

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Biologics Production

animal-derived materials biologics bovine serum bvdv cell culture media medium supplement viral inactivation

Identification of Worst-Case Model Viruses for Selected Viral Clearance Steps

Viral clearance validation studies evaluate the efficacy of upstream or downstream process steps for clearing (inactivating or removing) potential viral contaminants from biologics process streams. Inactivation steps are designed to render viruses non-infectious, while removal steps achieve actual physical removal of viruses from the process stream. During validation, the efficacy of viral clearance steps is challenged through evaluation of inactivation and removal capacity, both for viruses known to be capable of infecting the manufacturing process (relevant viruses) as well as for worst-case model viruses (i.e., those believed to be most resistant to removal or inactivation). Worst-case viruses are used to challenge the process steps in order to assure that unknown or novel viruses that may be present in the process stream will be adequately cleared. Historically, the parvoviruses have been used as worst-case models for viral clearance studies due to their small size and lack of a lipid envelope. These characteristics are known to challenge removal by viral filtration and inactivation by a variety of physical and chemical means. In the present paper, we examine the literature on removal of viruses by filtration, and inactivation of viruses by heat, ultraviolet light, and gamma radiation. We conclude that for viral filtration, as well as ultraviolet and gamma irradiation, the use of a parvovirus as a worst-case model virus may not adequately assure that all types of viruses will be cleared using these steps…

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Biologics Production

complex therapeutics downstream bioprocessing gamma irradiation model viruses parvovirus process validation product validation upsteam bioprocessing uv light viral clearance viral clearance validation viral filtration viral inactivation

Evaluation of Disinfection Procedures for Control of Potential Contamination of Biologicals

An effective disinfection program is an essential component of a pharmaceutical/biopharmaceutical manufacturer’s contamination control strategy. A good disinfection program can help prevent microbial or viral contamination of the manufactured product, further ensuring product safety for patients. The term disinfection is often used interchangeably with cleaning, but the purpose of disinfection is quite different from that of cleaning. Disinfection of a surface will result in inactivation of infectious agents such as bacteria, fungi, and viruses, whereas cleaning a surface removes soil, debris, and other residues.

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Analytics Biologics Regulatory Risk Analysis and Management

biologicals disinfection challenge microbe contamination control strategy disinfection strategies infectious agents spike controls viral inactivation

Identification of Worst-Case Model Viruses for Low and High pH Inactivation

In this paper, we review the efficacy data for low and high pH inactivation of viruses in solutions (i.e., liquid inactivation) and discuss the mechanisms of action and the impact of temperature and treatment time, as these are the primary determinants of inactivation efficacy, besides pH, for different viruses. Only enveloped viruses were considered for low pH inactivation, as the literature concerning low pH inactivation of non-enveloped virus is not extensive and low pH is not considered to be an effective inactivation approach for most non-enveloped viruses. We conclude that for low pH treatment of enveloped viruses, and high pH treatment of both enveloped and non-enveloped viruses, an enteric flavivirus such as bovine viral diarrhea virus represents a worst-case model virus…

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Biologics Production

contaminant control pH inactivation purification viral clearance viral inactivation