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Pondering Different Scales of Knowledge

by Verne A. Luckow, PhD, JD
Volume 16, Open Access (September 2017)

I am not particularly spiritual. But as the shadow of the moon began to approach on August 21, 2017, I started to think about the limits of my knowledge of the solar system, galaxies, and beyond, compared to my focus for decades on smaller objects, such as molecules, cells, and tissues. A week later, Hurricane Harvey developed rapidly and lingered over southeast Texas, dumping over 50 inches of rain in some locations, causing widespread flooding, releasing sewage and toxic chemicals into the water, and triggering outbreaks of mold. Hurricane Irma, on its path through the Caribbean and up the western coast of Florida, devastated vegetation, buildings, and power lines, with intense winds that once peaked at 185 mph...

Luckow VA. Opinion: pondering different scales of knowledge. BioProcess J, 2017; 16.

Posted online September 21, 2017.

Demonstration of Porcine Circovirus Type 2 Inactivation by the Low pH Step of the Trypsin Manufacturing Process Using a New Infectivity Assay

by Tara Tagmyer, PhD and Kathryn Martin Remington, PhD
Volume 16, Open Access (September 2017)

Porcine circoviruses (PCVs) are small (17 nm) non-enveloped viruses with a covalently closed, circular, single-stranded DNA genome. PCV type 1 (PCV-1) and PCV type 2 (PCV-2) belong to the circovirus genus within the Circoviridae family. PCV-1 was originally isolated as a contaminant of porcine kidney (PK15) cells, and although it was found to be widely distributed in domestic swine in both North America and Europe, no correlation to any porcine disease or disorder has been established. PCV-2, however, has been found to be associated with several disease syndromes in pigs. For manufacturers of biologics utilizing porcine tissue or porcine tissue-derived materials, PCVs represent a contamination risk. In fact, an independent academic laboratory detected PCV-1 in a live attenuated rotavirus vaccine using metagenomic analysis and a PCV-1-specific polymerase chain reaction (PCR). While this study did not detect PCV-1 or PCV-2 nucleic acid in rotavirus vaccine from a second manufacturer, subsequent testing by the manufacturer revealed low levels of both PCV-1 and PCV-2 DNA. The source of the PCV nucleic acid contaminating both vaccines was determined to be porcine pancreas-derived trypsin used in the manufacture of the vaccines. The manufacturer of the rotavirus vaccine that was initially found to contain PCV sequences determined that their cell banks and virus seeds were contaminated with the viral sequences. The strong safety record of both vaccines and the benefits of vaccination against rotavirus convinced both the United States Food and Drug Administration (US FDA) and the European Medicines Agency (EMA) to permit their continued use...

Tagmyer T, Remington KM. Demonstration of porcine circovirus type 2 inactivation by the low pH step of the trypsin manufacturing process using a new infectivity assay. BioProcess J, 2017; 16.

Posted online September 18, 2017.

Inactivation of Adventitious Agents by UVC Irradiation in a Plant-Based Influenza Vaccine Production Process

by Todd L. Talarico, Kevin Williams, Timothy Yeh, Bruno Pancorbo, Mélanie Bérubé, Michael Murphy, and Michèle Dargis
Volume 16, Issue 1 (Spring 2017)

Biologics are often produced in or derived from matrices that harbor the potential for introduction of adventitious agents to the drug product. This potential is not strictly theoretical, as viruses such as hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), porcine circovirus (PCV), and minute virus of mice (MVM) have been detected in biological products in the past. From a regulatory and safety perspective, assurance that adventitious agents are not present in the drug product is a critical measure of product quality. Guidelines for assuring safety, with respect to adventitious agents in blood-derived products and products produced in mammalian cell culture, are addressed in specific guidances from the Food and Drug Administration (FDA) and the Committee for Proprietary Medicinal Products (CPMP). These guidance documents suggest that safety is best assured through screening donor material or production cell lines, by controlling animal-derived raw materials used during manufacture, incorporating viral removal and inactivation steps in the production process, and protecting the product from the environment during manufacture. Even though Medicago develops products that are produced in plants, a host that does not support the replication of viruses that infect mammals, various regulatory agencies have advised that the production process should contain one or more operations that remove or inactivate adventitious agents. Medicago has investigated multiple methodologies to accomplish this goal, and has found ultraviolet C (UVC) irradiation treatment to be effective for adventitious agent inactivation in the production process used to manufacture their quadrivalent influenza vaccine without detrimental impact to the product...

Talarico TL, Williams K, Yeh T, Pancorbo B, Bérubé M, Murphy M, Dargis M. Inactivation of adventitious agents by UVC irradiation in a plant-based influenza vaccine production process. BioProcess J, 2017; 16(1): 15–24.

Posted online May 8, 2017.

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

by Raymond Nims, S. Steve Zhou, and Mark Plavsic
Volume 16, Issue 1 (Spring 2017)

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...

Nims R, Zhou SS, Plavsic M. Identification of worst-case model viruses for low and high pH inactivation. BioProcess J, 2017; 16(1): 7–14.

Posted online May 8, 2017.

Gamma Irradiation of Frozen Animal Serum: Dose Mapping for Irradiation Process Validation

by Bart Croonenborghs, Andy Pratt, Lorraine Bone, and Mara Senescu
Volume 15, Issue 3 (Fall 2016)

The treatment of animal serum by gamma irradiation is performed to mitigate the risk of introducing undesired microorganisms (viruses, mollicutes, or other microbes) into a cell culture. Serum manufacturers and end-users utilize irradiation contractors to perform this process. The irradiation process must be validated, which involves establishing the: (A) minimum dose that achieves the required inactivation of the microorganisms of interest; (B) maximum acceptable dose at which the serum still maintains all of its required functional specifications; and (C) process used by the contract irradiator that allows treatment of the serum product within these defined limits. In the present article, we describe the best practices for qualifying the distribution and magnitude of absorbed dose (performance qualification [PQ] dose-mapping) when serum is gamma irradiated. PQ dose-mapping includes the following: (1) documentation of dose distribution characteristics in defined product load configurations for a specified pathway through the irradiator; (2) assessment of the process capability of the defined product load configurations and irradiation pathway for respecting the dose specification for the serum; and (3) development of a method for routine dose monitoring of the irradiation process with the defined product load configurations and the specified irradiation pathway...

Croonenborghs B, Pratt A, Bone L, Senescu M. Gamma irradiation of frozen animal serum: dose mapping for irradiation process validation. BioProcess J, 2016; 15(3): 7–13.

Posted online November 15, 2016.

Gamma Irradiation of Animal Serum: An Introduction

by Rosemary J. Versteegen, PhD, Mark Plavsic, PhD, DVM, Raymond Nims, PhD, Robert Klostermann, and Karl Hemmerich
Volume 15, Issue 2 (Summer 2016)

This article serves as an introduction to a series of papers that are being authored under the sponsorship of the International Serum Industry Association with the purpose of establishing best practices for processes employed in the gamma irradiation of animal serum. It is comprised of a discussion about the role of serum in cell culture and the management of the associated risks. Additional articles in the series will address a number of topics of interest to the cell culture community, including, but not limited to: (1) performance of absorbed dose mapping for irradiators; (2) validation of the ef ficacy of pathogen reduction during gamma irradiation of animal serum; (3) comparability evaluation of irradiated serum; (4) product management throughout the irradiation process; and (5) ensuring a quality outcome when using gamma irradiation. The intent of the series is to increase awareness of the scientific community regarding the conduct of gamma irradiation and the strengths and limitations of this serum treatment approach for achieving the goals of adventitious agent risk mitigation...

Versteegen R, Plavsic M, Nims R, Klostermann R, Hemmerich K. Gamma irradiation of animal serum: an introduction. BioProcess J, 2016; 15(2): 5–11.

Posted online July 30, 2016.

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