fbs – BioProcessing Journal

From the Editor-in-Chief: Production Technology for Lentiviral Vectors

I’ve had some very interesting technical issues cross my desk in the last month, and one involves the “state-of-the-art” production technology for lentiviral vectors. And while you’d think this process should be quite advanced since the industry has been manufacturing viral gene vectors for over 20 years, it appears that we’ve fallen back on old technology and we’re dealing with processing issues we would typically avoid…

Biologics Production

attachment-dependent production biologics bioproduction fbs fetal bovine serum hek 293 cells hek 293T human embryonic kidney lentiviral vector systems packed bed bioreactor stable cell lines sv40 t antigen viral gene vectors

Fetal Bovine Serum: The Impact of Geography

Viral clearance studies are required for pharmaceuticals derived from human and/or animal sources such as recombinant proteins produced in eukaryotic cell lines, human blood products and vaccines, and even for some critical class III medical devices. It is mandatory to demonstrate that steps in the manufacturing process are capable of inactivating or removing potential viral contaminants. For this, a laboratory-scale (downscale) of the process step is developed and challenged with different model virus solutions. The viral concentrations are quantitatively determined in the feed material and the relevant product fraction. The ratio of both defines the reduction in virus and specifies the viral inactivation or viral removal capacity of the investigated process step…

Biologics Production

animal-derived materials disease/agent profiles fbs fbs geography fetal bovine serum geographic origin global origins fbs

Fetal Bovine Serum: What You Should Ask Your Supplier and Why

In today’s volatile sera market, it is critical that sera users worldwide thoroughly review their supply relationships and update sourcing and risk mitigation strategies. BioProcessing Journal’s recent article by Siegel and Foster highlighted the impact of selecting the appropriate country of origin as one criterion for purchasing decisions. Many more vital selection criteria exist to ensure a sera supplier provides long-term assurance of supply and integrity of supply. This article identifies critical questions sera users should ask their suppliers and explains why they should ask them…

Biologics Production

biologics biopharmaceuticals country of origin fbs fbs risk mitigation fetal bovine serum sera market sourcing of fbs supply integrity fbs

Fetal Bovine Serum: Risk Management

Safety is typically viewed, perhaps unconsciously, as the result of a collection of factors, conditions, or behaviors. For example, consider “safety” in the context of personal, financial, or travel. With each, safety is defined as a set of component risks that have been managed to satisfactory levels for a particular situation. The same is true for product safety and risk, whether it be for raw materials or finished goods. The “safe” use of fetal bovine serum (FBS) is achieved by the management of controllable risks to a level that is acceptable for each particular application. For example, risk reduction requirements for research applications are not as stringent as for diagnostic, therapeutic, or manufacturing applications. Each end-user must decide on the level of risk reduction that is appropriate for their application…

Biologics Biologics Production Bioreactor Scale-Up Cell & Gene Therapy Cell Lines Fed-Batch Bioreactor Process HEK293 Mammalian Cell Culture Manufacturing Regulatory Viral Reference Materials Viral Vectors

animal sera animal-derived materials biologics raw materials biotherapeutics cell culture cgmp fbs fetal bovine serum gamma irradiation geographical origins isia safe use serum serum traceability vaccines

Serum: What, When, and Where?

For over 80 years, fetal bovine serum (FBS) and other animal-derived materials have been widely used in the production of vaccines, and more recently, biotherapeutics, for both human and animal applications. Ever since FBS was initially developed as a cell culture reagent, there have been efforts made to avoid the use of this critical commodity. The International Serum Industry Association (ISIA) recognizes the requirement for robust risk assessment and management, and has several ongoing programs designed to help mitigate the risk of using animal-derived materials. This article will provide an outline of the state of the industry and of these programs…

animal sera animal-derived materials biologics raw materials biotherapeutics cell culture fbs fetal bovine serum isia serum traceability vaccines

Gamma Irradiation of Animal Serum: Validation of Efficacy for Pathogen Reduction and Assessment of Impacts on Serum Performance

The treatment of animal serum by gamma irradiation, for the purpose of mitigating the risk of introducing a pathogen (virus, mollicute, or other microbe) into a cell culture, is a process that has been executed (and perhaps understood) primarily by irradiation contractors utilized by serum manufacturers. The selection of appropriate exposure conditions and irradiation doses is driven by a number of critical factors including: (1) the validation and control of the irradiation process itself; (2) the efficacy of the applied irradiation dose range for inactivating pathogens of interest; (3) determination and control of critical process attributes; (4) the potential impacts of these irradiation dose levels on the serum being irradiated; and finally, (5) the potential impact of irradiated serum on the medicinal product and the associated manufacturing process where serum is ultimately used. In order to increase awareness of these topics throughout the cell culture community, we have addressed these critical factors in the current review…

abattoir albumin animal serum animal-derived materials antibody biomedical research blood-derived products calf serum calicivirus cell culture cell medium challenge virus design of efficacy dose mapping fbs fetal bovine serum gamma irradiation heat inactivation isia kgy kilogray microbes mollicute nbcs pathogen reduction product management risk mitigation serum product serum risks spiked serum therapeutic proteins traceability viral reduction whole blood

Gamma Irradiation of Animal Serum: An Introduction

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 efficacy 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.

abattoir albumin animal serum animal-derived materials biomedical research blood-derived products calf serum cell culture cell medium dose mapping fbs fetal bovine serum gamma irradiation heat inactivation isia nbcs pathogen reduction product management risk mitigation serum risks therapeutic proteins traceability whole blood

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