Biologics Production – Page 31 – BioProcessing Journal

Strategic Approaches to Viral Safety and Viral Clearance Assessment in Cell Culture-Derived Pharmaceutical Products

Viral safety and viral clearance evaluation are high-profile areas for product safety. Regulators are keenly focused on viral safety and expect high-quality data to support it, particularly for IND and BLA approvals. Familiarity with process and regulatory requirements, as well as expertise in the key areas of viral clearance, are essential for strategic planning and can yield savings in time, effort, and money…

Biologics Production Manufacturing Regulatory

cell culture safety viral clearance viral safety virology

NS0 Batch Cell Culture Process Characterization: A Case Study

The characterization of a batch cell culture process to produce a monoclonal antibody from a GS-NS0 mouse myeloma cell line is described. Productivity and cellular metabolism were monitored during scale-up to both characterize the process and aid in assessing cell culture stability. During fermentation scale-up studies, it was found that as culture generation number increased, productivity declined. In both flask and bioreactor cultures, declining production started abruptly at approximately generation 60. In this study, we assessed whether the decline in productivity was due to genetic instability of the cell line, which resulted in the generation of a non-producer sub-population, or a shift to a less productive state of cellular metabolism…

Biologics Production

analysis cell culture characterization monoclonal antibody scale-up

Emerging Virus and TSE Issues for Bovine-Derived Raw Materials Used in the Manufacture of Biological Products

The use of animal products, such as bovine serum, in the manufacture of biologics is a common practice. The United States’ Code of Federal Regulations, part nine (9CFR), dictates mandatory testing for viruses. In the last few years, we have learned that certain viruses undetected in industry standard tests, like the 9CFR assay, can cause significant contamination of bovine products. Last year in Europe, new guidelines from the Committee for Veterinary Medicinal Products (CVMP), and draft guidelines from the Committee for Proprietary Medicinal Products (CPMP), were published to address testing requirements for bovine serum. The use of these European Guidelines for bovine serum testing broadens the ability to detect viral contamination…

Biologics Production Manufacturing

biologics contaminant control raw materials testing viral contamination

Assuring Viral Safety in Products Produced in Milk from Transgenic Animals: What Can Be Learned from Ascites-Derived Products

Various systems are used for production of biopharmaceuticals, including bacteria, yeast, mouse ascites, and animal cell culture. Each production system has its own set of risk factors for infection by viruses and their potential transmission in the final product. Viral contamination in products can arise from the animals themselves, from environmental sources, from the starting cells, or from materials introduced during the production and purification procedures. Methods have been developed for the prevention and control of these risks. The strategy used to minimize the risk of viral contamination combines several levels of viral safety…

Biologics Production Risk Analysis and Management

contaminant control purification safety viral contamination

Methods for Detection and Evaluation of Replication Competent Adenovirus (RCA)

In the past, researchers developing gene therapy applications used replication-defective human Adenovirus 5 (Ad5) as a vector for delivering DNA sequences, almost exclusively. Ad5 vectors are typically rendered replication defective by the deletion of E1a gene sequences. A complementing cell line containing the E1a gene makes it possible to produce Ad5 vectors in large scale. Of the various cell lines that have been constructed for the purpose of high-titer Ad5 production, HEK293 cells and PER.C6 cells are the most widely used…

Biologics Production Viral Vectors

adenoviral vectors adenovirus serotype 5 replication replication-competent

Production Criteria in the Development of a K562-Based Vaccine Platform

The K562 cell line is a human myelogenous leukemic cell which has been used by several groups, including ours, as a vehicle for cell-based vaccines and immuno-gene therapies. The attractiveness of K562 cells is the ease with which they can be cultured, plus the fact that they express very low levels of MHC proteins. Low MHC expression facilitates the use of these cells in patients with different MHC backgrounds, and it may improve the in vivo survival of the cells by delaying immune rejection. Based largely on these properties, we have been developing the K562 cell line as a universal platform for expressing cytokines, tumor antigens, and other immuno-modulating proteins…

Biologics Production

cryopreservation ELISA immunotherapy mammalian cell culture protein expression vaccines

Chemical Cell Lysis for Large-Scale Adenoviral Vector Production

Production of non-enveloped viruses generally requires a cell lysis procedure to liberate mature particles trapped within their host cells. The standard bench-scale practice of using freeze/thaw cycles is simple and effective, but heat transfer limitations restrict the technique to relatively small applications. Here we show that a ten-minute treatment with a dilute mixture of polysorbate-80 and tri-butyl phosphate effectively liberates adenovirus from host cells…

Biologics Production Viral Vectors

adenoviral vectors adenovirus cell lysis scale-up

Complex N-glycosylation of Recombinant Proteins by Insect Cells

The insect cell/baculovirus expression system typically results in more rapid expression and higher concentrations of recombinant proteins than what can be achieved with other animal cell culture systems. The lack of complex glycosylation in the proteins produced by this system, however, limits its use in the commercial-scale production of therapeutics. Complex glycosylation is required in many cases for adequate protein activity and pharmokinetic characteristics. In contrast to the protein’s primary structure, which is encoded by the genetic material and is constant regardless of the host utilized, the extent of glycosylation is determined by the host, and by the protein itself. Even cells from different tissues of the same organism provide different glycosylation profiles. In addition, culture conditions and the cellular metabolic state can also influence protein glycosylation…

Baculovirus Expression Technology Biologics Production

glycosylation N-glycosylation pharmokinetics recombinant proteins

Media Supply and Development

Based on feedback received from a number of our recent conferences, cell culture media development remains one of the biggest challenges in the development of biological products. With more products reaching larger production scale and licensed production, it is becoming ever more important that we gain a better understanding of the media supply industry, and that we find ways to make media development more economical, reliable, and reproducible…

Biologics Production

cell culture media

A Rapid Method for the Capture and Purification of a Protease Sensitive Protein

The baculovirus expression vector system (BEVS) is one method utilized for the production of recombinant proteins, and typically works without significant difficulties. However, some proteins are produced in insoluble forms, and degradation can occur. This article will focus on this degradation issue, and present a method to stabilize a protease-sensitive protein that has been produced at the 40-liter scale…

Baculovirus Expression Technology Biologics Production

protease-sensitive protein purification recombinant proteins stability

Category: <span>Biologics Production</span>

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