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Manufacturing Cellular Therapy Products in an Academic Facility

by Adrian P. Gee, PhD
Volume 2, Issue 1 (January/February 2003)

Cellular therapy is currently generating great interest in the treatment of a variety of diseases. In turn, this interest has stimulated the Center of Biologics Evaluation and Research of the Food and Drug Administration to examine its regulatory approach to the products used for these therapies. As a result, facilities preparing cell therapy products are now regarded as manufacturers, and are expected to comply with current Good Manufacturing Practices and/or the proposed current Good Tissue Practices. Compliance with these practices can be a culture shock to some academic centers whose background is firmly in research. The FDA has indicated that there is a sliding scale of compliance depending on the phase of the clinical study. The difficulty for centers is deciding where they fall on the compliance scale, as well as determining what changes must be made to come into compliance. This article reviews some of the factors that must be considered when making these decisions...

Citation:
Gee AP. Manufacturing Cellular Therapy Products in an Academic Facility. BioProcess J, 2003; 2(1): 39-43.

 
FDA Perspectives on Characterization and Comparability of Cellular Therapy Products

by Kimberly Benton, PhD
Volume 2, Issue 1 (January/February 2003)

As product development proceeds in the field of cellular therapies, adequate product characterization remains a challenge for both IND Sponsors and FDA/CBER. Cellular therapy products are not considered to be well-defined products, and therefore the control and characterization of each stage of the production process helps to ensure product safety and consistency. Product characterization of cellular products includes demonstration of safety, plus determination of identity, purity, potency, and product stability. Development of appropriate specifications for each of these parameters is necessary for lot release, and also provides an important database of knowledge for addressing regulatory issues, such as lot-to-lot consistency and potential issues with product comparability, should the manufacturing process, or other aspects of product development, change over time...

Citation:
Benton K. FDA Perspectives on Characterization and Comparability of Cellular Therapy Products. BioProcess J, 2003; 2(1): 44-47.

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

by Marshall Dinowitz, ScD
Volume 2, Issue 1 (January/February 2003)

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...

Citation:
Dinowitz M. Strategic Approaches to Viral Safety and Viral Clearance Assessment in Cell Culture-Derived Pharmaceutical Products. BioProcess J, 2003; 2(1): 48-50.

 
NS0 Batch Cell Culture Process Characterization: A Case Study

by Brian Kearns, David Lindsay, Matthew Manahan, John McDowall, and Dennis Rendeiro
Volume 2, Issue 1 (January/February 2003)

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...

Citation:
Kearns BG, Lindsay D, Manahan M, McDowall J, Rendeiro D. NS0 Batch Cell Culture Process Characterization: A Case Study. BioProcess J, 2003; 2(1): 52-57.

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

by Merribeth J. Morin, PhD
Volume 2, Issue 1 (January/February 2003)

The use of animal products, such as bovine serum, in the manufacture of biologics is a common practive. 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...

Citation:
Morin MJ. Emerging Virus and TSE Issues for Bovine-Derived Raw Materials Used in the Manufacture of Biological Products. BioProcess J, 2003; 2(1): 58-61.

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

by Katherine F. Bergmann, PhD and Leonard J. Schiff, PhD
Volume 2, Issue 1 (January/February 2003)

Various systems are used for production of biopharmaceuticals, including bateria, 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...

Citation:
Bergmann KF, Schiff LJ. Assuring Viral Safety in Products Produced in Milk from Transgenic Animals: What Can Be Learned from Ascites-Derived Products. BioProcess J, 2003; 2(1): 62-65.

 
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