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FDA Educational Partnerships to Improve the Development of Cell and Gene Therapy Products

by Darin J. Weber, PhD, Stephanie Simek, PhD, and Raj K. Puri, MD, PhD
Volume 2, Issue 4 (July/August 2003)

On January 31, 2003, FDA under the leadership of Commissioner Dr. Mark McClellan, issued a report entitled "Improving Innovation in Medical Technology: Beyond 2002." One of the goals described in this report is to "speed potentially important emerging technologies to the market by reducing regulatory uncertainty and increasing the predictability of product development." The technology areas of cell therapy and gene therapy were specifically identified. This article highlights some of the challenges for manufacturers and regulators of these products and describes ongoing efforts at FDA — as well as opportunities to partner with FDA — to improve the product development process for cell therapy and gene therapy products...

Weber DJ, Simek S, Puri RK. FDA Educational Partnerships to Improve the Development of Cell and Gene Therapy Products.
BioProcess J, 2003; 2(4): 23-25.

Clinical-Scale Production of Antigen-Specific T Cells Directed Against Hepatitis B Virus

by Alan Hardwick, PhD, David McMillen, Jennifer Martinez, Amanda Austin, Aaron Posey, Connie Ave-Teel, Phillip Maples, PhD, and Susanne Schneider, PhD
Volume 2, Issue 4 (July/August 2003)

A clinical-scale manufacturing process has been developed for the ex vivo expansion of autologous cytolytic T lymphocytes (CTLs) directed against cells infected with the hepatitis B virus (HBV). The process is based on the Rapid Expansion Method (REM) technology originally developed at the Fred Hutchinson Cancer Research Center in Seattle, WA by Greenberg and Riddell. Preparations are underway to initiate a company-sponsored Phase I clinical trial in which REM will be used to expand rare autologous HBV-specific CTLs that will then be infused to patients chronically infected with HBV. Earlier studies have shown that such patients mount only a weak CTL response to HBV. Chronic hepatitis B can lead to severe liver damage such as cirrhosis and hepatocellular carcinoma. By infusing clinical-scale quantities of autologous HBV-specific CTLs into chronic HBV patients, it may be possible to boost the immune system so that it can control the viral infection...

Hardwick A, McMillen D, Martinez J, Austin A, Posey A, Ave-Teel C, Maples P, Schneider S. Clinical-Scale Production of Antigen-Specific T Cells Directed Against Hepatitis B Virus.
BioProcess J, 2003; 2(4): 27-31.

Cell and Tissue Bioprocessing: Opportunities for Regional Blood Centers

by Edward P. Scott, MD
Volume 2, Issue 4 (July/August 2003)

Within the United States, greater than 90% of the available transfusible blood products are collected, processed, and distributed by regional blood centers. The remaining blood products are collected by hospital-based blood banks and are usually provided only to patients in the collecting facility. The "region" in which a blood center offers services (i.e., collecting blood from volunteer donors and providing blood components to healthcare facilities), is usually an arbitrarily and independently defined group of contiguous counties surrounding a major metropolitan area. However, the borders of the region can be elastic and easily altered by gaining or losing access to donor groups or customers. It is not uncommon for a geographic area to be simultaneously "claimed" by neighboring competing blood centers. America's Blood Centers (ABC) is a not-for-profit trade organization that provides services and advocacy for independent not-for-profit regional blood centers. ABC's seventy-five members collect approximately 45% of the country's blood products...

Scott EP. Cell and Tissue Bioprocessing: Opportunities for Regional Blood Centers.
BioProcess J, 2003; 2(4): 33-38.

QC Release Testing of an HIV-1 Based Lentiviral Vector Lot and Transduced Cellular Product

by Kathy Schonely, Cathleen Afable, Vladimir Slepushkin, MD, PhD, Xiaobin Lu, PhD, Kris Andre, Jessica Boehmer, Karen Bengtson, Michael Doub, Reuben Cohen, David Berlinger, Tatiana Slepushkina, Ziping Chen, PhD, Yuexia Li, PhD, Gwendolyn Binder, PhD, Brian Davis, PhD, Laurent Humeau, PhD, and Boro Dropulic, PhD
Volume 2, Issue 4 (July/August 2003)

The first HIV-based lentiviral vector to be used in humans, VRX496, is currently being tested in Phase I clinical trials (initiated in January 2003). With each new therapeutic comes the need to establish quality control (QC) testing designed specifically for that product. The QC testing for VRX496 was developed in accordance with the Code of Federal Regulations (CFR) 21 for pharmaceutical and bulk chemical GMPs, Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals (1993) from the Center for Biologics Evaluation and Research (CBER) at FDA, and the United States Pharmacopeia (USP) 1046 for Cell and Gene Therapy Products. This report describes the QC testing of lot VRX496V02-009 of our clinical grade vector, which is being used in an ongoing clinical trial evaluating the first lentiviral gene therapy vector in humans. All assays are performed according to established standard operating procedures (SOPs) and in accordance with the principles of cGMP regulations...

Schonely K, Afable C, Slepushkin V, Lu X, Andre K, Boehmer J, Bengtson K, Doub M, Cohen R, Berlinger D, Slepushkina T, Chen Z, Li Y, Binder G, Davis B, Humeau L, Dropulic B. QC Release Testing of an HIV-1 Based Lentiviral Vector Lot and Transduced Cellular Product. BioProcess J, 2003; 2(4): 39-47.

Cell Counting and Viability Assessments in the Process Development of Cellular Therapeutics

by Lawrence Lem, PhD
Volume 2, Issue 4 (July/August 2003)

With the advent of whole cell-based therapeutics has come a growing standardized quality control and quality assurance of the processes employed for developing and manufacturing cellular materials, similar to the controls over traditional drugs and biologicals. Cellular therapeutics present unique process and quality control challenges due to the innate complexities of living cells, making it important to use whole cell assays to provide detailed pictures of the status and consistency of cell preparations that will be used to treat patients. This article illustrates how a cellular assay from Guava Technologies addresses these issues...

Lem L. Cell Counting and Viability Assessments in the Process Development of Cellular Therapeutics.
BioProcess J, 2003; 2(4): 57-60.

Evaluation of In Vitro Methods for Monoclonal Antibody Production

by Jun T. Park, PhD, Cheng J. Cao, PhD, Sarah J. Cork, Kevin P. O'Connell, PhD, Darrel E. Menking, Tracy Coliano, and James J. Valdes, PhD
Volume 2, Issue 4 (July/August 2003)

Foreign substances, such as disease-causing viruses and other infectious agents are recognized by the body's immune system as invaders. Parts of the spectrum of our defenses are antibodies that bind these antigens and direct their destruction by other elements of the immune system. Antibodies have two very useful characteristics. First, they are extremely specific; that is, each antibody binds to one particular antigen. Second, the body retains the memory of encounters with antigens, enabling it to reproduce an antibody response to a later attack by that that same agent or disease. These properties make it possible to develop vaccines. It is the first trait of antibodies, their specificity, which makes monoclonal antibody (MAb) technology so valuable. Not only can antibodies be used therapeutically, to protect against disease, they also can help diagnose a wide variety of illnesses and can detect the presence of infectious agents (including biological threat agent). The use of MAbs specific for biological warfare agents in fielded assays requires maintaining a high-quality and economical supply of these reagents...

Park JT, Cao CJ, Cork SJ, O'Connell KP, Menking DE, Coliano T, Valdes JJ. Evaluation of In Vitro Methods for Monoclonal Antibody Production.
BioProcess J, 2003; 2(4): 49-56.

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