896. Local Direct Injection of BMP2-Modified Fibroblasts Induces Ectopic Bone Formation in Immunocompetent Mice

Abstract

The United States Pharmacopeia (USP) is a nongovernmental, standards-setting organization that advances public health by ensuring the quality and consistency of medicines founded in 1820. USP standards are developed by a unique process of involvement by the scientific and regulatory communities and are accepted worldwide. Within the USP, the development of standards for gene therapy products is being lead by the Gene Therapy, Therapy and Tissue Engineering Expert Committee (GCT). This group is composed of scientists and clinicians from academic medical centers, the biopharmaceutical industry, and various government agencies, including Health Canada, U.S. National Institutes of Health, U.S. National Institute of Standards and Technology and U.S. Food and Drug Administration (FDA). Activities of GCT include the development of the USP general information chapter Cell and Gene Therapy Products, which became official in April 2002. This general chapter summarizes the issues and best current practices in the manufacturing, testing and administration of cell and gene therapy products. GCT is currently developing a general information chapter on the qualification of ancillary materials (also referred to as ancillary products, ancillary reagents, processing agents) used in the manufacture of gene and cell therapy products. The proposed general chapter Ancillary Materials for Cell, Gene and Tissue-Engineered Products, will be published in the USP publication Pharmacopeial Forum in March 2004 for public review and comment. GCT is also working with other USP Expert Committees to revise the general chapter Design and Analysis of Biological Assays. This presentation will outline the content and scope of USP general information chapters relevant to cell and gene therapy, and explain how the scientific community can become involved in the development of standards for gene therapy products at USP.