Transmissible Spongiform Encephalopathy and Medicinal Products in the United States and Europe
- PDF / 587,688 Bytes
- 9 Pages / 504 x 719.759 pts Page_size
- 9 Downloads / 169 Views
0092-8615/2001 Copyright 0 2001 Drug Information Association Inc.
TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY AND MEDICINAL PRODUCTS IN THE UNITED STATES AND EUROPE SHARONS. ROWLAND, PHD, RAC Senior Regulatory Scientist, Department of Regulatory Affairs, GloboMax“ LLC, Hanover, Maryland
Transmissible spongiform encephalopathy (TSE) is an inclusive term for a group of slowly progressing, neurodegenerative diseases with long incubation periods. Design and validation of manufacturing processes that eliminate TSE agents is dificult because of TSE resistance to standard chemical and physical measures and the lack of quick, reliable diagnostic assays. Thus, preventive measures have been put into place by regulatory authorities. Bovine spongiform encephalopathy (BSE), the cause of “mad cow disease, ’’ is of particular concern since it is believed to cause Creutgeld-Jakob disease in humans. Many medicinal products contain or come in contact with substances of bovine origin during manirfacture. As a consequence, regularions and guidances have been established in the United States and Europe for bovine-derived materials used in manufacturing medicinal products. Manufacturers must assess active substances, excipients, raw materials, production reagents, and materials coming into direct contact with manufacturing equipment or product containers. United States and European regulatory authorities have used different approaches toward documentation required for bovine materials used in the production of medicinal products. The relevant documentation must be included in the investigational or marketing application. Key Words: Bovine spongiform encephalopathy; BSE; Creutzfeld-Jakob Disease; CJD; Prions; Medicinal products; Transmissible spongiform encephalopathy; TSE
INTRODUCTION TRANSMISSIBLE SPONGIFORM encephalopathy is an inclusive term for a group of slowly progressing, neurodegenerative diseases with long incubation periods. The illness is always fatal. Examples of diseases that fall within the TSE group are kuru [humans], Creuztfeldt-Jakob disease (CJD) [humans], new variant CJD (vCJD) [humans], scrapie [sheep and goats], bovine spongiform encephalopathy (BSE) [cattle], chronic wast-
Reprint address: Sharon S. Rowland, PhD, RAC, 7250 Parkway Drive, Suite 430, Hanover, MD 21076.
ing disease (CWD) [deer and elk], transmissible mink encephalopathy [mink], and feline spongiform encephalopathy [domestic cats]. The TSE agent has not been fully characterized. Disease is believed to be caused by “prions,” infectious proteins lacking any detectable nucleic acid. Disease is associated with the presence of an infectious abnormal host-encoded protein, referred to as a prion protein. Two other theories regarding TSE etiology are that: 1. TSE agents are unusual viruses, and 2. TSE agents are virinos (a small regulatory nucleic acid coated with host-derived protein) (1).
993
Downloaded from dij.sagepub.com at GEORGIAN COURT UNIV on January 21, 2015
994
Sharon S. Rowland
TSE agents are extremely resistant to chemical and physical proc
