Long-term growth of the biopharmaceutical industry is increasingly relying on outsourcing to overcome the current capacity constraints, especially for monoclonal antibody production. Companies are often reluctant to commit to building multimillion dollar manufacturing facilities for potential products with no guarantee of approval. Therefore to offset risks, companies will enter into contract manufacturing arrangements…
Category: <span>Risk Analysis and Management</span>
Xenotransplantation has been defined by the US Public Health Service (PHS) as any procedure that involves the transplantation, implantation, or infusion into a human recipient of either (a) live cells, tissues, or organs from a nonhuman animal source, or (b) human body fluids, cells, tissues, or organs that have had ex vivo contact with live, nonhuman animal cells, tissues, or organs (PHS Guideline on Infectious Disease Issues in Xenotransplantation). In the US, several xenotransplantation clinical trials are in progress under US Food and Drug Administration (FDA) oversight. The PHS and the FDA have issued guidelines and guidance documents to address the potential for cross-species infection posed by the use of xenotransplantation products in humans. To minimize the infectious disease risk, these documents provide recommendations on how to screen and maintain source herds, individual source animals, and when possible, xenotransplantation products themselves. However, while precautions can be put in place to remove exogenous infectious agents, the endogenous retroviruses that a source species may carry cannot be removed…
Electron microscopy (EM) provides data for viral clearance studies, information on the presence and quantitation of endogenous retroviruses, and the detection and characterization of other potential contaminants. The technique is favored in this field because it is simple, reliable, and can give reliable quantitation for risk assessments. This article describes the main EM techniques currently used for testing cell cultures, culture supernatants, and bulk harvests. It also includes an in-depth description of a thin sectioning technique used to estimate virus titre in culture supernatants and bulk harvests…
Risk management deals with planning for, and reacting to, hazard or loss. The regulatory authorities are focusing on the issues associated with establishing alternative sources of raw materials, especially as they are noticing a number of related quality problems in biopharmaceutical manufacturing. Supply chain management for critical raw materials used in biopharmaceutical manufacturing is an appropriate subject for risk management. This paper analyzes five important areas in risk management as it applies to the supply chain for critical raw materials…
Growth media for mammalian cell culture are complex mixtures of raw materials that include amino acids, vitamins, inorganic salts and a wide variety of other components. The risk of infectious agent transmission, when some of these components are derived directly from animals, is a major concern in the biopharmaceutical industry, and is being actively addressed. However, the risk associated with the use of indirectly, or secondarily, derived animal components is less recognized and addressed. We have developed a classification system to define the contact level that a cell culture medium component has had with animal-derived materials. This classification system has increased the accuracy and reliability of the information we are able to obtain from raw material manufacturers, and is being used as part of a risk assessment analysis for a serum/protein-free media we are moving from development into manufacturing…