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…
Category: <span>Risk Analysis and Management</span>
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…