With the development of bacterial fermentation and mammalian cell culture as the sources for new recombinant products came a standardization of raw feed stocks. Therefore, manufacturers came to share the same types of problems. This standardization allowed a more systematic approach to process development divided into upstream (bacterial and yeast fermentation or mammalian cell culture) and downstream processing activities…
Tag: <span>viral clearance</span>
Manufacturers must demonstrate, with a very high degree of assurance, that biopharmaceutical products derived from mammalian cells or from human plasma are safe and free of viral contamination. Viruses can be physically removed from most proteins using filtration. Often air diffusion is used as a nondestructive test to ensure that a process filter is installed properly and free of defects that can compromise virus retention. In this article, theoretical models were used to relate air and liquid flow rates through integral and defective filters. The effect of defect diameter and defect density on the virus retentive ability of a filter was also modeled…
Viral safety and viral clearance evaluation are high-profile areas for product safety. Regulators are keenly focused on viral safety and expect high-quality data to support it, particularly for IND and BLA approvals. Familiarity with process and regulatory requirements, as well as expertise in the key areas of viral clearance, are essential for strategic planning and can yield savings in time, effort, and money…