Tag: <span>virology</span>

An Overview of the United States Pharmacopeia’s Recent Activities in the Areas of Vaccines, Virology, and Biological Standardization

The United States Pharmacopeia (USP) is a not-for-profit nongovernmental organization founded in 1820 that develops public standards for drug substances and products; these standards are enforceable by FDA and have been adopted by many nations around the world. USP General Chapters provide industrial and academic researchers alike with crucial guidance, particularly in areas where there is a regulatory void. A good recent example is the proposed USP general information chapter…

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Regulatory

ancillary materials characterization immunology standards USP vaccines virology

Strategic Approaches to Viral Safety and Viral Clearance Assessment in Cell Culture-Derived Pharmaceutical Products

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…

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Biologics Production Manufacturing Regulatory

cell culture safety viral clearance viral safety virology