2023 FDA Science Forum
An evaluation of real-world biotechnology product viral clearance via chemical inactivation and virus filtration unit operations
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Contributing OfficeCenter for Drug Evaluation and Research
Abstract
The manufacturing process of complex biotechnology products in mammalian host cells must be monitored and controlled for their ability to clear endogenous and potential adventitious viral contaminants. As such, the manufacturing processes of these biotechnology products must incorporate robust viral clearance unit operations. These unit operations must demonstrate adequate inactivation and/or removal of potential harmful viruses to achieve safety requirements described in the Code of Federal Regulations (CFRs). Applications for these complex biotechnology products (e.g., biological license applications (BLA) and investigational new drug (IND) applications) include data that establishes the control process and validates the clearance capabilities of dedicated viral clearance unit operations (including chemical inactivation and virus-retentive filtration).
The data from these applications have been evaluated for viral-clearance process parameters per unit operations, and their impact on a wide range of biotechnology products via the establishment of a viral clearance database. A case study on the impact of process parameters of dedicated unit operations on the viral clearance and subsequent safety factor of the biotechnology product will be discussed. This presentation aims to demonstrate the impact of the viral clearance database at large as another valuable tool which uses real-world data to show real-world trends in the clearance capabilities of these dedicated viral clearance unit operations.
