◉ Service Background

The production of biological products often involves the risk of viral contamination. Its virus safety control strategy should be combined with the control of raw materials, virus contamination screening in the production process, and verification of virus removal and/or inactivation processes. Based on risk assessment, comprehensive consideration should be given to the product characteristics. The purpose of virus clearance validation is to evaluate the ability of the production process to remove and/or inactivate known viruses. The sample is processed using a reduced model and simulated process parameters. The titer of indicator viruses in the sample before and after the virus removal/inactivation process is detected, and the virus clearance effect of the production process is judged based on the log reduction value（LRV）.

◉ Service Scope

Virus removal/inactivation validation studies are applicable to biotechnology products such as blood products, biological tissue/body fluid extracts, animal-derived monoclonal antibodies, and recombinant products expressed by eukaryotic cells, covering all stages of research and development (R&D), new drug clinical trial application (IND), and biologics license application (BLA). In addition, virus inactivation validation is also used for technical review and application of medical devices.

◉ Service Features

Based on the relevant guidelines of the International Council for Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Q5A, the National Medical Products Administration, the Chinese Pharmacopoeia (ChP), and the European Medicines Agency (EMA), ATCC standard virus strains are used to validate the virus removal process under various scaled-down models.

◉ Service process