Validation of Virus Removal and Inactivation

The raw materials of biological products include microorganisms and the cells, tissues and body fluids of human or animals. Therefore, the production and preparation of biological products involves the risk of viral contamination. International regulations have been put forward for the viral safety of biological products. The verification of virus removal and inactivation is an important means to ensure virus safety in production process.

The verification of virus removal and inactivation assesses the ability of manufacturing processes to remove and inactivate known viruses. The service uses a scaled-down model and simulates process parameters to process samples. The virus removal and inactivation effect of the production process can be judged by detecting the titer log reduction value (LRV) of the indicator virus in the samples before and after the virus removal and inactivation process.

STEMart designs solutions for virus removal and inactivation verification of different types of biological products and medical devices, and provides professional verification services and reports to prove the virus safety of the production process.

Service Application

The verification of virus removal and inactivation is applicable to biotechnology products such as blood products, biological tissue and body fluid extraction products, animal-derived monoclonal antibodies, recombinant products expressed by eukaryotic cells, etc.

This service can be used for research and development (R&D), clinical trial application for investigational new drug (IND), biologic license application (BLA), and technical review and application for medical devices.

Verification Standard

• International Council for Harmonisation (ICH) Q5A Guidelines of Technical Requirements for Pharmaceuticals for Human Use
• European Medicines Agency (EMA) Guidance Principles
• United States Pharmacopeia

For more information about our validation services of virus removal and inactivation, please contact us.