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Biological products such as monoclonal antibodies and recombinant proteins have become very important products in the biopharmaceutical industry due to their strong targeting, few side effects, and significant curative effects. They lead the global pharmaceutical market and are also an important driving force for the future development of the biopharmaceutical industry. Quality is life, and since biological products are usually administered by direct injection, if the product is contaminated with viruses, it may cause significant harm to patients. Therefore, the virus purification process must be verified by virus removal or inactivation in preclinical and pre-production application materials to ensure that no virus contamination will occur in clinical trial patients for injection or marketed products.
Animal cells are often used as protein expression production systems in modern biological products to ensure the correct conformation and activity of the product. Exogenous viral contamination may occur during cell culture. Lifeasible provides virus inactivation service for insect expression system products to realize the product purification process, so that the products will not be contaminated by viruses.
Lifeasible has many years of experience in virus clearance verification. Before the clearance research is carried out, dedicated experimenters will connect with customers to help you choose the appropriate virus and process for verification, so as to improve efficiency and save costs. At present, Lifeasible has completed a lot virus clearance verification studies, including antibody, protein, vaccine and other product types, and successfully supported customers to complete IND and BLA declarations.
The negative pressure virus laboratory is designed and managed in strict accordance with GLP specifications, and has passed the record of a biosafety level 2 laboratory to ensure biosafety. There are more than 100 sets of advanced equipment such as AKTA purification system, ultracentrifuge, transmission electron microscope, high performance liquid chromatography, Mettler instrument, and nanofiltration filtration equipment. All major instruments have been verified and calibrated, and AKTA instruments are deeply cleaned after the project is completed to avoid cross-contamination between projects.
Lifeasible can provide a full set of virus safety evaluation services for process research and development, new drug clinical trial application (IND), biological product license application (BLA), supplementary verification of post-market products, covering monoclonal antibodies, proteins, vaccines and other products expressed in insect systems, blood products, biochemical drugs, animal-derived medical devices, gene therapy products, etc.
Lifeasible's virus removal validation lab has several advantages, as follows:
Lifeasible provides virus inactivation service for insect expression system products by our professional team to realize the product purification process, so that the products will not be contaminated by viruses. If you are interested in our services or if you have any questions, please click online inquiry for more detailed information.
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