Your Products Our Service Our Quality About Us Downloads Consultancy + Risk Assessments Our experts are happy to support your prion/virus risk assessment An essential part of your biopharmaceutical product license application is a formal pathogen safety risk assessment. With our expertise in virus and prion safety, ViruSure offers services to conduct such risk assessments. Our risk assessments are based on the history of your cell/virus system, the raw materials used during production, the testing regimes, and the ability of your downstream process to remove and inactivate potential contaminants. When pathogen safety issues arise in your product application, process design, or ongoing manufacturing, support and expert advice is often required. Therefore, we also offer consultation services for any questions around pathogen safety of your product or your manufacturing process. Virus safety has always been a challenging field from a regulatory perspective. Designing the most cost-effective strategy requires the thought, experience, and planning that ViruSure can offer. Andy Bailey is regularly invited as virus safety specialist for talks at several regulatory agencies such as UK MHRA, German PEI, French AFFSAPS, US FDA and EMA. Did you know? To schedule a meeting with a ViruSure expert to discuss risk assessment, please click below. SCHEDULE A MEETING © ViruSure GmbH. All Rights Reserved. Downloads Imprint / Privacy Policy Contact Us Donau-City-Straße 1, A-1220 Vienna, Austria

Your Products Our Service Our Quality About Us Downloads Recombinant Products Biopharmaceuticals produced from Recombinant Technology ViruSure offers unmatched expertise to support your banking and biosafety testing needs for therapeutic proteins produced by recombinant technology. Monoclonal Antibodies Monoclonal antibodies (mAbs) are the largest segment of marketed biopharmaceuticals today. Whether you are developing an originator molecule or a biosimilar, your antibody derived from a recombinant cell line such as Chinese Hamster Ovary (CHO) must meet regulatory standards for the absence of virus and other pathogens. LEARN MORE Recombinant Proteins Recombinant proteins are proteins expressed in cell lines which have been genetically modified by DNA recombinant technology. These therapeutics include recombinant blood clotting factors, hormones, enzymes, interferons, growth factors and other bioengineered proteins. LEARN MORE © ViruSure GmbH. All Rights Reserved. Downloads Imprint / Privacy Policy Contact Us Donau-City-Straße 1, A-1220 Vienna, Austria