Prion and Virus Consultancy Services and Risk Assessments

At ViruSure, we provide expert pathogen safety risk assessments and consultancy services for biopharmaceutical products, ensuring compliance with the highest regulatory standards. With decades of experience in virus and prion safety, our team specializes in prion and virus clearance, and molecular biology, helping you navigate complex safety challenges across recombinant products, mAbs, plasma-derived products, vaccines, animal-derived products (e.g., raw materials, medical devices), cell and gene therapy, cultured meat, and other biological products. Our expertise as virologists enables us to provide scientifically rigorous, customized solutions that ensure the safety and integrity of your processes, from early product development to full inspection readiness.

A comprehensive pathogen safety risk assessment is a critical component of any biopharmaceutical product license application. At ViruSure, we leverage our extensive expertise as virologists in virus and prion safety to deliver scientifically rigorous, product-specific risk assessments tailored to your unique needs.

Our assessments encompass the entire product lifecycle, from evaluating the history of your cell or viral system, raw materials and reagents used in production, to analyzing the efficacy of your downstream processes in removing or inactivating potential contaminants. Whether you are developing Advanced Therapy Medicinal Products (ATMP, CGT), animal-derived products, cultured meat products or any other biopharmaceutical product, we ensure that your processes adhere to the highest safety standards. Our prion testing expertise encompasses extensive experience with Bovine Spongiform Encephalopathy (BSE), a well-known prion-related condition. Our consultancy services, including Cell Therapy CMC Readiness and Cultured Meat Innovation, are designed to support your advancements in these cutting-edge fields.

Beyond risk assessments, we provide expert consultancy to address pathogen safety concerns throughout your product development, process design, or ongoing manufacturing operations. Our team of virology specialists, with deep expertise in BSE, virus safety, and molecular biology, can guide you through complex safety challenges and support you in meeting stringent regulatory requirements. Additionally, our Inspection Readiness services offer guidance on the regulatory landscape, ensuring your compliance with confidence.

Managing virus safety from a regulatory perspective demands strategic planning and specialized expertise. With decades of experience, ViruSure is uniquely positioned to assist in designing a cost-effective and compliant virus and prion safety strategy that meets regulatory standards and facilitates the successful development of your product.