ViruSure GmbH products

Gene therapy has brought hope to many diseases with unmet clinical need. The potential to permanently cure the patient through replacement of a defective gene with a healthy gene underscores the surge of interest in this exciting biopharma modality.

Numerous medical devices contain components of animal origin (e.g., pericardium, heart valves, collagen) where the risk of virus and prion contamination needs to be controlled. Medical devices present several challenges due to the possible incorporation of components of animal origin as well as the inactivation of virus on solid matrices and surfaces. This makes the generation of suitable data for regulatory review particular challenging. ViruSure provides support both via virus/prion clearance studies as well as with risk assessments and literature reviews in compliance with ISO 22442.

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.

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.