Viral safety is a critical part of biological products throughout their development and their commercial release. Being a safety risk for patients and having financial burdens on biopharmaceutical companies, viral contaminations can occur by contaminated cell substrates or by introduction during the manufacturing process.
ViroInspect® is a rapid, highly sensitive and highly specific testing system with integrated quality controls.
The ViroInspect® kits are designed for the detection and identification of viruses, including those mentioned in the context of safety regulations, having caused contaminations in the recent past, have been used as model viruses in viral clearance studies, or that are stable and difficult to remove by inactivation. The Rodent product line focuses on viruses, of which rodents are the natural host, as >80 % of biopharmaceutical production is performed in rodent cells.
ViroInspect® Rodent 1 allows the detection and the identification of Rodent Parvoviruses1, Porcine
Circoviruses 1/2, Vesivirus 2117 and related isolates in biological materials such as cell culture samples. Additionally, the ViroInspect® Rodent 2 enables the detection and identification of
Rodent Calici-, Corona-, Paramyxo-, Picorna- and Reoviruses .
ViroInspect® is characterised by short throughput times, a high sensitivity, specificity, robustness, repeatability and intermediate precision. It provides fast data analysis and delivery of simple and precise results that enable ‘go’ and ‘no-go’ decisions in a timely manner.
ViroInspect® - Features and Benefits:
- Time-to-results in less than 9 hours, saving three weeks by replacing current in vitro and in vivo tests
- Integrated sample preparation, extraction of viral DNA and RNA, reverse transcription, PCR amplification, microarray, hybridisation, and software-based evaluation
- Comprehensive on-chip controls
- Sensitivity equal to / better than in vitro and in vivo tests
- Processing of sample volumes of up to 10 mL
- Validated in compliance with the ICH Q2(R1) guideline
- Virus detection and identification within one test
- Parallel analysis of up to 48 samples
- Simple, precise results and automated report generation enable ‘go’ /’no-go’ decisions in a timely manner
- Less expensive than in vitro and in vivo tests