Test and evaluate purification steps of drug production processes to ensure inactivation and/or removal of potential viral contamination. Consultancy services from early R&D to market release.

Services

Viral clearance GLP studies

  • Only site in the Nordic countries
  • 50 combined years of laboratory and regulatory experience
  • Experience of a broad range of biologics
  • Multiple service models

Non-GLP studies

  • Flexible study design
  • Solution-oriented team with a broad research background
  • High success rate in method optimization

Consultancy

  • Compilation and evaluation of virus risk assessment reports
  • Early stage process development
  • Regulatory expertise

Virus and cell production

  • Production and storage
  • Complete documentation and full traceability
  • BSLII and BSLIII laboratories
  • Extensive cultivation experience

Why choose Vironova Biosafety?

  • Fast service from first contact to quote
  • Highly experienced and versatile team
  • Modern GLP-certified laboratories
  • Flexible and cost-effective service solutions
  • Located in central Stockholm

About Vironova Biosafety

Vironova Biosafety is a contract research organization (CRO) specialized in performing viral clearance studies on biologics. Operating in BSLII and BSLIII certified cell and virus laboratories and in compliance with good laboratory practices (GLP), services range from early R&D to market release.

Our office and laboratories are located in central Stockholm, Sweden, and the facility is the only one of its kind in the Nordic countries. Our customers can be found worldwide.

Learn more

Vironova Biosafety has assisted clients with viral safety since its GLP certification in 2011. Close collaboration with Vironova Biosafety at an early stage of process development will ensure an optimized manufacturing process with respect to viral safety, which could save both time and money at a later stage in the process development.

Vironova Biosafety has performed GLP viral clearance studies for clients prior to approval for clinical trials, as well as for market release. We have also conducted early phase studies in a non-GLP manner to verify and compare virus inactivation and/or removal efficacy in various manufacturing steps. Additionally, consultation and other services have been provided to several clients.