Solutions

With our 20 years of experience we offer a large range of services allowing the safe use of genetically modified organisms and protection from infectious disease agents.

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Environmental risk assessment for recombinant products

Science based, sound, transparent: Evaluation of new techniques and environmental risk assessment for research, clinical trials, field releases or market application.

Services

  • Recombinant cell and gene therapy products

  • Synthetic biology and nanomedicine

  • Oncolytic viruses and recombinant live viral and bacterial vaccines for human and animal use

  • Genome editing and gene drives

  • Risk assessment of deliberate release of genetically modified and pathogenic microorganisms

  • Regulatory support and interaction with the regulator

Expertise

  • Environmental risk assessment for clinical trial and market authorization applications of Advanced Therapy Medicinal Products to EU member states and the European Medicines Agency, respectively

  • Biologics assessment for the Biologics License Application to the US Food and Drug Administration

  • Environmental risk assessment in the context of deliberate release of genetically modified (micro)organisms

Communication

  • Risk Assessment of Synthetic Biology, U. Jenal, European Society for Gene and Cell Therapy Conferences, Madrid, Spain, October 2012 and Helsinki, Finland, September 2015

  • Production and application of nano-bio-objects the crossroad of nano-bio risk management, U. Jenal, European Biosafety Association Annual Conference, April 2011, Estoril, Portugal

  • Environmental Risk Assessment of Gene Therapy Products, U. Jenal, European Society for Gene and Cell Therapy Conferences, October 2012, Madrid, Spain and September 2015, Helsinki, Finland

  • Environmental Risk Assessment of Glybera, an AAV-based Gene Therapy Product, regarding the Authorisation of the Placing on the Market in Europe, U. Jenal, F.G.C. Salmon, Annual Conference of the American Biosafety Association, October 2014, ABSA, San Diego, USA

  • More about these Communications‚Ķ