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