Challenges for biosafety in the rapid changing field of biotechnology
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1 Challenges for biosafety in the rapid changing field of biotechnology Gijsbert van Willigen, PhD Coordinator CBRN Safety & Security LEIDEN UNIVERSITY MEDICAL HOSPITAL 1Insert > Header & footer 14-Apr-17
2 Trends in biotechnology Next generation sequencing Gene editing (Crispr/Cas) Personalized medicine Gene therapy GMO-insects Gene silencing 3D bio printing Synthetic biology 2 7 th Biosafety & Biosecurity symposium, Milan, Italy March 23, 2017
3 Trends in biotechnology Next generation sequencing Gene editing (Crispr/Cas) Personalized medicine Gene therapy GMO-insects Gene silencing 3D bio printing Synthetic biology 3 7 th Biosafety & Biosecurity symposium, Milan, Italy March 23, 2017
4 Gene editing: Crispr/Cas 4 7 th Biosafety & Biosecurity symposium, Milan, Italy March 23, 2017
5 Gene editing: Crispr/Cas Advantages: Simple to use Highly specific Highly efficient Flexible Disadvantages: Off target events Mosaicism 5 7 th Biosafety & Biosecurity symposium, Milan, Italy March 23, 2017
6 Crispr/Cas: number of publications 6 7 th Biosafety & Biosecurity symposium, Milan, Italy March 23, 2017
7 Crispr/Cas: Applications 7 7 th Biosafety & Biosecurity symposium, Milan, Italy March 23, 2017
8 Crispr/Cas: Applications 8 7 th Biosafety & Biosecurity symposium, Milan, Italy March 23, 2017
9 Crispr/Cas: Safety challenges Off target events GuideRNA binds to a site homologous to the target site Gene drives: Genetic changes are distributed rapidly and irreversibly within a population Prerequisites: Crispr/Cas and the guide RNA are located on one DNA-vector that integrates in the genome Sexual reproduction Risk: A gene drive cannot be repaired 9 7 th Biosafety & Biosecurity symposium, Milan, Italy March 23, 2017
10 Crispr/Cas: Safety challenges 10 7 th Biosafety & Biosecurity symposium, Milan, Italy March 23, 2017
11 Crispr/Cas: Ethical issues Accepted applications: Repairing genetic defects: Cure genetic diseases in germ line cells Correction of recessive genetic disorders Controversial application: Improving mankind: Protection against cancer Enhance properties of human (length, IQ, build-up of muscles) Equip humans with new features (new sensors, improving genes) 11 7 th Biosafety & Biosecurity symposium, Milan, Italy March 23, 2017
12 Crispr/Cas: Biosecurity issues Available, easy to use and cheap technique Can be used by anyone: DIY bio, neighborhood labs, biohacking Weaponizing micro-organisms Not recognizable for diagnostic labs Weaponizing gene drives Creating killer mosquitos using gene drives Gain of function research using Crispr/Cas 12 7 th Biosafety & Biosecurity symposium, Milan, Italy March 23, 2017
13 Crispr/Cas: Is the resulting organism a GMO? The application of Crispr/Cas is considered a GMO technique The resulting gene-edited organism does not contain the Crispr/Cas machinery any more Hard to detect whether the organism is made using gene editing How can we make sure these products are labelled properly? 13 7 th Biosafety & Biosecurity symposium, Milan, Italy March 23, 2017
14 Crispr/Cas: Is the resulting organism a GMO? The application of Crispr/Cas is considered a GMO technique The resulting gene-edited organism does not contain the Crispr/Cas machinery any more Hard to detect whether the organism is made using gene editing How can we make sure these products are labelled properly? 14 7 th Biosafety & Biosecurity symposium, Milan, Italy March 23, 2017
15 GMO insects Technique of sterile insect techniques already used in the 1950 s Irradiated male insects Seen as tool to reduce infectious diseases spread by insects Mating with sterile males does not results in new insects: Insect population decreases Advantage: reduction in use of insecticides 15 7 th Biosafety & Biosecurity symposium, Milan, Italy March 23, 2017
16 GMO insects Recent developments: use of GMO-insects Examples: Insects with a suicide gene Use of Crispr/Cas as gene drive 16 7 th Biosafety & Biosecurity symposium, Milan, Italy March 23, 2017
17 GMO insects: suicide gene Advantage: Have same fitness as normal male insects Easy selection (100% contains suicide gene) GMO insects will die Insect population will not die out completely Disadvantage: After some time the population will be back to normal 17 7 th Biosafety & Biosecurity symposium, Milan, Italy March 23, 2017
18 GMO insects: suicide gene Safety and security issues: Effect on the eco system Affects biodiversity Ethical issues: Decrease of infectious diseases No freedom of choice for the general public Developing countries will be dependent of Western countries to use the technique 18 7 th Biosafety & Biosecurity symposium, Milan, Italy March 23, 2017
19 GMO insects: Crispr/Cas Gene drive Gene drive: Spreads through the population very quickly (non Mendalial transfer of the effect) Considered stable in the genome First example: No egg production female mosquito s 19 7 th Biosafety & Biosecurity symposium, Milan, Italy March 23, 2017
20 GMO insects: Crispr/Cas Gene drive Advantages: Mutation will spread quickly Mutation will eventually affect the entire population Disadvantages: In theory it will eventually extinct an entire population Gene drive affects the fertility and fitness of the insects 20 7 th Biosafety & Biosecurity symposium, Milan, Italy March 23, 2017
21 GMO insects: Crispr/Cas Gene drive Safety and security issues: Effect on the eco system and affects biodiversity What happens when an entire population of an insect will be extinct? Is it really save to release these insects already? Can we assess the risk? Ethical issues: Decrease of infectious diseases No freedom of choice for the general public Developing countries will be dependent of Western countries to use the technique 21 7 th Biosafety & Biosecurity symposium, Milan, Italy March 23, 2017
22 Gene silencing Plant breeding techniques: Non-GMO: Selective breeding natural process Cross breeding natural process Reverse breeding hybrid cells Infiltration transfer of genes into a plant Targeted mutagenesis use of chemical or radiation mutagenesis GMO: Gene silencing - RNAi Genome editing Crispr/Cas, TALEN, Zinc finger 22 7 th Biosafety & Biosecurity symposium, Milan, Italy March 23, 2017
23 Gene silencing Plant breeding techniques: Non-GMO: Selective breeding natural process Cross breeding natural process Reverse breeding hybrid cells Infiltration transfer of genes into a plant Targeted mutagenesis use of chemical or radiation mutagenesis GMO: Gene silencing - RNAi Genome editing Crispr/Cas, TALEN, Zinc finger 23 7 th Biosafety & Biosecurity symposium, Milan, Italy March 23, 2017
24 Gene silencing Technique of gene silencing: 24 7 th Biosafety & Biosecurity symposium, Milan, Italy March 23, 2017
25 Gene silencing Types of gene silencing: Silencing a gene in the organism itself GMO Artic apple (Polyphenol oxidase free) Amylose free potato Non GMO Spraying dsrna Silencing a gene in a different organism Pest control 25 7 th Biosafety & Biosecurity symposium, Milan, Italy March 23, 2017
26 Gene silencing Safety issues: Are the GMO s safe for food and feed? Impossible to test? Safety issues for persistence of RNAi in the environment Are there security issues related to the technique? Ethical issues: No freedom of choice for the general public Developing countries will be dependent of Western countries to use the technique 26 7 th Biosafety & Biosecurity symposium, Milan, Italy March 23, 2017
27 Gene silencing Safety issues: Are the GMO s safe for food and feed? Impossible to test? Safety issues for persistence of RNAi in the environment Are there security issues related to the technique? Ethical issues: No freedom of choice for the general public Developing countries will be dependent of Western countries to use the technique 27 7 th Biosafety & Biosecurity symposium, Milan, Italy March 23, 2017
28 Synthetic biology What is synthetic biology: Synthetic genomics Synthesing genes and genomes from scratch Minimal genomes Organisms that contain only the most essential genes Synthetic cells Synthetic genomes in synthetic hulls Xenobiology Using synthetic non-natural nucleotides Metabolic pathway engineering Production of specific molecules by genetically altering the organism 28 7 th Biosafety & Biosecurity symposium, Milan, Italy March 23, 2017
29 Synthetic biology Safety and security issues: Can we predict the risks of organisms created by synthetic biology using the present risk assessment techniques? Can we predict the environmental impact of organisms created by synthetic biology are released Can be used by anyone: DIY bio, neighborhood labs etc 29 7 th Biosafety & Biosecurity symposium, Milan, Italy March 23, 2017
30 Synthetic biology Advantages: Cheaper production of raw materials and chemicals Biofuels, food supplements Easier production of medication Production of synthetic vaccines (cheaper and quicker) 30 7 th Biosafety & Biosecurity symposium, Milan, Italy March 23, 2017
31 General conclusions New techniques in biotechnology are considered beneficial General questions: Are the techniques safe to use? Do the techniques bring biotechnology in to an uncontrolled environment? Are the techniques an issue in biosecurity? Ethical issues of the techniques 31 7 th Biosafety & Biosecurity symposium, Milan, Italy March 23, 2017
32 General conclusions Challenges for biosafety: More research is needed to identify potential risks of the new techniques before placing products on the market More oversight is needed for the use of the new techniques Identify potential biosecurity issues related to the new techniques 32 7 th Biosafety & Biosecurity symposium, Milan, Italy March 23, 2017
33 General conclusions 33 7 th Biosafety & Biosecurity symposium, Milan, Italy March 23, 2017
34 General conclusions 34 7 th Biosafety & Biosecurity symposium, Milan, Italy March 23, 2017
35 Gijsbert van Willigen, PhD Leiden University Medical Center Leiden, the Netherlands Phone:
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