Biosafety of Recombinant Viral Agents

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1 Biosafety of Recombinant Viral Agents

2 Viral Vectors for Gene Therapy Introduction Biosafety Principles Biosafety Risk Categories Biosafety Risk Assessment

3 Viral Vectors for Gene Therapy Classes of Viral Vectors Methods Applications Biosafety Considerations

4 Gene Therapy The transfer of genetic material to living organisms: Correct a genetic defect Exert a phenotypic change Drug delivery Vaccines Viral and non-viral vectors

5 Biosafety Basic Principles Primary containment protection of lab personnel and the immediate laboratory environment laboratory practice and technique knowledge of infectious agents and risks strict adherence to standard microbiologic techniques develop protocols and procedures to be followed by all lab personnel working with biologic hazards

6 Standard Operational Practices 1. Access to the laboratory is limited or restricted at the discretion of the laboratory director when experiments or work with cultures and specimens are in progress. 2. Persons wash their hands after they handle viable materials,after removing gloves, and before leaving the laboratory. 3. Eating, drinking, smoking, handling contact lenses, applying cosmetics, and storing food for human use are not permitted in the work areas. Persons who wear con tact lenses in laboratories should also wear goggles or a face shield.

7 Standard Operational Practices 4. Mouth pipetting is prohibited 5. Policies for the safe handling of sharps are instituted. 6. All procedures are performed carefully to minimize the creation of splashes or aerosols. 7. Work surfaces are decontaminated at least once a day and after any spill of viable material. See Health Canada Laboratory Biosafety Guidelines for details

8 Standard Microbiological Practices 8. All cultures, stocks, and other regulated wastes are decontaminated before disposal by an approved decontamination method such as autoclaving. 9. A biohazard sign may be posted at the entrance to the laboratory whenever infectious agents are present. The sign may include the name of the agent(s) in use and the name and phone number of the investigator.

9 Biosafety Basic Principles Primary containment safety equipment bio-safety cabinets (class 2) centrifuge covers personal safety devices - gloves, goggles, protective clothing, etc

10 Biosafety Basic Principles Secondary containment protects personnel in the laboratory and persons outside the laboratory facility design

11 Bio-Safety Levels Bio-Safety Level 1 suitable for organisms not known to cause disease in humans primary containment is standard operational practices personal protection - eyeware, gloves, labcoat, etc. other primary or secondary barriers are not required sink for handwashing

12 Bio-Safety Levels Bio-Safety Level 2 suitable for organisms known to cause moderate disease in humans suitable for work involving human-derived tissues and fluids hazard relates to accidental percutaneous or mucous membrane exposure or ingestion

13 Bio-Safety Levels Bio-Safety Level 2 other primary or secondary barriers are not required if the potential for aerosolization is low bio-safety cabinets should be utilized if there is a risk of aerosols or large volumes/concentrations of infectious agent are used Restricted access to infectious agents (locked up)

14 Bio-Safety Levels Bio-Safety Level 2 primary containment is standard operational practices personal protection - eyeware, gloves, labcoat, etc. waste decontamination sink for handwashing

15 Bio-Safety Levels Bio-Safety Level 3 required for agents where respiratory transmission is possible and cause serious or potentially lethal disease in humans hazard to lab personnel relate to autoinocluation and exposure to infectious aerosols greater emphasis on primary and secondary containment to protect lab personnel

16 Bio-Safety Levels Bio-Safety Level 3 all work must be performed in biosafety cabinets or other enclosed equipment secondary containment includes restricted lab access and special ventilation to minimize release of infectious aerosols into the surrounding environment

17 Bio-Safety Levels Bio-Safety Level 4 suitable for rare and exotic agents that are transmissible via aerosols, pose a high risk of life-threatening disease, and for which there is no known treatment or cure complete barrier between lab personnel and the infectious agent is required special secondary containment facilities

18 Group 1 Risk Groups Agents that are not associated with disease in adult humans Group 2 Agents that are associated with human disease which is rarely serious and for which there are preventative or therapeutic measures often available Group 3 Agents that are associated with serious or lethal disease in humans for which preventive or therapeutic measures may be available Group 4 Agents that are associated with serious or lethal disease in humans for which preventive or therapeutic measures are not usually available

19

20 Refer to Laboratory Biosafety Guidelines manual from Health Canada

21 Biosafety Basic Principles Risk assessment biology of wild-type virus prediction of biology of recombinant virus vectors Principle investigator in conjunction with the institution biosafety office is responsible for assessing risk and setting biosafety level

22 Biosafety - Risk Assessment Biology of wild-type virus Most vectors based on ubiquitous viruses, most of which cause mild or no significant disease in humans Route of transmission (potential for aerosol) Agent stability (capsid vs envelope) Animal viruses - some are controlled independently by governmental regulations

23 Biosafety - Risk Assessment Recombinant vectors Human viruses adapted for gene therapy are generally modified to reduce pathogenicity understand the origin and mechanism of attenuation Some recombinant vectors are still replication competent Risk of generating replication-competent virus in vitro or in vivo through homologous sequences changes in selective pressure can produce viral mutants genetic variability Integrating vectors

24 Biosafety - Risk Assessment Recombinant vectors Genetic alteration of viruses tropism or host range route of transmission stability pathogenicity or virulence Effect of the transgene toxins oncogenes suicide genes cell cycle genes genes that might increase the replicative capability of the virus immune-modulating genes

25 Biosafety - Risk Assessment Recombinant vectors Consideration of the nature of the work Volume or concentration of vector Potential to produce aerosols Previous toxicity or animal studies Availability of prophylaxis or therapy Consideration of the likelihood of rare events Animal transmission

26 Biosafety

27 Refer to NIH Guidelines on Recombinant DNA

28 Viral Vectors Retrovirus Adenovirus Adeno-Associated Virus Lentivirus Other viruses

29 Retrovirus Vectors Moloney murine leukemia virus based

30 Retrovirus Vectors

31 Retrovirus Vectors

32 Retrovirus Vectors

33 Advantages: Retrovirus Vectors Broad tropism that can be altered via the envelope protein Easy to generate (especially with VSV pseudotype). Packaging cell lines available Accommodate up to 8 kb insert Integrates into host genome Non-immunogenic

34 Retrovirus Vectors Disadvantages: Unable to transduce non-dividing cells Integration into host is random, and thus the potential for insertional mutagenesis LTR can affect activity of downstream promoters Transgene expression unstable

35 Biosafety Retrovirus Vectors murine based vectors are BSL-1 especially if produced in ecotropic cell lines risk of RCR depends on the packaging cell line used viral genes separated into different transcription units (env gene) amphotropic cell lines (lack endogenous retroviral sequences) effects of transgene

36 Lentivirus Vectors Subgroup of the retrovirus family includes HIV

37 Lentivirus Vectors

38 Lentivirus Vectors

39 Lentivirus Vectors Advantages Infects dividing and non-dividing cells due to nuclear localization signals on the preintegration complex Risk of RC virus low absence of most HIV genes including env Integrates Silent LTR Non-immunogenic

40 Lentivirus Vectors Disadvantages RC virus production is not completely eliminated Vectors can be rescued by wild type infection. Creates the possibility of novel infectious agents Insertional mutagenesis

41 Lentivirus Vectors - Biosafety Based on HIV (Group 3 agent) Major risk is production of RCR Effect of transgene BSL-2+ or BSL-3 should be employed

42 Adenovirus Type 5 Genome regulatory proteins ITR E1AE1B 0mu L1-4 L5 E3 100 mu ITR E2B E2A E4

43 Adenovirus Vectors

44 Adenovirus Vectors

45 Adenovirus Vectors Disadvantages Induce host inflammatory and immune responses transient gene expression HD systems not completely devoid of helper virus

46 Adenovirus Vectors Advantages: Can be grown in high titer Very efficient gene transfer Infects a variety of replicating and nonreplicating cells Epichromosomal, thus insertional mutagenesis does not occur Helper-dependent systems can accommodate over 30 kb of DNA

47 Adenovirus Vectors

48 Adenovirus Vectors

49 Adenovirus Vectors - Biosafety Group - 2 agent Persists on surfaces for long periods Transmitted via numerous pathways Risk of aerosol Effect of transgene BSL-2 recommended

50 Adeno-Associated Virus Non-enveloped, single-stranded DNA parvovirus Needs helper virus for replication adenovirus E2, E4 Integrates into host genome to produce latent infection No known disease in humans

51 Adeno-Associated Virus

52 Adeno-Associated Virus

53 Adeno-Associated Virus Advantages Broad tropism, infects dividing and nondividing cells low immunogenicity stable, long term gene transfer improved production methods has eliminated helper virus contamination Neglible risk of RCR during production

54 Adeno-Associated Virus Disadvantages conversion to double stranded DNA rate limiting step small, accomodates only 4.7 kb DNA does not integrate in the absence of rep can be rescued in vivo difficult to work with in vitro

55 Adeno-Associated Virus Biosafety AAV is a group 1 agent can be handled in BSL-1 conditions if not produced with helper virus risk of aerosol prudent to use BSL-2 effect of transgene

56 Other Virus-Based Vectors Herpesvirus Vaccinia Virus Alphavirus Semliki Forest and Sindbis Baculovirus Influenza Hybrids

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63 The End

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