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PRODUCT AND COMPANY IDENTIFICATION

Product Identification

Replication defective lentiviral vector containing a type A insert

Replication defective lentiviral vector containing a type B insert

Replication defective and integration deficient lentiviral vector containing a type A insert

Replication defective and integration deficient lentiviral vector containing a type B insert

Replication defective and reverse transcription deficient lentiviral vector containing a type A insert

Replication defective and reverse transcription deficient lentiviral vector containing a type B insert

 

Product Use

Replication defective lentiviral vectors provided by GEG Tech are for Research use only and are not intended for therapeutic or diagnostic applications. Replication defective lentiviral vectors provided by GEG Tech can in no circumstances be administered to humans.

Replication defective lentiviral vectors provided by GEG Tech can be used in vitro on cell lines or primary cells.

Replication defective lentiviral vectors provided by GEG Tech can be used in vivo.

Replication defective lentiviral vectors provided by GEG Tech as well as wastes generated by use and handling of replication defective lentiviral vectors provided by GEG Tech must be stored and handled in accordance with regulations in force regarding Biosafety level 2 GMO products and may require prior authorization and establishment of an emergency plan. Please refer to your local relevant competent authorities.

For more information on Biosafety and Biorisk Management, see WHO guidelines 

 

Company identification

Biosource

23 rue d'Anjou

75008 Paris

France

Phone: +33 9 82 56 19 29

Fax: +33 9 86 24 78 50

 

MSDS prepared 03/11/2013, revised 20/12/2016.

 

Emergency contact

Please refer to your local emergency plan

 

 

COMPOSITION AND INFORMATION

Replication defective lentiviral vectors provided by GEG Tech are biological products consisting in replication defective lentiviral vector derived from HIV-1, containing Self-inactivating long terminal repeats (deletion in the U3 region) and deprived of regulatory proteins Vpr, Vpu, Vif and Nef.

Titers are determined specifically for each production batch; refer to Quality Control data sheet.

Lentiviral particles are provided as frozen suspension in Phosphate Buffered Saline.

 

Hazards Identification

Lentiviral vectors are biological compounds and should be handled and stored in accordance to your local regulations regarding biosafety level 2 containment.

Be aware of your local emergency plan before using and storing lentiviral vectors.

 Bioharzard biosafety 2 level containment

 

Lentiviral vectors transduce dividing and non-dividing cells.

Lentiviral vectors pseudotyped with non-native envelope can transduce a broad range of cell type, including human cells.

Lentiviral vector genome can integrate host cell chromosomes, thereby inducing a potential risk of insertional mutagenesis.

Type A transgenes contained in lentiviral vectors are not potentially dangerous for the experimenter or the environment.

Type B transgenes contained in lentiviral vectors are potentially dangerous for the experimenter or the environment.

The classification of lentiviral vectors is independent from the host (target cells or organisms) used by the experimenter, which may itself require higher biosafety level containment. It is the responsibility of the experimenter to determine the biosafety level containment suited for the host (target cells or organisms).

Lentiviral vectors are not flammable or explosive.

Lentiviral vectors are not chemically reactive.

 

FIRST AID MEASURES

Lentiviral vectors must be handled and stored according to biosafety level 2 containment.

Use suited personal protection equipment and avoid contact with skin, eye, avoid inhalation and ingestion.

Be aware of your local emergency plan before use.

In case of an exposure incident, please refer to your local emergency plan.

 

FIRE FIGHTING MEASURES

Lentiviral vectors are not flammable and not explosive.

 

 

ACCIDENTAL RELEASE MEASURES

Lentiviral vectors must be handled and stored according to biosafety level 2 containment.

Use suited equipment to avoid lentiviral vector release, including suited biosafety cabinet.

Be aware of your local emergency plan before use.

In case of a release incident, please refer to your local emergency plan.

 

HANDLING AND STORAGE

Lentiviral vectors must be handled and stored according to biosafety level 2 containment.

Wastes generated by lentiviral vectors handling and storage must but discarded according to biosafety level 2 containment.

Using lentiviral vectors may require prior authorization, please contact your local relevant competent authorities.

Be aware of your local emergency plan before use.

Lentiviral vectors must be stored at -80°C, avoid repeated thaw and freezing.

 

EXPOSURE CONTROL AND PERSONAL PROTECTION

Lentiviral vectors must be handled and stored according to biosafety level 2 containment.

Wastes generated by lentiviral vectors handling and storage must but discarded according to biosafety level 2 containment.

Using lentiviral vectors may require prior authorization, please contact your local relevant competent authorities.

Be aware of your local emergency plan before use.

 

Use suited personal protection equipment and avoid contact with skin, eye, avoid inhalation and ingestion.

Use suited equipment to avoid lentiviral vector release, including suited biosafety cabinet.

Be aware of your local emergency plan before use.

 

In case of a release incident, please refer to your local emergency plan.

In case of an exposure incident, please refer to your local emergency plan.

 

PHYSICAL AND CHEMICAL PROPERTIES

Lentiviral particles are provided as frozen suspension in Phosphate Buffered Saline.

Lentiviral vectors are not flammable and not explosive.

Lentiviral vectors are not chemically reactive.

 

STABILITY AND REACTIVITY

Lentiviral particles are provided as frozen suspension in Phosphate Buffered Saline.

Lentiviral vectors should be stored at -80°C.

Storage at higher temperatures may alter lentiviral vector efficiency.

Repeated thaw and freezing may alter lentiviral vector efficiency.

Lentiviral vectors are inactivated when heated for 15 minutes at 50°C.

Lentiviral vectors are not stable in air, water.

Lentiviral vectors may be degraded by alcohol solutions, sodium hypochlorite solutions, detergent solutions.

Degradation and alteration of lentiviral vectors, either by temperature or by chemical agent contact, will reduce their efficiency without generating hazardous decomposition products.

 

TOXICOLOGICAL INFORMATIONS

No information available

 

 

ECOLOGICAL INFORMATION

Lentiviral vectors are genetically modified organisms (GMO) and subjected to specific regulation.

Lentiviral vectors transduce dividing and non-dividing cells.

Lentiviral vectors pseudotyped with non-native envelope can transduce a broad range of cell type, including human cells and mammalian cells, in vitro and in vivo.

Lentiviral vector genome can integrate in host cell chromosome, thereby being transmitted to the progeny of transduced cells.

 

Animals and cells treated with lentiviral vectors must be handled and housed/stored in accordance with regulation in force regarding GMO.

Type A transgenes contained in lentiviral vectors are not potentially dangerous for the experimenter or the environment.

Type B transgenes contained in lentiviral vectors are potentially dangerous for the experimenter and/or the environment.

 

DISPOSAL INFORMATION

Replication defective lentiviral vectors as well as wastes generated by replication defective lentiviral vectors use and handling must be stored and handled in accordance with regulations in force regarding Biosafety level 2 GMO products and may require prior authorization and establishment of an emergency plan. Please refer to your local relevant competent authorities.

Use suited personal protection equipment and avoid contact with skin, eye, avoid inhalation and ingestion.

Use suited equipment to avoid lentiviral vector release, including suited biosafety cabinet.

Avoid using sharps and needles.

Liquid and solid wastes must be handled and discarded after inactivation, according to regulation in force and approved protocols.

 

TRANSPORT INFORMATION

Guidance on regulations for the Transport of Infectious Substances 2013-2014 (Applicable as from 1 January 2013)

Packaging instruction P650 (transport of infectious substance in category B assigned to UN 3373, class/division 6.2) shall be observed.

Packaging instruction P003 (transport of Carbon dioxide, solid and Dry ice assigned to UN 1845, class/division 9) shall be observed.

http://apps.who.int/iris/bitstream/10665/78075/1/WHO_HSE_GCR_2012.12_eng.pdf

 

REGULATORY INFORMATION

Replication defective lentiviral vectors are GMO Danger Group II (GII), defined by HCB as biologic agents which may induce a severe disease in humans and represent a danger for experimenters, or have damaging effects on the environment. However, the risk of propagation is low and prophylaxis and/or treatment methods exist.

Handling and storage of Replication defective lentiviral vectors GII is risk class 2 (C2), or more.

Replication defective lentiviral vectors as well as wastes generated by replication defective lentiviral vectors use and handling must be stored and handled in accordance with regulations in force regarding Biosafety level 2 GMO products and may require prior authorization and establishment of an emergency plan. Please refer to your local relevant competent authorities.

The risk classification of lentiviral vectors is independent of the target cell used by the experimenter, which may itself require higher biosafety level containment. It is the responsibility of the experimenter to determine the biosafety level containment suited for the used target cells. Please refer to ATCC classification.

 

OTHER INFORMATION

Key references:

Biorisk management, September 2006, World Health Organization

(http://www.who.int/csr/resources/publications/biosafety/WHO_CDS_CSR_LYO_2004_11/en/index.html)

 

Guidance on regulations for the transport of infectious substances 2013-2014, applicable as from 1 January 2013, World Health Organization

http://apps.who.int/iris/bitstream/10665/78075/1/WHO_HSE_GCR_2012.12_eng.pdf

 

Biosafety level, ATCC

http://www.lgcstandards-atcc.org/Support/How_to_Order/Biosafety_Level.aspx?geo_country=fr

 

Manuel du Haut Conseil des Biotechnologies pour l’utilisation confinée d’organismes génétiquement modifiés, 1 February 2013, Haut Conseil des Biotechnologies

http://www.hautconseildesbiotechnologies.fr/IMG/pdf/Manuel_HCB_utilisation_confinee_OGM.pdf