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Technical Bulletin

MONTANIDETM ISA 760 VGReady to use adjuvant for veterinary vaccines

MONTANIDETM

ISA 760 VG is based on synthetic lipophilic polymer andbiodegradable ester mix with an extremely refined emulsifier obtainedfrom mannitol and purified oleic acid of vegetable origin. It has beendeveloped for the manufacture of water-in-polymer emulsions.

MONTANIDETM

ISA 760 VG is free of animal origin ingredients.

Vaccine formulations with MONTANIDETM

ISA 760 VG induce a strong and long

term immunity. Compared to traditional oil emulsions, MONTANIDETM

ISA 760VG emulsions are very stable, well tolerated and easy to inject.

1. VACCINE PREPARATION:To prepare 100 g of vaccine, a typical composition is recommended:

MONTANIDE ISA 760 VG: 70 g Aqueous antigenic medium: 30 g

Stable preparations are obtained by mixing the aqueous medium into the MONTANIDETM

ISA 760 VG, at roomtemperature or less, under vigorous stirring. The use of a high shear mixer is necessary to prepare a stable and efficientvaccine. Adjuvant concentration can be adjusted at 60 % (W/W) to get more room for the antigenic media, while checkingthe stability and the injectability of the emulsion.

2. EMULSION CHARACTERISTICS: (on placebo antigenic medium)

TYPICAL STABILITYTYPE

VISCOSITY(mPa.s)

CONDUCTIVITY(S/cm)

DROPLET SIZE(micron)

After storage at4C

After storage at25C

After storage at37C

W/P(water-in-polymer)

About 40at 25C

< 10 1 or less At least 12 months At least 6 months About 15 days

3. IMMUNE RESPONSE: MONTANIDETM

ISA 760 VG is capable of improving vaccine efficacy via the induction of a strongand long lasting immunity. Its a promising adjuvant to stimulate humoral responses. This product is recommendedfor bacterial, mycoplasma, viral or parasite antigens.

4. ANIMAL SPECIES: MONTANIDE ISA 760 VG adjuvant is recommended for different vaccines for cattle, swine,poultry and fish.

5. STRENGTH: This adjuvant is a flexible and robust formulation. It is adapted to prepare water-in-polymeremulsions, which induce a strong efficacy similar to oil emulsions. Furthermore it offers the possibility to reduce theinjected dose or to dilute antigenic media with a constant injected volume while keeping the same level of protection.

6. SAFETY AND REGULATORY: The toxicological tests made on MONTANIDETM

ISA range (Berlin test, Oral LD 50, IP LD 50,ocular irritation test, dermal irritation test, pyrogenicity) conclude to the safety and favourable tolerance of theseadjuvants.Montanide adjuvants and their components have been considered as safe by the Committee for Veterinary MedicalProducts (CVMP) for use in immunological products and are included as authorized substances in the annex of theEuropean Council Regulation n 470/2009 (previously 2377/90/EC) needing no further MRL studies, or included inalready registered veterinary commercial products.The properties of the antigenic media are crucial for the vaccine efficacy but also for its safety. Each team developing avaccine will have to study the safety and efficacy profile of the underdevelopment formula according to local marketacceptance criteria.

For more information on this product or for any advice regarding the optimization of your vaccine,please contact our teams on www.seppic.com or on Montanide@airliquide.com

Hydrophobic phase made oflipophilic polymer and bio-degradable esters(Does not contain mineral oil)

For stable, fluid, and welltolerated vaccines

Induces a strong and longlasting immune response

MONTANIDE listed on AnnexII of the European CouncilRegulation 2377/90/EC

Key Points :