SDA 7749
- Oil-in-water microemulsion concentrate, mineral oil
- Ready to combine with aqueous antigen at ratio of 1 part of oil phase to 9 parts of antigen
- Particle size = ~20 nm
- Colorless, transparent appearance
- Mix with 10 mg DOTAP to generate 10x CNE (Cationic Nanoemulsion)
- Viscosity: <20 mPa.s
Application
Advantageous for human and those animal species with safety as concern. Induce rapid immune response. SDA7749 is ready-to-dilute adjuvant containing a mixture of micro-emulsions and an immunostimulant compound. They can be used with several antigens — bacterial, viral, parasitic or subunit; in swine, poultry, fish, horse, and pet, for injection, mucosal, parenteral, and immerse.
Generate by mixing with PBS the clear type diluent for MLV antigens, and for spray or immerse immunizations.
Process
Some vaccine manufacturers mix adjuvant with antigens and filter the end products
Some vaccine manufacturers pasteurize bulk adjuvant and cool re-homogenize prior to mix with antigens.
Mechanical stirring process is recommended. Most customers use speed of 60-120 rpm for tank mixing.
Vaccine formulations can be obtained by an easy dilution of the aqueous medium into microemulsion, at room temperature or less, under gentle agitation (e.g. marine propeller, magnetic stirrer).
Alternatively, SDA 7749 adjuvants can be emulsified in the presence of an aqueous medium or PBS. The end users combine the transparent microemulsion with antigen according to a dedicated manufacturing process.
Ingredients
The fatty phase can consist of an oil from a mineral (Drakeol 6VR), vegetable derived squalene, or synthetic origin, or of a combination of these different oils. The surfactant is synthesized and selected for each adjuvant by optimizing its hydrophilic-lipophilic balance, depending on the type of emulsion sought and the fatty phase selected.
SDA BIO transparent (colorless, clear), micro-nano-emulsions, are the ready-to-dilute self-emulsifying vaccine adjuvants with the average size of 20 nm and may vary from 10 to 100 nm. The efficient production of nanoemulsions, with oil droplet sizes of less than 100 nm would facilitate the inclusion of both oil and water soluble bio-active agents into emulsion with highest carrying capacity. SDA7749 has particle density of 6 x 10^16 in the 10x diluted concentrate. Small droplet sizes lead to transparent emulsions so that product appearance is not altered by the addition of an oil phase or large quantity of antigens. Small transparent O/W nanoemulsions with average diameters as low as 20 nm from mineral oil or squalene is achieved using self-emulsifiying technology and a surfactant/co-surfactant/oil system that is well optimised for extremely high immunogenicity, safety, fluidity, and stability. Vaccine formulations are obtained by an easy dilution of the aqueous antigen into micro-nano-emulsion at 10% to 50%, at room temperature or less, under gentle agitation.
- High safety leads to unique application for stressful species, widely used in swine, poultry, horse, pet, and fish.
- Recommended for mucosal parenteral vaccination, as well as immerse vaccination.
- Can be supplied as preserved or terminally sterilized, pre-emulsified transparent nanoemulsion concentrate (micro-nano) emulsion – SDA7749-PE (to be diluted at 1:3).
- Smaller size allows best application to combine with cationic lipids into cationic nanoemulsion for DNA and RNA delivery.
SDA 4580
SDA 6050 (Known as IMS 1313)
