Mineral oils used in veterinary vaccines are derived from petroleum distillation with one exception of Shell Ondina oleo line, which uses the GTL – gas to liquid technology using natural gas instead of crude oil, claiming an absence of polycyclic aromatics or pristane, hopanes, or steranes. They are also free of sulfur and nitrogen compounds and have low systematic accumulation and rapid elimination. Oils used as adjuvants contain an optimal number of carbon atoms, representing a balance between an inadequate immune response (from an oil with a high carbon number) and an unacceptable rate of adverse reactions (from an oil with a low carbon number). White light paraffin oil is the most included in veterinary vaccines and accepted by the authorities (Committee for Veterinary Medicinal Products Mineral Hydrocarbons – summary report/EMEA/CVMP/069/95-Final).
Using such chemicals has helped vaccine producers to generate a robust and long-lasting immunoreaction; vaccines such as poultry inactivates, autogenous, FMD, water-in-oil emulsions, double emulsions, and oil-in-water emulsions have been used this product for years with immense success.
In some formulations, the use of such products corresponds to 40, 50, or even 70 % of the entire formulation; hence, the importance of such components. The fundamental question is how to choose the right mineral oil partner and what products to choose. Although they are all from the same raw material, significant differences in the purification process, oil source, viscosity, density, etc, can impact the antigen and the final vaccine formulation.
While testing mineral oil options, our experience shows cases in which the adverse reaction increased by two or 3-fold and product loss of stability, making the switch from one brand to another in the later stages of vaccine production not viable simply because the risks and the regulatory concerns are too high.
In our experience, mineral oil can cause severe adverse reactions, incompatibility with the tensoatives, vaccine stability issues, and potency issues; hence, note only the cost should be accounted for. Below is a table (table 1) with mineral oil manufacturers with the most common oils used in veterinary vaccines.
While choosing the mineral oil supplier, carefully monitor the product viscosity, “candle” layer effect, and density because this can directly influence vaccine viscosity and syringeability – a parameter often overlooked but relevant in a large veterinary vaccination scheme.
Quick note: A typical test used to screen for mineral oil is to refrigerate (2-8° C) a sample; this can create a solid film or layer like a “candle layer” that can be mistaken for fungus contamination (picture 1) if the oil presents such characteristics, it can latter jeopardize the emulsion stability by breaking the micelles and consequently the vaccine stability.
Once the oils pass all tests, you can start formulating your vaccines with your choice and test for viscosity and stability at 2-8°C and 37°C. General rule – one week with the product (final product) at 37°C can be equivalent to 1 year of emulsion stability (OIE Chapter 2.1.5/ICH Q5C Stability testing of biotechnological/biological products – Scientific guideline)
Finally, you can start the animal testing phase, where local reactions, safety, residual levels, duration of immunity, vaccine stability, etc., are evaluated. Additionally, oil prices can fluctuate; hence, it is advisable to have a long-term contract with the supplier to ensure a continued supply at a competitive cost. Once these factors are established and accounted for, your product is ready for large-scale manufacturing.
Picture1: Example of “candle layer” when the oil is refrigerated
Table1: Table with major Mineral oil names and suppliers”
| Commertial Name | Kinematic Viscosity | Relative Density | Vendor |
|---|---|---|---|
| Marcol 52 | 7/8 | 825/834 | Exxon Mobil |
| Marcol 82 | 13.5-16.5 | 843/855 | |
| Primol 352 | 8.5 | 864/874 | |
| Shell Ondina X 409 | 3.5 | 785 | Shell |
| Shell Ondina X 411 | 6 | 800 | |
| Shell Ondina X 415 | 9.3 | 806 | |
| Klearol AV | 7/8 | 825/834 | Sonneborn |
| Klearol EU | 7/10 | 820/840 | |
| Klearol NA | 6.7/9.7 | 827/846 | |
| Drakeol 5 | 7/9.6 | 818/8610 | Penreco |
| Drakeol 6VR | 9.4/10 | 834/838 | |
| Eolane 130 | 7.2 | 810 | Total Energies |
| Eolane 150 | 8.6 | 814 | |
| Eolane 170 | 7.8 | 823 |
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