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Alhydrogel® Guidelines

The ALHYDROGEL® series addresses three main applications:

1) Human applications for use in vaccines and blood fractionation

2) Veterinary applications for use in vaccines

3) Experimental immunology.

Within these fields ALHYDROGEL® may be used in both basic research and R&D, as well as small and large scale production.

Human applications:

Distinctions are as follows -

1) Profyllactic Vaccines (vaccinating a sound patient to protect against infections).

2) Therapeutic vaccines (vaccinating a patient already sick to cure or treat the disease).

3) Blood fractionation industry (using the product to purify/separate various blood components).

Veterinary applications:

Most, if not all vaccines are profyllactic, but in some respects they can be distinguished between:

1) Profyllactic Vaccines for live stock animals (decisions to vaccinate to be based on economical benefit).

2) Profyllactic vaccines for companion animals (vaccinating also when there is no economical benefit, but emotional attachment to the individual animal only).

Application of Alhydrogel®: Dosing

In veterinary vaccines there is no defined maximum limit for the allowed content of aluminium ADJUVANTS. Here the dose is normally set from a balance between efficacy and local reactogenicity. However, there are limitations for the content of aluminium allowed in vaccines for humans. These limits are 1.25 mg aluminium per dose in Europe 1, and in USA 0.85 mg aluminium per dose if determined by assay, 1.14 mg if determined by calculation and 1.25 mg if safety and efficacy data justifies it 2.

1 Ph.Eur. 6.ed. (2009) vaccines for human use pp. 3971.
2 Code of Federal Regulations (2009) 21, vil. 7: sec 610.15 (constituent materials) rev. 1. April.

Application of Alhydrogel®: T helper cell stimulation

Alhydrogel® promotes an immune response skewed towards the Th2 profile.

Grun, J.L. and Maurer, P.H.
Different T Helper Cell Subsets Elicited in Mice Utilizing Two Different ADJUVANT Vehicles.
The Role of Endogenous Interleukin-l in Proliferative Responses.

Cell. Immunol. 1989, 121 (1), 134-145.

Application in blood fractionation:

In blood fractionation industry the protein adsorption capabilities of Alhydrogel are utilized to remove some serum components during the purification processes, leading to the final product. This means that in these applications the Alhydrogel is not injected as part of the final product administered to the patient.