Standardized Allergen Extracts – Pollens, Dust Mites, Insects, Fungi, and Proteins

The allergen extracts used for diagnosis and treatment of allergic diseases. In the process of fabricating of allergen extracts, it is important to apply the standards to address the variability nature of the materials. Other important consideration is to look for the way to reproduce and control the optimum safety and efficaciousness when used in clinics.

Standardization in allergen extracts includes the control of the total chain of production processes, including the collection of raw materials for building healthy and reproducible production under Good Manufacturing Practices (GMP). It is important to note the formulation of allergen extracts for use a clinical allergies diagnosis of allergy determined (in vivo and in vitro) and allergen vaccination.

Allergens are molecules with the ability to cause IgE response in humans. Inhaled allergens are proteins, easily soluble in water and the presence of suspended particles. When stimulated with low doses of allergens, most hypersensitive patients’ body respond with production of IgE specific for several proteins / allergens in the source material. Each antigen is composed of a material departure because of the potential for answering IgE. It is consequently important that all protein antigens / allergens in order to ensure the allergenic source material is exposed to people who should be included in the material.

Because of the complexity of the allergen extracts nature, the important thing to achieve standardized of allergen extracts is by using standards. In most cases, the best source material is pretty obvious, but in some cases, the source of the allergen is still under discussion (eg salivary cat / pet dander /pelt mouse or urine or hair). Raw materials should be chosen with attention to the need for specialization and participation of all relevant allergens in sufficient quantity.

The accumulation of source materials should be performed by qualified and professional individuals and having conducted appropriate measures. This measure will ensure that the collector verify the qualifications and procedures for collecting appropriate, the identity and quality of substance. Only specifically identified allergenic materials that do not contain foreign materials should be used in the manufacture process to create allergenic extracts. The processing and storage of raw materials made to ensure that the products are not intentional, including micro-organisms imported materials.

1. Pollens Allergens

Natural sources of inhaled allergens in human’s body are from grass pollens or plants pollen. Pollen can show large differences in quantitative composition according to season and location of development and achieve a relatively stable composition, crops of different years and locations for the collection, be determined in detail the characterization in vitro for the distribution of production of allergenic extracts.

2. Mammals Allergens

Allergens of mammalian origin can be found in various sources (eg, warehouses, serum, saliva or urine). In any case, the optimal combination of the source or sources of allergens should be done for mammals, with a large group of sera from allergic individuals. If filed by dandruff or body fluids, which are more allergens in fur. Precursors are often better dandruff, hair, because the protein insoluble.

3. Acarids or Dust Mites Allergens

The raw material is either Pure Mite Bodies (PMB) or Whole Mite Cultures (WMC). WMC on the basis of statements containing material bodies of the mites, eggs, larvae and fecal matter and decomposition of mites on, and includes all materials exposed to an allergy to house dust mites in natural conditions. Pure Mite Bodies extract prevented widespread contamination with residual culture medium.

4. Food Allergens

Food is a diverse sector and provision of standardized allergenic extracts is uncommon. Therefore, the source of allergens that is both qualitatively and quantitatively very different.

Ideally, the raw materials for standardized allergen extracts subspecies reflect local conditions and cultivation practices, harvesting, storage and cooking. The difficulties in the production of allergenic extracts consistent and reproducible have resulted in many doctors food retail health prick diagnostic method. The use of organic precursors should be preferred.

5. Fungi Allergens

The forms were grown under controlled conditions. The materials collected should be composed of mycelium and spores. Given the difficulties in maintaining a stable composition of fungal cultures, it is recommended that preparations should be taken from several independent cultures of the same species.

6. Insects Allergens

In the condition where insect debris or whole insects are inhaled, the condition of whole body insects are acted as source of allergen. In the case of biting or stinging insects, venom and saliva, both are the real source of allergen