Starting materials
Starting materials
Of natural origin, pollens, molds, animal dander, insects and venoms are often present in the form of a powder containing several active compounds.
Breeding of mites
Since 1991, in the interest of pharmaceutical quality and biological safety, STALLERGENES has possessed structures for breeding mites, which have no equivalent in the industry. The breeding conditions have been optimised in order to improve the yield and the purity of the allergen extracts.
At present, 9 species of mites (house dust mites and storage mites) are currently produced with yearly production of about 300 kg. The manufacturing process is standardised.
To accomplish this, STALLERGENES has developed and patented a Stalmite APF® culture medium from synthetic amino acids and plant substrates (totally devoid of animal or human protein), thereby eliminating all risk of transmission of infectious disease.
Standardisation
The allergen extracts are used for the diagnosis and treatment of allergies.
In the 1980s, standardisation of allergens was implemented in order to improve the safety of treatment and the reproducibility of the diagnosis. It a basic fact that the composition and allergenic potency of the products administered should be as constant as possible. The standardisation of allergen extracts has the purpose of ensuring the production and supply of extracts with a constant qualitative and quantitative composition, of which the units reflect the activity.
Since 1998, the WHO consensus has recommended the use of standardised allergens as soon as possible. The monograph "Produits allergénique"(Allergenic products) of the European Pharmacopoeia states the obligation to standardize the therapeutic extracts.
