Allergenic extracts are used to diagnose and treat allergic diseases. Many types of allergenic extracts are available, including those from mites.
Different mite species are used to produce allergenic extracts. The most common mite species raised for this purpose include Dermatophagoides pteronyssinus and Dermatophagoides farinae, which are grown on media rich in nutrients until the culture is mature. Subsequently, mites are separated from residual non-consumed mite growth media, processed, and stored until used to produce allergenic extracts.
Allergenic extracts have to comply with the requirements of medical regulatory agencies, including the Food and Drug Administration (FDA) in the USA, as well as the European Pharmacopoeia (EP) and the European Medicines Agency (EMEA) in Europe.
While the composition of mite growth media varies among manufacturers, USA and European medical regulatory agencies recommend that non-allergenic components be used. Because of the potential transmission of infective agents, USA and European medical regulatory agencies have requirements for product safety when animal-derived components are used to manufacture medical products, including allergenic extracts.
For mites, both USA and European regulatory agencies recommend that non-allergenic components be used to prepare mite growth media. Because of the potential transmission of infective agents, regulatory agencies, particularly in Europe, have requirements for product safety when animal-derived components are used for the manufacture of medical products, including allergenic extracts. The EMEA specifically requests that the mite cultivation method as well as the mite growth media be described and submitted (1). The EMEA also recommends that media free of animal components be preferably used.
Transmissible spongiform encephalopathies (TSE) are diseases of the nervous system caused by prions, characterized by the accumulation of glycoprotein in the brain and other areas. TSE diseases have been reported to affect cattle, sheep, goats, cervids, felines, ungulates, and humans. Therefore, according to the EMA, when substances of animal or human origin are used as source materials, including mite media, compliance with TSE requirements should be demonstrated. It is recommended that when manufacturers have a choice, the use of materials from non-relevant animal species should be given (2).
Allergen Science & Consulting has experience in the formulation of non-allergenic mite growth media without animal components to comply with the requirements of medical regulatory agencies. Contact us to discuss your needs.
1.- Guideline on allergen products: Production and quality issues. Europe4an Medicines Agency. London, November 20, 2008. EMEA/CHMP/BWP/304831/2007.
2.- Note for guidance on minimizing the risk of transmitting animal spongiform e’ncephalopathy agents via human and veterinary medicinal products (EMEA/410/01).