Inmunotek manufactures allergen extracts for producing diagnostics and vaccines under Proper Manufacturing Standards and therefore is authorized by Spain’s Medication Agency.
The quality of its extracts is guaranteed due to a strict raw materials control , an optimized production process, modern and adequate facilities and highly qualified staff.
The extract batches manufactured by Inmunotek for immune therapy, of the native and modified types, are submitted to the prior approval of the Paul Ehrlich Institut (Germany) since September 2009. This Institute ensures that product specifications are fulfilled.
Biological standardization Inmunotek standardizes the allergen extracts following the Nordic Countries Norms*, which define that “the activity of an allergen extract has 10,000 Biological Units (BU) when it causes a skin reaction of the same size as that of the positive reference solution consisting of 54.3 mml/L of histamine (histamine dihydrochlorhydrate at 10 mg/mL) when both solutions are administered with the same technique (prick test) in at least 20 subjects who are clinically allergic to the corresponding allergen extract”.
* Nordic-Council-on-Medicines. Registration of allergen preparations. Nordic guidelines. Prepared by the Nordic Council on Medicines in cooperation with the Drug Regulatory Authorities in Denmark, Finland, Iceland, Norway and Sweden. Uppsala (Sweden): Nordiska Läkemedelsnämnden. 1989.
The standardized extracts that are biologically available for immune therapy are shown in green in the attached filed.