For the production of modified allergen extracts for both, therapeutic and diagnostic purposes, HAL Allergy established GMP manufacturing in the Leiden Bio Science Park, The Netherlands, in 2009. All our activities comply with the principles and guidelines of Good Manufacturing Practice (GMP), including freeze-drying.
In terms of technology, cutting-edge equipment was installed and the laboratory utilizes advanced equipment. Quality and quality assurance meet the highest demands in biopharmaceutical drug manufacturing. The entire plant is subject to regular inspection according to GMP criteria.
Complete control of development and manufacturing of allergy therapeutics
The production process starts with qualified sourcing and controlled allergen extraction. Precise purification and controlled allergen modification leads to creation of a unique API (Active Pharmaceutical Ingredient). The API is a standardized pure modified allergen preparation. The standardized pure modified allergen preparation has a direct impact on the immune system and allows disease modifying treatment.