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Stallergenes group
Raw materials and standardisation
Raw materials
Stallergenes undertakes to maintain and develop the highest quality standards in its processes and to regularly undergo checks on compliance with the most stringent quality standards.
The quality of allergen extracts depends first and foremost on the quality of the raw materials. These must meet strict quality and safety standards in compliance with European regulatory requirements demonstrating aspects such as their origin, processing, identification and purity.
The company works in a context of Good Manufacturing Practices examined by the European Commission. They guarantee the quality of manufacture and controls.
Stallergenes respects the requirements of the European Pharmacopoeia and the EMA (European medicines Agency). The introduction of a quality policy for the selection of its raw materials is aimed at:
- minimising the risk of contamination by systematic radio-sterilisation of mould and house dust mite raw materials and allergens of animal origin;
- controlling contamination of pollens by pesticides and heavy metals.
Production of house dust mites
Stallergenes is the leading producer of house dust mites in the world with output of around 500 kg/p.a.
The company has developed its own system for producing house dust mites and patented its culture medium, STALMITE APF*, presenting the following characteristics:
- No animal or human protein: medium composed of a mix of amino acids and plant substrates entirely calibrated;
- Stability: medium tailored to the development conditions of house dust mites;
- Pharmaceutical quality and safety: validation of primary colonies, elimination of the risk of transmission of viruses and prions, absence of residual allergenicity.
After around 2 to 3 months growth depending on the species, the house dust mites are collected and frozen at -30°C for at least 24 hours. They are then freeze dried, so ensuring optimised stability before the starting material is subjected to radio-sterilisation with Gamma rays in order to prevent any microbial development. The starting material obtained is then packaged and stored at between +2°C and +8°C, optimum temperature conditions to ensure proper storage. There then follows a quality control stage with several standard immunological techniques upon which acceptance of the batch is conditional. Finally, the starting material undergoes several processing stages in compliance with Good Manufacturing Practices before arriving at the finished product stage.
Production of pollen
The production of pollen meets stringent specifications.
The starting material selected must be easily extractable. Moreover, the purity standards are defined by official regulations limiting the presence of pollens from other species in the extract to 1%. Any contamination by particles from the original plant cannot exceed 10% for most species.
Stallergenes selects suppliers who undertake to comply with strict specifications in terms of the quality and traceability of each product. Pollen is harvested either by direct aspiration or after the collection of plants and pollination in greenhouses. There then follow the stages of sifting, drying and storage of the starting material. Suppliers are controlled by means of a certificate of analysis for each batch and monitoring of inspections on delivery to ensure the allergenic quality of the pollen upon which acceptance of the batch is conditional. Finally, the starting material undergoes several processing stages in compliance with Good Manufacturing Practices before arriving at the finished product stage.
Since 2010, Stallergenes has benefited from a pollen production unit. Part of the production is effective for grasses which enables the group to control its production process and further secure its supplies.
Standardisation
Stallergenes standardised extracts are made from raw materials of natural origin.
The aim of standardisation is to guarantee the reproducibility of the allergenic activity from batch to batch. This reproducibility makes it possible to reduce variations inherent in all biological products.
Standardisation is a guarantee of quality and the specificity of the diagnosis as well as the effective treatment of the respiratory allergy.
All standardised allergenic extracts made by Stallergenes are controlled and compared with the corresponding internal reference extract.
The reference extracts are controlled by physico-chemical and immunological methods.
During establishment of a new reference extract, it is calibrated in-vivo during a clinical trial in diagnosis by skin testing (prick test) in order to meet the definition of the RI reactivity index/ml defined by Stallergenes.
36 allergen references are standardised according to this definition.
The reactivity index (RI): An allergenic extract obtains the strength of 100 RI/ml when, used in a prick test with a Stallerpoint® in 30 subjects sensitized to this allergen, it provokes a weal with a diameter of 7mm (geometric average). The cutaneous reactivity of these subjects is simultaneously demonstrated by the positive result of a prick test to histamine hydrochloride (or codeine phosphate).
Quality Assurance
In 2007, Stallergenes deployed a quality plan based on Good Manufacturing Practices which covers testing laboratories and industrial operations but also areas of activity in R&D framed by good practices and standards.
To achieve its objectives, the group has tripled its staff engaged in quality assurance.