Production of allergen source material
For our production of source material we use mites as raw materials to prepare various extracts, e.g. from whole cultures or mite bodies, to obtain defined freeze-dried extracts. Both the raw materials as well as the freeze-dried extracts can be used for diagnosis, research and immunotherapy purposes, provided that the consistency is ensured. At Citeq, we produce under well-defined parameters which are monitored and documented, offering a consistent product quality to meet customer standards.
The production process to obtain an acceptable and an as pure as possible freeze-dried extract as end product from raw materials consists of several steps. First, to extract the allergenic proteins it is important that the appropriate buffers are used in the starting material as well as temperature controlled circumstances during the process. Next, the allergenic proteins which are in the solution are separated from non-soluble substances by means of centrifugation and filtration.
To ensure extract consistency, source materials are obtained from cultures in a well-defined medium. The culture conditions have been established for each of the mite species to support optimal growth as well as controlled major allergen content.
In an ideal world, we would supply allergens with a quantified biologic activity. Unfortunately, science cannot define this biological activity. To secure our production process we have defined parameters to set our specifications, which we monitor and document.
Major advantages of Citeq’s freeze dried extracts:
- High extract consistency
- Extreme low allergy content of medium
- Direct use of freeze dried extract; production occurs without preservatives or buffer Salts
- Defined source material, we deliver our material with extensive information about the amount of allergens in our material so you really can tell what you are using for your application. Click for more info
- Large batches, we produce in large batches so we can deliver from the same batch over a longer period of time. This means you are assured of the same material and consistency. If you are using our material and you are satisfied with it you can even place a reservation of a specific LOT so you will receive the same material in the future. Click for more info
- Freeze-dried, our material will be delivered in freeze-dried form (lyophilization) to assure a long shelf life and can easily be used to reach targeted dilutions. Click for more info
- Available in different sizes such as 10 mg, 100 mg and 1 gram (specific sizes can be delivered on request).
- No animal or human components, our mites are cultivated on defined media without any animal or human components.