Raw allergen source materials
Besides our widely used allergen extracts we also produce mite whole cultures and mite bodies from Dermatophagoides pteronyssinus, Dermatophagoides farinae, Acarus siro and Blomia tropicalis. All products are produced by Citeq Biologics under well-defined parameters. Using house dust mites as raw materials, various extracts can be prepared, e.g. from whole cultures or mite bodies, to obtain defined freeze dried extracts. Ensuring the consistency of both raw materials as well as freeze dried extracts, these products can be used for diagnosis and immunotherapy purposes. All products will be provided with certificates and documentation to meet regulations and even more important, the materials are produced to high standards to ensure they meet your requirements.
Citeq is one of the few suppliers which has a medium without any animal components as protein source. This makes Citeq mites unique. We avoid using human dander because human dander is a real source of prions and viruses. This has been a challenge for all mite cultivation companies. Some of them has used e.g. liver powder, fish powder or insects as protein source. Our specialty starts with our cultivation medium which has an absolute low in foreign protein. Our cultivation technique leads to high concentrations of the major allergens, resulting in strong raw materials. All our house dust mite products contain the native proteins, with no denaturing treatments during production and purification.
Active pharmaceutical ingredient (API) starting materials
Both materials, whole cultures as well as mite bodies are active pharmaceutical ingredient (API) starting materials. This means these materials can be used for further processing such as extraction procedures under GMP pharmaceutical requirements by, for example, allergen vaccine producers and diagnostic companies. The responsibility for the extraction procedure under GMP lies with our clients. Our quality systems incorporate the important aspects of GMP standards to meet regulations and make sure that you will receive source material with the best fit for your application.
Description whole mite culture
Whole mite cultures are produced by freeze drying a mite culture. A whole culture consist of all the materials of the house dust mite cultivation, including mite bodies, eggs, larvae, skin parts, cultivation medium and the excrements. From egg to mite there are different stadia. The skin of a mite is of chitin. This is a form of sugar. A chitin skin is not flexible, so when a mite grows, the body must get out of the skin and grow into a new phase. Whole culture contains all components which are also present within households. In real life, atopic patients respond to the whole culture of house dust mites. Patients respond especially to the excrements of the mites, the size of excrements is between 20 and 60µm. With this size the particles are floating in the air.
Why use whole culture?
- Product is very much like in nature, this is found in the specific studies (similar in protein profile).
- High concentration of excrements (higher than in mite bodies). Excrements contain important mites allergens (1 group allergens).
- High ratio allergenic proteins: non allergenic proteins (1 + 2 group allergens : total extractable proteins).
- The price for whole culture is lower than for the other forms: mite bodies, extract and purified allergens.
- Variable allergen contents: allergen contents can be adapted to the demands of the customer. The allergen contents changes during growth. The mite culture can be harvested when the allergen contents is within the specifications of the customer.
Cons whole culture
- Contamination with growth-medium. However, our mites are cultivated on defined media without any animal or human components.
- When the medium is analysed on allergenicy and is (almost) non allergenic, the danger that it cause (allergenic) side-effects is nil.
- There has to be an opinion about the medium. For example, non-animal/non allergenic and tested with various methods.
- Undefined mixture.
Description mite bodies
Mite bodies are produced by separating the living mites from the growth medium. This is done by physical separation methods. When the mites are separated they are freeze-dried.
Why use mite bodies?
- Less possible contamination with medium, and therefore less possible allergological contamination of the medium in the product (although there is always medium present and allergy is on minimal components). For this there has to be an opinion about the medium.
- Less medium in the product. The regulation for mite bodies wsa designed to avoid medium in the product. The product is mostly used in the US and US related countries.
Cons mite bodies
- Medium has still to be defined, there is always a small amount of medium still present (The medium is used in the gut as a form of transport, on the medium the enzymes are placed).
- The production process is more complicated and therefor mite bodies are more expensive.
- Rigid allergen contents, allergen contents cannot be adapted to the demands of the customer.
- Possibility of contamination with solvent, when the mite are separated from the medium with the flocculation procedure (solvents like glycerol / methanol / ethanol or acetone). This can lead to a lower amount of the mite allergens excrements.
Supply chain of allergen source material
To meet the regulations and demands of regulators we can provide you with the full supply chain of our products. Information about the manufacturing location, origin of the material (biological/ synthetic), packaging and handling environment employed, details of any toxic substances such as solvents or heavy metal catalysts used during manufacture, and change-control elements. We constantly learn how to work with ever changing guidelines.
To meet GMP regulations Citeq has implemented several measures:
- Our mites are cultivated on defined media without any animal or human components.
- Mammals are kept within a maximum barrier with strict personnel access procedures.
- Our documentation is GMP ready. All chemical, microbiological, and plant source components of the mite cultivation media are well documented.
- We provide full documentation with our products.
We have defined parameters to set our specifications, which we can measure and document. The parameters are the results of 40 years’ experience in preparation of whole cultures and mite bodies. We are confident this illustrates what is meant by “content uniformity”. Next to these parameters, we comply to US and European regulations and guidelines. Our samples contain less than 1% impurities (FDA). We do not use any substances listed in the EU regulations.
If you have established the desired quality for the required raw material for each application we can supply our materials with the best fit. Our quality systems incorporate the important aspects of GMP standards to meet regulations without over-engineering and adding unnecessary cost to the product. In-process controls are important to maintain healthy cultures and to determine the optimal harvest-time, both for whole cultures and mite bodies. Trend analyses are important indicators for the quality of both the analysis and the final product.