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Shipping & Receiving Extracts All allergen extracts are shipped expedited using a reputable courier under non-refrigerated conditions. It is important to ensure that a member of your staff be available on the day your products are scheduled to arrive to minimize the amount of time the extracts are out of refrigeration. When your supplies arrive,… read more

How to Perform Dilutions Once you have prepared the patient’s treatment vial (e.g., Red Vial), you will need to perform a series of dilutions before you begin treatment. Subcutaneous allergen immunotherapy begins with a small dose of a highly dilute allergen solution and, over time, increases in volume and concentration until the maintenance dose has… read more

Dosing One of the primary objectives when mixing allergenic extracts is to prepare a patient’s treatment set in a way that ensures an optimal therapeutic dose of each allergen in the patient’s allergen extract vial. Therefore, the limiting step when mixing is deciding what volume of each allergen to add to a patient’s maintenance vial.… read more

Oral Allergy Syndrome Many common food allergens are cross-reactive with unrelated (or distantly related) pollen allergens, such as Apple with Birch, or Melon with Ragweed. This is bec

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se they share evolutionarily conserved protein structures that have a similar function across species. For example, the major allergen, Bet v 1, found in Birch, is an essential… read more

Effect of Storage Conditions on Stability Allergenic extracts should be stored in a refrigerator when not in use. The proper storage temperature is 2-8°C (36-46°F). It is recommended to include a recording device in a refrigerator in order to monitor temperature and to note any deviations if they occur. In the event of a power… read more

Effect of Formulation on Stability Below is a figure that shows how expiration dating varies by formulation. For standardized products, these dates were established through FDA-approved testing methods. For non-standardized products, these dates were established by the FDA. For more information on extract formulation, please see the section on Extract Formulations Expiration dates for bulk… read more

Major Allergen Characterization The active ingredients of allergenic extracts are the proteins that the immune system responds to. Within an extract, there may be multiple allergenic proteins. Major allergens are those proteins to which at least 50% of a population are sensitized to. Some of these allergens, such as Fel d 1 in cat, are… read more

Non-Standardized Extracts Allergenic extracts that are considered non-standardized do not undergo additional laboratory testing to verify relative biologic strength. Instead, non-standardized extracts are assigned potency values based on either the product’s extraction ratio (source material-to-extracting solution) or on an estimated measure of total protein. Weight-to-Volume (w/v): This is simply a ratio of grams of dry… read more

Standardized Extracts The FDA has mandated standardization testing for a limited number of extracts. The purpose of standardization is to minimize the amount of variability between lots and manufacturers of the same extract. Extracts that have been standardized by the FDA include the northern pasture grasses (Timothy, June, Meadow Fescue, Orchard, Redtop, Perennial Rye, Sweet… read more

Formulation Concern – Glycerin Source ALK uses glycerin that is derived from plant materials and is over 99% pure. Occasionally patients may have a concern that there could be corn allergens present in the glycerin, since corn is one of the likely source materials; however, there is a lack of adequate evidence to support the… read more