Friday, April 28, 2023

Definations terms used in biopharmaceuticals related to allergenic test produtcs

What are 1.Allergen patch tests2.Allergenic extracts 3.Allergenic products 4.Biological drug substance. ?

What should be the source for .Allergenic extracts and Allergen patch tests products 

What is allergen patch test
Allergen patch tests are diagnostic tests applied to the surface of the skin. Patch tests are used by physicians to determine the specific causes of contact dermatitis, and are manufactured from natural substances or chemicals (such as nickel, rubber, and fragrance mixes) that are known to cause contact dermatitis.

What is Allergenic extract

Allergenic extracts are used for the diagnosis and treatment of allergic diseases such as allergic rhinitis ("hay fever"), allergic sinusitis, allergic conjunctivitis, bee venom allergy and food allergy. Allergenic extracts are injectable products that are manufactured from natural substances (such as molds, pollens, insect venoms, animal hair, and foods) known to elicit allergic reactions in susceptible individuals. Food extracts are only used to diagnose food allergies, but other allergenic extracts may be used for both diagnosis and treatment of allergic disease.

Allergenic products

Allergenic products are biological products which are administered to man for the diagnosis, prevention, or treatment of allergies [21 CFR 680.1(a)] and include Allergenic Extracts and Allergen Patch Tests.

Source material

Allergenic products are usually obtained by the extraction or formulation of active constituents from source material. Source material includes pollen, insects (including venoms), mold, food, chemicals, and animals. It may contain either a single allergen or mixture of allergens.

Biological drug substance

For Allergenic Extracts, the biological drug substance is the sterile intermediate solution produced from the extraction and sterile filtration of source material and contains the biologically active ingredient(s). This intermediate solution is defined as the bulk or stock concentrate. A bulk product is an intermediate solution derived from a single allergenic source and may be filled directly into final containers or used as stock concentrate. A stock concentrate is used in the manufacture of more than one lot of product and is an intermediate solution from which dilutions or mixtures are made [21 CFR 680.3(b)(1)]. For the Allergen Patch Test , the biological drug substance is defined as the allergen (or allergen mix) formulated with the vehicle prior to filling or assembling into the final dosage form.

Biological drug product

The biological drug product is the finished dosage form in its final container. For Allergenic Extracts , it may be the single or mixed allergen extract individually filled, mixed with other allergens, diluted, adsorbed to alum, or lyophilized in the final container. For lyophilized Allergenic Extracts , the diluent used for reconstitution is considered to be a component of the biological drug product. For Allergen Patch Tests , the biological drug product can be an allergen or allergen mix dissolved or suspended in a vehicle, packaged in a final container to be applied to the skin through the use of a suitable holding device (e.g., Finn chamber along with surgical tape), or the biological drug product can be an allergen or allergen mix uniformly dispersed in a gel and coated onto a support (e.g., a plastic sheet cut into patches which are assembled onto surgical tape and directly applied to the skin).

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