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They can be used in both human and animal medicine. [2] [3] Terminology surrounding biopharmaceuticals varies between groups and entities, with different terms referring to different subsets of therapeutics within the general biopharmaceutical category.
Products manufactured for medical or food use must be produced in facilities designed and operated according to Good Manufacturing Practice (GMP) regulations. Cleanrooms are often required to control the levels of particulates and microorganisms. Sterilization and aseptic processing equipment are required for production of injectable products.
The United States Food and Drug Administration (FDA) has defined bioequivalence as, "the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose ...
Produce products that maintain all of the quality standards of biopharmaceutical drugs [4] Supply both clinical and commercial quantities of therapeutic cells throughout the various stages of development. The processes and production technologies must be scalable, [3] and; Control the cost of goods (CoGs) of the final drug product.
Specialty drugs or specialty pharmaceuticals are a recent designation of pharmaceuticals [1] [2] classified as high-cost, [3] [4] [5] high complexity and/or high touch. [4] Specialty drugs are often biologics [ 3 ] [ 6 ] —"drugs derived from living cells" [ 7 ] that are injectable or infused (although some are oral medications). [ 4 ]
Pharmaceutical formulation, in pharmaceutics, is the process in which different chemical substances, including the active drug, are combined to produce a final medicinal product. The word formulation is often used in a way that includes dosage form .
Medical foods are regulated by the US Food and Drug Administration under the Food Drug and Cosmetic Act regulations. 21 CFR 101.9(j) (8). [1]The term medical food, as defined in section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee (b) (3)) is "a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary ...
Biotechnology is the research and development in the laboratory using bioinformatics for exploration, extraction, exploitation, and production from any living organisms and any source of biomass by means of biochemical engineering where high value-added products could be planned (reproduced by biosynthesis, for example), forecasted, formulated ...