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Biologics can refer to a wide range of biological products in medicine. However, in most cases, the term is used more restrictively for a class of therapeutics (either approved or in development) that are produced using biological processes involving recombinant DNA technology. These medications are usually one of three types:
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.
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 ...
Amongst the earliest uses of biotechnology in pharmaceutical manufacturing is the use of recombinant DNA technology to modify Escherichia coli bacteria to produce human insulin, which was performed at Genentech in 1978. [1] Prior to the development of this technique, insulin was extracted from the pancreas glands of cattle, pigs, and other farm ...
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.
Obtain a patent on the new medicine preventing other companies from producing that medicine for a certain allocation of time. [33] The inverse benefit law describes the relationship between a drugs therapeutic benefits and its marketing. When designing drugs, the placebo effect must be considered to assess the drug's true therapeutic value.
The pharmaceutical industry is a medical industry that discovers, develops, produces and markets pharmaceutical goods such as medications and medical devices. Medications are then administered to (or self-administered by) patients for curing or prevention of disease , as well as alleviating symptoms of illness or injury .
As indicated above, some mammals typically used for food production (such as goats, sheep, pigs, and cows) have been modified to produce non-food products, a practice sometimes called pharming. Use of genetically modified goats has been approved by the FDA and EMA to produce ATryn, i.e. recombinant antithrombin, an anticoagulant protein drug. [20]