Legislation in the 21st century has addressed this by recognizing an intermediate ground of testing for biosimilars. The filing pathway requires more testing than for small-molecule generics, but less testing than for registering completely new therapeutics. In , the European Medicines Agency introduced an adapted pathway for biosimilars, termed similar biological medicinal products.
This pathway is based on a thorough demonstration of "comparability" of the "similar" product to an existing approved product. When a new biopharmaceutical is developed, the company will typically apply for a patent , which is a grant for exclusive manufacturing rights. This is the primary means by which the developer of the drug can recover the investment cost for development of the biopharmaceutical. The patent laws in the United States and Europe differ somewhat on the requirements for a patent, with the European requirements are perceived as more difficult to satisfy.
The total number of patents granted for biopharmaceuticals has risen significantly since the s.
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In the total patents granted was This had climbed to 15, in , and by there were 34, patent applications. Biopharmaceuticals may be produced from microbial cells e. Alternative platforms of production which are being tested include whole plants plant-made pharmaceuticals. A potentially controversial method of producing biopharmaceuticals involves transgenic organisms, particularly plants and animals that have been genetically modified to produce drugs. This production is a significant risk for the investor, due to production failure or scrutiny from regulatory bodies based on perceived risks and ethical issues.
Biopharmaceutical crops also represent a risk of cross-contamination with non-engineered crops, or crops engineered for non-medical purposes. One potential approach to this technology is the creation of a transgenic mammal that can produce the biopharmaceutical in its milk, blood, or urine.
Once an animal is produced, typically using the pronuclear microinjection method, it becomes efficacious to use cloning technology to create additional offspring that carry the favorable modified genome. In the European Union , a biological medicinal product  is one of the active substance s produced from or extracted from a biological living system, and requires, in addition to physico-chemical testing, biological testing for full characterisation.
The characterisation of a biological medicinal product is a combination of testing the active substance and the final medicinal product together with the production process and its control. For example:.
Animal Cell Technology - From Biopharmaceuticals to Gene Therapy (Electronic book text)
Approval may require several years of clinical trials , including trials with human volunteers. Even after the drug is released, it will still be monitored for performance and safety risks. The manufacture process must satisfy the FDA's "Good Manufacturing Practices", which are typically manufactured in a clean room environment with strict limits on the amount of airborne particles and other microbial contaminants that may alter the efficacy of the drug.
In Canada, biologics as well as radiopharmaceuticals are reviewed through the Biologics and Genetic Therapies Directorate within Health Canada. From Wikipedia, the free encyclopedia.
See also: Biologics for immunosuppression. Main article: Vaccine. Main article: Biosimilars. The authors of the chapters are leaders of internationally-recognized animal cell culture research and have extensive experience in the areas covered in their respective chapters. Review This Product No reviews yet - be the first to create one!
Animal Cell Culture and Technology by Mike Butler
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