The biological product manufacturing is a complex process which produces products derived from recombinant DNA technology to develop a series of processes to manufacture therapeutic products. A biological product can be a virus, antitoxin, vaccine, blood component or derivative, allergenic product, or analogous product, or any therapeutic serum used for the treatment of a disease in humans. These biological products were developed from multicellular systems comprising of plants, animals, unicellular organisms and a mammalian cell. Biological products are composed of sugars, nucleic acids or combination of both.
During the 20th century, the world witnessed many great discoveries in the biological product manufacturing industry. One of the first biological products to be introduced in the U.S. market was a blood protein known as Factor VIII which was first sold in 1966.The first FDA approved modern biological product designed for human therapeutic use was insulin; the approval was given in 1982.During 1985, FDA approved human growth hormone (HGF).The manufacturing of biological product differs from product to product; the process involves product-specific process consideration. One very important step involved in biological product manufacturing is controlled the environmental control of particulate and microbial contamination of the biological product production facility. The difference between biological products and conventional drug are, the biological product is heat sensitive and are prone to cross-contamination. Therefore they require a contaminant free environment during manufacturing.
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Biological product manufacturing facilities use analytical and process development capabilities for the developing and scaling up the process for increased production maintaining the quality of the biological product. The implementation of such process control assist the Phase 1 clinical studies which focus on the product safety and efficacy. The biological product manufacturing is governed by many various regulatory authorities which make it harder for products approvals, because of overlapping opinions and other redundancies. Therefore to bring all regulatory authorities under one roof, the international conference on harmonization of technical requirements was formed in 1990 for the registration of pharmaceuticals for human use. The ICH has helped biological product manufacturers to register and develop a better quality product which is safe and more efficient.
The biological products are produced in three ways: by developing ways to achieve commercial production of the substance to be used, by gene alteration of the molecule and finally by developing an entirely new substance. Some of the tools used by modern day researcher in the manufacturing of biological products are recombinant DNA and monoclonal antibodies. Recombinant DNA involves altering of the DNA chain of one organism with desired DNA molecule to produce a novel biological product. Monoclonal antibodies were developed from single cell cultures using cloning techniques; these were designed to fight against toxins, viruses, and cancer cells. The first genetically engineered biological product approved for use in the U.S. was a vaccine for hepatitis-B which was approved in 1986, in the same year, other biological products like therapeutic monoclonal antibodies (MAB’s) and alpha interferon’s were approved.
The biological product manufacturing strictly follows GMP (Good manufacturing practices) rules for all production process from beginning to the last step for biological product manufacturing. These guidelines imply to the change in facility, manufacturing processes and other guidelines regarding clinical trials of the biological product related to its safety and purity. The major drivers for biological product manufacturing market increase in population, increasing the incidence of chronic diseases and increased government initiatives.
However, the major restraining factors for biological product manufacturing market are the high cost of manufacturing of biological products, high level of price competition amongst competitors and efficacy and reliability of the biological product.
By regional presence, global biological product manufacturing market is segmented into five key regions viz. North America, Latin America, Europe, Asia-Pacific-Pacific, and the Middle East & Africa. The region of North America is a forerunner in biological product manufacturing market globally mainly because of strong product development, technological advancements and increasing the population. The North America market is closely followed by Europe and Asia-Pacific. The region of Asia Pacific is an emerging market for referral management system mainly because of increasing proficiency in IT skills and growing healthcare expenditure in the region.
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The leading players in the referral management market are Novartis AG, F.Hoffmann-La Roche Ltd., Merck & Co., Inc., Bayer AG, Lonza, China Biologic Products, Inc., Pfizer Inc., Sanofi, GOLDEN WEST BIOLOGICALS, Inc., Teva Pharmaceutical Industries Ltd., Amgen Inc.
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