Biopharmaceuticals are nothing but medicines produced by applying Biotechnology. These medicines are manufactured from cells of micro organisms and plant cell cultures and the manufacturing process is done in bioreactors having varied configurations. There are also some controversial methods adopted for making medicines which include genetic modification of plants and animals. This is considered as a controversial method because the manufacturer is putting himself in a risky situation if the research fails. Sometimes the research may be successful but the drug may not be approved by government bodies due to some perceived risks and other ethical concerns. Thus the manufacturer bears the risk of losing his investment in a failed project. Another risk in the production of Biopharmaceuticals is cross contamination with crops engineered for non-medical use or non-engineered crops.
Basically, Biopharmaceutical plants require heavy machinery and should be designed using the guidelines set by professional bodies like Food and Drug Administration (FDA). The medicines should be manufactured in “clean room” environment which complies with the standards fixed for airborne particles. The medicines may have to undergo clinical trials for many years before they are approved. And in many cases, the drug is closely monitored for safety risks and performance after it is released for consumption. The medicine is not approved and released in case it fails to satisfy the “current Good Manufacturing Practices” (cGMP) and regulations prescribed by FDA. There are companies that manufacture the machinery required for the manufacturing processes carried out in a Biopharmaceutical plant. These companies offer various quality services ranging from engineering the design, supervision of the construction process, testing of operations and commissioning of project, validation, and complete execution of the project on a turnkey basis. The machinery installed includes bioreactors, fermentors, media & buffer production systems, ultra-filtration units, storage tanks, stoppering and capping lines.
The Biopharmaceutical plants must employ Clean in Place (CIP) and Sterilization in Place (SIP) methods for ensuring disinfection and automated cleaning of equipments and machines used in production processes. These cleaning methods are essential to ensure undisturbed production and cleaning of huge equipments without dismantling and disassembling the machines. The laboratories must be designed and constructed keeping in view the maintenance of aseptic conditions and considering heating, ventilation and air conditioning (HVAC) measures. Biopharmaceuticals produced include proteins, nucleic acids, vaccines used for therapeutic and diagnostic purposes. These are essential to ensure the health and well being of human life.
Author: Anjali Goswami
Article Source: EzineArticles.com
Provided by: Beading Necklace
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