Introduction
In modern medicine industry, biological techniques are widely used in the production of pharmaceuticals. Pharmaceutical biotechnology products are the medical products extracted from native biological sources and used for therapeutic or in vivo diagnostic purposes. Normally, these biological products include proteins, such as antibodies, and nucleic acids, such as DNA and RNA. However, as the high sensitivity to external environment, the stability of biopharmaceutical products are easily affected by some physicochemical factors, biological factors, etc. As a result, during the process of manufacturing, packaging and storage, biopharmaceutical products have a high risk of degradation which could lead to significantly negative influences
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Stability of pharmaceutical biotechnology products emphasizes that, during the period of storage and use, the properties and characteristics of biopharmaceutical products need be as same as those at the time of production, and a product could be defined as failure to meet its specification when it generates “significant change”. For pharmaceutical biotechnology products, the molecular conformation and biological activity of components both depend on covalent and non-covalent forces, so strict and comprehensive stability studies should be performed for these biopharmaceutical products. Normally, the active components of biopharmaceutical products include proteins, plasmids or polypeptides, which are extracted from cell culture, tissues or through the use of recombinant DNA technologies. As these products are extremely sensitive to the external environmental factors, such as temperature, hydrolysis, radiation, oxidation and so forth, these products must be able to maintain their quality in the whole intended storage period. As a result, to ensure the activity and to avoid degradation, before the new biopharmaceutical products have access to the market, manufacturers need to perform comprehensive stability studies, including physical testing, chemical testing, biological testing etc., to evaluate these products under different environmental situations …show more content…
- Light: Consult corresponding regulatory agencies to determine the guidelines for testing.
- Container: Manufacturers need submit the stability data about all the containers which will enter the market. The interaction between biological products and containers may lead to the change of product quality. As a result, stability studies should contain samples in the inverted, horizontal or upright position so as to analyse the influence of containers on products.
- Stability after reconstitution of freeze-dried product: For freeze-dried biopharmaceutics, maximum storage period should be demonstrated by stability testing, and some labelling should meet relevant regional requirements.
coli cells were grown at 37 degrees Celsius with calcium ions. These cells were then incubated in ice and placed into 4 polypropylene tubes. Each tube consisted of 25 microliters of E.coli cells. Two of the four were labeled with (+) while the other two were labeled (-). Positive was with samples that contained 100 pg/ microliter of pGLO, while negative was for the samples that did not. The 4 tubes were incubated in ice for 30 minutes, then heat shocked for 30 seconds at 42 degrees Celsius. The 4 tubes were then returned to the ice bath for 5 minutes. After the removal, .975 microliters of LB media was added to each tube at room temperature. The tubes were then shook at 225 RPM at 37 degrees Celsius for one hour. 300 microliters of cells were then extracted from the tubes and then placed in agar plates. The cells were spread across the plate and the incubated overnight at 37 degrees
Background: Merck & Co. is an American pharmaceutical company and one of the largest pharmaceutical companies in the world. In 1971 the United States approved the use of an MMR vaccine made by Merck, containing the Jeryl Lynn strain of mumps vaccine. In 1978 Merck introduced the MMR II, using a different strain of the rubella vaccine. In 1997 the FDA required Merck to conduct effectiveness testing of MMRII. Initially it was over 95%; to continue the license; Merck had to convince the FDA that the effectiveness stayed at a similar rate over the years.
This report will explain the current status of Lazar Sharipoff’s final report to Richard A. Durst, the chairman of the Food Advisory Committee for the Food and Drug Administration (FDA). This status report includes the relativity of labeling Genetically Engineered (GE) products to Richard, who the stakeholders are, disagreements among experts on GE products. The most interesting information Lazar has found so far, and what information he needs to complete his research.
Being presented with the problems in the implementation of the SAP ERP system, it is evident that Novartis Pharmaceuticals requires a comprehensive action plan that resolves key issues and the underlying problem. Refer to Exhibit A for a graphical representation of the action plan.
Early research involving biotin first began in the production area of swine (Comben et al., 1984). Positive results have been document in numerous research studies involving u...
An Analysis of GlaxoSmithKline The business that I have done research into is GlaxoSmithKline. This company is a globalised research-based pharmaceutical public limited company. Its ownership structure has changed a great deal since the original company was first established in 1715. Originally a pharmacy, the company has expanded, merged with and taken over other companies over the decades.
Size and stability: Liquid formulation can be bulky, difficult to transport and store.1 During storage under the stated conditions, it’s necessary that oral solutions are not subject to precipitation, fast sedimentation, caking or formation of lump.2 They have poor stability compare to solid dosage form formulation due to hydrolysis.1 Therefore, it’s important to optimize the active ingredient stability in liquid formulation including those prepared from powder or granules.2
Redwan, El-Rashdy M. "Animal-Derived Pharmaceutical Proteins." Journal of Immunoassay and Immunochemistry 30.3 (2009): 262-90. Web.
The past twenty years have seen rise to a new burgeoning scientific field: genetically modified foods. During the plant breeding process, geneticists interfere with the reproduction and modify the genes of the new seedling by introducing a fragment of DNA from another organism that possesses the desired trait. With genetic modification, scientists can increase the pest, herbicide, cold, and drought tolerance so that the crop can survive in harsher climates. In some cases, the nutritional value can even be increased (Ulrich 9). Despite the obvious benefits of more nutritious foods and crops that are hardier and more resistant to harsher climates, there are some concerns surrounding GM foods. Each new alteration can cause an unforeseen allergic reaction, negate the effects of antibiotics, or potentially cause some adverse effects to the environment (Falkner 101). Every newly developed GM food must be tested on a case by case basis as there is no universal method that determines the safety of all modified components. As a result, long term effects of ingesting food with altered material are unknown.
Perego, P., Sordi, A., Guastalli, R., & Converti, A. (2007). Effects of changes in ingredient
R & D risk is the risk of failure due to the possibility of technology development . Many reasons for failure of food research and development are technical problems and high development costs .New technologies field of food processing are emerging , such as bio-fermentation technology, membrane separation technology, enzyme technology, biomass energy, biomass and other high-tech materials. Application of these technologies also have a lot of uncertainty and risk.
Therefore, the attention has been drawn from quantity of food to quality and safety. A gap between food demand and safe food supply becomes an urgent issue to be solved, which also affects global food market and food security.
Food Preservatives are added to food to reduce the decomposition period. Although some food preservatives are naturally found in some of Earths fruits, vegetables, and beans, many food preservatives are man-made chemicals and toxins to extend the life of food to an unnatural level. MedX India researched on how “Substances that are added to food items in order to inhibit, retard, or arres...
Apart from vitamin B12 microorganisms of the genus Streptomyces produces a large no. of bioactive compounds which are used in pharmaceutical and food industries, in biote...
The basis of the discipline focused on understanding of the chemistry of food components such as proteins, carbohydrates, fats and water and reaction during processing than storage. Good understanding about processing and preservation method are needed which includes drying, pasteurization, canning and irradiation (Susan, 2012).