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High-quality Product (high-quality + product)
Selected AbstractsGood practice in plasma collection and fractionationISBT SCIENCE SERIES: THE INTERNATIONAL JOURNAL OF INTRACELLULAR TRANSPORT, Issue n1 2010C. Schärer The control strategy to ensure safety of blood products includes a combination of measures focusing on ensuring the quality and safety of starting material by careful donor selection and testing strategies at different levels, together with validated manufacturing processes, including steps to inactivate or remove potential contaminating agents. Using an approach based on good manufacturing practice (GMP) provides a manufacturing model that allows for a documented system of incorporating quality throughout the entire manufacturing process and describes the activities and controls needed to consistently produce products that comply with specifications and are safe for use. There are no doubts that the aim of providing safe and high-quality product to the patients should be the same for all products derived from human blood, independent of its use either as a blood component for direct transfusion or as industrially manufactured product. It would be difficult to justify whether for blood components the good practice standards and for plasma derivatives the GMP standards for manufacturing would not ensure equivalent levels of quality and safety. To ensure a high level of quality and safety of blood components and plasma derivatives, the implementation of double standards in blood establishments and fractionation industry would not be effective and should be avoided. Harmonized standards and good practices for collection and fractionation, based on the principles of GMP, should be envisaged in the whole chain of manufacturing blood components and plasma derivatives. Global initiatives to further promote the implementation of harmonized GMP for the collection in blood establishments and a stringent regulatory control are ongoing. This would further contribute to the global availability of plasma-derived medicinal products. [source] GAMMA IRRADIATION ON FROZEN AND PACKAGED HEADED SHRIMPJOURNAL OF FOOD QUALITY, Issue 4 2009V.K.G. ABREU ABSTRACT The objective of this work was to evaluate the effects of , irradiation (0, 2, 4 and 6 kGy doses), applied on frozen and packaged headed shrimps, on pathogenic Vibrio cholerae O1 and Salmonella enteritidis bacteria, as well as on some of the physical and sensory characteristics of this kind of food. The 6 kGy dose was highly efficient in inhibiting V. cholerae O1 and S. enteritidis and in decreasing lipid oxidation in shrimps compared with the nonirradiated product. Shrimp texture was not affected by any of the irradiation doses studied, but the lightness of the surface color increased in shrimps irradiated with 6 kGy compared with those irradiated with 2 kGy. Shrimps irradiated with 6 kGy showed lower overall acceptability than those irradiated with 2 kGy or were nonirradiated. The application of , irradiation in doses up to 6 kGy on frozen and packaged headed shrimps could improve the microbiological quality of this commodity. PRACTICAL APPLICATIONS The use of , irradiation has the potential to ensure safety effectively by inactivating bacteria, increasing shelf life and maintaining food quality without significant chemical changes in the food matrix. Besides, this process can be applied to frozen and packaged products. Thus, irradiation of frozen and packaged shrimps could benefit the local processing industry, which could offer the international market a high-quality product, with an additional safety treatment. [source] Pricing U.S. North Atlantic bluefin tuna and implications for managementAGRIBUSINESS : AN INTERNATIONAL JOURNAL, Issue 2 2001Michael T. Carroll Bluefin tuna is regarded as a high-quality product in the Japanese market and is characterized by an unusual marketing system by seafood industry standards. Each fish is individually inspected for various quality attributes before being flown to Japan for the fresh tuna market. The first objective of this study is to formally evaluate the degree to which the price of U.S. fresh bluefin tuna is determined by quality attributes of each fish, rather than by just the quantity supplied. This is accomplished using a Hedonic model. The results support the hypothesis that the fresh bluefin tuna price is, in fact, significantly influenced by the quality attributes of the fish, including the freshness, fat content, color, and shape. Interesting implications for public management of this highly valued resource arise from the results. [Econ-Lit citation: L150, L190, L660] © 2001 John Wiley & Sons, Inc. [source] (203) Manufacturing Process for a Highly Purified, Stable Liquid Formulation of Botulinum Toxin Type B (MyoblocÔ)PAIN MEDICINE, Issue 3 2001Andrew Grethlein Botulinum toxin type B (BoNT-B; MyoblocÔ) is a new botulinum toxin with demonstrated efficacy in patients with cervical dystonia, and has been found to decrease neck pain associated with this disorder. Developmental work has led to the commercial-scale production of a uniform, highly purified toxin complex in a liquid formulation. Production of BoNT-B involves fermentation, recovery and purification from Clostridium botulinum. The reliability and robustness of the process were tested by altering critical process parameters (eg, pH, temperature) and showing that a high-quality product resulted even in conditions detrimental to C botulinum fermentation. Consistency and key quality attributes (purity, complex integrity, percent nicking, specific activity) of the toxin were assessed using a series of biochemical tests, which were validated as precise and accurate and are now routinely used in quality control analysis. Results confirmed production of an intact, uniform toxin complex with consistent purity, percentage nicking (a measure of toxin activation) of over 70%, and specific activity over 90 U/ng in three manufacturing runs. BoNT-B is manufactured as a slightly acidic liquid formulation that maintains complex integrity, reducing the potential for generating neutralizing antibodies. The potency of drug substance, dilute bulk solution, and finished product was shown to be reliable using the validated mouse intraperitoneal LD50 potency assay. The liquid formulation of BoNT-B was found to be stable for at least 9 months at 25°C and at least 3 years at 2,8°C. BoNT-B has a long shelf-life and may be produced on a commercial scale reliably and reproducibly, making it readily available and convenient to store and use. Support of Elan Pharmaceuticals is gratefully acknowledged. [source] PROFIT MAXIMIZATION AND SOCIAL OPTIMUM WITH NETWORK EXTERNALITY,THE MANCHESTER SCHOOL, Issue 2 2006URIEL SPIEGEL The paper analyzes the options open to monopoly firms that sell Internet services. We consider two groups of customers that are different in their reservation prices. The monopoly uses price discrimination between customers by producing two versions of the product at positive price for high-quality product and a free version at zero price for lower-quality product. The monopoly can sell advertising space to increase its revenue but risks losing customers who are annoyed by advertising. Network externalities increase the incentive to increase output; thus we find cases where the profit maximization is consistent with maximum social welfare. [source] Comparative Effectiveness Research and Evidence-Based Health Policy: Experience from Four CountriesTHE MILBANK QUARTERLY, Issue 2 2009KALIPSO CHALKIDOU Context: The discussion about improving the efficiency, quality, and long-term sustainability of the U.S. health care system is increasingly focusing on the need to provide better evidence for decision making through comparative effectiveness research (CER). In recent years, several other countries have established agencies to evaluate health technologies and broader management strategies to inform health care policy decisions. This article reviews experiences from Britain, France, Australia, and Germany. Methods: This article draws on the experience of senior technical and administrative staff in setting up and running the CER entities studied. Besides reviewing the agencies' websites, legal framework documents, and informal interviews with key stakeholders, this analysis was informed by a workshop bringing together U.S. and international experts. Findings: This article builds a matrix of features identified from the international models studied that offer insights into near-term decisions about the location, design, and function of a U.S.-based CER entity. While each country has developed a CER capacity unique to its health system, elements such as the inclusiveness of relevant stakeholders, transparency in operation, independence of the central government and other interests, and adaptability to a changing environment are prerequisites for these entities' successful operation. Conclusions: While the CER entities evolved separately and have different responsibilities, they have adopted a set of core structural, technical, and procedural principles, including mechanisms for engaging with stakeholders, governance and oversight arrangements, and explicit methodologies for analyzing evidence, to ensure a high-quality product that is relevant to their system. [source] Prospects in Lyophilization of Bovine PericardiumARTIFICIAL ORGANS, Issue 3 2009Adolfo A. Leirner Abstract Almost 30 years after the introduction of heart valve prostheses patients worldwide are benefiting from the implant of these devices. Among the various types of heart valves, the ones made of treated bovine pericardium have become a frequently used replacement of the heart's native valve. Lyophilization, also known as freeze-drying, is an extremely useful technique for tissue storage for surgical applications. This article gives a brief overview on the current bovine pericardium lyophilization development, including the chemical modification to improve physical,chemical characteristics and the advanced technologies used to guarantee a high-quality product. It was shown that lyophilization process can be successfully applied as a method of bovine pericardium preservation and also as a technological tool to prepare new materials obtained by chemical modification of native tissues. [source] Preemptive Spacing With Vertical Differentiation When Input Quality is of Inelastic SupplyAUSTRALIAN ECONOMIC PAPERS, Issue 2 2000Mark R. Frascatore This paper examines a model of vertical differentiation in which an incumbent engages in preemptive spacing to prevent entry. Input quality is of fixed supply, and the incumbent prevents high-end entry by producing a product with all the quality available. It also commits to the production of a minimum-quality product to deter low-end entry. There is no entry in equilibrium, and the incumbent monopolist chooses to sell only its high-quality product. Commitment to the production of the minimum-quality product is used merely as a credible threat to vigorously compete should an entrant also produce a minimum-quality product. [source] | |||||||||||||