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Final Word: The Economic Impact of the Supreme Court Decision in Merck v. IntegraOn June 13, 2005, in Merck KgaA v. Integra Lifesciences I, Ltd., the US Supreme Court ruled unanimously that the exemption to patent infringement outlined in Title 35, Section 271(e)(1) of the US Code extends to all uses of patented inventions reasonably related to the development and submission of any information under the Food, Drug, and Cosmetic Act, including preclinical studies. In practice, this means that the exemption will allow companies to use other firms' patented compounds for experimentation on drugs that are not ultimately the subject of a submission to the Food and Drug Administration.
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Risk-Based Cleaning Validation in Biopharmaceutical API ManufacturingValidation of a cleaning process demonstrates that it can reliably and effectively remove residue to an acceptable level.
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Production of Recombinant Therapeutic Proteins in the Milk of Transgenic AnimalsCapital investments in production plants represent a significant portion of the cost of new recombinant drugs
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Form Fluidly Follows FunctionIn the fast-changing pharmaceutical industry, adaptable planning provides a competitive edge.
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Protecting Patents for Personalized MedicineThere are several challenges associated with protecting patents for personalized medicines.
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Boosting Mammalian Cell-line Manufacturing Pilot Plant—A Case ReportCell-line and process development expertise, along with disposable systems, assist in implementing strategies for fast expression enhancements.
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Knowledge Management Strategies for Biologics Research$200 million and two years could be shaved off a drug's development time by using informatics effectively.
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Chromatographic Purification of MAbs with Non-Affinity SupportsAn anionic column with modified chitosan bead matrix performs well in purifying cell culture. A pair of cationic-exchange columns shows promise in purifying S25 antibody.
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Violet Diode-Assisted Photoporation and Transfection of CellsVarious methods for transfecting molecules such as DNA, RNA, proteins, or drugs with high efficiency and low toxicity have been implemented and optimized for many different cell types. These include widely used techniques such as chemical transfection (lipid-based techniques), the use of viral vectors and electroporation.
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Conducting the Audit - Ready or Not, Here They ComeWhen an FDA inspection is imminent, it pays to have a plan. Start by getting your paper in order and your facility in a state of good repair. Train a team to manage interaction with inspectors. Coach your employees on how to answer questions. And don?t forget to take notes.
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Boosting Mammalian Cell-line Manufacturing Pilot Plant—A Case ReportCell-line and process development expertise, along with disposable systems, assist in implementing strategies for fast expression enhancements.
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Next Generation Peptide Mapping with Ultra Performance Liquid ChromatographyUltra performance liquid chromatography (UPLC) is a new category of liquid chromatography that researchers are using to increase resolution, speed, and sensitivity in a variety of applications. These benefits result from packing columns with 1.7 ?m particles and using instruments that are optimized for such columns.
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Next Generation Peptide Mapping with Ultra Performance Liquid ChromatographyUltra performance liquid chromatography (UPLC) is a new category of liquid chromatography that researchers are using to increase resolution, speed, and sensitivity in a variety of applications. These benefits result from packing columns with 1.7 ?m particles and using instruments that are optimized for such columns.
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Designing a Shorter Vertical Leg for Sanitary Steam TrapsSteam traps are part of a steam-in-place system. The current design allots 18 in. of vertical leg for condensate backup. A design with a sensitive bellows has been proven in laboratory tests to need only 6 in. of vertical leg during the 15 min. of 121?C sterilization. Loads of 1 to 27 lb/h are covered by the capability of the new trap, equivalent to required steam for vessels 20 to 40,000 L.
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Maximizing Protein Expression in Filamentous FungiOne of the major challenges in fungal biotechnology is preventing proteases of the fungi from degrading recombinant proteins.
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Form Fluidly Follows FunctionIn the fast-changing pharmaceutical industry, adaptable planning provides a competitive edge.
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Validating RNA Quantity and Quality: Analysis of RNA Yield, Integrity, and PuritySeveral methods are available to assess RNA integrity and purity, which may affect downstream applications.
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Building Automation Systems in a PAT FrameworkA well-understood, validated, and correctly maintained BAS reduces the chance of a critical room parameter slipping out of specification.
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Fermentation & Cell Culture: University StyleUse of a fermentor for cell culture study advances research in directions previously thought unimaginable.
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Asset Management for Growing Biotech CompaniesThe challenge is to determine the optimal frequency for preventive maintenance and the optimal frequency and tolerances for calibration readings.
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A Statistical Method to Account for Plate-to-Plate Variability in Multiple-Plate Bioassaysby James D. Williams, Virginia Polytechnic Institute and State University, Jeffrey B. Birch, and Steven Walfish Statistics don't lie, but if you don't include appropriate data, the resulting statistical analyses can be misleading. In biopharmaceutical development, if the variability from several different microplates is not addressed, assays testing the relative potency against a standard can be inaccurate. A statistical method that accounts for plate-to-plate heterogeneity is needed ? and presented here.
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Building Automation Systems in a PAT FrameworkA well-understood, validated, and correctly maintained BAS reduces the chance of a critical room parameter slipping out of specification.
Latest:
Designing a Shorter Vertical Leg for Sanitary Steam TrapsSteam traps are part of a steam-in-place system. The current design allots 18 in. of vertical leg for condensate backup. A design with a sensitive bellows has been proven in laboratory tests to need only 6 in. of vertical leg during the 15 min. of 121?C sterilization. Loads of 1 to 27 lb/h are covered by the capability of the new trap, equivalent to required steam for vessels 20 to 40,000 L.
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Strengthening the Chain: Addressing Pedigree Challenges Across Outsourced OperationsDespite the current regulatory uncertainty, pharmaceutical companies should move forward with planning for serialization and pedigree.
