Culture Development White Papers and Case Studies
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The Case For Integrated Processes
3/28/2007
Based on research and documented case studies, it is clear that companies are realizing significant value by developing integrated processes across the enterprise. This white paper discusses what integrated processes are, how they create value, specific cases of companies succeeding with integrated processes, as well as a checklist to determine how integrated your own company’s processes are. Submitted by SAP Americas
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The Case For Integrated Processes
8/14/2006
Whitepaper: The Case For Integrated Processes
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Filtration Processes Applied In Viral Vector Based Gene Therapy Production
Gene therapy involves the transfer of genetic material into a patient’s cells in order to correct a disease state. The objective is to provide the necessary genetic material to correct a genetic deficiency and allow a particular therapeutic protein to be temporarily or permanently expressed. Candidates for gene therapy are often missing a particular gene or have deficiencies in their genome preventing them from producing fully functional, therapeutic proteins. By 3M Purification Inc
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Filtration Processes Applied In Therapeutic Monoclonal Antibody Production
Monoclonal antibodies were among the first biotechnology produced drugs approved by the FDA and are used to treat specific diseases, as ligands in purification schemes and for use as diagnostic reagents. The primary method of monoclonal antibody production involves using murine systems to produce antibodies to specific (human) antigens. The antigens can be nucleic acid or protein molecules associated with a disease state and the antibodies directed against these antigens are exquisitely specific and identical in structure and function. By 3M Purification Inc
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The Effect Of Cell Culture Method On Long-Term Primary Hepatocyte Cell Health
Hepatotoxicity studies are an important part of the drug discovery process following lead molecule generation.
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Automated Cell Dispensing And Image-Based Spheroid Formation Tracking
Scientists using cell culture for drug discovery, toxicology, stem cell biology, and basic research realize the critical importance of 3-dimensional (3D) models. Data from cells cultured in a non-physiologic, monolayer format on plastic surfaces has long been suspected to differ from true in vivo physiology, and there is mounting evidence that this difference is slowing the pace of scientific discovery. By Brad Larson and Peter Banks, Applications Department, BioTek Instruments, Inc., and Nicky Slawny, 3D Biomatrix, Inc.
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Connection Technology Advances Closed System Processing
The global demand for new biologics and vaccines, combined with the growing emergence of biosimiliars, is challenging drugmakers to re-evaluate their processes and seek ways to make them more flexible, reliable, and cost-effective. By John Boehm, Colder Products Company
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Staying Current In Cold Chain Management
Our aim with this article is to explore the latest revision of Chapter <1079> from the U.S. Pharmacopeial Convention (USP) and to address questions that Vaisala, as a creator of systems used in cold chain applications, receives from customers and contacts who manage temperature-controlled supply chains. By Paul Daniel and Piritta Maunu, Vaisala, Inc.
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Benefits And Risks Of (UV) Ultraviolet Radiation
Soon after the discovery of microorganisms, biologists began to observe that many varieties of these creatures were able to be incapacitated by exposure to sunlight. Following the discovery of the ultraviolet bandwidth in 1801, scientists attributed the sun’s lethal effect to this invisible energy. Facilitated by the findings of a large body of experimental evidence collected in the decades following these initial hypotheses, contemporary scientists have determined that nearly all bacterial activity can be eradicated or at least attenuated by some wavelength of ultraviolet energy.
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Continuous Biomanufacturing: 10 Reasons Sponsors Hesitate
The industry is abuzz with talk about continuous biomanufacturing (CB), and its virtues have been well described. Here we will look at some of the barriers or concerns perceived to limit its value to the industry. Justified or not, quite a few concerns have been expressed regarding the implementation of this new, rather disruptive technology.