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 Agitator helps optimize processes
Chemineer’s (Dayton, OH) Model 20 HT/GT top-entering agitator provides various gear ratios to help optimize customers’ processes and mechanical designs. The Model 20 offers more output-speed options than previous units, thus enabling operators to reduce the power demands for a given process by as much as 25%. The agitator’s tapered roller output bearing design improves the system’s integrity by reducing vibration levels, minimizing rises in temperature, and enhancing the rigidity of the output shaft, which keeps the gearing in contact. The Model 20 device also can operate in an up-pumping or down-pumping mixer configuration. These features, coupled with the agitator’s reverse-rotation capability, enhance process flexibility and control.
The unit’s cast dry well seal eliminates the possibility for oil to contaminate the process fluid and prevents production from being wasted. The agitator is available in a modular right-angle configuration with spiral-bevel gearing and in a parallel-shaft configuration with all helical gearing.
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Agilent Technologies (Santa Clara, CA) and the Wyss Institute for Biologically Inspired Engineering at Harvard University formed a research pact. Under the multiyear agreement, Agilent will provide financial support, tools, and materials to support Wyss's biomaterials evolution, programmable nanomaterials, and biomimetic microsystems platforms.
Catalent Pharma Solutions (Somerset, NJ) expanded its development capabilities for oral controlled-release dosage forms and now offers formulation-development and optimization services in its Winchester, Kentucky facility. The new formulation and process-development area is expected to be open for business in early December. Catalent also plans to launch commercial capabilities in its Schorndorf, Germany, oral controlled-release facility in 2012.
Eden Biodesign (Liverpool, UK), the biopharmaceuticals business of Watson Pharmaceuticals (Corona, CA), signed an agreement with Crucell (Leiden, The Netherlands) to become a preapproved authorized provider of process development and current good manufacturing practice (CGMP) manufacturing services using Crucell’s proprietary PER.C6 cell-line technology. Under the terms of the agreement, Eden Biodesign will be able to offer its services to Crucell’s PER.C6 licensees in the field of vaccines and gene therapy. Crucell is currently in the process of being acquired by Johnson & Johnson (New Brunswick, NJ).
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Management of Water/Cleaning Validation
From inspections of the water used in drug manufacture to cleaning validation, Shimadzu’s TOC analyzers are ideal for the management of the total amount of organic carbon in drug manufacturing processes. Multiple oxidation methods (combustion catalytic and wet chemical) are available, and they can be used with the swab direct combustion method when combined with a solid sample combustion unit.
 Learn more.
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The US Food and Drug Administration approved Eisai’s (Woodcliff Lakes, NJ) anticancer drug Halaven (eribulin mesylate), designed for patients with metastatic breast cancer who have received at least two prior chemotherapy regimens for late-stage disease. Halaven is a synthetic form of a chemotherapeutically active compound derived from the sea sponge Halichondria okadai. This injectable therapy is a microtubule inhibitor, believed to work by inhibiting cancer cell growth, according to an FDA press release.
Eli Lilly (Indianapolis) won its patent case for Alimta (pemetrexed for injection) against Teva Parenteral Medicines (Irvine, CA) in the US District Court for the District of Delaware. Lilly’s patent provides protection for Alimta until July of 2016.
GlaxoSmithKline (GSK, London) and the Oswald Cruz Foundation (Fiocruz) will extend their long-standing collaboration to research and develop medicines to treat tropical diseases. The partnership will enable scientists at Fiocruz and GSK’s Tres Cantos facility in Spain (which is dedicated to diseases of the developing world) to openly share new research and ideas. The agreement will initially focus on Chagas and leishmaniasis because of Fiocruz’s experience in these areas; malaria and tuberculosis will also be studied.
Laureate Pharma (Princeton, NJ), a biopharmaceutical contract development and manufacturing organization, launched a regulatory affairs group and appointed Robert G. Burford as vice-president of regulatory affairs. The group will initially focus on the creation and delivery of electronic Common Technical Document (eCTD) regulatory submissions and will expand to provide a range of regulatory support services, according to a company press release.
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Contract Manufacturing and Packaging for Solid Oral Dosage Ropack, a leader in packaging solutions for the pharmaceutical, biopharmaceutical and nutraceutical industries, now provides the technology and expertise for stickpack packaging of solid oral dosage in a low relative humidity and temperature-controlled environment. Stickpacks – slim, tube-shaped packets the size of a stick of gum – offer impressive benefits: fill accuracy, portability, product differentiation, reduction in paper and foil usage, product differentiation and ideal sample option.
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Novartis (Basel) ended its development program for the investigational cancer treatment ASA404 (vadimezan) after interim results from a Phase III trial showed that the compound would not likely meet the primary endpoint of significantly extending overall survival when used in combination with chemotherapy for the second-line treatment of patients with advanced nonsmall cell lung cancer.The company expects to take a charge of approximately $120 million in the fourth quarter of 2010 in the Novartis Pharmaceuticals division.
Pfizer (New York) established its Global Centers for Therapeutic Innovation, a network of partnerships with academic medical centers focused on research and development by translational researchers. Pfizer will create sites with each of its partners and provide access to its proprietary antibody libraries and research tools. The company will also offer equitable intellectual property and ownership rights as well as milestone payments and royalties on developed products. The University of California, San Francisco, is the first collaboration in the program.
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Roche (Basel) detailed a restructuring program that the company had announced in September 2010. The company plans to reduce its workforce by 4800 positions, or 6% of its current workforce, during the next two years. The largest reductions are planned in sales and marketing (2650 positions affected) and in manufacturing (1350 positions affected). Roche said it intends to sell its sites in Florence, South Carolina, and Boulder, Colorado, and will reorganize some technical operations at sites in California, Mannheim, Germany, and various other sites. The company will discontinue its RNA interference research programs in Kulmbach, Germany, Nutley, New Jersey, and Madison, Wisconsin, outsource certain functions, and plans to close its Graz, Austria, and Burgdorf, Switzerland, sites. Restructuring costs will be $2.7 billion from 2010 through 2012, and Roche expects an annual cost savings of $1.8 billion in 2011 and $2.4 billion from 2012 onward. More details of the restructuring can be found in the company’s press release.
Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to ptpress@advanstar.com |
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Althea Technologies (San Diego), a provider of contract development and manufacturing services, appointed Rick Hancock president of the company. Hancock was Althea's COO from 1998 to 2007.
AmerisourceBergen (Valley Forge, PA), a service provider, named Steven H. Collis president and COO. Collis previously was executive vice-president of AmerisourceBergen and president of AmerisourceBergen Drug Corporation (ABDC), its largest subsidiary. He continues to report directly to R. David Yost, AmerisourceBergen’s CEO.
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Thousands of pharmaceutical, biologic, generic, and contract services professionals gather annually at INTERPHEX (March 29-31, 2011, Javits Convention Center, New York City) to see new products, network, and learn about emerging trends surrounding drug manufacturing. At INTERPHEX 2011, you’ll find the solutions and education you need to ensure quality, improve efficiency, and solve your manufacturing and supply chain problems. Register for a free exhibit hall pass at
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Mark Lewis was promoted to president of BIOQUAL (Rockville, MD), a contract research organization. John Landon will remain as CEO and chair of the board.
BioReliance (Rockville, MD) named Marilyn J. Aardema chief scientific officer of toxicology. She will report to the president and CEO, Charles C. Harwood, Jr.
Lawrence S. Olanoff, president and COO of Forest Laboratories (New York), a pharmaceutical company, will retire on Dec. 31, 2010. Olanoff will remain a director of the company and will become senior scientific advisor. The company’s chair and CEO, Howard Solomon, will become president upon Olanoff’s retirement. Kevin Walsh, vice-president of information systems and manufacturing operations, was promoted to senior vice-president and director of operations. Other senior appointments can be read in the company’s press release.
Sigma-Aldrich’s (St. Louis) chair, president, and CEO, Jai P. Nagarkatti, died suddenly of an apparent heart attack on Saturday, Nov. 13, 2010. Nagarkatti spent his entire career with the company beginning in 1976, with his positions spanning research and development, manufacturing, operations, sales, and marketing. The company’s succession plan named Rakesh Sachdev president and CEO. Sachdev most recently served as chief financial officer, chief administrative officer, and senior vice-president of the international business. The board of directors elected Barrett Toan chair as of Nov. 14, 2010.
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Regulation of Excipients
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