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 Cone mill increases throughput
L.B. Bohle’s BTS high-speed cone mill has a new impeller design intended to help manufacturers increase throughput by more than 50% on low-density materials, compared with traditional mills. Standard impeller designs consist of a straight bar that relies mostly on its own centrifugal force and the static pressure of the material above. Bohle’s impeller consists of two flat bars curved into the direction of rotation. The curved impeller pushes material into the screen, and this forced movement helps to increase the rate at which the material moves through the screen, says Martin Hack, the company’s vice-president and general manager.
Bohle provides a simple tool to allow users to remove the mill’s screen and impeller. The entire mill head also can be removed and cleaned in an autoclave. The mill is delivered with a mobile, height-adjustable cart that allows the machine to be docked easily with containers of various sizes.
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The contract and development manufacturing organization (CDMO) AAIPharma Services has relocated its compendial raw materials testing group to a new laboratory space located within the company’s Wilmington, NC, headquarters facility. The new laboratory will tie together the compendial raw-material testing laboratory and its supporting business group under one roof. The new location aims to increase turnaround times for raw materials testing; a standard 10-day turnaround will be offered for most compendial raw materials.
ATMI, a provider of single-use components, formed a distribution pact with Finesse, a manufacturer of measurement and control systems. The deal gives ATMI the right to sell Finesse T700 control systems with the ATMI single-use Integrity PadReactor system. The combined turnkey system will provide the single-use market with a ready-to-use bioreactor platform.
BASF has outlined an integration plan following the acquisition of specialty chemical company and excipient producer Cognis. The company expects to generate synergies of EUR 275 million ($391 million) of additional EBIT (earnings before interest and taxes) and have one-time integration costs of EUR 290 million ($413 million). BASF plans to maintain 26 of the 28 Cognis production sites. The Hythe, UK, site will be sold. For the site in Tromsoe, Norway, future strategic options will be evaluated. Of Cognis’ 37 nonproduction sites, 26 will be consolidated with existing BASF sites or exited, nine will remain, and two are still under review. To achieve the growth targets, 230 additional jobs will be created worldwide, mainly in the Care Chemicals division. At the same time, BASF plans to reduce 680 positions due to overlaps in functional and administrative units as well as measures to improve efficiency. This means an overall reduction of 450 positions in the BASF Group, most of which will be realized by the end of 2012. The employees will be offered a suitable position within BASF whenever possible.
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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.
 http://www.ropack.com/en/service/primary-packaging/stick-pack
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Bayer HealthCare will consolidate its East Coast business at a consolidated site in New Jersey, according to an Apr. 4, 2011, press release issued by New Jersey Governor Chris Christie’s office. Bayer, which now has facilities in Wayne and Montville in New Jersey, said several sites near the company’s current locations are under consideration. The move will keep 1000 jobs in New Jersey and add up to 500 more, according to the release. A final decision on the site is expected to be made within the next few months. First moves are expected to occur in late 2011/early 2012 and proceed through the end of 2013. About 300 of the additional 500 jobs will be relocations from other Bayer sites with the other 200 expected to be created.
The biopharmaeutical company Biota Scientific Management received a $231 million contract from US government to produce laninamivir. The contract is designed to provide US-based manufacturing and clinical data to support
a new drug application for laninamivir to the US Food and Drug Administration.
Daiichi Sankyo began operations of vaccine joint venture, Kitasato Daiichi Sankyo, whose principle business will be manufacturing and marketing biological products for humans and animals and research and development (R&D) of vaccines with
Kitasato University, other domestic and overseas universities, and research institutes.
Dainippon Sumitomo Pharma has formed a drug-development pact with the biopharmaceutical company Intercept Pharmaceutical for the development and commercialization of Intercept’s FXR agonist obeticholic acid (OCA). DSP will advance OCA in Japan and China for the treatment of chronic liver diseases, with an initial focus on primary biliary cirrhosis and nonalcoholic steatohepatitis.
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Pharmaceutical starches from Grain Processing Corporation (GPC) range from basic unmodified starches for tableting to very specialized, innovative starches for unique applications. Spress® Pregelatinized Corn Starches NF perform as binders, disintegrants and lubricants for granulations, direct-compression tablets, capsules, dry blends and roller compaction. PURE-COTE® film-forming starches are designed for coating applications, oral thin films, capsules and any applications where clear, flexible films are required.
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Eagan Analytical Services, a contract analytical services company, acquired contract analytical service company Chemir and affiliates CAS-MI Laboratories and Cyanta Analytical Services. Chemir and CAS-MI will continue to operate under their current names, and Cyanta will begin the process to be renamed EAG Life Sciences to reflect its planned expansion of service offerings. All three laboratories will continue operations at their respective facilities.
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Fujifilm Diosynth Biotechnologies, the former Merck Biomanufacturing Network, began operations under its new name following the completion of the acquisition of the Merck Biomanufacturing Network by Fujifilm. Fujifilm Diosynth Biotechnologies will provide contract biologics development and manufacturing services.
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The latest in news and information from Bosch Packaging Technology At our new Blog  http://boschpackagingpharmana.wordpress.com/
Currently on the blog 150 years of Packaging History, single-use
dosing technology updates, and a capsule filling system comparison.
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The biopharmaceutical company Gilead Sciences and Yale University signed a R&D pact that will initially span four years with an option to renew for up to 10 years. Gilead will provide $40 million in research support and basic science infrastructure development during the initial four-year period and will provide a total of up to $100 million over 10 years should the collaboration be extended through that timeframe. Gilead will have the first option to license Yale inventions that result from the collaboration.
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Johnson & Johnson recalled one additional lot of Tylenol 8-Hour Extended Release Caplets 150 count bottles distributed in the United States due to moldy smell. The uncharacteristic odor is thought to be caused by the presence of trace amounts of chemicals, 2,4,6-tribromoanisole and 2,4,6-trichloroanisole.
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The contract manufacturing organization (CMO) Lonza will invest £16 million ($23 million) to further develop the flexibility and capability of its Slough, UK, biopharmaceutical manufacturing facility to respond to a broader range of customer projects and strengthen its global network of biologics development and manufacturing.
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Management of Water/Cleaning Validation
Shimadzu’s new TOC-L Series analyzers are ideal for the management of the total amount of organic carbon in pharmaceutical manufacturing processes. They feature the patented catalytic combustion oxidation method, fully automated sample pretreatment, and a wide measurement range, and when combined with a solid sample combustion unit, the carbon in attached residues can be measured for cleaning validation. Learn more
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Merck KGaA formed a strategic and corporate initiative, Merck Serono Israel Bioincubator Fund, which targets Israeli biotechnology start-ups. The incubator program is designed to accelerate the development of entrepreneurial start-up companies and will offer both seed financing and the opportunity of using a dedicated part of Merck Serono’s Israeli research and development center, Interlab, for their own research. Over a seven-year time span, Merck Serono will invest a total of €10 million (about $14 million).
Merck & Co. has agreed to acquire specialty pharmaceutical company Inspire Pharmaceutical. Under the terms of the agreement, Merck, through a subsidiary, will commence a tender offer for all outstanding common stock of Inspire at a price of $5.00 per share in cash, a 26% premium to the closing price of Inspire's common stock on April 4, 2011. The transaction has a total cash value of approximately $430 million.
CMO Suven Life Sciences received FDA approval as part of the renewal inspection process for its API (active pharmaceutical ingredient) manufacturing facility in Hyderabad, India.
The specialty pharmaceutical company Valeant Pharmaceuticals made a $5.7 billion bid for the biopharmaceutical company Cephalon. Valeant plans to propose a slate of directors to replace Cephalon's board with its own nominees.
Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to [email protected] |
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The CDMO AAIPharma has promoted Dean Shirazi, PhD, to vice-president, analytical development.
The CMO AMRI named Peter J. Hansbury vice-president of aseptic services. In this role, he will assume leadership for AMRI's aseptic fill-finish facility located in Burlington, Massachusetts.
Daiichi Sankyo Inc., the US operations of the Japan-based Daiichi Sankyo, has hired John Gargiulo as the new president and chief executive officer.
The biopharmaceutical company Generex Biotechnology made several management changes and has appointed John Barratt, chairman of the company's board of directors. The company has also named Mark Fletcher as president and CEO. In addition, the board has appointed David Brusegard, PhD, as chief operating officer and current vice-president of finance, Stephen Fellows, as acting chief financial officer of Generex to complete its new management team. Gerald Bernstein, MD, will continue as the company's vice-president for medical affairs.
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A new web search feature on FDA.gov allows consumers to search for product recalls more quickly and easily than in the past. The new feature falls under the January 2011 FDA Food Safety Modernization Act.
FDA Commissioner Margaret Hamburg delivered the opening remarks at the Food and Drug Law Institute's 54th Annual Conference on April 5, 2011, in Washington, DC. The agenda includes a report from the Government Accountabilty Office, sessions on technology, drugs, regulation, and more.
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| Scrutinizing the Subvisible |
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Regulators question whether particles that they can't see hurt patients.
Coming Soon: Be sure to check out PharmTech.com for our latest special issue on solid dosage and excipients, featuring articles from industry and
standard-setting organizations
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QbD and CMC
Do you think that quality by design has become or is becoming an important element in the CMC requirements between a contract manufacturing organization and sponsor company?
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