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 Instrument analyzes particle size and shape
The ANALYSETTE 22 NanoTec instrument from FRITSCH (Idar-Oberstein, Germany) automatically analyzes particle-size distribution and particle shape. Scientists can move the instrument’s measuring cell easily between the Fourier lens and the detector to achieve high resolution. The instrument analyzes coarse materials best when the measuring cell is far from the detector.
The instrument provides high-resolution images of small particles when the measuring cell is close to the detector. Through a small opening at the center of the detector, a second laser beam irradiates the sample from behind, and backward-scattered light can be captured with full resolution. The moveable measuring cell contributes to the instrument’s measuring range of 0.01 to 2000 μm.
The instrument performs wet and dry measurements and cleans its measurement circuit automatically. In addition, the analyzer switches between dispersion units automatically. The vertically positioned optical system gives the product a small footprint. |
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AMRI Burlington (Burlington, MA), formerly Hyaluron and now a subsidiary of AMRI, received a Warning Letter from the US Food and Drug Administration for violations of good manufacturing practices. Among the violations listed in the letter are: failure to thoroughly investigate batch failures, including the presence of particulate contaminants in products, and a lack of procedures to avoid microbiological contamination of sterile products. AMRI acquired Hyaluron in June 2010, and the business now operates as AMRI Burlington.
CMC Biologics (Copenhagen), a contract manufacturing organization, completed a new disposable manufacturing facility at its Seattle, Washington, site. The multipurpose, single-use facility will allow for early-phase clinical manufacture of a range of biopharmaceuticals, including monoclonal antibodies and other mammalian cell culture-based recombinant proteins. The facility contains a 100 L and two 500 L single-use bioreactors and disposable mixers.
Catalent Pharma Solutions (Somerset, NJ), a provider of solutions for the global pharmaceutical industry, worked with BioAlliance Pharma (Paris) on the development, approval, and launch of miconazole 50 mg buccal tablets for the local treatment of oropharyngeal candidiasis. The product, which has been on the market in Europe since 2007 under the name Loramyc, was approved in April 2010 by FDA and has been launched in the US under the trade name Oravig by Strativa Pharmaceuticals, a division of Par Pharmaceuticals (Woodcliff Lake, NJ).
In a separate announcement, Catalent said it entered into a clinical-supply-services agreement to support Sunesis’ (South San Francisco, CA) Phase III VALOR trial of vosaroxin, a drug to treat cancer, in first relapse or primary refractory acute myeloid leukemia (AML). Catalent will provide services in labeling and kitting of the clinical-trial materials to be used in the trial and will provide supply-chain support to clinical sites. The clinical packaging and logistics will be handled in Catalent’s Philadelphia, Pennsylvania, and Schorndorf, Germany, facilities.
IBA (Ion Beam Applications, Louvain-la-Neuve, Belgium) entered into an agreement with Bayer Schering Pharma (Berlin) for chemical-process development and clinical-trial doses supply of Florbetaben, a molecular-imaging compound in development for the detection of Alzheimer’s disease pathology. Under the terms of the agreement, IBA will manufacture and supply Bayer with doses of the compound Florbetaben for clinical trials. Under the terms of the agreement, IBA will receive several million euros of milestone payments and fees depending on the amount of required doses for the clinical trials.
Lonza (Basel) acquired Vivante GMP Solutions (Houston, TX), a custom manufacturing organization focused on viral-based therapeutics. As a result, Vivante’s employees have joined Lonza and will operate as Lonza’s Viral-based Therapeutics Business.
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Meda (Solna, Sweden), a specialty pharmaceutical company, agreed to acquire Alaven (Marietta, GA), also a specialty pharmaceutical company. Closing of the transaction is subject to regulatory approval, and the companies expect the acquisition to be completed by early October.
Novartis (Basel) completed its purchase of the eye-care company Alcon’s stock from Nestlé, resulting in 77% ownership of Alcon. Novartis completed the acquisition of the remaining 52% of Alcon shares owned by Nestlé for a total of $28.3 billion.
Ricerca Biosciences (Concord, OH), a contract research organization, completed the purification of an active pharmaceutical ingredient (API) under current good manufacturing practices (CGMP) controls. The process involved chiral separation of a single API from three chiral isomers. More than 800 g of material was processed to produce 525 g of the desired isomer with > 99.7% chiral purity and > 99% achiral purity. With the current configuration of the Prep HPLC system, Ricerca can process up to 1–2 kg of material under CGMP controls, and the system is expandable to 6–8 kg capacity. It includes an automated fraction collection system to assist in the purification process.
Stirling Pharma (Sydney, Australia) is on schedule to open its manufacturing plant in Cape Breton, Canada, in September. The plant will manufacture acetaminophen.
Xcelience (Tampa, FL), a contract research organization, and IriSys (San Diego), a contract services organization, entered into a business alliance agreement to advance the ability to streamline access to CMC and regulatory services for North American pharmaceutical and biotechnology companies.
Xcellerex (Marlborough, MA) will provide XDR GMP single-use production bioreactors to Project GreenVax’s new facility currently under construction in Bryan, Texas. Project GreenVax is spearheaded by the Texas Plant-Expressed Vaccine Consortium, which consists of G-Con (College Station, TX) and The Texas A&M University System. Financial terms were not disclosed.
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In a separate announcement, Xcellerex said it signed a memorandum of understanding with SK Chemicals (Seoul, South Korea), a manufacturer of synthetic drugs, natural products, vaccine/blood preparations, and drug-delivery systems, for an alliance to develop and commercialize SK-developed vaccines with Xcellerex’s FlexFactory biomanufacturing platform. The companies expect to define specific terms of the alliance in the coming months.
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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Bionor Pharma (Oslo) appointed Henrik Lund as its CEO. Lund, who previously worked at AstraZeneca (London), took over the position from Trond Syvertsen.
Pharmaceutical company Celgene (Summit, NJ) appointed Jacqualyn A. Fouse senior vice-president and CFO, effective Sept. 27, 2010. Fouse will report to Robert J. Hugin, CEO of Celgene.
Frank Baldino, Jr., chairman and CEO of Cephalon (Frazer, PA), a biopharmaceutical company, took a temporary medical leave of absence. During Baldino's absence, J. Kevin Buchi, the company's COO, will assume Baldino's responsibilities. Before assuming the newly created role of COO earlier this year, Buchi served as the company's CFO for 14 years.
PPD (Wilmington, NC), a contract research organization, named Neil McCullough vice-president of quality-management systems. McCullough previously worked at Pfizer (New York).
Verenium (Cambridge, MA), a biotechnology company, appointed Kevin Bracken vice-president of manufacturing. Bracken will report to Janet Roemer, president and COO of Verenium's enzymes business.
XenoPort (Santa Clara, CA), a biopharmaceutical company, announced that President William J. Rieflin has been elected to the XenoPort board of directors, effective Sept. 17, 2010, and will resign as president of XenoPort to accept a position as CEO of a private biotechnology company. He will continue to serve as a consultant to XenoPort during a transition period.
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The FDA Transparency Blog now hosts a section about the agency’s advisory committees. The blog is part of the US Food and Drug Administration’s efforts to provide information about how the agency works to industry and the general public. The new section appears on the blog and on the FDA Basics web page and offers a Q&A about what advisory committees are, how members are selected, and how the committees contribute to larger FDA's decisions about drugs.
FDA will hold two public meetings taking place this September. The first meeting, taking place Sept. 17, in Rockville, Maryland, is meant to solicit stakeholder input on the development of a generic-drug user-fee program. According to the FDA announcement, “a user fee program could provide necessary supplemental funding, in addition to current Congressional appropriations, to allow for the timely review of such applications. Although the President’s Fiscal Year (FY) 2011 budget includes generic drug user fees, new legislation would be required for FDA to establish and collect user fees under such a program.”
The second hearing, taking place Sept. 27 and 28, in Silver Spring, Maryland, will address a new framework for the development and distribution of patient medication information for prescription products. The agency says that the current system of providing information to patients, which may include duplicates or be difficult to understand, needs to be revised. The agency is seeking input about the use of a single standardized document to include drug-product information.
Per its June 2010 guidance for industry on bioequivalence recommendations, FDA has updated its listing of individual product bioequivalence recommendations regarding active pharmaceutical ingredients. The updates include 26 new recommendations and 10 revised recommendations.
The agency also updated its adverse-event reporting system (AERS) database to include information from the second quarter of 2010 (i.e., from April to June). The database lists the names of products, potential signals of serious risks, and new safety information that was identified for the products during the review period. FDA posted the information as part of the 2007 Food and Drug Administration Amendments Act of 2007.
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Recall News
Question: How do you normally hear about recalls of pharmaceutical products?
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