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 Data-monitoring unit offers process control
The new model of Stratophase’s benchtop data-monitoring unit lets personnel track eight independent SpectroSens probes simultaneously and has a smaller footprint than the previous model did. The new machine includes a built-in touch-screen monitor that eliminates the need for a separate monitor, keyboard, or mouse. Users can implement the benchtop data-monitoring unit as stand-alone process-monitoring and data-analysis system, or network it with other process-control equipment as part of a process-management system. The probes’ optical microchip sensor technology offers measurements that can indicate process status and product quality.
Stratophase’s data-monitoring unit uses a temperature-compensated refractive index as a measurement of concentration, thus providing information that can be used to control a process directly. Personnel can use the data gathered by Stratophase’s system to profile the process and compare real-time data to a historical process model. Deviation from this model can help identify and remedy process failures. The system also is appropriate in process development, process transfer, and scale-up.
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Almac opened its new 240,000-ft2 North American headquarters, built on 40 acres in Souderton, Pennsylvania, north of Philadelphia. The new facility offers integrated clinical packaging, drug-supply management, and technology services to pharmaceutical and biotech clients. The facility has analytical laboratories that complement existing facilities in the UK.
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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.
 http://www.ropack.com/en/service/primary-packaging/stick-pack |
Capsugel, a manufacturer of hard capsules and a provider of drug-delivery systems, acquired the FlexTab technology, a dosage form developed during the past eight years within GlaxoSmithKline (GSK). The technology uses injection-molding processes to produce capsule-shaped dosage forms that offer a new platform for formulating a range of pharmaceutical and consumer health products. The deal between Capsugel and GSK was brokered by SR One, GSK's corporate venture fund.
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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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Catalent Pharma Solutions, a provider of development, technology, and manufacturing services, entered into a license agreement with the development company Pantec for the exclusive worldwide development rights to the Lyopan fast-dissolve technology for healthcare products.
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It’s all about the science that distinguishes Aptuit as the most complete global API provider. It’s about getting the API right the first time, every time and recognizing the critical impact the API has on everything needed to launch breakthrough drug products. Come to Informex Booth 1242 to speak to Aptuit professionals. Visit
 www.aptuit.com to learn more. |
Biopharmaceutical company Cephalon formed an agreement with Alba Therapeutics, also a biopharmaceutical company, to purchase all of the assets relating to larazotide acetate, a tight-junction modulator progressing toward a Phase IIb clinical trial for the treatment of celiac disease. Cephalon will pay Alba a $7-million upfront option payment and will provide a credit facility to fund Alba's Phase IIb clinical trial expenses for larazotide acetate. Cephalon may exercise its option at any time prior to the expiration of a specified period after receipt of the final study report for the Phase IIb clinical trial. If Cephalon exercises its option, the company will purchase Alba's assets for $15 million. Alba could receive additional payments related to regulatory and sales milestones.
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Single-use filling solutions designed to grow with your product. Systems are available for lab through high-speed production. PreVAS is the most complete solution available including bags, tubing, connectors, pumps and filling needles preassembled, presterilized and ready to use. Systems are now available with both peristaltic and rolling diaphragm pumps.
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Elan and Boehringer Ingelheim entered into a development and manufacturing agreement for antibody-based therapeutics. Elan will lead the discovery science, preclinical activities, clinical development, and commercialization of such antibodies. Boehringer Ingelheim will perform the technical development, clinical manufacturing, and all related regulatory filing support services for antibodies discovered by Elan.
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World’s Only No Compromise UHPLC
At 19,000 psi, Shimadzu’s modular Nexera meets all analysis requirements: conventional, ultra-high speed, high resolution, high temperature, green, multidimensional, etc. with no compromise in data integrity. Features include the world’s fastest injection (10-second cycle time), near-zero carryover (0.0015% without rinsing), maximum resolution with the widest pressure/flow range (130MPa up to 3mL/min), and excellent injection reproducibility (0.25% area %RSD).
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Eli Lilly and the Juvenile Diabetes Research Foundation (JDRF) have signed an agreement to fund early-stage research that could enable patients with Type 1 diabetes to regenerate insulin-producing cells destroyed by the disease. The JDRF-Lilly agreement will support a three-year, $1.4-million preclinical research effort.
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Feel the empowerment that comes from knowing that SAFC is ready to meet your contract manufacturing needs with quality products, innovative ideas and superior service. We stand ready to work with you every step of the way, anticipating your needs and offering keen insight. If you missed us at Informex, please visit our website and discover for yourself the SAFC difference.
 www.safcglobal.com |
GlaxoSmithKline announced revised US prescribing information and medication guides for all rosiglitazone-containing medicines (Avandia [rosiglitazone maleate], Avandamet [rosiglitazone maleate and metformin HCl] and Avandaryl [rosiglitazone maleate and glimepiride]) to include additional safety information and restrictions on the use of these medicines. The new label content reflects FDA’s review of cardiovascular event data in Type 2 diabetes patients treated with Avandia, and follows a meeting of the joint Advisory Committees in July 2010 and a decision in September 2010 by FDA to restrict access to these medicines.
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Reports from the Waters Bioanalysis World Tour
At APA and AAPS last year, Waters gathered some of the brightest minds in bioanalysis to discuss the impact and opportunities made available with recent advances in LC/MS technologies. Read reports from these special events written by the Bioanalysis Journal and look for future symposia dates.
 waters.com/biotour |
Optimer Pharmaceuticals formed a drug-development pact with Astellas Pharma Europe for fidaxomicin, an investigational antibiotic for Clostridium difficile infection (CDI), in Europe and certain other countries in the Middle East, Africa and the Commonwealth of Independent States. In return for an exclusive license to fidaxomicin, Astellas will pay Optimer an upfront cash payment of approximately $68 million, additional payments of up to $156 million upon the achievement of certain milestones, and royalty payments on net sales of fidaxomicin.
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Spirax Sarco Presents a Solution for the Prevention of Reverse Flow and Cross Contamination The CVS10 provides a solution to protect any item of equipment from pressure surges associated with hydraulic forces such as waterhammer.
Additional features include: full traceability of wetted materials
throughout the valve, .507psi (35mbar) opening pressure as standard, high kv value with minimal pressure loss, and a choice of surface finish to maintain sterility and reduce risk of microbial growth.
 http://www.spiraxsarco.com/us/about/news-article.asp?news_id=48 |
Nuron Biotech selected the Merck BioManufacturing Network, Merck’s contract manufacturing division, in the UK to manufacture large-scale GMP clinical supplies of NU100 and undertake process validation leading to long-term commercial operations. NU100 is a proprietary recombinant human interferon beta compound being developed for the treatment of multiple sclerosis. Nuron Biotech plans to take NU100 into Phase III clinical trials in 2011.
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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
 www.INTERPHEX.com |
sanofi-aventis and Genzyme have entered into a definitive agreement under which sanofi-aventis is to acquire Genzyme for $74.00 per share in cash, or approximately $20.1 billion. In addition to the cash payment, each Genzyme shareholder will receive one contingent value right (CVR) for each share they own, entitling the holder to receive additional cash payments if specified milestones related to Lemtrada (alemtuzumab) are achieved over time or a milestone related to production volumes in 2011 for Cerezyme and Fabrazyme is achieved. The transaction, which has been unanimously approved by the boards of directors of both companies, is expected to close early in the second quarter of 2011, subject to customary closing conditions.
ScinoPharm, a provider of active pharmaceutical ingredients (API) and contract research and manufacturing (CRAM) services, will provide commercial manufacturing services for the API vilazodone hydrochloride for the pharmaceutical company Clinical Data’s Viibryd. Viibryd is a new drug entity recently approved by FDA for the treatment of adults with major depressive disorder.
Selexis, a biotechnology company specializing in the development and engineering of high-yield and stable mammalian cell lines for therapeutic protein manufacturing, completed a expansion of its laboratories and staff. Selexis’ Swiss-based facilities now total over 13,000 ft2, a 100% increase over the former space. The additional space houses larger laboratory and production functions, including a protein-purification unit for small batches of purified research/preclinical proteins.
The Telstar Group has integrated its offerings in specialist services (engineering, consulting, construction, and maintenance) for the life-sciences market into a single functional division, Telstar Life Science Value Services. Telstar Life Science Value Services is the combined result of the experiences of its SVS, TPRO, Duelectron, and Pharmaster divisions, which have been developed over some fifteen years. These Group companies conduct business primarily in Latin America, Europe, North Africa, India, and China. They provide services in engineering and construction of pharmaceutical and biotechnology plants and laboratories, as well as the services of consulting, validation, regulatory compliance and implementation of logistics management and maintenance systems.
The World Health Organization (WHO) reported it will begin accepting shipments of Crucell’s Quinvaxem pentavalent vaccine from its Shingal, South Korea, manufacturing facility. WHO concluded its investigation of Crucell’s temporary hold on shipments of the vaccine last October after the company suspected sterility problems, and WHO said in a press statement that it is “assured that the problems identified in 2010 have been resolved.” Shipments are expected to resume this month.
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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Aegerion Pharmaceuticals, a biopharmaceutical company, appointed Diane L. Tribble to its executive team as chief scientific officer. Tribble was most recently vice-president of clinical development at Isis Pharmaceuticals.
DPT Laboratories, a contract development and manufacturing organization, named Grant Gilker general manager of operations for the company's center of excellence for semisolids and liquids manufacturing facility in San Antonio, Texas. DPT also named Luis Velez director of development services.
Eli Lilly and Company promoted Sue Mahony from senior vice-president of human resources and diversity to the position of senior vice-president and president of Lilly Oncology. She continues to report to John Lechleiter, Lilly's chairman, president, and CEO. Mahony succeeds John H. Johnson, who resigned last month. Steve Fry, currently vice-president of human resources for two of Lilly's business areas, bio-medicines and emerging markets, was promoted to Mahony's former role. Fry also reports to Lechleiter.
Kendle, a clinical research organization, announced that effective May 1, 2011, senior vice-president and COO Stephen Cutler will become the company's next president and CEO. Chairman and CEO Candace Kendle will continue to serve as chairman. Jamie Macdonald will assume the role of senior vice-president and COO.
David L. Grange will retire as CEO and a member of the board of directors of the contract research organization PPD, effective May 18, 2011. The board started the succession planning process and will initiate a search internally and externally for a successor.
Specialty-biopharmaceutical company Shire appointed two senior research and development executives to its Specialty Pharmaceuticals business. Lawson Macartney was appointed senior vice-president of the emerging business unit, and Mario Saltarelli was named senior vice-president of clinical development and medical affairs.
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The European Medicines Agency (EMA) plans to focus on the implementation of its new pharmacovigilance legislation and the pending falsified drug legislation throughout 2011, according to its work program
announcement
on Feb. 11, 2011. Other planned activities for EMA in 2011 include: communicating and engaging with its stakeholders, including patients; continuing to increase the agency's level of transparency and openness; contributing to international activities and responding to the globalization of pharmaceutical research, development, and manufacturing; responding to public-health needs, including the availability of medicines for the elderly and improving animal health; and fostering the European medicines regulatory network. The work program for 2011 is the first step of the agency’s Road Map to 2015 (see
back story).
FDA Acting Principal Deputy Commissioner John Taylor said the agency plans to use more contractors for foreign plant inspections, according to a Bloomberg report. Taylor said FDA will outsource inspections in an effort to leverage its resources, saying, “We recognize that third-party inspection programs need to be a bigger part of the discussion because we can’t do all the work ourselves.” Taylor made the remarks at a conference in Washington sponsored by consulting firms Venn Strategies and Greenleaf Health, says Bloomberg.
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Tableting Equipment
From which region do you buy the majority of your tablet manufacturing equipment?
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