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 Analytical system incorporates two close-coupled modules
Hiden Analytical’s (Warrington, UK) CATLAB system combines a microreactor and mass spectrometer with fully integrated control software. The two close-coupled modules are designed to offer continuous real-time analysis of catalytic activity. The system also evaluates various reaction components simultaneously and provides overall response times of less than 0.5 s, according to the company.
The system’s fully preprogrammable and automated analysis cycles enable users to control ramp rates, temperature range, temperature dwell periods, gas flows, pulse switching, and the mass spectrometer. More than 4000 processes can be completed in one cycle. The reactor incorporates a bypass channel so that gas flow may be set up and mixtures prepared independently of the protected sample environment.
Operators can detach the CATLAB system’s mass spectrometer easily for use offline. The high-sensitivity quadrupole mass spectrometer has a detection limit of 0.1 to 1 ppm, subject to spectral interference, and takes as many as 1000 measurements/s. |
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Aurobindo Pharma (Hyderabad, India) entered into a licensing and supply agreement with AstraZeneca (London) to supply several solid dosage and sterile products for emerging markets. The products include the therapeutic segments of anti-infectives, cardiovascular system, and central nervous system. Financial terms were not disclosed.
Boehringer Ingelheim (Ingelheim, Germany) opened its new Center of Competence (CoC) in Shanghai. The EUR 10 million CoC will focus on optimizing active pharmaceutical ingredients and chemical intermediates procured in China. The Center is part of the company’s EUR 100-million ($127.5-million) expansion project in China.
Eli Lilly and Company (Indianapolis) announced that the US Court of Appeals for the Federal Circuit has affirmed a prior ruling by the US District Court for the Southern District of Indiana that the company's method-of-use patents for its osteoporosis drug Evista (raloxifene HCl tablets) are valid. These patents provide protection for Evista in the U.S. through March of 2014.
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Nabi Biopharmaceuticals (Rockville, MD) entered into a five-year commercial manufacturing agreement with Diosynth RTP (Research Triangle Park) for the manufacture of a drug substance integral to the production of Nabi’s investigational vaccine NicVAX, designed for the treatment of nicotine addiction and prevention of smoking relapse. Diosynth will produce the drug substance for NicVax, combine it with an adjuvant, and fill it in syringes.
NextPharma (Surrey, UK), a European services provider, added microbiology testing services to its offerings at its site in Göttingen, Germany by expanding the facility. The expansion of the microbiology department includes the addition of three laboratories equipped with modern air ventilation, laminar-flow benches, and temperature-controlled incubators linked to a computerized monitoring system that regulates temperature.
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Orexigen Therapeutics (San Diego) and Takeda Pharmaceutical (Osaka, Japan) entered into a partnership to develop and commercialize Contrave (naltrexone SR/bupropion SR), Orexigen’s investigational obesity drug, in the US, Canada, and Mexico. Orexigen will receive an upfront payment of $50 million, and Takeda will obtain an exclusive marketing right in the US, Mexico, and Canada while Orexigen retains the right to copromote with Takeda in the US. Orexigen is eligible to receive more than $1 billion in milestone payments and royalties on sales.
Pfizer (New York) will acquire the pharmaceutical company FoldRx Pharmaceuticals (Cambridge, MA), adding to Pfizer’s orphan and rare diseases program within its specialty care business. FoldRx's portfolio includes clinical and preclinical programs for investigational compounds to treat diseases caused by protein misfolding, which is increasingly recognized as an underlying cause in many chronic degenerative diseases, according to a company press relase.
RecipharmCobra Biologics (Keele, UK), a biopharmaceutical manufacturer, was granted European and United States patents for its antibiotic resistance gene-free plasmid maintenance technology, called oriSELECT, which is designed to improve biomanufacturing yields.
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Roche (Basel) and biopharmaceutical company reMYND (Leuven, Belgium) entered into an agreement to develop therapeutics that could slow down neurodegeneration in Parkinson’s and Alzheimer’s patients by inhibiting α-synuclein and tau toxicity. Roche will be responsible for all clinical development and worldwide commercialization. reMYND could receive more than half a billion euros in milestone payments, other payments, and royalties.
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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BioStorage Technologies (Indianapolis), a company focused on temperature-controlled biomaterial storage, cold-chain logistics, and sample management, appointed Russ Hager global director of supply chain. Hager previously held positions at Abbott Laboratories (Abbott Park, IL).
Cubist Pharmaceuticals (Lexington, MA) promoted Steven C. Gilman as its executive vice-president of research and development and chief scientific officer. Gilman joined Cubist in 2008 as senior vice-president of discovery and nonclinical development and chief scientific officer.
NeoStem (New York), a biopharmaceutical company with operations in the US and China, appointed Ian Zhang president and managing director of NeoStem China. Zhang is the former head of Asia-Pacific integration at Life Technologies (Carlsbad, CA).
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Hyaluron
AMRI Receives Pfizer Route Design Innovation Award AMRI was selected as the inaugural winner of the Pfizer Route Design Innovation Award, beating out 40 companies who were invited to share innovative ideas for process chemistry and large API production.
"This award stands as testament to the technical expertise and entrepreneurial spirit of our scientific team, and our ability to generate intellectual property as a value-added service to our customers."
-- Dr. Thomas E. D'Ambra, AMRI Chairman, President and CEO Learn more about AMRI and the Pfizer API Route Improvement and Innovation Challenge.
 Learn more about AMRI and the Pfizer API Route Improvement and Innovation Challenge. |
Pevion Biotech (Berne, Switzerland), a vaccine company, appointed Evert Kueppers as its CEO. Kueppers succeeds Thomas Stauffer.
The board of directors of Pierre Fabre (Castres, France) appointed Olivier Bohuon as the company's CEO. Bohuon previously served as executive vice-president of Abbott (Abbott Park, IL) and president of its pharmaceutics division.
Protalix BioTherapeutics (Carmiel, Israel), a biopharmaceutical company, appointed Tzvi Palash as its COO. Palash will be responsible for overseeing the company's manufacturing activities and implementing the expansion phase of the company's facility as it transitions from a research-and-development organization to a biotechnology company. |
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The International Conference on Harmonization's Implementation Working Group (IWG) for the quality guidelines, Q8 Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System, is holding a series of training workshops. The US workshop is being held in Bethesda, Maryland, Oct. 6–8, 2010. The International Society for Pharmaceutical Engineering (ISPE) and Parenteral Drug Association (PDA) are sponsoring the workshop, which is meant to help industry understand how the quality trio can benefit pharmaceutical development, manufacturing, regulatory assessment, scale up to commercial operations, and GMP inspection. Regulators from various countries and regions will be presenting at the meeting. Four breakout discussions will address design space, control strategy, the pharmaceutical quality system, and quality risk management. Feedback from workshop participants will help IWG with harmonization efforts. |
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| Going Digital |
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Erik Greb
Software and online monitoring are helping the pharmaceutical industry improve its corrective and preventive action programs. This article contains bonus online material.
Coming Soon: A special report focuses on vaccine production and formulation in Pharmaceutical Technology’s October issue. |
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Recall News
Question: How do you normally hear about recalls of pharmaceutical products?
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