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Advertisement:
analytica, March 23 – 26, 2010 in Munich, Germany
The world’s leading trade fair for Laboratory Technology, Analysis and Biotechnology. More than 1,000 exhibitors and 33,000 trade visitors attended analytica 2008. The 2010 show promises to be the most international analytica to date - there has been a 13% increase in international exhibitors so far. More information at
 www.analytica.de/en
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 Robot performs isolated filling
The Stericlean robot from Stäubli (Duncan, SC) is designed for use in barrier–isolator systems. The robot’s special surface coating and seals enable it to withstand cleaning with vapor-phase hydrogen peroxide. During cleaning, the robot arm can methodically move through its full range of motion, thus allowing for all surfaces to be decontaminated.This cleanability and adaptation for use in an isolator helps protect personnel and sensitive products.
The technology does not include restrictive enclosures and, thus, does not raise concerns related to glove ports and heavy mechanical arms. In addition, the Stericlean robot does not require human intervention in the process.
Stäubli’s new device simulates human motion and helps companies meet their productivity goals. The robot can fill syringes at a high-speed rate of 800 syringes/min. The unit also can be adapted for other production needs such as cell culturing.
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The US Food and Drug Administration evaluated Amgen’s (Thousand Oaks, CA) Complete Response submission for Prolia (denosumab) for treating postmenopausal osteoporosis, and classified it as a Class 2 resubmission. FDA set a Prescription Drug User Fee Act action date of July 25, 2010.
Avantium Pharma (Amsterdam), Beckloff Associates (Overland Park, KS), Cambridge Major Laboratories (Germantown, WI), and Xcelience (Tampa, FL) will hold a symposium, “Chemistry Playbook: Proven Modular, Expedited CMC Solutions from Carbon to Commercialization,” on Thursday Mar. 4, 2010, from 2:00-7:00 PM, in Waltham, Massachusetts. Beckloff Associates will provide insight on regulatory oversight, and Cambridge Major Laboratories will provide expertise on active pharmaceutical ingredient manufacturing. Avantium will offer analysis of solid-state characterization, and Xcelience will offer expertise on formulation development. Details for registering for the symposium may be found here.
Advertisement:
TOC Wet Chemical Analyzer Ensures Ultra-pure Water
Utilizing the exclusive Heated-UV-Persulfate oxidation method to provide rapid, efficient breakdown of hard-to-oxidize compounds, Shimadzu’s TOC-VW ensures ultra-pure water for pharmaceutical applications. Reduce analysis time with such features as random-access autosampler control and a high-sensitivity NDIR detector that eliminates false peaks. In addition, reduce the cost of ownership with low-cost consumables.
 Learn more. |
Merck & Co. (Whitehouse Station, NJ) announced it would eliminate about 15,000 jobs out of its 100,000 employees worldwide over the next two years as part of a company restructuring following its 2009 acquisition of Schering-Plough (Kenilworth, NJ). Merck plans to eliminate approximately 2,500 vacant positions as part of the first phase of the restructuring program, according to a company release. The reductions will primarily come from the elimination of duplicative positions in sales, administrative, and headquarters organizations, and from the consolidation of manufacturing facilities and research and development (R&D) operations, the release said. The company expects the first phase of its restructuring program to yield 2012 cost savings of approximately $2.6 billion to $3 billion.
Pfizer (New York) will eliminate 72 employees at its Pearl River, NY facility. The employees are part of the facility’s chemical division and will lose their jobs by May 21, 2010.
Advertisement:
 Vetter Development Service Chicago
Peter Soelkner
Managing Director, Vetter Pharma International GmbH
Listen to this podcast recorded live from the show floor of AAPS 2009. Clinical development is key for new drugs. In order to minimize risks and take advantage of opportunities, you need comprehensive know-how and years of experience. Vetter, as a specialist in the aseptic filling of injection systems, will provide with its new facility the manufacturing of preclinical, Phase I and Phase II clinical batches in Chicago. We invite you to find out more about Vetter Development Services USA Inc.
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The US Drug Enforcement Agency approved Pharmatek Laboratories’ (San Diego, CA) security and handling procedures. Pharmatek, a contract development and manufacturing organization, received approval to manufacture cytotoxic compounds at its San Diego facility.
Contract development and manufacturing organization Recipharm (Haninge, Sweden), which recently acquired Cobra Biomanufacturing (Keele, UK), has combined the biologics of both companies in Sweden. The integrated business will be known as RecipharmCobra Biologics and will operate as Recipharm’s specialist biologics division.
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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The US Food and Drug Administration and the International Serious Adverse Event Consortium have issued the third release of data on the genetic basis of drug-induced liver injury (DILI) and serious skin reactions (SSRs). The data focus on the genetics associated with DILI and SSR and may help researchers better predict an individual’s risk of developing these serious complications, according to a Feb. 19, 2010 FDA release. The new research data complement previous releases of data in December 2008 and May 2009. “The continued accumulation of scientific information on the genetic basis of adverse drug events provides researchers with invaluable tools for understanding why some people respond to medicines differently than others," said ShaAvhree Buckman, MD, PhD, director of the Office of Translational Sciences in the FDA’s Center for Drug Evaluation and Research, in the release.
The International Society for Pharmaceutical Engineering (ISPE) released a new guidance document for good automated manufacturing practice (GAMP), GAMP Good Practice Guide: Manufacturing Execution Systems (MES): A Strategic and Program Management Approach. According to a news release from ISPE, the new guide recommends a life-cycle approach for developing and implementing MES for regulated manufacturing. The guide addresses how to achieve control and compliance in the project and operational phases.
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PhRMA (Washington) announced that Billy Tauzin, its president and CEO, will step down at the end of June. Tauzin, who has served in those roles for five years, will continue to serve as a consultant after a successor is found.
PPD (Wilmington, NC) named Lee E. Babiss executive vice-president of global laboratory services. He will be responsible for the strategic direction and scientific leadership of the company's bioanalytical, current good manufacturing practices, and global central laboratories, vaccines and biologics operations, and for BioDuro, the China-based drug-discovery company PPD acquired last year.
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Science and Sensibility |
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| Michelle Hoffman | |
The death of a pioneer in molecular genetics recalls age-old
questions about social fitness to ensure the ethical uses of scientific advances.
Coming Soon: The March supplement to Pharmaceutical Technology focuses on sterile manufacturing and bioprocessing, including the results of our annual biomanufacturing survey.
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FDA Spending
FDA increased its budget by 19% between FY 2009 and FY 2010, and has asked
for another 23% increase for FY 2011. Rate FDA's request.
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View the poll archive. |
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