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 Operations-management platform is designed for quick deployment
The LITETrak system is a version of Parsec Automation’s (Brea, CA) TrakSYS operations-management platform designed for rapid deployment without programming. The software can track production lines within an operations environment. The system contains the most commonly used features and functions of TrakSYS and is preconfigured with templates and dashboards. The LITETrak system allows users to define attributes for each product, define production schedules, analyze asset and product performance, and track opportunities for improvement. The software’s web-based interface displays business-intelligence reports and key-performance-indicator dashboards, thus eliminating the need for a client-side software installation. The LITETrak software allows operators to contextualize automatically captured data, thus enabling root-cause analysis. Users also can trigger production stoppages manually.
The LITETrak software can scale up to a complete manufacturing execution system that interfaces with various enterprise resource planning (ERP) systems. The software provides ERP systems with real-time manufacturing information.
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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.
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Alnylam Pharmaceuticals (Cambridge, MA), a developer of RNAi-based therapeutics, granted Tekmira Pharmaceuticals (Vancouver) a new target-specific InterfeRx license to discover, develop, and commercialize an RNAi therapeutic for the treatment of Ebola virus infection (TKM-Ebola). Detailed financial terms were not disclosed, but Alynylam will receive royalties on sales of any resulting product under the licensing agreement.
In a separate announcement, Alnylam described a colloboration with Medtronic (Minneapolis), a medical device company, and CHDI Foundation (New York), a virtual biotech company focused on Huntington's disease treatments. The companies will advance ALN-HTT, a drug-device combination for the treatment of Huntington's disease. ALN-HTT consists of an RNAi therapeutic targeting huntingtin, the gene responsible for Huntington's disease, that is being developed for delivery to the central nervous system using an implantable infusion system developed by Medtronic.
ATW (Warwick, RI), a provider of custom manufactured metal components and services, announced the opening of Parmatech-Proform’s, a subsidiary of ATW, new manufacturing facility in East Providence, Rhode Island. The company focuses on metal injection molding for the medical, telecommunications, firearms, hand tools, semiconductor, and electronic packaging markets. The new facility will serve as Proform’s headquarters.
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Management of Water/Cleaning Validation
From inspections of the water used in drug manufacture to cleaning validation, Shimadzu’s TOC analyzers are ideal for the management of the total amount of organic carbon in drug manufacturing processes. Multiple oxidation methods (combustion catalytic and wet chemical) are available, and they can be used with the swab direct combustion method when combined with a solid sample combustion unit.
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Biocon (Bangalore, India), a biotechnology company, plans to invest $161 million in Malaysia in a biomanufacturing and research and development facility. Through a partnership with Biotechcorp (Ampang, Malaysia), an agency of Malaysia’s Ministry of Science, Technology and Innovation, the facility will be established in Bio-Xcell, a biotechnology park in Iskandar. The facility, targeted to be operational by 2014, will focus on the research and development and production of biosimilars and other biopharmaceutical products.
Bristol-Myers Squibb (New York) and AstraZeneca (London) received approval for their combination therapy Kombiglyze XR (saxagliptin and metformin HCl extended-release) for the treatment of Type II diabetes in adults. According to a company press release, the drug is the first and only once-a-day metformin extended-release (XR) plus dipeptidyl peptidase-4 (DPP-4) inhibitor combination tablet offering strong glycemic control across glycosylated hemoglobin levels (HbA1c), fasting plasma glucose (FPG), and post-prandial glucose (PPG).
Bristol-Myers Squibb (New York) and Simcere Pharmaceutical Group (Nanjing, China), a pharmaceutical company, formed a pact to codevelop BMS-817378, a preclinical small molecule MET/VEGFR-2 inhibitor. Under the terms of the agreement, Simcere receives exclusive rights to develop and commercialize BMS-817378 in China while Bristol-Myers Squibb retains exclusive rights in all other markets. Financial terms were not disclosed.
The US Food and Drug Administration determined that additional time is required to complete the review of Bristol-Myers Squibb’s (New York) biologics license application (BLA) for ipilimumab in pretreated advanced melanoma, and has moved its decision date from December 25, 2010, to March 26, 2011. In response to an FDA request, the company submitted further analysis of data for review and the agency considers this to be a major amendment to the drug’s BLA.
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Vetter Secondary Podcast , The market for parenteral drugs has been growing for years, and competition in the sector is fierce. The focus on patient- and user-friendliness is intensifying. In response, Germany-based contract manufacturer Vetter built its state-of-the-art Vetter Secondary Packaging facility. Listen to find out more information
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Contract manufacturing organization Cambrex (East Rutherford, NJ) acquired a 51% stake in Zenara Pharma (Hyderabad, India), a pharmaceutical company focused on the formulation of final dosage form products. Cambrex’s CEO, Steve Klosk, said in a company statement that he was excited to partner with Zenara and provide products for the approximately $1.5-billion nicotine replacement therapy market. Zenara will be renamed Cambrex Zenara.
Catalent Pharma Solutions (Somerset, NJ), a service provider, added the Xcelodose microdosing system to its Research Triangle Park, North Carolina, facility. This system is designed to provide metering of powder active pharmaceutical ingredients into capsules, which eliminates the need for upfront formulation activities.
Contract research organization Covance announced its third-quarter financial results and said it will implement restructuring actions such as consolidating its North American toxicology services by closing its toxicology facility in Vienna, Virginia; reducing spending across the company, including corporate overhead; realizing savings from process improvements and automation investments; and restructuring the executive management team.
Eli Lilly (Indianapolis) agreed to acquire Avid Radiopharmaceuticals (Philadelphia), a company developing molecular imaging compounds intended for the detection and monitoring of chronic diseases. Lilly will acquire all outstanding shares of Avid for an upfront payment of $300 million, subject to adjustment based on existing cash on hand at closing. Avid stockholders will also be eligible for up to $500 million in milestone payments for the performance of the company’s lead candidate florbetapir F 18 (18F-AV-45), a molecular imaging agent designed to detect amyloid plaque in the brain. Upon completion of the acquisition, Avid will continue to operate from its facility in Philadelphia, Pennsylvania.
Sanofi Pasteur (Lyon, France), the vaccines division of sanofi aventis (Paris) reported that its dengue vaccine is in final stage of clinical development. The vaccine candidate, developed to prevent dengue disease in children and adults, entered its first Phase III clinical study in Australia. Currently, there is no specific treatment available for dengue fever, which is a threat to nearly three billion people and a public health priority in many countries of Latin America and Asia where epidemics occur, according to a company press release.
Specialty pharmaceutical company Valeant Pharmaceuticals International (Mississauga, Canada), formerly known as Biovail, and S.A.C. Capital Advisors (SAC) have agreed to settle SAC's Connecticut action against Valeant for vexatious litigation. As part of the settlement, Valeant will pay SAC $10 million, a portion of the costs SAC expended in defending two earlier actions filed by Biovail and its shareholders.
Waters (Milford, MA) launched its Centers of Innovation Program, an initiative designed to support scientific innovation in the fields of health and life-science research, sports science, food safety, clinical research, and environmental protection. Through the program, Waters is partnering with research scientists using ultraperformance liquid chromatography and mass spectrometry in their studies.
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 European Medicines Agency is seeking a new executive director. Interested candidates have until Nov. 24, 2010, to submit their applications to the European Commission. Thomas Lönngren, the current executive director, will leave the agency on Dec. 31, 2010, following the expiration of his second five-year mandate. EMA appointed Andreas Pott, the current head of administration, to serve as acting executive director from Jan. 1, 2011, until a permanent successor is named.
BioStorage Technologies (Indianapolis), a provider of sample management, cold-chain logistics, and biomaterial storage, appointed Gregory Swanberg as its CEO. F. John Mills will vacate his current position as CEO but will continue as chair of the board.
Codexis (Redwood City, CA) appointed William Rothwell to the new position of vice-president and general manager of biobased chemicals. Rothwell will report to Alan Shaw, the company’s president and CEO.
Cyanotech (Kailua Kona, HI), a developer of microalgae technology, named Brent Bailey as a member of the board of directors, effective immediately, and as president and CEO, effective Jan. 11, 2011. He will replace David I. Rosenthal, who has served as interim president and CEO since Feb. 27, 2010. Rosenthal will remain as a director.
IBA Molecular North America (Dulles, VA), a provider of radiopharmaceutical products, appointed Michael Hickey president of IBA’s molecular tracers North America division. He will be based in Dulles, Virginia, and will report to Renaud Dehareng, president of IBA molecular tracers worldwide. Hickey previously spent 24 years with AstraZeneca Pharmaceuticals (Wilmington, DE) in a wide range of roles spanning marketing, sales, and general management.
Metamark Genetics (Cambridge, MA), an oncology molecular diagnostics company, appointed Mark R. Straley as the company's president, CEO, and as a member of its board of directors. Kenneth E. Weg, a Metamark cofounder who previously served as interim CEO, will continue as chair of the board.
OctoPlus (Leiden, The Netherlands), a drug-delivery company, appointed Jan Hendrik Egberts as its CEO. He will replace OctoPlus's current CEO, Simon Sturge, who will leave the company on Jan. 1, 2011.
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The Product Quality Research Institute (PQRI) and the US Food and Drug Administration are hosting a joint workshop called Process Drift: Detection, Measurement, and Control in the Manufacture of Pharmaceuticals, in December in Bethesda, Maryland. The workshop will address: a life-cycle approach to monitoring manufacturing performance that assures prompt detection and correction of meaningful variation; technological and management system approaches to better control process variation and mitigate product variability; and the impact of process drift on product performance, safety, and efficacy. Several industry and regulatory leaders are on the roster.
The Medicines Quality Monitoring surveillance program, a colloboration of the US Pharmacopeia (USP), Ghana Food and Drugs Board (FDB), and US Agency for International Development (USAID), uncovered substandard and counterfeit versions of 13 antimalarial medicines in multiple locations across Ghana. The program was established in 2008 and is implemented by USP’s Promoting the Quality of Medicines (PQM) initiative. According to a USP press release, the program uncovered a counterfeit version of Novartis’ Coartem, a widely used antimalarial, in 2009. The discovery of the counterfeits resulted in a nationwide recall of all 13 drugs, including publicizing the names of the outlets where they were found.
This week, the steering committee and expert working groups of the International Conference on Harmonization have been meeting in Japan to discuss current harmonization efforts, including the implementation of the quality guidelines and the draft of the Q11 guideline on the Development and Manufacture of Drug Substance. Post-meeting summaries are expected soon. |
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Regulation of Excipients
Do you feel there is a need for stringent regulations relating to excipients for pharmaceutical use?
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