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 Sensitive system detects leaks
The HVLD Micro Leak Detection System from PTI Inspection Systems and Nikka Densok USA provides a nondestructive means of detecting pinholes, cracks, and defective seals in pharmaceutical packaging. The device’s electrode probes scan glass, plastic, and poly laminate containers that are filled at least 30% with liquid. Differences in current flow indicate breaches in the container. HVLD can be used on various liquid-based products, including suspensions, emulsions, and proteins. The offline laboratory unit helps personnel determine the approximate location of the breach.
PTI can provide test fixtures designed for rigid containers (e.g., syringes, vials, ampuls, and bottles) and for pouches and flexible packaging. The instrument can detect imperfections as small as 1 µm without contaminating the product. Users can adjust the system’s sensitivity to accommodate various package specifications and test requirements. The HVLD method can be migrated easily from the laboratory offline to 100% online inspection at high production speeds.
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On April 5 & 6, 2011, Dr. Stephen R. Byrn and Scientists from SSCI will present a 2-day overview of pharmaceutical solid-state research for process chemists, engineers, materials scientists, intellectual property attorneys and pharmaceutical scientists. Location: Hyatt at The Bellevue, Philadelphia, PA. Register today at:  http://www.aptuit.com/Resource-Library/Aptuit-Events/SSCI-Short-Course-2011.aspx |
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The contract development and manufacturing organization (CDMO) Almac has expanded its commercial facilities to include an additional 6124-ft2 of cold and frozen storage.The expansion is a joint investment with a commercial client, for which Almac provides central EU importation, warehousing, and distribution services. The expansion includes dedicated -70 °C, -20 °C, and 2–8 °C storage for drug antibody, drug linker, bulk drug substance, placebo, and filled vials.
Astellas Pharma has exercised its option to purchase all of Maxygen’s equity interests in Perseid Therapeutics, a company specializing in protein pharmaceutical development, at the current exercise price of $76.0 million. Under the terms of the companies’ 2009 joint venture arrangement, Maxygen transferred substantially all of its protein pharmaceutical programs and related assets and research and development (R&D) personnel to Perseid and granted Astellas an option to acquire all of Maxygen’s ownership interest in Perseid at specified exercise prices that increased each quarter over the term of the option, which was scheduled to expire on September 18, 2012.
Boehringer Ingelheim formally acquired Amgen’s biopharmaceutical development and manufacturing facility in Fremont, California. This acquisition involves leasing buildings, acquiring physical equipment, and assuming manufacturing processes done at the Fremont site. The facility currently employs more than 300 employees and consists of more than 200,000 ft2 for laboratories, manufacturing, and process development suitable for clinical and market supplies. The purchase agreement was signed in January 2011.
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Gerresheimer, a pharmaceutical packaging company, has acquired the Brazilian company Védat to strengthen its pharmaceutical plastic packaging business in South America.
JHP Pharmaceuticals, a provider of contract manufacturing services for sterile injectable products, has entered into a multiyear contract-manufacturing agreement with an undisclosed biotechnology company. JHP will be responsible for manufacturing and supply of a sterile liquid product used in processing biologics.
The CDMO Lonza has formed an agreement with the biopharmaceutical company Athera Biotechnologies. Lonza will initiate cell-line and process development for Athera’s monoclonal antibody PC-mAb. Athera’s PC-mAb is intended for the treatment of patients with acute coronary syndrome who are at an increased risk of secondary cardiovascular events and death. This agreement secures a development and cGMP manufacturing plan for Athera. Lonza will initiate cell-line and process development using Lonza’s GS Gene Expression System.
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Merck & Co. and the biopharmaceutical company Portola Pharmaceuticals have announced that Merck plans to return to Portola all rights for betrixaban, an investigational oral Factor Xa inhibitor anticoagulant being evaluated for the prevention of stroke in patients with atrial fibrillation.
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At Solvay Chemicals, we manufacture BICAR® Sodium Bicarbonate and Soda Ash IPH to meet the exacting specifications of the US and EP Pharmacopeias and National Formulary. Produced according to cGMP, these are the products of choice for API or excipient applications requiring effervescent or desiccant properties. Solvay Chemicals, Inc. is part of the Solvay Group, the leading global producer of sodium bicarbonate and soda ash.
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Merck KGaA has agreed to acquire the microbiology business of Biotest, a company specializing in immunology and hematology. This business consists of heipha Dr. Müller GmbH, located in Eppelheim, Germany, as well as the Hycon business located in Dreieich, Germany, subsidiaries in France, Japan, and the US as well as further activities and employees in several European countries. Closing of the transaction is expected in the second half of 2011.The acquisition allows the Merck Millipore division to complete its product portfolio in industrial microbiology for contamination detection. Specifically, the business will add to Merck Millipore’s existing dehydrated cell-culture media and testing systems.
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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
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PerkinElmer has agreed to acquire CambridgeSoft, a provider of software, scientific databases, and professional services to the pharmaceutical industry, and has completed the purchase of ArtusLabs, a provider of data integration for electronic laboratory notebooks.
Greenstone, a Pfizer subsidiary, is voluntarily conducting a recall, to the patient level, of medicines with lot number FI0510058-A on the label. The recall applies to citalopram 10-mg tablets (100-count bottle) and finasteride 5-mg tablets (90-count bottle), both distributed in the US market. The recall is due to the possibility that incorrect labels were placed on the bottles by a third-party manufacturer.
Procter & Gamble and Teva Pharmaceutical Industries have signed a master agreement to create a partnership in consumer healthcare by bringing together both companies' existing over-the-counter medicines (OTC) and related capabilities. The partnership will include a joint-venture (JV) company that combines the companies’ OTC businesses in all markets outside of North America. The markets in the JV generated sales of more than $1 billion in 2010. Teva will provide access to its drug portfolio, global R&D, manufacturing expertise, and infrastructure. As part of the partnership, the companies intend for Teva to take global responsibility for manufacturing to supply the JV markets and P&G’s existing North American business.
Sanofi-aventis formed a cooperation agreement with Fovea Pharmaceuticals, its Ophthalmology Division, and the Vision Institute (Institut de la Vision), one of the main eye-disease research centers in Europe, for research in the diagnosis, prevention, and treatment of ocular diseases. The agreement aims to set up a privileged partnership between sanofi-aventis and the Vision Institute on the model of translational R&D and to strengthen the collaboration of sanofi-aventis with the bodies constituting the Vision Institute, such as the Pierre and Marie Curie University (UPMC), INSERM, the French National Institute of Health and Medical Research, and CNRS, the French National Center for Scientific Research.
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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Mark Larsen has been hired as senior vice-president of Alfa Laval’s Hygienic Division. In this role, Larsen will be responsible for implementing sales and marketing strategies to drive profitable growth for the company’s life-science, sanitary, food and vegetable-oil segments.
The CDMO Catalent Pharma Solutions has appointed Tim McFadden as vice-president/general manager of Consumer Health Softgel, effective immediately. McFadden will be located at Catalent’s corporate headquarters in Somerset, New Jersey. Jorge Castro, the incumbent in this role, is retiring from Catalent at the end of March.
Richard J. Meelia will retire as president and CEO of Covidien, effective July 1. Meelia will serve as nonexecutive chairman of the board for a transition period of up to one year following his retirement as CEO. In addition, Jose (Joe) E. Almeida, president of Covidien's medical-devices business segment, has been elected to succeed Meelia as president and CEO.
Laureate Biopharmaceutical Services, a provider of contract biologics manufacturing services, announced that Ann M. Daus, PhD, has joined the company as vice-president, quality. Daus will lead the implementation of Laureate’s strategic quality plan, recruit new leaders to supplement the quality management team, lead the strategic expansion of testing services, and improve companywide systems.
The CDMO Pharmaceutics International (Pii) announced the appointment of Rampurna Prasad Gullapalli as
vice-president of drug delivery technologies. Gullapalli is responsible for providing strategic
scientific and technical leadership in areas of softgel, liquid-filled hard capsules, and drug-delivery
technologies for Pii’s contract development and manufacturing business.
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The International Conference on Harmonization (ICH) is hosting a series of new training sessions this spring. A follow-up training program to the organizations ICH Q8, Q9, and Q10 Quality Implementation program will take place in Japan. The workshop will provide comprehensive information on the integrated quality-trio guidelines and is cosponsored by the Japan Pharmaceutical Manufacturers Association and the Pharmaceutical and Medical Device Regulatory Science Society of Japan.
In related news, the ICH Global Cooperation Group (GCG) endorsed the SADC training for regulators on the ICH Q7 guideline (GMP for APIs). The training is scheduled for this summer in Tanzania. GCC also endorsed ASEAN's request for training regulators and industry on the ICH Q5C guideline (quality of biotechnological products) and that training will take place this spring Kuala Lumpur. Finally, GCC endorsed a request for training on the ICH Q5 series of guidelines (Q5A - Q5E) on quality of biotechnological products, which will take place in spring 2011. Visit the ICH website for further details on these programs.
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| Standards-Setting Activities of USP's Council of Experts |
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This report provides plans for the USP Council's work in the 2010-2015. This articles contains online bonus material.
Coming Soon: Live videos from the INTERPHEX 2011 conference and exhibition in New York City. Watch expert panelists discuss with PharmTech editors continuous processing, business in China, and global outsourcing. |
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INTERPHEX 2011
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