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Bio-IT Cloud Summit
September 19, 2011–September 20, 2011
La Jolla, California
2011 PDA FDA Joint Regulatory Conference & TRI Courses
September 19, 2011–September 23, 2011
Washington, D.C.
8th European Congress of Chemical Engineering
September 25, 2011–September 29, 2011
Berlin, Germany
Extractables and Leachables for Pharmaceutical Products 2011
September 27, 2011–September 28, 2011
Dublin, Ireland
IVT's 17th Annual Validation Week
October 24, 2011–October 26, 2011
Philadelphia, Pennsylvania
INTERPHEX Puerto Rico 2011
October 20, 2011–October 21, 2011
San Juan, PR USA
AAPS 2011
October 23, 2011–October 27, 2011
Washington DC, USA
CPhI Worldwide 2011
October 25, 2011–October 27, 2011
Frankfurt, Germany
4th West Coast Forum on Clinical Supply Chain Management
December 6, 2011–December 7, 2011
Burlingame, California
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 Liquid analyzer captures measurement data
Emerson Process Management’s Rosemount Analytical Model 56 dual-input liquid analyzer performs a range of online measurements. The analyzer includes a high-resolution, full-color LCD screen that displays process variables and an on-screen user manual. The unit also provides diagnostics, extensive full-color trend graphics, advanced control capabilities, and digital communications. Data and event-logging capacities provide extensive on-board data storage. The instrument captures measurement data for both channels every 30 seconds for 30 days that can be downloaded to a USB memory device.
The Rosemount Analytical Model 56 measures pH and dissolved oxygen, and the instrument can ensure that water produced for water-for-injection systems is produced consistently and complies with the US Pharmacopeia. |
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Alkermes, a biotechnology company, has announced that the company’s shareholders have approved the merger of Alkermes and Elan Drug Technologies, the drug formulation and manufacturing business unit of Elan Corporation. Both businesses will be combined under the name “Alkermes plc,” a newly formed company based in Ireland. Alkermes anticipates that the business combination will close on Sept. 16, 2011.
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Need testing for residual solvents and particulates?
Celsis Analytical Services is current on all USP changes including <788>. If you need particulate or residual solvent testing, we have the equipment and the experienced analysts to do the job-- on time and on budget. We also offer method feasibility, development and validation.
Request a quote online at  Celsis.com/quote or call us, toll-free (888) 468-3400. |
The pharmaceutical services provider AmerisourceBergen has completed the acquisition of IntrinsiQ, an informatics solutions provider for oncologists, for $35 million in cash. IntrinsiQ will become part of ION Solutions, which is a unit of AmerisourceBergen Specialty Group.
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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.  Learn more. |
Dendreon, a biotechnology company, has announced a reduction of approximately 500 employees to meet the company’s manufacturing requirements. The total employee-related cost of the restructuring is expected to be approximately $21 million, of which about $5 million are noncash charges related to stock-based compensation.
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The Silverson Verso In-Line Laboratory mixer is the result of 60+ years of mixing experience and untold hours of scale-up research. This bench top In-Line mixer bridges the gap between laboratory and full-scale pharmaceutical production, providing proven, predictable accuracy. The Verso allows reliable forecasting of the performance of larger Silverson In-Line mixers under full-scale conditions. For a  free on-site trial call 413-525-4825. |
The board of the European Fine Chemicals Group (EFCG) has agreed to ratify the proposal of FDA to put forward a legislative package, designed with the help of EFCG and US industry representatives, to deliver into US law a new Generic Drug User Fee Act (GDUFA). GDUFA requires FDA to commit to significantly improve and enhance its regulatory activities for the benefit of global generic-drug providers and US generic-drug users, in exchange for the global generic-drug industry providing FDA with $299 million in user fees each year during the next five years.
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Covance, one of the world's largest and most comprehensive drug development services companies, now offers a comprehensive and integrated set of CMC Pharmaceutical Development Services, including API development and supply, preformulation and formulation, analytical and stability, and regulatory documentation services. This offering is built on the combination of top-five pharma expertise, facilities, and decades of excellent client service record. Covance is committed to helping you reduce the time required to development milestones and improve your molecule hit rate.  www.covance.com/cmcpds |
The CMO Lonza, announced that LG Acquisition, an indirect wholly owned subsidiary of Lonza, has extended the expiration date for its previously announced tender offer for 100% of the outstanding shares of common stock of the biocides company Arch Chemicals to Sept. 30, 2011. The tender offer is at a price of $47.20 per share in cash.
The Pfizer subsidiary Pfizer Animal Health and Jilin Guoyuan Animal Health Company, an animal heath biological products provider, have announced an agreement to jointly develop, manufacture, and distribute animal health vaccines in China. The new joint venture, Jilin Pfizer Guoyuan Animal Health Co., will provide a range of vaccine products to help China’s livestock producers meet increasing demand for a safe and abundant supply of pork, beef, dairy, and poultry from healthy animals. The animal vaccine market in China is valued at $800 million per year. Pfizer Guoyuan Animal Health will focus initially on developing vaccines to protect the health of swine. Terms of the agreement were not disclosed.
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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.  http://www.solvaychemicals.us/marketsapplications/marketshidden/0,,40615-2-0,00.htm |
Sartorius Stedim Biotech, a biopharmaceutical service provider, has entered into a patent cross-licensing agreement with GE Healthcare Life Sciences. Under the agreement, Sartorius Stedim Biotech has granted GE Healthcare Life Sciences a sublicense to certain patents held by the University of Maryland to which Sartorius Stedim Biotech has access under an exclusive license agreement with Fluorometrix, a spin-off of the University of Maryland, Baltimore County. These patent rights cover bioreactors with at least two optical sensors for monitoring biotechnological manufacturing processes. GE Healthcare Life Sciences has granted Sartorius Stedim Biotech a sublicense to patent rights that it has licensed from SciLog. These patent rights cover proprietary technologies for the automated, aseptic transfer of solutions in bioprocessing applications. The financial terms of the agreement were not disclosed.
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QUALITY TABLET PRESS REPLACEMENT PARTS SHIPPED SAME DAY!
By stocking over 300,000 replacement parts for nearly every press on the market, we're able to provide quality parts at incredible prices, faster than anyone else in the industry. All Natoli replacement parts are manufactured in the U.S.A. and are available for international delivery – and most items are available with same-day shipping!.
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SGS, a contract analytical and testing firm, has announced plans to expand its service portfolio in its Poitiers, France, facility to include cell-based bioassays. The company has a recruitment plan in place over the next six months to meet customer demand.
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Pre-filled single-dose syringes save time and reduce the risk of administration of improper drug/dose to the patient. Smithers Pharma develops and characterizes biologic formulations suitable for storage in pre-filled glass syringes for Phase III therapeutics. Our services also include leachable and extractable testing of container closure systems, and GMP stability testing. Contact Smithers Pharma for information about biologic formulation development and stability services for pre-filled syringe delivery.  http://www.smitherspharma.com/index.php/formulations/biologics |
The CRO Xcelience expanded its manufacturing and packaging services to include four new pieces of equipment and a new automated packaging line. As part of the expansion, the company added an MG Futura (capsule-filling machine for powder and pellets), an LCI Multi-granulator MG-55 (extruder), a QJ-230T marumerizer (spheronizer), and a wurster insert (bottom spray) to the existing Glatt GPCG-3 fluid-bed processor. These new pieces enable production, coating and encapsulation of MUDF delivery systems. In addition, Xcelience has added a fully automated packaging line (including ink-jet coding) for primary bottling of tablets and capsules. The new packaging line enhances the speed at which batches are packaged, shortens timelines, and enhances the ability to package larger batches of drug product.
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Early ERP Adoption Is Key To Success in Life Sciences
When moving into the commercialization phase, many business applications tend to quickly reach their limitations. Forward-thinking manufacturers establish their business infrastructure early on with scalable ERP solutions that can keep up with exponential increases in production and federal regulations. Address these key ERP processes and requirements early to minimize your growing pains.
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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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Members of Rx-360, the international pharmaceutical supply-chain consortium, have been asked to testify before the US Senate Health, Education, Labor and Pensions committee about supply-chain security. The hearing took place Sept. 14, 2011, and focused on the quality of APIs and finished products imported into the US, FDA's role in the supply chain, and related legal requirements See above news story.
T-cell vaccine specialist Okairos has appointed Bill Burns, previously CEO of Roche's Pharmaceuticals Division, as chairman of the board, and Jean-Paul Prieels, former head of research at GSK Vaccines, as a board member
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FDA is making organizational changes within the Center for Drug Evaluation and Research’s (CDER) Office of Oncology Drug Products, which is the office that reviews drug and biologic applications for cancer therapies. The office will now be called the Office of Hematology and Oncology Products (OHOP). Richard Pazdur, MD, will continue to serve as the office director, according to an agency press release. The new structure contains four divisions: Division of Hematology Products (DHP), Division of Oncology Products 1 (DOP1), Division of Oncology Products 2 (DOP2), and Division of Hematology Oncology Toxicology (DHOT). “Two unique features of the reorganization include the creation of DOP1 and DOP2, the agency’s primary review divisions for cancer solid tumor therapies, and the creation of DHOT, which will review nonclinical information,” states the release. The division directors for each division are listed on the agency website. The agency’s Office of Compliance was also restructured earlier this year.
PDA has updated its membership structure to include an expanded Emerging Economy membership, a new option for Retired Membership, and additional assistance for members who are currently seeking employment in the Pharmaceutical industry, according to a press release. The association is holding its annual regulatory meeting with FDA next week Sept. 19-21, in Washington, DC. Listen to PharmTech’s preview coverage.
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| Continuous Progress in Continuous Manufacturing |
By Patricia Van Arnum, Rich Whitworth
Industry buy-in is increasing as pharma companies proceed with select projects and research.
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Coming soon: Don't miss our special coverage on oral vaccines in PharmTech's October issue. |
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FDA's Enforcement Strategy
FDA released its new enforcement strategy in August 2010. Has your company experienced FDA increased scrutiny in the past year?
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View the poll archive. |
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