 |
Lyophilization Technology - Practical Application of the Scientific Principles
June 13–June 15, 2011
Los Angeles, CA
Chemspec Europe 2011
June 15–June 16, 2011
Geneva, Switzerland
10th Annual Biological Production Forum 2011
June 20–June 22, 2011
Frankfurt, Germany
IVT's 2nd Annual ACE
June 21–June 23, 2011
Philadelphia, PA
NC3Rs/Society of Biology Symposium
June 22, 2011
London, United Kingdom
PharmaBrand Summit 2011
June 27–June 29, 2011
Montreux, Switzerland 
|
|
|
 |
 |

Chromatography columns enable parallel screening
GE Healthcare's PreDictor RoboColumn units are prepacked with the company's BioProcess chromatography media to enable parallel, automated screening of media and conditions using a robotic system. The miniature chromatographic columns can perform various screening techniques, including ion-exchange chromatography, affinity chromatography, multimodal chromatography, and hydrophobic-interaction chromatography.
Operators can perform high-throughput process development (HTPD) by using the PreDictor RoboColumns with a robotic liquid-handling workstation, such as Freedom EVO from Tecan. This technique allows users to execute parallel chromatographic separations automatically. The columns' miniature format also enables scientists to screen many conditions at the same time with low amounts of sample. The columns thus enable a technique that can improve companies' process understanding. In addition, automation and parallel screening help minimize manual labor and reduce experimental time.
The PreDictor RoboColumn units can be run the same way that conventional columns are run. Operators can use the products to screen various parts of the chromatographic cycle, such as binding studies, elution studies, and wash studies. The PreDictor RoboColumns are designed to yield highly reproducible data that are similar to the results from conventional columns.
Advertisement:
Seem like the only thing some contract labs are testing is your patience?
With Celsis, you get fast, accurate testing for a full spectrum of CGMP lab services performed accurately, on time and on budget. We offer compendial, non-compendial or custom methods. Raw material to container and finished product testing. We even have HPLC, LC-MS/MS, GC, IC, dissolution, AA and more. Get a quote now. celsis.com/labs/quote |
|
|
|
 |
The biopharmaceutical company Amarin has entered into several supply agreements regarding AMR101, a prescription-grade omega-3 fatty acid. Equateq and Chemport, manufacturers of polyunsaturated fatty acids for pharmaceutical and nutraceutical products, have agreed to provide Amarin with the active pharmaceutical ingredient (API) for AMR101. Equateq and Chemport, as well as Amarin's current API supplier, are each executing phased capacity expansion plans to create sufficient capacity. These suppliers are self-funding the expansions plans with some contribution for Amarin.
In return for certain exclusivity provisions and subject to product approval, Amarin is obligated to make minimum annual purchases from Equateq ranging from approximately $10 million to $20 million and has agreed to pay Equateq a development fee up to a maximum of $0.5 million and up to $5.0 million for purchasing initial raw materials to be credited against future API purchases. Amarin is obligated to make minimum annual purchases from Chemport ranging from
approximately $7.5 million to $15 million. Concurrent with its agreement with Chemport for commercial supply, Amarin agreed to take a minority-share equity investment in Chemport of up to $3.3 million. Amrin is also further considering adding a fourth API supplier. Additionally, Catalent Pharma Solutions, a contract development and manufacturing organization, and Banner Pharmacaps Europe, a provider of gelatin-based drug delivery technologies, have agreed to provide softgel encapsulation services for AMR101.
Advertisement:
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.
http://www.grainprocessing.com |
Eli Lilly commented on a ruling issued by the US District Court for the Southern District of California that granted a request by Amylin Pharmaceuticals for a temporary restraining order related to litigation involving the two companies’ diabetes collaboration agreement. “We are disappointed with the Court's decision to grant a temporary restraining order in this case,” said Robert A. Armitage, senior vice-president and general counsel for Lilly. “We have complied with our contractual obligations under our agreements with Amylin in a manner fully consistent with all applicable laws. We believe that Amylin's allegations against Lilly are entirely without merit and we fully expect to prevail in this litigation.”
Advertisement:
It's all about Aptuit service. Our customers say they respect our commitment to resolving challenging issues. They will work with us again because of our ability to accomplish goals in aggressive timelines while staying on budget. They are voicing their positive response to our recent breakthrough systems, and providing even greater global service efficiencies.
Across the entire drug development continuum, it's all about Aptuit service.
http://www.aptuit.com/ItsAllAboutTheService/service.htm |
Johnson & Johnson reports that it is reviewing its growth strategies for its pharmaceutical business with leaders from the company’s executive committee and pharmaceuticals segment. The company’s four strategies to grow its pharmaceuticals
business include: focusing on differentiated medicines by expanding in immunology, oncology, and vaccines; prioritizing investments in internal research and development (R&D), strategic licensing, partnerships and select acquisitions; strengthening its geographic presence and increasing investments in emerging markets as well as in certain developed markets, such as Japan; and investing in talent and organizational capabilities locally, regionally, and globally.
Advertisement:
HPLC familiarity with UPLC performance.
For laboratories that perform routine analyses or develop methods, or simply prefer the flexibility of a multi-solvent delivery system, the only choice has been HPLC-until now.
The ACQUITY UPLC H-Class system can enable your laboratory to access the productivity and chromatographic performance of UPLC® in a system that combines the flexibility of ternary or quaternary solvent blending with the simplicity of flow-through needle injections.
Learn More |
Labtec GmbH, a transdermal drug-delivery developer, has opened a GMP manufacturing facility for transdermal patches and oral dispersible films in Hamburg, Germany. The facility was certified as GMP-compliant following a three-day inspection by Hamburg health authorities in March 2011. The facility provides industrial mass production and includes coating and drying lines with variable coating widths, as well as slitting machinery and converting and packaging equipment dedicated to transdermal drug-delivery systems and oral dispersible films.
Advertisement:
IMPORTFAB is a well-established contract manufacturer, specializing in the manufacturing and packaging of semi-solid and
liquid products. Our objective is to maintain our position as a reliable reference point in the manufacturing of quality pharmaceutical products: essentially, a benchmark for modern, efficient production, assured through the use of highly performing equipment. IMPORTFAB is cGMP compliant by the FDA and Health Canada. www.importfab.com |
Pfizer has formed strategic partnerships with the contract research organizations Icon and Parexel International, both of which will serve as strategic providers of clinical-trial implementation services during a five-year period beginning in June 2011. The new partnerships will be fully implemented during an 18-to-24 month period.
Advertisement:
C.W. Brabender® Instruments, Inc. introduces the Stainless Steel 12mm Clamshell Segmented Twin-Screw Compounder with application to the pharmaceutical industry for hot melt extrusion, new product development, compounding, pilot-scale & nanocomposites applications. The clamshell barrel allows visual assessment of processing steps, ease of screw mounting and quick cleaning. The modular segmented screws offer various individual processing possibilities. C.W. Brabender® Instruments, Inc. is
where quality is measured.
12mm miniature co-rotating twin-screw extruder |
Canadian generic-drug company Pharmascience has opened new R&D and production facilities in Montreal. The company invested approximately $40 million in the expansion. Pharmascience also has acquired Aegera Therapeutics, a clinical-stage biopharmaceutical company. Financial terms were not disclosed.
Advertisement:
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 |
Radius Health, a developer of osteoporosis drug therapies, and 3M Drug Delivery Systems, a provider of inhalation and transdermal drug delivery technologies, have agreed to collaborate on the development of a transdermal delivery option for BA058, Radius’ parathyroid hormone-related protein analog, for the treatment of osteoporosis, now in Phase I clinical trials. The BA058 Microneedle Patch will use 3M’s microstructured transdermal-system microneedle technology to administer BA058 through the skin as an alternative to subcutaneous injection.
Advertisement:
TABLET PRESS REPLACEMENT PARTS SHIPPED SAME-DAY!
By stocking over 300,000 parts for nearly every press on the market, Natoli is able to provide quality parts at incredible prices, faster than anyone else in the industry. All Natoli parts are manufactured in the U.S.A. and are available for international delivery and most items are available with same-day shipping! Browse online or request a FREE QUOTE now!
http://www.natoli.com/parts |
Schott, a provider of specialty materials and pharmaceutical packaging, has opened a primary pharmaceutical packaging facility in Zavolzhe, Russia. The new production site will initially employ approximately 60 employees and will produce ampuls and vials.
Advertisement:
The latest in news and information from Bosch Packaging Technology
At our new Blog http://boschpackagingpharmana.wordpress.com
Currently on the blog 150 years of Packaging History, single-use
dosing technology updates, and a capsule filling system comparison.
|
SGS, a contract analytical and testing firm, has announced its plan to open a second life-science services facility in Mumbai, India. The new 15,000-ft2 facility will provide analytical development and quality-control testing services and is scheduled to become fully operational by mid-2012.
Advertisement:
Optimum FTIR Performance, Sensitivity, and Reliability
Shimadzu's IRAffinity-1 FTIR is ideal for high-precision infrared analysis in a multitude of pharmaceutical applications, from identification of foreign matter to analysis of contaminants. It features best-in-class sensitivity, long-term stability, increased reliability with self-diagnosis and continuous monitoring during operation, protection from humidity with a triple protection interferometer, and analysis support programs.
Learn more |
Sigma-Aldrich has acquired all outstanding shares of Vetec Quimica Fina, a Brazilian manufacturing and laboratory chemical supplier, to expand its presence in Latin America.
Advertisement:
Leadership. Partnerships. Breakthroughs.
The 2011 BIO International Convention draws the biotech world together for 4 days of collaboration to spark breakthrough solutions and drive the industry forward. Join 15,000+ international innovators in Washington, D.C., June 27 30. Meet potential partners in the BIO Business Forum, find solutions in the BIO Exhibition and learn from experts in an inspiring education program. Book housing and register today!
convention.bio.org |
Valeant Pharmaceuticals International a specialty pharmaceutical company, has agreed to acquire Sanitas Group, a specialty pharmaceutical company with products in Central and Eastern Europe, for approximately EUR 314 million ($452.1 million). The deal is subject to customary closing conditions and regulatory approval and is expected to close in the fourth quarter of 2011.
Watson Pharmaceuticals, a generic-drug company, has acquired the Greek generic-drug company Specifar Pharmaceuticals for EUR 400 million ($575.3 million). Under the terms of the agreement, Specifar's former owners could also receive
additional consideration based upon future profits of esomeprazole tablets during its first five years of sales, up to a maximum of EUR 40 million ($57.5 million). Specifar manufactures generic pharmaceutical products in a facility located in Athens with capacity for approximately 1 billion doses annually. A new facility is currently under construction outside of Athens. This facility will provide capacity to manufacture an additional 3 to 5 billion. EU certification of the new facility is expected in mid-2012. This capacity will permit Watson to convert additional third-party manufactured products to own-manufactured products. The transaction was signed and closed simultaneously and announced on May 25, 2011.
Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to ptpress@advanstar.com |
|
|
The biopharmaceutical developer Geron has made several senior management appointments. Stephen Kelsey, PhD, has been named executive vice-president, head of R&D, and chief medical officer; Jane Lebkowski, PhD, has been appointed as senior vice-president and chief scientific officer; and Melissa Kelly Behrs has been named senior vice-president of strategic portfolio management.
Christian Holtmann has been named as CEO of Klöckner Pentaplast Group, a producer of pharmaceutical films, effective June 1, 2011, succeeding Tom Goeke who will continue as an advisor to the company. Holtmann most recently served as CEO of PolymerLatex.
|
|
|
|
|
|

|
Shared Audits
Do you think shared audits can be a tool to help manage the pharmaceutical supply chain?
|

View the poll archive. |
|
|
|