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Probe enhances monitoring of cell-culture growth
FOSS NIRSystems’s Optimized BioProcess probes are available with a fixed or adjustable pathlength. The fixed-pathlength probe has a smooth surface and accumulates little debris, thereby facilitating cleaning in place. The adjustable-pathlength design enables users to adapt the probe for particular cultures or fermentations. FOSS can help clients optimize the pathlength for specific applications to allow sufficient flow through the gap and maximize sensitivity to low-level constituents.
The Optimized BioProcess probe, designed for use in bioreactors, has a small diameter that allows it to fit into standard bioreactor ports. Operators can use the smallest BioProcess Probe in a disposable bioreactor after it has been autoclaved with a proper aseptic-insertion device. The probes have several source and detector fibers that improve its ability to detect the light-scattering cells present in the bioreactor with a good signal-to-noise ratio. The number of fibers also allows the unit to measure low-level supernatant constituents.
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Join SSCI, A Division of Aptuit, for an educational short course on Pharmaceutical Solids: Essential Knowledge and Advanced Concepts
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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Eli Lilly and Company has made an irrevocable, unconditional offer to acquire the animal-health business of Janssen Pharmaceutica NV, a Johnson & Johnson company. According to the agreement, Elanco, Eli Lilly's animal-health division, would acquire products, manufacturing licenses, distribution rights, and the existing contract portfolio, as well as the related intellectual property and marketing authorizations. Janssen animal-health employees would transfer to Elanco.

Specialty-pharmaceutical company PROLOR Biotech is relocating its corporate office and research and development facility to a new, larger building located in the Weizmann Science Park in Nes Ziona, Israel. The move is expected to be completed by April 15.
Dendreon Corporation, a biopharmaceutical company, has received FDA approval for the remainder of its New Jersey manufacturing facility, thus allowing the company to significantly increase the availability of PROVENGE (sipuleucel-T) to help meet the needs of patients with asymptomatic or minimally symptomatic metastatic castrate-resistant (i.e., hormone-refractory) prostate cancer.
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Balances Deliver Speed, Durability, Precision
Quick…and to the point! Shimadzu balances deliver the performance, functionality, and value scientists need. The unique UniBloc one-piece manufacturing assembly assures stable temperature characteristics, excellent response, and a long operational life, while Windows® Direct Communication enables easy integration of weighing results with laboratory software.
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Epizyme has formed a worldwide partnership with Eisai Tokyo to discover, develop, and commercialize therapeutics targeting EZH2, an epigenetic enzyme, for the treatment of lymphoma and other cancers in genetically-defined patients. Under the terms of the agreement, Epizyme will receive $6 million in upfront and initial milestone payments, and may earn more than $200 million in additional research, development, and sales milestones, and up to double-digit royalties. In addition, Eisai will fund 100% of research and development through human proof-of-concept, at which point Epizyme will have the right to opt into a profit share and cocommercialization arrangement for the United States.

FDA has accepted for review AstraZeneca and Bristol-Myers Squibb's New Drug Application for dapagliflozin, an investigational compound for the treatment of adults with type 2 diabetes mellitus. A Marketing Authorization Application (MAA) for dapagliflozin has also been validated by the European Medicines Agency.
Amgen has signed an agreement with Pfizer to buy Pfizer’s manufacturing facility located at Dun Laoghaire, County Dublin, Ireland. The transaction is expected to close in the second quarter of this year.
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Feel the empowerment that comes from knowing that SAFC is ready to meet your contract manufacturing needs with quality products, innovative ideas and superior service. We stand ready to work with you every step of the way, anticipating your needs and offering keen insight. If you missed us at Informex, please visit our website and discover for yourself the SAFC difference.
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Grace Davison Discovery Sciences, a provider of separation services, opened a new technical-service knowledge center in southern India for customers in the pharmaceutical and biotechnology industries. The knowledge center will support Grace's customers in the areas of laboratory separations, bulk purification, excipients, and pharmaceutical intermediates.
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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 |
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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Eli Lilly and Company has appointed Greg Plowman as the vice-president of oncology research and senior vice-president of ImClone Systems research. In this new role based at ImClone's research center at the Alexandria Center for Life Science, New York, Plowman will oversee the oncology research efforts of both Lilly and its subsidiary, ImClone.
Labopharm, a specialty-pharmaceutical company, has selected Mark D'Souza, formerly the chief financial officer, as its new president and chief executive officer and a member of the board of directors. D'Souza replaces James Howard-Tripp as president and chief executive officer and Howard-Tripp as board member.
Sanofi-aventis has named Richard Klausner chairman of the strategic development and scientific advisory council, where he will work directly with Elias Zerhouni, president of global research and development. Klausner also will act as special scientific and strategic advisor to Christopher A. Viehbacher, chief executive officer.
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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
www.INTERPHEX.com |
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FDA and EMA announced on Mar. 16, 2011, that they would carry out a joint
pilot program for parallel assessment of quality-by-design-based new drug
applications. The pilot applies to applications submitted to both agencies.
According to a press release, the "parallel evaluation within this voluntary
pilot program means that reviewers from both agencies will separately assess
the quality/chemistry, manufacturing and control (CMC) section of the new
drug applications (NDAs) submitted to the FDA and marketing authorization
applications (MAAs) submitted to the EMA."
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INTERPHEX 2011
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