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On 25 September 2009, the results of Phase III clinical trials (ToGA) on Herceptin were submitted at the joint 15th congress of European cancer Organisation (ECCO) and the 34th Congress of European Society for Medical Oncology (ESMU) in Berlin, Germany. Herceptin is also used in combination with paclitaxel, docetaxel and aromatase inhibitors. Omnitarg and Herceptin, when used in combination, were found to act as a significant anti-cancer agent in the treatment of (HER2)-positive breast cancer. HDIs, because of their unique mode of action, have the potential to work in a wide variety of tumours, including those that do not over express HER2. In cancer cells, interfering with HER2’s ability to collaborate with other HER family receptors blocks cell signalling and may ultimately lead to cancer cell growth inhibition and death of the cancer cell. HDIs block the ability of the HER2 receptor to collaborate with other HER receptor family members (HER1/EGFR, HER3, and HER4). Omnitarg is a humanised antibody, the first in a new class of agents known as HER dimerisation inhibitors (HDIs). Roche also has an agreement with Genentech to market Omnitarg when it is released to the market. Herceptin during 2009 amounted to nearly CHF5.3bn. Since 1998, Herceptin has been used to treat nearly 600,000 patients with HER2-positive breast cancer worldwide.īecause of a different mode of action there are some side effects possible, such as congestive heart failure and lung conditions. Herceptin is marketed in the US by Genentech, in Japan by Chugai and internationally by Roche. “Products from the plant include the active substance trastuzumab (Herceptin) for the treatment of breast cancer.”
T DM1 CLINICAL TRIALS TRIAL
The approval followed positive outcomes from an international ToGA trial that proved the efficacy of Herceptin in prolonging the lives of patients with the disease. This was followed by approval as a stomach cancer treatment from the EU health authorities in January 2010. Herceptin received approval for use in the EU for advanced (metastatic) HER2-positive breast cancer in 2000, and for early HER2-positive breast cancer in 2006. Trastuzumab is the active ingredient of Herceptin that is believed to act in one of three ways: it may block tumour cell growth by binding to the HER2-positive cancer cells and blocking them from dividing it may attach to the HER2-positive cancer cells and signal the body’s immune system to destroy the cell it may work in conjunction with chemotherapy agents such as paclitaxel to destroy HER2-positive cancer cells. Penzberg is now the primary site outside the US for the biotech production of trastuzumab and will produce Herceptin for an additional 100,000 patients per year. Products from the plant include the active substance trastuzumab (Herceptin) for the treatment of breast cancer. The investment for the new facility was estimated at $290m (approximately €186m) over a three-year period. The new plant has provided approximately 150 jobs for qualified personnel in office, laboratory and production work as well as biologists, microbiologists, biochemists, biotechnologist, chemist and biological/chemical technical assistants.
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The skids hook-ups were installed over a period of six weeks. The field commissioning of the skids was undertaken by highly trained teams working with petrochem shutdown techniques and two seven-day-per-week shifts.
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Plant building occurred concurrently with the fabrication and in some cases installation and commissioning of the skids. The plant was outfitted with skid-mounted equipment modules so that installation and fabrication were telescoped into a shorter timescale. Lang and Peitler provided design, commissioning and installation services for the automation systems at the plant. The construction manager was SIBC GmbH (a subsidiary of Turner and Townsend). LSMW GmbH (Total Life Science Solutions) was the process engineer and designer for the plant. The construction work continued into 2005 and the planned start of production occurred in the second quarter of 2007. The construction work was started in July/August 2004 with the surface preparation and foundations, which continued into September and involved the preparation of an old existing car park at the site. The engineering work was overseen by Roche Pharma Global Engineering. The architect for the new building was Koppenhoeffer and Partner GmbH. “In September 2010, Roche announced that it plans to build an anaerobic plant that will biologically pre-treat the partial wastewater flow from the Penzberg site.”