上海翻译公司完成制药英文翻译
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Overlooking Lake Geneva in Corsier-sur-Vevey, Switzerland, is one of the world’s largest and most technologically advanced biopharmaceutical plants.
Here, at the Merck Serono Biotech Center, highly skilled professionals unlock the potential of living cells to produce therapeutic proteins through recombinant DNA technology...and deliver biologic medicines of the highest quality. |
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A single human gene is first isolated, then integrated into the nucleus of a mammalian cell. Once the proper gene is inserted, the cells are able to express a protein close or identical to proteins found in the human body. The highest performing recombinant cells are then selected for cell line development and multiplied in order to create a cell bank.
The next step is developing state-of-the art manufacturing processes.
The quality and the stability of the molecule produced by the cells is closely monitored, using advanced analytical instruments and methods.
After a number of optimization and validation steps, a robust manufacturing process is ready to be applied at large scale. |
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At the start of each production cycle, a small vial of cells is thawed and placed in a nutritious culture medium, in order to multiply. When the desired population is reached, the cells are transferred to a bioreactor for upstream processing.
A bioreactor is a closed and sterile environment allowing strict control of conditions like temperature, pressure, aeration, and pH. Culture conditions are optimised to enhance the growth of the cells and obtain a maximum output of the desired protein.
Two different upstream processes are used: Perfusion and Fed-batch:
With perfusion technology, the culture medium is continuously fed into the bioreactor while the cells are kept inside through a specific cell retention device. The product is harvested at regular intervals over a 2- to 3-month period. Smaller quantities of proteins are produced in bioreactors of up to 300 liters capacity.
For large-scale production, fed-batch technology is used. The culture medium is fed into the bioreactor over a period of up to 3 weeks. The volume is increased by successive media additions and scale-ups through several seed bioreactors, up to 15,000 liters. The entire content of the final production bioreactor is centrifuged, and clarified by filtration, to remove cell debris and allow collection of the final harvest.
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In Downstream Processing, the protein contained in the bioreactor harvest is purified through several stages of ultra-filtration and chromatography, in order to isolate the therapeutic molecule.
After final filtration, the product quality is analysed and the batch records checked to verify purity and conformity of the drug substance, before release by quality assurance teams.
The bulk drug substance produced at the MSBC is dispatched to other Merck Serono sites for fill and finish operations, and packaging, before the final drug products are distributed and commercialized to patients worldwide.
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The Merck Serono Biotech Center is a fully integrated site for the development and manufacture of biologics. It specializes in mammalian cell technologies at both small and large scale – from just a few liters in process development to large-scale production runs. Its 4 production suites offer bioreactors ranging from 75 to 15,000 liters capacity.
The Merck Serono Biotech Center complies with the highest quality standards, according to current good manufacturing practices for the biopharmaceutical industry.
The site has passed inspections from regulatory authorities around the world including FDA, EMA and Swissmedic.
It has operated since 2005 under ISO 14001 certification, the international environmental standard for excellence.
Merck Serono is committed to reducing any impact of its activities with a strict environmental management program helping to reduce waste and continuously improve onsite energy consumption.
A nature reserve built to protect a rare species of toad offers a living testament to Merck Serono’s commitment to environmental responsibility.
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This commitment also extends to ensuring excellence in all operations around the manufacture of Merck Serono’s biopharmaceutical products.
Advanced plant management systems electronically monitor every step of the complex biotech production process, from molecule to medicine.
Engineering teams provide constant monitoring and technical support to ensure overall equipment effectiveness.
An automated high-bay warehouse offers the latest in efficient logistics and supply chain optimization.
Today, the MSBC is the main production site serving global market needs for Rebif,Merck Serono’s leading interferon beta 1-a treatment for multiple sclerosis.
Following a recent expansion, the site is now able to produce large quantities of monoclonal antibodies, like the targeted cancer therapy, Erbitux. |
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The Merck Serono Biotech Center brings together an international group of highly qualified biologists, engineers, laboratory technicians and support personnel who all share a common goal: to deliver the active ingredients for biopharmaceutical medicines of the highest quality.
Combining a proud heritage as a biopharmaceutical pioneer with a strong commitment for the future, the Merck Serono Biotech Center is building upon its reputation as a world-class center of excellence in biotechnology.
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