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Amgen Pharmaceutical Manufacturing Facility, West Greenwich, Rhode Island, USA
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Key Data Start year Project type Location Estimated investment Completion Sponsor Full specifications
2000 (retrofit project approval) Pharmaceutical production facility West Greenwich, Rhode Island, USA $700m plus 2005 validation, 2006 start of operations Amgen, Immunex
West Greenwich, Rhode Island, US, is the site of a new pharmaceutical manufacturing facility dedicated to the production of Immunex's rheumatoid arthritis drug, Enbrel. Although the continuation of the project was briefly put in doubt when the takeover of Immunex by Amgen was proposed, the continuation of construction was one of the conditions of the deal. The completed pharmaceutical plant is now one of the biggest mammalian protein manufacturing plants in the world. The project involved the retrofit of an existing facility (BioNow project), and the construction of an entirely new manufacturing plant as well (the BioNext project). Both plants use Immunex's T1 Enhanced Process developed by the Immunex Process Science Group.
Expand Image Immunex decided to purchase an existing manufacturing facility in West Greenwich, and retrofit it to produce the Enbrel drug.
HARD TIMES FOR AMGEN
In March 2007 Amgen announced that there were problems with two of its drugs: Epogen and Aranesp are both erythropoiesisstimulating agents (ESAs) that are used to treat chemotherapy-induced anaemia among other conditions. Studies indicated that patients taking the drugs to attain higher haemoglobin levels were more likely to suffer from serious cardiovascular events.
Amgen suffered from a sharp decline in sales for its ESA medications that resulted in Expand Image a serious drop in profits and a slump in sales even for the very successful arthritis Work on the BioNext project drug Enbrel. These problems have led to Amgen instigating a cost cutting programme in West Greenwich began in which will see the laying off of 1,500 employees across all of its operation to cut November 2001. costs by $1.9bn. The effect on Rhode Island is the loss of 300 employees with the closure of the BioNow building (scheduled to close by the end of 2007). Originally there had been 450 redundancies planned at the Rhode Island facility but sales of Enbrel improved in the third quarter of 2007 to $821m up from $705m for the same period in 2006.
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. The new facility houses nine bioreactors with a capacity of 20. The BioNext facility included a production building. mammalian cell culture.000 gallons per day. Tote Systems International (solids handling systems – media and buffer powder). Other process equipment suppliers included: bioKinetics. a central utility plant (47.. Amgen then had its engineers design and build a stateof-the-art wastewater recycling plant and also a water conservation system that has cut the plant's water usage by 160. Kinetics Modular Systems (smaller bioreactors – 3. Expand Image Part of an interim Enbrel manufacturing site at West Greenwich owned by WyethAyerst Pharmaceuticals and using Immunex's process technology. At that time the plant was already using 500. Ground was broken for the BioNext project in November 2001..pharmaceutical-technology. The plant is dedicated for human therapeutics production. ADP Marshal (one of the BioNext project managers) and the 21st Century Labor Management Partnership were instrumental in setting up a successful Project Labour Agreement (PLA) for the construction project. Amgen wanted over 800.000l – and the harvest module). The area covered was 500. (process equipment design). and the estimated cost was $500m. harvest and purification. 2 of 4 3/27/11 12:43 PM . Cascade Controls (automation.Amgen Pharmaceutical Manufacturing Facility. including upstream and downstream processing. WATER DISPUTE In 2005 a dispute arose between Amgen and Kent County Water Authority over the plant's demand for water. Turner Construction was initially appointed as construction manager but was replaced in 2002 by Fluor. including Delta V installation). a subsidiary of Alfa Laval. Kinetics Group Inc was involved in the design and process engineering of the equipment skids and additional equipment in the facility. Edward Rouse Architects designed the new pharmaceutical facility and Kvaerner Engineering and Contracting had a key role in designing and building it. a warehouse. The disagreement escalated and eventually in January 2006 the State passed a bill guaranteeing the water supply for the company and forcing Kent County water authority to back down.000ft²). and ITT Industries' Pure-Flo Solutions Group (ultra hygienic valves and skids).000l and 15.000l each.000 gallons per day. BIONEXT PROJECT (NEW ENBREL MANUFACTURING PLANT) The second stage of the project involved building a new manufacturing plant. The ESA problems have been addressed by the commissioning of new clinical studies into safety and by an improvement in the warnings included with the two drugs Epogen and Aranesp. and a quality laboratory. The facilities include media/buffer prep. West Greenwic.. http://www.com/projects/westgreen. inoculum prep. This is about ten times the size of bioreactors currently used in most pharmaceutical manufacturing plants. The BioNext plant employs 350 workers to give a total of 700 personnel employed on the site." Expand Image Immunex has also recently invested in a pharmaceutical facility in Bothell in Washington. The new manufacturing plant received FDA approval in a 2005 validation audit and is now in full production. The BioNext plant is to be kept open to supply the market with Enbrel. WEST GREENWICH BIONEXT PLANT CONTRACTORS "In 2005 a dispute arose between Amgen and Kent County Water Authority over the plant's demand for water. The project was executed in a fast track mode (33 months conceptual design through to mechanical completion) with extensive use of modularisation and off-site fabrication. Expand Image Part of the utilities infrastructure at the new BioNext mammalian protein manufacturing facility.000ft². E2 Engineers were the structural engineers for the construction of the QC laboratories.000 gallons per day for the plant and the authority said it could not be done.
The idea was that this day.5in to 4in. The retrofitted Enbrel plant was completed in 2001 and validated for use in the production of Enbrel by the FDA in 2002.000 Pure-Flo valves have been installed in the West Greenwich facility on the upstream side. Related links Safety Plan for Potentially Dangerous Cancer Drugs Related Projects: Americas Unilife Corporation Commercial Production Facility. Over 500 PFSG valves. The total cost of the project was $225m. http://www. were employed in cryogenic vessels. including the new ISG valve.com/projects/westgreen. divert valves. These economies of design saved $100m in construction cost and reduced the project schedule by many months. used traditional and custom zero-static valves with sizes ranging from 0. Downstream applications at the plant. The retrofit involved the adoption of: 120 pieces of major equipment. by-pass valves and double block and vent valve blocks were used in critical control applications.000l bioreactors. Expand Image The water treatment plant Immunex agreed to take over an existing manufacturing facility from American Home will use 800. such as ultrafiltration (UF)." The valves have been used in dozens of cell culture applications throughout the seed and production bioreactor systems.. Ultra hygienic valves and skids from ITT Industries' Pure-Flo Solutions Group were chosen for use in the manufacturing process. RETROFITTED DRUG MANUFACTURING FACILITY facility would be retrofitted to produce biotech pharmaceutical products.000 gallons per Products' sub-division..pharmaceutical-technology.. "The retrofitted Enbrel plant was completed in 2001 and validated for use in the production of Enbrel by the FDA in 2002. Post to: Delicious Digg reddit Facebook StumbleUpon 3 of 4 3/27/11 12:43 PM . which are used to control freezing. 240 miles of electrical wire and 300t of heating and cooling ducts. West Greenwic. Expand Image The plant is now fully operational. PFSG 5-way chromatography valves. The existing facility covers approximately 250.Amgen Pharmaceutical Manufacturing Facility. bioKinetics used their K-TOPS software to model the new plant systems and were able to demonstrate that production goals could be met with only one harvest and purification train. Their knowledge of bioreactor design and construction allowed the elimination of over half of the I/O and piping found on similar equipment in the existing facility. 25 miles of pipe.. Over 3. thawing and storage of biological products in portable vessels. Greenwich Holdings (BioNow project). which minimises contact surfaces and hold up volumes. They were also able to minimise the number of prep tanks and CIP skids by suggesting the use of pre-sterilised plastic bags.000ft² and is equipped with eight 8. PROJECT SPECIFICS During conceptual design. The ISG was selected due to its internal design.5in to 3in. ranging in size from 0. In chromatography. Blu Pharmaceuticals Facility Pharmatek Laboratories cGMP Facility Ash Stevens Riverview Facility Fraunhofer Plant-Based Vaccine Factory.
4 of 4 3/27/11 12:43 PM ...com/projects/westgreen.. http://www.Amgen Pharmaceutical Manufacturing Facility..pharmaceutical-technology. West Greenwic.
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