The 13,500 sq. ft. leased facility will focus on the early phase development of solid, semi-solid and oral liquid dosage forms, including the production of clinical trial materials for Phase I and II trials.

Patheon said that its’ "Quick to Clinic" program, which accelerate molecules to clinical trials while minimizing active pharmaceutical ingredient (API) requirements, will also be supported at the site.

Meanwhile, US CMO Metrics has now commenced operations in its $18m, 47,000 sq. ft facility addition, which nearly doubles its previous space at the site.

It was commissioned to allow the firm to "dramatically expand services", which include pharmaceutical formulation, analytical development, clinical trial manufacturing, and validation.

The new addition includes four new analytical laboratories, stability storage facilities, a dedicated cytotoxic and potent compound laboratory, and a new microbiology laboratory.

As part of its plant expansion, Metrics indicated that it is also employing at least 50 additional pharmaceutical scientists and technicians, adding to its current level of 225 staff.

Meanwhile, Welsh firm Penn Pharmaceuticals has also opened a new facility in the country that will allow it to manufacture highly-potent compounds in a contained environment.

The firm's services are focused on producing drugs for clinical trials and company chief executive Peter George said that the demand for high-potency drug manufacturing is strong due to the nature of new treatments such as cancer drugs, many of which require high-potency compounds, emerging from drug pipelines.

George also said that the new facility will allow Penn to further develop the range of services it offers to pharma firms and assist it in its mission to expand further across Europe, in addition to breaking into the lucrative US market.

Clairvest and LSNO Open New Facility

Canada's Clairvest Group, along with Clairvest Equity Partners III Limited Partnership, recently announced a combined $20m minority investment in US firm Lyophilization Services of New England (LSNE).

LSNE is a CMO focused on providing lyophilisation (freeze-drying) services to biopharma and medical device manufacturers and currently operates two facilities: one in Manchester and the other in Bedford, New Hampshire.

Clairvest's investment will assist LSNE in the construction of a third, larger facility to accommodate expected future growth.

The lyophilisation industry is worth an estimated $1.3bn per year and is said to be growing at a double digit rate, driven by the increasing number of biologic drugs being developed, many of which require lyophilisation in order to retain the stability of the API, in addition to a trend amongst biopharma firms to outsource manufacturing to CMOs.

GSK Expands Manufacturing Facility in Ireland

GlaxoSmithKline (GSK) is to expand its over-the-counter manufacturing facility in Dangarvan, Ireland. The firm will invest around €30m to establish a new manufacturing unit to produce an as yet unidentified smoking cessation product for markets outside North America.

Plans for the new unit were announced by Ireland's minister for social and family affairs Martin Cullen. He was visiting the County Wexford site to open a recently completed €23m granulation and production unit. Cullen said that the new investment would create around 50 new jobs in functions ranging from production, to quality assurance and engineering.

At present the site, which employs almost 700 staff, manufactures OTC brands such as Panadol, Coldrex and Solpadeine. In addition, GSK's Oral Care unit, which is also based in Dungarvan, produces denture care brands such as Polident, Poligrip and Corega.

Microbix Opens New Virology Plant

Canada's Microbix Biosystems has completed the purchase of a new virology manufacturing plant in Toronto. The site will manufacture the firm's range of virology products including Urokinase, Virusmax and its Semen Sexing Technology kits.

Eastman Chemical Company Closes Plant in Wales

Eastman Chemical is to close its manufacturing site in Anglesey, Wales and is ceasing production of the Vitamin E TPGS (d-alpha-tocopheryl polyethylene glycol 1000 succinate) excipient that is current synthesized at the facility.

Eastman said that the site no longer fits with its corporate strategy and, following consultation with employees at the factory, has decided to decommission the facility before the end of the year. The firm also said that it would provide a transitional supply to its existing customers, based on historical orders.

Unigene Builds New Plant in China

US drug maker Unigene has begun construction of new facilities in China as part of its joint venture with a state-owned Chinese pharmaceutical company to establish research, development and manufacturing capacities in the nation.

The joint venture is in conjunction with state owned Shijiazhuang Pharmaceutical Group Corporation (SPG), its subsidiary China Pharmaceutical Group (CPG) and NBP Pharmaceutical Company (NBP).

The facility is designed to comply with the good manufacturing practice and good laboratory practice guidelines laid down by the US Food and Drug Administration and Chinese State Food and Drug Administration, as well as International Conference on Harmonization (ICH) guidelines.

Although global standards are being adhered to the facility is very much aimed at the Chinese market.

The PRC (People's Republic of China) pharmaceutical market for Western-style pharmaceuticals in 2006 was $13.1 billion, representing year-on-year growth of 30 per cent, one of the fastest growth rates in the world. It has been projected that the PRC will become the world's leading consumer of pharmaceutical products by the year 2020.

The plant will initially focus on the development and production of osteoporosis treatments salmon calcitonin and parathyroid hormone, primarily for the Chinese market. A phased completion of the site is planned, with a four-storey building scheduled to be finished first, around the end of 2008.

Facilities for molecular biology, fermentation, purification, pharmacology, analytical chemistry, formulation and pilot-scale production of biotechnology products will be housed within this first building.

Looking down the line further manufacturing facilities will be added for peptide production and manufacture of oral and nasal finished formulations. Production and validation activities are expected to go live in 2009.

SPG has provided the 215,000 sq ft of land in the Shijiazhuang economic and technology development zone of Hebei Province on which the plant will be constructed.

The bulk of the funding is coming from SPG's subsidiary CPG, meaning the deal is effectively an acquisition of Unigene's technology by Chinese state-owned or affiliated companies.

In addition, NBP has opened up some of its facilities for 40 SPG/CPG employees to work exclusively on projects relating to the joint venture.

Financially the venture is quite complex but the financial burden on Unigene is minimal owing to the technology they are providing. In addition there is an option for Unigene to repay a loan from CPG by providing additional technologies or reduce its share in the partnership at a later date.

This structuring of the deal should minimize the risk for Unigene in entering the Chinese market. The company is still very much in the developmental stage and made a loss of $3.45m for the 2007 calendar year.

Schott Forms JV in India

German-based technology group Schott has formed a joint venture with Kaisha in an attempt to gain access to the glass primary pharmaceutical packaging market in India.

India-based glass pharmaceutical packaging company Kaisha has manufacturing facilities at Mumbai and Daman which the joint venture will utilize, with Schott sharing its technological knowledge. Each company will have a 50 per cent share in the venture.

Kaisha claims to manufacture four million vials and ampoules a day. This makes it a major player in the Indian primary pharmaceutical packaging market, with sales of $17.4m, and Schott will be hoping this strong starting position allows it to sew up the sector.

For many years Schott has sold Kaisha pharmaceutical glass tubing so the two companies already had a working relationship prior to the joint venture.

However, Schott has now decided it's the right time to establish a more substantial presence in India. This move is motivated by desire to access the pharmaceutical packaging market in India, which is growing at approximately 10 to 15 per cent per annum, according to Schott.

This double-digit growth should continue as increasing numbers of Indian pharmaceutical companies look to supply their products in international quality packaging.

Over the last few months Schott has been looking to establish itself in developing markets, with the company planning to be set up in Russia by 2009.

This is in addition to its pharmaceutical packaging production sites which are already established in Brazil, Indonesia and China, as well as seven other countries.

The China plant in particular was given a boost recently after it received the official license to manufacture and supply vials and ampoules to the Chinese pharmaceutical industry by China's State Food and Drug Administration. China recently introduced a more stringent approval process for suppliers of pharmaceutical packaging with the intention of raising standards across the nation.

SurModics’ Brookwood Pharmaceuticals Expand

SurModics’ Brookwood Pharmaceuticals subsidiary acquired an additional facility in the Birmingham, AL area for $30 million. This site will expand Brookwood’s R&D and clinical manufacturing capacity in support of customer projects. Additionally, SurModics’ corporate center for commercial GMP manufacturing of drug delivery products will also be located here.

Brookwood’s employee population could reach roughly 300 over the next three to five years.”

Genzyme to Construct R&D Center in Beijing

Genzyme unveiled plans to construct an R&D center in Beijing. Expected to open in 2010, the site will cost about $90 million. The 200,000 sq. ft. facility will be able to accommodate 350 employees, Genzyme reports.

The 200,000-sq.-ft. facility will be located in Zhongguancun (ZGC) Life Science Park and will be constructed with low-impact environmental techniques and methods that incorporate a range of green features including: a living roof to reduce pollution caused by storm water runoff; a solar thermal system that will provide a significant portion of the building's hot water and reduce its energy consumption; and low-flow fixtures to limit water usage. The company is seeking necessary government authorizations and expects to complete and open the facility in 2010. The facility will accommodate 350 employees.

Genzyme's core R&D operations are located in Massachusetts. The company also has a research site in Cambridge, U.K. The Beijing facility will be the company's second product-focused R&D site outside of the U.S

The firm will conduct research in orthopedics, oncology, and endocrinology as well as transplant, immune, and cardiovascular diseases at this center. It will also include laboratory-scale operations for MACI® (matrix-induced autologous chondrocyte implantation) cell therapy and polyclonal antibody operations.

The facility will feature an environmentally clean design. It will incorporate features like a living roof to reduce pollution caused by storm-water runoff, a solar thermal system that will provide a significant portion of the building's hot water and reduce its energy consumption, and low-flow fixtures to limit water usage. An all-glass exterior will provide employees with significant natural light, reducing the building’s dependence on electricity.

James Madison University Builds New Biotechnology Facility

The General Assembly approved $167 million in construction projects for James Madison University.

About $64 million of that spending is state money, the lion's share coming from the $1.5 billion bond package designed to finance higher-education projects around Virginia. Lawmakers gave their OK to the bonds during a special session.

About $103 million of the approved figure will be generated by the university, officials said.

According to a JMU release, the following expenditures will be funded by the state:

The biotechnology building, called Centennial Hall, will cost $44.8 million. The planning phase is to begin July 1 and construction should be complete in about three years, JMU officials said. The building will be a "key component of the ‘science corridor' on the university's east campus" and will be the focus of much of JMU's life sciences instruction and research, according to the university. The building, according to JMU's press release, will "be a great complement to the partnership between SRI International, JMU and other Virginia institutions of higher education."

JMU will begin the first phase of replacing the boiler for its power plant. The work will cost $6 million.

The state approved $2.6 million to plan the renovation of the west wing of Rockingham Memorial Hospital. Although the estimated cost of the total project will cost $51.4 million, that figure has not yet been approved by the state. The legislature did, however, approve $8.6 million as the last payment for the existing hospital facility.

Lawmakers also approved $250,000 for planning and design work for the Duke Hall expansion. That project, once approved by the General Assembly, will cost $43.7 million. But again, the total figure is only an estimate and was not included in this year's approved spending.

EMD Serono Invests $50 million in Research Center

Merck Serono and its US affiliate EMD Serono, Inc., both part of Merck KGaA, Darmstadt, Germany, announced a planned expansion of EMD Serono’s US presence with an anticipated investment of $50 million at its Billerica facility northwest of Boston. The company anticipates that this investment will create more than 100 new jobs in Massachusetts. The investment will support the construction of a center of excellence in discovery, creating critical mass in research with a common goal of finding new treatments for unmet medical needs.

Once complete, the new site will accommodate approximately 200 scientists with expertise in cancer biology, cancer immunotherapy, oncogene signaling, manufacturing cell lines, medicinal chemistry, molecular modeling, protein engineering, and therapeutic antibodies, across the research areas of cancer and fertility, as well as approximately 50 employees in Technical Operations who specialize in process development and protein production.

The company’s protein production facility in Billerica, which manufactures products for early stage clinical testing, is a significant reason why the site was selected for expansion; the close proximity of protein production to research drives collaborative interactions and supports the rapid transition from research to manufacturing.

Construction at the new site will begin early next year and is expected to be complete in 2010. Upon completion, the total square footage of the Billerica Campus will be approximately 210,000 square feet, including more than 160,000 square feet of lab space.

The US headquarters of EMD Serono will remain in Rockland. The company will strengthen its leadership position in its current therapeutic areas of Neurodegenerative Diseases and Endocrinology, and build the necessary infrastructure to support an increase in US clinical trials, as well as commercial growth in new areas of expertise, including cancer and autoimmune/inflammatory diseases.

Krakow Site for New Biotech Facility

PM Group and Ekocentrum have been appointed to oversee the design and construction of the first phase of a new biotech park in Kraków. The value of the investment is estimated at 14.6 [zł 50] million and construction has already begun.

Jagiellonian University's LifeScience Biotechnology Park project will be the first real estate product for the commercial life-science market in the CEE region. It is expected to provide high-class office and laboratory infrastructure to host businesses from the biotechnology and biomedical sectors. The complex will comprise three interlinked buildings whose total space will amount to approximately 25,000 sqm. (260,000 sq. ft.)

The university hopes the LifeScience project will create a regional research hub accommodating approximately 500 scientists and scholars. "This is a chance to launch and develop high-tech biotechnology and biomedicine enterprises. The development may attract big companies from the United States and Western Europe," said Pawel Błachno, president of the Jagiellonian Centre of Innovation, the university-run enterprise responsible for the LifeScience project.

The first stage is scheduled for completion by the end of this year. It will feature 6,000 sqm (64,560 sq. ft.) of high-quality office space and laboratory facilities. The LifeScience park will be located in the Kraków Special Economic Zone, allowing it to take advantage of significant tax benefits.

The architectural design was developed by IMB Asymetria - best known for its flagship Galeria Kazimierz shopping center project in Kraków.

Both companies responsible for the first phase of the development boast an extensive portfolio of completed infrastructure developments. PM Group, established in Dublin in 1973, is a leading engineering consultancy in Ireland. It has been successfully operating in Poland since 1997. Apart from LifeScience Park, it is currently managing development projects for Dell and LG Philips.

Metrics Adds Lab Space

Metrics Inc., Greenville, N.C., a contract pharmaceutical development laboratory, opened an $18 million, 47,000-square-foot facility addition, which nearly doubled its space. The expansion allows the company to dramatically expand services to clients, according to a statement.

Metrics provides pharmaceutical formulation, clinical trial material (Phase 1, 2, and 3) and commercial manufacturing, and analytical development/validation services to the pharmaceutical industry.

Metrics' facility addition includes four new analytical laboratories, stability storage, a dedicated cytotoxic and potent compound laboratory, and a microbiology laboratory.

Inotek Closes Israeli Plant, Returns to Massachusetts

US firm Inotek has launched a restructuring program which will see its Israeli manufacturing plant sold off and all operations brought back to its Massachusetts headquarters.

In addition, several international offices are to be closed and all resources focused on the development of its two main clinical program and the advancement of its two preclinical program.

The manufacturing plant in Israel was purchased by Inotek in 2004 and since then $5m worth of investment has been spent on construction and capital equipment.

Inotek's redevelopment of the 40,000 sq ft site has created a GMP manufacturing facility with the capacity for scale-up, process research and pilot manufacturing.

A particular niche served by the site is multi-step synthesis and scale-up under cGMP conditions. The site has also been used to provide services, including R&D, QC testing, analytical development and process manufacturing, to chemical and pharmaceutical companies

Around 45 staff are employed at the site and they are listed among the facilities at the site in the brochure advertising the sale of the plant.

The cut-backs by Inotek coincide with the ending of their collaboration with Genentech which focused on the discovery and development of inhibitors of poly (ADP-ribose) polymerase (PARP) for the potential treatment of cancer

Alcon Builds Plant in Singapore

US-based ophthalmic specialist Alcon has given a boost to the flagging Singapore pharmaceutical manufacturing industry by building a plant there.

The site, construction of which will commence in 2009, will manufacture pharmaceuticals for distribution throughout Asia. In 2012 the site will become fully operational, by which time 150 people will be employed there.

Alcon is to lease a 20-acre plot of land in the Tuas Biomedical Park on which to build its 250,000 sq ft facility which the company expects to have a manufacturing rate of more than 53m units per year by the end of the third operational year.

The Tuas Biomedical Park has proven popular with pharmaceutical and biotech companies, with Pfizer, GlaxoSmithKline and Genentech among those with operations there.

Despite these household names operating in Singapore the nation's biomedical manufacturing industry has been buckling under the weight of the potential US recession.

Output in December was down 34 per cent on the previous year and any fresh investment will be welcomed amid fears that the heavily trade-reliant economy will collapse as US financial activity slows.

Regardless of these concerns Singapore still presents an attractive location.

Alcon already has a manufacturing site for surgical intraocular lenses in Beijing but at present its pharmaceutical plants are in Europe, the US, Mexico and South America.

Competitors are also seeking to establish in the Asian market, with eye care specialist Bausch & Lomb buying China's leading ophthalmic pharmaceutical company, Shandong Chia Tai Freda Pharmaceutical Group in 2005.

However, the growing prosperity in the region, with the lifestyle and age-related ailments this entails, means there should be a sizeable market for Alcon to take a share of.

Icelandic Actavis Buys Chinese Company

Actavis has purchased a 90 per cent stake in Zhejiang Chiral Medicine Chemicals (CMC), a Hangzhou, China-based active pharmaceutical ingredients (API) maker.

The move, which is for an undisclosed sum, is in keeping with the Icelandic generics giant's previously stated strategy to aggressively reduce costs, particularly in terms of its API production operations.

The new purchase will also complement the activities of Actavis' existing manufacturing facility in China's southern Guangdong province. The site currently produces a wide range of tablets, capsules, suspensions, creams and ointments.

Overall though, the acquisition of CMC and the improved access to APIs that it provides will help Actavis expand its production capacity and maintain the momentum of its extensive program of product launches. The firm's Bulgarian subsidiary for example, has introduced 29 new products to the local market.

The deal is also part of the expansion program that has already seen Actavis acquire Pfizer's manufacturing facility in Nerviano, Italy, this year. To date, the firm has established a presence in 44 countries around the world, with 21 facilities involved in the production of generic pharmaceutical products.

CMC Increases Manufacturing Capacity

CMC, which was founded in 2001, currently employs around 200 people at its 15,000 square meter API manufacturing facility. The company already supplies a variety of drug ingredients to pharmaceutical companies both inside and outside China.

CMC holds Chinese State Food and Drug Administration good manufacturing practice (GMP) certificates for a range of ingredients, including methyldopa and carbidopa. Additionally, according to CMC's website, the company is currently seeking US FDA GMP certification for the anticonvulsant gabapentin.

The addition of CMC to Actavis' portfolio of global API sites, which already includes several state of the art facilities in India, will also improve the Icelandic firm's standing as an API supplier to drug makers worldwide. The deal increases Actavis' workforce in China to around 500 employees.

CRI Expands Philadelphia Space for Clinical Trials

CRI Worldwide has announced the completion of a "major" expansion of its research facility in Philadelphia, with the firm stating that it has nearly quadrupled its existing space, and can now conduct both inpatient and outpatient clinical trials, from early through to late stage, within the one facility.

The company´s upgraded clinical unit, located within the Kirkbride Center, an acute care psychiatric hospital, features a new laboratory, exam rooms, patient consent rooms, inpatient clinical support, conference rooms, storage areas, a waiting room and physicians' offices.

Six physicians, with central nervous system expertise ranging from pain to psychiatric disorders, will serve on the staff in a full-time capacity, the firm said.

Pharmaceutical Product Development (PPD) Opens New Office at the North Carolina Research Campus.

PPD, the global contract research organization (CRO) will create up to 300 new jobs in the region over the next two to three years.

PPD´s expansion of its operations into the 40,000 sq. ft facility will require a range of new staff from clinical research associates, clinical project managers, among other
medical and scientific personnel.

Only two months ago, PPD announced it is also moving into Russia via the purchase of InnoPharm, another CRO based in Smolensk, which also has offices in Moscow and St Petersburg and a staff of 300.

The acquisition of InnoPharm, which offers Phase II-IV clinical trials, data management and biostatistics services, will not only provide PPD with a foothold in the vast clinical territory of Russia, but also in neighboring Ukraine, where it has an office in Kiev.

Meanwhile, one month prior to this, the ambitious company also initiated new central laboratory services in China in response to the country's budding clinical trials scene.

The CRO did so by has forming an exclusive agreement with Peking Union Lawke Biomedical Development Limited (PUL) that allowed it to "begin immediately" providing its central lab services to biopharma firms in the country.

The firm currently has other central labs in Brussels, Belgium and Kentucky in the US and said that China's attractiveness lies in the fact that it is a "high-growth clinical research market." PPD, along with several other global CROs already currently run clinical trials in China.

Bio-Bridge Science Builds New Vaccine Plant in China

Bio-Bridge Science, Inc., a biotechnology company engaged in the commercial development of vaccines for the prevention and treatment of human infectious diseases announced that it has entered into a non-binding memorandum of understanding (the "MOU") with JR Scientific, Inc., a Woodland, California based manufacturer of classical and custom cell culture medium and sera products ("JRS”) and Mr. Jan Baker, President and CEO of JRS. Under the MOU, Bio-Bridge Science will form a joint venture together with JRS and several other investors in China. The JV is expected to mainly produce culture medium, serum, and other biomaterial for sale in China and other countries under the brand name of the JV. Cell culture medium and serum are used in vaccine production as well as scientific research. The total investment for the JV is planned to be around RMB 10 million (US about $1.4 million). The JV will fit into our strategic plan by providing a potential source of revenue as well as vaccine material for our own vaccine research and production.

Bio-Bridge signed a contract in March of 2008 with a local electricity construction company and the electricity construction work for Bio-Bridge’s GMP facility in Tianzho (Beijing) is currently underway. Bio-Bridge projects that the facility will be operational for producing vaccines for clinical trial purposes in the second half of 2008.

BioTime Opens Tissue Culture Facility

BioTime reports that it has opened an 11,000 sq. ft. tissue culture GMP-capable facility in Alameda, CA. The site is certified as Class 1000 and Class 10,000 laboratory space and includes cell culture and manufacturing equipment.

BioTime’s subsidiary, Embryome Sciences, will use the plant for the production and marketing of embryonic progenitor cells, progenitor cell lines, and products derived from those embryonic progenitor cell lines. The products developed in the new facility will be produced and sold for research purposes.

BioTime plans to move its headquarters from its current location in Emeryville, CA, to this new space.

Stem Cell Center in California Planned

San Diego's four largest research institutes plan to build the nation's first-of-its-kind stem cell center, which scientists have dubbed a “collaboratory”, in La Jolla.

In a proposed $115 million building to be built near the Torrey Pines Gliderport, teams of scientists will collaborate to unlock the regenerative mysteries of stem cells and how they can be used to address critical health issues.

The center is envisioned as the core for a larger organization: the San Diego Consortium for Regenerative Medicine. Its members are UCSD, Scripps Research Institute, the Salk Institute and the Burnham Institute for Medical Research.

While it is common for teams of scientists to work together, it is rare for four independent institutes that compete for the same grants and philanthropic dollars to enter such a collaboration. By eliminating duplication, the effort should leave more money for pure research.

Salk has a strong stem cell program, as does the Burnham Institute. Scripps is renowned for its medicinal chemistry, which is needed to make targeted and effective drug compounds. And UCSD, along with a strong stem cell program, has bioengineers and a medical school with access to patients who could benefit from the therapies being developed.

The $3 billion voter initiative created the state stem cell institute to fund research independently of the federal government.

The site of the consortium's proposed center, which would have four floors and a basement, is a 7½-acre parcel at North Torrey Pines Road and Torrey Pines Scenic Drive. The land, owned by UCSD, is valued at about $15 million and is within walking distance of all four member campuses.

The consortium hired Louis Coffman, a former chief operating officer at the Burnham Institute and Seattle's Institute for Systems Biology, to pull together its grant application. He oversaw the construction of major additions at both the Burnham and Seattle institutes.

The San Diego consortium has applied for $50 million, but it is doubtful that the consortium will get all the money it wants.

The site contains the remnants of old military bunkers and is covered with grasses and eucalyptus trees.

The structure the scientists envision would meet federal requirements for a green building and would contain 23,740 square feet of laboratory and support space. Labs would be built without walls separating them. There would also be a cafeteria, as well as an auditorium, to be named for the philanthropic donor.

Further space would be provided where scientists could meet with colleagues to discuss projects and ideas. There would be experts from many fields other than stem cells looking to meet there, including biologists, chemists, physician researchers and bioengineers, as well as computational biologists. Scientists from outside the building also would be welcome.

The 21 scientific teams stationed there each would be led by a senior scientist who would act as a mentor to junior faculty, visiting scholars and postdoctoral fellows. Junior scientists would be chosen competitively.

Costa Rica Feeling Crunch

Costa Rica is on the verge of losing a multimillion-euro donation from the European Union (EU) to build a state-of-the-art biotech facility, because of government procrastination.

The EU put forward €10.9 million (US$17.3 million) for the National Centre for Biotechnological Innovation (CENIBiot) in 2005, but is threatening to withdraw it because the Costa Rican government has so far failed to produce the necessary contracts to purchase equipment and begin construction at the facility. The government, which is to contribute €4 million, is finally expected to issue its first tenders. But these will have to be answered, reviewed and approved by the end of this year if the money is to be kept. “The project is at a critical stage,” says Roelf Smit, the first councillor at the European Commission's delegation in San José, Costa Rica.

CENIBiot was conceived as a technology-transfer laboratory to meet the needs of the Costa Rican economy, mainly in agriculture. Planners hope the centre will aid Costa Rica's coffee, pineapple and banana trade and lead to the development of locally grown biofuels. But two years after its inception, equipment has not been purchased and renovations have yet to begin at the site in a San José suburb. Smit says the decision to recall the money is standard procedure for the EU. “We don't want to have money sitting around for more than three years,” he says.

New Facility in Londonderry

The first sod of a new £2m state-of-the-art Academic Business and Clinical Research and Innovation Facility (ABC-RIF) at Altnagelvin Hospital, Londonderry was cut this week. The unique project involves a joint partnership between the University, the Western Health and Social Care Trust, and Derry City Council, bringing health, education and business under one roof.

The development will support the research and innovation and generate commercial opportunities in the region and will link the University’s research to the clinical expertise within the Western Trust, and focus on improving the general health and well-being of the 290,000 people living in the Western region.

Professor Bernie Hannigan, Pro Vice Chancellor at the University of Ulster and Director of Research & Development for Health & Social Care in Northern Ireland, said: “The ABC-RIF will provide specialist workspace and services for academic researchers, clinical researchers and the biotechnology industry, including the pharmaceutical, bio-pharmaceutical and medical device sectors. The promoters expect that activities within the facility and access to world class expertise in biomedical science from the University of Ulster will lead to significantly increased capacity for research, novel patented therapies, licensing opportunities and spin-out companies.”

Invest NI is providing £1.3m of EU support on behalf of the Special EU Programmes Body under the INTERREG IIIa Programme and a further £464,000 through the Integrated Development Fund (IDF) to support the project. IIex which has a coordinating role for the package of local IDF supported projects, views the project as an important element of its work in regenerating the City of Derry. Additional funding is being provided by Western Trust (£300,000) and Derry City Council (£200,000).

The ABC project was initiated and supported by the North West Science and Technology Partnership. It is expected that the ABC-RIF will have a significant health and economic development impact across the entire North-West and the promoters have already had significant commercial interest in utilizing the facility and associated expertise.

Dr Reddy's, Ranbaxy Laboratories and Shilpa Medicare (India) Announced New Merger and Acquisition (M&A) Deals

M&A activity in the pharma industry involving Indian players has been recently becoming more commonplace as the country’s large firms begin to push hard for a more global presence.

Dr Reddy's Buys Dow Small Molecule Business

Dr Reddy's has revealed it is boosting its contract manufacturing business with the purchase of US firm Dow Chemical's small molecules business.

The acquired unit operates out of Dowpharma´s UK sites at Mirfield and Cambridge. Together they employ 80 staff and are said to be worth $25m. No financial terms of the deal were disclosed except that that it is expected to be finalized at the end of this month.

In addition to gaining the sites along with their customer contracts, products, process technologies, intellectual property and trademarks, Dr Reddy´s will also obtain a non-exclusive license to Dow's Pfenex Expression Technology for biocatalysis development.

Ranbaxy Offloads Liquid Manufacturing Unit

Meanwhile, one or Dr. Reddy´s larger rivals, Ranbaxy, has announced that it is hiving off the oral liquid manufacturing unit of its Romanian subsidiary, Terapia, located in Bucharest.
The company is reportedly in talks with several global pharma companies who may be looking to purchase the business, which is said to be worth $15-20m, and it is expected that a deal with be closed by the end of this quarter.

Although the business is profitable, liquid manufacturing is not a core focus of Ranbaxy and the firm acquired the unit when it bought Terapia in 2006 for $324m.

According to India’s Economic Times, the intended sale is part of a "rationalization" move being made by Ranbaxy to expand its manufacturing operations at its main Romanian facility in Kluez. The country has been identified by the firm as a key location from which to tap into the European generics market and it plans to step up its activities in this regard.

Shilpa Adds Austrian APIs

The third M&A announcement comes from Shilpa Medicare Ltd, who has revealed the purchase of LOBA Feinchemie, an Austrian company based in Vienna.

The newly-acquired business provides specialty active pharmaceutical ingredients (APIs), organic intermediates, biochemical diagnostics, and custom synthesis for the global pharma industry and its facility is approved by the Austrian Ministry of Health and the US Food & Drug Administration (FDA).

In addition to obtaining better access to the highly-regulated markets of the US and Europe, Shilpa also gains a new foothold in the South Korean market where two of LOBA´s products, gemcitabine HCl and ambroxol HCl, have just been approved for sale.

Shilpa is India´s largest API producer and currently also provides, fine and specialty chemicals, intermediates, bulk drugs, as well as oncology products, to locations across the globe.

Schering-Plough to Reduce Its Manufacturing Plants and Cut its R&D Expenditure

U.S. drugmaker Schering-Plough is to reduce the numbers of its manufacturing plants and cut its R&D expenditure in an attempt to achieve savings of $1.5bn by 2012.

The move will also see a reduction in the product portfolio and ten per cent of the company's 55,000 workforce stand to lose their jobs.

The reduction in R&D will see resources focused on to fewer, higher potential projects such as the Phase III thrombin receptor antagonist (TRA) cardiovascular compound SCH 530348.

Ireland Pharma Expanding

Genzyme is putting another €130m into its manufacturing facility in Waterford, Ireland, where the US biotech first put down roots in 2001 and has been steadily expanding ever since.

The latest phase, which includes undisclosed support from IDA Ireland, will build on Genzyme's existing sterile fill/finish manufacturing capabilities at the Waterford campus, expand the site's quality control (QC) laboratories, introduce softgel capsule manufacturing and provide new office space.

The investment will create 170 jobs in manufacturing, quality and engineering, taking Genzyme's total headcount in Waterford up to more than 600, and will significantly increase manufacturing capacity at the site over the next three years, said the company and the IPA.

The announcement was a coup for the County Waterford region, which will also see 100 new high-level positions created in Dungarvan over the next five years as US company Lancaster Laboratories capitalizes on last year's acquisition of Irish laboratory Microchem (now Lancaster Laboratories Europe).

A subsidiary of Thermo Fisher Scientific, Lancaster supplies outsourced testing services to the pharmaceutical, biotechnology and environmental sectors.

Another 165 jobs will come over five years from a €65m investment by Israeli generic manufacturer Teva Pharmaceuticals in its existing Waterford facility. This initiative, announced in March, was also supported by IDA Ireland, which has energetically pursued foreign investment in pharmaceutical manufacturing, research and development.

The enhancements to Genyme's biological fill and finish operations at Waterford include the addition of a second isolated filling line, three more lyophilisers and associated upgrades as well as new utilities and support areas.

Design work on this project has already begun and planning permission has been sought to extend the 6,800 sq m (73,168 sq. ft.) building to accommodate the extra equipment, which will quadruple existing capacity to over 250 fills per year.

Construction is expected to be underway this summer, with completion scheduled for late 2009, followed by a start-up, commissioning and validation phase that should see the facilities ready for commercial production in mid-2011.

At the same time, the Waterford site infrastructure will grow significantly with 5,600 sq m (60,256 sq. ft.) of new offices, cafeteria and associated facilities, together with the expansion of the existing QC laboratories. The extra laboratory space will double existing capacity, with additional microbiology, chemistry, stability and associated support areas, Genzyme said.

Design work is underway on all of these developments, with construction expected to start this summer and completion slated for the summer of 2009.

The provision of softgel oral dose capacity within Genzyme's newly validated second oral dosage facility at Waterford is to satisfy demand for Hectorol, the company's doxercalciferol capsule formulation for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease (CKD). Design work is well advanced for this €6m program, with completion expected in 2009.

As Genzyme pointed out, the latest wave of investment is the fourth major development at the 37-acre Waterford site, which by 2010 will have absorbed total capital investment of more than €410 million.

The first phase was a tableting suite with packaging lines for the manufacture of Renagel (sevelamer hydrochloride), which controls serum phosphorus in CKD. The Waterford facility has been shipping the product out to dialysis patients worldwide since 2003.

The biologics fill finish facility at Waterford started commercial supplies of Thymoglobulin to global markets in 2006 and the second oral dose plant is due to begin operations this year.

The new product launches (both biologicals and oral-dose formulations) planned for 2008 will bring to eight the total number of Genzyme products being supplied globally from Waterford, the company noted.

The recent votes of confidence in County Waterford as a manufacturing and laboratory base from Genzyme, Teva and Lancaster Laboratories are a tonic for what has been a rather variable pharmaceutical investment trend in Ireland over the last year or so.

While there have been significant gains, such as Merck & Co's recent choice of Carlow in south east Ireland for a new €200m vaccines and biologics facility, or GlaxoSmithKline's decision last year to locate a €23m manufacturing plant for over-the-counter medicines in County Waterford, there have also been some disappointments.

In March 2007, for example, Sanofi-Aventis announced it was shutting down its manufacturing plant in Waterford to trim off excess capacity in its production network.

Last October Amgen indefinitely postponed plans for a €71m manufacturing facility in Cork, while in December Abbott Vascular said it would close down its Galway plant, citing "significant improvements in manufacturing efficiency" and "current market conditions" in the stent sector

China's Shanghai CP Guojian Pharmaceutical Building a New Facility

U.S.-based engineering services firm Emerson announced at Interphex that it has been selected to digitally automate a new facility in China that will produce the country's first monoclonal antibody (mAb) drugs.

China's Shanghai CP Guojian Pharmaceutical Company is building a new active pharmaceutical ingredient (API) production suite for the purpose, which will also house the largest mammalian cell-culture system in Asia.

mAbs are antibodies which have been produced in the laboratory against a specific antigen and are extremely specific when they bind to their target antigens. They are now being used in a range of next-generation biologic drugs to help combat diseases such as cancer.

Emerson has been chosen by Shanghai-based engineering procurement contractor M+W Zander, to design and install its PlantWeb digital plant architecture, integrated with its DeltaV system and Foundation fieldbus instrumentation, for networking intelligent process instrumentation to speed the drug production process.

To further speed startup, Emerson said it is supplying its AMS Suite software that communicates with smart field devices for "efficient commissioning".

Emerson's role will also be to reduce the complexity of field wiring and support asset management of the smart field devices, in addition to the configuration and integration of all field devices with the control system, and the provision of the necessary on-site services to validate the system before start-up.

Located in the Zhangjiang Hi-Tech Park in Shanghai, the new plant is expected to begin producing mAb drugs in China by August this year and the company said it expects to meet international standards with the products made in the facility.

Synchron Research Expanding Operations

Synchron Research has revealed it is close to opening up new operations in Vietnam and Hong Kong - within the next six months - and has just bought a new business in France and strengthened its ties with Parexel.

The Indian contract research organization (CRO) is planning to plant itself in the chosen Asian locations by either making an acquisition or forming a joint venture in order to "minimize start-up time," and is already involved in talks with "interested parties" in the two countries.

In doing so, the company aims to increase its presence in the Asia-Pacific region, an area that is heating up in terms of clinical research services and is attracting many CROs and pharma firms to set up new operations.

Synchron recently made a similar move in its own country this time last year when it acquired local start-up CRO Innovance - a first-of-its-kind buyout for India's clinical research scene.

Through the acquisition, the Ahmedabad-based firm increased its clinical capacity by adding three Phase I units to its already existing three clinical sites, boosting its bed capacity from 90 to 200.

Half of the company's revenue comes from European clients, 30 per cent from the US and the remaining is generated in India.

Synchron's acquisition move came on the heels of its first foray into the Asian space, where it increased its bioanalytical, bioequivalence, clinical research and data management services capacity by building a new 32,000 sq. ft facility in Bangkok, Thailand.

Meanwhile, Synchron, through its subsidiary Synexel Research International, has also just gained new a business in France, with the $6.7m purchase of a bioanalytical and biomarker laboratory in Poitiers, belonging to large CRO Parexel International.

Staff of the laboratory will join Synchron's bioanalytical business unit.

The acquired laboratory is good laboratory practice (GLP) Class A certified by Afssaps, France, and develops highly sensitive bioassay methods for use in all phases of drug development, from preclinical to Phase IV, for the determination of new chemical entities as well as marketed compounds.

The biomarker facility provides singleplexed and multiplexed immunoassays for early clinical, preclinical and clinical studies.

At the same time, Parexel also expanded its minority interest ownership in the clinical pharmacology business of Synchron in Ahmedabad, from 19.5 per cent to 31.0 per cent, at a cost of $5m.

In 2004, Parexel entered into an exclusive partnership with Synchron, which was expanded in 2006 when the CRO acquired a majority stake of Synchron's clinical trials business operations in Bangalore, and a minority equity interest in Synchron's Ahmedabad clinical pharmacology business, which it has now just increased.

In 2007, Parexel then opened an office in Hyderabad, India to offer clients clinical research and data management services from this location, in addition to its many other locations across the globe.

Bayer Uses Siemens to Update

Siemens Energy & Automation, Inc. announced that it has been awarded a project valued at more than $1 million to modernize the automation system at the Bayer CropScience site in Institute, West Virginia, with Siemens SIMATIC(R) PCS 7 distributed control system (DCS).

Bayer CropScience is one of the world's leading innovative crop science companies in the areas of crop protection, non-agriculture pest control, seeds, and plant biotechnology. The migration to the PCS 7 DCS will enable Bayer CropScience to meet challenging scheduling requirements while modernizing two manufacturing processes at the Institute site.

SUNY Upstate Medical University Plans Expansion

SUNY Upstate Medical University will become the new owner of the vacant, 14-acre Kennedy Square apartment complex in Syracuse and plans to construct a $40 million biotechnology research center, classroom and lab space on part of the site, state officials announced today.

The center will stand on four acres. Demolition could begin as soon as this summer and the plan is for construction to begin within a year, Upstate President Dr. David Smith said.

As for the other 10 acres, the university plans to seek proposals from private firms that would develop commercial and residential projects, and possibly more classroom space, Dr. David Smith said. The residences would be for university students, he said.

Indian Vaccine Plants Close to Become Laboratories

The Indian government has reacted to the enforced closure of three of its oldest vaccine manufacturing plants by launching a plan to convert them to drug testing laboratories.

The BCG Vaccine Laboratory, Pasteur Institute of India and the Central Research Institute were shut down in January after failing to comply with current good manufacturing practices cGMP.

However, they will now receive a new lease of life testing the safety and efficacy of drugs and vaccines produced and sold within the country or exported. In addition to this they will be responsible for detecting counterfeit and spurious batches of drugs.

According to data from the Pharmaceutical Security Institute (PSI), in 2006 India was the fifth most common country of origin for fake drugs, after China, Russia, the US and Brazil.

This process will include training by drug regulatory experts from Health Canada and the World Health Organization to assist staff in the conversion process.

Between them the three plants had met the needs of the national immunization program since its launch in 1978. However, with the oldest of the plants opening 103 years ago and the GMP standards being made more stringent they had to cease production.

The closure of the plants has been on the cards for several years, following criticisms by the WHO following inspections in 2001 and 2004.

WHO after the plant closures the Indian Minister for Health Anbumani Ramadoss said: "In 2007, when things were not to their satisfaction, they warned of derecognising the Indian NRA itself."

The units could have continued to produce the vaccines for the domestic market but Ramadoss said: "Derecognising Indian NRA as a country means even private units that are cGMP certified will not be able to export."

To replace the obsolete plants a centralized 'vaccine park' with modern infrastructure for production and research facilities is proposed to be set up near Chennai.

In the meantime vaccine production for India's immunization program will be taken up by the private sector.

Florida Biologix Expands Fill/Finish Area

Florida Biologix, a non-profit cGMP biopharmaceutical contract manufacturing organization, recently expanded their total fill and finish area 50 percent to increase capacity and improve filling services. The new area is a dedicated module which allows more space for post-fill processing, labeling, inspection and packaging. They also added new equipment, such as repeat pipettors, a Flexseal 10 semi-automatic crimping machine and a Sartocheck 4 Integrity Tester. "The new space and equipment are important for us to better fulfill client needs for our formulation and aseptic cGMP fills" explains Linna Lim, the Director of Operations. The fully validated multi-product cGMP facility has an ISO 6 fill suite in which fills occur in ISO 5 vertical laminar flow stations

Florida Biologix has more filling capacity than most CMOs of its size and has conducted multiple media fill validations for both automated and manual fills. Each media fill validation is renewed at least annually. The automated filler produces up to 4,000 standard glass vials per day (includes vial washing, filling, stoppering and inspection). In addition, up to 3,000 final containers (cryovials, conical tubes, bags or syringes) can be filled per day manually. The experienced fill team can also work with clients to suggest ways to optimize efficiency and reduce costs when planning how to formulate and fill a protein biologic, oligonucleotide, peptide or other bulk material.

San Francisco General Hospital to Get a Face Lift

The city revealed Tuesday the first detailed look at the renovation of San Francisco General Hospital - an $887.4 million project that is set to go before voters in November.

The construction plans, presented in a 51-page report during a Health Commission meeting, include a nine-story building with 284 patient beds on the edge of the hospital campus.

The old hospital, with 252 beds, is considered seismically unsafe and under state law must be renovated or replaced by 2013. Under the plan presented to the commission it would remain standing, and would hold psychiatric beds, clinical laboratories and outpatient facilities, along with the cafeteria.

The project will go before the Planning Commission for public comment. If a bond to pay for the renovations is approved by voters on Nov. 4, construction would start on the new building next summer. The hospital would be complete by 2015.

"This hospital is the anchor to our entire system of health care delivery," Mayor Gavin Newsom said during Tuesday's Health Commission meeting. "We have a historic chance to do something that will secure our future."

Newsom and health commissioners said they were pleased to see such an extensively detailed plan of the proposed hospital months before it will go before voters. The city spent $25 million studying renovation concepts and preparing the proposal.

The goal, Newsom said, was to avoid a situation similar to a bond measure for Laguna Honda Hospital nine years ago. Voters at the time approved a $299 million bond to rebuild the hospital, but the cost has more than doubled. The hospital is expected to be complete next year. Newsom said that the detailed San Francisco General plan makes the cost of the project clear, right from the start.

Under state law, all acute care hospitals must be seismically safe by 2013; if they have no plans to do that, they must close by the end of this year. Hospitals can ask for extensions on the 2013 deadline if they are in the process of renovating.

Bladen Community College Adds Labs and Cleanroom

Bladen Community College held a groundbreaking ceremony on March 27 for a project that will update the school’s shop complex and ultimately allow implementation of some biotechnology programs that cannot be offered with existing facilities.

The $1 million project is the first major upgrade of the technical shops since they were constructed in the 1970s.

The long sought after project was made possible by a competitive grant from the North Carolina Community College System designated for facility renovation and program expansion. The North Carolina General Assembly allocated $15 million to the system last year for such projects.

A new biotech area (clean room) will be constructed to support the training needs of biotech industrial applications. All of the shop areas will also be equipped with new climate control systems.

According to BCC Executive Vice President Lloyd Horne, actual construction of the facility was projected to begin on March 31. He pointed out that the construction schedule calls for project completion in the late summer or early fall, hopefully in time for the beginning of the fall semester.

Sid Peterson Hospital Moves to New Facilities

The new Peterson Regional Medical Center (PRMC), built over the past two years to replace the Memorial Hospital, opened its doors for a grand opening on Sunday, April 6. One week later, on April 12, existing patients will be moved and new patients were admitted at the $82 million Medical Center facility.

The 270,000 square-foot hospital includes diagnostic, treatment and patient-care areas. Hospital staff, which exceeds 800 full time employees as the largest employer in Kerr County, will serve patients at the 125-bed facility.

Amerine said that the facility was designed to reflect more of a resort feel than the typical antiseptic, cold hallways of a hospital. Every patient room is private and includes large windows to the outdoors, hallways are spacious and warmly-lit, and rooms feature wireless internet and LCD televisions to help pass the time during treatment.

The old facility is under contract with a commercial developer, although Amerine said she did not know what was planned for the old location.

Hagerstown Community College, PA Opens Biotech Labs

Hagerstown Community College, PA, recently finished its biotechnology wet labs complex and opened its extension center at the former Fort Ritchie U.S. Army base, which is being redeveloped into a residential, commercial and retail complex.

Isogen Building Injectable Filling Plant

Sterile process engineering consultancy firm Isogen is taking a maiden voyage into the manufacturing side of drugs with the construction of its first facility, aimed to fill a gap in small-scale injectables.

The firm is spending over $100m to build a new seven suite small-scale injectable filling plant in Delaware, US, company CEO Les Edwards said in an interview at this year's Interphex trade show, held in Philadelphia.

Building new commercial sterile filling lines for clinical fills in-house is cost prohibitive - companies can easily spend upwards of $100m and take at least four years to develop sterile manufacturing capacity, but they are highly reluctant to do this until they are certain the candidate drug will receive regulatory approval, Edwards explained.

Moreover, he said that existing large contract fillers are mainly interested in commercial scale manufacturing, which is more financially lucrative, and have no financial incentive to service clinical volume-size projects, while small specialist clinical fillers lack the necessary expertise and equipment to adequately deliver against a pharmaceutical company's complex needs.

Within the new site, Isogen's science centre, which consists of an analytical chemistry lab, will be up and running in 2009. This service, which will undertake testing to characterize compounds in the clinical stage, is particularly useful to small biopharma firms, who generally don't have any real specialty in the manufacturing side of things, in addition to the fact that biologic drugs are harder to scale up than small molecules.

Meanwhile, the first four out of the seven small-scale manufacturing suites will be fully operational by early 2010. The remaining three suites would take another 12 to 15 months.

The expansion is being paid for by investors, bank loans and the pre-sale of manufacturing slots to "partner" clients with whom the company will work with on a long term basis for multiple drugs. About 50 per cent of existing capacity is expected to be pre sold in this way.

Within the new facility, Isogen will accommodate liquid or lyophilized fills ranging in batch sizes from a few hundred to 30,000 vials or 100,000 syringes, on the same equipment, with common validation and document packages, "while setting new industry standards for sterility and containment assurance," said Edwards.

Isogen will be using barrier isolation technology in each of its manufacturing suites "to provide best-in-class sterile processing for potent and non-potent compounds," he said.

All equipment in the facilities will be built to handle potent products using isolation technology - every filling line is enclosed in an isolator.

Part of the reason the company designed the facilities this way is due to the large numbers of biologic and potent anti-cancer products that are expected to start coming out of the pipelines in the near future. Edwards anticipates that half of all the products coming through the facility will be potent.

While the capital cost of installing isolators across the board is high, Edwards believes that it is balanced out by the high operational costs of running clean rooms, as would be required instead.

Quintiles Provides Lab Services

Quintiles Transnational has signed an agreement with Medca Japan to provide central laboratory services in Japan. Quintiles will have its own staff at the College of American Pathologoists-certified Medca laboratory in Saitama, a city in the Greater Tokyo area. The lab will support clinical trials in Japan.

"Recent changes in legislation are allowing Japanese pharmaceutical companies to extend clinical trials normally conducted in Japan to other countries in Asia, but these companies have had difficulty finding central lab services that are harmonized throughout the region," said Tom Wollman, Senior vice President, Quintiles Global Central Laboratories. "With CAP-certified labs in Beijing, Singapore, Mumbai and now Japan, we can provide well-controlled processes and harmonized testing services throughout the Asia-Pacific region to customers in Japan as well as our multinational customers. This lab, along with all labs in our network, will follow the same standard operating procedures, and data will be available on our QNET database."

Medca provides a broad range of laboratory services, including biochemical tests as well as endocrine testing, tumor marker testing, drug-level testing, immunology testing and microbiological testing. The laboratory has undertaken specimens for examination from about 4,000 medical institutions throughout Japan.

The relationship with Medca will be managed within Quintiles by Alan Ong, Vice President and General Manager, Quintiles Labs Asia, who will give technical guidance, and Narimatsu, who will provide his expertise on the Japan market.

NicOx and Archimica Work Together to Supply APIs

NicOx has signed an agreement with the fine chemical company Archimica, for the commercial manufacturing and supply of the active pharmaceutical ingredient (API) of its Phase III osteoarthritis drug naproxcinod.

The aim of this agreement is to generate enough of the drug to ensure an adequate supply when it is commercially launched. The filing of a new drug application (NDA) for naproxcinod with the US Food and Drug Administration (FDA) is anticipated in mid-2009.

Archimica is installing dedicated equipment required to manufacture the API at its site in Springfield, Missouri, and although it will feature as a "significant component" of NicOx' supply chain for naproxcinod, it is unlikely to be the firm's only supplier.

As part of NicOx' strategy to maximize the commercial potential and economic value of naproxcinod, the firm said it may sign agreements with up to two additional suppliers.

Nassau University to Build New Medical Center

Nassau University Medical Center in East Meadow plans to build a $55 million emergency department that will double the size of emergency facilities.

The board of directors of the Nassau Health Care Corp. announced its approval of the project, intended as the centerpiece of the hospital's modernization efforts. It will include new radiology facilities and an expanded psychiatric emergency program. Construction is expected to begin next year.

Funding will come, in part, from a county program that uses money from the settlement of a class-action lawsuit several years ago against large tobacco companies. The project also will rely on state Department of Health grants that help restructure health care facilities.

The new facilities will be double the current 26,000 square feet and have 82 treatment rooms, almost double the existing 43, and a separate pediatric treatment area.

A new roof helipad, portable decontamination shower tents and isolation rooms will be in place to help personnel respond in a disaster. Officials from the Nassau County Police Department ambulance and aviation bureaus were included in design discussions.

Cannon Design, a Manhattan architectural firm, designed the new structure, hospital spokeswoman Shelley Lotenberg said.

Riverhead Hospital Expands

A recent $1-million gift from Bobby and Dhonna Goodale of Flanders will help fund the $50-million hospital expansion project under way at Peconic Bay Medical Center in Riverhead.

The hospital recently opened one part of the project, an $8- million, 10,000-square-foot emergency center with 17 treatment rooms. A 40,000-square-foot surgical pavilion is expected to open next year.

PRA Triples Operations

PRA International has tripled the size of its operation in Mumbai India after moving to a larger facility that is more centrally located to transport hubs.

The contract research organization expects to grow its clinical staff at the site from its present number of 20, to 50 by the end of the year. The firm said it also will potentially increase its service capacity by 150 per cent in comparison to September 2007.

PRA's Mumbai office currently carries out project management, clinical monitoring, investigator identification and recruitment, study site selection and validation, regulatory submissions, safety monitoring, pharmacy and drug depot services, among other things, and the additional services that will be offered as the office grows will include increased safety monitoring, protocol development, and medical writing, as well as other clinical consultation services, the CRO said.

In addition to the office in Mumbai, where the clinical team is located, PRA also provides data management services out of its Pune office.

Osogen Chooses AES Clean Technology for New Cleanroom

Isogen LLC has chosen AES Clean Technology, Inc. to design and build their new cleanroom macro environment in New Castle County, Delaware. AES Clean Technology, Inc. is the leader in design, construction and manufacture of cleanroom facilities for life science and technology companies, specializing in modular project execution.

"What makes this project especially significant is the approach to isolation and containment within micro and macro environment. The concept of an isolator, within a gas-sterilizable modular cleanroom makes this contract manufacturing facility ideal for smaller volume clinical or early stage commercial fills where a dedicated filling facility is financially untenable," said Satterfield "There is increasing concern among regulators and healthcare organizations with regard to the risk of cross contamination where potent compounds, live viruses, and cytotoxics are being filled. This concern is well documented especially in multi-product facilities, and CMOs are often used for such clinical fills", Satterfield added.

Isogen chose modular cleanroom construction rather than traditional "stick built" construction to maximize value for the delivery of functional, adaptable cleanroom systems with the benefits of predictable cost, schedule, and quality.

Isogen CEO Les Edwards concluded, "In addition to construction efficiency, performance is critical; the isolator cleanrooms must be both an effective barrier and be demonstrably cleanable to enable multi-product use. The integrated design of the AES modules with integrated HVAC and utility chases combined with AES design and installation expertise ensures our facility will meet the highest standards of containment," said Edwards.

First of 5 Buildings Part of Planned Hopkins Research Hub

A $54-million life sciences building has opened as the cornerstone of an ambitious plan to remake East Baltimore into a research Hub complete with parks, businesses and more than 2,000 new homes.

The seven-story glass-and-steel building will house the John Hopkins Institute for Basic Biomedical Sciences and three other tenants. Four more life sciences buildings are expected to open in the next decade. (00 properties have been acquired, and many of them demolished, to make way for the $1.8 billion project just north of Johns Hopkins Hospital.

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