oct 07 update

Germany is the largest market for biotechnology and pharmaceuticals within the EU. Biomedicines are the focus of 366 companies there; 85 have approved biopharmaceuticals or are testing new candidates in clinical trials.

Pfizer began construction in September of a new 60 million euro production plant in Illertissen, Bavaria. Pfizer already employs about 600 workers in the region. Construction should be completed by early 2008.

Walter Köbler, the head of Pfizer in Germany, said that the “high qualification and know-how of our staff” turned the balance toward investing in a new production site in Illertissen.

Despite the high degree of automation, Pfizer intends to create 50 jobs. The company currently employs 610 workers in Illertissen, which is the largest drug production site in Bavaria.

Quintiles Transnational Corp., a global pharmaceuticals services company based in Research Triangle, N.C., is launching an operation in Berlin. The company’s Berlin offices will work on clinical trials of medicines.

Recognizing the importance of biotech sector, Germany’s Federal Ministry of Education and Research (BMBF) established a new 150 million euro fund available to younger, experienced scientists who can convert their biotech research activities into entrepreneurial ventures. Called ExistGo-Bio, the incentive program is directed specifically at those scientists who have already acquired experience in research teams, industrial R&D or clinical settings.

Smith & Nephew’s New Cleanroom

In Memphis, Smith & Nephew’s has decided to build a new distribution center at the Memphis Logistics and Technology Center (MELTECH). The 210,000 square-foot, Class A warehouse/distribution facility will be constructed on 37 acres of land at MELTECH, which Smith & Nephew acquired from Belz Enterprises.

The new DC will be the largest Smith & Nephew distribution facility in the world. The facility will be taller and more modern than the existing Smith & Nephew facility, and it will be climate controlled for the surgical orthopedic products. The facility will also have a 1,200 square foot clean room designed to eliminate dust particles to avoid contamination of the surgical products. Back-up generators will also be installed in case of a power outage.

Construction is scheduled to be complete by the summer of 2008.

Moore Norman Technology Completes Construction Projects

Moore Norman Technology Center construction technology and biotechnology students have new places to call home.

An 8,500-square-foot building designed for construction and carpentry study and a 2,800-square-foot expansion that will house the school’s newest medical program have opened to students and faculty.

In March, construction crews began re-modeling the health education building. The final touches on the wing were made last week. Construction costs totaled $276,000. The company bought $130,000 in equipment and furniture.

One section is divided into a lab that contains a chemical storage closet. Four students will be assigned to one table that supplies weighing scales and electric stirrers.

Biotechnology students will be able to analyze DNA and study its replication process. The program allows hands-on experience for those enrolled in the class.

Construction cost was about $1.6 million and the school spent $25,000 for equipment.

Most of the equipment we moved from the existing building to the new facility.

Funds for Pharmas Top €1 Billion

Ireland attracted more foreign direct investment (FDI) in the life sciences sector than any other European country over the year to the end of June this year.

Investment into Ireland in life sciences areas like pharmaceutical, healthcare and biotechnology accounted for more than a quarter of the total investment in the European market.

This is according to the latest FDI indicators, which were released yesterday by Belfast-based FDI database OCO. It found there were 101 new investment projects across all sectors during the period, with Ireland attracting 17 projects and a total investment of $1.54 billion (€1.1bn).

Chief executive of OCO Mark O’Connell said there has been a marked shift in inflows to Ireland towards high-quality investments in the life science, business and financial services and the ICT sector, which is good news for the Irish economy.

Ireland is attracting high quality investments with 55% of projects derived from the life sciences, financial and business services and the ICT sector. The life sciences sector resulted in 1,960 new jobs in the past year.

The significance of foreign investment in the pharmaceutical, healthcare and biotechnology industry in Ireland is that it tends to create high-value jobs and contributes to long-term sustainable economic growth.

A little more than a third of all FDI projects are located in Dublin. Cork and Clare accounted for more than 30% of the total investment in Ireland.

Lab-on-a-Chip

Singapore research collaborators recently demonstrated a lab-on-a-chip that can detect avian flu (H5N1) in less than 30mins. Lab-on-a-chip bird flu tests, created by the University of Colorado, have been validated by the U.S. Centers for Disease Control and Prevention (CDC) for U.S. medical clinics. Now Asia, where influenza is entrenched in poultry, according to the Singapore researchers, has access to a flu chip, too.

The lab-on-a-chip was developed by Singapore's Agency for Science, Technology and Research (A*STAR). Collaborators there propose that medical- and humanitarian-aid workers throughout Asia head off a global pandemic by performing routine examinations using the while-you-wait test.

The Singapore researchers' lab-on-a-chip only requires that a throat swab be taken by the medical- and humanitarian-aid workers. After transferring the sample to the device, it is mixed with silica-coated magnetic nanoparticles so it can be routed around the microfluid device with magnetic force. According to the researchers, they have devised ways to use magnetic force to perform the functions of a pump, valve, mixer, solid-phase extractor and real-time thermocycler. All the complex steps in the medical test are preprogrammed into the lab-on-a-chip, enabling the integration in a single platform of all the steps needed for viral RNA isolation from the sample, its purification, preconcentration and detection—in less than 30mins.

The collaborators also said that their design for the lab-on-a-chip enables it to be quickly adapted by medical personnel to SARS, HIV, hepatitis B or other future threats.

In Asia, there have been 201 human cases of avian flu, according to the World Health Organization—most resulting in death. Worst hit has been Indonesia, where 108 cases have resulted in 87 deaths. Unfortunately, avian migration patterns have spread the flu outside Asia, with deaths already reported in Azerbaijan, Cambodia, China, Egypt, Iraq, Laos, Nigeria, Thailand, Turkey and Vietnam.

UCB Opens Ireland Facility

UCB has opened a new manufacturing facility in Shannon. The new facility will enable the production of Fesoterodin for over-active bladder, which has been developed by Schwarz Pharma, now part of the UCB Group, and is licensed exclusively to Pfizer. Construction and other site upgrades at the facility will be completed by the end of this year and the plant will be in operation in 1Q2008.

The new facility will enable the production of an important new drug.

Pharmaceutical Manufacturers were in Full Force at this Year's CPhI Trade Show Held in Milan, where Several New Company Announcements were Made

Opthalmics manufacturer Moorfields Pharmaceuticals has signaled it has now validated a new blow-fill-seal facility in London in order to help it increase demand for those requiring clinical supplies of these sterile liquid products.

Spanish firm Bioiberica said it has recently increased its heparin extraction and purification by the construction of a new 1,500 square meter plant in Olerdola, near Barcelona.

Japanese sulfur intermediate supplier, Sumitomo Seika said it will start building a new GMP plant and clean room in the second quarter of next year, which it hopes will be

up and running six months later.

Meanwhile, Dutch services firm ChemShop has indicated it is undertaking a major capacity expansion of its pilot production facilities, to be used in the process development and scale-up of active pharmaceutical ingredients (APIs). The expansion will double its current capacity by 50 per cent by its expected completion mid next year, said the firm.

In other news, contract packing firm Chester Medical Solutions has received an IMP license from the European Medicine's Agency (EMEA) for its clinical trials packaging services.

Province Has One-Quarter of Country's Biotech

Research and development spending in Saskatchewan still lags the nation, but the biotech industry centered in Saskatoon is one of the bright spots, says the Institute of Chartered Accountants of Saskatchewan's latest "checkup" on the provincial economy.

Biotech firms in Saskatchewan, many of them centered at Innovation Place in Saskatoon, account for 27 per cent of all biotech companies in Canada, did 15 per cent of all Canadian biotech R&D and earned 18 per cent of Canadian biotech R&D revenue. The institute based these figures on 2005 data.

Saskatchewan is the leader in biotechnology with Saskatoon being Canada's biotechnology capital. So it's a very bright spot for Saskatchewan.

The Petroleum Technology Research Centre in Regina as another plus for the province's R&D sector. In Saskatoon alone, there were 2,300 jobs created in the natural and applied sciences area

The CA report found Saskatchewan's rising corporate profits in 2006 were driven by world demand for potash and uranium, and the growth of energy and agri-food exports. It also credited the provincial government's aggressive fiscal policy initiatives in reducing general corporate taxes and the corporate capital tax for boosting after-tax profits in the province.

Amgen Delays Expansion

Amgen, the Thousand Oaks, Calif.-based biotechnology company that has faltered recently, has postponed an ambitious expansion of its Seattle campus that could have accommodated a doubling of its work force there.

In March 2006, the company said it would build an additional 550,000 square feet of office, laboratory and warehouse space at its 40-acre "Helix" campus on Elliott Bay. But three people close to the project said Wednesday that those plans are on hold.

Amgen has struggled as the sales of two of its principal products -- the anemia-fighting drugs Aranesp and Epogen -- have slowed. The drugs performed poorly in clinical studies, and most Medicare contractors no longer reimburse patients who buy Aranesp. In March this year, the FDA added boxed warnings in the prescribing information of both drugs. Over the past year, the company's stock has fallen about 24 percent. It closed Wednesday at $55.52.

In response to the problems, the company announced in August it would lay off between 2,200 and 2,600 workers and "rescope and make other changes to certain ongoing capital projects." People close to the Helix campus expansion said the decision to delay the project had been made before that announcement.

Amgen said that it would shut down its operations in County Cork, Ireland, and indefinitely postpone building a manufacturing facility there, citing its "evolving business environment."

Molecular Insight Acquires Manufacturing Facility

Molecular Insight Pharmaceuticals, Inc. has completed the purchase of a commercial-scale radiopharmaceutical manufacturing facility in Denton, TX. The company purchased the facility from NeoRx Manufacturing Group, Inc., a subsidiary of Poniard Pharmaceuticals, for $3 million. The facility provides more than 80,000 sq. ft. of pharmaceutical manufacturing, warehouse, cleanroom and administrative office space.

SAFC to Add API Conjugation Suite

SAFC, a member of the Sigma-Aldrich Group, plans to begin construction of a new cGMP potent active pharmaceutical ingredients (APIs) conjugation suite at its St. Louis manufacturing site. This addition will support oncology drug substance requirements for a combination of small molecule chemistry, containment engineering, highly regulated biologics manufacturing and extensive quality control capabilities.

The new suite will enable the conjugation of highly potent active pharmaceutical ingredients (HPAPIs) to a variety of targeted delivery molecules, including monoclonal antibodies for the anti-cancer market. The new 600-sq.-ft. conjugation suite, expected to be operational in late 2007, will be SafeBridge certified and will accommodate early-stage clinical supplies of potent conjugated APIs, with capabilities to expand production into commercial-scale, handling multi-Kg quantities of conjugated HPAPIs per batch.

Biopharma Solutions’ Halle (Westfalen), Germany Facility Completes Lyophilization Expansion

Baxter’s BioPharma Solutions announced the recent completion of the lyophilization capacity expansion at their cytotoxic contract manufacturing facility in Halle (Westfalen), Germany. The facility was expanded to meet the growing demand of the cytotoxic contract manufacturing market. The expansion increased their total cytotoxic lyophilization capacity to four dedicated lyophilizers and over 1,100 square feet.

Two large-scale lyophilization units were added to freeze-dry clients’ cancer therapy drugs. The expansion includes innovative technologies to safely handle organic solvents including a state-of-the-art fully automated loading cart and in-process quality analysis technology. The cart navigates in the building with sensors, transporting the cytotoxic vials from filling without human attendance, and auto-loads the freeze driers.

“Our experience in barrier isolators enabled us to realize this cutting edge technology while considering specific customer requests. By using the latest technology, we eliminate human exposure to the cytotoxics, and reduce contamination-risk of the products,” said Thomas Julien, director of manufacturing. The high containment manufacturing expansion was designed to improve product quality, safety, and integrity, while allowing more control over the manufacturing process.

The expansion has been designed to meet EU, US, and JP requirements. “Our customers benefit from the expanded capacity, leading edge technology, and 50 years of experience in handling cytotoxic parenterals. This investment reflects Baxter`s commitment to ensure customer focus on high-quality services with state-of-the-art technology,” said Dr. Burkhard Wichert, vice president of manufacturing for Baxter’s Halle facility.

Establishment of Mitsubishi Tanabe Pharma Corporation

Mitsubishi Tanabe Pharma Corporation announced that the company was created through the merger of Tanabe Seiyaku Co., Ltd. and Mitsubishi Pharma Corporation. Mitsubishi Tanabe Pharma Corporation will work on R&D for the creation of new drugs which are globally competitive as well as using business platform strengthened by this merger to accelerate the development of business operations overseas and establish at an early stage a position as an international drug discovery corporation aiming at the future. In addition, the company will also be positive in taking up the challenges presented by new business opportunities in response to changes in medical environment, such as generic business and personalized medicine. Along with contributing to the health of people around the world, Mitsubishi Tanabe Pharma Corporation will continuously develop activities in order to maximize corporate value.

Stanley Hall Dedication Heralds New Era of Bioscience Innovation

The campus is celebrating the opening of the $162.3 million Stanley Hall. Supported by a combination of state and private funds, the new building is considered one of the few biophysical science research facilities in the United States.

Stanley Hall is the first building on campus in which decisions about space allocation support a multidisciplinary program, rather than being controlled by a department or college.

"We actually dispensed with the notion of departments altogether and instead focused on the different types of science that would take place in the facility," she said. Marqusee, a leading expert on research in protein folding, worked closely on the building's design with the faculty and the architectural firm Zimmer Gunsul Frasca Architects LLP.

Instead of being clustered by discipline, researchers are dispersed throughout the building in "neighborhoods" where they work alongside colleagues in other fields. Their space is flexible in order to evolve with the science. Each neighborhood includes three to four research labs, equipment rooms, office and conference space, and a shared workroom that serves as a "community center" where researchers can interact.

Under the roof of the 11-story building - three floors of which are below ground - one can find a wide swath of the campus community, from undergraduates to award-winning scientists, including one Nobel laureate. Along with modern classrooms and instructional spaces, the building has 33 wet laboratories and eight computational suites that will be used by bioengineers, biologists, chemists, physicists, mathematicians and computer scientists. Altogether, there is space for 650 faculty, students and staff members, many of whom began moving into Stanley Hall in April.

That six of the departments represented in Stanley Hall are ranked in the top 10 nationally illustrates the breadth of excellence represented in the building, not to mention at UC Berkeley.

Named for the late Wendell M. Stanley, a UC Berkeley biochemist and virologist who received the Nobel Prize in Chemistry in 1946, the building measures approximately 285,000 gross square feet, more than four times the size of the outdated, seismically poor research building it succeeds.

The plans for the new Stanley Hall began in the late 1990s with a vision led by three distinguished UC Berkeley faculty members: Paul Gray, professor of electrical engineering, who was then dean of the College of Engineering; Graham Fleming, professor of chemistry; and the late Daniel Koshland Jr., professor of molecular and cell biology. Dubbed the "Gang of Three," they proposed a building that would not only enable collaborations among scientists from different disciplines, but one that would make such alliances inevitable.

Located at the East Gate entrance to campus, the building is the UC Berkeley home of QB3 and the relatively young Department of Bioengineering. A pubic-private partnership between three UC campuses - Berkeley, San Francisco and Santa Cruz - and industry, QB3 is part of the California Institutes of Science and Innovation launched by the state in 2000.

Just as Stanley Hall provides the physical infrastructure to support science that crosses boundaries between traditional scientific disciplines, QB3 provides the program infrastructure that breaks down the boundaries between departments and colleges. At UC Berkeley, QB3 provides specialized services for projects that involve multiple investigators, campuses and institutions, with the result that the campus has recently received major funding for new research in synthetic biology, energy biosciences and other multidisciplinary areas.

The Stanley Hall project also represents phase one of the UC Berkeley Health Sciences Initiative, a $400 million campus-wide fundraising campaign to support the construction of two new interdisciplinary research centers at UC Berkeley: Stanley Hall and the Li Ka Shing Center for Biomedical and Health Sciences. Groundbreaking for the latter facility is scheduled for early 2008.

Stanley Hall houses specialized core research facilities, including a nuclear magnetic resonance (NMR) facility that was specifically designed to house a powerful, 900 megahertz magnet, one of only a few in operation worldwide. The 7-ton device, funded by a $6 million grant from the National Institutes of Health, will be used by researchers throughout Central and Northern California.

Other support facilities at Stanley Hall include the Biomolecular Nanotechnology Center, dedicated to the fabrication of bio-MEMS and microrobotic devices; the Keck MacroLab, designed to support protein expression studies; the Vincent Coates Functional Genomics Center; and mass spectrometry and proteomics facilities.

Scientists from other universities and industry will have opportunities to use the Stanley Hall facilities, Fleming said, which will stimulate active partnerships between these researchers.

NanoRite Opens in Wisconsin

NanoRite, a $5 million center designed to house and advance business ventures in the ultrasmall, opened August 24, 2007 in Eau Claire, Wisconsin. Bill Ihlenfeldt, president of Chippewa Valley Technical College (CVTC) and leader of the effort to build the center, said it will "be a catalyst for substantial economic growth." Wisconsin Secretary of Commerce Mary Burke said NanoRite will serve the entire state. "It's going to move Wisconsin forward." She said Wisconsin has stemmed the loss of manufacturing jobs and has grown exports 50 percent faster than nation in general — and she attributes both trends to Wisconsin's emphasis on education. The Center will serve as an incubator and abuts the CVTC manufacturing campus on Alpine Road. Jack Uldrich, whose consulting firm NanoVeritas months ago advised Ihlenfeldt and the CVTC board not to undertake a center that would be purely nano-oriented, said that a few years ago he spoke to a large audience of college presidents and several approached him afterwards to have him speak at their campuses on the economic future of nanotechnology. But of that large group, Uldrich said only Ihlenfeldt had put a plan into action and built a nano facility. Only when a vision is turned into action do you change the world, the consultant said. Partnerships, a hallmark of Dr. Ihlenfeldt's 13 years as CVTC president, are the stuff of progress. Jeff Halloin, a principal in the Gateway Technology Park that donated land to CVTC for the facility, said the "Chippewa Valley does partnerships very well." Although western Wisconsin doesn't have a research university, cooperation with intellectual talent like Dr. Forest Schultz of University of Wisconsin-Stout, and Dr. Doug Dunham of the UW-Eau Claire, and Hans Mikelson and Dr. John Wagner of CVTC will achieve the same or more, Ihlenfeldt said. Wagner only recently left the top technical post at Cray Computer to join the CVTC Nanoscience Technology faculty. NanoRite's first tenant is OEM Micro, a unit of OEM Fabricators of Woodville. OEM, a rapidly growing machine shop, has embarked on the new venture to address opportunities arising from the concentration of Twin Cities manufacturers of medical devices. Other tenants are now sought and Ihlenfeldt said two prospects might convert soon.

Micromachining, a technology that employs Swiss Screw machinery with its ultrafine cutting and fast spindle speeds, is one of the three major technology groups in NanoRite. Microfabrication, including photoetching, is another. Nanotechnology is the third.

NIH gives $31 Million for Atlanta Clinical and Translational Science Institute

A partnership led by Emory University has won a $31 million grant over five years from the National Institutes of Health (NIH) to speed up the development of lab discoveries into treatments for patients.

The partnership — the Atlanta Clinical and Translational Science Institute (ACTSI) -- also includes Morehouse School of Medicine, Georgia Tech and Children's Healthcare of Atlanta. Georgia collaborators include the Georgia Research Alliance, Kaiser Permanente of Georgia, the Atlanta Veterans Affairs Medical Center, Georgia Bio and Grady Memorial Hospital and Health System.

The partner institutions and collaborators will match the NIH award with financial commitments, space, personnel and other support.

ACTSI will bring together laboratory scientists with clinical investigators, community clinicians, professional societies and industry collaborators in a variety of dynamic programs and research projects. The institute will apply new research methods in genomics, imaging, nanotechnology, proteomics, metabolomics, glycomics and informatics to develop the most advanced and innovative therapies. It also will create and sustain partnerships to conduct community-based clinical research with Atlanta's disadvantaged communities.

Spain Doubles Research & Development Spending

To become more competitive, Spain will double research and development spending to €47 billion (US$65 billion) for 2008-2011.

R&D “is an essential factor in improving competitivity. If Spain wants to continue to grow and generate employment we have to be capable of generating our own knowledge," Spanish First Deputy Prime Minister Maria Teresa Fernandez de la Vega said.

The cash will be primarily earmarked for research into health, biotechnology, energy and climate change, as well as telecommunications and information and nanotechnology.

Spanish Prime Minister Jose Luis Rodriguez Zapatero announced in January that Spain intended to lift R&D spending from a current 1.13% of public expenditure to 2.0%, the EU average as a whole in 2004, according to the EU statistical office Eurostat.

SAFC Tops Off Month’s Facility Upgrades with $29 Million Investment in Jerusalem Site

SAFC is investing $29 million to enhance its drug substance capabilities in high-potency biologics at the Sigma-Aldrich site in Jerusalem, Israel. In the last month, the company has reported a slew of facility expansions in Wisconsin, Ireland, and Switzerland, totaling $14.6 million.

SAFC Pharma notes that the Israel plant upgrade will allow the company to provide process development and cGMP manufacturing to customers requiring large-scale and high-potency toxic or hazardous drug substances. It is scheduled for completion in the first quarter of 2009.

The 50,000 sq. ft. high-potency fermentation expansion will focus on manufacturing secondary metabolites, cytotoxins, and large-molecule proteins. An area of 30,000 sq. ft. will be designed to be Biosafety Level 2 compliant, enabling manipulation of human pathogens. Site capabilities include 1,000 L and 4,000 L tank capacities for bacterial and fungal fermentation.

These capabilities will enable SAFC Pharma to offer fermentation-derived high-potentcy API manufacturing, according to the company. The revamped Israel site will complement the multistep organic synthesis flagship facility at Madison, WI, as well as the biotechnology facilities in St. Louis, MO.

Imtech Receives €250 Million in New Orders in Germany

Dutch technical services group Imtech NV said has received orders worth €250 million in Germany over the past two months in the industrial and construction sectors.

In the industrial market Imtech has received contracts from Volkswagen AG unit Audi for the technical infrastructure in a new production hall and from Bayerische Motoren Werke AG for an innovative test centre.

For wood producers Binder-Holz and Heggenstaller, Imtech is providing high-grade energy systems. At gas producer Linde AG, a high-tech gas cooling system is being built. For optical equipment producer Zeiss Oberkochen a new production unit is being fitted with complex clean room systems.

In the pharmaceutical industry Imtech is providing the technological equipment for advanced laboratories and production plants for, among others, Novartis (NYSE:NVS) Pharma, Hexal and Boehringer Ingelheim.

For BASF AG, Imtech is providing the technical infrastructure for a new production facility, the Dutch company said.

In the healthcare sector Imtech has won important new contracts from the university hospitals in Duesseldorf and Tuebingen.

Atlas Clean Air Provides Turnkey Aseptic Suite to Royal Lancaster Infirmary

Specialist cleanroom contractor Atlas Clean Air was commissioned by the University Hospitals of Morecambe Bay NHS Trust in early 2007 to provide a full ‘turnkey’ solution for the new aseptic suite, itself part of an entirely new pharmacy department.

The Atlas Clean Air package included cleanroom design and construction, full systems commissioning, compliance testing and documentary validation to comply with regulatory authority requirements.

In addition to the design and build project, Atlas provided a range of specialist equipment, including a range of recently upgraded pharmacy isolators, manufactured by Atlas Clean Air, and incorporating the latest technology in automated pressure decay testing.

The company believes that an important element of modern cleanroom technology projects is the need to ‘future proof’ the design as much as possible, with emphasis on recent developments in ‘clean air’ compliance under European Directives and GMP guidelines.

Continuous monitoring of aseptic cleanroom facilities and pharmacy isolators is in its infancy but the Royal Lancaster project incorporates both automated particle monitoring systems and pressure testing facilities on isolation and containment systems

Japan Firms to Collaborate on Biochip Research

Seeking new revenue sources in a market currently dominated by U.S. firms, Toshiba Corp., Canon Inc. and 30 to 40 other Japanese firms reportedly plan to collaborate to develop biochips.

The companies, including synthetic-fiber maker Toray Industries and electronics firm Yokogawa Electric, will together standardize microchips that respond to genetic material, said the report quoting Takashi Kawai, a spokesman for medical-consulting firm MediBic.

The companies will work together to standardize biochips for medical diagnoses and food safety checks, targeting a market they expect to grow to $863 million in 2010 in Japan, he said.

Demand for biochips in Japan comes mostly from research institutions, where U.S. firms Affymetrix and Agilent Technologies are the dominant suppliers. The two hold patents for technologies that pinpoint DNA or RNA on membranes.

Canon and its Japanese peers are beefing up investment to develop products in quest of new growth drivers amid increasing competition in existing businesses from rivals in China, South Korea and Taiwan. The group, with administrative support from government-affiliated Kazusa DNA Research Institute, plan to form a consortium October 19, calling on some 100 companies to join.

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