PHARMACEUTICAL & BIOTECHNOLOGY

INDUSTRY UPDATE

 

August 2011

 

McIlvaine Company

www.mcilvainecompany.com

 

TABLE OF CONTENTS

 

UNITED STATES

Rest of the World

 

 

 

UNITED STATES

 

N.C. Biotech Center to Launch Marine Biotechnology Center

The North Carolina Biotechnology Center has awarded a $2.5 million grant to establish a marine biotechnology center that would support the commercialization of biotechnology-based products coming from research and development originating on the North Carolina coast.

 

“Seventy percent of the earth is covered by water,” said Biotech Center spokesman Jim Shamp. “There’s an awful lot of possibilities that are untapped.”

 

The four-year grant will go toward establishing the Marine Biotechnology Center of Innovation, or MBCOI, which will be charged with working with researchers and businesses to develop new products in areas such as healthcare and diagnostics, as well as food and energy. The grant follows a $100,000 planning grant previously given by the Biotech Center to invite industry representatives and academics to join in planning MBCOI. MBCOI could work with companies such as Agile Sciences, a Raleigh startup and North Carolina State University spinout whose research with sea sponges is the foundation of a breakthrough technology to combat biofilms. Agile Sciences is eying medical applications, but it is also pursuing industrial and agricultural applications of the technology as well.

 

MBCOI will be the fourth such “center of innovation” seeded by the Biotech Center. The others are the Center of Innovation for Nanobiotechnology, or COIN, and the Drug Discovery Center of Innovation, which operates on the campus of The Hamner Institutes for Health Sciences in Research Triangle Park.

 

The grant comes with milestone targets, including the recruitment and hiring of a president/executive director to lead MBCOI. As with the other center of innovations, MBCOI must meet business milestones and ultimately become independent and self-sustaining over the life of the four-year grant.

 

Nypro Expanding

Nypro Inc. is expanding its pharmaceutical packaging and health-care plant in Mebane, N.C., and adding a medical-device development and design center at its headquarters in Clinton, MA.

 

Construction on the 90,000-square-foot expansion in Mebane is slated to begin this month, and the new portion of the plant will be operating by June 12, according to Ray Grupinski, group president of Nypro Healthcare. The expansion includes a 40,000-square-foot cleanroom. The Mebane plant currently has 113,000 square feet of space.

 

“The expansion is largely for our pharmaceutical packaging business,” Grupinski said. “Our opportunities there have been growing.” Currently, about half of the Mebane plant is used for pharmaceutical packaging, and the other half is used to make health-care devices and components.

 

Grupinski said the design center in Clinton, scheduled to open in February, will use existing space and be similar in size to its current design center in Dublin, Ireland.

 

In addition, he said Nypro is building a new design innovation center in Ireland that will open Jan 1, replacing the existing center.

 

“This will enhance our ability to win more business because development is so integrated with design,” Grupinski said. “OEMs aren’t just outsourcing their manufacturing. They are now outsourcing parts of their research and development work, but retaining oversight” of those projects.

 

He said the center in Clinton will enable Nypro to use its engineering, automation and tooling expertise to reduce production development and manufacturing costs.

 

“When you develop the device from the ground up, you improve speed to market, you get improved manufacturability and you get reduced cost,” he said.

 

“”We’re very bullish and expect to grow in the double-digits in 2011,” said Grupinski. Nypro is gaining market share in the medical sector because of three trends: the continued shift to outsourcing, the drive by OEMs to consolidate their global supplier footprint and the desire by OEMs to have suppliers with a presence in the three key regions worldwide, North America, Europe and Asia.

 

“Every one of our customers compete in two of those three regions and wants to get into the other,” Grupinski said. “And they are looking to reduce their number of suppliers to two, maybe three. They want one stop-shopping where they can get everything from design to end product handling and they want customers with geographic reach. We have the ability to manage projects for them from concept to product development.”

 

He also said OEMs are increasingly looking to their top suppliers for innovation and partnerships, and to help them cut costs.

 

“There is a lot more pressure on our customers to reduce costs, so our customers are much more open than ever to design modifications to take costs out of product,” Grupinski said. “A lot of customers are looking to our lean Six Sigma team to help them take costs out.

 

The latest expansions in the medical market come on top of other expansion efforts by Nypro in that market in the past year.

 

A 75,000-square-foot expansion at Nypro’s Asheville, N.C., health-care plant, which makes injectable insulin pens, is near completion. That project will double the plant’s cleanroom space.

 

And, in January, Nypro completed its acquisition of Schlosser Medizintechnik GmbH of Knittlingen, Germany, a supplier of medical plastic parts for diagnostic devices. Schlosser has a 169,000-square-foot factory with Class 7 and Class 8 cleanrooms.

 

In addition, Nypro began using solar and wind power at its Mebane plant last month as part of an initiative to use more renewable energy and reduce its greenhouse gas emissions.

 

Nypro spent than $1 million to cover the building’s 113,000-square-feet roof with solar panels and to build a wind farm with four wind turbines. The energy generated by the system will be provided to the local electric company and will, in turn, offset the cost of providing energy to at least six electric injection molding presses in the 200-ton range.

 

The Mebane project is part of a corporate initiative to have all of its packaging plants some day run on renewable energy sources.

 

Nypro had $1.3 billion sales in fiscal 2010, which ended June 30, with health care accounting for 30 percent of the company’s revenues. That was a 14 percent increase over fiscal 2009.

 

In addition, its profit in fiscal 2010 before cost employee share option plan cost and taxes was $46.4 million, up 84 percent from 2009, and its earnings before interest, taxes, depreciation and amortization set a record high of $114 million.

 

Novo Nordisk Plans U.S. Headquarters

Novo Nordisk, Inc., and a joint venture led by Ivy Equities and LCOR in partnership with Intercontinental Real Estate Corporation, announced a $215 million redevelopment project to completely renovate and upgrade a 770,000-square-foot office building in the Princeton Forrestal Center in Plainsboro, NJ, that will serve as the new U.S. headquarters for the Danish pharmaceutical company.

 

The company has signed a long-term lease for the entire building, with the initial phase of occupancy being approximately 500,000 square feet and the option to take the balance of the space within the building at any time. The deal represents New Jersey's largest commercial real estate transaction this year. Construction on the redevelopment, which will create more than 500 union construction jobs, is scheduled to begin in September. The building is located at 800 Scudders Mill Road and will be able to accommodate approximately 1,500 employees.

 

Novo Nordisk will be relocating from its existing headquarters at 100 College Road West in Princeton, and plans to occupy its new space in spring 2013 upon completion of the full-scale rehabilitation. Novo Nordisk's initial lease at the new building will expand its presence in the Princeton-area market by approximately 150,000 square feet.

 

LCOR and Ivy Equities will execute a top-to-bottom, gut rehabilitation of the property that will strip the vintage 1985 building to its skeletal frame. The plans include replacement of the building's façade, roof, interiors and mechanical systems, and attainment of LEED certification for the building from the U.S. Green Building Council. The renovated property will feature state of-the-art electrical and mechanical systems. Granum A/I is the project's exterior design architect, while HOK is serving as the architect of record.

 

Millennium Science Complex Nears Finish

Rising up along Pollock Road between Shortlidge and Bigler roads on Penn State's University Park campus, the 297,000-square-foot Millennium Science Complex is impressive for its size alone. But what is truly remarkable about the new building is in the details.

 

"Every aspect of this building has been very thoughtfully designed in great detail, from the highly sensitive research labs to the configuration of the plants on a green roof," said Gordon Turow, director of campus planning and design. "It's very impressive that a building of this size could so successfully address such a huge range of complex design details."

 

Contractors are putting the finishing touches on those details as the building nears completion. After nearly three years, most construction work was finished by the end of July, and the University expects soon to receive an occupancy permit from the Department of Labor and Industry verifying it has been built to code.

 

The Millennium Science Complex will serve as the new home for cutting-edge discoveries by researchers in Penn State's Huck Institutes of the Life Sciences and Materials Research Institute, promoting cross-disciplinary efforts within and between the institutes. But before that research can get under way in its new home, there is still work to be done.

 

Dick Tennent, Office of Physical Plant project manager for the building, said furniture has been ordered and will be arriving through August. New and existing lab equipment must be moved and set up in the new spaces, which for some research can be a complicated and meticulous endeavor. Staff will begin moving into the building beginning in September and continuing through October.

 

Before approximately 300 researchers and staff can move into the building, specialists conduct a systems commissioning to ensure the building's mechanical systems, such as heating and cooling, are working to specifications, which for research laboratories can require extreme precision.

 

"We basically need to run the building through its paces before the users get there," Tennent said. "Lab buildings by nature are more complicated. The criteria for their needs can be a lot more exacting, and it can take awhile to get everything ready to go."

 

The building, the most comprehensive research facility and largest academic building at the University, required innovative solutions from the start. Designed to be free from vibration and electromagnetic forces that disturb sensitive equipment, quiet labs are isolated by their location, extra-thick concrete slabs, double walls and aluminum plating around floors, walls and ceilings, among other means. A cleanroom at the heart of the building is designed to have a very low level of environmental pollutants and particles, achieved through a separate exhaust system and dedicated delivery tunnel.

 

"We built the building to some pretty tight specifications from the research requirements. We haven't built to this extent before," Tennent said. "There are construction expectations dealing with vibration and interference dampening that we tried to meet and we're confident we have met them."

 

In addition to the research lab needs that had to be considered, design and construction of the building also required the balancing of multiple priorities such as creating an aesthetic fit on campus, meeting environmental standards and enhancing pedestrian paths.

"It's quite remarkable that a building with such sophisticated architecture and of this scale could fit so comfortably on campus," Turow said.

 

Designed by architect Rafael Vinoly, the Millennium Science Complex's most visually notable architectural feature is a large cantilever joining the life sciences and material sciences wings. Beneath the cantilever is a plaza and garden that doubles as a green roof for the lab space below. Green roofs are part of efforts to make the building LEED-certified, the U.S. standard for environmental and energy efficiency.

 

Turow added that the building's landscaping and walkways enhance pedestrian connections from Shortlidge Mall to Bigler Road and from Pollock Road to the Student Health Center. He also said the expansive green space in front of the complex was graded to include a plateau about the size of a recreation field so that students could use it for informal recreation and leisure purposes.

 

"We see students use the space in front of the law school's Lewis Katz Building and in front of the Business Building," Turow said. "Observing how the campus is used in informal ways is as important as the formal ways. That's why we created the plateau at Millennium."

 

Like those recently constructed buildings and the Information Sciences and Technology Building on campus, also designed by Vinoly, Turow said he expects the Millennium Science Complex to become a memorable campus structure, not only for its size and design, but for what it represents.

 

"This building is a symbol of Penn State's commitment to advanced research," Turow said. "With the creation of this iconic building dedicated to promoting interdisciplinary collaboration in the fields of materials science and life sciences, the University has demonstrated its commitment to excellence in cutting-edge research for the future."

 

A formal dedication of the building is being planned for November.

 

Bosch Sells Line to Pharmalucence

Robert Bosch Packaging Technology has sold a filling line to U.S. firm Pharmalucence Partners, which is expanding its contract pharmaceutical manufacturing business.

 

The technology in question, an isolated aseptic fill and finish line, will be installed at the 70,000 sq. ft. drug production facility in Billerica, Massachusetts that Pharmalucence started work on this time last year.

 

In addition to providing the technology, Germany-based Bosch will also help with Pharmalucence implementation, which is due to be delivered sometime next year and available for commercial scale production early in 2013.

 

Miroslav Horvat, sales manager at Bosch’s Product Division Pharma Liquid said: “Upon completion, Pharmalucence will offer New England's first advanced barrier isolated aseptic fill and finish facility operating in the contract manufacturing market.

 

This was echoed by Pharmalucence CEO saying the investment will “help us achieve the highest level of sterility assurance and regulatory compliance for our products and for those of our contract manufacturing clients.

 

Pharmalucence makes radiopharmaceuticals for a variety of diagnostic and imaging applications, supplying clients like UPPI, Cardinal Health, Covidien, GE, Lantheus Medical Imaging.

 

The firm also provides contract manufacturing services using its excess manufacturing capacity, which is an area of its business it has sought to expand in recent years.

 

Medicago cGMP Vaccine Facility, North Carolina, USA

Canada-based pharmaceutical company Medicago broke ground for the construction of a new influenza vaccine production plant in October 2010.

 

The new facility is located at the Research Triangle Park, North Carolina, and will serve as the company's U.S. headquarters. Construction is scheduled to be completed in the third quarter of 2011.

 

Medicago is involved in the production of vaccines for the prevention of pandemic and seasonal flu. The company's vaccines are still at the clinical stage. The current project will create 96 jobs and is estimated to cost $42 million.

 

Medicago USA partnered with NC Bioscience Organization of North Carolina to see that its facilities are in compliance with federal, state and local public policies.

 

Medicago operates a cGMP production facility with a Biosafety Level 2 greenhouse and an extraction and purification unit in Quebec. It also operates a 13,000ft˛ rented facility in Quebec, including a 2,500ft˛ area for purification purposes and the remaining space for storage and office use.

 

The Medicago cGMP vaccine facility will cost $42 million.

 

The Medicago cGMP vaccine facility spans 97,000ft˛ and will include a 27,000ft˛ fully automated greenhouse unit and an extraction and purification unit.

 

The greenhouse unit will be a large, cost-effective and scalable facility built in accordance with cGMP standards.

 

The facility has a targeted production of ten million doses of vaccines per month. It will produce 40 million doses of seasonal flu vaccine or 120 million doses of pandemic flu vaccine annually. The main advantage of the facility is its capability of producing vaccines in a quicker manner.

Construction of the Medicago cGMP vaccine facility is about 75% complete and is on schedule.

 

The facility is expected to be operational by September 2011.

 

Medicago aims to produce vaccines in a faster way in order to avoid an H1N1 outbreak similar to the one experienced in 2009.  The new Durham facility will produce vaccines for the prevention of influenza using the virus-like particle technique instead of the traditional egg-based or cell production techniques.

 

The vaccines will be developed from a new strain of Australian tobacco plant Nicotiana benthamiana, which will be grown in the greenhouse area. The leaves of this plant are more delicate and sensitive to infectious pathogens.

 

A protein will be isolated from the flu virus and its gene later injected into bacteria. These bacteria are then injected into the tobacco plant, which leads to the production of flu proteins. These proteins are extracted, purified and then used as vaccines.

 

The Australian-strain tobacco plants can germinate within five weeks. Robotic technology will move the plants all over the greenhouse.

 

Proficia technology is another technology Medicago will employ for producing vaccines at the facility. Living plants are used in this technique to produce the vaccines in a quicker way.

 

KBR's Building Group was awarded a $19m contract to build the new vaccine facility in November 2010 by Alexandria Real Estate Equities. AREE, a real estate firm that deals with biological industries, leased the land for Medicago's new facility.

 

The construction is being handled from KBR's Raleigh office.

 

"DARPA provided $21 million for the project in August 2010."

 

The project is partly financed by the Defense Advanced Research Projects Agency (DARPA) and AREE. DARPA provided $21m for the project in August 2010. The funding was a federal grant given as part of the Accelerated Manufacturing of Pharmaceuticals program for encouraging quicker (less than three months) production processes of H1N1 vaccines.

 

Medicago received $3.8m and $5.6m in March and June 2011, respectively. The company has so far received $16.3m from DARPA.

 

Medicago will contribute $7.5m and Alexandria Real Estate Equities will contribute $13.5m towards the project.  

 

Cubist Pharmaceuticals Facility Expansion, Lexington, USA

U.S. based biopharmaceutical company Cubist Pharmaceuticals owns and operates a lab and research facility in Lexington, Massachusetts. The company has expanded the facility from 89,000ft˛ to 269,000ft˛ over a period of ten years since it was opened in 2001. The facility occupies Cubist-owned property at 65 Hayden Avenue and leased property at 45-55 Hayden Avenue.

 

A $50m expansion to the facility broke ground in September 2010 in response to the company's 30% revenue hike in 2009.

 

The 104,000ft˛ expansion will provide additional operational space for pharmaceutical development. The expanded space will accommodate 150 newly employed scientists and support staff. The expansion is slated for completion in 2012.

 

The facility spans 269,000ft˛ including a 90,000ft˛ single storey laboratory building, and 180,000ft˛ of non-laboratory space for technical operations and the associated support functions.

 

The facility sits on a 12 acre parcel of land that accommodates two other buildings of the company. The other two buildings accommodate approximately 170,000ft˛ of non-laboratory and administrative space.

 

The facility will be expanded to 373,000ft˛ including 166,000ft˛ of lab space and 207,000ft˛ of non-lab space. Two new floors of laboratory space will be added atop the existing 90,000ft˛ lab building, referred to as the north building.

 

"The Richmond Group was appointed as the construction manager for the expansion."

Due to space limitations and the current building area, vertical expansion was considered the most cost effective option.

 

The state-of-the-art laboratories will be designed specifically for medicinal chemistry, high-throughput purification, crystallography, recovery and purification of biosynthetic products and formulation, toxicology and discovery biology.

 

To connect the two new floors of the north building with the existing top floors of the south building, a connecting three-story glass atrium will be constructed.

 

The atrium will house a new main entrance, a cafeteria, elevators for passenger movement and service purposes, walkways and space for informal meetings and gatherings. The existing lower level entrance driveway will be converted into an outdoor courtyard for employees.

 

The expansion will also add a new molecular modeling room, several conference rooms, offices, and break zones. The expanded facility will also accommodate space for future expansion for discovery biology and non-clinical development.

 

To accommodate the parking requirements for the new floors, an 180,000ft˛ structured parking garage with capacity for 300 cars will be built.

 

The garage will have four levels and will be constructed within the general limits of the existing surface parking lot. A pedestrian bridge will connect the garage to the laboratory building.

 

The new floors will incorporate a high efficiency and environmentally friendly design.

 

A $50m expansion to the facility broke ground in September 2010.

 

The new building will have energy efficient plumbing, lighting fixtures, heating and cooling systems designed to provide controlled distribution.

 

In addition, advanced mechanical equipment and appliances with energy star rating will be installed.

 

The new lab space will also be designed with extensive air quality control measures to ensure superior indoor air quality.

 

It will include necessary ventilation techniques and separate supply and exhaust ducts for the laboratories.

 

The expansion is being partially funded through a $1.7 million tax incentive granted by the Massachusetts life sciences center. The tax incentive was awarded as part of the state's $1bn ten-year life sciences initiative proposed by Governor Deval Patrick in 2007 and signed into law in June 2008. In return, Cubist has committed to creating 58 new jobs.

 

The Richmond Group was appointed as the construction manager for the expansion. The structural engineering contract was awarded to Goldstein-Milano. Highpoint Engineering was appointed for the site and civil engineering.

 

The core and shell architecture has been provided by Spagnolo Gisness and Associates. Micheal Wasser Associates is the landscape architect.

 

In January 2011, the Richmond Group selected Dailey Precast to fabricate and erect the multilevel parking garage for the expansion. The erection works commenced in June 2011.

 

Smithsonian Builds Green Lab

In the U.S., a US$45m federal grant to the Smithsonian Institution will enable the Smithsonian Environmental Research Center (SERC) in Edgewater, MD, on the Chesapeake Bay, to build what is expected to be one of the most energy efficient labs in the US.

 

Creating a more sustainable laboratory, especially one with chemistry research, where fume hoods can consume up to three times more energy than an average home, presents a challenge. The expanded and remodeled Mathias Laboratory will reduce its environmental impact on all fronts, from where it gets its power to where it gets its materials.

 

Analysts estimate it will consume at least 37 percent less energy, and emit 37 percent less CO2 than a similar building that meets baseline LEED certification standards.

 

Besides leaving a less intense carbon footprint, the new building will enhance SERC’s capacity for cutting-edge environmental research. SERC scientists specialize in a multitude of disciplines, including global change, terrestrial and marine ecology, invasive species and nutrient pollution.

 

The groundbreaking ceremony on 6 May 2011 marked the beginning of the two-year project. Totaling 90,000 sq. ft., the new building will add 69,000 sq. ft. of labs, office and support space to 21,000 sq. ft. of remodeled existing space. A two-storey atrium will connect the old and new sections and create an area where researchers from the various departments can share ideas.

 

The project will seek gold-level LEED certification by the U.S. Green Building Council, targeting the maximum gold score of 51 credits. In addition to its low-flow fume hoods for chemistry experiments, the new laboratory will include:

 

*An HVAC system supplied by a large geothermal well field (300 wells, 350ft deep) and high-efficiency enthalpy wheels that recover energy from exchanged air

 

 

 

 

 

 

 

The lab will also use regional materials to prevent long-distance transportation and use only certified sustainable wood.

 

EwingCole of Philadelphia provided the architects and engineers for the project, with Howard Skoke as principal. The general contractor is Hensel Phelps.

 

Watson to Expand Salt Lake City Facility

Watson Pharmaceuticals is set to expand its Watson Laboratories plant in Salt Lake City, Utah in a US$44m investment that will take its products into selected international markets

 

This facility carries out pharmaceutical research, development and manufacturing for the firm’s transdermal patches and topical gels.

 

The expansion includes upgrading approximately 20,000 sq. ft. of existing space and the construction of around 17,000 sq. ft. of future manufacturing space.

 

Watson says the expansion could ultimately result in the addition of around 300 employees within the next 3–5 years. There are currently around 175 people at the facility.

 

The move also supports a potential tripling in annual manufacturing batch capacity to support future new products, including the generic version of the Lidoderm transdermal pain management product, which could be launched next year.

 

Paul Bisaro, Watson Pharmaceuticals’ president and chief executive, said Salt Lake City is the firm’s centre of excellence for the manufacture of branded and generic pharmaceutical products that use topical or transdermal patch drug delivery technologies.

 

‘This expansion not only supports our near-term product manufacturing and packaging needs, but also positions us to more efficiently meet anticipated future consumer demand for products that are currently in various stages of development,’ he said.

 

Sanyo Installs Cell Processing Workstation at University of Alabama

The Biomedical Solutions division of Sanyo North America Corporation has installed its Cell Processing Work Station (CPWS), an integrated, stand-alone system for GMP compliant processing and preparation of regenerative stem cell and cell therapies for research use, at the University of Alabama at Birmingham (UAB).

 

Sanyo, based in Woodvale, IL, says this is the first installation of the CPWS in the U.S., and the first outside Japan.

 

The workstation provides the required Class 100 aseptic environment in a compact footprint and at a lower cost than a traditional cleanroom, the company says.

 

The CPWS installed at the university is a positive pressure system, which will aid the school in its research into gene and cellular therapies. A negative pressure CPWS is in development.

 

The small footprint of the CPWS allows installation into existing or new lab spaces using conventional utilities and minimal site preparation. Offering an efficient operational capacity, the workstation also includes GMP-compliant equipment for aseptic processing and provides user-friendly operation controls.

 

As well as requiring lower capital costs, the Sanyo CPWS also saves approximately 35% of the operating costs usually required for conventional cleanroom environments.

 

Sanyo expects the CPWS to make a significant contribution to advancing research in the cell therapy market. Current and future applications of the CPWS include preclinical regenerative cell therapy research for organ and tissue repair and immunotherapies for treating cancer. Additional opportunities for the CPWS include the pharmaceutical bioprocessing market.

 

The University of Alabama will use the CPWS to manufacture induced pluripotent stem (iPS) cells and gamma-delta T cells for research use. The iPS cells will be studied as a cure for sickle cell anemia, while Gamma-delta T cells will be studied for treating cancer.

 

“The CPWS allows seamless preparation of cell and gene therapy products in a totally contained temperature controlled aseptic environment, drastically reducing the risk of microbial contamination,” said Larry Lamb, director of the UAB Cell Therapy Lab, which houses the Sanyo CPWS.

 

“The technology also has the ability to change over the entire system in 90 minutes allowing for multiple cell products to be produced in a single CPWS.”

 

YRMC Expanding Hospital Buildings

Several improvements at Yuma Regional Medical Center and at off-site locations are under way to improve the quality of patient care.

 

The city of Yuma has issued a permit for YRMC to complete the fourth floor of the tower, which will provide an additional 36 beds. Also under construction at the main campus is a new “clean room” in the pharmacy that will allow pharmacists to mix drugs on site instead of having them shipped in from other pharmacies.

 

Off site, work is progressing at the hospital's IT Center, where a new electronic medical records system is expected to go online next spring. In addition, the Yuma Regional Plaza Laboratory in the Foothills will be moved to a new building at 11282 E. North Frontage Road.

 

“These are all very important initiatives that will help us provide quality care to the community,” said Camie Overton, YRMC vice president of clinical service lines.

 

The addition of beds on a new fourth floor should help relieve wait times in the Emergency Department (ED) Overton said.

 

While 36 additional beds might not seem like a large amount, she said it will definitely make a difference.

 

The fourth floor is expected to be completed in the autumn months. In the long term, YRMC is planning to build a new ED.

 

“The board clearly understands the need for it and we are actually doing a master site plan process right now to help determine where the ED should be located on the campus. It will take us two years to build a new emergency department.”

 

The pharmacy cleanroom “is a state-of-the-art facility and is one that will carry us and our pharmacy needs for many years to come,” said Overton. “It is specifically to help us meet very stringent guidelines that exist for the preparation and dispensing of a lot of the bag mix IVs as well as the chemotherapy drugs.”

 

The ability to mix the drugs on site will benefit the hospital immensely, Overton added. “Given where we are located geographically — we are an island — so it is much better for us to meet the needs of the community by having this pharmacy center inside.”

 

Overton said the IT Center should also be completed in the fall. The hospital staff is currently undergoing intense training in anticipation of the May 2012 electronic records launch date.

 

The Yuma Regional Plaza Laboratory in the Foothills is being moved into a former clinic that has been refurbished to better serve the public, Overton said.

Eventually YRMC plans to build more medical facilities in the Foothills area — “not only diagnostic, but education-type facilities for our patient population and community there.”

 

Nanopore Expanding

Oxford Nanopore said that it is adding 7,000 square feet to its headquarters in the Oxford Science Park in Cambridge, UK, adding to 10,000 square feet of existing labs and offices. The new facility will focus on informatics and be based at Chesterford Research Park.

 

Hospital Gains Efficiencies and Cuts Space

Texas Health Partners wanted its new 185,000-sq.ft., 103-bed Presbyterian Hospital Flower Mound to be lean, cost efficient, and delivered quickly: 11 months for programming and design documentation, 16 months for construction. Extensive pre-design preparation by the physician owners was instrumental in enabling the integrated project delivery Building Team of Texas Health Partners (owner), HKS, Inc. (architect), and Balfour Beatty (GC) to meet those goals.

 

Well before a shovel went into the ground, the physician owners reviewed their current clinical procedures and researched how future users might work within the hospital. The data was mapped in a process flow chart to help identify and eliminate inefficiencies in procedures and travel distances.

 

This list of “needs,” “wants,” and “don’t wants” provided the Building Team with a strong starting point that greatly reduced the planning process. The list included:

 

        Designing pre-op/hold/recovery adjacent to the emergency department so that the ED could flex during times of high activity, typically in the evening.

        Having the surgery department share PACU with ICU as flex space, gaining synergies between similarly skilled nurses.

        Locating the surgery department on the same floor as ICU and the step-down unit to minimize patient transport.

        Consolidating women’s services on the same floor, including physician offices to be located in the connected MOB.

 

The streamlined patient flow process and flexible spaces allowed the Building Team to deliver a hospital 20 percent smaller than the average 100-bed facility. The efficient design also allowed the hospital to preserve a large forested area of mature trees on its wooded 12-acre site.

 

The hospital opened in April 2010—on time and under budget. According post-occupancy analysis, actual construction cost was $54 million versus the $60.2 million budgeted. Other findings:

 

        Flower Mound has 1,786 sq. ft. per hospital bed, versus the industry average 2,300 sq. ft. per hospital bed; this reduced the size of the total facility by 52,942 sf.

        Taking more than 50,000 sq. ft. out of the finished building is trimming $132,255 a year in energy costs (at $2.50 per sq. ft.).

        Med/surg room size is 260 sq. ft. versus average hospital size of 300 sf.

        Energy-efficient medical equipment (averaging 15% better than code) is saving the hospital another $69,000 a year.

 

Brinkman Dedicates ORNL Materials Research Facility

The following information was released by Oak Ridge National Laboratory:

William Brinkman, director of the U.S. Department of Energy's Office of Science, joined officials from DOE and Oak Ridge National Laboratory to dedicate a new Chemical and Materials Sciences Building.

 

The event celebrated the completion of a 160,000 square foot facility that provides modern laboratory and office space for ORNL researchers who are studying and developing materials and chemical processes for energy-related technologies, including advanced batteries and high-efficiency solar panels.

 

The Chemical and Materials Science Building replaces an aging 1950s-era complex limited by high maintenance and energy costs and outdated laboratory spaces. The new three-story facility has been designed and constructed to be Leadership in Energy and Efficiency Design (LEED) Gold certified and meets strict guidelines for environmental sustainability set by the U.S. Green Buildings Council.

 

The building includes 56 laboratories that meet modern standards for safe and efficient operations, which were virtually impossible to attain in the old complex. The building design also provides 164 offices and 91modular work stations, with an emphasis on more open, collaborative environments and flexibility to respond to future mission changes. It is home to two DOE Energy Frontier Research Centers, the Center for Fluid Interface Reaction Structure and Transport (FIRST) and the Center for Defect Physics (CDP).

 

Construction of the $95 million facility began in June 2009, supported in part by funds from the American Recovery and Reinvestment Act. The construction contractor for the facility was McCarthy Building Companies; the architect-engineer was Cannon Design.

 

ORNL is managed by UT-Battelle for the Department of Energy's Office of Science.

 

StemCells, Inc. Relocates Headquarters and Labs

StemCells, Inc. has relocated its corporate headquarters and U.S.-based research and development operations to 7707 Gateway Blvd, Newark, CA 94560, USA. The new facilities comprise newly constructed, custom designed laboratory and office space, and will house the majority of the company's U.S. workforce.

 

"This is a 'win win' situation for employees and shareholders alike," said Martin McGlynn, President and CEO of StemCells. "Not only are we providing our scientists with modern, state of the art, R&D facilities designed to foster their ground breaking work, but by moving to the Pacific Research Center in Newark, we are significantly reducing the company's annual facility lease and operating expenses."

 

StemCells' other facilities in Cambridge, UK, where the company researches, develops and manufactures its SC Proven line of media and reagent products, and in Mountain View, California, are not affected by this move.

 

Sherpa Opens CTM Facility

Sherpa Clinical Packaging, a privately held provider of clinical trial material management services, opened  its newly constructed state-of-the-art, CGMP production facility in San Diego, CA. Sherpa's employees and invited guests celebrated the commissioning of its new facility co-located adjacent to the Althea Technologies' campus in Sorrento Valley. Sherpa and Althea entered into a co-marketing agreement in March 2011.

 

Sherpa's new facility includes five controlled access and monitored packaging suites, and walk-in 2-8°C and -20°C storage areas. Redundant refrigeration systems, alarms, and on site emergency backup generator power were specified to minimize potential risks associated with cold storage.

 

"We purpose-built the facility to accommodate the needs of pharmaceutical and biotech clients that require controlled environments for their clinical study materials," said Mark Paiz, Sherpa's president. "The site offers companies conducting clinical studies an option to label, package, store, and distribute on the West Coast, which is particularly important for many biotechnology companies whose products require cold storage. Through our relationship with Althea, our clients are able to simplify logistics and significantly reduce total product release time." The company anticipates expanding its San Diego workforce in the coming months.

 

Vince & Associates Opens Neuropsychiatric Center

Vince & Associates Clinical Research, a leading provider of early development clinical trials to the global biopharmaceutical industry announces the opening of their new, dedicated Neuropsychiatric Research Center in Overland Park, KS. This research facility supports the needs of the pharmaceutical and biotechnology sectors by providing effective study recruitment, medical management and oversight in study volunteers across a range of neuropsychiatric disorders including both acute and chronic schizophrenia.

 

“While Vince and Associates has been conducting clinical trials in schizophrenia over the past decade, this dedicated unit will allow us to better serve the needs of both study volunteers and our biopharmaceutical clients,” said Dr. Brad Vince, President and Medical Director.

 

Debra Kelsh, MD, a Board-Certified Psychiatrist and an Investigator in over 300 clinical trials, will serve as Medical Director of the new Neuropsychiatric Research Center. “The safety and security of our study volunteers was highly emphasized during the design of the unit,” said Dr. Kelsh.

 

Successful subject recruitment at Vince & Associates is driven by the extensive and proprietary database in excess of 40,000 verified patients and healthy normal volunteers. By conducting an in-depth medical history, Vince and Associates helps ensure an accurate estimate of study volunteers available for clinical trials. Full-time recruitment staff, a community outreach team and an in-house call center establishes a strong foundation in subject recruitment and routinely positions Vince and Associates as a top enrolling research facility.

 

Rest of the World

 

SAFC Plans New Facility

Denca Controls Ltd of Widnes, UK, has won the E&I controls contract for a new IPB2 facility designed by lab and cleanroom specialist T Squared, for its end user SAFC – a biochemical and organic chemical products major, based in Irvine, Scotland. The scope is to build and automate a cell culture media, reagents and buffer solutions manufacturing system, CIP system, WFI/SIP system and filling system at the SAFC facility. Denca will supply a control system consisting of E&I design, manufacture of system control panels, system software and validation documentation to GAMP, installation and testing/commissioning.

 

Daiichi Sankyo and Ranbaxy to Expand in Mexico

Tokyo Japan and Gurgaon India-Daiichi Sankyo Company, Limited and Ranbaxy Laboratories Limited announced the expansion of business in Mexico to maximize their Hybrid Business Model, encompassing both innovative and affordable, high quality, generic medicines.

 

Daiichi Sankyo and Ranbaxy have agreed to expand the business in Mexico with the launch of Olmesartan medoxomil. The product is expected to be introduced to the market before the end of 2011. Daiichi Sankyo Mexico S.A. de C.V, a newly established subsidiary of Daiichi Sankyo, and Ranbaxy Mexico S.A de C.V. will leverage the Group's Hybrid Business Model in Mexico by utilizing the business know-how and cost advantage of Ranbaxy, thereby offering both innovative and affordable, high quality generic medicines.

 

'We are pleased to announce the synergistic business development with Ranbaxy in Mexico,' said Joji Nakayama, President & CEO of Daiichi Sankyo. 'We are determined to work with Ranbaxy to further serve diversifying medical needs in this strongly emerging market.'

 

Commenting on the development, Arun Sawhney, Managing Director of Ranbaxy, said, “Mexico is an important emerging market for us, and Ranbaxy and Daiichi Sankyo will work together in providing innovative options and solutions to customers through the Hybrid Business Model.”

 

Daiichi Sankyo and Ranbaxy will continue to reinforce their respective and consolidated business platforms over the longer term by further accelerating their global business coordination.

 

Angel Re-Commission Plant

CMO Angel Biotechnologies has called in UK-based engineering group WH Partnership to help re-commissioning its GMP standard biomanufacturing facility in Cramlington near Newcastle-upon-Tyne.

 

The facility was closed in 2007 after the UK-based contract manufacturing organization (CMO) decided to concentrate on its other plant in Edinburgh, which specializes in mammalian cells in culture, particularly stem cells.

 

At the time Angel told Outsourcing-pharma.com that: “The cost burden associated with that facility had become too large to support and, together with the delay in securing orders, had led to a decision to close the plant.”

 

However, this position changed in March when Angel unveiled plans to re-open the Cramlington facility, announcing that it has secured a fifteen year lease, with an option to break after five years, on the facility in Cramlington.

 

Under the new collaboration WHP will supply the engineering support and services required to refit and expand the plant to increase Angel's manufacturing capacity in a project scheduled to be completed early in 2012.

 

Angel CEO Gordon Sherriff said WHP “has an excellent reputation and track record in the GMP biomanufacturing arena. Many of its [WHP’s] staff were involved in the initial design and build of the facility in 2005/6.”

 

He added that WHP was also involved in the decommissioning of the facility in 2007 and is hence well placed to help restart its manufacturing activities.

 

The news follows just a few weeks after Angel won a new contract to provide neuroscience drug developer ReNeuron with development and GMP manufacturing services in support of its development program for its ReN001 stem cell therapy for stroke.

 

The work program, which is expected to continue through to mid-2012; the value of the contract was not disclosed, will see Angel produce supplies of the candidate drug for the PISCES clinical trial.

 

Novo Nordisk to Build in Denmark

Novo Nordisk says it is investing close to 1 billion Danish kroner, about 134 million euros, in a new factory in its home country.

 

The facility, in Kalundborg, will be used for the production of biopharmaceuticals such as the haemophilia drug NovoSeven (recombinant Factor VIIa), the growth hormone Norditropin and the glucagon product GlucaGen. The plant is expected to create 120–150 new jobs over the next three years.

 

Per Valstorp, head of product supply at Novo, said the firm needs to expand capacity to meet future demand for existing drugs, "but also to be ready to produce future haemophilia products that are in the pipeline”. He added that the company already has a similar site in Gentofte, and has "built up great expertise in the production of biopharmaceuticals in Denmark".

 

He concluded by saying that "we were therefore never in doubt that this new factory should be placed in Denmark”. The packaging facility is expected to be operational in 2013, while the other units, which require a prolonged running-in period, are expected to be up and running in 2015.

 

ClinTec Expands into China, Singapore and Thailand

ClinTec International, a UK-based clinical research organization (CRO), has opened offices in China, Singapore and Thailand, consolidating its presence in the Asia Pacific region.

 

Over the next three months, the firm says it will also make strategic moves into South Korea, Taiwan, Malaysia and Indonesia.

 

The international expansion has been strengthened by the recent appointment of several regional CRAs, plus Mary Pan, director Asia Pacific, who has more than 12 years’ international experience in clinical research.

 

Dr. Rabinder Buttar, ClinTec’s chief executive, president and founder, said: ‘Since ClinTec was established in 1997, entering into the emerging markets has always proved to be a huge success for us and we expect the same from the Asia Pacific market.

 

In the past two years, ClinTec has entered 25 new countries worldwide.

 

Novartis Starts Construction in St. Petersburg

Novartis has held a groundbreaking ceremony as the first step in the Swiss pharmaceutical firm’s construction of a new pharmaceutical manufacturing plant on a greenfield site in St. Petersburg, Russia.

 

The construction in the Novoorlovskaya Special Economic Zone (SEZ), north of the centre of St Petersburg, is part of a US$500m five-year investment into Russia announced by Novartis last December.

 

Novartis says this facility is the most significant it has made in Russia to date. It will expand the company's capabilities to produce and deliver new drugs and high-quality generics to the Russian market.

 

The plant should be completed in 2014 and will produce approximately 1.5 billion units a year. It will also employ more than 350 people.

 

‘The establishment of the new Novartis manufacturing facility demonstrates our commitment to invest in the Russian healthcare infrastructure and to contribute to the long-term goals of improving healthcare in Russia, set by the government,’ said Joseph Jimenez, chief executive of Novartis.

 

Novartis and its predecessors have been active in Russia since the 1860s, and today the company employs more than 2,000 people in Russia across all business divisions, spanning Pharmaceuticals, Alcon, Sandoz, Consumer Health and Vaccines & Diagnostics.

 

Gerresheimer Extends Plant in the Czech Republic

Gerresheimer, a German specialist in glass and plastic packaging, has invested €12m to extend its Czech production plant and support growth in the market for plastic systems for pharmaceutical, diagnostics and medical technology.

 

The plant in Horsovsky Tyn manufactures inhalers, insulin pens, lancing devices and various diagnostic systems.

 

Gerresheimer, headquartered in Düsseldorf, plans to double the production area at the facility to around 10,400m2 (111,904 sq. ft.) and increase the workforce from 375 to approximately 450.

 

Gerresheimer’s chief executive Uwe Röhrhoff said as the treatment of illnesses such as diabetes and asthma becomes more widespread, so the company aims to grow its market share of medical plastic systems for diagnostics and the application of drugs to treat them.

 

‘Our Czech plant will play a crucial role in this process because it’s one of our most modern medical plastic systems production facilities,’ he said.

 

The extension is due to be completed before the end of 2011.

 

Gerresheimer’s Plastic Systems division is now one of the company’s fastest-growing divisions. Gerresheimer Medical Plastic Systems produces insulin pens for diabetics, inhalers for asthma sufferers, lancing devices and laboratory disposables.

 

Labtec Opens Facility for Patches and Films

Labtec of Germany, the pharmaceutical business of self-adhesive products manufacturer tesa, has opened a facility for the manufacture of transdermal drug delivery systems (TDS) and oral dispersible films (ODF) using its proprietary RapidFilm technology.

 

The unit took 18 months to complete and is located within tesa’s largest manufacturing site, tesa Werk Hamburg.

 

Labtec says the facility provides industrial mass production and features state-of-the-art coating and drying lines with variable coating widths, as well as modern slitting machinery and high-precision, flexible converting and packaging equipment dedicated to TDS and ODF products.

 

According to Labtec, the plant operates a cleanroom environment and is fully GMP compliant. There is sufficient space at the facility for future expansion.

 

‘It took only one-and-a-half years from the initial planning phase until completion of construction and start of operation of the unit,’ said Ingo Lehrke, Labtec’s managing director.

 

‘This quick implementation is the result of an extremely close and dedicated cooperation between experts from tesa, Beiersdorf and Labtec. We are now able to combine Labtec’s pharmaceutical know-how with tesa’s extensive manufacturing expertise to supply our customers with innovative drug delivery products.’

 

Vetter Invests in Additional Lyophilisation Capacity

Vetter, a German specialist in aseptic filling, has installed three additional state-of-the-art lyophilisers at its Ravensburg Vetter South facility, increasing the number of freeze-dryers across all plants by 30 percent. In total, the site will be able to produce up to 24 million lyophilized units annually.

 

The company says it made the investment to meet anticipated future demand for aseptically filled biologics and other sensitive compounds, which often require lyophilization to prolong shelf life and potency. According to the U.S. FDA, in the last three years, more than 30 percent of all new drugs approved in the U.S. were lyophilized and experts predict continued growth.

 

Vetter introduced freeze-drying services in 1981 and developed the innovative dual-chamber technology, used by the Vetter Lyo-Ject syringe and V-LK cartridge, to reconstitute lyophilized compounds. With this technology, lyophilized drug resides in one chamber with the diluent in the other. Just prior to administration, the diluent is pushed through a channel between the two chambers to reconstitute the drug. In addition to ease of use, the closed system supports more accurate dosing and increased API yield, the firm says.

 

‘We anticipate substantial growth in the demand for lyophilized compounds,’ said Peter Soelkner, managing director at Vetter. ‘They have become pivotal components of the portfolio and strategy of many pharmaceutical and biotech companies, which are continuously developing new drugs in this segment.

 

‘In turn, as a strategic partner to our clients, we continuously invest in the infrastructure and equipment needed to support their needs in commercial manufacturing.’

 

Expansion at SAFC Plant in Scotland

Automation control systems specialist Denca Controls has been awarded the E&I controls contract for the new IPB2 facility being designed by laboratory and cleanroom specialist T Squared for SAFC, a leader in biochemical and organic chemical products, based in Irvine, Scotland.

 

The project involves building and automating a cell culture media, reagents and buffer solutions manufacturing system, CIP system, WFI/SIP system and filling system at the SAFC facility.

 

Denca, based in Widnes, Cheshire, will supply a full control system consisting of E&I design, manufacture of system control panels, including motor control panel, PLC/instrument control panel and multiple remote I/O, solenoid, HMI panels, system software and associated validation documentation to GAMP (Good Automated Manufacturing Practices), installation and testing/commissioning through to client handover.

 

Ontario Institute for Cancer Research Plans Expansion

The Ontario Institute for Cancer Research said that it will receive C$420 million (US$445.4 million) in funding from the Government of Ontario over the next five years for research, and that it plans to expand its genomics and bioinformatics research facilities within a business development center in Toronto.

 

The investment from the Canadian government will fund studies that pursue OICR's current five-year strategic plan, which includes research into cancer prevention, detection, diagnosis, and treatment.

 

OICR President and Scientific Director Tom Hudson said that the institute will expand its genomics and bioinformatics facilities into two new floors of a new phase of the MaRS Centre in Toronto, where it already has offices and headquarters.

 

The institute said that the funding will enable it to continue its Ontario Health Study effort to recruit patients and pursue research into cancer and other chronic diseases.

 

Merck and Simcere Sign China Joint Venture

Merck & Co., Inc., Whitehouse Station, N.J., acting through an affiliate and known as MSD outside the United States and Canada, and China's Simcere Pharmaceutical Group announced the signing of a framework agreement to establish a joint venture focused on serving China's rapidly expanding health care needs by providing significantly improved access to quality medicines in major therapeutic areas.

 

This novel and innovative partnership will combine the extensive resources and expertise of a global health care company and a leading Chinese pharmaceutical company in support of Merck and Simcere's goal of building a strategic partnership with development, registration, manufacturing and sales capabilities. The initial focus of the partnership will be branded pharmaceutical products for cardiovascular and metabolic diseases.

 

Merck is proud to partner with Simcere, one of China's leading pharmaceutical companies and an organization that shares Merck's commitment to enhancing health care in China,' said Mr. Schechter. 'This partnership is another step forward in Merck's strategy to grow our business in China and is fully aligned with the Chinese government's goal to increase access to quality products.'

 

'This partnership between Simcere and Merck is not only strategically significant for both organizations, but also a landmark event for Jiangsu's biopharmaceutical industry,' said Mr. Luo. 'Biopharmaceuticals is an emerging industry of strategic importance for Jiangsu Province and this partnership will bring additional momentum to the development of this industry. It will help Jiangsu in providing more quality pharmaceuticals to China and the world.'

 

The establishment of this joint venture is subject to satisfying certain agreed to closing conditions.

 

Merck Animal Health Breaks Ground for Vaccine Plant Expansion

Merck Animal Health, formerly known as Intervet/Schering-Plough Animal Health, announced today that it has embarked on the expansion of a vaccine manufacturing unit at its Biosciences Center Boxmeer campus in the Netherlands. The $18 million investment will result in a doubling of the capacity of its Tissue Culture Department, one of the departments where antigens for viral and parasitological vaccines are manufactured for international markets.

 

The new facility, which is scheduled to be fully operational by early 2013, has been designed to operate with optimal efficiency as well as to meet current and future requirements with respect to Good Manufacturing Practice (GMP) and Safety, Health and Environment (SHE). It will also allow for the anticipated globally growing demand for veterinary vaccines. In addition, the increase of the manufacturing capacity that will be realized anticipates for large-scale emergency production of veterinary vaccines when extensive amounts are needed within a short time period such as during outbreaks of emerging diseases.

 

Dr. Helmut Finkler, Chairman Animal Health Operations The Netherlands said: “The investment in the extension of the Tissue Culture Department here in Boxmeer is of significant importance as it demonstrates the continuous commitment of Merck towards Biosciences Center Boxmeer as a strategic site within our global Animal Health network”.

 

The Tissue Culture Department Boxmeer is an EU-GMP licensed facility and produces viral and parasitological antigens that are used as active components of veterinary vaccines. The department specializes in complex biotechnological production processes that require high flexibility, using roller bottles, cell factories and other suitable cell and virus culture and purification systems. In 2010, the department produced 12 different antigens, totaling almost 300 million vaccine doses for cattle, horses, dogs, cats, fish and swine.

 

To address the specific regional needs for veterinary medicines, Merck Animal Health operates manufacturing sites in various countries distributed over the 5 continents. Of these, Biosciences Center Boxmeer is a global lead site in the company’s network and the animal health industry. It is the largest biotechnology site in the Netherlands. The company markets more than 350 licensed vaccines of which over 100 are manufactured in Boxmeer. The company continuously invests in its operations to accommodate growth and to ensure that it meets GMP and other standards as well as the most stringent environmental requirements.

 

Indian Government Institute Gets Funding for Food Testing Lab

Food testing in India got a boost when a key government-owned research institute received a grant to set up a new state-of-the-art food laboratory.

 

According to an official at the Ministry of Food Processing Industries, the Central Institute of Post-Harvest Engineering and Technology (CIPHET) has been given a US$500,000 grant for setting up a food-testing laboratory.

 

CIPHET was established in 1989 as a nodal institute to undertake lead researches in the area of the post-harvest engineering and technology appropriate to agricultural production catchment and agro-industries.

 

The grant has been given under the ministry’s goal of further strengthening the food-testing scenario in India, which has come under criticism from experts of being too lax and slow.

 

“The laboratory will be equipped with new and highly sophisticated instruments for the testing of different food products, which will serve the interest of food products manufacturers and consumers in the northern region,” he said.

 

The official said that the laboratory as a food testing hub, the laboratory and would offer services to the farmers, small-scale entrepreneurs, and food industries in only the northern part of India.

Similar sort of laboratories, some which have been set up and some that will be set up in the near future will undertake food testing in other parts of the country, he added.

 

The official also said that the food testing discipline in India suffers from some obvious challenges that the government is working to overcome. These include the question of talent and also clearances for imported equipment.

 

Vetter Completes Structural Work at New Ravensburg Facility

Structural work on Vetter's new German facility Ravensburg Vetter West has been completed within eleven months of groundbreaking. As scheduled, the company concluded structural work on its centre for visual inspection and state-of-the-art high-bay warehouse for cold-storage and room-temperature products. Interior work and the construction of an environmentally friendly power supply system will be finished by late 2011, when operations will begin. In addition to photovoltaics and biogas, the facility will also use geothermal sources of power. More than 20 companies from the region participated in the implementation of the €31m project. The facility will employ more than 230 staff.

 

With its new centre for visual inspection and logistics, located in the industrial area of Erlen, adjacent to Ravensburg, Vetter further meets the needs of its international customers. The facility offers optimized quality control processes and material supply, enabling even more efficient and reliable product delivery around the world. To respond to the growing demand for stability tests, the centre will offer advanced-design stability chambers, with expanded capacity for long-term stability testing under a range of temperatures.

 

The facility will harness renewable energy across the site: Vetter is installing photovoltaic cells on the facade to generate solar electricity. The company is also collaborating with regional farmers who run, exclusively for Vetter, a biogas plant used to operate a block heating and power plant within the company's site. Geothermal energy will be used to regulate temperatures in the high-bay warehouse.

 

"Our new facility in Erlen reinforces Vetter's position in international markets," says Thomas Otto, Vetter managing director. "It combines efficiency and sustainability, and its advanced processes support a high level of product and delivery security. Our investment both in the facility and in renewable energy testifies to our commitment to the region. In Erlen, we are laying important groundwork for Vetter's continuing growth and success on the world market."

 

Jerusalem:  The Biotech Capital

A number of major international biomedical companies are negotiating to open research and development centers in Jerusalem. Among the big names in contact with the Jerusalem Development Authority are Pfizer, Merck and Bristol-Myers Squibb.

 

The CEO of the JDA, Moty Hazan, and Chen Levin, the executive director of the Bio-Jerusalem project confirmed the contacts.

 

For a decade, Israel has attempted to bring large pharmaceutical companies to open R&D centers here, but not with much success. Large R&D centers would give a big push to the biotech industry. Today, the Israeli biotechnology sector is characterized by well-developed academic research, but local industry has not been able to fulfill the potential of the academic research. The state expects the new R&D centers will create a new environment and push the local biotech and biomed industries to reach international levels.

 

"My dream is to turn Jerusalem into the Israeli and international center for biotechnology within five years," said Hazan. "Jerusalem has a lot to offer multinational companies, who are looking for the best minds in the world. When they come to Jerusalem, we show them Yissum, the Hebrew University's technology transfer company, and Hadasit from Hadassah Medical Center, and the university and the surrounding labs," he added.

 

The state, in conjunction with the Jerusalem municipality and the JDA will invest NIS 71 million in a program to strengthen the biotech sector in the capital over the five-year period 2011-2016.

 

Jerusalem's biomed industry employs over 3,500 workers, about 12% of all employment in the city. Forty-three percent of all the basic biomedical research in Israel is conducted in the capital, and the city has 150 companies operating in the sector - a 50% increase over the past three years. Fifty percent of all clinical research in the country is conducted in Jerusalem, and some 1,800 students in life sciences graduate from Hebrew University very year.

 

"The city has the status of a national priority area, and there are grants and high salaries here. We are in contact with about 10 multinational companies, and the goal is that when they open research and development centers in Israel, they will do it in Jerusalem," said Hazan.

 

The Bio-Jerusalem project will provide economic incentives for companies and employees for moving to Jerusalem. The sums can reach NIS 80,000 per worker for two to three years.

 

Mid-sized and large companies will receive grants only for R&D employees, while startups can receive grants for all workers. There is an extra 20 percent grant for those employees actually living in the capital, and not just working there.

 

The program will support the construction of labs for rent for the first time in Israel. These labs will be for small and medium-sized firms. The first such facility is now being planned, and the developer will be offered a subsidy covering almost the entire cost of construction. There are other grants for buying equipment.

 

One of the biotech companies that moved to Jerusalem is Omrix Biopharmaceutical, which was bought out by Johnson and Johnson in 2008 for $438 million. Omrix is now spending $20 million on a new plant in the capital that will employ 60.

 

Rafa Laboratories, which sells 5% of all the medicines in Israel with local revenues of $70 million, is building a new factory at a cost of $38 million. The company will employ 300 workers in the capital when the new plant opens in 2013.

 

Teva Pharmaceutical Industries, which has been Jerusalem in various forms since it was founded in 1901, opened a new plant in the Har Hotzvim industrial area in 2005, with an investment of $80 million. Teva has two manufacturing facilities in Jerusalem that together employ 1,000 people.

 

Sigma-Aldrich also opened a new plant in the capital in 2010, and is planning on expanding it. Sigma's two facilities in Jerusalem employ 100 people.

 

Israel's first biomed park for startups was built in the Hadassah complex in Ein Karem. The Bio-Jerusalem project will turn the capital into the center of the Israeli biomed industry, said Chen.  

 

Gen-Probe Life Sciences Completes Consolidation

Gen-Probe said that its Gen-Probe Life Sciences division has completed the consolidation of its molecular genetic services business into its newly expanded facilities in Manchester, UK. The life sciences division already provides nucleic acid extraction and array-based services and plans to further develop a suite of genomic services aimed at the R&D stage of drug development, such as biomarker qualification and validation.

 

Granules and Ajinomoto OmniChem to Open Indian API Facility

Granules and Ajinomoto OmniChem have teamed up to produce high value APIs and intermediates at a new Indian plant.

 

India-based Granules, a vertically integrated pharmaceutical manufacturer, will share ownership of the new venture with Belgian-based fine chemicals maker OmniChem.

 

The new company, which will operate under the Granules-OmniChem Private Limited umbrella, will be a marriage of Granules’ technological know-how, and OmniChem’s sheer muscle power; their extensive customer base.

 

Granules-OmniChem expects its new facility to open for business in 2013, in the Pharmacity special economic zone (SEZ) in Vishakhapatnam, Andhra Pradesh, with a capital expenditure of over $20m (€14m).

 

The company will initially focus on high-value, low-volume active pharmaceutical ingredients (APIs) and intermediates for existing customers.

 

Krishna Prasad, managing director (MD) of Granules, said: “The partnership will allow Granules, from day one, to focus on leveraging our core competency, which is offering high quality products and exemplary customer support with industry leading efficiency.

 

“Our shareholders will benefit since this will enable Granules to diversify its business by offering high value APIs and intermediates which will increase our profitability. In addition, Granules will have an opportunity to manufacture formulations for the joint venture (JV) APIs.”

 

However they look to a future in manufacturing new chemical entities.

 

OmniChem’s Thierry Van Nieuwenhove, Head of the Pharma Fine Chemicals business unit, told In-PharmaTechnologist: “Omnichem is already active in NCE manufacturing out of the three manufacturing sites we have in Belgium.

 

“Eighty five per cent of OmniChem's turnover is achieved in Custom Manufacture for innovative pharma companies with a portfolio of NCE as well as products.

 

“In a second phase of construction, foreseen within next 2 to 3 years, the JV will also aim at having capabilities to start manufacture of NCEs at small and medium scale. Customer base for this will be same as current clients of OmniChem.”

 

Though the opening of the new facility is at least a year and a half away, companies and existing clients have already shown an interest in outsourcing fine chemical production. 

 

The new venture follows a growing trend of European companies reaching out to India for high quality low yield products; traditionally not seen in the ‘low margin, high numbers’ facilities of the East.

 

Ghana’s Biotech Lab Operational in November

Ghana’s scientific community will soon have an ultra-modern biotechnology laboratory facility to aid its agricultural research activities.

 

The construction of the $1.8million complex in Kumasi started in January 2011 and is expected to be completed in November, 2011.

 

Biotechnology techniques have served as efficient tools for enhanced agricultural production in developed countries. They are essential for preparing clean planting materials for distribution to farmers.

 

Micro-propagation – the practice of rapidly multiplying stock plant material to produce a large number of progeny plants – ensures the production of clean planting materials with high crop yield.

 

It has being reported, for instance, that the use of clean planting materials can lead to about 30% increase in sweet potato tubers.

 

The biotech facility is an offshoot of the West African Agricultural Productivity Program (WAAPP), a World Bank funded-project, being implemented by the Ministry of Food and Agriculture and the Crop Research Institute (CRI) of the Council for Scientific and Industrial Research (CSIR).

 

Jeremy Agyemang, WAAPP Monitoring and Evaluation Officer, told Luv FM the lab complex should facilitate the generation and dissemination of new technologies to farmers, processors and other end-users.

 

According to him, the overall objective is to establish the CSIR-CRI in Kumasi as the West African sub-region hub of root and tuber crops, including cassava, sweet potato, cocoyam and yam.

 

“This is a biotech lab; they can do their tissue-culturing and other advanced cell biology techniques there and we have to develop a centre of specialization for roots and tubers and this is going to be a centre of specialization not only for Ghana but for the whole sub-region. So anyone working on root and tubers anywhere can come to Ghana, Crop Research Institute to do their research and analysis, and interact with other scientists”, Mr. Agyemang stated.

 

The WAAPP, since taking off in 2008, has come up with four new high yielding and disease-tolerant cassava varieties.

 

Mr. Agyemang said the materials are being disseminated to farmers in 24 districts in Ghana under MOFA’s directorate of agricultural extension services.

 

He expects new varieties of sweet potato and cocoyam to be released next year.

 

Other countries in the sub-region are also establishing centers of specialization in other agricultural commodities.

 

 

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