PHARMACEUTICAL & BIOTECHNOLOGY
UPDATE
December 2011
McIlvaine Company
TABLE OF CONTENTS
First U.S. Cell-Based Flu Vaccine Plant Dedicated
$8 million Facility to House Growing Biotech Companies at Fitzsimons
Eisai Opens U.S. Cancer Facility
U.S. Firm Offering Modular Plant Leases
Pfizer and MIT Host Groundbreaking for New Research Units
Hoover Precision Adding Cleanroom in Michigan
Versatile Packagers Adds Cleanroom
Ferring Pharmaceuticals Expands U.S. Operations
Auburn Breaks Ground on $29M Research Center
Caron Announces Major Expansion
South Texas Research Facility Opens at University of Texas
New Orleans BioInnovation Center
Boehringer Ingelheim Invests in U.S. Expansion Projects
Accellent Opens Manufacturing Facility in Malaysia
Elan and UCD Create Irish Biotech Alliance
Agilent, Monash Partner to Create Microarray Center in Malaysia
AstraZeneca to Acquire BeiKang Pharmaceutical
Ethiopian Quality Control Lab Gains Accreditation
Haupt Site in Japan Successfully Inspected
Almac Diagnostics UK Facility Gets CAP Accreditation
UK Expands New Institute for Animal Health
Bilcare Opens New Bötzingen, Germany Line
FDA Clears BioMarin Plant Expansion
Schott and Xinkang Form Joint Venture in China
Pharmaceutical Action in Ireland
Work Begins at Colchester General Hospital and Essex County Hospital.
Marine Science Park Construction Underway in Argyll
New Cleanroom Facility for Chemviron Carbon
Shonan Research Center Expands
Evonik Expands Laboratory and Production Capacity
RNL Opens Stem Cell Center in China
Bayer Plans Further Expansion in Asia
ICON Division Expands in Europe
inVentiv Establishes Operation in Korea
The first U.S. facility to use a faster and more flexible technology to make influenza vaccine was dedicated, as part of an initiative that could provide vaccine supplies sooner in an influenza pandemic. The plant in Holly Springs, N.C., can create vaccine using cultured animal cells instead of the conventional process of using fertilized eggs. The facility is a public-private partnership of the U.S. Department of Health and Human Services, and Novartis Vaccines and Diagnostics, Inc. of Cambridge, Mass. This partnership will be maintained under contract for at least 25 years.
The dedication signals that in an influenza pandemic the facility can produce cell-based influenza vaccine that could be authorized by the U.S. Food and Drug Administration for use during the emergency.
"Today we're marking the first change in influenza vaccine manufacturing in the United States in 50 years," said Robin Robinson, Ph.D., director of the Biomedical Advanced Research and Development Authority in HHS's Office of the Assistant Secretary for Preparedness and Response (ASPR). Robinson led the effort for HHS. "The pandemic readiness of this facility is a major milestone in national preparedness for pandemic influenza and other diseases." In an influenza pandemic, the new Novartis facility may be able to produce 25 percent of the vaccine needed in the United States. In addition, cell-based technology used in this facility for manufacturing seasonal and pandemic influenza vaccines may be adapted to produce vaccines for other known and unknown emerging infectious diseases in an emergency. The United States joins several European countries with the capability to manufacture cell-based influenza vaccines on a large scale.
Investing in new vaccine technology to improve the time necessary to produce pandemic vaccine and increase the nation's surge capacity was recommended in two August 2010 reports, the Public Health Emergency Medical Countermeasures Enterprise Review released by Secretary Kathleen Sebelius and the President's Council of Advisors on Science and Technology Report to the President on Reengineering the Influenza Vaccine Production Enterprise to Meet the Challenges of Pandemic Influenza.
In addition to partnering to bring cell-based flu vaccine and adjuvant technologies to the United States, HHS and Novartis are partnering with Synthetic Genomics Vaccines of Rockville, Maryland on new technologies to shorten the vaccine manufacturing timeline by optimizing vaccine virus seed strains used for flu vaccine production.
BARDA and Novartis also are working with North Carolina State University to train scientists from other countries to use cell culture based manufacturing techniques similar to what is used in the new facility. The training program is part of a World Health Organization initiative to strengthen the ability of developing countries to produce flu vaccine, potentially reducing the global threat from influenza.
HHS is the principal federal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. ASPR is an HHS leader in preparing the nation to respond to and recover from adverse health effects of emergencies, supporting communities' ability to withstand adversity, strengthening health and response systems, and enhancing national health security.
Numerous biotech startup companies have found a home in the Bioscience Park Center on the Fitzsimons campus in Aurora, CO., including MBC Pharma, Inc. The Fitzsimons Redevelopment Authority announced plans for an $8 million expansion of its Bioscience Park, which is designed to house start-up biotech businesses.
The authority said it will add a 37,000-square-foot "accelerator" facility.
"The new accelerator space will be leased to companies in the modest growth stage," said Denise Brown, the authority's interim executive director.
There are five companies from the biopark's incubator facility that are negotiating leases for the accelerator facility, said Vicki Jenings, an authority spokeswoman.
"These are companies that are ready to take the next step and in a financial position to take long-term leases," Jenings said.
The companies are developing a range of therapeutic, diagnostic and medical devices products, Jenings said.
In addition to the local companies, the authority is also discussing leases with several out-of-state companies. Companies moving to the accelerator will sign three- to five-year leases for $19 a square foot. In the incubator facility, generic laboratory and office space is available from 700-square-feet to 2,500 square-feet for a lease as short as one year.
The accelerator building will provide custom space of 1,500 square-feet to 10,000 square-feet for its tenant companies, Jenings said.
The aim of the new three-story building is to give its tenants easy access to the amenities already in place at the bioscience park, eliminating the need to replicate conference rooms and other amenities in the expansion and to provide a place capable of housing highly technical life science research and development activities
The facility should be able handle the expected 10 to 12 University of Colorado spin-off companies coming out of the university annually.
Catalent says it will increase biologics capacity, joining the growing list of contractors investing in biodrug production.
The expansion project will see Catalant transfer biologics manufacturing operations – which are based on its GPEx cell line engineering technology - from its existing its facility in Middleton, Wisconsin to a new, larger plant in neighboring Madison.
Facility general manager Mike Jenkins said the move will increase Catalent’s cell line engineering capacity, explaining that: “We have seen tremendous growth in the number of customers choosing GPEx technology to advance their projects.”
“We are hiring approximately 60 incremental headcount some of which have already been hired,” he explained, adding that “we are looking for people experienced in cell line engineering, mammalian cell line process development, purification, QA, QC, and cGMP manufacturing.”
The move follows just a few months after Catalent partnered with Japan’s Toyobo biologics in a bid to increase sales of its cell line technology to manufacturers in the world’s second biggest pharmaceutical market.
Contract manufacturer interest in biologics – and hence competition - has increased markedly of late with existing players like ShangPharma, Lonza and DSM all bolstering their offerings in the area.
Others like Cobra Biologics, Gallus BioPharmaceuticals, CMC biologics and Angel Biotechnology have also added biologics production capacity through facility expansions, acquisitions and joint-venture partnerships.
And, more recently, companies outside the CMO sector have begun to take an interest with Fujifilm and Samsung both moving to strengthen their presence in the biomanufacturing industry.
However, Catalent is confident that its cell line technology, combined with the additional capacity that comes with the expansion, will give it the edge over the competition according to Jenkins.
“There are lots of companies offering mammalian cell culture contract manufacturing; we differ in that we offer the best mammalian cell line engineering technology. We offer solutions, not just capacity.
“Our GPEx technology offers a solution that all the companies above should be using. Our recent partnership with Toyobo Biologics in Japan is just one example of our flexible approach to provide solutions globally to our customers.”
The new facility will quadruple capacity in Madison, allowing the company to enhance its offerings in the development and manufacturing of biologic products. The expansion will enhance Catalent’s GPEx cell line engineering technology and process development capabilities, as well as other mammalian cell lines.
The new facility will include three individual cGMP compliant production suites that will increase Phase I and II production capacity to 1,000L bioreactors. Catalent will also transition from stainless steel bioreactors to single use bioreactors.
“Plans for the biologics facility are designed to meet our customers’ needs through improved delivery of integrated services in the areas of biologic development and manufacturing,” said Kent Payne, Ph.D., vice president and general manager of Catalent’s Biologics business. “This is the first step in a series of strategic development initiatives designed to enhance our offerings in this rapidly expanding market.”
Japanese pharmaceutical company Eisai has opened a new facility in Massachusetts to house its H3 Biomedicine unit.
The company has pledged that it will invest $200m into research funding at the centre, and intends to recruit a team of 70 to research innovative cancer treatments.
The facility will undertake the development of drugs designed to treat challenging cancers through advances in synthetic organic chemistry, with the overall aim of creating breakthrough drugs that are more precise and efficacious than existing therapies.
The unit will focus research into two main principles; identifying drug targets that define the root cause of the cancer and using synthetic organic chemistry to develop a library of compounds, used to develop novel small-molecule drugs against cancers previously thought of as 'undruggable'.
H3 Biomedicine was originally established in December 2010 as a subsidiary of Eisai.
Biologics Modular is leasing its mobile production facilities to help clients make FDA regulated drugs without fixed plants.
In partnership with MEI Healthcare Capital Biologics Modular will lease its mobile, modular facilities and cleanrooms. Biologics Modular thinks the model will appeal to research park innovator biopharm that need access to flexible and affordable GMP (good manufacturing practice) production capacity.
“The current business model for drug manufacturing companies is changing, and as we see more offsite research and development, there is a growing need for affordable quality facilities”, Clark Byrum, Jr, president and CEO of Biologics Modular, said.
Biologics Modular is pitching the model as an alternative to outsourcing to contract manufacturing organizations (CMOs). Instead of outsourcing manufacture of clinical trial materials biopharm can have a Biologics Modular facility temporarily installed at their site to handle production.
The facilities are manufactured by Biologics Modular at its site in Indiana before being qualified and validated. Clients also receive support with process validation, GMP quality control and regulatory strategies.
By taking this modular, pre-constructed, pre-tested approach to facility design Biologics Modular claims it can deliver a plant within 20 weeks. Validation and commissioning is said to take days.
The facilities are housed in steel shipping containers. Inside the containers Biologics Modular installs pre-constructed, pre-tested modules, like giant Lego pieces, to equip the production facility.
Once constructed the facility is relocated to, for example, a leased light industrial warehouse. When the plant is no longer needed it can be decommissioned and, in most cases, Biologics Modular will handle the removal.
Pfizer Inc. and the Massachusetts Institute of Technology (MIT) recently held the official groundbreaking of the new location of Pfizer's Cardiovascular, Metabolic and Endocrine Diseases (CVMED) and Neuroscience research units at 610 Main Street, Cambridge, Mass.
In September, Pfizer announced it had entered into a 10-year lease agreement with MIT for more than 180,000 square feet.
In February Pfizer announced a strategic shift in research and development, to focus the company's efforts on a smaller number of research areas where the potential for impact is greatest, including its CVMED and Neuroscience research units. As part of this shift, Pfizer announced it would substantially boost its presence in Cambridge by moving these two important research units there. This relocation makes Pfizer the second largest biopharmaceutical company in Massachusetts in terms of number of employees.
"We deliberately chose to move to Cambridge, MA, as a key part of our research and development strategy, in order to foster productive collaborations between our drug discovery experts and the outstanding scientists of Cambridge's world-class institutions," said Pfizer Worldwide R&D President Mikael Dolsten.
Pfizer said that it plans to bring around 400 new research jobs to Cambridge. In addition to relocating key Pfizer scientists to the area, the company anticipates hiring a significant number of scientists for the two research units, including biologists, chemists and individuals with other areas of research expertise.
"Kendall Square's thriving innovation cluster makes a strong case for the creative power of proximity. Pfizer has supported MIT research for more than a decade, and we are convinced that establishing their new research facility right next door will accelerate the cycle of discovery and innovation. Connecting MIT's pioneering research with Pfizer's commitment to delivering real- world solutions for patients is a potent formula for impact," said MIT President Susan Hockfield.
InVivo Therapeutics Holdings Corp., a life sciences company focused on potential treatments for spinal cord injuries, has entered into a six-year lease for a new 21,000 square-foot headquarters at One Kendall Square in Cambridge.
The company currently occupies offices at the Cambridge Innovation Center at 1 Broadway in Cambridge, and also a small facility in Medford devoted to manufacturing, with a total of 4,000 sq. ft. The company expects to move into the new facility – which will include offices, lab space and a cleanroom – in early 2012. Terms of the deal were not disclosed.
The new facility will support upcoming human trials on potential treatments for spinal cord injuries, which are currently awaiting the go-ahead from the U.S. Food and Drug Administration. InVivo currently has 20 full-time employees and plans to add 12 more over the coming year, CEO Frank Reynolds said in an interview. The new facility can accommodate 47 workers and can be expanded to an additional 6,000 square feet.
The company was founded in 2005 on the basis of technology co-invented by MIT professor Robert Langer, and Dr. Joseph P. Vacanti, who is affiliated with Massachusetts General Hospital.
Hoover Precision Products LLC plans to start construction next spring on an expansion to its manufacturing plant in Sault St. Marie that will boost its cleanroom manufacturing for the medical industry.
That 13,000 square foot expansion, which will include an 8,000 square foot clean room, will boost the overall size of the plant to 60,000 square feet when it is completed in late 2012. Current plans are to add three injection molding machines for the new clean room.
The company currently has a 2,000 square foot Class 8 clean room for medical, and the Sault St. Marie plant has seven all-electric injection molding machines, ranging in size from 165-240 tons, and five hydraulic injection molding machines, ranging from 55-120 tons.
Hoover Precision Products LLC—a long-time manufacturer of medical assay beads used in medical diagnostic testing, has also been making plastic injection molded parts for medical devices and plastic substrates for EIA/RIA and DNA PCR since 2003.
The company said it annually makes more than 450 million polystyrene assay beads and other plastic balls that are used in diagnostic testing in the medical market.
According to the company’s website, plastic balls are injection molded, and plastic spheres are manufactured from extruded rod. Other uses for the plastic balls are as lightweight check balls, track balls and plug balls.
Hoover Precision Products LLC is a plastic injection molding company is the specialty division of Hoover Precision Products Inc., based in Cumming, Ga.
Hoover Precision Products Inc. is a manufacturer of high precision balls—made from plastics, metals and ceramics—for the automotive, aerospace, energy/infrastructure, industrial and medical markets.
Hoover Precision Products Inc. is a wholly owned subsidiary of Tsubaki Nakashima Co. Ltd., which is headquartered in Nara, Japan.
Florida-based contract packaging company, Versatile Packagers, has added a cleanroom to its 150,000ft2 facility in Tampa.
The cleanroom provides a controlled environment on site for handling food-related products. Along with the company's food permit from the department of agriculture, Versatile Packagers can process dry foods in the new space.
The company says it will also use the space to provide nutraceutical packaging. It can currently carry out blister packaging, shrink wrapping, fin sealing, and polybagging in the cleanroom.
Rick Shave, chief executive of Versatile Packagers, said: “The walls and ceilings of our cleanroom are washable, and it has been built away from all high traffic areas. Products are fully packaged in this environment before being taken out into the warehouse.”
Since 1991, Versatile Packagers has provided a range of contract packaging services. The firm also uses its warehouse space for product storage, fulfilment and distribution. A warehouse management and order processing system enables customers to manage their inventory efficiently.
Ferring Pharmaceuticals has purchased a 25-acre site in Parsippany, NJ that will house an expanded U.S. Operations Center. The facility will serve as an integrated pharmaceutical center and will house management, administration and support, commercial operations, manufacturing and product development, including a manufacturing suite, product development labs, an education and training conference center, and administrative offices.
"As a private company, Ferring has a long term orientation, as well as a commitment to follow the science to benefit patients. This new facility underscores our long-term commitment to the U.S. market, as well as the State of New Jersey," said Aaron Graff, president and chief operating officer of Ferring Pharmaceuticals, Inc. "Together with our Global Research Center in San Diego, this symbolizes our focus on accelerating Ferring growth in the U.S. The local community has continuously expressed support for our endeavors, and we are so pleased to expand our operations in an area with such a large base of talented, highly trained pharmaceutical professionals."
Auburn University has broken ground on a $28.8 million research center that will house a range of scientific disciplines including genomics, bioinformatics, water, and ecological research, as well as architecture and forestry studies.
Auburn held a ground-breaking ceremony on Friday for the 84,000 square-foot facility, called the Auburn University Center for Advanced Science, Innovation, and Commerce (CASIC), at the Auburn Technology Park.
The project was funded with $14.4 million in stimulus funding from the American Recovery and Reinvestment Act through the National Institute of Standards and Technology, and matching funds from the state, Auburn, and the Alabama Agricultural Experiment Station.
The CASIC facilities will house 21 labs including three genomics labs, three labs for predictive biology, two labs for bioproducts, two detection and food safety labs, and four labs for ecosystem health forecasting and marine aquaculture, among others, according to the US Department of Commerce, which runs NIST.
Auburn said that the genomics and informatics-based technologies developed at CASIC "could attract new businesses and enterprises to Alabama, creating employment opportunities to foster a science-based and technology-driven economy that attracts additional clean and green industry to Alabama."
The Center's predictive biology and informatic forecasting research cluster will apply genome-based research to fundamental issues related to biodiversity ecosystems and development of commercial traits and genetic enhancement of commercially valuable marine species.
Auburn's VP for Research, John Mason, said in a statement that the research will be crucial to the pursuit of the university's strategic research initiatives focused on issues that are important for the state.
"These issues include our focus on cyber systems and security, energy and environment, health sciences and food systems and transportation," Mason said. "To address these critical areas, state-of-the-art research and development laboratories and facilities are essential for encouraging and supporting the high level of interdisciplinary, collaborative projects that will deliver results.
"This new facility will create the environment and provide the infrastructure required to develop, test and implement solutions for these strategic research initiatives," Mason added.
Auburn said that the building's emphasis on renewable energy will help advance the state's green economy and its food safety research will position the state as a hub for new testing, technology development, and training programs.
Caron Products & Services, Inc. broke ground September 8, for a major addition to its current manufacturing and operations facility in Marietta, Ohio. The expansion will double the size of the existing manufacturing area, increase warehouse space, and add R&D lab space and additional offices to accommodate a growing technical staff.
Novavax is leasing a cGMP plant in Maryland under ‘very favorable terms’ to meet anticipated demand for its VLP vaccines.
US-based Novavax will double its current good manufacturing practice (cGMP) vaccine production capacity when the 74,000 sq. ft. of leased manufacturing, laboratory and office space comes online.
“We anticipate that it will enable us to supply our vaccines, most immediately our seasonal and pandemic VLP (virus-like particle) influenza vaccines, to meet our projected clinical- and commercial-supply requirements for the foreseeable future”, Stanley Erck, president and CEO of Novavax, said.
Novavax is modifying the two facilities and expects to complete work by mid-2012. As well as giving Novavax production capacity the site in Gaithersburg, Maryland will also meet its clinical, research and development, and administrative needs.
Once the site is ready Novavax will move its headquarters from Rockville, Maryland to the new campus in Gaithersburg. The Rockville site includes a pilot plant but its future is unclear.
Opening the plant will equip Novavax to handle an anticipated uptick in demand. In the third quarter Novavax posted revenues of $5.0m (€3.7m), up from $175,000 a year earlier, as the contract with the US Office of Biomedical Advanced Research and Development Authority (BARDA) ramped up.
BARDA is funding Novavax’ seasonal influenza vaccine through Phase III and its pandemic product through early stage clinical trials. It is these products that Novavax expects to account for the bulk of initial production at its new plant.
The BARDA-driven uptick in business helped Novavax slash its operating loss, although it still posted a $4.0m deficit. In the first nine months of the year Novavax came close to halving its losses but was still down $17.3m.
The University of Texas Health Science Center (UTHSC) opened the new South Texas Research Facility (STRF) at its campus in San Antonio, US, in October 2011. Built with an investment of $150m, the new facility will serve UTHSC's growing research activities.
"The City Council of San Antonio announced in June 2011 it is providing $3.3m funding for the construction of the facility."The STRF project was approved in August 2007 and construction commenced the following year in August 2008. The facility will house more than 350 researchers and scientists who will conduct research on cancer, aging, diabetes, neurosciences and regenerative medicine.
UTHSC is one of the biggest health sciences universities in the US. The STRF will help in transforming new discoveries made by the university into potential cures for various diseases. It is expected to support the growth of the local economy and generate new jobs.
The new three-storey facility has a built up area of 190,000 sq. ft. It has a horizontal design to encourage interaction between researchers and facilitate new idea generation. It includes a durable coated concrete masonry wall system which provides an impermeable surface ideal for laboratory activities.
The first floor of the STRF includes a main entrance, four lobbies, a conference room and other meeting rooms.
An ultra-modern laboratory, support space, vivarium spaces and offices are located on the second floor. The laboratory space is spread over 125,000 sq. ft. and primarily includes wet labs.
About 20% of the area is provided for dry labs. A corridor runs through the centre of the floor connecting all the facilities. The support space is located on either side of the corridor.
The laboratory has an open-space design which can be shared by various research teams to promote interaction. The labs are fitted with modular casework which provides maximum flexibility. They can be reconfigured according to the research needs.
The laboratory space features state-of-the-art equipment such as an ultra-high-resolution optical N-STORM microscope. It is the first such microscope to be installed in Texas and enables researchers to view 3-D molecular structures of a cell. It was installed at a cost of $377,000.
The microscope can capture up to 50,000 image frames and transform them into a single, super-resolution image. Researchers can use the microscope to examine the interaction between human cells and viruses.
The third floor includes offices, meeting rooms and a bioinformatics core. The Institute for Integration of Medicine & Science and South Texas Technology Management are also located on the third floor.
Electricity for the facility will be generated by 758 solar panels installed on the building's roof and over parking spaces. The solar panels were installed with the grant received under the American Recovery and Reinvestment Act. The panels are expected to generate energy savings of 210,000kWh or $15,000 annually.
Only 62% of the space will be occupied while the remaining space will be left for accommodating out-of-town teams of scientists.
About $100m was provided by the state's Permanent University Fund and tuition bonds.
"The University of Texas Health Science Center (UTHSC) opened the new South Texas Research Facility (STRF) at its campus."Another $42m was raised through philanthropy.
The City Council of San Antonio announced in June 2011 that it is providing $3.3m funding for the construction of the facility.
The funds will be provided over three years in three installments through the San Antonio Economic Development Corporation (SAEDC).
The first installment of $1.1m is expected to be given towards the end of October 2011.
Under an agreement with SAEDC, the STRF will return 15% of its profits earned from equity investment in start-up companies. The companies are established to commercialize the discoveries made at the facility.
The facility was designed by Rafael Vinoly Architects. Vaughn Construction was the general contractor. E&C Engineers & Consultants was the mechanical, electrical and plumbing contractor. Technology infrastructure was supplied by DataCom Design Group. Byrne Metals was contracted to supply metal panels and aluminum louvers.
New Orleans BioInnovation Center (NOBIC) is located on Canal Street in New Orleans, US. It was opened in June 2011 and officially inaugurated in September 2011. Spread over 66,000 sq. ft., the four-storey building will act as a biotechnology and research incubator. It was built at a cost of $47m.
The new facility will provide infrastructure to university researchers and biotechnology start-ups to commercialize technologies. It is situated in the New Orleans life sciences hub called the Greater New Orleans Biosciences Economic Development District.
"The NOBIC project was funded by the Louisiana Department of Economic Development."NOBIC's close proximity to two hospitals, three universities and a cancer research facility will help in promoting collaboration within the community.
Biotech companies currently occupying the facility include the Southern Research Institute, InnoGenomics, NuMe Health, NOvate Medical Technologies, MiniVax and TMS Bioscience among others. Louisiana Fund II, a venture capitalist firm, and Southcoast Angel Network are also operating at the facility.
NOBIC also provides opportunities for educational institutions such as Louisiana State University Health Sciences Center, Tulane University Health Sciences Center, the University of New Orleans and the Xavier University to commercialize technologies.
The facility is expected to generate 200 direct jobs.
NOBIC was conceptualized nearly ten years ago after a feasibility study identified the huge potential economic impact of the life sciences research that was taking place in New Orleans. Local research institutions and biotech companies were unable to commercialize their research into profit-yielding products due to lack of the right resources. The state government approved the development of the facility in order to address this problem.
The two-storey Wirth Building constructed in the late 1950s was chosen as the site for the construction of NOBIC. The old building was demolished to enable construction of the new facility. Hurricane Katrina, however, hit New Orleans in 2005 just after the demolition of the building, delaying the start of construction.
Rise in construction costs by nearly 40% forced the developers to delay the construction of the NOBIC. The construction was resumed in August 2008.
Test pilings driven at the site led to the discovery of storage tanks which were part of a gas station that operated at the site from 1938 to 1949. Removal of these storage tanks required state and federal environmental approvals, leading to further delays in construction.
Actual construction of the facility started in October 2009.
The facility has space for conference rooms, universally adaptable wet-lab suites and 2,000ft2 of retail space. It has a lobby with an open atrium, 3,000ft2 courtyard area and ceiling-to-floor glass windows. The facility can accommodate about 40 to 50 companies in the top three floors.
The conference rooms can accommodate 100 people and feature state-of-the-art audiovisual equipment.
The NOBIC project was funded by the Louisiana Department of Economic Development. Additional funds were provided by the Economic Development Administration.
NOBIC was designed by Eskew+Dumez+Ripple in collaboration with NBBJ.
Turner Construction was the general contractor. Gibbs Construction was the local contractor. Adams Management provided project management services while Morphy Makofsky was the civil / structural engineer.
TMG was responsible for contract administration services during demolition activities at the site. Mechanical, electrical and plumbing contractor was Newcomb & Boyd.
Laboratory equipment was provided by Fisher Hamilton. Frischhertz Electric supplied electrical components including motion sensors, access controls, lighting, security cameras and video conferencing facilities.
NOBIC is the first LEED Gold project to be developed in New Orleans. It incorporates several environment friendly features. It is clad with precast panels fitted with glass, which reduces the amount of heat entering the building. Sunscreens on the glazing provide lighting and storm protection and reduce energy costs. The white reflective roof of the building also reduces the energy costs.
Other sustainable features of the facility include a rainwater retention system to collect water from the roof and electric vehicle charging stations.
New Orleans BioInnovation Center is part of the New Orleans Central Business District. NOBIC will act as a biotechnology and research incubator for companies in New Orleans. The new facility will partner educational institutions, such as Tulane Health Sciences.
Boehringer Ingelheim Pharmaceuticals announced that it has made more than $350 million worth of capital investments throughout its U.S. operations this year, in order to further bolster its drug discovery, development and manufacturing capabilities. Privately-held, family-owned Boehringer Ingelheim continues to grow by improving its state-of-the-art facilities and enhancing its research, development and manufacturing capabilities.
The latest investment is a 72,000 square-foot research and development facility at the company's U.S. headquarters in Ridgefield, Connecticut. When complete the $65 million facility will handle production of active pharmaceutical ingredients used in early development activities. Products developed here, if approved, move on to Boehringer Ingelheim's full-scale R&D facilities in Ohio and Virginia, as well as Germany and Italy.
Other investment announcements by Boehringer Ingelheim in 2011 include:
In August, the company announced its investment in a new drug safety assessment building in Ridgefield, Conn. The $42 million project is scheduled to be completed in 2013 and will provide space for non-clinical safety studies.
The company's U.S. animal health business, Boehringer Ingelheim Vetmedica, Inc., this summer dedicated its new $89 million vaccine research facility in Sioux Center, Iowa, one of three special vaccine research buildings it will build there. The company also announced a $100 million expansion of its biological manufacturing facility in St. Joseph's, Missouri.
In September, Boehringer Ingelheim Roxane, Inc., opened a new $50 million High Containment Operations facility in Columbus, Ohio in order to meet a growing market demand for high potency and oncology products. The building uses state-of-the-art technology to develop and manufacture differentiated high potency oral solid tablets and capsules in support of Roxane Laboratories', Inc. rapidly growing multisource business.
In addition to these capital investments, Boehringer Ingelheim gained a presence on the West Coast with the acquisition in March of Boehringer Ingelheim Fremont, Inc. The facility, acquired from Amgen, manufactures biological medicines, and consists of more than 300,000 square feet for laboratories, manufacturing and process development suitable for clinical and market supplies.
"These are exciting projects; ones that increase Boehringer Ingelheim's research and development capabilities and reinforce our commitment to growth and innovation in the U.S.," said J. Martin Carroll, President and CEO of Boehringer Ingelheim's U.S. operations. "Through these investments we are improving our ability to research, develop and manufacture the medicines of tomorrow and in doing so fulfilling our promise to bring more health to patients and their families."
Boehringer Ingelheim Pharmaceuticals, expanding as other Big Pharma firms cut back, has started construction on a $65 million research and development facility on its 294-acre campus in Ridgefield, the second major expansion there this year.
The privately-held German drugmaker, with its U.S. headquarters and about 3,000 employees in Ridgefield, said the new facility "will handle production of active pharmaceutical ingredients used in early development activities."
The new, 72,000-square-foot facility will replace a smaller, older building on the campus. The new facility will be attached to the old building until at least 2015 when the construction -- to be completed in stages -- is expected to be finished.
Jim Baxter, senior vice president of development for U.S. operations, said the pharmaceutical giant chose to keep the new facility in Connecticut because it is vital to the rest of the research that is done in Ridgefield. The new facility isn't expected to add jobs, at least not initially, but shows the company's commitment to its Connecticut research facility, Baxter said.
In August, the company began work on a $42 million drug safety assessment building in Ridgefield, for non-clinical safety studies. That building is scheduled to be completed in 2013.
Together, the two buildings represent an investment of more than $100 million in Connecticut.
Boehringer Ingelheim has more than a dozen buildings on its campus, including 10 that are connected to each other.
Both Connecticut projects are part of more than $350 million in capital investments in the United States in 2011, with projects in Iowa, Missouri and Ohio. The company also acquired a business in California from Amgen.
Boehringer Ingelheim, with more than 42,000 employees worldwide, had net sales of $16.7 billion in 2010.
Ohio State University has received a five-year, $23 million grant from the National Cancer Institute for the continued support of its Comprehensive Cancer Center (OSUCCC), which conducts genomic and molecular biology-focused studies, along with a range of other research efforts.
According to OSU, the renewal of the core grant represents a nearly 24 percent increase over the funding NCI provided for the center in 2005, and followed a "rigorous" review process that included a site visit from 28 scientists from other universities. During the review center was evaluated for its scientific impact, cancer care, and clinical trials enrollment as well as its service to the community.
"The money provided to us by the NCI is critical for our infrastructure and facilitation of groundbreaking research to prevent, detect, treat and cure cancer," explained Michael Caligiuri, OSUCCC's director and CEO of the James Cancer Hospital and Richard J. Solove Research Institute.
OSU said that the core grant is the center's major source of funding for supporting scientists and the administration, and for shared technology and services that are provided to more than 250 cancer researchers at Ohio State.
The OSUCCC will also keep its designation as an NCI “comprehensive” cancer center, which only 41 institutions nationwide currently hold, the school said.
Caliguri said that the funding "will help us recruit the best and brightest minds to Ohio State by leveraging our status as the only NCI Comprehensive Cancer Center with a freestanding cancer hospital attached to an academic medical center on the campus of one of the largest universities in the country."
The center has six core research programs, including the Molecular Biology and Cancer Genetics and the Molecular Carcinogenesis and Chemoprevention research programs. The molecular biology program focuses on studies of gene expression, DNA replication and differentiation, and other projects focused on understanding the molecular basis of cancer screening, diagnosis, prognosis, and treatment.
The primary goal of the center is to increase understanding of the associations between genes and cancer by identifying human genes that lead to an increased predisposition to cancer, determining the molecular mechanisms underlying gene expression and function, and promoting clinical applications of gene identification and gene function for use in diagnosis, prognosis, and surveillance.
Scientists at the molecular carcinogenesis and chemoprevention center work to understand the causes of cancer by characterizing molecular and cellular changes, developing and characterizing novel agents for cancer chemoprevention, identifying efficacy and safety mechanisms, and implementing translational studies focused on people who are at high risk for exposure to carcinogenic or cancer promoting agents.
Accellent Inc., a provider of outsourced manufacturing and engineering services to the medical device industry, has opened a 65,000-square-foot manufacturing plant in Penang, Malaysia.
The new facility is joining plants in five countries. Accellent currently has 14 manufacturing facilities in 12 U.S. states as well as manufacturing operations in Germany, Ireland, Mexico and the United Kingdom.
“This site will serve as an important hub for our Asia business since several of our key customers are located nearby,” said Donald Spence, president and CEO of Accellent. “We also expect that this new facility will provide cost-effective solutions for our other global markets and help support our proven track record of bringing customer innovations to market quickly and efficiently.”
The company provides fully integrated outsourced manufacturing services as well as engineering design, prototyping, assembly, and logistics support to medical device companies in various markets, including cardiology, endoscopy, orthopedic, and neuromodulation.
The company chose Penang both to be close to the growing Asian market and because of the stable political environment, officials said. In addition, Accellent was able to purchase and transform the plant in less than 12 months as a result of support from organizations such as the Malaysian Industrial Development Authority, Invest Penang, and several departments within the State Government of Penang.
“The Penang state government wants to transform Penang into an international and intelligent city, a preferred destination for foreign direct investment,” said Yab Tuan Lim Guan Eng, chief minister of Penang.
“We are seeking to broaden our manufacturing base by diversifying into services. To move up the value chain, Penang seeks convergence in products, technology and services. Accellent’s investment speaks directly to our vision of making Penang the location of choice for high-tech manufacturers.”
Accellent is privately owned and based in Wilmington, MA.
Fresh from linking up with Cambridge University to find therapies for Alzheimer’s and Parkinson’s disease, Elan Corp has signed another academic pact, this time with Ireland's University College Dublin.
An initiative has been announced which is designed to create "a leadership position in the global biotechnology industry", says Elan, adding that the cornerstone of this will be the establishment of Europe’s first interdisciplinary chair in the ‘business of biotechnology’. In addition, Elan will contribute over 3 million Euros to UCD's new 67,000 square meter (720,920 sq. ft.) science centre that is nearing completion.
Elan's chief executive Kelly Martin said that rapid advancements in biology, computational application and diagnostics "combined with the globalization of the biotechnology industry require future business leaders ..to manage a portfolio of assets within the environment of a dynamic and ever-changing risks/reward equation". He added that "future industry and company success will be defined by those with the ability to make good decisions within this integrated space".
The UCD link-up follows an announcement last month that Elan is investing $10 million over five years in the initial phase of The Cambridge-Elan Centre for Research Innovation and Drug Discovery, newly launched at the University of Cambridge.
Agilent Technologies and Monash University Sunway campus announced the creation of a center to provide training in molecular and genetic studies.
The center, called the Monash-Agilent Authorized Microarray Service Center, will be established at the Australian university's campus outside Kuala Lumpur, Malaysia, where it will be equipped with microarray instruments to provide competency training to the center's professionals undertaking research in human disease.
The organizations will share knowledge, including real-time communication of new developments in microarray applications. They will also be able to network with Agilent's global customers.
"The establishment of the AMSC will be a timely boost in the collaboration between Agilent and Monash University Sunway campus through the Jeffrey Cheah School of Medicine and Health Sciences, providing the opportunity to access advanced technologies to strengthen our current genomics research in diabetes, cancer, neurobiology, and infectious diseases," Dato' Dr Anuar Zaini Md Zain, head of the medical school, said in a statement.
The partnership, the first for Agilent with a university in Malaysia, is expected to support that country in becoming a leader in life science research and development in Southeast Asia, they said.
AstraZeneca announced it has entered into an agreement to acquire Guangdong BeiKang Pharmaceutical Company Ltd, a privately-owned generics manufacturing company, based in Conghua City, Guangdong province, China. The deal will give AstraZeneca access to a portfolio of injectable medicines used to treat infections which AstraZeneca will make available to patients in China.
Following completion of the acquisition, AstraZeneca will be responsible for the manufacture and commercialization of these medicines. Effectiveness of the agreement is contingent on the approval of certain regulatory authorities, including the approval of the Ministry of Commerce in China. The transaction is expected to close in the first quarter of 2012. Financial terms were not disclosed.
The acquisition reinforces AstraZeneca’s commitment to bringing innovative original and high quality branded generic medicines to Chinese patients. Coming on the heels of AstraZeneca’s $200 million investment in a new manufacturing facility, located in China Medical City, Taizhou, Jiangsu province, the announcement accelerates the company’s ‘broad market’ strategy, which aims to increase the accessibility and affordability of medicines for wider patient populations that are currently underserved.
Mark Mallon, President of AstraZeneca’s Asia-Pacific region, said: “AstraZeneca continues to invest in the key emerging markets such as China where the combination of growing populations, elevated levels of chronic diseases and increasing income are driving demand and expectations for better healthcare treatment. Our new acquisition further underscores our intention to serve the health needs of Chinese patients through our innovative medicines and, increasingly, high quality branded generic treatments that are locally produced to global standards.”
It is estimated that there are over 800 million patients in China who are not covered by the network of big hospitals in large cities, and who currently have only limited access to quality treatments. The Chinese Government’s focus on healthcare reform, along with investment in improving healthcare infrastructure and expanding insurance coverage, are expected to continue to drive growth and demand for quality medicines over the long term. The Chinese pharmaceutical market grew from $10 billion in 2004 to $41 billion in 2010 and, according to IMS Health, is expected to grow to over $100 billion by 2015.
Since first establishing a presence in China in 1993, AstraZeneca has invested around $500 million in China and has fast become one of the leading biopharmaceutical companies in the country, with a turnover of more than $1 billion in 2010.
Sanner GmbH, a manufacturer of plastic packaging components for pharmaceutical, medical and healthcare products, is strengthening its presence in Asia. Along with expanding its plant in Kunshan, China, the packaging specialist opened a new sales office in Indonesia in October. Sanner is now in a position to better serve its growing customer base in Asia. Production at all Sanner plants worldwide is based on the company's "Made in Germany" principle.
With nearly 100 employees at its plant in Kunshan, China, the packaging specialist manufactures standard products, including tubes and desiccant closures and develops custom packaging solutions. Sanner China supplies packaging to leading pharmaceutical and diagnostics industry manufacturers in Asia. "We are very satisfied with the development of Sanner China," explains Sanner CEO Holger Frank. "The plant site opened in 2000 has become an important unit within our corporate group. We see further growth potential in Asia."
Sanner opened a new production facility in September and now has the space it needs to expand in the Asian market. The extended production area and existing manufacturing unit are designed as cleanroom facilities. "The new building extension doubles our cleanroom production capacity and ensures controlled production in a carefully monitored environment," says Holger Frank.
Construction of the new production facility was completed within 12 months. Sanner has invested several million Euros in the new building and production systems. The extension also resulted in a 20-percent increase in the number of employees at the site. "Our ultra-modern, state-of-the-art production facility meets the highest hygiene and quality standards," explains Holger Frank. Sanner operations in China are in line with increasing pharmaceutical packaging standards in the Asian market. The demand for technically advanced packaging and custom designs is growing in emerging economies. "Sanner customers can always be assured that they are getting a top-quality product – regardless of whether it comes from production operations in Germany, Hungary or China. All of our manufacturing facilities operate according to our 'Made in Germany' principle" explains Holger Frank.
In order to provide better, faster services to customers in Asia, Sanner opened a new sales office in Jakarta, Indonesia in October. This office will primarily serve customers in Southeast Asia. The sales office in Shanghai, China will continue to serve other Asian regions.
Stevanato Group has pulled forward the expansion of its EZ-Fill facility in Italy by one year in a bid to dominate a bigger portion of the “rapidly expanding” ready-to-fill vials market.
Thanks to an additional €4m ($5.3m) investment, the Italian glass packaging provider’s new line – at their Padua plant – can now wash, depyroginate and sterilize up to 40m containers of their EZ-Fill vials and cartridges per year.
The company said the expansion was to keep up with the demands of the ever expanding ready-to-fill market – now accounting for 2.8bn pieces of the syringes and vials market as a whole, and worth an estimated €1bn.
Sergio Stevanato, president of Stevanato, told in-PharmaTechnologist: “We started out by focusing on clinical trials. “However, with more companies outsourcing none-core activities, saving their capital investments for their traditional lines, there is an increased interest in the market for EZ-fill vials and cartridges.”
He added that with more companies jumping on the outsourcing bandwagon – Stevanato has more than 100 projects in play at the moment – the only way to be effective was to industrialize the process.
General Manager Franco Stevanato added: “We decided to pull the project forward because many customers want to expand their company now, not in a year’s time. “
Previously, EZ-Fill has mainly been supplied to the US and Europe.
However the company says it has now seen a surprising uptick in BRIC (Brazil, Russia, India, and China) market interest and is now working on a more global scale.
“We have seen an unpredictable interest worldwide and especially in emerging countries, where new manufacturing pharmaceutical plants are going to be created,” added Sergio Stevanato.
“This is a good opportunity for the companies to adopt a configuration fully compatible with our EZ-Fill solution from the onset.”
In conjunction with their expansion in Italy, the firm is also doubling capacity at its production facility in Monterrey, Mexico.
Following an initial €4.5m ($6m) investment – expected to hit €30m upon completion – the firm says the 20,000 m2 (215,200 sq. ft.) facility will be capable of supplying glass containers, ampoules, vials and cartridges to the North, South and Central American markets.
Sergio Stevanato said: “With the second phase expansion we are adding completely new lines, designed and manufactured by our Engineering Division SPAMI, in order to double the global capacity.
“This shift will aim to cover the increasing demand of high quality glass containers for pharmaceutical use coming from North American market but also South and Central American markets.”
India-based Vivimed Labs is buying Uquifa for £35m ($55m) to add API capabilities in Europe and Latin America.
Buying Uquifa gives Vivimed Labs three API (active pharmaceutical ingredient) production sites, two in Spain and one in Mexico. Vivimed Labs plans to use the assets to expand outside of its home market.
“Multi-geographical locations spell stability and cement long-term relationships with customers and channel partners. With Uquifa, Vivimed will have a footprint into Latin America and deeper into Europe”, Santosh Varalwar, managing director of Vivimed Labs, said.
In 2008 Vivimed Labs bought a UK-based dye manufacturer but the Uquifa deal marks its push into the European API sector. Vivimed Labs said Uquifa’s pipeline of filings in Europe and the Americas will drive growth over the next five years. Uquifa posted a £4.5m profit in 2010.
“Strengthening of R&D efforts, opening out new markets and the untapped potential by virtue of our combined knowledge of pharma, a strong and consolidated customer base, ably complemented with cost-efficiencies will mean Uquifa reinforcing its avowed position”, Varalwar said.
Yule Catto, the owner of Uquifa, will receive £28.6m in cash, followed by £6.4m in three years, for the assets. Uquifa’s 390 employees, including CEO Mark Robbins, will transfer to Vivimed Labs.
The Ethiopian national quality control laboratory has gained ISO accreditation to improve access to safe medicines.
Achieving accreditation equips the Ethiopian Product Quality Assessment Directorate (PQAD) to ensure drugs standards. The Promoting the Quality of Medicines (PQM) Program supported the effort.
Patrick Lukulay, director of the PQM Program, said: “PQAD demonstrates that its technical operations and administrative systems are functioning at the highest quality levels by international standards, producing accurate, valid results that can be trusted by the international community.”
The PQM Program is backed by the US Agency for International Development (USAID) and run by the US Pharmacopeial Convention (USP). PQM has worked with laboratories in Southeast Asia and South America on accreditation, but Ethiopia is its first project in sub-Saharan Africa to reach this level.
PQAD gained ISO/IEC 17025:2005 accreditation, which covers testing and calibration, for “seven key analytical tests”. Having the certification could help the Ethiopian Food, Medicine and Health Care Administration and Control Authority (FMHACA) internationally.
“With this achievement, we have demonstrated our ability to produce reliable results that will give authorities—within Ethiopia and internationally—confidence in decisions impacting the health of patients”, Denekew Yehuleu Alamneh, director-general of FMHACA, said.
Efforts to raise standards will continue. “PQAD’s dedication to continuous improvement will put the laboratory in a position to contribute to improving access to good quality medicines in Ethiopia and the entire region”, Sheri-Nouane Duncan-Jones, deputy health office chief USAID Ethiopia, said.
Efforts are underway to boost production in nations neighboring Ethiopia. In April the East African Community (EAC), comprised of Kenya, Uganda, Tanzania, Rwanda and Burundi, approved a draft regional manufacturing plan and it is expected to boost local production capacity.
Standardization of regional policies will allow companies to sell drugs across the five member states, The East African reports, and businesses, such as Biodeal, plan to expand to meet rising demand.
Haupt Pharma’s site in Toride, Japan was successfully inspected at the end of October by Ibaraki prefecture, the local authority, without any significant observation being issued. The inspection covered all GMP areas and was conducted for the renewal of a manufacturing license.
“Particularly against the background of the earthquake disaster in March of this year, the result of the inspection underlines the expertise and commitment of the site’s team, which contributed to this very good result,” said Keizo Yanagisawa, managing director of Haupt Pharma Toride.
The site manufactures sterile drugs in 1 ml, 2 ml and 5 ml ampoules, which are sterilized in their final container through processes such as microwave sterilization and steam autoclaves. Haupt Pharma Toride offers the service of subjecting imported bulk goods (injectables) to a visual inspection and then labeling and packaging them for the Japanese market. This service is also offered for products that require cold chain storage.
Almac said that its Diagnostics business has received accreditation from the College of American Pathologists for its Craigavon, Northern Ireland facilities.
CAP accreditation is recognized by the federal government as being equal to or more stringent than the government's inspection program, according to Almac.
Accreditation from CAP's Accreditation Committee follows an examination of Almac's laboratory records and quality control of procedures for the preceding two years. Staff qualifications, equipment, facilities, safety program and record, and overall lab management are also assessed.
"This accreditation allows us to further support our clients by running clinical diagnostic tests for trial enrichment," said Paul Harkin, president and managing director of Almac Diagnostics.
The UK government will invest an additional £80 million ($125.9 million) to fund continued development of the Institute for Animal Health (IAH) at Pirbright, an institute of the Biotechnology and Biological Sciences Research Council that is being built in Surrey.
The new funding will support the second phase of development of the IAH campus, which is already under construction at Pirbright, as well as the transfer of IAH's facilities at Compton, in Berkshire, which is scheduled to close.
This second phase of construction will include development of high-containment laboratories, experimental facilities, and supporting infrastructure for research into avian and other animal diseases with a focus on developing vaccines and testing tools. BBSRC said this lab will join a £100 million high-containment lab that is already under construction at Pirbright and is due to be running in 2014.
IAH's research is focused on viral diseases that affect livestock and poultry and employs a range of overlapping approaches, including genomics, genetics, epidemiology, proteomics, molecular and structural biology, and others.
"The new facilities in this next phase of development are urgently required to underpin UK and EU capability in research on virus infections of poultry and livestock. They will provide a single site that has a variety of bio-containment level working environments," IAH Director John Fazakerley said in a statement.
"The Institute for Animal Health at Pirbright is not only involved in furthering scientific knowledge and promoting innovation but in protecting animal health, rural livelihoods, and food security," added BBSRC Chief Executive Douglas Kell. "The new facilities for studying avian and other diseases will help to protect huge sectors in the UK economy and protect hundreds of thousands of jobs that would be at risk during an animal disease outbreak."
According to BBSRC, the UK poultry industry is worth around £8 billion per year, and a major outbreak of Marek's disease could wipe out up to 90 percent of the industry while a major avian influenza outbreak could destroy 20 to 50 percent of the poultry industry.
Bilcare Opens New Bötzingen, Germany Line
Bilcare Solutions, a manufacturer of mono- and multi-layer barrier films for the pharmaceutical industry, is debuting its new off-line laminating line. Through its Pharma Packaging Innovations (PPI) business, Bilcare is now laminating barrier films at its facilities in Bötzingen, Germany.
FDA-compliant multi-layer barrier films will be produced under GMP conditions with the new "DIN EN ISO 15378 validated laminating line," Bilcare reported in a press release. "This makes Bilcare Solutions the sole provider of high-barrier films in Europe, offering in house production of barrier films from the actual manufacturing over lamination to coating, all under one umbrella," the release reads.
“With the investment in this new laminating line, we consequently continue to implement our growth strategy and strengthen our leading position as integrated system provider for mono-, duplex- and triplex films for the pharmaceutical industry,” comments Thorsten Kühn, CEO Bilcare Research AG, Switzerland, in the statement.
Bilcare Solutions, Bilcare Global Clinical Supplies, and Bilcare Technologies are part of the Bilcare Research Group, which operates 13 sites with 2,300 employees worldwide. Bilcare Solutions globally produces rigid films such as rigid PVC and PVC-PE films and offers coating, stentering, laminating, and metalizing. It also extrudes PET films.
BioMarin Pharmaceutical Inc.’s expanded manufacturing plant in Novato won approval from the Food and Drug Administration.
BioMarin completed construction of the 21,800-square-foot cleanroom addition in November 2009. It invested $60 million to expand the facility to about 70,000 square feet, including about 40,000 square feet of cleanroom space.
When production is up and running in the new space, a company spokesman said, BioMarin will have more than 100 new employees. Some of those new hires may already be on board, he said.
The expansion was needed, the spokesman said, as BioMarin's list of marketed products and drugs in clinical trials continues to grow. BioMarin is known for developing and selling “orphan drugs” — those aimed at diseases with populations of 200,000 patients or fewer — particularly enzyme replacement therapies.
The Novato plant will handle initial production of a new drug, GALNS for the lysosomal storage disease MPS IV, or Morquio A Syndrome. GALNS, or BMN-110, is in a Phase III trial, with results expected in second-half 2012.
The expansion, built by Novo Construction of Menlo Park, also will make drugs for trials, including a new drug that BioMarin said will be disclosed at its R&D day DEC. 8.
“The approval of this facility supports the manufacturing requirements for anticipated peak sales of our commercial products and also support several of our clinical and preclinical programs,” BioMarin CEO Jean-Jacques Bienaime said in a press release.
BioMarin this summer spent $48.5 million to buy a 133,000-square-foot Pfizer Inc. plant in Shanbally, Ireland, which Bienaime said will provide “manufacturing diversity” and ensure that there are enough drugs to meet demand.
German technology giant Schott has signed an agreement with a Chinese firm to provide the fast-growing pharmaceutical market with a range of high-end glass packaging products.
The deal sees Schott strengthen its presence in China, and builds on its established pharmaceutical operations in other emerging markets such as Brazil, Russia and India, where it maintains similar facilities.
Udo Ungehauer, chairman of Schott's board of management, explained the reasoning behind the partnership, and how the new deal represented part of a wider strategy aimed at capitalizing on the burgeoning Chinese market.
“With the formation of this joint venture between Schott and Xinkang, two strong partners are joining forces,” he said.
“By combining Xinkang’s knowledge of the local market with Schott’s technological expertise, we will be able to supply Chinese pharmaceutical companies with high-quality packaging products even more effectively in the future.”
The joint enterprise will make use of Schott's existing manufacturing plant in Suzhou, Jiangsu province, and a further site in Jinyun, Zheijiang Province.
Schott's 2500 sq. m. (26,900 sq. ft.) Suzhou plant opened in 2008 and specializes in the production of high-end glass packaging solutions. It was the first of its kind to be opened by a global manufacturer in the country.
The plant already serves both the Chinese domestic market and multinational pharmaceutical companies with what the company refers to as 'premium products.'
Ungehauer said striking a partnership with an established Chinese manufacturer such as Xinkang served to highlight the company's commitment to building and developing closer ties with the local market.
Industry analysts claim China is destined to become the world's largest pharmaceutical market by 2050, and though the glass packaging sector is still dominated by low-priced products, Schott said it expected rapid development to drive up demand for higher quality services.
ShangPharma is opening a 100,000 sq. ft. facility dedicated to serving a big customer as it continues to strengthen ties to top clients.
Demand from top 10 customers drove double-digit third quarter sales growth at ShangPharma. To continue this trend and deepen links to one of its biggest clients ShangPharma is investing in a new facility.
“During the third quarter, we made a critical investment in a new facility, which is fully dedicated to one of our top customers”, Michael Xin Hui, founder and CEO of ShangPharma, said. ShangPharma is renovating the facility, which it began leasing in June, ahead of its opening by the end of 2011.
Leasing the facility for months before it contributes revenues is dragging on profits at China-based ShangPharma. Operating profit fell 34 per cent year-on-year but ShangPharma expects to recover quickly.
As well as adding to revenues the site eases “some of the over capacity pressures that ShangPharma was beginning to experience at the existing locations”, Hui said. Buying a Shanghai toxicology site from Charles River Laboratories was also part of efforts to prepare for expected growth in 2012.
Hui said the site will accommodate continued fast growth in in-vivo pharmacology, with oncology and metabolic disease work particularly in demand. ShangPharma has shown clients around the site and is confident utilization will ramp up over the next few quarters.
China-based clients and biology services are other growth areas at ShangPharma. Both posted triple-digit sales growth in the third quarter, off small bases, and play key roles in ShangPharma’s plans for next year and beyond.
In a welcome boost, Ireland is seeing a wave of biotechnology investments and new companies. With pharmaceutical and chemical products making up more than 50% of Irish exports, such developments are vital to the country’s economy.
Pfizer says it will invest $200 million to expand its Grange Castle biotech manufacturing facility near Clondalkin. The site is already Pfizer’s largest investment in Ireland and the only facility in Europe to manufacture biopharmaceuticals, pharmaceuticals, and vaccines at one location, the company says. The move, Pfizer adds, will strengthen its manufacturing and supply network.
According to the industrial development agency IDA Ireland, Pfizer is Ireland’s largest pharmaceutical investor, having spent more than $7 billion there. But Pfizer has been shedding other Irish operations. In March it sold its Dún Laoghaire biologics formulation and fill facility to Amgen. Three months later its bulk biologics plant in Shanbally went to BioMarin Pharmaceutical.
Meanwhile, mergers involving other firms are creating new, larger businesses with headquarters in Ireland. Palo Alto, Calif.-based Jazz Pharmaceuticals will acquire Ireland’s Azur Pharma to form a Dublin-based firm with expected annual sales of about $475 million. As an Irish company, Jazz will see its tax rate drop by at least five to 10 percentage points.
The formerly U.S.-based Alkermes has opened headquarters in Ireland after merging with Elan Drug Technologies, once part of Ireland’s Elan. Alkermes also announced a deal to make a finished drug at its Athlone, Ireland, site for a top 10 drug firm. The deal is expected to generate up to $20 million in annual revenues by 2016.
The Contec’s facility in China has expanded its offices and manufacturing facilities in Suzhou Industrial Park in Suzhou China.
“We have been manufacturing in China for the last five years and made the decision to expand our operations. After months of planning, we are now operating on a full scale basis in the new facility.
“The new facility has approximately 70,500 square feet of manufacturing space, with room for future expansion,” says Don Batts, Project Manager. “It includes state-of-the-art ISO Class 4 and ISO Class 6 cleanrooms, laundry and saturation, allowing Contec to continue making the quality products people are used to seeing.”
Redundant Manufacturing, Quality and Research and Development in both the United States and China allows Contec more flexibility and gives our international customers more options than ever before.
Work has begun on a £5m project to build a state-of-the-art unit to sterilize surgical instruments at Colchester General Hospital and Essex County Hospital.
The Hospital Sterilization and Decontamination Unit (HSDU) will be located next to the Old Boiler House on the former Turner Village site on the edge of the Colchester General Hospital site. It will replace the existing facility, which is in the hospital’s Main Block and will be equipped with brand-new state-of-the-art equipment.
The HSDU re-processes instruments and equipment required for clinical intervention in the treatment of patients. The majority are theatre instrument sets which are cleaned and decontaminated, inspected, packed, sterilized and returned for re-use. Nick Chatten, Special Projects and Estates Director for Colchester Hospital University NHS Foundation Trust, which runs Colchester General Hospital and Essex County Hospital, said it was a significant investment.
“The Trust has outgrown its current HSDU and this replacement unit will be bigger,” he said.
“When it is complete, it will mean Colchester will have one of the most efficient HSDUs in the NHS East of England region.
“For example, the new major re-processing equipment will benefit from the latest advances in technology and substantially reduce water consumption in comparison to the machines currently in use, resulting in an eco-friendly addition to the Trust’s estate.”
The main contractors for the project will be Rose Builders Ltd of Lawford and the new unit is scheduled to become operational in July next year. Its cost will be funded entirely from the Trust’s own resources.
The Trust has 34 whole-time equivalent staff working at its HSDU. During weekdays, cover is provided 24 hours a day with day shifts at weekends. The location of the new unit away from the main hospital will mean that it can be built without any major impact on the rest of the hospital.
Aesica has plans to grow and expand following a significant investment from Silverfleet Capital, a European private equity firm. Silverfleet Capital has agreed to a majority investment in Aesica and members of Aesica have reinvested for a large minority stake in the company.
The investment will allow Aesica to continue its expansion into new markets and grow its position as a major supplier of APIs and Formulated Products to the global pharmaceutical industry. Aesica has six manufacturing sites across Europe and sales representation across the U.S., Europe and Asia, and plans to extend its current capabilities and global manufacturing facilities.
Dr. Robert Hardy, chief executive officer of Aesica said, “We have known the team at Silverfleet Capital for a number of years and chose them as our financial partner because of their deep knowledge of our market and their experience and successful track record of building global businesses of scale through buy and build strategies. Our long term strategic plan was to establish a manufacturing presence in the U.S. and Asia in 2012 and with the support from Silverfleet Capital we can continue to expand into new markets, evolve and grow more swiftly.”
Construction of the ambitious European Marine Science Park is underway at Oban in Argyll.
Highlands and Islands Enterprise (HIE) is investing £7.5m to create the first phase - which will take advantage of significant opportunities in marine science, marine biotechnology and renewable energy.
The 20,000 sq. ft. of office and laboratory space will support businesses in Scotland's growing Life Sciences and Energy sectors and has the potential to support up to 125 jobs.
The site of the development, Dunstaffnage near Oban, is already an internationally recognized centre of excellence for marine science, with the Scottish Marine Institute being home to the Scottish Association of Marine Science (SAMS), and the European Centre for Marine Biotechnology. These provide marine science research and education as well as incubation space for new and growing businesses.
Robertson, the infrastructure, support services and construction group, are now on site to begin work on phase one, which will provide a supportive atmosphere for businesses to continue to grow in a high-specification sustainable building, located in an outstanding marine environment.
Energy, Enterprise and Tourism Minister Fergus Ewing said: "The Scottish Government and its enterprise agencies are working hard to retain Scotland's position as the most competitive environment for business in the UK.
"The £7.5 million European Marine Science Park will create a European Centre of excellence in marine science, research and development at Dunstaffnage, which will strengthen the local economy through attracting new jobs and investment to the area.
"I am delighted that work has started on phase one of this ambitious Highlands and Islands Enterprise project - this brings us another step closer to making this major infrastructure project a reality for this community and local businesses."
Douglas Cowan, Area Manager for HIE, said: "The European Marine Science Park is a landmark project for Argyll and is of national significance. It builds on our strong reputation in marine sciences and will lead to more businesses employing more people in high value jobs, creating greater prosperity for north Argyll and the wider area."
SAMS Director, Professor Laurence Mee, commented: "With the success of the European Centre for Marine Biotechnology at SAMS we have demonstrated how the private sector can make innovative use of the scientific knowledge and unique natural assets available in Argyll. HIE's European Marine Science Park will build on this, allowing entrepreneurs to spin out companies that will bring new jobs to the region and create a knowledge-based society that will resonate nationally and internationally. This is a fantastic development and a huge vote of confidence from HIE, the private sector and the Scottish Government."
In August 2010, the HIE Board approved an investment of £7.5m to create the first phase of the Science Park on the site next to SAMS at Dunstaffnage. HIE will contribute £4.5m of its own grant-in-aid budget from the Scottish Government, and has attracted the remaining £3m towards this first phase from the European Regional Development Fund (ERDF).
Chemviron Carbon Cloth Division is pleased to announce the opening of a new state of the art cleanroom as part of the company’s multi million pound investment program.
The company’s overall expansion plan requires the creation of space on the factory floor to increase production capacity. The construction of the 120m2 (1,291 sq. ft.) cleanroom onto a new mezzanine level allows the company to sufficiently increase its space for production equipment on the ground floor level.
As an integral part of the company’s production capability, the cleanroom facility at Chemviron Carbon Cloth Division is primarily used for the processing of activated carbon cloth for wound dressings. Prior to the new commission, a temporary structure served as the company’s cleanroom.
The company’s overall production capability for wound dressing products includes lamination of the activated carbon cloth to other materials, slitting and cutting and final pouching of the wound dressing.
Certain wound dressing customers only require one or two elements of this process and many of the Cloth Division’s customers include some of the world’s leading medical device companies.
A two-storey cleanroom was constructed inside the existing factory, with creative use of slim line equipment to ensure the most efficient use of space within the new facility. As a key feature within the upper level cleanroom area, a number of transfer hatches were used to reduce the movement of operators throughout the cleanrooms and help eliminate contamination at each process point in the manufacture.
The Cloth Division’s previous temporary cleanroom structure was compliant with the ISO 13485 standard and Class 7 ISO 14644 in the Zone 3 pouching area. The newly constructed cleanroom retains the ISO 13485 standard and expands the scope of the ISO 14644 standard with the addition of the lamination area complying with Class 8 ISO 14644.
Much consideration was given to the planning of the cleanroom as an integral part of the company’s expansion plan.
Consultations were made with wound dressing customers, consultant microbiologists and the company’s notified body. The Cloth Division required the contractor, WH Partnership, to come up with a solution that maximized manufacturing areas, reduced carbon footprint and energy costs and streamlined the process, without disruption to existing manufacturing.
Chemviron Carbon's Cloth Division (formerly known as Charcoal Cloth International) develops and manufactures Zorflex Activated Carbon Cloth. The Cloth Division, based near Durham, UK, is the world’s leading manufacturer of 100% activated carbon cloth. Activated Carbon Cloth (ACC) was originally developed by the British Ministry of Defense for use in chemical warfare suits however nowadays Zorflex has many more applications.
Pharmaniaga LifeScience's small volume injectables (SVI) facility in Puchong, in the Selangor district of Malaysia, commenced commercial production in January 2011.
The Puchong factory will carry out SVI fill and finish contract manufacturing for both regional and global companies. Built at a cost of RM149m, the plant has a production capacity of 40 million units a year.
"Malaysia has been importing more than 90% of its SVI products from India and Australia."The new facility is compliant with the good manufacturing practices (GMP) of the European Union, US Food and Drug Administration (FDA) and Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S).
Pharmaniaga constructed the SVI facility to expand its manufacturing base and accommodate future manufacturing capabilities. As a long term strategy, Pharmaniaga plans to relocate its entire manufacturing operations to the new site.
Pharmaniaga LifeScience is a subsidiary of Malaysian investment holding company Pharmaniaga.
The concept design and the plant specifications were completed in 2002 and 2003 respectively, by a UK-based consultant.
Construction of the plant commenced in July 2004. Officials from National Pharmaceutical Control Bureau (NPCB) visited the facility in 2007 and recommended improvements necessary to begin production.
The factory acceptance test (FAT) was undertaken in early 2008 after implementing the NPCB recommendations. An engineering trial run was conducted in the third quarter of the same year.
The facility obtained the cGMP certification from the Ministry of Health in August 2010. The first product license for commercial production was obtained in December 2010.
The SVI plant has been constructed on a 17.5ha plot and has a built up area of 9,000m2 (96,840 sq. ft.). It is the first facility in Malaysia to feature clean-rooms of classes A, B, C and D.
The main building includes a warehouse, manufacturing and packaging area, equipment workshop, quality control and microbiology laboratories and an office.
The Puchong factory is equipped with European processing equipment such as a solution preparation line, ampoule filling line, terminal and parts autoclave, external washer and inspection machine, leak tester machine and a purified water system.
The engineering, procurement, construction management and validation works contract was awarded to Bovis Lend Lease in 2004.
Scope of work included design and construction of the facility as per Pharmaniaga's product list, sales forecast and future extensions, while making the best use of available land.
Installation and qualification (IQ) and operational qualification (OQ) tests of the purified water system were conducted by Synertech.
Mechanical and piping services were provided by Engmech + Pharmaserv.
OLSA supplied the solution preparation machine, Bausch and Strobel supplied the ampoule filling line, Fedegari the autoclave sterilization systems, Seideneder external washing and inspection systems and Bonfiglioli supplied the leak testing machine.
The project received external and internal funds. The SVI facility was part-financed by the Islamic Financing Facility (IFF). RHB Sakura Merchant Bankers was the lead banker.
The IFF committed an RM60m loan raised through the Islamic Medium Term Notes Program.
Construction of the new plant is part of Pharmaniaga's growth strategy aimed at tapping both regional and global markets.
"The Puchong factory will carry out SVI fill and finish contract manufacturing for both regional and global companies."Malaysia has been importing more than 90% of its SVI products from India and Australia.
The new SVI plant help the company participate in the RM400m market for SVIs in the country. Pharmaniaga has 15-year concession up to 2019 to supply medical products to government hospitals. The contract was renewed in 2010.
Pharmaniaga aims to become a world-class SVI fill and finish contract manufacturing company. It has identified Europe and South East Asian regions as priority markets. The Puchong facility's compliance with international GMP will enable Pharmaniaga to export products to developed regions such as the US and Europe.
Shonan Research Center is a new drug discovery and development centre located in Fujisawa City, Kanagawa prefecture, Japan. Built at a cost of ¥147bn ($1.9bn), the plant was officially inaugurated in February 2011.
"Construction of the Shonan Research Center was started in June 2009 and mechanically completed in February 2011. Full-scale operations at the facility will begin in November 2011. Takeda Pharmaceutical Company (Takeda) is the owner and operator of the facility.
The Shonan Institute will facilitate medicine research and development (R&D) in early stages. It will also collaborate with academic universities and bioventure companies to develop innovative medicines. The centre will support collaborative research programs.
Takeda is the largest research-based pharmaceutical company in Japan and one of the largest in the world. The company was founded more than 230 years ago. Takeda works on the development of medicine through its R&D pipeline, producing several pharmaceutical products such as Candesartan Cilexetil, Lansoprazole, Pioglitazone Hydrochloride and Leuprorelin Acetate. The in-house drugs are exported to more than 90 countries.
Takeda also operates research facilities in the US, UK and Singapore. The Shonan Research Center will act as the control base for Takeda's global research operations. It will lead the basic research such as discovery of drug targets, research of synthesis, pharmacology and pharmacokinetics.
The main therapeutic areas of new drugs development include gastroenterological diseases, central nervous system diseases, urological and oncology diseases and immunology / inflammatory and metabolic (diabetes and obesity) diseases.
Takeda's new research facility is located at the centre of Kamakura and Fujisawa cities, about 50km west of Tokyo. It consolidates the research facilities of the company at Tsukuba, Ibaraki prefecture, and Osaka, Osaka prefecture. It will bring together about 1,200 researchers under one roof and accommodate 800 support staff.
The location of the facility is in proximity to several pharmaceutical institutions in the Kanagawa prefecture, which is expected to increase the research related opportunities.
The ten-storey building is constructed on a 250,000m2 (2,690,000 sq. ft.) greenfield site. Laminated rubber foundations reduce the impact of earthquakes on the building.
The facility has a built-up area of more than 72,000m2 (774,720 sq. ft.) and boasts about 308,000m2 (3,314,080 sq. ft.) of floor area with flexible layout for R&D. It has five research wings and a Center Station wing. The layout of the synthetic chemical, animal and biochemical research facilities eases the coordination between similar functions.
The building houses a P3 laboratory with exhaust HEPA filters, high-pressure sterilizer and wastewater treatment processing facilities for genetic recombination experiments. It also has a library and refreshment area for employees. Interstitial space on all the research floors is used as equipment flooring, which also eases maintenance.
Taikisha supplied the heat source and HVAC facilities of the plant. The environmentally friendly equipment and energy-saving HVAC technologies include hyper drydeco decontamination system and heat source optimal control system.
The centre is surrounded by woodland and waterside area. The isolated structure increases safety and reliability of the building.
"Shonan Research Center is a new drug discovery and development centre located in Fujisawa City, Kanagawa prefecture, Japan. "The centre also has many green features such as a landscaped rooftop, energy-saving ventilation system and extensive use of natural light.
The facility is installed with CO2 emission control equipment to curb emissions. It also has a flood control basin. The building fully complies with the Japanese environmental protection, human safety laws and regulations requirements.
Construction of the Shonan Research Center was started in June 2009 and mechanically completed in February 2011. The forest landscape and waterbody were preserved during construction.
Construction management services for the facility were provided by Yamashita PM Consultants and Yamashita Sekkei. The design and construction supervision services were provided by Plantec Architects. The detailed design, construction and management were carried out by Takenaka Corporation and other subcontractors.
Evonik Industries AG has set up a new laboratory at their Hanau site for highly potent active pharmaceutical ingredients (HPAPI) and expanded their cGMP capacity for HPAPI on a kilogram scale at Tippecanoe Laboratories (Lafayette, Indiana, USA). The new laboratory allows Evonik to develop and optimize syntheses for HPAPI now also in Germany. At their US site Evonik has similar laboratory installations. Given the expanded capacity, Evonik now has a reactor volume for HPAPI of a total of 170 m3. Of this volume, approximately 135 m3 are being used for the production of HPAPI on the metric-ton-scale, and approximately 35 m3 are being used for small batch production and manufacturing development quantities. “For exclusive synthesis, we can now manufacture the entire spectrum of highly potent active ingredients from the clinical phase to commercialization," noted Dr. Klaus Stingl, head of the Exclusive Synthesis product line of the company’s newly created Health Care business line.
Highly potent active ingredients are active pharmaceutical ingredients that are effective even at very low concentrations. A maximum of 0.2 milligrams per kilogram body weight or 10 milligrams per day is needed to have a significant therapeutic effect. These active ingredients include hormones, peptides, or cytostatic drugs for cancer treatment. “The demand for synthesis development and small batch production of HPAPIs for the clinical phase has gone up significantly in the past few years,” explains Stingl, justifying the investment in Hanau and Tippecanoe. According to Stingl, this is due in part to new developments in the treatment of tumors and endocrine diseases.
Due to their high potency, measures must be taken to protect the environment and laboratory and production employees when HPAPIs are handled. All of Evonik's HPAPI facilities are designed so that they can handle even active ingredients for which the allowed workplace threshold limit value (TWA, eight hours) is only 0.1 microgram per m3 of air.
“Currently there are very few companies worldwide that are even allowed to work with highly potent active ingredients,” says Kevin Haehl, who is responsible for the exclusive synthesis of active ingredients at Evonik’s Tippecanoe site. “Evonik is one of the most high-performance suppliers because, as one of the very few companies, we can also adhere to respectively low workplace threshold limit values. This means that we can also safely handle those active ingredients that, due to their extremely high potency in e.g. destroying cancerous tumors could be harmful to healthy people. “
The exclusive synthesis of highly potent active ingredients is carried out mainly at the Tippecanoe site, which Evonik acquired from the American pharmaceuticals company Eli Lilly in early 2010. The approximately 650 employees at the site have more than 20 years experience in handling, developing syntheses, and producing HPAPIs. With Evonik’s establishment of a similar laboratory in Hanau, this highly specialized expertise is now also available in Europe.
South Korean adult stem cell company RNL Bio has opened a stem cell medical center in Beijing's Yanda International Medical Research Institute.
The facility, spread over 41,600 ft² of the research institute, has a capacity to store stem cells of 20,000 patients. Under the partnership with Yanda Group, RNL will take up the charge of stem cell storage in the GMP facility and management of medical treatment.
The clinical research and treatment of patients by stem cell therapy will be administered by Yanda Group.
RNL Stem Cell Institute president Jeong Chan Ra said through the stem cell treatment in China, the company hopes to offer broader opportunities to patients with incurable diseases.
The Bayer Group plans to further expand its production, distribution network and research activities in Asia and considerably increase its sales in the region in the coming years. "We aim to achieve a more than 60 percent increase in our sales in Asia by 2015," Management Board Chairman Dr. Marijn Dekkers said on Wednesday at Bayer's international press conference "Perspective on Growth in Asia," held in Shanghai, China. This would mean annual sales of well over €11 billion by 2015 at today's exchange rates. Of this figure, Greater China is planned to account for some €6 billion. Dekkers officially inaugurated a new production facility for TDI -- a raw material for the production of flexible foams -- at the Bayer Integrated Site Shanghai.
At the press conference, attended by more than 100 media representatives -- with journalists in India, Vietnam and Indonesia participating via live video link -- Dekkers explained the company's perspectives in the emerging countries of Asia. He said the Bayer Group already does a significant proportion of its business in Asia. Twenty years ago, Asia accounted for only about 10 percent of sales, equivalent to just over €2 billion. Ten years ago, the proportion had grown to about 15 percent, and last year the region already accounted for some 20 percent of sales. In the Asian region, Bayer achieved sales of €6.9 billion in 2010, including €2.9 billion in Greater China, and anticipates further growth in Asia in 2011. "We have made capital expenditures of €3.4 billion in Asia over the past 10 years, creating a basis for outperforming market growth in this region," said Dekkers.
Bayer has laid a firm foundation for expansion. "Our country organizations here have had local roots for many years, in fact we have been operating for more than a century in China, India and Japan," said Dekkers. "We are familiar with the markets, and we know how to tune our approaches to the different conditions prevailing in different markets in order to further expand our business."
Asia is a remarkable continent with particularly strong growth momentum, Dekkers continued. He said the change processes resulting from global megatrends are especially rapid and fundamental in the emerging markets. These megatrends include rising life expectancy, which is greatly increasing the demand for health care. "Products from Bayer HealthCare help to keep people healthy, cure diseases and significantly improve the quality of life -- also for elderly people," said Dekkers.
Another megatrend is the growth in the world population, which is expected to increase by another 2 billion to 9 billion over the next 40 years. At the same time, more and more agricultural land is being used for energy production. "Our researchers at Bayer CropScience are helping to increase yields on the limited amount of agricultural land available, and to reduce harvest losses," Dekkers pointed out.
According to Dekkers, humankind must also bring the megatrend of climate change to a halt and start reversing it. Asia consumes more energy than North America and Europe combined, he said. "Products from Bayer MaterialScience not only help to save energy through high-performance thermal insulation in buildings or lighter-weight materials in vehicles, they also improve the performance of wind turbines, for example. And we take care to use energy-saving processes in the manufacture of our products."
All the Asian countries are intended to play a part in achieving the sales increase targeted for 2015. Apart from China, this applies particularly to India, where sales are expected to grow from just over €0.5 billion last year to about €1 billion. Sales in Japan are planned to rise from just under €2 billion to around €2.4 billion. To meet its targets, Bayer intends to improve the availability of its products in Asia. "We already operate major production facilities here and intend to go on expanding in the future," said Dekkers. He said Bayer will continue to expand its distribution network to serve the subcenters and rural areas as well.
In addition, Bayer intends to participate in the region's transition to an innovation hub of the globalized world. Here the company is focusing on collaborations with the leading institutes and centers of expertise, as well as its own activities. "We will also continue to invest in local research and development and thus contribute our know-how to the R&D landscape here. And in doing so, we are taking account of Asia's particular needs," said Dekkers. That applies, for example, to diseases that occur more frequently there than in other parts of the world—such as liver cancer. Bayer also wants to improve access to its new medicines in Asia by integrating Asian patients into the early stages of global development programs, and plans to submit innovative medicines for registration concurrently in Asia, Europe and the United States.
Bayer CropScience works with agricultural crops that are particularly important in Asia, Dekkers explained. The subgroup's focus is therefore on research and development projects for crops such as oilseed rape/canola, rice, cotton, soybeans, wheat and vegetables. Bayer MaterialScience not only supplies industrial customers with locally manufactured polymer products, it also offers the necessary technical advice and applications development know-how through its systems houses.
To meet its growth targets in Asia, Bayer plans to develop the necessary personnel resources, Dekkers continued. The company's Asian workforce has increased by nearly 8 percent in the past 12 months alone. "And we expect to see a further rapid increase in employment in the coming years." The number of employees in Asia could increase from 23,700 in 2010 to more than 30,000 by 2015. Capital expenditures of some €1.8 billion are also planned during this period.
A major focus of Bayer's activities is Greater China, now the company's biggest market in the region. In the first nine months of 2011, Bayer had some 11,000 employees in Greater China and sales of €2.2 billion (RMB 19.8 billion), which was 8 percent of Bayer Group sales. Bayer MaterialScience accounted for 59 percent, Bayer HealthCare for 37 percent and Bayer CropScience for approximately 4 percent of this figure. "We want all of our subgroups in China to continue their rapid growth," said Dekkers. Bayer plans to increase sales in Greater China to about €6 billion by 2015, with MaterialScience accounting for about €3 billion of this figure, HealthCare for €2.5 billion and CropScience for a good €300 million.
Dekkers described the steady double-digit growth rates in the Chinese pharmaceutical market as remarkable, pointing out that Bayer is one of the five largest health care companies in China. Local sales of Bayer HealthCare in 2010 amounted to €926 million (RMB 8.2 billion), with the prescription medicines of the Pharmaceuticals Division accounting for 80 percent of this figure and non-prescription medicines, medical devices and animal health products for 20 percent.
With a market share of nearly 5 percent and €130 million (RMB 1.2 billion) in sales, Bayer CropScience is the number three supplier in the Chinese crop protection market. "Our aim is to be the supplier of choice in China's most important crops—especially rice and vegetables," said Dekkers, adding that the key to this lies in comprehensive solution packages—including innovative products—that give effective support to farmers.
The Chinese market is of considerable importance for the MaterialScience business. For example, China is the world's biggest market for the construction industry, for automobiles and railway vehicles, for the electrical and electronics industry, and for shoe production. These industries are among the principal customers of Bayer MaterialScience. Last year Bayer MaterialScience had sales of €1.8 billion (RMB 16.3 billion) in Greater China.
In the presence of numerous guests as well as high-ranking politicians and officials, Dekkers inaugurated a new TDI production facility with a planned capacity of 250,000 tons per year at the Bayer Integrated Site Shanghai. The plant is based on a new process technology that reduces solvent use by some 80 percent compared with plants of a similar size that use the conventional process. It also lowers energy consumption by up to 60 percent. The use of this technology also enables substantial savings on operating costs and a reduction of roughly 60,000 tons per year in carbon dioxide emissions. In addition, the new technology cuts the investment costs for large-scale plants of this type by around 20 percent.
"We have been operating at the Shanghai Chemical Industry Park for ten years," the Bayer CEO remarked. Bayer MaterialScience has invested €2.1 billion in production facilities for all of its major products on this site. The company intends to follow this first phase of investment with a second phase. Bayer plans to spend a further €1 billion to expand its MDI capacity to 1 million tons per year, increase its polycarbonate capacity to 500,000 tons annually and build a new HDI line that will raise annual capacity by 50,000 tons. "These are considerable capital expenditures involving significant capacity expansions. It goes without saying that we use the very latest technology in our facilities," Dekkers stressed.
ICON Plc’s resourcing division, DOCS, has expanded in Europe with the opening of new offices in Milan, Budapest, Brussels and Berlin, bringing the total number of European offices to 22.
DOCS provides resourcing solutions, including functional service provision (FSP), strategic sourcing and permanent placement. The European expansion follows the launch in Asia-Pacific in early 2011. The company plans to further expand in other key markets, including Latin America, Eastern Europe, the Middle East and Russia, in 2012.
“DOCS has always been strong in Europe and we have a large client and candidate base in the region,” said Colin Stanley, president, DOCS. “Investing in local support and infrastructure will ensure that we support the current and future needs of both clients and candidates. We have aggressive growth plans for the future and will continue our market expansion in line with these plans.”
inVentiv Health, Inc. has established inVentiv Health Korea, a Seoul-based operation that will provide clinical development and commercial services to healthcare clients.
The Korean operations will provide outsourced sales services through the company's Selling Solutions segment. The company recently signed an agreement with a top 20 pharmaceutical company to provide medical representatives to promote several of its products in Korea. inVentiv Health Korea is currently providing clinical development services to several pharmaceutical clients through its clinical segment, PharmaNet/i3.
“Our clients are expanding their businesses in Asia and as they do, inVentiv is broadening its geographic reach to meet their outsourcing needs,” said Paul Meister, chief executive officer of inVentiv Health, Inc. “As a $15 billion pharmaceutical market expected to grow by significant margins over the next several years, Korea is an attractive opportunity for us. Not only are our pharmaceutical clients increasingly conducting clinical research in Korea, it is also a market where many leading pharmaceutical brands in the U.S. will be launching in the coming years, creating a growing need for outsourced sales and marketing support. Our move into Korea also reflects our commitment to expanding inVentiv’s best-in-class services into key emerging markets.”
inVentiv Health Korea will be led by Jae-Hee Kim, who will serve as president. Mr. Kim has more than 20 years of executive leadership, new business development, client services, and sales and marketing experience. Prior to his current position, Mr. Kim was a representative director at Enters Partners Co. Ltd., a marketing and consulting company to the pharmaceutical industry. He has also held several senior-level positions with Korean Green Cross Corp, SmithKline Beecham, and Quintiles Transnational.
“Jae-Hee Kim brings a great depth of experience to this role having held senior roles at top pharmaceutical manufacturing companies and within leading service-side healthcare businesses. With unmatched knowledge of the Korean marketplace, Mr. Kim is the ideal candidate to help inVentiv establish a strong presence in this important geography,” said Rick Finnegan, executive vice president, Global Operations, inVentiv Health.
Pharmaceutical giant Pfizer Inc. said it is delaying a plan to build a new Anti-Infectives Research Unit in China after shutting down its anti-bacterials program in Groton earlier this year.
David Shlaes, an industry consultant from Stonington, blogged over the weekend that Pfizer had announced internally the cancellation of plans to pursue antibiotics research in China.
But a Pfizer spokeswoman said that the planned Anti-Infectives Research Unit's timeline for implementation in Shanghai has simply been extended. Earlier this year, the company said the move to China would occur over a two-year period; it did not commit to any specific schedule in its latest announcement.
"Our business priority is to maximize the investments we are making in the mid-stage portfolio so that we can deliver new products more quickly," Pfizer spokeswoman Kristen Neese said in an email. "The creation of a new Anti-Infectives Research Unit in Shanghai will now be implemented on a longer timeline."
The announcement hit a raw nerve with advocates for antibiotics research, who have bemoaned R&D cutbacks worldwide in recent years even as life-threatening superbugs kill more and more people in U.S. hospitals -- an estimated 70,000 in the past year.
"They had a spectacularly talented group of people and an exciting pipeline and they've destroyed their program," said Brad Spellberg, a UCLA researcher, in an email. "From the perspective of someone who believes that we need talented people developing important antibiotics to help treat our patients, this was a crushing blow. To find out now that the Shanghai thing is not proceeding, well it just adds insult to injury."
The U.S. Congress is considering several ways to boost antibiotics research, including a bill co-sponsored by U.S. Sen. Richard Blumenthal, D-Conn., called the Generating Antibiotic Incentives Now Act. The bill would double to 10 years the time drug companies can market new antibiotics with exclusive patents and would speed up the regulatory review process.
New York-based Pfizer announced the planned closure of the Groton anti-bacterials unit in February as part of a downsizing of its research-and-development contingent worldwide. Locally, 1,100 jobs were to be eliminated over an 18-month period, the company said at the time, and two other major research units -- focusing on neurological and cardiovascular diseases -- were slated to move to the Boston area.
In September, Pfizer announced that it had completed the move of its cardiovascular medicine and endocrine disease research unit to Cambridge, Mass., over the summer. The move of its neuroscience unit would follow next year, Pfizer said.
It is not clear what impact the delay in the Shanghai plan would have on operations in Groton.
At the same time, Pfizer had said Groton's anti-infective medications research unit was in transition. The company said earlier this year that it was building a new research site in Shanghai, but promised "we will continue to run our existing clinical and pre-clinical programs in the U.S. to ensure uninterrupted progress on these important programs in areas of high unmet medical need."
Pfizer said it has retained scientists with anti-bacterial expertise at the Center for Discovery and Development Sciences in Groton.
"This includes medicinal chemists and clinical pharmacologists among other specialized disciplines that have extensive anti-bacterial expertise," the company said. "Our vaccines research organization, which continues to be very successful, has extensive anti-infective expertise."
In its latest announcement, Pfizer said the pullback from immediate plans to build an anti-bacterials unit in Shanghai, which would have been the first complete move of an American R&D unit to China, will not affect operations already in Shanghai and Wuhan.
"R&D investment in China continues to be centrally important to the innovative core of Pfizer," Pfizer said.
Pfizer also said it plans to pursue investments "in the treatment and prevention of infectious disease, an effort that includes several gram negative (antibacterial) projects approaching the clinic and numerous vaccine R&D programs."
Pfizer said that in addition to retaining scientists with anti-infectives expertise in Groton, its Specialty Care Business Unit "remains committed to progressing our projects that are in clinic as planned."
Horizon Pharma, Inc. and Sanofi announced that the U.S. Food and Drug Administration has approved the use of the sanofi-aventis Canada Inc. manufacturing site in Laval, Quebec to manufacture DUEXIS®, (ibuprofen/famotidine) a proprietary single-tablet combination of ibuprofen (800 mg) and famotidine (26.6 mg). DUEXIS was approved by the FDA in April 2011. Sanofi will serve as the primary commercial manufacturer for DUEXIS in the United States.
"The approval of the Sanofi Laval manufacturing site provides Horizon with an experienced commercial manufacturer as we move forward with the launch of DUEXIS," said Timothy P. Walbert, chairman, president and chief executive officer of Horizon Pharma. "We look forward to making DUEXIS available in the next few weeks to patients who suffer from osteoarthritis and rheumatoid arthritis and who may be at risk for upper gastrointestinal ulcers stemming from ibuprofen use."
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