PHARMACEUTICAL & BIOTECHNOLOGY
INDUSTRY UPDATE
March 2014
McIlvaine Company
TABLE OF CONTENTS
Neuroscience Building, University of Miami, United States of America
Black Hills State University to Build Underground Campus and Cleanroom
Spaulding Rehabilitation Hospital Unveils its State-of-the-Art New Hospital
Hospira Opens New Quality Laboratory at North Carolina Plant
Stonehill & Taylor Create Research Center for NY Psychiatric Institute
Univ. of Wyoming Begins Construction on Science & Tech Facility
Salk Institute and Stanford Lead New Stem Cell Genomics Center
Univ. of Florida Clinical Translational Building, Gainesville
Rafael Viñoly Designs Science Building for Univ. of Buenos Aires
Ireland's First Human Use Stem Cell Production Facility Opens
Sanofi and Transgene Start Construction of New Bioproduction Platform in France
Fraunhofer IZI Granted Authorization for Second GMP Facility
The University of Miami began construction of a new neuroscience facility at the Coral Gables campus in April 2012. It is located adjacent to the Cox Science Centre at the University campus.
The new facility is currently under construction and is expected to be ready by the end of 2013. It will provide great collaboration for scientists in the field to discover the neurological processes and related diseases, upon completion.
The new neuroscience building will be located in a three-story building with a total floor space of 37,700ft². It will be used as a centre for interdisciplinary research on neurological imaging and health research. It will have ample space for research laboratories, offices, a vivarium and an MRI suite.
The facility will enable the scientists from biology and psychology departments of the university to collaborate with the Miller School of Medicine. Scientists, clinicians and engineers will work together on fundamental aspects of brain function at the new facility.
The building will include a transformational facility and also provide training programs for neuroscientists and health psychologists. The laboratory will be used for diagnosing and treating myriad neurological diseases.
The neuroscience building is installed with advanced functional magnetic resonance imaging equipment. It has a human functional magnetic resonance imaging (fMRI) scanner. It was hoisted into place and positioned within a specially shielded room on the first level of the building.
The latest in molecular imaging is installed at the second floor of the building. The floor will also include a photon-based microscope for observing living proteins at work, plus a variety of cutting-edge microscopes for the research.
The advanced laboratory equipment will enable neuroscientists to study how molecular changes in the nervous system relate to behavior. The equipment will enable scientists to analyze molecular patterns in the nervous system to predict successful treatment of neurological diseases.
The research programs in the facility will be equipped to study model systems in animals. The studies on animals can be correlated with human behavior to find functional changes in different regions of the brain. The laboratories will be equipped with sophisticated systems to track the nerve cell activity and make real time connections to human behavior in order to study the brain.
University of Miami neurosciences facility construction
The pre-construction and construction services contract for neuroscience facility was awarded to Arellano Construction, a subsidiary of Obrascon Huarte Lain.
Tropic Mechanical was awarded with a $5m worth contract to provide state-of-the-art laboratory at the neuroscience facility. The work was completed in March 2013.
The building is being constructed in compliance with LEED Silver green-building standards. It is designed to be environmentally sustainable.
The National Institutes of Health (NIH) contributed $14.8m grant under the American Recovery and Reinvestment Act for the construction of the neuroscience building in February 2010.
Life sciences and molecular diagnostics company Arrayit Corp. has commenced business operations from its new corporate headquarters located in Sunnyvale, Calif. The new corporate headquarters feature expansive modern offices and meeting rooms, R&D, manufacturing, packaging and shipping facilities, and cleanroom laboratories that are currently undergoing Class 100 enhancements and certification for Clinical Laboratories Improvement Amendments (CLIA) and International Organization for Standardization (ISO) 9001 and 13485.
Arrayit develops, manufactures, markets, sells, and supports microarray products and services for university laboratories, government agencies, and life sciences, biotechnology, diagnostics, and pharmaceutical companies worldwide. The company uses its life sciences tools revenue to fund pre-symptomatic diagnostic testing for major treatable human conditions including ovarian cancer and Parkinson’s Disease.
Arrayit OvaDx for pre-symptomatic ovarian cancer monitoring and screening, is scheduled for United States Food and Drug Administration (FDA) 510(k) submission during the first half of 2014.
A site has been designated for a Black Hills State University Underground Campus at the 4,850-level of the Sanford Underground Research Facility in Lead, S.D.
“This is a banner day for Black Hills State University and for our students,” says BHSU President Kay Schallenkamp. “The BHSU Underground Campus creates unparalleled opportunities for our students to have unique research experiences. It also recognizes the close relationship that the University has established with the Sanford Lab since it was established in 2007.”
“This new laboratory expands our capacity to host a variety of experiments deep underground,” says Mike Headley, director of the Sanford Lab. “It’s very exciting for us to be working with BHSU to make it a reality.”
The Underground Campus will include a cleanroom that allows students and faculty to conduct a variety of research projects including low-background counting physics experiments. The Campus will also accommodate other experiments such as biology and geology and provide storage for equipment.
The Underground Campus will give BHSU faculty and staff even more opportunities to collaborate with scientists from all over the world and participate in groundbreaking research, according to Schallenkamp. When completed, the underground space will be the site for research by BHSU undergraduate and graduate students. The site will be used for ongoing physics and biology research as well as include flexible space for future research across a variety of disciplines.
BHSU’s location, less than 20 miles from the deepest underground lab in the U.S., has created a number of unique experiences for students and faculty. BHSU science faculty are trained to go into the lab and take samples for other scientists across the U.S. The university has been designated the lead regental institution for the Sanford Science Education Center, and serves as a Quarknet site, an educational program funded by the National Science Foundation and the Department of Energy to enhance physics education in high schools. BHSU students and faculty are currently preparing the lead bricks used in the Majorana Demonstrator physics research.
Every year a number of students complete internships at Sanford Lab in communications and photography as well as network and computer services internships. A group of business students are working with Sanford Lab officials to create marketing plans.
The Underground Campus is another example of the partnership the university has with the Sanford Lab. The BHSU campus will house the Sanford Science Education Center. This collaboration will enable the university to combine its teacher program with research creating new opportunities in teaching math and science. Last summer, the University and Sanford Lab announced a $4.5 million project to convert the Jonas Science building on the BHSU campus into a facility to complement Sanford Lab’s education efforts in Lead. The South Dakota Science and Technology Authority, who owns and operates the Sanford Lab, is providing $2.5 million to the Jonas redesign, which will be part of the Sanford Science and Education Center. The donation is part of a $70 million gift from philanthropist T. Denny Sanford. The SDSTA is using much of Sanford’s gift to convert the former Homestake gold mine into a world-leading underground research laboratory.
The University of Connecticut has inked a partnership with KeraFast to make stem cells developed at the university available globally.
KeraFast will market two stem cells lines created in 2009 from skin cells taken from patients with deletions of sections of chromosome 15 who develop Angelman Syndrome and Prader-Willi Syndrome. The stem cell lines were developed in the laboratories of UConn researchers Stormy Chamberlain and Marc Lalande.
Lalande is the executive director of Genomics and Personalized Medicine Programs at the university, as well as director of the UConn Stem Cell Institute and the Institute for Systems Genomics. He said, "The aim is to make UConn's line available to broaden the research base into more common disorders such as autism and schizophrenia."
According to Lalande, UConn's stem cell lines are the first being marketed by KeraFast.
Institutions that have requested the stem cell lines for research and drug discovery include the University of Cambridge, the National Cancer Institute, the Salk Institute, and the University of California, Davis, UConn said.
Headquartered in Boston, KeraFast markets life science reagents and tools developed by researchers from universities and other not-for-profit institutions.
Financial terms of the deal were not disclosed.
Spaulding Rehabilitation Hospital unveiled its new 262,000 square foot, 132 bed patient-centered hospital to the public. The facility has already been recognized for its LEED Gold status, reflecting its commitment to green design principles. Located at 300 First Avenue in Charlestown, the hospital will be previewed for the public and areas providers prior to the full patient and staff move on Saturday April 27th, when the operations transfer from its former location.
Since its founding in Boston’s West End by Dr. Josiah Spaulding in the late 1960’s at the beginning of the disability rights movement in Massachusetts, Spaulding Rehabilitation Hospital (originally opened as Massachusetts Rehabilitation Hospital) has helped thousands of patients and families recover from complex conditions and serious illnesses such as stroke, severe burns, limb-loss, spinal cord injury and traumatic brain injury. The hospital has grown into a national leader in rehabilitative care and research as a Harvard Medical School teaching hospital and the only rehabilitation hospital in New England recognized as a best hospital by US News and World Reports each year since 1995.
Despite the tremendous recognition, the building that Spaulding had called home since its inception had reached its capacity for updating and an urgent replacement facility was needed. With broad support from government and the community, Spaulding embarked on an ambitious project to build a patient centered state-of-the-art hospital in the Charlestown Navy Yard that would a model of inclusive and sustainable design. “Spaulding is a beacon of hope and healing for people around the state and the world,” said Governor Deval Patrick. “I congratulate them on opening this extraordinary rehabilitative care and state-of-the-art research facility.”
The leaders at Spaulding approached the project with the same critical eye towards improvement that its clinicians use with their patients. It was not enough to build a new hospital. The goal was to build a new type of rehabilitative hospital and in the process provide an example of how to create a patient-centered environment for people of all abilities while also using the best practices in “green design”.
“For far too long, rehabilitative care was an afterthought to many, relegated to the basements of hospitals and out of site. This hospital makes a bold statement that a new era of rehabilitative medicine is here by bringing together scientific innovation and patient-centered design that puts this institution on par with the major centers of healing in the world,” said David Storto, President, Spaulding Rehabilitation Hospital. “It’s truly an honor to lead Spaulding and serve this region with its leaders who have the forethought to understand how vital Spaulding will be for decades to come.”
Annually, Spaulding serves more than 2,500 inpatients and almost 30,000 outpatients per year. One of those 2,500 inpatients, Mayor Thomas M. Menino, was a strong supporter in enabling the hospital to be built and understanding the difference the patient-centered experience will be in this new setting.
The new facility brings a broad range of key innovations to its design as well as enabling new methods of delivering care. An aquatic therapy center was created with a large therapy pool and a smaller resistance training pool which will serve inpatients, outpatients and community programming. The exterior has an extensive outdoor therapy garden to allow clinicians to work with patients to practice navigating on a variety of surfaces such as sand, cobblestones, concrete stairs and a boardwalk. Nature, light and the outdoors were incorporated into the design whenever possible to aid in the healing process for patients. Each patient room is private and lines the exterior of the building so they receive the maximum amount of natural light possible. From the floor markings to room signage, all aspects of the hospital were created to be both functional and provide therapeutic value.
“In rehabilitation medicine, we use everything at our disposal to improve our patients’ ability to achieve their therapeutic and quality of life goals. What this new hospital will do is allow our clinicians to have almost unlimited tools to work with patients in novel ways from the gym, the halls or the outdoors,” said Dr. Ross Zafonte, VP of Clinical Affairs, Research and Education at Spaulding and Chair of the Department of Physical Medicine and Rehabilitation at Harvard Medical School. “The freedom we now have to expand our scientific explorations in this environment in such a dynamic way will have
Gresham, Smith and Partners, a leading multi-disciplinary design and consulting firm for the built environment, announces the completion of Methodist Olive Branch Hospital (MOBH) in Olive Branch, Mississippi, designed and constructed by an Integrated Project Delivery (IPD) team including GS&P, Smith Seckman Reid, Inc. (SSR) and Turner Construction Company. Set to be opened to the public on August 26, 2013, the new 210,000 square-foot, 100-bed hospital, which is on track for LEED Gold certification, offers Northern Mississippi residents state-of-the-art healthcare in a sustainable setting that features several energy-saving innovations only rarely seen in U.S. hospitals
"The northern region of Mississippi has grown tremendously over the past two decades, but many residents have still traveled across state lines to seek healthcare in Memphis. Looking at this trend, we saw an important opportunity for a top-quality, full-service hospital to better serve area residents," explained David Rosenbaum, Vice President, Facility Management, Methodist Le Bonheur Healthcare. "Our team was committed to providing a new hospital that would play a vital role in the community and that would also reflect our organization's commitment to building innovative, sustainable facilities."
MOBH is the first hospital in the U.S. to use a dynamic, photoelectric glaze that can transition from clear to a variable tint at the touch of a button, enabling operators to instantaneously reduce glare and solar gain. The glaze, which is produced by local manufacturers, was installed in the hospital's two-story lobby to minimize the energy needed to heat and cool the large atrium space. MOBH's geothermal heat pump system represents another leading-edge innovation, used in only two other hospitals in the country. 211 geothermal heat pumps were installed throughout the building, including one in each patient room. The pumps take advantage of the earth's natural heat sink and use water to distribute heat throughout the facility – a strategy which is seven times more efficient than air at carrying heat.
"Understanding Methodist's commitment to sustainability, our team designed an innovative building that uses cutting-edge energy-saving strategies while also maintaining an overall focus on patient comfort and satisfaction," commented GS&P Principal Greg Gore, AIA, NCARB. "For example, our designers created specially-designed soundproof closets to house the geothermal heat pumps in each patient room, allowing the patient to enjoy both individualized climate control and a consistently quiet, calming atmosphere. We wanted to create an environment that was both efficient and serene, and I am proud of how our team worked to fulfill that goal."
The IPD delivery method created interdisciplinary teams among all stakeholders, with the goal of fostering collaboration and delivering the best results in the most timely and cost-efficient method possible. With the IPD structure in place, Olive Branch Hospital was designed, constructed and opened within in 23 months, on schedule and under-budget.
"The new hospital was designed to be cost-effective and energy-efficient in both the short and long-term, and I believe it will be an asset to the community for many years to come. Our team was proud to be a part of the project, and it is exciting to see it come to fruition," commented R. Clay Seckman, P.E., senior principal at Smith Seckman Reid, Inc. SSR provided engineering design, medical communication system planning, commissioning and LEED facilitation services for the project.
Turner Construction Company provided construction management services for the project and served as the general contractor. Randy Keiser, vice president of Turner Construction, commented, "Our team enjoyed being a part of the IPD process and working with designers and engineers to deliver a great project in a timely, cost-effective manner. Residents of Olive Branch should be very proud of their new hospital."
About Gresham, Smith and Partners:
Gresham, Smith and Partners provides design and consulting solutions for the built environment that contribute to the success of national and international clients. For more than 45 years, GS&P has focused on enhancing quality of life and sustainability within our communities. GS&P consists of industry-leading professionals practicing architecture and engineering design as well as scientists and highly specialized strategic and management consultants in Aviation, Corporate and Urban Design, Environmental Services, Federal, Healthcare, Industrial, Land Planning, Transportation and Water Resources. GS&P consistently ranks among the top architecture and engineering firms in the world.
Hospira, a provider of injectable drugs and infusion technologies, opened a new quality and analytical testing laboratory at its site in Rocky Mount, NC. The new laboratory is part of a more than $200-million investment at the Rocky Mount site, which includes further capital investments. This new quality laboratory will be home to 200 employees, responsible for evaluating and testing more than 450 different products.
The Rocky Mount site, which encompasses more than 1.4 million ft2, provides injectable manufacturing with various technologies, including isolator filling lines and form, fill, and seal operations. The primary product families manufactured at the plant include irrigation and intravenous (I.V.) solutions, renal and cardiovascular care products, therapeutics, local and general anesthesia, analgesia and anti-infectives. Most products are available in a variety of dosage strengths.
Gallus BioPharmaceuticals, LLC (Gallus), a premier pure-play biologics contract manufacturing organization (CMO) has completed a second expansion of its Process Development (PD) facility at its headquarters in St. Louis, Missouri. This expansion provides additional laboratory space and state-of-the-art instrumentation to support Gallus’ growth and commitment to leading pharma and biotech clients in the development of new biotherapeutics.
Mark R. Bamforth, Gallus’ President and CEO, stated “Following the acquisition of the Laureate Biopharma business last September, Gallus is now supporting 5 of the top 15 pharmaceutical companies and a growing number of emerging and mid-sized biotechs in bringing new molecules to the clinic. This additional investment increases Gallus’ capacity to serve our clients’ needs with our team of over 70 Process Development scientists. We’ve designed the new integrated PD labs to facilitate collaborative and efficient development and tech transfer of processes. The design allows our Process Development team flexibility in adjusting for project specific configurations as needed.”
The expansion includes the addition of the state-of-the-art ambr™System from TAP Biosystems, a high throughput system designed for microscale clone and media selection and bioreactor process optimization. This addition is in response to the rapidly growing need for optimizing the yields and purity of complex biotherapeutic molecules. “The ambr™ high-throughput mini-bioreactor system allows Gallus to develop robust, high-producing cell culture processes for our clients while reducing time lines and meeting regulatory expectations”, stated Matt Caple, Director of Cell Culture Development at Gallus.
The Weill Cornell Medical College at Cornell University is set to have a new translational research building in its premises by mid-2014. The research building is named after Robert Belfer, a former American billionaire and a current member on the Weill Cornell Board of Overseers, who along with his wife donated $100m for the new research facility.
The Weill Cornell Belfer Research Building is situated near the ambulatory care building of the medical college on 69th street in New York City, USA. The new research building will be an international hub accommodating global network of scientists and physicians engaged in translating medical research discoveries into therapeutic approaches for treating major infectious and chronic diseases.
The research building will have 18 floors with a total floor space of 480,000ft2. It will have 13 floors dedicated for clinical research. The total laboratory floor space in the building will be about 455,000ft2. The building will also have three floors dedicated for academic programs and two floors for offices, conference rooms and classrooms.
The building will accommodate translational bench-to-bedside medical research facilities targeting diseases such as cancer, cardiovascular disease, neurodegenerative diseases as well as Parkinson's and Alzheimer's, and other global health and infectious diseases.
It will house 16 program areas, several well-equipped laboratories, and principal investigator office suites.
The new building will double the research space at the Weill Cornell medical college. It will host more than 30 scientists from abroad, as well as provide additional research space for scientists and physicians from the Weill Cornell Medical College.
The design of the research building incorporates open floor plans to facilitate communication and collaboration between scientists as well as encourage interdisciplinary research. The building will have a glass façade that will provide the interior areas with natural sunlight.
The building is being built as part of Weill Cornell's $1.3bn Discoveries that Make a Difference Campaign. The total estimated cost of the project is $650m.
The project received more than 38 donations and gifts apart from the $100m donation from Robert Belfer and his wife Renée. The Chairman of the Weill Cornell Board of Overseers Sanford I Weill and his wife, Joan, contributed $135m for the construction of the research building, which was part of the historic $250m pledge made in 2007.
The Starr Foundation donated $75m, and Corinne and Hank Greenberg provided $25m for the project.
Ground breaking for the construction of the research building was held in 2009. The building was topped out in November 2011. It was in final stages of construction by the end of 2013.
The building construction employed Building Information Modeling (BIM) method. The environmental sustainability and energy efficiency features of the building make it a strong contender for Leadership in Energy and Environmental Design (LEED) silver certification.
The research building design was provided by the New York-based architectural firm Ennead Architects. Tishman Construction was appointed as the construction manager.
The double curtain wall for the building was provided by Permasteelisa Group. The scope of the contract included providing 15,800m2 of curtain wall including single and double wall facades, sunshades, screen walls, zinc panel system, ribbon windows, skylights, and storefronts.
Metrics Inc. has opened a new laboratory to support fast-track development of pharmaceutical products. The $1.6 million, 4,524-sq.-ft. facility, located on the company’s main campus in Greenville, NC, is engineered to provide maximum flexibility for early formulation and analytical method development. The facility is designed for preclinical development of early formulation prototypes and related analytical methods. Segregated from the main Metrics operations and containing fully dedicated equipment, the new processing suites have independent HVAC systems and state-of-the-art engineering controls.
In this laboratory setting, formulators and chemists will have significant autonomy to conduct development activities more quickly, according to Dr. Brad Gold, Metrics' vice president of pharmaceutical development. “These suites offer our scientists tremendous flexibility, which will support the fast-track development of drug products,” Dr. Gold said. “Prototype formulations and methods developed in this lab will be transferred to the adjacent facility for further development and manufacture of clinical trial materials and registration batches. There, they will be manufactured under the exacting auspices of current Good Manufacturing Practice so that Metrics will continue to deliver proven scientific and operational excellence in oral solid dosage forms.”
The ground floor of the new facility consists of five processing rooms and one analytical laboratory. The second floor consists of workstations, office space and a conference room. This project increases to 16 the total number of processing rooms, which are in addition to the analytical laboratories and large-scale manufacturing and packaging operations that Metrics has available.
The company has also added to its equipment portfolio with a Gerteis Mini-Pactor, a high pressure-precise roller compactor that provides Metrics’ formulation development scientists greater flexibility in batch sizes and throughput.
Housed within Metrics’ main facility in Greenville, the new Gerteis Mini-Pactor has capacity ranging from 10 grams for pilot projects to 100 kilograms per hour for small-scale production, making it especially useful in a formulation development laboratory setting, according to Dr. Gold, who added, “While big pharma companies may already be familiar with this particular roller compactor, Metrics can be considered an early adopter among CDMOs. This equipment investment reflects Metrics’ ongoing commitment to operational excellence and to conducting science that is most meaningful to our clients and the patients we collectively serve.”
"The fast-track development laboratory and Gerteis Mini-Pactor represent continuing investment efforts at Metrics to support the changing needs of its contract services clients," said Stefan Cross, president of Mayne Pharma USA, the parent company of Metrics.
Stonehill & Taylor recently completed the renovation of a 10,950-sf lab facility in the KOLB Building of the New York State Psychiatric Institute. With the aim of creating a comfortable research and collaboration environment for scientists studying molecular therapeutics, the firm employed a warm, welcoming style for the learning areas and highly technical expertise for the lab areas.
The reception area serves as a branding platform for the facility. It has a combination of wood-paneled and existing exposed-brick walls. The interior designers used images provided by the up views of colorful microscopic imagery, including those of the fruit fly. These images aim to highlight the beauty of the field for the working scientists and visitors alike.
The public spaces include a flexible conference space and classroom that can be easily partitioned by moving walls. Hallways also serve as incidental meeting areas to encourage interaction within the facility, in a less structured way. The marker board cladding and flexible leather stools allow scientists to gather, discuss and exchange ideas.
The new research and education center includes open labs, as well as specialty procedure rooms for microscopy, electrophysiology, fly behavior and histology. Stonehill & Taylor approached these areas with the goal of maximum flexibility in mind. The lab benches are served from above with quick connects for easy reconfiguration. The electrophysiology suite has framing in place to divide the space into two separate rooms with minimal disruption, and similarly, the storage room can easily be reconfigured into a lab room as all rooms were kept on the same lab bench module. Scientists’ individual workstations overlook spectacular views of the Hudson River, George Washington Bridge and Upper Manhattan.
Construction began this month on the Univ. of Wyoming’s Michael B. Enzi STEM (science, technology, engineering and mathematics) facility.
Sallie Means of By Architectural Means, is architect for the project, and AP Wyoming is constructing it. The three-story building will include teaching labs for introductory courses such as general chemistry, general biology, organic chemistry, elementary physics, mathematics, computational sciences, computer science and other large-enrollment lab courses. The nearly 100,000-sf facility will house about 32 labs, eight preparatory rooms and eight offices. It will not house research labs.
Funding for the new building was made available through a 2011 Wyoming legislative appropriation of $50 million in federal Abandoned Mine Lands dollars. Completion is scheduled in late spring 2015.
Construction on a new energy research facility at the U.S. Dept. of Energy (DOE)'s Pacific Northwest National Laboratory (PNNL) campus will start April 2014.
The project, valued at approximately $10 million, will build a facility that will house a broad variety of energy research and PNNL's campus sustainability program. Research conducted there will address national challenges in the power grid's reliability and resiliency, the integration of renewable energy onto the power grid, reducing energy use in buildings and much more.
DOE is funding the project. DGR*Grant Construction of Richland was awarded a contract earlier this month to design and build the facility. The DGR*Grant-led team includes Meier Architecture Engineering of Kennewick, WA. Construction will begin in April and is expected to finish in late spring 2015.
To speed up construction, DGR*Grant's contract allows the facility to be completed in phases. Current plans call for a 22,000-sf building with a mix of lab, computational, control room and office space. At least 45 staff members are expected to work in the facility. It will be located on the north end of PNNL's Richland campus.
PNNL's Building Operations Control Center will also relocate to the new facility. PNNL uses the center to monitor energy use and the system performance of PNNL buildings. The center is an ongoing partnership between PNNL research and facilities staff and uses building energy-efficiency software and approaches developed at PNNL. The new facility allows greater collaboration between research and operations staff and enhances PNNL's use of its own facilities.
Long committed to the advancement of health sciences, the Univ. of Minnesota has a legacy of pioneering biomedical research and discovery. Its Academic Health Center comprises one of the largest, most comprehensive health centers in the country, incorporating six professional schools, five allied health programs and 15 interdisciplinary centers. Within the next decade, the university strives to become one of the top three public research universities in the world, and in 2013 it completed construction of its new Cancer and Cardiovascular Research Building (CCRB), an approximately 285,000-sf facility designed to meet the challenge of creating state-of-the-art research space and infrastructure that can support the university’s aspirations and continued expansion.
Visionary campus planning shaped the direction of the CCRB before design began in 2009. In 2007, the university petitioned the Minnesota state legislature to provide a funding program dedicated to planning and building facilities that advance biomedical research in Minnesota. In 2008, the State of Minnesota established the Biomedical Science Research Facilities Funding Program, and recognizing the need to plan for future growth, the university began work that same year on a master plan for the East Gateway District, where buildings authorized under the state funding program would be constructed.
Adjacent to the east bank of the Twin Cities campus, the East Gateway District remains one of the last undeveloped areas available for campus expansion. Historically an industrial rail yard for the vast grain storage and transport needs of the upper Midwest, the 54-acre area has undergone significant transition. Over the past 10 years it has transformed into a research hub with the construction of three new facilities: the Lions Research Building/McGuire Translational Research Facility (Lions/MTRF), the Center for Magnetic Resonance Research (CMRR) and the Wallin Medical Bioscience Building (MBB). The southern edge of the district is bounded by the TCF Bank Stadium, completed in 2009.
With capital funding in place, the university renamed the East Gateway District to the Biomedical Discovery District (BDD) and implemented a phased development strategy. Phase I renovated and enlarged the CMRR to house even more advanced equipment, specifically a 16.4-T magnet for research studies and a 10.5-T magnet for clinical imaging. Phase II began to realize the vision of the district master plan: A distinct, cohesive complex of research, support and athletic facilities integrated with the existing campus, serviced by multi- modal transit options (including a proposed light rail) and centered around the new CCRB as the front door and iconic gateway element into the district.
The CCRB forms the core of the BDD research functions and public amenities, while also establishing a central point for future district expansion. Under the master plan, the university drafted several planning principles to shape development in the BDD:
Architectural distinction, integrity and brand with a sense of community and place.
Collaborative research environments that leverage common shared support space and assets.
Efficient use of land resources to maximize opportunity for growth and change.
Flexible, open lab spaces to address the evolving needs of interdisciplinary, translational research.
A unified, memorable system of public open spaces.
To meet these objectives, the CCRB houses faculty and staff associated with the expanding cancer and cardiovascular research programs on campus together with a shared research commons, lab space, researcher offices and a public commons, including a cafeteria and seminar room.
Designed by ZGF Architects LLP and Architectural Alliance, the CCRB features a four-story curved curtain wall that frames a public plaza situated at the threshold between the existing university athletic buildings and the BDD. Offices located along this curving glass form join the building’s two flanking lab wings, which are clad in brick to match the present architectural palette of the district. Aligning with the three other research facilities in the BDD, the south-facing façade completes the district’s public street face along the primary axis of 6th Street, reinvented as part of Phase II with a new pedestrian boulevard, shade trees, native landscape plantings, a 10-ft-wide bituminous bike path, bioswales and public art, as well as a new moniker, Science Discovery Walk. Behind this street frontage, the research commons stretches across the first floor and attaches directly to the adjacent MBB.
The research commons incorporates an animal research facility and shared instrumentation spaces to optimize critical adjacencies in district planning. Consolidating these programs in a single location avoids duplication of equipment, improves staff accessibility and, in turn, reduces the overall cost of research. Secured and separated from the public areas of the CCRB, the research commons connects to the lab on the floors above via a service elevator. A secure support corridor running the entire length of the research commons links the service elevator to the loading dock. A second elevator serves the mechanical penthouse for the research commons and offers a possible future connection point to the CMRR or other on-site development. Should future building expansion occur, the service court, which also supplies the MBB, can extend north to serve the needs of a larger complex.
At over 40,000 sq.ft. the research commons accounts for more than half of the CCRB’s first floor area. Shared with the MBB for greater operational efficiency, the research space represents the primary program and, given the current research in the BDD, is designed as a small-animal facility with flexibility for suite layouts and holding. The rest of the research commons is comprised primarily of instrumentation spaces, including cellular imaging, long-term physiology care, small-animal imaging, flow cytometry and the Biomedical Genomics Center, as well as staff support areas such as barrier lockers, offices and a break room. Additionally, an interstitial space above the animal research facility allows unimpeded access to building systems without disruption to researchers. Taking advantage of the building’s orientation and sun angles, an extensive green roof over the interstitial space contributes to sustainability goals and provides a district amenity with outdoor seating and gathering spaces.
The research labs are contained within two multi-story blocks that straddle the lobby and a central atrium. The CCRB was designed to accommodate over 60 principal investigators and more than 600 staff and faculty total, with office, conference and informal meeting space distributed throughout the building to foster collaboration and dialogue between the cancer and cardiovascular departments. Biology labs occupy the top two floors, while chemistry labs are located on the second floor to maximize allowable chemical storage per building code. In the labs, expansive windows grant unobstructed access to views and daylight, and movable desks and lab benches can be reconfigured to enable planning flexibility. The lab support zone, which includes tissue culture rooms, procedure rooms, fume hoods and various instrumentation rooms, sits between the perimeter workstations and a linear equipment room that leads to the service elevator and research commons.
Like the research commons, the public commons encompasses different programs to create a district amenity that not only facilitates researcher interaction, but also enhances the visibility and vitality of the BDD at street level. The public commons consists of three main spaces: 1) a multi-purpose seminar room with capacity for about 150 people and technology infrastructure to accommodate a variety of live and video presentations; 2) a full service cafeteria and dining area with outdoor seating under the curved curtainwall façade and in the public plaza; and 3) an exhibit space for showcasing and celebrating the history of the university’s research, recent work and faculty in the BDD. Together these programs form a dynamic and flexible space connected to the lobby and atrium that can serve the daily needs of the building’s occupants, as well as host special events. In addition, the facilities in the BDD interconnect through a series of public pathways; and similarly an interior corridor links the public commons to the MBB, permitting the public commons to extend across the district and expand with future development.
Vivarium-based study is integral to cancer and cardiovascular research programs. It requires energy-intensive mechanical, electrical and plumbing systems that run continuously and must be maintained with minimal disruption to research. As a state-funded project, however, the CCRB was required to meet the mandatory conditions of the B3 (Buildings, Benchmarks, and Beyond) Guidelines and the Minnesota Sustainable Building 2030 Law. B3 covers project management practices from programming through commissioning and operations, along with design requirements related to site, water, energy, indoor environmental quality, materials and waste. The 2030 law stipulates energy performance that achieves a 60% reduction from an average building of its type based on lifecycle analyses.
Multiple system strategies were required to meet these aggressive sustainability goals. Heat-recovery systems in the general exhaust and fume hoods, mechanical condensate collection and a night setback mode for biosafety cabinets that reduced air change rates in the labs contributed to substantial energy savings. Electrical loads were reduced through the use of occupancy sensors, LED lighting and task lighting at lab benches. Other sustainable features include extensive sun shades on the exterior of the building (while still exceeding the B3 daylighting requirements for occupied spaces), reduced potable water consumption through high-efficiency fixtures and native plantings and storm water control from the green roof over the research commons.
The desire to enhance and promote the university as a top-tier research institution constitutes a fundamental value that drove the design of the CCRB. Researchers there benefit from the collective resources in the BDD, and flexible planning allows the CCRB to adapt to ever-changing research requirements and provision for future growth, which is already underway less than a year after the facility opened officially. A new microbiology building is planned on site that will connect directly to the CCRB and tie into the research commons and other district amenities the CCRB provides, a fitting testament to the forward-thinking vision embedded in the BDD and the university’s clear commitment to its future research goals.
In an effort to better meet customer needs for instrument design and development, Shimadzu Scientific Instruments (SSI) has opened its new Shimadzu Solution Center.
The facility, operating out of SSI’s North American headquarters in Columbia, Md., will enhance collaboration with customers and enable the company to more quickly respond to customer needs for new scientific instruments, software platforms, and applications.
The new, innovative, 4,100-square-foot facility is now open to customers. In addition to showcasing Shimadzu instruments and platforms, the center will also provide space for more collaborative research, and enables SSI to more quickly develop new software applications and focus-based solutions to better serve growing customer demands.
“We are excited to offer this new capability to our current and prospective customers,” said Shuzo Maruyama, President of Shimadzu Scientific Instruments.
Maruyama continued, “Customers require that instruments and software fit their specific needs and workflows. Off-the-shelf or one-size-fits-all solutions are missing the mark for many customers. Much of our current success is due to our agility in being able to modify hardware or create software directly from specific customer input. With the addition of the Shimadzu Solution Center, we have greatly enhanced our potential to collaborate with our customers on research and the development of new instruments, software and diagnostic technologies.”
The Solution Center provides a showcase for more than 30 scientific instruments highlighting SSI’s full range of products and capabilities, including molecular/atomic spectrophotometers, mass spectrometers, liquid/gas chromatographs, x-ray spectrometers, balances, TOC analyzers, and materials testers.
The center also features high-definition video and conferencing equipment to facilitate customer interactions both within the center and in collaboration with manufacturing, software, and R&D groups.
When Mölnlycke Health Care, a global manufacturer of long-term wound-care products headquartered in Sweden, wanted to expand into the U.S market, Harriman Architects + Engineers, was chosen to make their vision for a new $46 million facility a reality. The company selected Brunswick Landing, the former Brunswick Naval Air Station, as the plant's location because of its proximity to Rynel, a Wiscasset-based Mölnlycke subsidiary. The new facility was built by PC Construction and opened for production in September.
The 79,800 sq. ft. facility houses a clean room production area, two-story office wing, and a warehouse. The exterior skin is comprised of aluminum sandwich panels in a variety of textures and colors, and the inviting curtain wall façade is punctuated with a bold entrance leading into a vibrant two-story lobby. Once inside, a viewing walkway provides visitors a glimpse into the manufacturing area.
The cleanroom area is designed to rigorous ISO level 8 standards - 100,000 particles of micron 0.5 size per cubic foot - and mechanical systems are designed to meet these standards The ISO 8 level environment requires pressure mapping of clean to dirty spaces, tight temperature and humidity control ranges, pre and final air filtering, and a stratified air flow delivery system that maintains a laminar air flow and particulate control from the ceiling area of the 28,000 sq. ft. cleanroom to the low returns located around the base perimeter. Harriman designed system redundancy so that all criteria could be met while routine maintenance is performed. Heat recovery ventilation and heat recovery from the various facility processes are captured and used for efficient heating and reheating of spaces or airflows. The cleanroom also features a walkable ceiling that segregates mechanical and electrical systems from the space for ease of service and further protection of sensitive production processes.
Mölnlycke wanted a space that maximized natural lighting where possible, that provided a sense of place, and also acknowledged the company's European aesthetic. Clean lines and warm materials provide a European feel to interior spaces. Skylights at the second floor office area along with south facing windows bring in light. Using a light color pallet with occasional bold strokes of color, Harriman was able to make maximum use of reflected natural light to create the light and airy work environment.
The Mölnlycke logo - an "M" comprised of green globes - created a design opportunity. Using curved sofas and work surfaces as well as globe-shaped occasional seating to contrast with the rectilinear elements of the architecture provided drama. A custom light fixture over the lobby stair uses a replication of the "M" logo to provide a focal point in the dramatic two-story lobby. Finally, the building layout, systems, and structure are designed for easy expansion.
With this new space, Mölnlycke has underscored their commitment to the North American market with an efficient facility that honors their corporate ethos and looks to the future.
The Salk Institute for Biological Studies will join Stanford University in leading a new Center of Excellence in Stem Cell Genomics, created through a $40 million award by California's stem cell agency, the California Institute for Regenerative Medicine.
The center will bring together experts and investigators from seven major California institutions to focus on bridging the fields of genomics — the study of the complete genetic make-up of a cell or organism — with cutting-edge stem cell research.
The goal is to use these tools to gain a deeper understanding of the disease processes in cancer, diabetes, endocrine disorders, heart disease and mental health, and ultimately to find safer and more effective ways of using stem cells in medical research and therapy.
"The center will provide a platform for collaboration, allowing California's stem cell scientists and genomics researchers to bridge these two fields," says Joseph Ecker, a Salk professor and Howard Hughes Medical Institute and Gordon and Betty Moore Foundation Investigator. "The Center will generate critical genomics data that will be shared with scientists throughout California and the rest of the world."
Ecker, holder of the Salk International Council Chair in Genetics, is co-director of the new center along with Michael Snyder, a professor and chair of genetics at Stanford.
Salk and Stanford will lead the center, and U.C. San Diego, Ludwig Institute for Cancer Research, the Scripps Research Institute, the J. Craig Venter Institute and Illumina Inc., all in San Diego, will collaborate on the project, in addition to U.C. Santa Cruz, which will also run the data coordination and management component.
"This Center of Excellence in Stem Cell Genomics shows why we are considered one of the global leaders in stem cell research," says Alan Trounson, president of the stem cell agency. "Bringing together this team to do this kind of work means we will be better able to understand how stem cells change as they grow and become different kinds of cells. That deeper knowledge, that you can only get through a genomic analysis of the cells, will help us develop better ways of using these cells to come up with new treatments for deadly diseases."
In addition to outside collaborations, the center will pursue some fundamental questions and goals of its own, including collecting and characterizing induced pluripotent stem cell lines from patients with familial cardiomyopathy; applying single-cell genomic techniques to better understand cellular subpopulations within diseased and healthy brain and pancreatic tissues; and developing novel computational tools to analyze networks underlying stem cell genome function.
The award includes $19 million for the center team to carry out collaborative projects with California scientists from outside the center, including investigations of disease mechanisms and the development of stem cell-based therapies. The Data Coordination and Management program will enable the research to be shared with other investigators around California and the world.
In addition to the Center of Excellence, the stem cell agency's governing Board, the Independent Citizens Oversight Committee (ICOC), also approved more than $27 million in funding for the Basic Biology V awards. These go to researchers trying to advance the field by tackling significant, unresolved issues in human stem cell biology. Salk Professor Ronald Evans, holder of Salk's March of Dimes Chair in Molecular and Developmental Biology and a Howard Hughes Medical Institute Investigator, was among the recipients. He was awarded $1,491,900 to investigate the role nuclear hormone receptors play in the generation of stem cells, research that holds potential to expand scientists' understanding of cancer cell growth and the regeneration of tissues.
CIRM was established in November 2004 with the passage of Proposition 71, the California Stem Cell Research and Cures Act. The statewide ballot measure, which provided $3 billion in funding for stem cell research at California universities and research institutions, was overwhelmingly approved by voters, and called for the establishment of an entity to make grants and provide loans for stem cell research, research facilities, and other vital research.
The Univ. of Florida (UF) Clinical and Translational Research Building (CTRB) serves as the headquarters for clinical and translational science at UF and in the state. The building houses patient-oriented research venues for the Institute on Aging and the Clinical and Translational Science Institute, as well as several research groups studying topics including biostatistics, epidemiology, muscular dystrophy and health outcomes and policy. The highly collaborative nature of the CTRB's planning evolved through a series of informative workshops with the university's administration, representatives from the colleges that will use the facility, and the extended design and construction team. The numerous goals for the building included creating environments that propel innovative, interdisciplinary research and discoveries; interfacing with the community through education; developing a space that is adaptable, flexible and modular; and providing a variety of indoor and outdoor interactive healing environments. Natural elements heavily influenced the building's design, especially the sustainability components. A prism-like glass curtain wall reflects and refracts the area's copious sunlight.
Along with providing energy-saving natural daylight, 8 to 12% of the building's electricity is produced by a solar photovoltaic system. Rainwater is collected to provide irrigation to the landscaping and to terrace planters. Displacement ventilation systems help keep the building cool while limiting the need for air conditioning. The building has been submitted for LEED Platinum certification.
Project team: Perkins+Will, Coral Gables, Fla. (architect/lab planner); Moses and Associates, Gainesville, Fla. (commissioning); AEI, Gainesville, Fla. (MEP) Sibein and Associates, Gainesville, Fla. (structural engineer); Skanska, Tampa, Fla. (CM)
Completion date: June 2013
The MARBIONC Building, part of UNCW CREST Research Park, is located on the coast in Wilmington, North Carolina. This new facility connects biotechnology and life science research to commercial product development in the areas of health, food and energy. The building, opened in fall 2013, is connected to the university’s Center for Marine Science, which houses a full spectrum of marine science researchers with specialties in areas ranging from marine species, aquaculture and mariculture development to natural product research. The new MARBIONC Building supports seamless workflow and collaboration among researchers, students, and those invested in life sciences. The facility bridges the gap between biotechnology research and the public marketplace. This new building complements three other state-of-the-art research facilities within the park: Center for Marine Science, Marine Science Operations Facility and Experimental Shellfish Hatchery.
The open floor plan of MARBIONC Building — a LEED silver certified facility — features a lab-focused modular design, with spaces starting at 880 square feet, and numerous configuration possibilities. Leasable commercial lab features include movable lab benches, whiteboards, an AV-ready conference room, wall-mounted hoods and sinks, and dropdown ceiling-mounted utilities. UNCW CREST Research Park is suited for entrepreneurial startups, established firms, government agencies and universities focused on biotechnology and life sciences. While the common areas, such as the Ebb Tide Café and outdoor patios that overlook natural wetlands, facilitate open collaboration, MARBIONC Building is prepared for Category 3 hurricane-force winds, boasts round-the-clock physical and IT security, and is bordered by both wooded areas and North Carolina’s Intracoastal Waterway.
Onsite resources available to the building’s tenants include testing and analytical services, IT staff, marine biotechnology expertise, and skilled operators. Specific services include nuclear magnetic resonance, stable isotope mass spectroscopy, liquid chromatography-coupled mass spectroscopy, nutrient analysis, DNA sequencing and biological screening, among others.
Project Team: EYP, Charlotte, N.C. (architect); John R. McAdams Inc., Durham, N.C. (civil engineer); RFD (Research Facilities Design), San Diego, Calif. (lab planner); Surface 678, Durham, N.C. (landscape design); AEI Environmental & Engineering Consultants, Chapel Hill, N.C.. (ME); Laurene, Rickher & Sorrell, P.C., Charlotte, N.C. (structural engineer)
Completion date: August 2013
Eli Lilly says investment in its Sao Paolo, Brazil packaging plant will support growth for the local market.
The US-headquartered pharma giant is investing BRL 15m ($6.4m) over the next two years to redevelop its Sao Paolo manufacturing facility.
“As part of our recapitalization plan, we are replacing two of our blister-pack machines with the latest-generation, state-of-the-art technology,” said Lilly spokesman Andrew McLaughlin, adding the firm was also “optimizing layout and improving control systems in other lines.”
He continued: “These investments will increase our productivity,” adding they “will help our site continue supporting our sales affiliate for future growth.”
According to Brazilian publication Gestao Farma , the site currently makes 10 million packages a year and this investment will increase this capacity significantly to serve the local market.
“The Brazilian production plant is prepared to meet the needs of the country in which it operates demonstrating that Brazil is one of the focus markets of the company,” said Jose Eduardo Fuxa, Manufacturing Director of Eli Lilly in Brazil.
The site is Lilly’s only facility in Brazil and - according to its website – it makes some drugs in their entirety (such as Cialis, Evista, and Zyprexa), whilst also producing the packaging for imported products intended for the local market and some neighboring South American countries.
Lilly previously invested over BRL 42m in the site between 2002 and 2007.
For packaging, there are examples of Lilly using third parties – such as Rexam – but for manufacturing the company has been vocal on investing in its own capacities.
Recent investments of $700m into its own facilities have been driven by its intention to focus on the “growing diabetes epidemic” and in November McLaughlin said it had no intention to outsource, for insulin at least.
“We have built up significant internal capability in insulin manufacturing and believe we can leverage this more effectively than using third parties,” he said.
Bayer plans to acquire 100 percent of the shares of Dihon Pharmaceutical Group Co., Ltd., Kunming Yunnan, China, a privately held pharmaceutical company specializing primarily in over-the-counter (OTC) and herbal traditional Chinese medicine (TCM) products.
Dihon is a leading player in China's OTC industry with products such as Kang Wang for the treatment of dandruff and other scalp disorders and Pi Kang Wang, an antifungal cream, as well as TCM product Dan E Fu Kang for the treatment of various women's health indications. Financial details have not been disclosed. The transaction is subject to fulfillment of certain conditions, including merger control clearance, and is expected to close in the second half of 2014.
'We aim to strengthen our Life Sciences portfolio with strategic bolt-on acquisitions globally. We are very pleased to have identified a consumer health care company in China with such a strong track record of success built by its dedicated employee base,' said Dr. Marijn Dekkers, CEO of Bayer AG. 'This acquisition moves us into a leading position amongst multinationals in the OTC industry in China. It also brings a portfolio of well-known consumer brands, which will allow us to provide consumers with an even broader range of self-care options.'
'Adding the strong OTC brands from Dihon to our portfolio will significantly advance our business in China and positions us well for future growth,' said Dr. Olivier Brandicourt, CEO of Bayer HealthCare. 'Equally important is the foothold we will gain in TCM, which makes up about half of the OTC segment in China and is a well-accepted and sought after line of natural science-based alternative therapies for consumers looking for trusted solutions for their healthcare needs. We think we can leverage our recent acquisition of Steigerwald in combination with Dihon's herbal TCM expertise and pipeline to benefit both these areas, which have a different but related heritage.'
'Self-care is a critically important component of healthcare in China and internationally, and OTCs are an important tool to help people live happier, healthier and longer,' said Dr. Zhenyu Guo, Chairman & CEO of Dihon Pharmaceutical Group Co., Ltd. 'As such, we're pleased to have been able to build a business with brands that bring relief to consumers across China and other parts of the world. We believe that Bayer, with its marketing, sales, distribution and research expertise, is well positioned to take our success to the next level. This acquisition will further strengthen the Yunnan pharmaceutical industry and offers the potential to further expand TCM to other parts of the world.'
Dihon generated sales of 123 million Euro in 2013. The company employs approximately 2,400 people in R&D, manufacturing, sales and marketing. In addition to operations in China, Dihon brands are sold in other countries such as Nigeria, Vietnam, Myanmar and Cambodia. Dihon's headquarters is in Kunming, China. The company also has several manufacturing sites throughout China.
Almac has expanded its pharmaceutical development service offering with an investment of more than $10 million. The company has doubled its development service capabilities with the opening of a new dedicated non-GMP facility and two analytical laboratories at its Craigavon, UK headquarters.
The new non-GMP formulation development facility offers formulation and process development, which can then be progressed and transferred to the existing GMP development facility located on the same campus. Almac has also doubled its analytical capacity with new analytical labs for processing the large sample sets from non-GMP process development work for clients looking to better understand their processes in line with the principles of QbD. Almac has also invested in additional Xcelodose technology, which comes with an Xcelohood providing the capability to dose potent API directly into capsules.
“Almac is continually assessing and investing in solutions to accelerate the manufacturing of our client’s clinical supplies, while ensuring quality at all times. The investments this year in the new non-GMP facility and Xcelodose equipment strengthens Almac’s position as an integrated service provider in the pharmaceutical development sector,” said John McQuaid, vice president of Technical Operations.
Rinchem Co. Inc. has opened a new 40,000 ft2 chemical logistics facility in Neot Hovav (Ramat Hovav), Israel. The facility includes warehousing areas for regulated and non-regulated chemicals and gases, and possesses cleanroom capabilities for the handling of high purity chemicals and gases in a cleanroom environment. Services that will be offered at this site include customized, temperature-controlled storage and handling of high purity chemicals and gases primarily for the semiconductor industry.
Rinchem globally provides warehousing, transportation and supply chain services within areas such as the semiconductor, chemical manufacturing, paints and coatings, oil and gas, solar, pharmaceutical, and biotechnology industries.
"Our new Neot Hovav facility represents Rinchem's ongoing commitment to providing specialized capabilities and services to semiconductor manufacturers in Israel," says Chris Wright, Rinchem's Global Director of Sales and Marketing. "This facility has multiple temperature zones, areas of chemical segregation, fire suppression, spill containment, air exchange, and security systems that deliver comprehensive, customized solutions to the customers that we serve."
The Neot Hovav facility utilizes Rinchem's Chem-Star warehouse management system, providing customers with inventory visibility across Rinchem's global network of 26 locations. According to Larry Tanner, the Rinchem's Director of Operations for the region, "The new Neot Hovav facility also showcases a customized, narrow aisle racking and a computer-guided forklift system that increases order picking accuracy and efficiency."
The redevelopment, led by Kier Construction, received planning permission in 2012 and includes 10 new wards, providing accommodation for 210 patients within a new secure environment.
The design, led by Oxford Architects in conjunction with LDA Design, will include a new entrance building, central facilities building, gardens, recreation areas, and extensive landscaping. As part of the enabling works package for the project, a new energy centre and staff training facility have also been constructed.
Since 2012, LDA design has continued to work with the West London Mental Health NHS Trust and contractor, Balfour Beatty, to deliver other phases of enabling works, including the design and completion of the main access road to the new hospital, constructed to minimize local community disruption.
The landscape proposals for the main redevelopment, by LDA Design, include a range of new gardens and high-quality spaces for use by patients, staff and visitors.
Mike Foster, project director at LDA Design, said: “It is great news that the main redevelopment has officially started. We are looking forward to continuing our work with West London Mental Health NHS Trust and the construction team over the next few years to deliver an exemplar environment at Broadmoor Hospital to support its excellent mental health care.”
David Phillips, redevelopment program manager, added: "Achieving Department of Health full business case approval, then celebrating the cutting of the sod ceremony just one month later on a build of this scale shows what an important project this is and just how well the trust and its partners operate together.
Originally built in 1863, Broadmoor Hospital provides specialist mental health care services within a high-secure environment for male patients from London and the south of England. It is one of three high-secure hospitals in England, and is internationally recognized for its specialized work with patients with some of the most challenging mental health needs as well as its research activities.
Rafael Viñoly Architects announced the design of a new academic building for the Universidad de Buenos Aires - Facultad de Ciencias Exactas y Naturales. With over 100,800 students and a faculty of over 6,500 teachers, Universidad de Buenos Aires is the premier institution for scientific study and research in Argentina and the core of academic learning for South American nations.
The innovative building design responds to the site with an interior ellipse and infinity-shaped courtyards that were purposely carved out of the central atrium to protect the native trees that predate the development of the site. The building features an enclosed space that is flooded with daylight and natural ventilation via two interior courtyards located in the central atrium. On the ground level these areas are bordered by a cafeteria and student lounges, and on the second level by research laboratories that overlook the gardens. These courtyards house clusters of native and exotic trees and provide occupants with lively gathering spaces and an energizing research environment.
Designed to be highly sustainable, the building's heat gain is prevented by a high performance glass facade that is covered with a system of metal fins, which deflect sunrays away from the building. These fins provide building occupants with privacy as they shield them from distracting outdoor activities and block out sounds from the exterior. A roof-top garden not only provides a pleasant view for surrounding buildings but also reduces heat gain, and a radiant cooling/heating system takes full advantage of an underground river that flows directly beneath the site.
Building features include:
The new building will house three institutions: The Departments of Mathematics, Computer Sciences and Environmental Sciences.
Clusters of native and exotic trees predating development of the site are preserved by carving two courtyards in the shape of an ellipse and infinity curve, providing students and faculty members with an outdoor gathering space.
Roof-top garden reduces heat gain whilst controlling storm water run-off.
The building is integrated into the campus via a passageway that links the new facility to the former Sciences Building
State of the art healthcare facilities for NHS Greater Glasgow and Clyde are due to be completed in 2015.
Mach-Aire has been awarded a major aseptic cleanroom contract by Brookfield Multiplex, the company responsible for the design and construction of the New South Glasgow Hospitals, which is due to be completed in Spring 2015.
Mach-Aire has been appointed to provide a turnkey solution; building, commissioning and validating a complex aseptic pharmaceutical facility within the new hospital. Once complete, the facility will be used to prepare and dispense cytotoxic and non cytotoxic medication for the treatment of patients.
In addition to building and commissioning the aseptic pharmaceutical facility, Mach-Aire will also design, build and install two negative pressure isolators, six laminar flow cabinets and six Class 2 Safety cabinets.
Richard Phillips, Cleanroom Product Manager, Mach-Aire, said: 'We are pleased to have the opportunity to work with Brookfield Multiplex on this exciting project, providing a high quality solution for this state of the art healthcare facility.'
G-CON Manufacturing, a builder of flexible, autonomous bioprocessing cleanroom solutions, has been selected to build an ISO Class 5 POD for Instituto Butantan, a biomedical research centre linked to the Sao Paulo Secretary of State for Health. Instituto Butantan, based in Sao Paulo, Brazil, ordered the POD for use in the clinical production of recombinant BCG, a product intended to be an improved treatment for bladder cancer.
Instituto Butantan is purchasing a standard size POD that is 12ft wide by 42ft long and 11.5ft high (3.66m x 12.80m x 3.51m). The POD is designed to provide approximately 312ft2 (29m2) of cleanroom space with a custom configuration for the filling and finishing of the clinical product.
G-CON will provide the shipping, delivery and installation of the POD and it will be the first project to be delivered internationally by the cleanroom manufacturer.
G-CON’s founders have experience in the design, build, operation, and maintenance of a variety of traditional biomanufacturing facilities and have leveraged this experience to create the G-CON POD as a cost effective flexible, multipurpose and repurposable cleanroom space.
The Centre for Cell Manufacturing Ireland (CCMI) at NUI Galway – the country's first facility to receive a license from the Irish Medicines Board to manufacture culture-expanded stem cells for human use – opened for business on January 27, 2014.
In addition to stem cell manufacture, the CCMI will offer a custom advanced therapeutic medicinal product (ATMP) manufacturing service to industry and also a cleanroom leasing service to Irish SMEs which often have difficulty in procuring cleanroom space.
Researchers at the Regenerative Medicine Institute (REMEDI) in NUI Galway have been working to develop new stem cell therapies for many areas of unmet medical need. Over the past few years REMEDI has developed the Centre for Cell Manufacturing Ireland, a custom-built facility designed to expand stem cells for use in human clinical trials, which has now been successfully accredited. It plans to supply stem cells for use in clinical trials following regulatory approval arising from pre-clinical data generated at REMEDI.
Its opening by the Minister for Research and Innovation Seán Sherlock, TD, marked the start of the first clinical trial using CCMI-manufactured stem cells being funded by the Health Research Board and Science Foundation Ireland. It will investigate the safety of using mesenchymal stem cells (MSCs) isolated from bone marrow for the treatment of critical limb ischemia, a common complication associated with diabetes and which can often result in limb amputation.
MSCs must be grown in the laboratory to generate sufficient quantities following their isolation from the bone marrow of adult donors.
Professor Tim O’Brien, Director of the Centre for Cell Manufacturing Ireland said: 'The presence of this facility in Ireland positions us well to develop new therapies for a broad array of clinical problems which do not have effective treatments today. It will also allow us to translate discoveries from the basic stem cell research program led by Professor Frank Barry at the Science Foundation Ireland-funded REMEDI to the clinic and to be competitive for grant funding under the Horizon 2020 program of the EU.'
John O’Dea, Board member of the Irish Medical Devices Association (IMDA) said revenue from Regenerative Medicine products was approximately $1.3bn in 2013, with sales growth of 40% in 2013 alone. Nearly $1.4bn was invested in companies in this space in 2013. He added: 'The Centre for Cell Manufacturing Ireland is a key step in the demonstration of national competence in this space and I look forward to seeing its continued growth to assist in developing the skillsets and techniques that will be needed to embrace the new manufacturing opportunities that this exciting area will bring.'
The new Centre for Cell Manufacturing Ireland (CCMI) in Galway means Ireland-based scientists will be able to manufacture culture-expanded stem cells for drug research for the first time.
The Irish Medicines Board-licensed facility was opened in last month by Minister Seán Sherlock who said it positions Ireland as a global player in the regenerative medicine field.
The researchers based at the Regenerative Medicine Institute (REMEDI) in NUI Galway have been working to develop new therapies to impact many different areas of unmet medical need.
To develop any new human therapy, the treatment must first be tested for safety and effectiveness in a series of rigorous clinical trials. Over the past number of years REMEDI has developed the Centre for Cell Manufacturing Ireland which is a custom-built facility designed to expand stem cells for use in human clinical trials.
Now it has been successfully accredited, the Centre for Cell Manufacturing Ireland plans to supply stem cells for use in clinical trials following regulatory approval arising from pre-clinical data generated at REMEDI.
The facility will be part of plans for the first clinical trial using CCMI- manufactured stem cells which is being funded by the Health Research Board and Science Foundation Ireland. The trial will investigate the safety of using mesenchymal stem cells (MSCs) isolated from bone marrow for the treatment of critical limb ischemia, a common complication associated with diabetes.
Minister of State for Research and Innovation Seán Sherlock said: “The Centre for Cell Manufacturing Ireland is clear evidence of the potential benefits offered by this Government’s substantial investment in applied research. Stem cell technology, developed in the first instance to help patients with diseases such as diabetes, arthritis, heart disease and critical limb ischemia.”
Sherlock also said “the facility will play a key role in ensuring REMEDI’s continued success in EU funding initiatives, in particular Horizon 2020”.
Ireland’s government, through SFI, will work to ensure that Ireland maximizes its participation in the Horizon 2020 program, which is the biggest EU Research and Innovation program ever with nearly €80 billion of funding available over 7 years (2014 to 2020) – in addition to the private investment that this money will attract.
In addition to stem cell manufacture, Centre for Cell Manufacturing Ireland (CCMI) are offering a custom ATMP (advanced therapeutic medicinal product) manufacturing service to industry and also a cleanroom leasing service to Irish SMEs who often have difficulty in procuring cleanroom space.
SMC Ltd., a medical device contract manufacturer based in Somerset, Wis., is expanding its operations in Latin America.
The company, which also has operations in California, Massachusetts, Ohio and India, is moving its Costa Rica facility to a larger site, with company officials citing increased demand as the reason for the move. The facility will move to a new location within the Coyol Business park in Alajuela, Costa Rica. The move will double the company's manufacturing space and offer an additional 32,291 square feet for future growth.
The new building provides an increased assembly area, giving the firm's global customers more options in manufacturing, according to company officials.
“We have been fortunate to see a lot of growth over the last year and as a result, we have out grown our current facility. The new facility will not only double our manufacturing space, but allow us to provide additional services to our global customers,” said Jason Larocco SMC's Costa Rica facility manager.
SMC offers design, molding services, and finished devices for the medical and pharmaceutical industries. The company’s medical operations offer ISO 13485 quality systems, white room, class 7 and 8 clean rooms with services including: design, engineering, project management, and validation. Integrated capabilities include: thermoplastic molding (including 2-shot), liquid injection molding, secondary operations, micro molding, assembly, and kitting and packaging of finished devices.
French pharmaceutical firms Sanofi and Transgene have started the construction of the manufacturing platform dedicated to the production of viral vectors such as TG4010, a subcutaneously administered cancer vaccine based on Co-X-Gene Technology.
Being built on the Genzyme Polyclonals site in Lyon, France, the new production unit will cost €10m over two years, with each company financing half the cost.
The new unit will be dedicated to production of viral vectors via a broad range of technologies, including mammalian cell culture up to 1m3 using single use bioreactors, combining the excellence of Genzyme, Sanofi-pasteur and Transgene in Lyon area.
Under the deal, Sanofi will provide to Transgene its know-how in bioproduction and experience in launching biologics.
Transgene chairman and chief executive officer Philippe Archinard said: "Our decision to invest now reflects the increasing confidence in our programs, including our cancer immunotherapy candidate, TG4010, for which we recently announced topline preliminary data from a clinical study in non-small cell lung cancer."
Through the Genzyme Polyclonals site for the manufacturing and the CEPIA organization (Commercial & External Partnership Industrial Affairs) for all commercial aspects, Sanofi will act as Transgene's contract manufacturing organization (CMO) and Transgene will be the preferred customer of the platform through 2028.
Following completion, the production unit will be Sanofi's exclusive property that will help it produce a new breakthrough class of APIs (Viral vectors).
Transgene's MUC1 targeted cancer immunotherapy TG4010 uses the Modified Vaccinia Ankara virus vector, a poxvirus that combines distinguishing advantages for an optimized systemic vaccination.
It is currently under development for the treatment of metastatic non-small cell lung cancer.
TG4010 expresses the entire MUC1 gene sequence and has the potential to generate an immune response to all antigenic epitopes of MUC1, a major tumor-associated antigen that provides a viable target for immunotherapy.
Jazz Pharmaceuticals has begun construction on a manufacturing facility in Ireland a month after acquiring a late stage narcoleptic compound.
The 55,000 sq. ft. facility has an expected completion date in 2016 and is located in Monksland, County Roscommon. With an estimated $60-68m (€45-50m) investment it is set to become the first manufacturing facility to be built by the company.
“This investment not only strengthens our international manufacturing capabilities, but importantly represents our commitment to expanding our presence in Ireland,” said Jazz CEO Bruce Cozadd.
The ground-breaking ceremony was attended by Irish Prime Minister (Taoiseach) Enda Kenny and members of the Irish development agency, the IDA.
“Jazz Pharmaceuticals’ decision to build a manufacturing site in Ireland is testament to the excellent reputation Ireland has as a global location for biopharmaceutical development and manufacturing,” said Barry O’Leary, CEO IDA Ireland.
“This is a strategically important development for Jazz Pharmaceuticals and Ireland is well placed to support manufacturing for the company’s growing commercial portfolio.”
At full capacity, the facility will employ approximately 50 people.
Last month the firm acquired the rights to ADX-N05 - a compound in clinical development for the treatment of excessive daytime sleepiness in patients with narcolepsy – from Aerial BioPharma for an upfront payment of $125m (€92m).
This is the first manufacturing facility to be built by Jazz Pharmaceuticals.
Tech Group Europe, a Dublin-based subsidiary of West Pharmaceutical Services, is expanding its manufacturing and development center in Dublin by 12,000 sq. ft., after securing a contract with a global pharmaceutical partner.
Tech Group will manufacture and assemble a complex injectable device for the diabetes market and will begin full-scale production in 2015. The device will be shipped to the customer’s European filling site for final assembly.
Don O’Callaghan, vice president and general manager of Tech Group Europe, said, “This expansion reinforces the commitment to developing the Dublin capability as part of an ongoing long-term investment plan. This first phase in the expansion comes about as a result of an exciting win with a leading global pharmaceutical partner in the fast-growing diabetes market, and further strengthens West’s position as one of the world’s leading manufacturers of complex medical devices for the pharmaceutical market.”
Tech Group Europe supplies engineering and manufacturing services for complex drug delivery devices and diagnostic solutions for the pharmaceutical and healthcare sectors.
AbbVie is investing $320 million to establish manufacturing operations in Singapore for small molecule and biologics active drug substance. Once completed, the facility will provide manufacturing capacity for compounds in AbbVie's oncology and immunology pipeline to serve global markets. The investment is expected to result in additional headcount of more than 250 new employees. AbbVie anticipates the facility will be fully operational by 2019.
AbbVie’s operations in Asia currently include R&D functions in Tokyo, Japan and Shanghai, China, as well as commercial operations throughout the region. AbbVie currently employs 120 personnel in Singapore, supporting commercial operations, global R&D, and general operations.
"As Asia's fastest-growing bio-cluster, Singapore is an ideal location to expand our manufacturing network while maintaining rigorous standards of quality and delivery for the patients we serve around the world," said Azita Saleki-Gerhardt, Ph.D., senior vice president, Operations, AbbVie. "Our presence in Singapore will help assure geographic balance and continuity of product supply as well as increased capacity to deliver on our growing biologics and small molecule product pipeline."
The first center for research and development of generic pharmaceutical products in Puerto Rico has been officially launched. The inauguration ceremony was led by Puerto Rican Gov. Alejandro Garcia Padilla, who stated that the new facility was a major milestone for the Caribbean island on its way to economic diversification and job creation.
The Center for the Development and Innovation of Pharmaceutical Products, or Cediprof, will focus on research and experimentation of generic drugs. It was built thanks to a $12 million investment by Mexican company Neolpharma, which established its presence in Puerto Rico in 2013, reports said.
The project includes a 2,000-square-foot pilot plant that will test new pharmaceutical products, as well as an analytic and forensic laboratory and a 4,000-square-foot storage facility. The center is equipped with state-of-the-art technology to produce a wide range of pharmaceutical goods, including liquid and solid forms, tablets, capsules and beads, Neolpharma said. The maximum capacity of the facility is 5.2 billion units annually.
By 2015 the research and development center is expected to work on between 12 and 15 new pharmaceutical products that will then be submitted to the U.S. Food and Drug Administration for approval. If they are granted approval from the regulator, Neolpharma will start manufacturing them commercially for the U.S. market.
Company’s cleanroom capacities shall again be expanded by mid-2015.
On January 10, 2014 the existing manufacturing authorization, according to Art. 13 of the German Drug Act (AMG) of the Fraunhofer Institute for Cell Therapy and Immunology IZI, was expanded to cover the first extension of the existing cleanroom facility.
After extensive qualification and inspection by the Regional Council of Saxony, the »Certificate of GMP-Compliance of a Manufacturer« was also updated. This seal of approval doubles the institute's capacities to manufacture cell-based medicinal products, or so-called »Advanced Therapy Medicinal Products« (ATMP).
Cell therapy products for clinical studies can now be produced on a total cleanroom area of over 750 m² (8,070 sq. ft.) in sixteen cleanroom class B manufacturing rooms to be operated independently.
The specific facility design allows for the parallel manufacture of several cell therapy products without the risk of mutual cross-contamination.
A separate part of the facility is furthermore specifically designed for the manufacture of products that must meet special safety requirements with respect to genetic engineering or protection against infection.
The operation of two separate and independent facilities provides maximum flexibility and continuity in the manufacturing processes, especially for bridging regularly scheduled maintenance periods.
A major part of the new facility is already booked out with manufacturing projects for various different clinical studies up to Phase III.
The staff consisting of 61 qualified employees currently handles both GMP facilities, the associated projects and the comprehensive quality assurance system. These professionals have profound expertise in the production and quality control of autologous and allogeneic cell therapy products, process development, and the validation of production processes as well as quality controls.
The cleanroom capacities of the Fraunhofer IZI shall again be expanded with a third construction section by mid-2015 to meet the continuously growing demand in this business sector.
Algorithme Pharma is expanding its clinical facility in Montreal, Quebec, with a seventh clinical unit, for a total 265 beds. The open concept design has three independent lounges, soundproof dormitories and facility-wide WiFi, and aims to provide sponsors with increased flexibility and efficiency for conducting complex study designs requiring large panel sizes.
Ingrid Holmes, vice president Clinical Operations, Algorithme Pharma, commented, “In response to our sponsors’ early phase development needs, we’ve added 41 hospital beds to our existing footprint. The new clinic is a great addition to our existing facility. The flexibility in the open concept design allows for increasingly complex protocol functions to occur either in a common area or at the bedside. This design feature, coupled with the ability to perform studies requiring intensive safety monitoring, makes this a unique space. The clinic has been designed for safety, functionality and the comfort of our study participants, and will allow us to continue to increase our service offering in the early phase market.”
McIlvaine Company
Northfield, IL 60093-2743
Tel: 847-784-0012; Fax: 847-784-0061
E-mail: editor@mcilvainecompany.com
Web site: www.mcilvainecompany.com