PHARMACEUTICAL & BIOTECHNOLOGY
INDUSTRY UPDATE
June 2013
McIlvaine Company
TABLE OF CONTENTS
AAIPharma Expands Parenteral Manufacturing Facility
Genesis Plastics Adds Third Cleanroom
GenPath Oncology to Create Advanced Molecular Laboratory
Cancer and Cardiovascular Research Building, University of Minnesota
Nature Made® Vitamins and Pharmavite Open New Facilities
ECA Moves Headquarters to Larger Facility
New Next-Gen Sequencing Facilities in New York
GBI Awarded Process Development Sub-Contract
Oklahoma Health Sciences Opens New Genetics Lab
Flow Dry Technology Receives $140K for Cleanroom
Kansas Officials Breaks Ground On NBAF Project
Emory University, Georgia Tech to Create Exposome Center
Allergy Testing Facility to Expand
GE Healthcare Investing in New SC Plant
Work Stops on Central Indiana Pharmaceutical Facility
ILC Dover Receives Cleanroom Certification
Rutgers Builds New Genomics Technology Center
Clinical and Translational Research Building, University of Florida
University of Washington (UW) Medicine Research Complex, Seattle
Rexam Healthcare Invests at Plant in Normandy, France
Centre for Pharmaceutical Advancement and Training Opens in Ghana
Boehringer to Build new cGMP Biopharmaceuticals Facility in China
Celerion Expands Belfast Facility
BioCote Launches Bacteria Testing Service
Nestlé Opens Advanced Laboratory
Plainfield Precision Completes Cleanroom in the Dominican Republic
Manchester Unites with NHS on New Genomic Medicine Center
Brazil Plans $680M for Research Institutes; includes Genomics Center
Qiagen, BioBay Open Translational Medicine Center in China
Sinovac Beijing Obtains China GMP Certificate
BioDuro Opens State-of-the-Art Discovery Lab in Shanghai
Sanofi Expanding Research Site in Toulouse, France
South Australian Health and Medical Research Institute (SAHMRI), Adelaide, Australia
Singapore Single-Cell Research Centre Opens Door for Asian Biological Discoveries
CooperVision and Covidien to Expand Operations in Puerto Rico
Kemwell Expands Capabilities in India
New UK Hub for Start-up Medical Device Developers
AAIPharma Services Corp. is expanding capacity and capabilities at its parenteral manufacturing facility in Charleston, SC. Facility expansions currently underway include the installation of compounding and aseptic processing suites to contain a newly acquired Monoblock vial filling machine, expansion of the microbiology lab, and addition of on-site formulation development capabilities and enhanced analytical instrumentation.
The fill and finish capabilities at the FDA- and EU-approved facility support vial sizes from 2 mL to 50 mL and can include 100% weight check. Manufactured products include solutions, lyophilized products, emulsions and suspensions with batch sizes ranging from a few hundred vials to 20,000 or more.
"In addition to the new fill line, integration of our formulation development and technical services capabilities through the build-out of a new pilot suite allows us to seamlessly support the manufacturing process from development through scale-up, further enhancing our compound to clinic strategy" said Paul Maffuid, Ph.D., vice president of pharmaceutical operations. "Expansion of the existing laboratories with a new cleanroom for on-site sterility testing using isolator technology continues our primary objective of providing a world-class parenteral manufacturing facility with all supporting infrastructure under one roof."
Genesis Plastics Welding has added a third Class 7 medical cleanroom at its facility in Indianapolis, Ind. The facility also meets 13485:2003 ISO certification standards.
"Recent national mandates have made infection prevention a leading concern of health care providers, creating this increasing need for these products," says Genesis Plastics Welding CEO Tom Ryder. "We are in a great position to help supply products to meet those increasing demands."
Genesis' experience in RF welding, including its heat-sealing technology ecoGenesis, enables the company to manufacture phthalate-free products.
Genesis manufactures single-use, disposable medical products such as blood pressure cuffs, instrument covers, media reservoir bags, inflatable bladders, hot and cold therapy devices, compression therapy sleeves and coolant bags, and fluid drainage bags. The company is a contract manufacturer providing radio frequency welding and heat sealing applications of plastic products for military, medical, and other industries.
Oncology physician group Regional Cancer Care Associates and Bio-Reference Laboratories' business unit GenPath Oncology are partnering to create an advanced molecular laboratory located at the John Theurer Cancer Center in Hackensack, NJ. The multi-year partnership will start with the development of a physician-owned immunophenotyping service for hematologic malignancies. GenPath will also provide "a significant" amount of esoteric diagnostic testing to RCCA's network of 92 oncology physicians, the partners said.
The Cancer and Cardiovascular Research Building is being constructed at 23rd Avenue, south east of Minneapolis city in Minnesota, USA. It is expected to open in July 2013. The new facility will be for the research and development of new treatments and therapies for cancer and cardiovascular diseases. The project is sponsored by the state of Minnesota and the University of Minnesota.
The new research building is being constructed as part of Biomedical Discovery District (BDD) project by the University of Minnesota. The BDD is a complex of research buildings, which will accommodate researchers across the Academic Health Centre to work side-by-side. The BDD project was approved by Minnesota Legislature in 2008.
The new research building is expected to accommodate up to 24 lead cancer and cardiac researchers and their support staff. It will be used to carry out research on biochemistry, which will focus on the role of chemical carcinogens in causing cancer.
The researchers based in the building will prepare new models to find better cancer treatments. The research will also study cardiac regeneration and development, muscular dystrophy, congenital heart medicine and genomics.
The design of the new research building was approved by the Board of Regents' Facilities Committee in June 2010. Architectural Alliance and Zimmer Gunsul Frasca (ZGF) Architects designed the new building.
The façade and curtain wall of the research building will be curved. The façade will also be covered with brick and glass. The building will also include an atrium, skybridge, sun shading and green roof.
The new building will have a total floor space of about 280,000ft2 over five floors. It will feature shared research space, laboratory areas, researcher offices and public areas such as a café and a seminar room. The building will feature offices situated near the lab spaces. Researchers from the Lillehei Heart Institute and Masonic Cancer Centre will be accommodated in the new building.
The new building will be fitted with state-of-the-art laboratory equipment. It will have an attached vivarium, and will also have research space for chemistry, genetics and mouse modeling.
"The new research building is expected to accommodate up to 24 lead cancer and cardiac researchers and their support staff."The building will have the most advanced laboratories, instrumentation and support facilities to carry out research on cancer and heart diseases. It will also feature high-end microscopes, centrifuges and MRI machines.
Construction on the new cancer and cardiovascular building broke ground in May 2011. About 55% of the construction was completed by May 2012. All building construction is scheduled to be completed by June 2013, and the centre is expected to be occupied by the researchers in July 2013.
The building design was prepared by Architectural Alliance, a company based in Minneapolis, in association with Zimmer Gunsul Frasca (ZGF) Architects of Seattle.
The building construction contract was awarded to Mortenson Construction.
The contract for design and installation of mechanical systems in the building was awarded to Metropolitan Mechanical Contractors. The mechanical work represents about 30% percent of the building construction cost.
The overall estimated investment for the construction of the building is approximately $200m. The State of Minnesota agreed to contribute 75% of the capital costs for the facility. The University of Minnesota will contribute the rest of the investment.
Pharmavite LLC, one of the largest U.S. manufacturers of high-quality vitamins, minerals and other dietary supplements, including Nature Made® vitamins, will officially announce the opening of the company's new manufacturing facility at the Northeast Opelika Industrial Park.
Nature Made is the number one retail national vitamin and supplement brand in the US, and the new facility is a key part of Pharmavite's strategic plan to meet the growing global consumer demand for health and wellness products. The U.S. dietary supplement industry has tripled in size since 1995 and is expected to grow at a similar annual growth rate through 2020, and Pharmavite believes the new facility is well-positioned to meet that need.
Growth in the U.S. dietary supplements market has been driven by greater consumer awareness and usage of vitamins and supplements, and according to the Nutrition Business Journal, as of 2010, 66 percent of American adults use dietary supplements at least occasionally, up from 52 percent in 1999. What's more, even existing consumers of dietary supplements are buying approximately 20 percent more supplements per month in 2010 than they were in 1999.
"Pharmavite has been a pioneer in this industry for more than 40 years. Our new facility in will help us continue our leadership role and supports our vision of people creating new products for better health worldwide, which is the mission we share with our parent company, Otsuka Pharmaceutical Co., Ltd.," said , Doug McLean, chief executive officer of Pharmavite. "We are grateful to everyone who contributed to the planning and building process for our new facility, and we look forward to a bright future for this community, our company, and the vitamin and supplement industry as a whole."
"At 330,000 square feet, the Opelika-based Pharmavite facility is one of the largest vitamin, mineral and supplement (VMS) manufacturing facilities built in the last 10 years in the US," said Mark Walsh, chief operating officer of Pharmavite. "This facility is also the first dietary supplement manufacturing facility in Alabama, bringing a new industry to the state."
"Pharmavite's facility will carry on our tradition of setting high standards of quality in all areas, from our production facilities, to rigorous testing and third-party verification programs, to conducting the scientific research on our products and producing groundbreaking vitamin innovations," continued Walsh. "We set high standards in all that we do, and our facility will carry on this legacy."
ECA Medical Instruments, a manufacturer of single-procedure, torque-limiting, and fixed-driver surgical instruments and procedural kits, has relocated to a new corporate headquarters building in Thousand Oaks, Calif. The company also has added a design center of excellence and product development laboratory in the new 24,000-square-foot space.
The recently-remodeled facility will house the company’s corporate executives as well as sales, marketing and product development teams. The design center and lab features state-of-the-art equipment and facilities permitting both ECA and customer design and engineering teams to collaborate on developing new single-procedure surgical instruments and surgical kits for the medical device implant market.
“Our company expansion allows us to scale rapidly to meet pent up demand for our surgical instruments and procedural kits in the U.S., off-shore and in emerging markets,” said John Nino, ECA’s president and CEO. “This new facility augments our existing U.S. Food and Drug Administration registered manufacturing site located just blocks away and provides space for our sales and marketing team and a world class design center for our product development group to create the industry’s next generation of single-procedure surgical instruments and procedural kits.”
ECA offers a portfolio of disposable torque-limiting and fixed-driver surgical instruments and multi-instrument surgical kits used to secure screws, fasteners and connectors for cardiac rhythm management, neuromodulation, cardiovascular and orthopedic implants. The company is a strategic supplier to major medical implant manufacturers worldwide including developers of pacemakers, defibrillators, ventricle assist devices and essentially every type of orthopedic implant including spine, small bone, extremities, trauma, cranial-maxillofacial, knee, hip, shoulder and general reconstruction products.
Empire Genomics, the University at Buffalo, and Life Technologies have joined to develop CLIA-certified next-generation sequencing facilities in upstate New York.
The facilities will be set up at the UB's New York State Center of Excellence in Bioinformatics and Life Sciences and at the Buffalo, NY, headquarters of Empire Genomics. Life Technologies is providing Ion Torrent sequencers to the facilities.
The technology along with the expertise of UB researchers and Empire Genomics "will help researchers develop new diagnostic tests that, in the future, could enable physicians to prescribe treatments tailored to each individual based on genetic make-up," the three partners said.
Financial and other details of the deal were not disclosed.
Goodwin Biotechnology, Inc. (GBI) was awarded a sub-contract from Emergent BioSolutions to conduct an early stage proof-of-concept feasibility process development to concentrate AVA filtrate for storage before the downstream process for BioThrax (Anthrax Vaccine Adsorbed). BioThrax is the only vaccine licensed by the FDA for the protection against anthrax disease.
"We're excited about the opportunity to contribute our protein purification as well as processing experience and expertise which have been developed and refined over the last 20 years," said Muctarr Sesay, Ph.D., vice president of process development at GBI. "Our goal is to develop process parameters that are amenable to routine GMP production and large-scale manufacturing in an effort to contribute to the production of BioThrax at large scale."
Heidi Nielsen, process development engineer for the Biodefense Division of Emergent BioSolutions said, "This phase of process development is critical to our project. We chose to work with Goodwin Biotechnology based on their Quality Systems and experience with large scale, GMP-compliant protein purification and processing."
The University of Oklahoma Health Sciences Center has opened a new genetics lab that will incorporate clinical genetic testing and research aimed at better diagnosing and treating childhood diseases.
Located on the University of Oklahoma's campus in Norman, the new lab provides more than twice the space of the previous clinical genetics laboratory, the university said.
The expansion was funded by private supporters, including the Children's Hospital Foundation, which raises money for the Children's Hospital in the OU College of Medicine.
"This new lab space will help accelerate that work and give our physicians the tools they need to further advance pediatric care," Oklahoma Gov. Mary Fallin said at a ribbon-cutting event opening the new lab.
Since it opened in 1999, the clinical genetics lab at OU has focused on chromosome analysis, DNA sequencing, and metabolic testing for blood disorders, cancers, and other common and rare diseases. The research component of these labs has included molecular characterization of chromosomes, studies of congenital heart defects, and Dandy-Walker syndrome. The lab also provides DNA storage services.
OU said that doubling the size of its facilities will enable researchers and clinicians to expand their workload accordingly.
"This increase in lab space will allow us to greatly expand the repertoire of diagnostic tests leading to improved care for the families and children of Oklahoma," Sanjay Bidichandani, chief of the OUHSC pediatric genetics department, said in a statement.
Flow Dry Technology of Brookville, Ohio, will construct an ISO Level 8 cleanroom inside the current building with separate HEPA filters, HVAC, and limited entry and access points. The $140,000 grant has been approved for funding by the Montgomery County Board of County Commissioners, with the intention of spurring economic development in the area.
The company is currently constructing new production equipment capacity. When combined with the new cleanroom, it will allow the company to expand into the pharmaceutical market and add 18 new employees to its payroll by 2016. ED/GE dollars will be used to construct the cleanroom and expand the parking lot to accommodate the new employees.
Flow Dry provides a line of standard desiccant products and the capability to custom design innovative solutions for the gasket, packaging, and sealing business.
Kansas and federal officials were pleased with a congressional budget committee's recommendation to include $404 million in the next federal budget for the new biodefense lab in Manhattan.
The markup of the spending bill for the Department of Homeland Security is less than the $714 million that President Barack Obama recommended for funding construction of the $1.2 billion National Bio- and Agro-Defense Facility adjacent to Kansas State University.
"The president has more than committed to this process, which is a good sign," said Republican Rep. Lynn Jenkins, whose district used to include the Kansas State campus.
The lab, slated to conduct research on dangerous animal diseases, will replace an aging facility on Plum Island, N.Y. State officials expect the lab to create more than 300 new jobs averaging more than $75,000 in salary and benefits.
Ground was broken on the lab's central utility plant, which will provide a self-contained power supply to the lab. Jamie Johnson, director of national labs for DHS, said the construction on the research lab should begin in 2014.
Johnson said the $404 million appropriation, which still must go through the full House and a similar process in the U.S. Senate, would be sufficient funding to sign contracts and begin construction. The funding would be coupled with $202 million in new bonding authority from the Kansas Legislature.
State officials are yet to act on the additional bonds, which would raise the total state effort to $307 million in bonds and $35 million from the Kansas Bioscience Authority. The initial $105 million bonding are being used to construct the utility plant.
"If we get the same amount in the (U.S.) Senate it will be a major victory," said Sen. Pat Roberts, a Republican who began speaking of the need for the new lab more than a decade ago.
Kansas was awarded the project in 2009 but federal funding for the lab has lagged over concerns about the security of the facility and the event of an accidental release of a deadly pathogen, either by natural disaster, human error or act of terrorism.
The cost of the project has escalated with inclusion of additional security measures, including adding more concrete to the structure.
Scientists at Emory University and the Georgia Institute of Technology have received a four-year, $4 million grant to establish a center for research into the effects of environmental exposure on humans.
The Rollins School of Public Health at Emory along with partners at Georgia Tech will establish the Health and Exposome Research Center: Understanding Lifetime Exposure, or HERCULES Center, at Emory. The grant from the National Institute of Environmental Health Sciences is the first exposome-based center grant awarded in the US, according to the two universities.
The exposome is a new concept that "incorporates all of the exposures encountered by humans," they said adding that it is equivalent to the human genome and "includes lifetime exposures to environmental pollutants in food, water, physical activity, medications, homes, and daily stressors. Exposome research looks at the holistic view of the human body's exposures, how the body responds to those exposures, and their combined effects."
Combined with the growing understanding of genetics, the exposome could shed light on the underpinnings of complex disorders such as autism, asthma, and Alzheimer's disease, they added.
Included in the HERCULES Center is the systems biology core, which will provide expertise in computational methods for the analysis and integration of large datasets. Gary Miller, a professor and associate dean for research at the Rollins School of Public Health at Emory, is the director of the HERCULES Center. The systems biology core is headed by Eberhard Voit from Georgia Tech's biomedical engineering department.
Biogenics Research Chamber, an allergy testing facility in San Antonio, Texas, has broken ground on an extension. The 5,400 ft2 facility will house a large allergy exposure chamber, a specialty chamber and eye examination rooms. The chambers will utilize cleanroom technology with complete electrical back-up by generator. The extension will enhance capacity for simultaneous testing of large numbers of participants, while broadening therapeutic testing capabilities.
Biogenics Research Chamber, the only large permanent pollen exposure chamber in the U.S., opened in 2010 in the Medical Center of San Antonio. Projects have included pharmaceutical and vaccine trials and scientific studies elucidating the basic mechanisms and genetics of allergy. The extension, scheduled for completion in January 2014, is engineered to challenge with seasonal pollens as well as year-round allergy-provoking agents including dust mites and cat dander. The specialty chamber is designed for testing of novel agents for non-allergic eye and respiratory conditions.
GE Healthcare is investing $17 million in a Florence, S.C. plant that will turn helium gas into supercool liquid needed for medical imaging.
The company, which is a unit of General Electric Co., announced it's building a 5,000-square-foot facility next to its existing magnetic resonance plant. GE expects 10 of the 50 jobs created to be permanent.
The new plant will use GE's technology to capture pure helium gas and compress it into extremely cold liquid that's essential to MR production. GE says helium is the only element that can effectively keep an MR magnet at the necessary temperature of more than 440 degrees below zero Fahrenheit.
MR systems use superconducting magnets to help doctors see inside patients without radiation exposure.
GE Healthcare's MR magnet production plant has operated in Florence for 30 years and employs 350 people.
Construction has stopped on a pharmaceutical facility being built with a $6 million loan from a suburban Indianapolis city, Greenwood, Indiana.
Greenwood city attorney Krista Taggart says the city could foreclose on the Elona Biotechnologies facility within the next few weeks unless new investors take over the company. The city is exploring all its options for the facility near Interstate 65 where insulin was to be produced.
Greenwood officials three years ago approved $8.4 million of incentives for the project, including the construction loan. Elona said then it expected to employ some 70 workers and spend more than $25 million on a planned expansion.
The newspaper reports the company founders didn't return messages and that its phone number has been disconnected.
ILC Dover, the designer and manufacturer of NASA's space suits and a wide range of engineered film and fabric products, has received certification for its ISO Class 7 cleanroom.
Testing of the cleanroom was performed in accordance with ISO Standard 14644 and IEST RP-CC006.3. This facility will enhance ILC Dover's ability to support the global pharmaceutical industry with disposable systems engineered to contain powder transfers from cGMP to nanogram levels.
‘The ISO Class 7 cleanroom will allow us to expand our powder transfer offerings and better serve our biopharm customers,’ said Chris Rombach, Biopharm Products Manager for ILC Dover. ‘ILC has a long history of supporting the powder containment and handling needs of the pharmaceutical industry and this added capability will further enhance our ability to deliver customer focused, cost effective solutions to the biopharmaceutical market.’
The first product line to be produced in the newly certified cleanroom is the EZ BioPac – a powder transfer system to support media and buffer preparation. Made from ArmorFlex, the EZ BioPac is proven to reduce contamination that typically occurs during filling a powder transfer bag or, more importantly, when it is discharged to the reactor or mix tank.
An $11.8 million renovation of RUCDR Infinite Biologics, a university-based biorepository, has been completed, creating a new Genomics Technology Center.
The new center, comprising 12,500 square feet of laboratory, office, and storage space, is being housed on the Busch Campus of Rutgers, The State University of New Jersey.
The Genomics Technology Center, funded with a $9.5 million grant through the American Recovery and Reinvestment Act of 2009, more commonly known as the stimulus package, will provide services to government agencies, foundations, and private industry, including pharmaceutical companies, RUCDR said. With the expansion, RUCDR was also named by the National Institutes of Health as the provider of sample processing, analysis, and storage, and data management for research projects funded through four NIH institutes.
"The Genomics Technology Center was built through the stimulus for the purpose of stimulating NIH-funded research," Jay Tischfield, RUCDR founder and CEO, said in a statement. "This will advance our understanding of the causes of diseases, particularly mental disorders and addictions."
RUCDR is run through Rutgers and provides sample processing, analysis, and storage services. It also provides DNA, RNA, and cell lines with clinical data for research into mental health and developmental disorders, drug and alcohol abuse, diabetes, and digestive, liver, and kidney diseases. It said that it currently stores more than 12 million biosamples.
"We've integrated our operation to make us more efficient, thereby increasing our capacity so we can better serve NIH-funded researchers but also to make our services more available to the private sector," Andrew Brooks, COO, director of technology development and Rutgers associate research professor of genetics, said in a statement. "We've expanded out infrastructure and doubled our automation analytical capabilities. Our goal is standardize biosample collection, processing, distribution, and analysis to facilitate and accelerate the disease-discovery process."
The University of Florida started construction of a new clinical and translation research building at its Mowry Road, Gainesville campus in Florida in May 2011. The construction of the new facility is expected to be completed in 2013.
The facility is expected to serve as headquarters for clinical and translational science at the university. The project is being sponsored by University of Florida (UF) and the NIH National Center for Research Resources.
The facility will be a hub for expanding research network, which will connect all 16 colleges within the Florida university campus as well as Shands HealthCare and the North Florida / South Georgia Veterans Health System.
The design for the new clinical and translational research building was provided by Perkins+Will architects. The facility is being constructed on a 2.57 acre site located in the University of Florida campus.
The building will have two wings, which will be connected with a hub on the east side. It will have a two storey glass-walled atrium-lobby at the centre. The building will also feature a garden.
The new clinical and translation research building will have a total floor space of 120,000ft², which includes 40,000ft² ageing institute complex in the south wing, and 80,000ft² clinical and translational sciences institute in the north wing.
All the clinical research spaces will be located in the ground floor. The administrative, support spaces and offices for staff and researchers will be located respectively in second and third, fourth and fifth floors of the building.
The new facility will have a clinical and translational science institute, Institute on Aging, UF clinical research centre and department of health outcomes and policy. It will also have department of biomedical informatics, department of epidemiology, department of biostatistics and geriatric research.
The Institute on Aging will be a one-stop facility that will make it easier for mobility-restricted older adults to take part in clinical trials and strengthen connections among existing UF research centers including the Claude D. Pepper Older Americans Independence Center, the CTSI and the Cognitive Aging and Memory Clinical Translational Research Program. It will also include a geriatric medicine multispecialty clinic.
The facility will also have an array of other research departments, as well as sophisticated conference, training and reception areas.
The building was designed by Perkins + Will architects. The building construction contract was awarded to Skanska. Mechanical and electrical engineering support was provided by Moses and Associates.
Other key contractors involved in the construction of the building are AEI, SEG, Siebein and Associates, Brame Architects, Williams-Scotsman and Brentwood Company.
The estimated investment for the construction of the building is $45m. It was financed with $15m under the American Recovery and Reinvestment Act of 2009 by the NIH National Center for Research Resources. The University of Florida contributed $30m for the construction of the 80,000ft² facility.
The new building is being constructed with environmentally sustainable features. It is aimed to achieve LEED platinum certification. The building will have solar panels and systems. It will use rainwater for flushing toilets and irrigation. The designers increased the thickness of glass in the facility to keep out the noise of a power plant situated adjacent to the facility
The new medical research complex at University of Washington (UW) School of Medicine in South Lake, Seattle was completed in March 2013. The new facility will house many of the university's biomedical research laboratories. It is expected to receive certifications in spring 2013.
The construction was primarily sponsored by UW School of Medicine, Vulcan Real Estate and the National Development Council.
The new phase three research centre has a total floor space of about 330,000ft2, in a seven storey building. The research complex is surrounded with beautiful landscape and features a tree-lined sidewalk. It has two spacious seminar rooms with videoconferencing capabilities and also features 266 parking spaces located in two bays.
The third phase has laboratories for kidney research, vision sciences, rheumatology, immunology and infectious disease investigations. The scientists at the new facility will focus on a number of medical conditions, including multiple sclerosis, blindness, malaria, lupus and renal failure.
The new facility will be engaged in developing life-changing therapies and medical breakthroughs that will positively impact the health of future generations. The facility can accommodate between 1,000 and 1,200 researchers and support staff.
The construction of the research complex was completed in three phases. The total floor space of the medical research complex in all the three phases is about 800,000ft2.
The design and planning for the construction of the research complex began in September 2003. The facility broke ground for construction in 2004. The first phase of construction was completed in January 2005. It included a total floor space of 215,000ft2.
The facilities constructed in the first phase included laboratories intended to carry out research in microbiology, biomarkers, biologic imaging, cancer vaccines, heart regeneration, inflammation and proteomics.
The second phase of construction began in 2006 and was completed in 2008. It included 170,000ft2 laboratory building and 86,000ft2 office building.
The research facilities opened at the complex during the second phase included biology, therapeutic delivery systems, neurobiology, genetics, and regenerative medicine. The research facilities are specifically focused on diseases such as Parkinson's and Alzheimer's, diabetes, hearing loss, strokes, heart regeneration, liver diseases, and bone and joint regeneration and repair.
The Board of Regents approved the third phase of the medical research complex's construction in April 2010. The third phase broke ground in July 2011 and was completed in March 2013.
The building design and architectural support was provided by Perkins+Will. The landscape design was provided by Gustafson Guthrie Nichol (GGN). The construction contract for the building was awarded to Sellen Construction.
The structural engineer for the second phase of construction was Magnusson Klemencic Associates. The electrical and mechanical engineer was Affiliated Engineers NW. The civil engineer for the second phase was Coughlin Porter Lundeen.
The first phase of construction was sponsored by philanthropy funding from Jeffrey H Brotman. The second phase of construction was contributed by Tom and Sue Ellison, Lynn and Mike Garvey, the Oki Foundation, Quellos, Safeco and the Orin Smith Family Foundation.
The total investment on the third phase of the medical research complex construction was $165m. The construction cost of the building was $113m. The National Development Council sponsored the third phase.
Bend Research has expanded its GMP analytical capabilities and capacity for pharmaceutical development. The company has added on-site stability storage and additional GMP testing to support the manufacture supplies for clinical use. The new onsite stability storage will reduce the need to ship samples to a subcontractor. Formulations can be stored at conditions ranging from 5°C to 40°C/75% RH, meeting industry-standard stability-testing conditions suggested by the International Conference on Harmonization (ICH).
“Our customers asked us to add this on-site capability and we were happy to provide the service. Having this capability on-site will reduce the risks associated with stability sample shipment. It also provides our clients with more rapid product testing and more control,” said Tanya Hayden, Bend Research vice president.
Harlan Laboratories, a contract research organization and supplier of research models and services, has expanded its U.S. production facilities in Indianapolis, Indiana and Livermore, California.
The company said the expansion more than doubles the number of isolators at these sites allowing Harlan to meet growing demand for its immune-compromised models.
Joe Meyer, Vice President Global Commercial Operations at Harlan Laboratories said the investment underscores the company’s commitment to providing the highest quality research models and services. “We will continue to expand and enhance our facilities worldwide to meet the needs of the research community in key therapeutic research areas like oncology, immunology and toxicology with consistently dependable research models, diets and supporting services,” he said.
The facilities incorporate the latest technology and design. The environmentally controlled breeding isolators are supported by individual air supply and HEPA filtered air handling to ensure the integrity of the colony housed within each isolator. They also feature the latest equipment and biosecurity measures including a watering system with automatic flushing to help prevent the unwanted proliferation of organisms, as well as a whole building redundant backup power system.
Harlan Laboratories has also incorporated several sustainable components to the newly renovated facilities.
“We designed the facilities with a dual purpose – animal care and sustainability. We have incorporated energy efficient lighting and water systems, as well as designed workflows to support our biosecurity practices,” said Mike Lipke, Global Vice President of Operations at Harlan Laboratories.
Rexam Healthcare, a subsidiary of UK packaging group Rexam, is to improve its manufacturing plant at Le Tréport, Seine Maritime, France, in a €20 million expansion.
The plant has more than 50 years’ experience in assembly and injection molding and specializes in drug delivery systems, including the recently introduced Advancia pump, the design and development of which was co-financed by the European Regional Development Fund in Normandy.
Along with other site improvements, Rexam Healthcare is expanding its manufacturing unit so that there will be a total workspace of 5200m2 (55,952 sq. ft.) ; a 3750m2 production building including a cleanroom of 2900m2 (31,204 sq. ft.) ; and 1500m2 housing the machine and mould maintenance workshops, metrology unit, laboratory and administrative premises.
More than 50 new jobs will be created, adding to the 200 people already working at the plant.
The cleanroom is due to open in November, with full inauguration of the site scheduled for early 2014.
Rexam Healthcare utilizes plastic injection, injection blow molding, and high speed automated assembly to design, develop, and manufacture packaging, including containers and closures, drug delivery systems, pumps and valves, and medical components.
In an effort to increase the number of experts and available tools to combat falsified, substandard and counterfeit medicines in countries in Sub-Saharan Africa, the US Pharmacopeial Convention (USP) has launched the Centre for Pharmaceutical Advancement and Training (CePAT) in Accra, Ghana.
The new centre is the beginning of a series of global health initiatives to equip national and local regulatory authorities and officers, quality assurance and quality control professionals, manufacturers, and others in the pharmaceutical industry with knowledge and skills to promote access to good quality medicines. It is being launched as a Commitment to Action through the Clinton Global Initiative (CGI).
'CePAT is a natural extension of USP’s core mission of establishing public standards for the quality of medicines, foods and dietary supplements. As USP has become increasingly active throughout the world, the need to support efforts to provide good quality medicines to everyone who requires them has become more important,' said Dr Roger L. Williams, USP’s chief executive officer.
'CePAT is a positive step in that direction, and has been realized in part through our strong working relationships with the Ghanaian and other Sub-Saharan African medicines regulatory authorities.'
Ghanaians and many in Sub-Saharan Africa currently face a serious problem when it comes to accessing quality medicines. A 2013 report on the quality of uterotonics (oxytocin and ergometrine) in Ghana found that over 90% of the samples tested by USAID-USP Promoting the Quality of Medicines Program (PQM) failed either the test for the active ingredient or sterility, and only three of the 26 products tested were officially registered with the Ghana Food and Drug Authority (FDA).
A 2010 study on the quality of anti-malarials in African countries, collaboratively conducted between the World Health Organization (WHO) and PQM, revealed that 44% of the samples collected in Senegal failed to meet quality standards. In Madagascar and Uganda, 30% and 26% of the samples failed, respectively. These reports underscore the seriousness of the issue and the need for trained professionals to improve access to quality medicines, which CePAT hopes to help ensure.
'Serious public health issues related to poor quality medicines have been linked to lack of trained human resources, in countries with limited resources,' said Dr Patrick H. Lukulay, vice president of USP’s Global Health Impact Programs (GHIP), who also oversees CePAT operations. 'With the centre, we want to bring the opportunity to improve local quality assurance systems by training national regulatory agencies and quality control professionals so they can fight the problem of fake and substandard medicines in a sustainable way.'
CePAT’s first course offerings are on Medicines Dossier Evaluation, Quality Control (including hands-on laboratory training) and Good Manufacturing Practices for Pharmaceuticals. Applications are subject to a pre-evaluation to ensure that the appropriate candidates are chosen, based on their potential role in providing access to good quality medicines in the Sub-Saharan African region.
Germany's Boehringer Ingelheim is entering into a strategic alliance with Shanghai-based Zhangjiang Biotech & Pharmaceutical Base Development Company (ZJ Base Company) to construct a cGMP biopharmaceuticals facility in China.
Scheduled to commence operations early in 2016, the new facility will be the first to use mammalian cell culture technology in the production of biopharmaceuticals in China.
Set to carry out technical process development and cGMP manufacturing, the new facility will offer a range of development and clinical services.
Boehringer Shareholders Committee chairman Christian said, "Shanghai is our ideal partner with its advantages in investment environment, service system and talent resources."
The German company is likely to invest more than €35m in the project, which is expected to provide around 65 job opportunities.
ZJ Base Company general manager Lanzhong Wang said with the government support and a number of innovative medicines being developed by a cluster of middle to small-sized innovative companies in Zhangjiang, the company plans to begin the CMO manufacturing framework on a trial basis.
"This will provide an effective platform for middle and small-sized companies to industrialize their innovations," Wang added.
The MRC-NIHR Phenome Centre in the UK officially opened. The center, announced last summer during the London Olympics, is funded with £10 million ($15.6 million) from the Medical Research Council and the National Institute of Health Research. It said in a statement that it will examine about 100,000 blood and urine samples annually, investigating phenomes to help determine the causes of diseases and treatments that could be tailored for individual patients.
Celerion has added a containment room at the Belfast, Northern Ireland facility that will allow the company to develop programs that require studies using biologics and vaccines with primary and secondary containment. The containment room is a modular facility with a negative pressure processing room that houses a Biosafety Level (BSL-2) cabinet, enabling the processing of live class 2 and class 3 biologics.
“The addition of the containment room, coupled with our ability in the Belfast clinic to recruit large numbers of study participants, places Celerion in a strong position to conduct studies requiring biologics and vaccines,” said Phil Bach, vice president of Global Clinical Research at Celerion. “This announcement builds on the recent addition of the Bronchoscopy Suite and expansion of our services in the respiratory therapeutic area. The Belfast clinic is widely recognized as the Respiratory Centre of Excellence with experience in asthma, COPD, cystic fibrosis, and bronchiectasis clinical research.”
Global antimicrobial solutions experts BioCote has launched a bacteria testing service to help organizations check and monitor levels of bacteria and other microbes in environments where hygiene is important.
Failures in hygiene can lead to outbreaks of pathogenic bacteria such as MRSA, E. coli 0157 and salmonella, which can damage a firm’s reputation and incur costs. The bacterial testing and analysis service from BioCote aims to help organizations minimize this risk by understanding levels of bacterial contamination at their premises. This not only gives a good indication of general hygiene levels but can also help identify any possible risks of which the organization may be unaware.
The service is confidential and involves BioCote visiting the organization’s premises to take samples, which are analyzed in the laboratory and translated into a detailed report to present the findings and highlight any problems. The service can be tailored to meet an organization’s requirements and may include advanced microbiological techniques.
Richard Hastings, technical director at BioCote Ltd, explains, “Our Bacteria Testing Service ensures that organizations running factories, fast food outlets, hospitals or other hygienic facilities know about any possible bacterial contamination on their premises. We have been doing lab work like this for our existing customers for almost 15 years so it makes sense to make it available to the wider market. Of course every company faces different challenges, and we have already encountered lots of different reasons for using the service including hygiene checks for franchisees, to assess existing cleaning processes or even to track down the source of known contamination.”
Founded in 1994 in the UK, BioCote today supplies clients in 25 countries around the world.
Nestlé has opened the most advanced laboratories of their kind in the industry to study food-borne pathogens that are harmful to human health.
The new facilities at the Nestlé Research Center in Switzerland will have a high level of 'bio-containment', meaning certain areas will be sealed with access restricted to trained personnel who must wear protective clothing and adhere to strict hygiene procedures.
The company is using the most sophisticated scientific techniques available to refine the processes it uses to kill pathogens without destroying the nutritional value of its food.
"We constantly face familiar pathogens like salmonella, but there are newer threats as these pathogens evolve," said Nestlé's Chief Technology Officer Werner Bauer. "We have to stay one step ahead.
"The research done here will undoubtedly be a great asset for Nestlé, but we also have a responsibility to communicate and share the results with the scientific community and consumers, so everyone can benefit."
"Consumer health and safety are at very core of what we do today, and what we have always done.
"We need more data and more state-of-the-art technologies to guide our product development and to ensure our products continue to be absolutely safe."
Plainfield Precision has completed an ISO Class 8 cleanroom to position itself as a true contract manufacturing partner for Medical OEMs looking to utilize the strategic infrastructure of the Dominican Republic.
Operating in the Dominican Republic as Pixley Richards, Plainfield Precision believes the country offers a strategic manufacturing location for medical OEMs looking to reduce freight costs and lead times, while leveraging a competitive cost environment. The Dominican Republic is an ideal location to service the Americas and Europe.
'As part of our strategic intent to grow our medical business, the building of a cleanroom was the logical next step for us,’ says CEO Jonathan Soucy. ‘We chose to do this in the Dominican Republic because of our commitment and belief that the Dominican Republic offers unique benefits for medical OEMs.”
The expanded space will be a cleanroom environment for both precision plastic injection molding and assembly. Molding capabilities will range from 30 ton to 250 ton machines, and the assembly room is capable of handling multiple contract manufacturing projects at one time.
Located in the Zona Franca Las Americas in Santo Domingo, Plainfield Precision-Dominican Republic is a custom manufacturing centre specializing in precision plastic injection molding and assembly for the medical device industry.
In addition to the engineering support from Plainfield Precision-Plymouth, Massachusetts, the Dominican Republic facility has a skilled technical staff, full metrology lab and on site machine and mould maintenance.
The University of Manchester launched a new center for clinical genomics that will develop genetic tests and companion diagnostics and use them along with sequencing tools in the treatment of patients through the UK National Health Service.
The new Manchester Centre for Genomic Medicine (MCGM) is a collaboration between the university's Department of Genetic Medicine and the NHS Genetic Medicine Service at Central Manchester University Hospitals NHS Foundation Trust.
The MCGM at St. Mary's Hospital was funded with £1 million ($1.5 million) in equipment, staff, a diagnostics lab, and high performance computing facilities, from the NHS Trust and the University of Manchester.
The partners expect that the new collaborative facilities will create an environment in which physicians, genetic counselors, nurses, and diagnostic and computer scientists will pursue new projects and develop services that engage patients in personalized medicine.
"We are developing a significant portfolio of new tests based on the combined talents of MCGM as well as expanding our range of companion tests for prescribing cancer drugs and genomic tumor profiles for clinical trials," University of Manchester Professor Graeme Black said in a statement today.
This portfolio includes new tests for breast, lung, bowel, and skin cancer tumors, cystic fibrosis, genetic eye conditions that cause cataracts in newborns, inherited cardiac conditions, and screening for severe learning and developmental conditions. The tests are based on discoveries by Manchester-based researchers of over 15 genes that cause serious developmental problems in children.
"We are especially delighted to be working towards an NHS-based quality assured diagnostic exome sequencing service, delivered with clinical and scientific expertise from start to finish by the Manchester multidisciplinary team," Black added. "Our vision is to make personalized medicine a reality for NHS patients."
The center will use Life Technologies' 5500xl, Illumina's HiSeq 2500 and MiSeq NGS, and Sequenom's MassArray systems in delivering its testing services.
The university also said that it is developing a memorandum of understanding with colleagues from the Peking University Health Sciences Center, under which the MCGM and PUHSC will establish an integrated research and clinical delivery program.
A number of Brazilian research centers in the state of Sao Paolo, including a human genomics institute, will be funded with an estimated $680 million over the next 11 years, with $370 million of that funding coming from the Sao Paolo Research Foundation (FAPESP).
The 17 Research, Innovation, and Dissemination Centers (RIDCs) that will receive the funding will engage in a wide range of biomedical research projects and includes the Human Genome and Stem Cell Research Center (HUG-CELL) at the University of Sao Paolo, the foundation said.
Under the plan, FAPESP will provide $370 million over the 11-year period, and the multiple institutions that will host these centers will provide a total of around $310 million.
Each of these RIDCs will establish a research hub in its particular discipline, and they will aim to develop efforts that will contribute commercially or socially in high-impact areas and provide education programs.
The HUG-CELL at the University of Sao Paolo, which was formerly called the Human Genome Research Center (HGRC), will receive around $3 million for the first year of the program, including around $1.5 million to support scholarships.
The original genome center was established in 2000 with the goal of studying genetic diseases that are prevalent in the Brazilian population. Its projects focused on Mendelian disorders, and in 2005 it was expanded to incorporate stem cell research. Now that program has been revised and expanded again to include research into genomic instability associated with aging and degenerative diseases, epigenetic mechanisms that are involved in disease, and phenotypic variability between individuals with Mendelian disease mutations.
The HUG-CELL will use next-generation sequencing and cell sorting technologies and will engage in interdisciplinary projects. It also will aim to advance translational medicine projects, particularly stem-cell therapies in preclinical studies and therapeutic trials for particular genetic disorders with an eye toward commercialization.
According to HUG-CELL, the ethnic variation of Brazil offers a "rich foundation" for these studies. It has embarked on a program to offer molecular diagnostics and genetic counseling to the population, with the goal of developing new kits for diagnosing rare diseases and eventually translating these genomic tools through partnerships with start-up biotech enterprises.
Another HUG-CELL initiative, dubbed the 'over 80 project', will compare genomic variation and brain functioning, using MRI, of healthy individuals over the age of 80 with another group that is over 60.
Other institutes that will receive funding under the program include a Food Research Center; the Brazilian Research Institute for Neuroscience and Neurotechnology; the Center for Research on Inflammatory Diseases; the Center for Research and Innovation in Biodiversity and Drug Discovery; the Center for Research on Toxins, Immune Response and Cell Signaling; and the Center for Research in Cell Therapy, among others.
Qiagen and SIP Biotech Development announced the opening of the Qiagen Translational Medicine Center in Suzhou, China.
The translational medicine R&D center's goal is to accelerate the discovery and validation of biomarkers and to create companion diagnostics for the Chinese market. A joint venture of Qiagen and BioBay, a life sciences cluster in Suzhou Industrial Park, the center will provide services and consulting with Qiagen technologies to international and Chinese pharmaceutical firms and research institutes. It will work with partners situated in BioBay and elsewhere in China, Qiagen and SIP Biotech said.
SIP Biotech, short for Suzhou Industrial Park Biotech Development, oversees BioBay.
The four key service areas of the new center are biobanking, pharmacogenetics, next-generation sequencing, and pharmacogenomics. Qiagen Suzhou anticipates hiring about 50 employees within three years.
"Partnering with BioBay expands our commitment to translational research in biomarkers and companion diagnostics for China and other markets," Victor Shi, president of Qiagen Asia Pacific, said in a statement. "Pharma and biotech companies in China's dynamic market face special needs that we can address through this unique translational medicine collaboration, helping to accelerate the development of companion diagnostics."
Peizhuo Zhang was named general manager of Qiagen Suzhou, while Jean-Claude Muller is joining the board of directors.
Today's deal follows an agreement last year between Qiagen and Bio-X Center of Shanghai Jiao Tong University to create a translational medicine laboratory in Shanghai.
Sinovac Biotech Ltd. a provider of biopharmaceutical products in China, announced that Sinovac Beijing, the main operating subsidiary company of Sinovac, obtained the Certificate of Good Manufacturing Practices for Pharmaceutical Products (GMP Certificate) from the China State and Food Administration (CFDA) for its proprietary vaccines, its Haidian district bulk production plants, and its Changping filing and packaging facility. The GMP certificate covers Sinovac Beijing's vaccines commercialized in China and approved for stockpiling, inclusive of hepatitis A vaccine (human diploid cell), inactivated; hepatitis A and B combined vaccine; influenza vaccine (split virion), inactivated; pandemic influenza vaccine (inactivated, adjuvanted); pandemic influenza vaccine (split virion, adjuvanted); H1N1 influenza A vaccine (Split Virion, inactivated) The GMP certificate is valid for five years starting from April 17, 2013.
New GMP standards were implemented in China by the CFDA in March 2011. These new standards are in line with international standards. According to the notice for the implementation of new GMP guidelines (2010 version) issued by CFDA in February 2011, all China-based vaccine manufacturers are required to pass the new GMP certification by the end of 2013.
In December 2012, the CFDA conducted a on-site inspection on Sinovac Beijing's production plants in Haidian district and the new filling and packaging line in Changping district according to the Good Manufacturing Practice for Drugs (2010 Revision), the new GMP guidelines. The CFDA granted Sinovac the GMP Certification in April 2013 following the March 2013 public notification period.
Dr. Weidong YIN, Chairman, President and CEO, commented, "Sinovac Beijing's vaccine products, its bulk production plants, and its Changping filling and packaging facility have passed the GMP inspection and received the GMP certificate under the new version of GMP guidelines ahead of the year end 2013 deadline. The GMP guidelines adopted in China in March 2011 are consistent with international standards."
BioDuro, A PPD® Company, announced it has opened a new state-of-the-art laboratory in Shanghai, strengthening its ability to provide biopharmaceutical clients an extensive range of customized drug discovery services in Asia Pacific. The new lab also enables the company to better support the business needs of its clients by increasing efficiency during discovery and development, and providing greater consistency among the stages of development. In addition, the location of the lab in the Waigaoqiao Free Trade Zone and its proximity to local and multinational pharmaceutical and biotechnology companies in Shanghai will foster their working relationships with BioDuro.
The 72,000-square-foot lab, accompanied by 20,000 square feet of office space, offers integrated drug metabolism and pharmacokinetic (DMPK), bioanalytical, chemistry, discovery biology and oncology pharmacology services. And, because BioDuro is part of the PPD organization, clients also are able to take advantage of a complete menu of clinical research services, as well as an extensive library of assays for testing.
“As a fully integrated life science research service provider, BioDuro has an experienced team of researchers and scientists with expertise in a wide range of drug discovery services,” said Jasmine Cui, Ph.D., general manager and chief scientific officer of BioDuro. “This new lab will allow us to meet the business needs of our clients more effectively by streamlining the discovery and development process, and continuing to enhance continuity and smooth transitions throughout the stages of development. For example, after a compound goes into Phase 0, the PPD organization can offer full clinical research services to develop the compound through post approval.”
BioDuro also has a state-of-the-art, 110,000-square-foot laboratory in Beijing. Through the two operations, BioDuro provides fully integrated, comprehensive drug discovery services covering development from target identification to preclinical/Phase 0.
About BioDuro
BioDuro, acquired by PPD in 2009, is a leading drug discovery services company. It provides high-quality, integrated preclinical research and development services to biopharmaceutical clients, ranging from medicinal chemistry, discovery biology, pharmacology, DMPK and biologics.
The French ministerial mission presented the conclusions of its report regarding the Sanofi Research site in Toulouse, France.
The report confirms the necessity to reorganize Sanofi's Research in France, in particular to address its structural weaknesses and to open the Group to the external collaborations. This evolution is essential for the discovery of new medicines, to create an environment for long-term growth and to ensure the sustainability of the Group, especially its 26 industrial sites in France.
Consequently, Sanofi confirms its intent to regroup its research activities in France in the regions of Paris and Lyon, in Strasbourg and to transform the Montpellier R&D site into a strategic Development center for the Group.
The report provides a road map to transform the structures of the site in Toulouse, so that it keeps a scientific and technological mission, and to safeguard a maximum number of jobs in the region. Based on the options considered in the report, Sanofi will explore the following:
The creation of a technological platform to provide services for Sanofi and other biotechnological or pharmaceutical companies;
The spin-off of activities dedicated to the development of innovative therapeutic solutions;
The establishment of local start-ups on the site.
Sanofi commits during the next five years to accompany the transition of these new autonomous structures, while respecting tradition and social practices.
In addition, as already announced, the anti-infectious research of the site will be moved to Lyon, where Sanofi plans to create a global center of excellence.
These proposals are now going to be developed thoroughly with the social partners, also supported by working groups in Toulouse to prepare for the evolution of the site and to define the ways to support those new structures.
With the definition of its new model, Sanofi confirms its commitment to Research in France, where the Group employs 50 % of its global R&D workforce, in order to create a successful and dynamic research necessary for its future.
The South Australian Health and Medical Research Institute (SAHMRI) is being constructed at North Terrace in Adelaide, the state capital of South Australia. The facility is expected to be ready by the end of 2013. It will be a world class research facility for health and medical research in South Australia. The facility is being sponsored by the South Australia state government and the federal Australian government.
The new SAHMRI facility will have a total floor space of 26,000m² (279,760 sq. ft.) in a nine-storey building. It will be integrated with Royal Adelaide Hospital. The new facility will be used for fostering innovation and improvements in health services. It will be a place for carrying out research on themes such as cancer, heart diseases nutrition, metabolism and healthy mothers.
It will also enable research on other themes including the mind and brain, immunity, infection and babies and children. It will have sophisticated laboratory space to accommodate about 675 researchers.
The South Australian research facility will be provided with state-of-the-art laboratory equipment. It will be incorporated with the Physical Containment (PC) level two laboratory standards set by the Australian Government. It will have both wet and dry laboratory spaces.
The SAHMRI facility was designed by Woods Bagot. The building design is inspired by the skin of a pine cone. It features a transparent glass facade made up of triangular structures with glass and diagonal steel beam supports. The façade is designed to allow more natural light into the building.
The building also features two atriums inside. The west side atrium includes the entry and bridge links between the laboratories while the east side atrium utilizes an active workplace environment. The design also features glass lifts, wide open spaces, flexible working areas, lofty bridges and a spiral staircase.
Construction on the SAHMRI facility was started in February 2010. The concrete works were completed and tree topping ceremony held in August 2012. The building is expected to be ready for opening by the end of 2013.
The design and architecture support for the building was provided by an Integrated Design Team led by Woods Bagot. Woods Bagot received collaboration from RFD for lab design, Aurecon for structure design and NDY & Aurecon for services design.
The construction contract for the SAHMRI facility was awarded to Hindmarsh Construction. Aconex provided operations and maintenance support during the construction.
Shenyang Yuanda Aluminium Industry Engineering, a China-based company, was awarded with a contract to install the diagrid facade to the research facility in March 2013. The company has subcontracted the facade installation work to Samaras Structural Engineers. The facade installation is expected to be completed by June 2013.
Norman Disney & Young provided advanced building information modeling to the facility.
The Federal Government of Australia contributed $200m funding for the construction of the research facility in April 2009. The state government has contributed $15m for the research facility. The facility is being constructed with ecologically sustainable development (ESD) features. It is expected to achieve the LEED Gold rating. It is designed to provide maximum natural daylight through atriums and glass facade.
Government officials, academic, and industry leaders gathered to celebrate the official opening of the Single-Cell Omics Centre (SCOC). It is the first research centre in Asia exclusively dedicated to accelerating the understanding of how individual cells work, and how diagnosis and treatment might be enhanced through insight derived from single cells. This centre will be an important resource for both academic and industry researchers in Singapore and the region, who are keen to access integrated analytics for single-cell genomic applications.
Single-cell genomics is one of the hottest emerging areas of study in life sciences research. It is poised to help solve some of the most fundamental biological mysteries of our time and could lead to new ways to diagnose, treat and prevent diseases such as cancer (breast, prostate, leukemia, etc.), diabetes, memory loss, heart disease and more. For example, scientists now know that the loss of sight (macular degeneration), the biology of aging, and the spreading of infectious diseases all involve important single-cell phenomena that need to be studied.
The Single-Cell Omics Centre is a collaboration between the Genome Institute of Singapore (GIS), an institute under the umbrella of the Agency for Science, Technology and Research (A*STAR), and Fluidigm Corporation, an industry leader in single-cell genomics. Fluidigm became the first biochip company to set up shop in Singapore in 2005.
The SCOC is a dedicated 25 square-meter laboratory (269 sq. ft.) in GIS facilities in Biopolis, Singapore. It features advanced next generation genomic equipment and sequencing technologies. This includes the Fluidigm C1™ Single-Cell Auto Prep System, which automatically isolates individual cells from small tissue quantities or larger cell populations. This installation of a C1 system was one of the first in the world. The centre will also house the Fluidigm BioMark™ HD System that performs single-cell gene expression analytics and validation. Both instruments are manufactured at Fluidigm's factory in Singapore.
The SCOC expects to attract top researchers from Asia to conduct single-cell experimentation for foundational research. Scientists from various fields of biology can band together at the SCOC to learn how stem cells might be re-programmed for therapeutic treatments in the future, or to discover how various diseases work so they can develop new drugs or treatments to cure the sickly, or how to personalize medical care so it can meet the need of each patient.
Initially the SCOC is focusing on single-cell analysis of cancer, looking at lung and colon cancers in solid and circulating tumor cell (CTC) forms. CTCs are cells that have shed from the tumor and are circulating in the bloodstream, seeding growth of additional tumors in other organs in the body. Currently samples from solid tumors are studied in aggregate, grouping all the cells together in a mish-mashed genomic stew. The SCOC expects to develop a method where the cells of solid tumors can be easily converted into cells floating in a liquid solution. Then the C1 Single-Cell Auto Prep System will be used to individually isolate and prepare each cell for complete study and sequencing. This will allow researchers to understand -- for the first time -- what is happening in each cancer cell and also be able to study a thousand different cells individually from a tumor. The centre will compare cells taken directly from the solid tumor and those circulating cells from the same tumor to analyze them for commonalities or differences. If it turns out that CTCs closely correlate with cells from the solid tumor, it could eliminate the need for surgery to get samples from the tumor and allow the disease to be monitored by capturing CTCs from blood -- a liquid biopsy.
One of the SCOC's anticipated follow-on projects will involve the development of methods to compare cells treated with a drug against cells that have not been exposed to the drug in order to measure how differently the cells react. These measurements can then be used to find more effective treatments of disease.
These projects require analysis of a large numbers of cells and the work of the SCOC is expected to enable researchers to process hundreds of cells per day in a cost-effective, efficient manner. These breakthroughs could speed up scientific discovery in biology around the globe.
"Single-cell genomics research is both scientifically interesting and provides researchers with a high likelihood for extraordinary scientific discovery. Individual cells, even from the same tissue, do not function identically, and in order to understand and harness that biology, you have to study them individually. With the opening of this Single-Cell Omics Centre in Singapore, we expect the combination of rich application diversity, groundbreaking science and the endorsement from key opinion leaders throughout Asia to make this centre one of the growth engines of single-cell innovation in the world," said Mr. Gajus Worthington, Fluidigm President and Chief Executive Officer.
GIS Executive Director Prof Ng Huck Hui said, "GIS has identified Single-Cell Genomics as one of our new research frontiers. We are set up to build a repertoire of new research capabilities for single-cell analyses. Our initial collaboration with Fluidigm has borne fruit with the publication of a landmark paper by Dr. Paul Robson. This larger and very important collaboration will see an even greater synergy between the technologies from GIS and Fluidigm."
“Since the late 1830’s we have known the cell is the foundational unit of life but have been challenged to comprehensively study biology at this level. The technology has now arrived to do this and the local research and medical communities are abuzz with the possibilities," said Dr. Paul Robson, GIS Principal Investigator. "The Single-Cell Omics Centre aims to facilitate community access to these microfluidic technologies and thus enable unparalleled insight into underlying biological mechanisms operative in health and disease,” he concluded.
One of the largest eye care companies in the U.S. is expanding its operations in Puerto Rico.
CooperVision will invest $250 million to build 15 new production lines, a project that will create some 350 new jobs. The company currently employs 1,600 workers at a plant in the southern town of Juana Diaz.
Garcia also said that Irish drug and medical device maker Covidien PLC is investing $3 million to expand production at its plant in the southern coastal city of Ponce. The investment is expected to create 200 new jobs.
Kemwell Biopharma has expanded its analytical capabilities in India to service an FTE contract for a large, multinational pharma company. The new analytical lab is equipped with 10 HPLC's, one UPLC and nine dissolution apparatus and other analytical instruments. Kemwell will also employ 15 scientists dedicated to this project.
Ninad Deshpanday, president of R&D at Kemwell, said, "This project and lab expansion further reflects Kemwell's commitment to its customers. Kemwell has invested in a dedicated facility to meet the needs of this very important customer. The scope of the project includes method transfer, stability sample analyses and analytical method validation for various projects for the customer. We are actively looking to invest in and grow our development business."
Kemwell's R&D division employs more than 100 scientists and provides services from formulation development, analytical development and validation to clinical trial manufacturing.
There has been a rise in the number of medical clusters being developed throughout the world, and in the UK a new medical device campus is being promoted in Essex.
The pan-Essex project, which is a partnership between Chelmsford City Council, Harlow District Council, Southend-on-Sea Borough Council and Anglia Ruskin University, aims to grow the UK medical technology sector by £1.2bn and generate some 12,500 jobs across three sites in Chelmsford, Harlow and Southend-on-Sea.
A £6m building – The Anglia Ruskin University Medical Business Innovation Centre (MedBIC) – is being built on the Anglia Ruskin MedTech Campus in Chelmsford to help develop medical technology companies. With an opening date of April 2014, it will be mainly used by companies in the medical technology world and could see the design of new hospital devices and software programs.
Our aim is that the Anglia Ruskin University MedBIC, combined with the Anglia Ruskin MedTech Campus, will help Essex become a world-renowned centre of excellence for innovation, specializing in near-market developments in the medical technology sector,” said University Vice-Chancellor Professor Michael Thorne.
Inside the structure will be engineering research laboratories, 1,000m2 of office and meeting space, business support services and a student enterprise incubation space.
Enterprise Medical, a spin-out company from Southend University Hospital NHS Foundation Trust, is one of the first to relocate to the Anglia Ruskin MedTech Campus as soon as the site is up and running. It will provide flexible endoscopes sterilized with hydrogen peroxide gas to healthcare organizations. It will also offer scope hire services.
Penn Pharma, a UK bioscience company, has produced the first batch of coated tablets in its new £14.4m contained manufacturing facility in Tredegar, South Wales.
The 15,000ft2 plant has been built in less than 12 months for the clinical and commercial manufacture of tablets and capsules and will allow Penn Pharma to build on its expertise in the production and packing of specialist drugs for the worldwide market.
Richard Yarwood, Chief Executive of Penn Pharma, said: ‘It is a monumental day for Penn Pharma. In less than one year we have built a world class facility for contained manufacturing and produced our first batch of coated tablets. This gives our customers even greater confidence that Penn Pharma can meet the challenging timelines they require to get their products to market.’
Mark Dean-Netscher, Chief Operating Officer at Penn Pharma, added: ‘This success is the result of hard work and determination to get us to this stage in such a short space of time. A facility of this complex nature was a tight build in the timeframe, but we have demonstrated that when Penn Pharma commits to something, we always deliver
Irish medical and pharmaceutical mouldmaker Avenue Mould Solutions has completed a new 300m2 (3,228 sq. ft.) Class 8 (Class 100,000) cleanroom in Sligo.
The facility, which currently houses five molding machines, is producing short-run and pilot production components for a number of blue-chip customers.
The company, which specializes in providing single-source solutions to medical and pharmaceutical OEMs, including the design and manufacture of precision, multi-cavity, hot-runner injection moulds, mould flow analysis, mould validation optimization, through to launch-stock manufacture, previously provided cleanroom services through the use of softwall modular cleanroom enclosures.
As demand has grown the company has built a new, fixed-wall cleanroom, which meets ISO14644-2:2002 and is fully equipped with Netstal molding machines, with capacities from 50 to 240 tonnes, together with auxiliary equipment and robotic take-off facilities.
In addition to providing fully accredited process optimization and validation services, the company is also now able to offer short-run production for clinical trials and launch-stock. If required, customers’ own molding machines can be temporarily installed in the cleanroom to facilitate testing, process optimization and validation of both mould and molding machine.
The new cleanroom is the latest stage in an ongoing program of continuous improvement that has made Avenue Mould an international leader in its field. The company has a robotized toolroom equipped to machine parts to tolerances of +/- 1 micron, which is supported by Moldflow software and a skilled team of mould designers and toolmakers.
Within the medical and pharmaceutical sector Avenue Mould has particular expertise in the areas of drug delivery devices, including inhalers and pen-type injectors, airway management – with tracheal and laryngeal devices – medical filtration systems, syringe components, needle protection devices and IV administration set components.
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