The U.S. Department of Health and Human Services established three new centers to develop and manufacture medical countermeasures, such as vaccines and medicines used to protect health in emergencies, and can transition quickly and cost effectively between products. The centers will aid in bringing new medical countermeasures to the market faster and would help to train the biopharmaceutical workforce needed in the future.

“Establishing these centers represents a dramatic step forward in ensuring that the United States can produce life-saving countermeasures quickly and nimbly,” said HHS Secretary Kathleen Sebelius. “They will improve our ability to protect Americans’ health in an emergency and help fill gaps in preparedness so that our nation can respond to known or unknown threats.”

Created as public-private partnerships, the Centers for Innovation in Advanced Development and Manufacturing will provide the first major domestic infrastructure in the United States capable of producing medical countermeasures to protect Americans from the health impacts of bioterrorism as well as pandemic influenza and other epidemics.

In creating the centers, HHS is using a new public-private partnership model, bringing together the innovative ideas of small biotech firms, the training expertise of academic institutions, and the development and manufacturing experience of large pharmaceutical companies.

Each center will be run by a consortium led by an organization experienced in developing or manufacturing medical countermeasures. HHS will invest approximately $400 million in the initial phases of the centers, using contracts with the center leads.

Overseen by the Biomedical Advanced Research and Development Authority within the HHS Office of the Assistant Secretary for Preparedness and Response, each contract can be renewed for up to 25 years, representing a long-term commitment to this partnership with industry and to national security.

Under the contracts, each consortium will retrofit existing facilities or build new ones to incorporate flexible, innovative manufacturing platforms that can be used to manufacture more than one product. The facilities will use modern cell- and recombinant-based vaccine technologies that have the potential to produce vaccines for not only pandemic influenza but also other threats more quickly and in a more affordable way.

The centers’ use of these technologies also will allow each to develop and manufacture a variety of products quickly enough to respond to large-scale emergencies, providing needed domestic surge capacity. Together, the centers will be capable of domestically producing a quarter of the nation’s pandemic influenza vaccine within four months of the onset of a pandemic. In 2009, only one company had manufacturing facilities solely in the United States to produce H1N1 pandemic vaccine.

The private partners will provide approximately 35 percent of the total cost of the initial building phase. HHS will support the cost of operation and maintenance of the centers in subsequent years.

As the facilities become operational in 2014 and 2015, the center leads will begin assisting small biotech companies with technology, regulatory affairs, quality systems, and manufacturing expertise to reach the goal of a licensed and readily available product for public and private use. Also at that time, center academic partners will offer advanced training for the next generation of biotechnology workers.

Emergent Manufacturing Operations Baltimore LLC, with facilities in Baltimore and Gaithersburg, Md., will lead one center, working with a network of partners; Michigan State University, Kettering University of Flint, Mich., and the University of Maryland, Baltimore. This contract is for approximately $163 million over the first eight years.

Novartis will head a second center, leveraging existing public-private investments by HHS in state-of-the-art facilities in Holly Springs, N.C., and working with North Carolina State University and Duke University. The Novartis contract is valued at approximately $60 million over the first four years.

The Texas A&M University System will lead a third Center collaborating with GlaxoSmithKline Vaccines of Marietta, Pa.; Lonza of Houston, Texas, and Kalon Biotherapeutics of College Station, Texas. This contract is valued at approximately $176 million over the first five years.

Creating Centers for Innovation in Advanced Development and Manufacturing was recommended in the 2010 Public Health Emergency Medical Countermeasure Enterprise Review, a comprehensive, government-wide review called for by Secretary Sebelius when the department encountered challenges developing biodefense medical countermeasures, including the 2009 H1N1 pandemic flu vaccine.

The centers also address concerns raised by the President’s Council of Advisors on Science and Technology in the August 2010 Report to the President on Reengineering the Influenza Vaccine Production Enterprise to Meet the Challenges of Pandemic Influenza which called for flexible, nimble, and modern vaccine manufacturing technologies.

For more information on national public health and medical preparedness visit www.phe.gov and to learn more about the Centers for Innovation in Advanced Development and Manufacturing as well as other advances in medical countermeasures, visit www.medicalcountermeasures.gov.

Gilbane Awarded Contract at Ohio State University (OSU)

Gilbane Building Company has been awarded the Construction Manager At-Risk contract for the new 235,000-square-foot Chemical and Biomolecular Engineering and Chemistry Building (CBEC) at The Ohio State University (OSU). This is the first CM-at-Risk contract awarded under the new Ohio Construction Reform (OCR), a measure that allows public owners in the state to use a number of alternative construction delivery methods.

Located in the center of the Academic Core North area of the campus, the CBEC will contain research wet labs with ancillary support spaces, computational research spaces, shared core laboratories, instructional spaces and offices for faculty, administration and graduate students.

“Gilbane’s experience with complex lab facilities and our already strong working relationship with OSU made us a good fit for this exciting opportunity,” said Larry Mastella, vice president and district manager for Gilbane. “A significant pre-construction effort is already underway to make sure we will be able to achieve at least LEED Silver on the facility.”

Stantec, together with Pelli Clarke Pelli, will serve as the architect for the project. The project broke ground on June 18, 2012 and is scheduled to complete in September 2014.

Greatbatch Medical Opens Orthopedic Manufacturing Center

After announcing the project in January 2011, Greatbatch Medical has opened an 80,000-square-foot orthopedic manufacturing facility in Fort Wayne, Ind. The company has been making a concerted effort to grow its vascular and orthopedics business over the past few years through acquisitions and expansions.

In 2010, the subsidiary of Greatbatch Inc. established an orthopedic design center in nearby Warsaw, Ind., where it provides rapid prototyping capabilities. Last year, Greatbatch Medical dropped $6 million into its Indianapolis, Ind., manufacturing location, which produces orthopedic delivery systems. Also happening this summer is Greatbatch Inc.’s move to its new headquarters in Frisco, Texas.

“This $17 million investment is the third project Greatbatch Medical has deployed as part of an overall strategy to partner with orthopedic device makers,” said Mauricio Arellano, president of Greatbatch Medical. “We have made strategic investments with a focus on growing our global orthopedics business through a sound commercial strategy, continuous investments in medical device innovations and streamlined operations and best in class execution.”

Greatbatch president and CEO Thomas J. Hook said Greatbatch Medical will continue to focus on new medical device segments.

“Our company’s vision is to be the definitive leader in critical technologies by infusing integrity, innovation and operational excellence,” Hook said. “This investment is a critical part of our growth strategy as we strive to achieve growth in our core business, growth through targeted acquisitions and growth through new, innovative medical devices.”

The facility is named the Susan H. Campbell Orthopaedic Center, in honor of the late senior vice president of Greatbatch Medical Orthopaedics, who died in late 2010.

The center will develop instruments for hip procedures and spine fixation, as well as fracture fixation implants and instrumentation for orthopedic device companies. The new facility should provide Greatbatch Medical with increased capabilities and capacity for future growth, executives predict.

Arellano thanked the Indiana Economic Development Corporation, Fort Wayne city officials, Allen County administrators and the Allen County-Fort Wayne Economic Development Alliance in a statement.

“They have been great partners supporting our investment and growth in Indiana,” he said. “With their support we are poised for success that will benefit not only Greatbatch Medical and our associates but the local community as well.”

Greatbatch Inc.’s brands are Greatbatch Medical, Electrochem and the QiG Group. The company focuses on the cardiac, neurology, vascular and orthopedic markets, while Greatbatch Medical is responsible for the design and manufacture of critical technologies used in medical devices for the cardiac rhythm management, neuromodulation, vascular access and orthopedic sectors.

CoreRx Opens Facility

CoreRx, Inc. is pleased to announce they are now occupying their new 35,000 square foot facility in Clearwater, FL. This distinct facility will enable CoreRx’s scientific staff to custom formulate, analyze and manufacture the highest quality pharmaceutical products for their client-partners.

Their new complex will encompass nearly four times their former site and will more than triple per day production capacity, reinforcing CoreRx’s status as a leader in the pharmaceutical contract development and manufacturing industry. Enhancements are continually made their already strong record of providing the most outstanding customer service in the business while helping their customer-partners grow their share of the pharmaceutical industry.

CoreRx’s new plant is a high-capacity Good Manufacturing Practices (GMP) certified facility equipped with the latest Trane catalytic air cleaning system and climate-control systems for temperature, humidity and air quality. The analytical laboratories, outfitted with the latest scientific instrumentation, ensure that all products are tested and released to the highest standards of quality.

The flexible facility together with CoreRx’s cross-trained, multi-skilled work force ensures fast processing times, high-tech manufacturing capability, extensive excipient and packaging component inventory, superior customer service, and overall cost control. CoreRx’s expanded new facility allows them to quickly and efficiently transform their customer’s concepts into reality and manufacture products in order to shorten client’s time to the clinic and ultimately to the commercial marketplace. Fully appreciating that time-to-market is critical, CoreRx offers remarkably flexible, affordable, and rapid outsourcing services designed to meet clients’ specific development and manufacturing needs. CoreRx’s clients represent both small and large companies, within the pharmaceutical and biotechnology industries, and academic institutions who have a focus on clinical studies.

Coldstream Laboratories Upgrades Sterile Manufacturing Facility

Coldstream Laboratories, Inc., a Lexington, Kentucky, based pharmaceutical and biotechnology development and manufacturing firm announced the initiation of significant enhancements to its manufacturing facility. Work began on expanding a number of key systems in the sterile drug product manufacturing plant aimed at improving efficiencies and expanding capacity to produce parenteral products.

Dr. Vickie Hall, Vice President of Operations, stated, “The demand for our services has grown markedly over the last year. We are expanding our capacity to generate sterile water for injection and other systems to keep pace with demand.”

Additionally, Coldstream is improving lyophilization capacity to expand the range of solvents that can safely be handled. Coldstream has seen a significant increase in demand for production of lyophilized products that require the use of organic solvents. These upgrades to the company’s lyophilization and manufacturing capacity will enhance the safety and robustness of manufacturing operations. This process began last year with the expansion of the R&D lyophilization capabilities through facilities modification and the purchase of additional capacity, which also included a focus on increasing the solvents that can be used for product development.

“The market is signaling that the ability to handle organic solvents in our lyophilizers is an important differentiator for Coldstream,” remarked Eric Smart, Executive Vice President. “We have helped a number of clients overcome solubility and stability challenges in the development of practical manufacturing processes by employing organic solvents. While our lyophilization equipment was already capable of handling many organic solvents, these additional features will expand the number of solvents we can handle safely to help our clients overcome challenges in product development.”

The upgrades will be completed in August 2012 and are the latest in Coldstream’s ongoing efforts to expand contract manufacturing service offerings.

Coldstream Laboratories, Inc., is a specialty manufacturer of sterile injectable drugs and operates Kentucky's only sterile pharmaceutical manufacturing facility.

Muller Quaker Dairy Breaks Ground on First U.S. Yogurt Plant

Muller Quaker Dairy, the joint venture between PepsiCo and the Germany-based Theo Müller Group, has broken ground on its first U.S. yogurt manufacturing plant – less than a month after entering the market.

The firm launched Müller Corner, Müller Greek Corner, and Müller FrutUp just last month.

Last month, the firm announced the launch of its first three products - Müller Corner, Müller Greek Corner, and Müller FrutUp. The announcement marked both PepsiCo’s and Müller’s entry into the U.S. yogurt market.

Once completed, the Batavia-based 350,000 square foot state-of-the-art facility will be one of the largest yogurt manufacturing plants in the U.S. and is expected to create more than 180 new jobs, Muller Quaker Dairy revealed.

The firm has, however, declined to comment on the expected operational details of the plant.

Muller Quaker Dairy is spending $206m (€166.6m, £131.5m) on the facility – a big investment bearing in mind the firm’s infancy in the U.S. yogurt market.

In addition to the build, Muller Quaker Dairy plans to source its milk supply from U.S. dairy farmers, with the majority of their supply coming from New York and the Northeast.

“The city of Batavia is a great agricultural community and this manufacturing facility will only serve to further build the community and the area’s capability in the dairy business. The community has shared with us that they are excited about the potential job opportunities with Muller Quaker Dairy and we are thrilled to be bringing jobs to the area,” the spokesperson added.

Through their joint venture, PepsiCo and Müller hope to tap into increasing U.S. demand for value-added dairy products.

NY Genome Center Launches Innovation Center

The New York Genome Center has signed a 20-year lease for 170,000 square feet of space in a high rise in downtown Manhattan, the institute said.

The NYGC will occupy seven floors within the building, an office tower at 101 Sixth Avenue. Construction for the facilities will begin this month at an estimated cost of $47 million and is expected to be completed by mid-2013.

Edward J. Minskoff Equities, the building's landlord, will provide almost $9 million in tenant improvements for the building.

The facility will have sequencing, bioinformatics, and research labs as well as an Innovation Center for new technologies and computing infrastructure. It will also include a ground-floor auditorium and café, training facilities, and administrative offices.

The New York Genome Center launched its "Innovation Center", which will provide its founding members with access to new sequencing technologies.

The NYGC has allocated an undisclosed amount of capital and operational budgets to the Innovation Center to purchase new sequencing platforms for testing by its founding members. The "lab-within-a-lab" is expected to minimize cost and risk for the NYGC participants, while creating "a vibrant community of users that will help shape future sequencing technologies and applications."

The Innovation Center will initially be equipped with four Ion Proton sequencers from Life Technologies, which will be housed at Memorial Sloan-Kettering Cancer Center. The center will receive the platform, which promises to sequence a human genome in a few hours for under $1,000, under early access prior to its commercial release.

The NYGC's pilot laboratory at Rockefeller University is expected to house some of the Innovation Center's sequencing and data analysis until the NYGC moves into its permanent location in Lower Manhattan next year.

Data from the validation of the Ion Proton technology will be shared among the NYGC's founding members.

"The NYGC Innovation Center is serving as a broker of relationships to bring new technologies forward, of which Life Technologies’ Ion Proton sequencer is the first,” Nancy Kelley, founding executive director of the NYGC, said in a statement.

Scientists led by Scott Lowe in the cancer biology and genetics program at the Sloan-Kettering Institute plan to use the new instruments to study mutations in difficult-to-treat cancers, including acute myeloid leukemia and hepatocellular carcinoma. The technology is expected to enable them to examine genetic changes more quickly than previously possible.

In addition, the NYGC has established an offsite data center at the Sabey Intergate.Manhattan facility at 375 Pearl Street. According to the center, the Intergate.Manhattan is New York City's only purpose-built data center and has a highly secure location that is guarded by both the New York Police Department and Department of Homeland Security personnel.

The center will initially have 100 employees, a number that is expected to grow to more than 500 over the following five years.

The NYGC is already operational through a pilot lab at Rockefeller University that opened earlier this month.

The center has 11 institutional founding members: Cold Spring Harbor Laboratory, Columbia University, Cornell University/Weill Cornell Medical College, the Jackson Laboratory, Memorial Sloan-Kettering Cancer Center, Mount Sinai Medical Center, New York-Presbyterian Hospital, New York University/NYU School of Medicine, North Shore-LIJ Health System, The Rockefeller University, and Stony Brook University. The Hospital for Special Surgery is an associate founding member.

In addition, the center has two corporate collaborators at the moment, Illumina and Roche.

To date, the NYGC has raised more than $115 million from its institutional founding members; philanthropies such as the Simons Foundation, the Alfred P. Sloan Foundation, and Bloomberg Philanthropies; and other strategic relationships, including the New York City Economic Development Corporation and the New York City Investment Fund.

Novartis Gets Immune-Cell Cancer Therapy in UPenn Pact

Novartis AG (NOVN) will fund a $20 million research center at the University of Pennsylvania in a deal in which the drug maker gains technology that uses manipulated immune-system cells to fight cancer.

Under the pact, the Philadelphia school will receive money up front, research funds and payments for reaching clinical, regulatory, and commercial milestones, said Eric Althoff, a spokeswoman for Basel, Switzerland-based Novartis.

The university’s scientists, led by Carl June, used genetic engineering to manipulate white blood cells extracted from three leukemia patients. They then reinjected them in an experiment reported in August 2011 in the New England Journal of Medicine. The tweaked T-cells destroyed the disease, according to the report, and June said the patients remain in remission.

Novartis was one of three companies to negotiate with the university, according to June, who declined to name the other two. Novartis was selected in part because of its experience with Gleevec, a drug used to treat chronic myeloid leukemia.

The therapy pioneered by June reprogrammed the immune system’s T-cells to first target the leukemia, and then divide in its presence. The method also stimulates so-called memory T- cells, which may help protect patients against the cancer’s return, the studies said.

The treatment may point researchers to a new way to cure chronic lymphocytic leukemia, a malignancy diagnosed in about 15,000 people a year, according to the National Cancer Institute.

The only method used now for achieving remission in the disease is a bone marrow transplant, which carries a 20 percent death risk and offers a cure half the time, June, a professor of pathology and laboratory medicine at the school’s Abramson Cancer Center, said last year.

June’s group is now treating 1 patient a week, he said. The Novartis collaboration will help more people get treatment, said June, who is a professor of pathology and laboratory medicine at the University’s Abramson Cancer Center.

In addition to further trials in leukemia, the UPenn group has also engineered trials for lymphoma, mesothelioma, myeloma, and neuroblastoma.

Iowa Clinical Genetics Institute Plan Gets Green Light

A University of Iowa plan to create a genomics-based research and clinical medicine institute at its Carver College of Medicine was approved by the state's Board of Regents, which governs the state's public universities, a University spokesman said.

Funded with $5 million from the Helen Johnson Endowment, the Iowa Institute of Human Genetics will integrate the university's high-throughput genetic analysis resources and expertise with clinical capabilities at the Carver College to engage in multidisciplinary studies and to treat patients using genetics-based medicine.

The IIHG will house the talent and resources to coordinate large-scale gene discovery, gene-based clinical diagnostics studies, and clinical pharmacogenomics research projects, according to the proposal for the institute.

The university expects that the IIHG will generate enough revenues from clinical and lab activities, including whole-exome sequencing services, to be self-sufficient and cover its expenses by its sixth year of operation, according to the plan.

The university estimates that the institute's operating expenses next year will be around $3.1 million, and that its expenses will rise to round $4.3 million by 2017.

In 2017, the university expects IIHG to generate around $2.7 million in revenue from DNA and bioinformatics services, around $900,000 from clinical revenue, and around $263,000 from grants and institutional support.

It will provide genetic core facilities to University of Iowa investigators, promote intra-institutional collaborations between clinicians and basic research scientists, and provide seed grants for human genetics-based research focused on personalized genomic medicine.

The range of activities the IIHG will provide include individual genome-based clinical evaluations and consultations; genetic testing for a variety of diseases using targeted genome capture and massively parallel sequencing; management of common and rare congenital and inherited disorders; and clinical research collaborations focused on human genetics.

IIHG's initial efforts aimed at rare disease research will focus on development of a clinical genetics diagnostics platform that uses targeted sequence capture and sequencing to study genes involved in renal diseases. This platform will be expanded in the future to target other areas, such as cancer, diabetes, and neurological diseases.

The institute's initial drug therapy studies will focus on a pharmacogenetics-based platform to optimize favorable drug-patient outcomes.

The IIHG also will provide whole-exome sequencing services to select patients to support treatment and health management decisions.

The university will initially house the institute in its DNA Sequencing Core space. The plan does not call for the purchase of any new equipment, although the need for more tools and technologies could change in the future depending on the institute's volume of contracted services and its revenue.

The university expects that most of the IIHG's 24-member staff, including 10 DNA employees and around nine clinical employees, will be drawn from its current roster, and that most of its estimated 5 bioinformatics employees will be hired in the future.

L.S. Skaggs Pharmacy Institute, University of Utah, Salt Lake City

L.S. Skaggs Pharmacy Institute is a new research facility being built for the College of Pharmacy at the University of Utah (U of U) in Salt Lake City.

It will be dedicated to interdisciplinary research and development of new drugs for the treatment of diseases such as osteoarthritis, cancer and epilepsy, as well as wound healing. It is part of the Health Sciences Center of the University of Utah.

The pharmaceutical research complex is named in the honor of Leonard Samuel Skaggs, who along with his family's ALSAM Foundation, contributed about $30m towards the new research centre, in 2007.

Construction of the facility was started in August 2009. It is scheduled for completion in May 2013. The project is estimated to cost $69 million.

The Utah College of Pharmacy has been ranked among the top four institutes in the US by the National Institutes of Health (NIH). It is also the second best in pharmaceutical research productivity (only behind the University of California) and received $23m from the NIH in 2011.

The institute has so far screened 30,000 epilepsy compounds leading to the development of 11 new medications for the disease through the Anticonvulsant Drug Development Program. The college also provides research on new medication and drug delivery systems.

The new facility has been a long delayed plan of the University of Utah to provide additional state-of-the-art wet and dry research laboratories for the College of Pharmacy.

The new building will provide improved lighting, electrical and cooling systems to facilitate installation of larger equipment and enable rigorous research experiments to take place.

The project includes construction of a new 30,000 square feet, five-storey Pharmacy Research Building on the site of a former car parking lot. It is situated adjacent to the existing Skaggs Hall, the Pharmacy College facility built in 1965. The building was built with contributions from L.S. Skaggs, Sr.

"The college also provides research on new medication and drug delivery systems. "The new pharmaceuticals research facility will add two levels of unfinished open laboratory space, open research laboratories on another two floors, offices and conference rooms, a vivarium, a translational centre, computer imaging laboratories, one level of underground parking, utilities and support spaces. It will also accommodate the Utah Poison Control Center.

A new glass atrium will connect both the buildings. The four floors of atrium space will have elevators and meeting and studying areas. It is anticipated that this will help promote scientific and medical interactions. It will also provide structural stability for the existing hall. The entire complex will be renamed as the L.S. Skaggs Pharmacy Institute.

The 150,000 square feet research and educational complex will bring together six different department facilities of the college lying across the campus under one roof. The facilities to be integrated include the department of Pharmaceutics and Pharmaceutical Chemistry, Pharmacotherapy, Pharmacology and Toxicology and Medicinal Chemistry.

The new laboratory facility is expected to consume nearly 30% less energy than similar university facilities. It is also expected to save about 79% of the domestic water through reuse techniques.

The building also features energy saving façades, shading systems, sensors, roof insulations and HVAC systems. It is anticipated that it will achieve LEED Gold certification.

U.S. University of Utah's new innovation centre, the James L. Sorenson Molecular Biotechnology Building, was officially dedicated in 2012.

Contractors involved with U of U's Pharmacy Institute James L. Sorenson Molecular Biotechnology Building, Utah are:

NBBJ Architects and EDA Architects were selected in 2009 to design the facility.
The NBBJ/EDA joint venture was also the master plan designer of the pharmacy campus.
Construction of the building is being carried out by Jacobsen Construction under a $54m contract with the State of Utah.
Van Boerum & Frank Associates (VBFA) is the mechanical engineer and Envision Engineering is the electrical engineer.
Psomas is the civil engineering consultant. ArcSitio is the landscaping engineer. Atelier Ten is the environmental design and building services consultant.
Other consultant engineers include Gale Bate, Colin Gordon, Dunn & Associates, Spectrum and CCP.

Max Planck Florida Institute (MPFI), Jupiter, Florida, Opens

Germany-based Max Planck Society opened its new biomedical research facility, the Max Planck Florida Institute (MPFI), in June 2012. The new facility is located in Jupiter in Florida, US, and is the Society's first institute in the country.

Max Planck Society is an independent non-profit organization with nearly 81 institutes across the world. It was established in 1948 and has for the first time opened a facility outside of Europe. The Society plans to focus on gaining insights into brain function and neural circuits through the new facility.

The project broke ground in June 2010. About 73 people are currently employed at the institute. This number is expected to increase to 135 by 2015.

The research institute will add to the existing life sciences industry in Palm Beach County, creating more than 1,800 direct and indirect jobs. The facility is also expected to generate nearly $2bn in economic activity during the next 20 years.

MPFI has been established to carry out research on the structure and functioning of the neural circuits. The facility brings together some of the world's most renowned scientists. It will use the most advanced technologies to study molecules and tissues.

Understanding neural circuits is expected to help in fighting several debilitating neurological and psychiatric disorders, such as Alzheimer's, Parkinson's, Huntington's, autism and schizophrenia.

The institute has been built on three acres of land on the John D. MacArthur Campus of Florida Atlantic University (FAU). It is spread over three floors with a built-up area of 100,000 square feet.

The building is divided into three research wings which also include guest labs to encourage collaborative research. About 58,000 square feet of the facility is dedicated towards laboratory space including wet and dry labs, instrumentation labs, computational research and imaging facilities, as well as microscope suites. The laboratory space also includes offices for researchers and support staff.

Other facilities of the institute include conference rooms, a 100-seat auditorium, lounges and administrative offices centrally spaced around an open lobby. A large open atrium on the second floor acts as a gathering space enabling staff and visiting researchers to interact.

Outdoor seating and a 230-space parking lot are also part of the facility. It is linked to the other buildings in the FAU campus through pedestrian-friendly paths.

Palm Beach County Board of County Commissioners along with the FAU provided $94m for the facility under the Innovation Incentive Fund in March 2008.

The funding was part of an agreement signed with the Office of Tourism, Trade and Economic Development. Funds were allocated as an incentive to set up the facility in Florida.

Palm Beach County provided $86.9m for construction and operation of the institute. Additional incentives received for the project include a 50-year rent-free lease valued at $6.3m on the building site provided by FAU. The Town of Jupiter provided $260,000 in waived impact fees.

MPFI has been designed to be energy-efficient and meet the requirements of the US Green Building Council's LEED-NC accreditation program. The laboratory space especially has been designed to set a high standard for sustainable laboratory design.

The labs feature large windows to enable maximum daylight to enter. Labs facing the south feature sunshades which allow daylight but minimize heat and glare.

The air-conditioning in the building is divided into zones to minimize load. The building is fitted with mechanical systems to recover energy from the building exhaust. In addition, moisture generated from the building's dehumidification process is used in the cooling system.

Other environmentally friendly features include use of drought-tolerant landscaping and an irrigation system which uses municipal reclaimed water system.

Zimmer Gunsul Frasca Architects were the designers of the new facility. PGAL was the associate architect.

A joint venture of the Weitz Company and DPR Construction was appointed as the construction manager. Development and construction were supervised by LaSalle Americas.

Baxter Breaks Ground for New Biologics Manufacturing Facility

Baxter broke ground for a new manufacturing facility for biological medical treatments that will be located east of Atlanta near Covington. The facility will employ approximately 1,500 people, and total investment by the company will exceed $1 billion. Around 200 local leaders and public officials were present at the ceremony.

Baxter announced in April its plans to build a facility in Georgia that will manufacture plasma-based therapies that treat chronic and life-threatening illnesses. The company will also locate warehouse and plasma testing laboratory facilities at the Stanton Springs site. Construction is expected to begin in the first quarter of 2013, and completion of construction of the first manufacturing buildings is planned for 2015. Additional construction will continue into 2016 and the plant is anticipated to begin commercial production in 2018. In addition to the manufacturing facility, Baxter will locate plasma collection centers in a number of communities around the state.

In addition, Stanton Springs will also be home to a biotech training center that will provide a workforce pipeline for Baxter and other members of the state's bioscience industry. The training center will be owned by the state and operated by Georgia Quick Start, the top-ranked customized workforce training program in the country.

CMC Acquires XOMA Manufacturing Site

CMC Biologics has acquired XOMA's large-scale manufacturing operations and affiliated assets located in Berkeley, CA. Financial terms of the transaction were not disclosed.

The fully functional 31,000-sq.-ft. facility is a completely equipped biological manufacturing operation, including three 2,750L stainless steel bioreactors and two purification suites, as well as warehouse and office space. CMC Biologics expects to begin offering CMO services from this location immediately following the close of the transaction.

"We are very pleased to expand our clinical and commercial manufacturing operations to one of largest and most robust biotechnology clusters in the world," said Claes Glassell, chief executive officer of CMC Biologics. "Establishing a facility in the Bay Area complements our existing facilities located in Bothell, WA and in Copenhagen Denmark, and supports our continued growth and addresses the growing demand of our customers for cGMP clinical and commercial production of biopharmaceuticals."

Lonza Completes GMP Cleanroom at Texas Operations

Lonza, a Swiss supplier to the pharmaceutical, life science and healthcare industries industry, has completed its new GMP cleanroom at its Houston, Texas, US operations, which will accommodate growth in its viral manufacturing operation.

The cleanroom supports multiple types of viral vector and viral vaccine projects, with working volumes up to 2,000 liters.

Lonza has been trying to build its viral business since entering the sector in 2010 with the acquisition of Vivante GMP Solutions of Texas.

Last month Lonza signed a manufacturing agreement with Avalanche Biotechnologies in the US to focus on process development and scale-up efforts for the manufacturing of adeno-associated viral (AAV) vectors.

‘Since Lonza made the strategic decision to enter the viral manufacturing space less than two years ago, we have seen tremendous business growth,’ said David Enloe, Lonza’s head of viral-based therapeutics.

‘Many of our clients’ projects require higher working volumes than the gene therapy space has historically seen. This facility, along with the additions we’ve made to our process development and GMP manufacturing teams and the numerous other improvements made to our infrastructure and capabilities, will allow our clients to entrust their therapeutic and viral vaccine projects to Lonza from the early clinical phases up to commercial supply.’

Lonza announced the launch of this project in May 2011.

GE Healthcare and iBio Extend Alliance

GE Healthcare has formed a global alliance with iBio aimed at using plant-based technologies for the manufacture of biopharmaceuticals and vaccines. Financial terms were not disclosed.

The alliance builds on an existing development and marketing agreement between the two companies announced in 2010. It combines iBio’s plant-based vaccine manufacturing platform, iBioLaunch, with GE Healthcare’s capabilities in technologies for biopharmaceutical manufacturing.

iBio’s research and development collaborator, Fraunhofer USA Center for Molecular Biotechnology (CMB), will continue to play a key role in advancing the iBioLaunch platform.

iBioLaunch is a proprietary gene expression technology that induces plants rapidly to produce high levels of proteins such as vaccines, in a process which can be easily and reliably scaled-up in low cost, controlled-growth facilities.

GE Healthcare’s team of bioengineers and bioprocessing scientists are working with researchers from iBio and CMB to develop a single, flexible facility which could significantly reduce the capital and operating costs of biotherapeutic and vaccine manufacture compared with traditional animal cell and microbial based methods.

The iBioLaunch platform also has the potential to manufacture proteins which cannot be commercially produced in any other system.

In work funded by the Bill & Melinda Gates Foundation, iBio’s pioneering plant-based technology has been used to produce an avian influenza vaccine candidate that recently completed a successful Phase I clinical trial. The iBioLaunch platform was also used to produce a candidate vaccine against H1N1 influenza, for which a human Phase I trial was successfully completed in March. Olivier Loeillot, general manager of Enterprise Solutions at GE Healthcare Life Sciences, said: ‘We look forward to continuing our work with the talented teams at iBio and CMB to explore how this innovative technology could become a commercial reality.’

IVDiagnostics Opens New Lab

A Northwest Indiana life-sciences company has increased its presence at the Purdue Technology Center of Northwest Indiana by establishing a new laboratory to expand research that monitors and measures cells for improved cancer treatments.

IVDiagnostics develops, tests, and markets diagnostic tools that measure and monitor cancer tumor cells. The company's technology identifies circulating tumor cells, which are released from primary cancer tumors into the bloodstream and then lodge at distant organs to begin new cancer growth. Health-care providers use the information from IVDiagnostics to determine cancer treatment effectiveness.

"Our company supports the goals of raising the bar for molecular medicine," said Frank Szczepanski, CEO of IVDiagnostics. "Our expanded life sciences lab will enable us to provide even more detailed information for improved cancer treatments."

Thomas Szczepanski, director of marketing and support systems at IVDiagnostics, described why the company decided to expand in Purdue Technology Center.

"The Purdue Technology Center of Northwest Indiana is ideally equipped to offer readily available space and state-of-the-art facilities for companies such as IVDiagnostics," he said.

Frank Szczepanski also spoke about the opportunity to create a center for advanced cancer research in Northwest Indiana that can have a global impact. He is chief operating officer of The Foundation for Molecular Medicine, a group that supports research on improving the diagnosis and treatment of cancer, heart and neurodegenerative diseases.

"We strongly feel that teaching more biotechnology courses in Northwest Indiana, having regional hospitals put advanced molecular diagnostics and treatment options into practice, and doing more research collaboration between clinicians and biotech firms will be a driving force for collaboration among universities, hospitals, students and professors to learn and put into practice non-toxic molecular diagnosis and treatment alternatives," he said. "Together, with other biotech companies at both the Purdue Technology Center of Northwest Indiana and throughout the Midwest, we can make this happen."

Texas A&M Dedicates Biodefense Center

Texas A&M University dedicated the first element of its new national biodefense center where researchers are to work on strategies to respond to bioterrorism and swiftly develop vaccines for a pandemic or some chemical, biological or nuclear threat.

The A&M Center for Innovation in Advanced Development and Manufacturing is the first of five facilities being developed by the school's partnership with the federal government, other academic institutions and private firms. It is one of three such national centers. Others are in Maryland and North Carolina.

"This is a problem solving endeavor," Brett Giroir, vice chancellor for strategic initiatives of the Texas A&M University System, said. "These are not minimal problems. These are big important problems for the country. And we're going to bring everybody to the table we can ... to solve the problems and protect public health."

Texas A&M System officials have described the project as the largest federal investment in the state since NASA in the 1960s. Texas has committed $40 million to the nearly $300 million project on the A&M campus in College Station. The federal government is contributing $176 million.

"What this center will provide is not only the ability to take research and technology and make it into products but also become honor and duty," Robin Robinson, director of the Biomedical Advanced Research and Development Authority at the U.S. Department of Health and Human Services, said.

The A&M System, which includes 11 universities and 120,000 students, has projected the long-term investment in the billions of dollars under a contract that could last 25 years with the Department of Health and Human Services.

The center is tasked to use what A&M describes as "rapid, nimble and flexible approaches" to come up with vaccines against pandemic influenza; devise accelerated methods to develop those vaccines to licensure; develop therapies for chemical, biological, radiological and nuclear threats; and train "the next generation of professionals" to sustain the nation's capability in those areas.

A unique warehouse-size structure where the air is filtered to remove microscopic particles and where people entering labs don protective garb to minimize what officials called "bioburden" will hold up to 20 mobile "cleanrooms" the size of trailer homes costing up from $750,000 apiece. Six of the labs, which can float on a cushion of air like a puck on an air hockey table, already are in operation.

If a pandemic or bioterror attack occurs, the place is designed to suspend its day-to-day work, be reconfigured easily and focus entirely on finding and making a vaccine to combat the threat. The goal is to provide a vaccine in 12 weeks, about half the time it took researchers in 2009 to address the H1N1 — or swine flu — pandemic. As many as 50 million doses would then be manufactured within four months.

"Research is very important," Robinson said. "It is the lifeblood of what we do in America. Here this center has to do more than research. It has to produce. And that's a real dilemma one has going forward, when there is a real attack on America, be it Mother Nature or other terrorists. And you have to it and have to do it now."

Giroir said Texas A&M has already seen potential to apply the work to more general public health needs such as personalized cancer vaccines. He said the work "will have a profound transformational effect on the rest of pharmaceutical development."

Texas A&M is partnering with Belgium-based pharmaceutical giant GlaxoSmithKline's facility in Pennsylvania and more than 20 other public and private research organizations, companies and academic institutions from across the U.S.

In 2010, President Barack Obama said he wanted the country to develop a new plan for a better and quicker response to bioterrorism threats and attacks. The move came after the Commission on the Prevention of Weapons of Mass Destruction Proliferation gave the government a failing grade for its efforts to prepare for and respond to a biological attack.

Massachusetts General Cancer Center at Massachusetts General Hospital Expands

The Massachusetts General Cancer Center at Massachusetts General Hospital has received a $10 million gift from former Genzyme CEO Henri Termeer to create the Henri and Belinda Termeer Center for Targeted Therapies. The new center will focus on discovering personalized cancer medicines and will be led by Jose Baselga, chief of hematology/oncology and associate director of MGCC.

Synergy Flavors Plans Move into New Innovation Facility

Synergy Flavors aims to move all of its product development, marketing, commercial and admin functions to a new flavor innovation and manufacturing campus less than a mile from its current facility in Wauconda, Illinois, by the end of August.

The firm - which specializes in yeast extracts, flavorings and vanilla - plans to transfer production to the new facility in Q3 and Q4 of 2012 and into 2013, said chief executive Rod Sowders.

Synergy recently expanded its US empire with the acquisitions of Chicago-based beverage flavors expert Sethness-Greenleaf and Ohio-based natural coffee, tea and herb extracts and essences producer Sensus.

The plan is to consolidate Sethness’ Chicago production facility into the new facility at Wauconda in nine to 12 months, although Sensus' more modern manufacturing plant in Hamilton, Ohio, will remain operational, said Sowders.

“We announced plans to develop the new facility in Wauconda some time ago, but as soon as we made the Sethness and Sensus acquisitions, we added extra square footage to the plans to create an expanded 145,000 sq ft facility that will include a demonstration kitchen, flavor and applications development labs and sensory testing labs.

Sethness has given Synergy greater scale and access to new customers, while Sensus has given Synergy access to proprietary extraction methods for horticultural products plus a stronger position in the fast-growing natural flavors market, he said.

Sales teams across both newly-acquired businesses and Synergy’s global operations have now been trained to ensure cross-selling opportunities are maximized, added Sowders.

“In terms of customers, there is some overlap, but not a huge amount. Sensus has a strong presence in the foodservice market, which has not been a target for us in the past. As for Sethness – even though we’re both in the Chicago area - we have fairly exclusive sets of customers and there is surprisingly little overlap.”

“There is a lot of interest in more authentic taste profiles, and natural and nutritional trends combined, so natural extracts where you can pull off flavor and retain all the key nutrients at the same time.”

Consolidation in the flavors industry is likely to continue apace in the next couple of years, with the long tail of manufacturers behind the top 10 players increasingly likely to struggle, he predicted.

“It’s going to be very hard for some of these players to continue to exist with all the requirements we face now on labeling, regulatory, environmental and quality factors.

Synergy - which also has production, R&D and technical facilities in the UK, Ireland, SE Asia, and South America - is part of Irish firm Carbery Group, an international food ingredients and cheese company.

Large Lab Needed to Protect Animal, Public Health

It is "imperative" that the U.S. build a large-animal biocontainment laboratory to protect animal and public health, says a new report by the National Research Council. Two options that could meet long-term needs include the National Bio- and Agro-Defense Facility (NBAF) facility as currently designed, or a scaled-back version tied to a distributed laboratory network. Until such a facility opens that is authorized to work with highly contagious foot-and-mouth disease, the Plum Island Animal Disease Center located off Long Island should remain in operation to address ongoing needs. The report concludes that there are important drawbacks for the U.S., should it rely solely on international laboratories to meet large animal Biosafety Level 4 needs in the long term.

The proposed NBAF in Manhattan, Kan., would be the world's fourth Biosafety Level 4 laboratory capable of large animal research and would replace the aging Plum Island facility. NBAF would study highly contagious foreign animal diseases — including foot-and-mouth disease, which affects cattle, pigs, deer and other cloven-hoofed animals — as well as emerging and new diseases that can be transmitted between animals and people. However, given the estimated cost of $1.14 billion to construct NBAF at the proposed site and the country's current fiscal challenges, the U.S. Department of Homeland Security requested that the National Research Council analyze whether three options could meet the nation's laboratory infrastructure needs.

The three options as stipulated by DHS were: constructing NBAF as designed, constructing a "scaled-back" version of NBAF, and maintaining current capabilities at Plum Island Animal Disease Center. Because the Plum Island facilities do not have large animal Biosafety Level 4 capacity — containment of agents that are potentially life-threatening to humans and pose a high risk of transmission — this type of work would have to be conducted at foreign laboratories.

The scope of the committee's analysis was limited to examining the three options and explicitly excluded an assessment of specific site locations for the proposed laboratory facility; therefore, the report neither compares relative risks of the three options nor determines where foot-and-mouth disease research can be safely conducted. In addition, the committee concluded that to most appropriately fill laboratory needs, all factors of concern will need to be considered in a more comprehensive assessment.

The report concludes that DHS' first option — NBAF as currently designed — includes all components of the ideal laboratory infrastructure in a single location and has been designed to meet the current and anticipated future mission needs of DHS and the U.S. Department of Agriculture's Agricultural Research Service and Animal and Plant Health Inspection Service. However, the proposed facility also has drawbacks, including substantial costs associated with construction, operation, and management; and not leveraging existing capacity at other containment laboratories in the U.S.

Regarding the second option, the report finds that a partnership between a central national laboratory of reduced scope and size and a distributed laboratory network can effectively protect the U.S. from foreign animal and zoonotic diseases, potentially realize cost savings, reduce redundancies while increasing efficiencies, and enhance the cohesiveness of a national system of biocontainment laboratories. However, the cost implications of reducing the scope and capacity of a central facility are not known.

In its assessment of the third option, the report says that maintaining the Plum Island Animal Disease Center and leveraging foreign laboratories for large animal Biosafety Level 4 needs would avoid the costs of constructing a new replacement facility. However, the facilities at Plum Island do not meet current standards for high biocontainment. Given the uncertainty over priorities of a foreign laboratory and logistical difficulties in an emergency, it would not be desirable for the U.S. to rely on international laboratories to meet these needs in the long term.

The report adds that because foot-and-mouth disease research remains critical for the U.S. animal health system, it will be essential to maintain the Plum Island facility until an alternative facility is authorized, constructed, commissioned, and approved for work with the virus.

Regardless of the options considered for a central facility, the report recommends that DHS and USDA develop and implement an integrated national strategy that utilizes a distributed system for addressing foreign animal and zoonotic disease threats. The capital costs associated with maintaining or constructing modern laboratory facilities should be balanced with the need to support research priorities. Therefore, it is critical for DHS and USDA to develop solutions that strike a balance between facilities costs and the research and development effort needed to protect American agriculture and public health.

From ScienceDaily (July 13, 2012)

REST OF WORLD

Novasep Invests in HPAPI Manufacturing Capabilities

Novasep, a leading supplier of manufacturing solutions to the life sciences industries, announces a three million euro investment to expand its Highly Potent API (HPAPI) manufacturing capabilities at its Le Mans (France) facility. The expansion has been designed to allow Novasep to serve the increased demand for manufacturing of novel anti-cancer therapies.

Demand in the pharmaceutical industry has sharply increased for the manufacture of targeted and potent drugs that improve efficacy and reduce side effects, such as antibody-drug conjugates (ADCs). The new Le Mans facility adds to Novasep’s comprehensive global strategy for total synthesis of ADCs, including toxin and monoclonal antibody (mAb) production, mAb-toxin coupling, downstream processing, and formulation.

In the new facility, Novasep will be able to perform cryogenic chemistry at -60°C in hastelloy reactors as well as large-scale HPLC chromatography and drying in confined areas to manufacture ADC toxins at commercial scale. The plant expansion is expected to be fully operational by the beginning of 2013. In its expanded cGMP facility, Novasep will be able to perform the synthesis, purification and isolation of extremely potent compounds with an OEL (occupational exposure limit) lower than 30 ng/m³ at multi-kg scale per batch.

The solid experience of the Le Mans personnel in synthesis and purification of HPAPIs, as well as the investments made in the site over the past 25 years, have enabled Novasep to position itself at the forefront of ADC toxin manufacturing. This extensive experience at this site alone has led to SafeBridge^® certification since 2009, and the passing of several FDA inspections.

“Manufacturing for the life science sectors is facing a series of challenges. Drug candidates have become more specific and personalized, whilst the economic climate demands more cost-effective and safer solutions,” said Patrick Glaser, head of Novasep Synthesis, their Synthetic Molecule division. “Novasep’s development strategy has enabled us to anticipate these changes in the market, and today we are increasing our capability to meet future market demand. This new investment is the result of our continued commitment in HPAPI and our long-term collaboration with our customers.”

“With this new important investment in our HPAPI capacity in Le Mans, Novasep confirms its willingness to continue developing its global, differentiated and value-adding business model,” said Roger-Marc Nicoud, Novasep’s founder and CEO.

Biostar to Restart Gel Capsule Sales in China

Biostar Pharmaceuticals, a Chinese manufacturer of pharmaceutical and health supplement products for a variety of diseases, has been given the go-ahead from the Chinese regulator to restart sales of its gel capsule products.

The Xianyang-based firm said this follows last month’s ‘thorough inspection of raw materials in every production category’ by the Xianyang State Food and Drug Administration (SFDA).

The SFDA suspended sales of gel capsules in April across China after an investigation revealed chromium content higher than edible gelatin at 254 drug manufacturers in 28 provinces. One batch of Biostar Pharmaceuticals’ Xin Aoxing capsule, an over-the-counter (otc) medicine for chronic hepatitis B, was found to be contaminated.

Ronghua Wang, Biostar's chairman and CEO, said: ‘This was an isolated incident and sales of products made from the tainted batch represented approximately 0.2% of total 2011 net sales.’

He added that the suspension of sales of gel capsule products has ‘severely affected’ all China-based pharmaceutical companies that use gelatin capsules to manufacture their drugs, including Biostar.

‘This has been a major issue for China's pharmaceutical industry as many large pharmaceutical companies reported substantial losses for the April–July period. Unfortunately, we were not immune to the industry wide losses, and Biostar’s sales and overall results for the 2012 second quarter were similarly adversely affected,’ he said.

Wang expects net sales for Q2 to be around 50 percent lower than those in Q1 at US$7.5m–$8 million.

‘This is mainly due to an approximately 55% decrease in sales from products manufactured at our Aoxing facility, offset by an approximately 14% increase in sales from products manufactured at Weinan facility, acquired in October 2011,’ he said.

Wang added that following the SFDA’s green light to restart sales, the firm has added a second shift and staff are working overtime.

‘We expect sales for 2012 third quarter to significantly improve as compared to the 2012 second quarter, and a full rebound is expected for the last quarter of the year,’ he said.

In spite of this setback, Biostar Pharmaceuticals says its business and prospects remain strong. The firm aims to increase market share of its current products, while introducing new SFDA-approved otc and prescription drugs. It will also continue bidding for new hospital contracts for prescription drugs, which will provide it with ‘a more predictable recurring revenue stream’.

In addition, it will continue to cooperate with scientific research institutions to develop new drugs. The firm already has agreed to cooperate with The Fourth Military Medical University.

Bosch Inaugurates New Plant in Goa, India

Bosch Packaging Technology India has inaugurated its new manufacturing facility at Verna, Goa, India.

The German firm has invested Rs 34 crores (about €5m) to build the new plant on a plot of 33,000m2 (355,080 sq. ft.) to expand capacity and meet the increasing demand of India’s fast growing packaging market as well as international markets.

Bosch aims to double its production capacity in India from 200 to 400 machines over the next three years. At the same time it also plans to increase the number of employees at the plant from 130 to 160.

Speaking on the development, V K Viswanathan, managing director of Bosch Ltd and president of Bosch Group in India, said: ‘Bosch sees India and the South Asia region as a high potential market for packaging technology particularly in the pharmaceuticals and foods segments.

‘This state-of-the-art manufacturing facility in Goa will meet the growing needs of the region through appropriate products and packaging solutions. The new facility will also generate good growth and employment opportunities for the people of Goa.’

Bosch Packaging Technology India began its operations in Verna from a leased location in 2007.

From a turnover of €400,000 in 2000, Bosch Ltd has grown with a 33.6% CAGR and reported sales of around €10m in 2011. It aims to increase this to €15m in the next few years.

Bosch Packaging Technology in India designs, develops, manufactures and markets form, fill and seal machines for flexible bag packaging, flow wrapping machines for confectionery and food applications as well as filling and closing machines for liquid pharmaceuticals.

To date the firm has sold more than 1,200 packaging machines to leading names in the pharmaceutical, food and confectionery industries in India and international markets.

Friedbert Klefenz, president of Bosch Packaging Technology Germany, said: ‘This new facility will bring our new global offerings to India. It will also contribute greatly in pursuing our future plans and consolidating our leadership position in the Indian and international markets.’

Cambridge Joins Harvard in Opening Stem-Cell Institute

The University of Cambridge will receive 8 million pounds ($12.5 million) to create a new stem- cell research center, joining those established at the University of Oxford and Harvard University.

The institute, which will unite 30 research teams, will be funded by the U.K. Medical Research Council and Wellcome Trust, the council said in a statement. It will eventually be housed in an 8,000 square-meter (86,080 sq. ft.) facility to be constructed at the Cambridge Biomedical Research Campus. Cambridge, England, is home to the largest cluster of biotechnology companies in Europe, according to the statement.

Stem cells can reproduce themselves and can develop into any of the 200 or so cell types in the body. They are being explored as possible treatments for conditions such as liver disease, diabetes, blindness, spinal cord injury and neurodegenerative disorders such as Parkinson’s disease.

“Our aim is to close the knowledge gap and drive stem-cell research forward towards clinical applications,” Austin Smith, director of the new Wellcome Trust-MRC Cambridge Stem Cell Institute, said in the statement. “The world-class facilities will attract the best international talent from the fields of stem-cell biology and regenerative medicine to pursue this goal.”

Similar research organizations include the Oxford Stem Cell Institute, which links 42 research groups and is funded by the Oxford Martin School. The Harvard Stem Cell Institute in Cambridge, Massachusetts, established in 2004, is a collaboration of 225 faculty members and 1,000 scientists, post- doctoral fellows and students.

ICON Expands Hospital Presence for Translational Medicine

ICON plans to expand its UK hospital-based presence on the Manchester Royal Infirmary Campus, securing a 40,000-sq.-ft. site at Citylabs, a newly developed biomedical center of excellence.

ICON currently operates a hospital-based Clinical Pharmacology Unit on the Manchester Royal Infirmary Campus, where it will continue to run its Phase I operations until fully transitioning into the new Citylabs facility, which is expected to open in 4Q13.

Along with the Translational Medicine Research Center, Citylabs will feature biohealth organizations, including the Central Manchester University Hospitals NHS Foundation Trust, The University of Manchester and other commercial research organizations.

“We are pleased to be expanding our early phase development services through the establishment of a Centre of Excellence for Translational Medicine in Citylabs,” said Dr. Mario Rocci, president, ICON Development Solutions. “This expansion will enable ICON to increase the capacity of its Clinical Pharmacology Unit in Manchester as well as the scientific services that are essential in providing a world class offering.”

Mike Deegan, chief executive of Central Manchester University Hospitals NHS Foundation Trust, said, “This exciting development supports our progress to be the leading hospital for research and patient care in England and Citylabs will strengthen our capability to support the development of new medicines and diagnostics for our patients. We are pleased that ICON, who is one of the leaders in early phase trials, is expanding into Citylabs which will help our patients to get early access to leading edge new treatments.”

Mozambique Re-Establishes National Drug Quality Lab

Drug quality in Mozambique looks set to improve following the creation of a national QA/QC testing laboratory.

The Laboratório Nacional de Controlo da Qualidade de Medicamentos (LNCQM), the quality control (QC) arm of the Ministry of Health’s (MoH) Pharmaceutical Department, was formally inaugurated last month at its permanent HQ in Mozambique's capital Maputo.

The lab - which replaces the old national testing facility that closed in 2008 – was developed by the MoH with the support of the US Agency for International Development (USAID) and the United States Pharmacopeial Convention (USP) under their joint ‘Promoting the Quality of Medicines’ (PQM) program.

Patrick Lukulay, PQM director and vice president of global health impact programs at the USP said that: “The main day-to-day activities of the LNCQM are the testing of medicines for registration and post-marketing surveillance. Currently, the lab has 4 staff and more will be hired."

He added that the PQM will continue to work with the Mozambique Pharmaceutical Department to build the QC capacity at the LNCQM and help the lab meet international quality standards.

The current level of oversight of drug quality in Mozambique is hard to assess.

While a 2005 assessment of the national health plan - of the Plano Estratégico do Sector de Saúde - indicated the "availability of high quality medicines in all provinces," the World Health Organization’s (WHO) cites the lack of a "distinct national regulatory authority " as one of the key challenges facing the country's healthcare services.

The PQM has worked with the MoH since the closure of the original lab to both support on-going drug QA/QC assessments – which were carried out at several regional testing sites in the interim period – and to guide development of a replacement national facility.

In 2011 – after conducting a pilot study in Mozambique’s Gaza and Maputo provinces - PQM concluded that additional testing equipment and staff training was needed to help the country develop an effective monitoring system, prompting the creation of the new LNCQM.

Mozambique is not the only African country to have been supported by the USP. In February last year, the organization extended its technical assistance program (TAP) to include Ethiopia, Ghana, Kenya, Senegal and Sierra Leone.

In December the Maryland, U.S.-headquartered organization supported the Ethiopian Government’s s efforts to gain ISO accreditation for its national drug quality control and testing laboratory.

More recently the USP announced it would spend $1.5m to set up a lab in Ghana , West Africa, to provide QC services and offer training.

Sanofi Lantus Opens in Yizhuang, Beijing, China

Sanofi China opened a new assembling and packaging facility for prefilled insulin devices in Beijing, China, in May 2012. The facility will produce the SoloSTAR insulin injection pens prefilled with Lantus, the company's insulin drug. Sanofi China looks after the Chinese operations of the globally diversified healthcare company Sanofi.

The plant will help Sanofi serve diabetics in China and other Asian countries. During the plant's inauguration ceremony in May 2012, the company announced the addition of an aseptic production line for cartridges at the plant.

Sanofi built the new plant in Beijing in its attempt to increase production base in China. The company operates six manufacturing sites in China, including one plant each in Beijing, Shenzhen, Tangshan and Nanchang, and two plants in Hangzhou.

The Beijing plant was announced three years ago, in 2009. In April 2009 Sanofi signed an agreement with Beijing e-Town International Investment to set up a plant within the Beijing Economic-Technological Development Area (BDA).

The Beijing manufacturing facility is a $90m project for Sanofi. It is being built in two phases. The assembly and packaging plant formed the first phase of the project. The second phase will involve addition of the cartridge aseptic production line.

"Lantus SoloSTAR, the flagship product of Sanofi, combines the benefits of the insulin pen with an effective insulin drug."The new manufacturing plant is located in Yizhuang, a town in the Beijing suburban area. The BDA is a 46.8 square kilometer National Economic and Technological Development Zone and is the biggest of its kind in Beijing.

The plant currently includes an assembly unit integrated with a packaging facility. The construction on cartridge production facility is yet to begin.

The location of the BDA offers the plant quick and easy access to major logistics centers and transportation infrastructure. The Jingjintang Expressway, located on the east of the BDA, provides access to Tianjin Port. The facility is also connected to the 3rd Ring Road and 4th Ring Road by an expressway.

The Capital International Airport is located 25km from the facility. A railway freight station is located just seven kilometers from the plant, while a road freight station is situated within a five kilometer distance. In addition, an international Logistics Centre is located within one kilometer from the facility.

The plant does not produce any drugs but will manufacture insulin cartridges and fill Sanofi's insulin drug Lantus into prefilled injection pens.

"Sanofi China looks after the Chinese operations of the globally diversified healthcare company Sanofi."Lantus is a long-acting insulin drug produced by the company. The drug is approved for use in adult type 2 diabetics. It is also approved for treating adult and pediatric type 1 diabetics. It has to be subcutaneously administered once-daily.

Sanofi sells Lantus in the form of a prefilled injection pen called SoloSTAR. The easy-to-use disposable pen can be used to inject insulin doses from a minimum of one unit to a maximum of 80 units. It won a GOOD DESIGN award from The Chicago Athenaeum Museum of Architecture and Design in 2007.

The insulin drug was launched in China in 2004. The device with prefilled Lantus was launched in China in 2008.

The assembling and packaging unit is designed for a production capacity of 48 million prefilled insulin pens every year.

Lantus is the highest sold insulin injection in the world by volume, according to Sanofi. It is reputed for its long lasting action due to prolonged absorption.

SoloSTAR is an easy-to-use insulin injection device because it is small in size and eliminates the need for changing insulin cartridges.

Lantus SoloSTAR, the flagship product of Sanofi, combines the benefits of the insulin pen with an effective insulin drug, to benefit those with type 1 and type 2 diabetes.

Aeroton Adcock Ingram Critical Care (AICC) Factory, Gauteng, South Africa

The Adcock Ingram Critical Care (AICC) factory is an integrated pharmaceutical manufacturing and medical-grade plastics production facility located in Aeroton in Gauteng, South Africa. It is the only such facility in Africa.

"Adcock Ingram is a South Africa-based company operating in the health care and pharmaceutical markets."The plant manufactures intravenous medical equipment, blood collection bags, renal dialysis products, healthcare products and final finished products. Many of these products are used in intensive care units and operation theatres in hospitals. The AICC facility has about 750 employees.

The AICC facility was upgraded in May 2012 with an investment of about ZAR300m ($37m). The project was aimed at upgrading the machinery and equipment at the facility to improve the plant's operational efficiency. The site has scope for future production expansions.

Adcock Ingram is a South Africa-based company operating in the health care and pharmaceutical markets. The company has factories in Wadeville, Clayville, Bangalore and local and international partners.

It has distribution facilities in Johannesburg, Bloemfontein, Cape Town, Durban, Midrand and Port Elizabeth. The company employs about 3,000 workers across its operations.

Plans to upgrade the facility were unveiled in 2009. The project is part of the company's plan to invest ZAR1.5bn ($184m) in manufacturing, distribution and warehousing facilities across South Africa.

"The Critical Care Factory sprawls across a 10ha site in Aeroton on the south of Johannesburg."The project enabled the Aeroton Critical Care Factory to meet the international Pharmaceutical Inspection Convention and Pharmaceutical Co-operation Scheme Standards (PIC/S). The PIC/S has been adopted by South African Medicines Control Council (MCC). The facility also meets the World Health Organization requirements.

The upgraded facility enables Adcock Ingram to manufacture the products at global standards, cope with the international competition and tap the export opportunities.

The manufacturing capabilities of the plant will allow partnerships with dialysis providers and product distributors in the country.

The AICC upgrade project benefited the local community by providing training and upgrading of skills during the past two years.

The project will facilitate reliable supply of the products and meet the local demand from hospitals. The company also supports the Preferential Procurement Policy Framework Act of the South African Government to ensure cost efficient and secure supply.

Cipra Medpro Ltd, Durban, South Africa Expands

Cipla Medpro Pharmaceuticals is listed on the Johannesburg Securities Exchange and is one of South Africa's top ten and fastest-growing pharmaceutical groups.

The Critical Care Factory sprawls across a 10ha site in Aeroton on the south of Johannesburg. The 25,286 square meter (272,077 sq. ft.) facility has a 12,609 square meter (135,672 sq. ft.) production area, 7,144 square meters (76,869 sq. ft.) of warehouse space, 783 square meters (8,425 sq. ft.) of QC block, 1,473 square meters (15,849 sq. ft.) of amenities and 3,277square meters (35,260 sq. ft.) of administrative offices.

The integrated facility produces empty bags and final finished pharmaceutical products on site. The plant has extrusion facilities for medical grade plastics operation, such as sheeting, tubing exteriors and blend systems, as well as a heat seal unit for fabrication of Viaflex bags using radio frequency welding.

The manufacturing process involves compounding, filling, sterilizing, packaging, testing and releasing the drugs into market. The AICC plant produces several drugs including Vacoliter in glass bottles of capacities 200ml, 500ml and 1,000ml; and Viaflex, also called IV / Peritoneal Dialysis Solutions, in 50ml, 100ml, 200ml, 500ml, 1,000ml, 2,000ml, 2,500ml, 3,000ml and 5,000ml containers. The plant produces Diasol Solutions in five liter packages and Fenwal blood collection bags.

The AICC plant does compounding, filling, sterilizing, packaging, testing and releasing of small volume parenteral (SVP) and large volume parenteral (LVP) drugs. They are produced using blow-fill-seal (BFS) technology in 1ml / 2ml / 3ml / 5ml / 10ml / 20ml / 30ml. It also produces Nebsols using BFS technology and re-sealable water and saline pour bottles.

The plant incorporates several sustainable features such as recycling of about 100,000l of water a day, sensor-based lighting equipment and solar-powered water heaters for personal use.

The Critical Care Factory manufactures 60 fabricated components, 40 sub-assemblies and 150 local finished products (LFG's) every day. The production capacity rates are: 117,000/day of Viaflex; 120,000/day of SVPs; 13,800/day of pour water; 5,200/day of Vacolitre; 4,200/day of blood bags; 170,000/day of unfilled bags and 3,800/day of Diasol units.

Covidien Opens US$45 Million R&D Facility in China

Covidien, a leading global provider of healthcare products, announced the official opening of its China Technology Center (CTC) Research and Development (R&D) facility in Shanghai.

"Establishing this R&D facility in Shanghai reinforces Covidien' continued commitment to providing innovative new products that will help healthcare providers worldwide improve patient care and extend healthcare delivery to more people and more places," said José E. Almeida, Chairman, President and CEO of Covidien, who attended the opening event.

"China is a key market in our global strategy, and this investment is a reflection of our strategic initiatives." With a total investment of US$45 million over a three year period, the CTC will eventually employ more than 300 people. The facility spans more than 100,000 square-feet (9,290 square meters), houses 17 laboratories and has state-of-the-art surgical and simulation suites that enable healthcare professionals to be actively involved in the medical device design and development process.

The CTC has two core focus areas:

Design of Tailored Products –identify and develop products that are customized to meet the needs of China and other Emerging Markets.

Discovery of Breakthrough Platforms in medical technology –utilize the unique skillsets and expertise of employees in Asia to create and develop new medical device technologies.

The new Shanghai facility will provide a focal point for developing local Chinese talent and grooming the next generation of medical innovators for the industry.

“By collaborating closely with local medical experts who use our products, we can tailor devices to meet the demands of China and other Emerging Markets,” said Dong Wu, Vice President, China R&D, Covidien. “We are dedicated to improving patient outcomes, and we recognize the immense potential of basing an R&D facility in Shanghai. This location will help us tap into internationally renowned experts based here in China, including world-class engineering talent. We believe this collaboration will drive innovation in China and across the Emerging Markets healthcare landscape.”

The CTC complements Covidien's other operations in China, which include 10 commercial offices, a manufacturing center and training facilities for healthcare professionals. The Covidien Clinical Institute (CCI) offers training for healthcare professionals on the safe and effective use of the latest medical devices and procedures, advancing clinicians’ expertise and improving patient outcomes. Additionally, partnership programs with leading academic institutions in China help Covidien nurture young talent and gather fresh ideas for the advancement of the medical device industry.

“This fusion of expertise among healthcare professionals, students, scientists and engineers will be further reinforced by the cutting-edge capabilities of our new R&D facility, bridging clinical knowledge, market understanding and technical innovation,” added Wu. Underpinning

Covidien’s commitment to developing healthcare in China is the Company’s alignment of its plans with the Chinese government’s healthcare agenda, outlined in the 12 Five-Year Plan. Training at the CCI aligns with healthcare reforms to ensure that medical devices are used safely and effectively as part of healthcare infrastructure improvement. The capabilities of the new R&D facility address the healthcare reform objective of strengthening product technology to improve patient outcomes.

“The Chinese Healthcare industry is on a fast track of development. The Ministry of Commerce, Ministry of Health and Ministry of Science and Technology all launched specific policies to boost the medical device industry – and the key word is innovation. We are looking forward to Covidien providing more innovative technology and products to meet the local market demand,” said Mr. Wang Xin Pei, the Deputy Director of Shanghai Municipal Commission of Commerce, at Covidien’s opening ceremony.

Onyx Expands Capabilities

Onyx Scientific has entered an alliance with UK-based Reach Separations, a purification specialist, allowing Onyx to deliver more specialist purification and separation services for early stage development.

Onyx Scientific will now offer custom separation for companies in drug discovery and intermediate environments, including chiral, reverse phase and normal phase chromatography using Supercritical Fluid Chromatography (SFC) and High Performance Liquid Chromatography (HPLC).

Onyx Scientific supports pharma and biopharma companies from medicinal chemistry and preclinical through Phase I-III, scaling-up to large-scale commercial API production.

Denise Bowser, commercial director at Onyx Scientific, said, “We were very impressed with the major equipment investment at Reach Separations and the team’s exceptional knowledge in understanding our clients’ challenges in small scale purification. We expect this strategic partnership will play an important role in giving our clients quicker access to these types of services but with the added benefit of knowing it will be managed by us as part of the overall project.”

London Olympics Testing Lab to Become UK Phenomics Research Center

The UK lab that is currently serving as an anti-doping testing facility for the 2012 Olympic and Paralympic games will be turned into a research center that will focus on phenomics-based disease studies.

The UK's Department of Health said that the Olympics lab near London, in Harlow, which was provided by GlaxoSmithKline and is operated by King's College London, will be transformed into a facility that is supported by the Medical Research Council and the National Institute of Health Research.

Funded with £10 million ($15.6 million) over five years from the MRC and NIHR, with each contributing £5 million, the MRC-NIHR Phenome Centre will conduct research based on urine, blood, and other samples from patients and volunteers to discover new biomarkers for disease susceptibility and to develop personalized treatments.

Imperial College London will lead a Phenome Centre partnership, which will include GSK, Waters, and Bruker, and will provide academic and life sciences industry researchers access to phenotyping technologies and expertise. Waters and Bruker will contribute mass spectrometry and nuclear magnetic resonance technologies to the center.

MRC Chief Executive John Savill in a statement said the center will represent "a phenomenal legacy" from the 2012 Olympics.

"Rather than losing this investment once the Games are over, the collaboration – involving the MRC, NIHR, UK universities, the [National Health Service] and NIHR Biomedical Research Centers, and industry leaders in the field – will provide a unique resource that will ultimately result in benefits for patients," Savill added.

UK Health Secretary Andrew Lansley said the Phenome Centre is a "first of its kind" facility," where researchers will pursue treatments for common diseases such as diabetes, heart disease, and dementia.

"Patients will benefit from faster and more accurate diagnosis and researchers will be able to develop new drugs and treatments as we understand more about the characteristics of diseases and new sub-types of diseases are discovered. Alongside our investment in genomics and gene-based centers, we will in coming years develop world-leading diagnostic capabilities," said Lansley.

"As a scientific partner, Waters is dedicated to supporting the goals and vision of the centre through scientific and training support," Rohit Khanna, VP of worldwide marketing for Waters, said. "In addition to the more than a dozen ACQUITY UPLC/ Xevo and SYNAPT MS systems that will be installed at the facility, Waters will also be providing training and analytical expertise through dedicated, on-site support staff."

Nofima Breaks Ground on Facility

A processing plant designed to purposely produce food contaminated with potentially deadly pathogens is under construction in Norway.

The Ås-based facility, which is the only one of its kind in Europe, will offers researchers the opportunity to studying the survival and growth of pathogens such as E.coli and Listeria monocytogenes during production, packing and storage.

The project, which was funded by the Research Council of Norway, was the brainchild of food research institute Nofima and the Norwegian University of Life Sciences.

At the facility, researchers will be able to explore how raw materials and products become contaminated by equipment and conveyor belts, the most effective measures to destroy pathogens and the optimal way of disinfecting equipment.

The plant is scheduled for completion in mid-2013.

Helga Næs, research director of food safety and quality at Nofima, said that researchers will learn more about what happens to microbes during the production process through access to the facility.

“We could see that there was demand amongst researchers to experiment with contaminated foodstuffs under controlled conditions. They were looking to add pathogenic bacteria such as E.coli and Listeria to certain foodstuffs, then study how they survive and grow in a production environment,” she said.

Nofima hopes the development will attract researchers from Norway and further afield.

“We hope that this facility can attract researchers from across Norway and Europe and encourage collaboration,” said Næs.

“The main goal is to reduce outbreaks and reduce the number of incidents of food contamination.”

As well as appealing to researchers, Næs revealed that Nofima had been in talks with a number of food manufactures concerning use of the facility.

“We’ve had a lot of meetings recently with those people. They have told us what their needs are,” she added.

The facility will have a ‘Biosafety level 3’ grade – the second highest safety level. At this level, the microbes being used could lead to serious or lethal consequences.

Researchers will be required to wear protective gear and follow strict safety regulation inside the sealed facility, which will only be accessible through air locked doors.

External air flow will be microfiltered and low air pressure inside the room will ensure that microbes do not escape.

“It is a very complicated build because we basically have to build a room within a room. It has to be sealed from the outside world, so that no contaminants can escape,” Næs added.

Parexel Sets up BioPharm Unit

Parexel International, a global biopharmaceutical services provider, has set up the Parexel BioPharm Unit to focus solely on the needs of small and mid-sized biopharmaceutical companies to help them achieve their development goals.

The Parexel BioPharm Unit will support SMEs by providing the expertise, global infrastructure, operational excellence and turnkey technologies needed to help them advance their drugs through the development cycle. Its goal is to provide a tailored solution that accelerates development timelines, reduces costs and offers a high level of quality.

‘Small and mid-sized biopharmaceutical companies are truly the genesis of innovation and have been an important part of Parexel’s client base for more than 30 years,’ said Ubavka DeNoble, vice president of BioPharm Services.

‘The breadth and depth of our expertise gives us the ability to create customized solutions that are designed to meet the particular needs of each client – whether the company is a small research venture, a growing mid-sized business, or a global enterprise.’

BGI, University of Edinburgh Ink Genomics Partnership

BGI and the University of Edinburgh will partner in an effort aimed at enhancing the university's genomics and bioinformatics activities in biomedical research and livestock studies, BGI said.

BGI said that under a new memorandum of understanding it will partner with the university through research projects at three Edinburgh facilities: the GenePool Genomics Facility in the School of Biological Sciences, ARK Genomics at the Roslin Institute, and the Genetics Core at the Wellcome Trust Clinical Research Facility and the Institute of Genetics and Molecular Medicine.

"Edinburgh is already a hotbed of expertise in genomics and DNA sequencing, and a partnership with BGI would allow us to expand our work into clinical research and, ultimately, personalized genomics," Mark Blaxter, a University of Edinburgh professor and director of the GenePool Facility, said in a statement.

"This opportunity will keep Edinburgh and Scotland at the very leading edge of all aspects of medical genomics, from rare forms of inherited disease through to major causes of ill health over the life course and in ageing. It will be a crucial bridge between our world leading academic research and the needs of the [National Health Service]," added Professor David Porteus, director of the Genetics Core.

Teva, P&G to Build Indian Plant

Teva and Procter & Gamble's joint venture PGT Healthcare is to create a plant in India to produce consumer health and over-the-counter products, at an investment of 5 billion rupees ($89 million).

The plant, in Sanand, Gujarat, will produce inhalers, throat drops and cough syrups under P&G's Vicks brand, for both the Indian domestic market and for export.

PGT Healthcare's initial investment will be 2.5 billion rupees.

State of Gujarat’s Commissioner for Food and Drug Control Administration H G Kohsia said the proposed facility would initially hire 500 people, which could rise to 1,000.

PhytoSPHERE Systems to Open Medical Marijuana Production Facilities in Europe

Medical Marijuana, Inc. a leading hemp industry innovator, is pleased to announce that PhytoSPHERE Systems, a portfolio company of MJNA that develops pharmaceutical grade medicinal hemp production facilities, is expanding its production facilities to Europe. This expansion will be done through MJNA's newly formed portfolio company Canipa Holdings, which has established an office and team in the city of Bucharest, Romania, to handle its European product launch and distribution.

Canipa Holdings has been formed to assist Medical Marijuana Inc.'s expansion and marketing efforts into Europe. Canipa Holdings will focus its efforts on obtaining European product and marketing approvals for the entire line of Medical Marijuana Inc.'s portfolio of products as well as obtaining various licenses for the production of industrialized varieties of hemp.

PhytoSPHERE's core technologies consist of:

A module that places rows of plants in a manner to accelerate growth rates.
Computer operated sprayers that ensure even distribution of nutrients to plants.
A proprietary antibacterial product clipping, curing and packaging system, allowing for a truly pharmaceutical grade method of cultivation.
An extraction and production process for cannabinoid based compounds derived from the cannabis and /or hemp plants, which uses standardized processes and technology to create the world's leading pharmaceutical grade extracts / oil / raw ingredients.

PhytoSPHERE Systems has recently introduced its raw Cannabidoil (CBD) Oil product line for formulation and distribution through licensing partner, Dixie Elixirs in Colorado. In June, Dixie successfully launched the Dixie X product line, a family of non-THC, CBD based products. The Dixie X product line contains the highest

CBD/Cannabidiol concentrations of any product on the market today.

In addition to distribution in Colorado, portfolio company Red Dice Holdings recently announced that it would launch on-line sales of Dixie X and CBD-based CanChew gum through licensed distributors in the US within the next 60 days. Further, Red Dice Holdings will enter into exclusive licensing agreements with selected partners to distribute Dixie X and CanChew in California, Arizona and Washington D.C. within the next 90 days. The Company expects significant revenue increases once these distribution agreements are fully in place.

PhytoSPHERE Systems has documented over 200 industrial hemp varieties and has identified specific ones with the highest levels of Cannabidiol for further development and production by PhytoSPHERE Systems. Based on its technology, PhytoSPHERE Systems is able to produce the highest level of genetic purity without the typical seed-based inconsistency issues which lead to a higher rate of plant disease.

Currently companies involved in the production of Cannabis L Sativa varieties do not have a single source for genetic purity, consistency and cannabinoid profiles. Often plants grown from seeds develop mold, fungus or other diseases and little can be done to prevent this. Using tissue cultures, as PhytoSPHERE Systems does, the plants have a higher likelihood of success because of their genetic purity and identical attributes. Combined with other PhytoSPHERE Systems technology, this allows for a consistent high quality plant, which in turn delivers a consistent pharmaceutical-grade end product.

The combination of PhytoSPHERE Systems superior technology, proprietary and patented processes, genetically consistent products and tissue culture based plants will give us the ability to produce the cleanest and highest quality pharmaceutical grade extracts and compounds currently on the market. Initially, these extracts and compounds will only be used in the manufacture of products to be distributed through MJNA's portfolio companies, thereby giving these companies and MJNA a distinct competitive advantage in the marketplace.

"Once PhytoSPHERE Systems receives its European approval we will establish a production facility and begin producing our high value hemp extracts. For the past several months we have been working to obtain various industrial hemp licenses and form partnerships to further the PhytoSPHERE entry into Europe," said Medical Marijuana Inc. President Michael Llamas. "With our anticipated EU marketing approvals, we will be able to sell directly to the EU market from our EU facilities. This will cut our cost to produce and increase our net margin on the products we sell. We appreciate the continued support of our shareholders throughout this lengthy developmental process. We are very close to 'the finish line' and anticipate numerous additional revenue sources in the near future."

DSM Signs Manufacturing Agreement with Recepta Biopharma

DSM Pharmaceutical Products, the custom manufacturing and technology business of Royal DSM, has signed a biologics contract manufacturing agreement with its first Brazilian client, Recepta Biopharma in São Paulo.

The contract covers the process development and cGMP manufacture by DSM of one of Recepta's leading antibodies at its plant in Groningen, The Netherlands. Financial terms were not disclosed.

DSM started production to supply drug substance materials to be used in the initial clinical trials of this antibody in May.

Recepta Biopharma is a biotechnology company dedicated to the research and development of monoclonal antibodies to be used in the treatment of cancer.

Alexander Wessels, CEO of DSM Pharmaceutical Products said: ‘Working with Recepta in Brazil marks further advancement of DSM's stated strategy to grow its presence in high growth economies such as Brazil and South America.’

José Fernando Perez, CEO of Recepta Biopharma, added: ‘This manufacturing agreement with DSM moves us one step closer to serving patient needs for this important medical treatment. We are delighted to strengthen our global network of innovation to bring our new monoclonal antibodies to the market.’

Kemwell Receives Approval for Facility in Bangalore

Kemwell Biopharma has received approval from Health Canada to manufacture and supply oral solid dosage products from its facility in Bangalore to the Canadian market. The facility has been in operation since 2008 and received its first EMA approval in 2008.

Speaking on the occasion, Anurag Bagaria, chairman and managing director, said, "This approval will give access to Kemwell's current and prospective customers to the growing Canadian market. The approval also backs Kemwell's commitment to becoming a global partner and providing high-quality products."

The state-of-the-art unit is currently equipped to manufacture and package two billion units and this can be further expanded to produce five billion units per annum. Kemwell already produces a wide range of products including un-coated, coated, effervescent tablets and capsules for the European, New Zealand and Australian markets and is awaiting its first USFDA audit later this year.

UBC Pharmaceutical Sciences Building, Vancouver, Canada

The University of British Columbia (UBC) is constructing a new facility for the Faculty of Pharmaceutical Sciences in Vancouver, in the state of British Columbia in Canada. It will bring together all the learning, teaching, community outreach and research activities of the Faculty under one roof. The building will also accommodate the Centre for Drug Research and Development (CDRD).

Construction of the Pharmaceutical Sciences Building started in July 2010. The C$133.3m facility is expected to open in 2012. The Province of British Columbia has announced its commitment to contributing C$86.4m for the new facility, in September 2009. The remaining amount is funded by the UBC. The project will also be a sustainable development and aim to achieve LEED Gold certification from the US Green Building Council.

The new pharmaceutical sciences facility is located adjacent to the UBC Life Sciences Centre (LSC), the largest building on the Vancouver campus, which also won LEED Gold certification in 2006. It is expected to promote collaboration across the health disciplines including life sciences and medical students and researchers.

"The facility was designed by a joint venture between Saucier + Perrotte Architectes and Hughes Condon Marler Architects."The UBC Pharmaceutical Sciences Building will be a six-storey structure with 22,871 square meters (246,091 sq. ft.) of usable space. It will include educational spaces, 14 small case-based specialized learning laboratories, research spaces, classrooms, a lobby, lecture halls, distance learning educational facilities, informal learning spaces, administration and professor's offices, a student lounge, a cafeteria and conference rooms.

The building will also have a private multimedia recording room, laboratories equipped with portable tablet computers and a multipurpose lab with remote lab access. An exhibition area, called Story of Medicines, will be housed in the public spaces of mezzanine and ground levels. It will feature interactive screens and historical artifacts to allow the visitors to know about various aspects of pharmacy, such as evolution and life of the drugs.

Merck donated about C$250,000 worth of pharmaceutical equipment for use at the current and new facilities, in April 2011.

The new facility will enable the Faculty of Pharmaceutical Sciences to increase the enrolment of students into graduation and under-graduation programs by 47% (72 student spaces) a year. It is expected to have 896 undergraduate students by 2015.

The new building will also support the Doctor of Pharmacy (Pharm.D) and PhD programs. This in turn is expected to cope with the shortage of pharmacists in the British Columbia region.

The UBC pharmaceutical building project is expected to generate about 850 jobs during construction. It is easily accessible through public transportation and has several bicycle parking and showering facilities.

"Merck donated about C$250,000 worth of pharmaceutical equipment for use at the current and new facilities, in April 2011."The project will not add any new car parking spaces but will promote sustainable transport options.

The facility has glazed façade and two full-height atria to allow maximum daylight, passive ventilation and maintain temperature of the interiors throughout the year.

Heat from the data centre in the basement will be recovered to reduce the consumption of energy. An on-site stormwater runoff system, efficient irrigation system and 20% less potable water consumption are also planned.

Recycled, local construction materials, low-emitting materials and FSC-certified wood are being used to reduce environmental impact. The facility is also designed to increase the lifespan of the building and reduce maintenance costs.

The CDRD is an independent not-for-profit organization launched in 2007. It collaborates with institutions and research universities to reduce the gap between academic discoveries and commercialization of the developed new drugs in laboratories.

The faculty in collaboration with CDRD will allow the students to conduct pharmaceutical research and get hands-on experience in an innovative environment.

The organization will provide its expertise in technical, scientific and commercial aspects of drug development. It has so far raised about $75m from the government and pharmaceutical companies.

The Pharmaceutical Sciences Building is being developed by the UBC Properties Trust. The facility was designed by a joint venture between Saucier + Perrotte Architectes and Hughes Condon Marler Architects.

Ledcor is the general contractor. Glotman Simpson is the structural engineer. Stantec is the mechanical contractor, while Applied Engineering Solutions (AES) is the electrical works contractor. Perry + Associates is the landscape architect.

Pfizer to Launch Saudi Manufacturing Plant

US-based pharmaceutical major Pfizer is to construct a pharmaceutical manufacturing plant in Saudi Arabia.

The facility will be located in King Abdullah Economic City, north of Jeddah, and include medicine manufacturing and packaging technologies within the one site.

Although no financial details were disclosed, Saudi Press Agency stated the facility will cover 65,000 square meters (699,400 sq. ft.) and will recruit as many as 200 workers upon completion.

Saudi Arabia has vaunted KAEC as a business and industry centre, with Pfizer confirming the project will benefit from competitive advantages offered by the Saudi government.

UK-based Synexus Adding Facility in Pretoria, South Africa

The Nyeleti facility – Synexus’ fourth in the country – will focus on Phase II and III studies that involve 24 hour serial spirometry, mixed meal tolerance testing, PK visits requiring an overnight stay or when infusion is required.

This unit includes an in-patient ward, a secure, temperature controlled dispensing unit designed to manage supplies according to ICH GCP and national guidelines. It also houses emergency and other resuscitative equipment, a transit laboratory and food preparation area and has ambulance support.

Greatbatch Opens Facility in Singapore

Greatbatch Inc. is keeping up its momentum with a new Active Implantable Medical Device (AIMD) Research and Development (R&D) Center in Singapore, the announcement coming soon after the company completed construction on its new Fort Wayne, Ind. orthopedic manufacturing and design plant.

The new facility in Singapore will be the first R&D center for active implantable medical devices (devices powered by electricity or another power source besides gravity or the human body) in Singapore and in Asia. Greatbatch has been implementing a medical device growth strategy, and this marks its first step into the emerging market of the Asia-Pacific region.

“This announcement is another step in the process we began in 2008 to move Greatbatch forward and evolve from not only being an innovative component manufacturer but also being an innovator of complete medical device systems,” said Thomas J. Hook, president and CEO of Greatbatch. “Many factors contributed to our decision to establish the first multinational R&D center for active implantable medical devices in Singapore, including the nation’s commitment to developing its biomedical sciences cluster, as evidenced by its strong investment in research organizations. The work being conducted at several national research institutes serves as a perfect complement to Greatbatch and QiG’s resident expertise in the design and development of active implantable medical devices.”

In 2008 Greatbatch formed subsidiary QiG Group LLC to empower the design and development of new medical devices for its core markets: Cardiovascular, neuromodulation and orthopedics. The QiG group will partner with physicians and other key opinion leaders in Asia Pacific to focus on developing innovative active implantable medical devices. The Greatbatch Singapore AIMD R&D Center will leverage “frugal innovation” strategies to develop cost efficient active implantable medical devices and position Greatbatch to capitalize on emerging market business opportunities.

At first, the center will focus on the design and development of active implantable medical devices for the cardiovascular and neuromodulation markets. Both are multibillion-dollar markets with considerable long-term growth potential. For cardiovascular, Greatbatch will start to produce devices for interventional procedures, atrial fibrillation ablation, MRI conditional systems, as well as technologies that target health conditions related to cardiovascular diseases such as obesity and obstructive sleep apnea. To serve the neuromodulation market, the company currently is developing a spinal cord stimulator called Algostim, which will treat chronic pain in the trunk and limbs.

“The devices that the Greatbatch Singapore AIMD R&D Center will design and develop are to be tailored to the unique requirements that exist in emerging markets without sacrificing physician and patient benefits,” said Daniel Kaiser, Ph.D., chief technology officer of Greatbatch. “In order to develop such complex systems we’ll focus on world class talent with the capabilities to bring these solutions through the development and regulatory stages to serve Asia Pacific and broader worldwide healthcare markets.”

The Singapore facility will be headed by Kulbir Sandhu, with Kaiser providing direction as well. Sandhu has more than 15 years of medical device experience in the areas of new product development, program management and manufacturing transfer. In his most recent position as senior director of R&D at St. Jude Medical, Sandhu was responsible for assessing technologies to determine clinical viability, program risk, and return on investment by working with key opinion leaders and advisory councils.

“Mr. Sandhu has the experience and background to lead this effort as we identify clinicians and experts in the region to partner with QiG on our device initiatives,” commented Kaiser.

Singapore's economic development groups have not been shy about recruiting medtech companies to the tiny but prosperous city-state.

“We are delighted that Greatbatch has chosen Singapore for its first R&D Centre outside the United States, to develop and commercialize medical devices for Asia and global markets,” said Yeoh Keat Chuan, managing director of the Singapore Economic Development Board. “Companies are increasingly looking to growth opportunities in Asia. Singapore is well-positioned as a location for companies to develop the next generation of medical devices due to our strong pool of R&D talent, opportunities for clinicians and industry to collaborate, aggregate and translate regional clinical insights into new ideas.”

Cherwell Completes First Phase of Cleanroom Expansion

Cherwell Laboratories, a UK specialist in environmental monitoring and the validation of sterilization processes for the healthcare and pharmaceutical industry, has completed the first phase of its cleanroom expansion. The firm says the move will support growing demand for its Redipor prepared media, while maintaining the stringent quality requirements for its preparation.

The completed cleanroom will double the existing space from 440m2 (4,734 sq. ft.) to more than 940m2 (10,114 sq. ft.) and allows further improvements in product quality, as well as the automation of processes. Phase I covers 270m2 (2,905 sq. ft.) with a new inspection and packaging room, plus associated support rooms, including new gowning and office space. All Redipor prepared media products continue to undergo 100% inspection so that they can be used within critical areas.

The new inspection and packaging room contains new flow wrap machinery and offers increased space to allow Cherwell to continue to provide bespoke solutions to customers. A new automatic labeling system also reduces handling and increases reliability.

Phase II of the expansion is scheduled for 2013 and during this phase of growth Cherwell plans to increase production volumes to more than 6.5 million agar plates each year for the UK and export markets. It is estimated that 10–15 new people will join the company.

Andy Whittard, managing director of Cherwell Laboratories, said: ‘The first phase of our cleanroom expansion has been a tremendous success, which would not have been possible without the effort and dedication of the whole Cherwell team especially over the past six months. The changes we have made reflect our commitment to providing customers with the highest standards of product quality.’

Lilly Grows in China

On June 12, Lilly announced an increase of its network of manufacturing capabilities in China through an expanded collaboration with Novast Laboratories, LTD. Novast, a generic and specialty pharmaceutical company based in Nantong, Jiangsu province, has established high-quality systems and manufacturing facilities for the global and domestic Chinese markets. Lilly expects its expanded collaboration with Novast to greatly enhance its efforts to build a portfolio of Lilly branded generic medicines in China. The collaboration may also ultimately result in Novast providing local and regional manufacturing capabilities for Lilly's own pipeline of potential new medicines in development.

As part of the agreement, Lilly will increase its equity position in Novast by $20 million. Lilly made an initial equity investment in Novast several years ago through the Lilly venture capital unit, Lilly Asian Ventures. Novast has committed to set up a platform to support Lilly branded generic products and increase the manufacturing capacity at its Nantong site over the next several years, with Lilly providing technical support to enhance quality standards. The additional capacity will support the collaboration, but will not be solely dedicated to Lilly products.

"In China, Lilly is building for the future by investing across our value chain," said Eric Baclet, president and general manager of Lilly China. "We have made significant investments in research and development, increased our commercial presence to better serve patients and healthcare providers, and expanded our manufacturing capabilities both at Lilly-owned sites and through partner companies such as Novast."

"This long-term strategic partnership will combine Lilly's expertise in innovation, commercialization and operations with Novast's strengths in product development and quality manufacturing," said Dr. Guohua Zhang, president and CEO of Novast Laboratories.

According to Site Selection's New Plant Database, over the past five years, Eli Lilly's facility investments have included manufacturing expansions in Ireland and Puerto Rico, new manufacturing investments in Italy and R&D or office expansions in Singapore; Surrey, U.K.; and San Diego.

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