Along with corporate offices, BioConsortia’s 5,700-square-foot facilities include microbiology and molecular biology labs, growth chambers and resources for genomic analysis.

The Davis company has developed a proprietary system that uses advanced microbial selection and the latest genomic techniques to define products for specific crop improvement traits. It relies on what is known as microbial consortia, which are elements of natural communities of bacteria and fungi.

BioConsortia, which was founded earlier this year, says its system quickly identifies the best microbial communities that can improve plant traits and increase crop yield. The system is touted as an alternative to mixing individually identified microbes and does not rely on genetic modification. The company says the system rapidly identifies the right consortia and can apply to both conventional and genetically modified crops.

BioConsortia has drawn the interest of two Bay Area venture capital firms, Menlo Park-based Khosla Ventures and Palo Alto-based Otter Capital LLC, which earlier this year partnered to steer $15 million in funding to the Davis firm.

BioConsortia was established to further develop and commercialize the microbial consortia of BioDiscovery New Zealand Ltd., which was founded in 1994 and is now a BioConsortia subsidiary, which will continue to conduct research at its facilities in Auckland. BioDiscovery previously worked with national and international agriculture entities, including Monsanto Co. and AgraQuest.

Ashland Expands HPC Production in VA

Fine chemicals manufacturer Ashland has laid down plans to expand a Klucel hydroxypropylcellulose (HPC) plant in Virginia to meet growing pharma demand.

Expansion at the facility in Hopewell, Virginia, is expected to be completed in the second half of 2016 and will add extra capacity for the company’s Klucel HPC product range.

Klucel HPC is used by the pharma industry as a tablet binder and coating ingredient and according to the firm, demand for the ingredient has led to this investment, though no further details were disclosed.

However, in a statement Ashland’s VP of Pharmaceutical Specialties said the firm “is committed to the overall pharmaceutical market,” as demonstrated in a number of recent investments in its pharma ingredient network.

Ashland opened a pharmaceutical centre of excellence in Hyderabad, India, earlier this year and recently expanded plants in Wilmington, Delaware, and Texas City, Texas.

GE Healthcare to Move New Jersey Ops to New Massachusetts HQ

GE Healthcare has said it plans to relocate operations in New Jersey to its new Massachusetts life sciences headquarters.

The firm said it would base its Life Science division’s first US headquarters in Marlborough, Massachusetts, explaining that it chose the town – which is home to its Xcellerex bioreactor business – because of its proximity to potential customers and employees.

Spokesman Ben Fox said, “We chose Marlborough to be close to industry-leading talent, customers, and world-class academic and medical institutions across all the industry sectors we serve, from biotech and pharma, to diagnostics and medical devices.”

At present the Life Science business is split between operations in New Jersey, a manufacturing unit in Westborough and the Xcellerex facility in Marlborough that GE Healthcare gained as a result of the 2012 takeover.

Fox related: “There is no current plan to move roles from our other sites outside of our New Jersey and Marlborough, MA population,” adding that “we will locate any new or backfilled roles in whatever location makes the most sense.”

"While we will transition away from the Piscataway, NJ, site, a number of remote and field based Life Sciences roles will stay in New Jersey, and we have a small facility in South Plainfield with roughly 40 employees that will remain in the state.”

He also confirmed that GE has no plans to move its Hyclone culture media and sera units to the Marlborough site, explaining that “The newly acquired Thermo Fisher Scientific business will continue to operate in their current facilities [in Utah and Colorado].”

The new HQ, which is due to be operational in 2015 and expected to create 220 jobs, will house GE Healthcare’s cell and protein research units, its discovery services business and – according to Fox – “support large-scale manufacturing of biopharmaceuticals.”

DEA Approves Manufacture of GHB at Patheon Cincinnati Plant

Patheon has received approval from the DEA to bulk manufacture the schedule I product Gamma Hydroxybutyric Acid (GHB) from its facility in Cincinnati, Ohio.

The plant has been registered for over 30 years with the US Drug Enforcement Administration (DEA) to manufacture schedule II to V products, but in a document published by the Department of Justice, Patheon has been granted registration as a bulk manufacturer of Gamma Hydroxybutyric Acid, a basic class of controlled substance listed in schedule I.

Patheon Pharmaceuticals – part of DPx following the $2.65bn merger with Royal DSM’s pharma product business in March – applied for the registration back in January in order to manufacture the controlled substance for distribution to its customers.

“The DEA investigated the company's maintenance of effective controls against diversion by inspecting and testing the company's physical security systems, verifying the company's compliance with state and local laws, and reviewing the company's background and history,” the document said.

The 46,000m2 (494,960 sq. ft.) high-volume facility specializes in controlled release formulations as well as the development and manufacturing of Liquid-Filled Hard Capsules (LFHC), which the firm says is an ideal dosage form to meet formulation challenges associated with low solubility or high-potency compounds.

GHB is a naturally occurring substance found in the central nervous system, but if synthesized can be used as an anesthetic or to treat insomnia, narcolepsy and clinical depression. It has also gained infamy as both a recreational narcotic and a date-rape drug, which is why its production is strictly controlled by the DEA.

However, while making GHB requires schedule I approval, formulating it into a finished product does not which is why Patheon has been able to make Jazz Pharmaceutical's Schedule III cataplexy treatment, Xyrem, under contract since 2008.

Whether schedule I approval will see Patheon also begin making the Xyrem active pharmaceutical ingredient (API) - currently supplied by Swiss chemicals firm Siegfried under a contract due to expire in 2018 - is unclear.

While no such plan has been announced, Jazz's assertion in its most recent annual report that: “Although Siegfried has been our only supplier of sodium oxybate since 2012, we have the right to purchase a portion of our worldwide requirements of sodium oxybate from other suppliers" suggests Patheon could now be another option.

Novo Nordisk Buys Production Plant in New Hampshire

Novo Nordisk has announced the acquisition of a manufacturing facility in West Lebanon, New Hampshire, USA, from Olympus Biotech.

The facility was established in 1989, expanded in 2003-2006 and acquired by Olympus Biotech in 2011. It has been used primarily for mammalian cell manufacturing until production was phased out earlier this year.

Novo Nordisk intends to use the facility for production of active pharmaceutical ingredients primarily for its portfolio of biopharmaceuticals. Some of the plant's former employees have been offered jobs, which initially will focus on planning of the future plant setup. Final plans will determine potential and timing for future staffing increases.

Novo Nordisk and Olympus Biotech have agreed not to disclose the terms of the acquisition.

Project in Chicago’s Medical District Wins Approval

The Illinois Medical District Commission approved a 1.16 million sq. ft., $300 million mixed-use project in Chicago’s Illinois Medical District. The decision is an important step for the IMD Gateway Center project, a scaled-up version of an earlier $162 million proposal by Higgins Development.

Gateway Center will sit on a 9.5-acre site of mostly surface parking lots. Current plans include a 10-story, 225-room hotel; a 16-story, 200-unit apartment building; a second apartment building, of 224,000 sq. ft.; 92,000 sq. ft. of retail space; an 88,000 sq. ft. medical office building; 100,000 sq. ft. of lab space; and a five-story parking garage.

Lead developer, Gateway Development Partners L.L.C., is composed of Higgins Development Partners, Thomas Samuels Enterprises, East Lake Management & Development Corp. and Isaiah Real Estate L.L.C., which is headed by former NBA star Isaiah Thomas.

A groundbreaking is expected to be held within a year. The developer will hold a 75-year ground lease expected to provide the IMDC with more than $1 million annually.

NSF International Expands Laboratory in Bristol, Connecticut

NSF International has upgraded its informatics technology with the installation of Thermo Scientific's Watson LIMS (laboratory information management system) at its laboratory in Bristol, Connecticut, US. The laboratory has standardized on Watson LIMS to enhance reporting, improve efficiency and ensure data accuracy for its bioanalytical method development and validation services, enabling them to simplify compliance with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).

Thermo Scientific says the Watson LIMS brings time and cost savings to pharmaceutical companies and CROs involved in drug metabolism and pharmacokinetic (DMPK) studies for drug discovery and development by reducing validation time and improving overall efficiency.

'NSF International’s Health Sciences division has built a reputation for delivering technical expertise and consultancy across the full range of GMP and GLP analytical solutions,' said James Scull, Bristol Laboratory General Manager at NSF Health Sciences. 'Our Bristol laboratory needed an informatics platform that combined proven industry-specific performance with compatibility for reporting to FDA, DEA, and other regulatory agencies,' he added. 'By standardizing on Watson LIMS at our Bristol lab, we now have an automated method for sample management and greatly enhanced method validation, sample analysis and data management efficiencies with the rest of our labs worldwide.'

Boehringer Ingelheim Vetmedica to Open Plant in St. Joseph, MO

A company that handles animal medicines plans to open a missive new warehouse and packaging plant in St. Joseph, Missouri.

Boehringer Ingelheim Vetmedica Inc. will open its $28.7 million plant. It's about the size of four football fields, and eventually will have 150 employees.

Boehringer will package, handle and distribute animal vaccines and medicines for shipment to more than 50 countries. The products are used to prevent and treat disease in the swine, cattle, equine and pet markets.

Boehringer, with U.S. headquarters in St. Joseph, said the plant could be expanded by about 100,000 square feet for manufacturing. The company also has operations in Ames, Fort Dodge and Sioux Center, Iowa. It is a division of a Germany-based company.

University of Maryland Health Sciences Research Facility Opens in Baltimore

Construction of a new biomedical research facility known as Health Sciences Facility III (HSF III) began at the University of Maryland campus in September 2013. The research facility is being built by replacing Hayden Harris Hall located at the university campus in Baltimore, US. It will house a state-of-the-art collaborative research space upon its scheduled completion by the end of 2017.

The HSF III facility will continue to complement along with HSF I and HSF II facilities, which were constructed in the University of Maryland Baltimore (UMB) campus in 1995 and 2003 respectively.

The facility will provide employment to approximately 3,000 people during the construction phase and about 600 research scientists when it opens in 2018.

The new HSF III facility will have a ten-storey building with a total floor space of 428,970ft² (39,853m²). It will be occupied by the schools of medicine, dentistry and pharmacy to carry out advance scientific discovery and breakthroughs to address the most critical disease categories.

It will consist of two towers housing wet and dry labs that will be connected by a glass atrium with bridges across allowing for easy movement between the lab areas. The lower level will be equipped with a four modality imaging core, while the first floor will accommodate a nano-medicine and synthetic chemistry suite, and a Class 10,000 cleanroom. The top floor will include a vivarium that can house about 17,000 rodent cages, and varying species up to the size of non-human primates.

Approximately 70,000ft² of the floor space will be dedicated for open wet and support labs that can accommodate 92 principal investigators. The dry labs will include workstations and offices for computational research groups of up to 18 principal investigators.

HOK in collaboration with Design Collective was awarded the contract to provide architecture and interior design for the HSF III building. Jacobs provided the designs for laboratory planning and programming.

Barton Malow Company was appointed as the construction manager. Southland Industries was awarded the preconstruction and early mechanical construction contract. Its contractual scope includes preconstruction design, and installation of mechanical, plumbing and process piping services. It also includes the vivarium as well as administrative spaces.

The total estimated investment for the construction of the research facility is $305.4m. UMB will provide about $200m funding for the project, under the state capital improvement program. The University of Maryland Medical Centre will contribute $30m.

The new HSF III building will aim for LEED Silver certification. The building will include environment-friendly facilities such as a new chiller plant and a steam central plant. It will also include other eco-friendly systems such as rainwater harvesting and reverse osmosis. Fan-powered induction units and chilled beams will be provided in the lab spaces.

DuPont Plans Soybean Research Center

DuPont is expected to unveil plans for a new $35 million soybean research facility at its Stine Haskell Research Center in Newark, Delaware on August 14, the company reported. The facility will be the second of two DuPont Pioneer research facilities in this state. The facility will be about 134,000 square feet, and will include modern greenhouses. It will be mainly for the purpose of developing Pioneer soybean products, DuPont reported.

DuPont reports that U.S. growers have planted Pioneer brand soybeans more than any other brand for 20 years. During its quarterly earnings report last month, company executives stated that farmers are shifting much of their acres from corn to soybeans. Corn makes up about half of the company's seed business. Company officials have described this as a short-term problem.

The company, which was founded with a focus on chemicals, has been moving more toward agriculture and nutrition in recent years.

According to the announcement, the unveiling event "will highlight the importance of the State of Delaware to the company's strategic focus on Agriculture and Nutrition against the backdrop of a growing world population."

Estes Design & Manufacturing Expands Facility for Medical Device Production

Estes Design & Manufacturing Inc. is expanding to accommodate medical device production.

The Indianapolis, Ind.-based company is adding 35,000 square feet of manufacturing space in response to demand for sterilization cases and trays. A medical production cell will be the first cell set up in the new facility space. The expansion also will provide room for more medical production equipment to accommodate the continued growth of Estes’ medical business.

"This expansion provides much-needed capacity to meet the growing demand for our orthopedic and pharmaceutical products,” said Ron Estes, vice president of operations. “We feature a creative design staff that is committed to solving problems in the industry and finding new and better ways to get the job done. They’re backed by a GMP (good manufacturing practices)-compliant, world-class manufacturing operation that includes rapid prototyping, laser welding and over 30 years of experience in building orthopedic and medical products.”

The facility expansion is scheduled to be completed by the end of August.

Estes Design and Manufacturing is a full-service sheet-metal fabricator offering product design, engineering, rapid prototyping and manufacturing services, including 3-D laser welding. The company serves a variety of industries.

eNNOVEA Facility in N.C. Adds High-Speed Packaging Technology

eNNOVEA, a contract manufacturer for the medical, consumer and industrial markets is expanding with newly acquired technology at its facility in Asheboro, N.C. The addition of high-speed packaging rounds out the facility's clean-room molding and assembly operations, according to the company.

The company recently added a MC5-Digital drive Multivac R240 packaging machine to one of its six existing cleanrooms. Company officials characterized the system as "versatile and cost-effective" that, in addition, will increase speed and reliability on the production floor.

The Multivac has a full-transfer traversing coder and printer, along with an automatic cutting system that produces "precisely sealed and easy-to-open packaging" for medical supplies and devices, officials said, adding that the company has new customers lined up to take advantage of this new machine.

“With the addition of high-speed packaging, this capability has directly contributed to three new customers with a combined total business potential of $6 million in sales," James Wisser, business unit manager with eNNOVEA, told MPO.

eNNOVEA is a wholly owned subsidiary of EGI Inc. and, at present, operates seven facilities located in Atlanta, Ga.; Erie, Pa., as well as North Carolina.

Mapp & KBP Ramp Production of Plant-Based Antibodies to Treat Ebola

Two Americans stricken with the Ebola virus in Liberia were flown back to the U.S. following treatment with an unapproved treatment manufactured from tobacco plants in Kentucky. Manufacturing of the treatment is expected to ramp up as the patients improve.

Both patients were treated with ZMapp, which is the result of a collaboration between Mapp Biopharmaceuticals, San Diego-based LeafBio, Toronto-based Defyrus, the U.S. government and the Public Health Agency of Canada.

The CDC (Centers for Disease Control) said that the treatment “could be used in the future as production of the serum is increased. Looks like it might be a useful therapy.”

The Ebola outbreak is the worst in history, with over 700 killed by the virus in West Africa. There are no approved treatments for Ebola and funding is one of the main constraints in bringing new treatments to trial.

ZMapp was first identified as a drug candidate in January and has not been clinically evaluated in humans, though it has proved successful in non-human primates infected with Ebola. Composed of three monoclonal antibodies, the treatment is manufactured by contract manufacturer Kentucky Bioprocessing (KBP).

David Howard, a spokesman for Reynolds American Services, which owns KBP, commented that back in 2007, Mapp Bio engaged KBP to be a post-exposure treatment. “Mapp developed the protein and KBP has taken the protein and will inject it into tobacco plants, which produce or serve as a photocopier to produce the proteins and then they target, extract and purify it to create the compound,” Howard said, noting that the treatment has rapid growth potential and can be produced quickly.

“KBP is working closely with Mapp to increase production, and though not approved as a drug, we anticipate adhering to normal protocols on the compound later this year,” Howard said, referring to the clinical trials that the treatment will undergo later this year.

The US FDA said it’s ready to work with companies and investigators treating Ebola patients who are in dire need of treatment, an FDA spokeswoman told Bloomberg News.

According to Barry Bratcher, KBP’s COO, the plant-based system allows for considerable efficacy while the company’s automated facility in Owensboro, Kentucky keeps the treatment cost-effective and cuts down on the production time.

“Our facility can produce these proteins in two weeks at a substantial reduction in cost to other production methods,” said Bratcher. “This advanced method of manufacturing allows us to address needs quickly and inexpensively.”

The National Institutes of Health (NIH) has awarded a five-year grant of up to $28 million to establish a new center for excellence to find an antibody “cocktail” to fight the deadly Ebola virus. The project, which involves researchers from 15 institutions, will be led by Erica Ollmann Saphire, professor at The Scripps Research Institute

North Carolina-based BioCryst Pharmaceuticals and Canada’s Tekmira Pharmaceuticals are also developing Ebola treatments and vaccines against Ebola. The US FDA, however, put Tekmira’s trials on hold last month after seeking to ensure that higher doses of the drug were safe.

NewLink Genetics Corporation, through its wholly owned subsidiary BioProtection Systems Corporation, also announced a letter contract worth $1m with the US Defense Threat Reduction Agency (DTRA) for studies that will bring an Ebola vaccine licensed from the Public Health Agency of Canada closer to human clinical trials. The letter contract will fund Investigational New Drug (IND)-enabling pre-clinical toxicology studies and includes the manufacture of clinical materials.

Rady Children's Hospital to Establish Genomics Institute

Rady Children's Hospital-San Diego said it is establishing a pediatric genomics center with a $120 million pledge by Ernest Rady and his family, as well as $40 million from the hospital.

The Rady Pediatric Genomics and Systems Medicine Institute at Rady Children's plans on bringing together researchers, scientists, and clinicians to use a genomics and systems medicine approach to prevent, diagnose, treat, and cure childhood diseases, the hospital's Chairman David Hale said.

"The Institute will work closely with UC San Diego and establish relationships with other academic and research institutions, companies involved in genomics research, and other children's hospitals to advance the mission of the Institute," he said in a statement.

Along with the $120 million pledge by Rady, the hospital's board of trustees has committed $40 million to support the institute.

Brookhaven National Laboratory Going Green

Brookhaven National Laboratory (BNL) in Upton, N.Y. is pioneering the transformation of its high-performance research campus to be as environmentally sustainable as possible. To support its mission as a multipurpose research institution, funded primarily by the U.S. Department of Energy’s Office of Science (DOE), BNL requires the best expertise, the latest tools, and world-class facilities. Reducing energy consumption in its high performance facilities is critical to the DOE directives and consistent with its mission to achieve sustainable energy solutions for the future.

One way Brookhaven is reducing energy costs and greenhouse emissions is through campus-wide infrastructure upgrades as well as the addition of new facilities built for increased energy efficiency. The latest of these facilities, the Interdisciplinary Sciences Building (ISB), opened in April 2013. It was awarded LEED Gold certification by the U.S. Green Building Council (USGBC). An epicenter for energy-related research, the design of the new facility earned the maximum number of LEED points for energy performance, with an anticipated energy use savings of nearly 41 percent—far exceeding the EPAct 2005 requirements (30 percent as compared to ASHRAE baseline) for federal buildings.

The magnets that make up the NSNS-II machine traveled from across the globe, supplied by vendors from New Zealand, Russia, Denmark, China, U.K, and the U.S. The 87,700 square-foot, $47 million ISB facility includes high performance and flexible laboratories in which scientists engineer and optimize materials with the goal of developing breakthrough technologies for batteries, biofuels, and solar panels. The open and interdisciplinary research building houses 60 standard laboratories and four specialty labs, including a humidity-controlled dry room and two basement level ultra-low vibration labs, connected through a vacuum-locked system to a laboratory customized for a process called molecular beam epitaxy. This process allows scientists to make pure and precise semiconductor materials that are layered on top of each other to ultimately form devices such as transistors and lasers. With its energy-efficient design, the building truly embodies the energy science housed within it.

“Using an integrative process, we incorporated sustainable strategies in all areas of the design to maximize energy savings while satisfying scientific and research program requirements,” says Mark Jamison, project manager for HDR. The facility’s ventilation requirements were met and energy savings maximized by the special glazing, roof and wall insulation, reflective roofs and hardscape, and occupancy and daylight sensors. Cost-savings are obtained by using heat recovery systems, high-efficiency lighting systems and laboratory equipment, along with high-efficiency fume hoods in the experimental labs. The sustainable design also includes strategies to conserve water such as meeting the requirements for both storm water quality and quantity, avoiding the use of permanent irrigation, and reducing potable water use by 55 percent compared to the ASHRAE baseline.

Targeted labs required specific designs and solutions to accommodate a broad range of research environments. One of these laboratories, the ultra-low vibration (ULV) laboratory, is a one-of-a-kind lab used for characterization and imaging of atoms. Located in the basement, the lab is seated on a floating inertia slab of over 100 tons, with complete acoustic and radio-frequency isolation from the outside world. Brookhaven’s ISB Project Manager Peggy Caradonna says, “The design team conducted highly specialized site testing, used the latest modeling techniques to predict the laboratory performance. The independent tests confirmed that the finished laboratory space exceeded the stringent criteria we required and we expect that the research in the ULV lab will have far-reaching and beneficial effects for the laboratory.” Another dry lab requires a humidity-controlled environment with -40° Celsius dew point, and 21° Celsius dry-bulb temperature, where researchers can safely assemble and test new lithium-ion batteries.

As significant as the science research conducted within the building is the collaborative nature of the research. The building strategically groups energy research scientists into one facility to work together across disciplines. Rather than closeting the best minds in the world in silo-like labs, the environment is transparent and infused with natural light. Collaboration spaces of varying sizes and configurations are strategically placed to facilitate a spontaneous and productive sharing of ideas.

The 87,700 square-foot, $47 million ISB facility includes high performance and flexible labs for developing technologies for batteries, biofuels, and solar panels. (Image courtesy of HDR Architecture, Inc. ©2013 Ahmad Soueid)The 87,700 square-foot, $47 million ISB facility includes high performance and flexible labs for developing technologies for batteries, biofuels, and solar panels. (Image courtesy of HDR Architecture, Inc. ©2013 Ahmad Soueid)According to Mark Jamison, other sustainable building features include:

Over 20% of total building materials (by value) were recycled materials
Over 25% were obtained regionally (within 500 miles of the project site)
Over 54% of the wood used in the project was FSC-certified
Over 86% (1400 tons) of on-site construction waste was diverted from landfills
Low-emitting materials were used throughout for superior indoor air quality
Innovation LEED credit for Green Housekeeping Program (cleaning methods)

Adjacent to the ISB site, BNL built the Center for Functional Nanomaterials (CFN) which received a LEEd Silver certification in 2008. BNL’s investment in sustainable facilities also includes the National Synchrotron Light Source II (NSLS-II) Ring Building, which achieved LEED Gold certification in 2013. Attached to the NSLS-II are five Lab and Office Buildings (LOB 1, 2, 3, 4, and 5) which also achieved LEED Gold Certification. According to the BNL website, “Brookhaven integrates environmental stewardship into all facets of its research and operations.” These new LEED-certified buildings are a strong testimony to the laboratory’s ongoing commitment to sustainability.

New Veterinary Biomedical and Research Building (VBRB) at Washington State Univ.

The Veterinary Biomedical and Research Building (VBRB) at Washington State Univ. (WSU) celebrates the significant achievements and contributions that hundreds of small, often unknown academic institutions make in the field of global research. Located in a rural community of less than 6,000 residents, WSU attracts world-class research faculty. As public institutions nationwide compete for limited resources, faculty and graduate students; the new building breaks through the challenges of a harsh climate, isolated location and limited construction and operating dollars to become the latest source of pride for the College of Veterinary Medicine and a significant attractor for new faculty and research opportunities.

By paying close attention to the research done at the facility, facilitating community within and around the building and a focus on sustainable and efficient performance, the VBRB earned a High Honors Award in R&D Magazine’s 2014 Laboratory of the Year competition.

The VBRB provides a dramatic new presence for WSU; a major entrance to its emerging six-building, 750,000-sf research complex and a distinctive identity for the College of Veterinary Medicine.

The building is split into research neighborhoods, a concept that came about as a discussion in terms of how to organize the building in response to a request from WSU to limit the scale of the open lab space, according to Tim Evans, lab design principal with SRG Partnership, Portland, Ore., and lead architect on the project.

“The adjacent Biotechnology Building, which was the first new building in this complex, was designed with a very large open ballroom lab,” says Evans. “It was a traditional solution of a large open lab, an adjoining bar of lab support spaces and a corridor and then a bar of offices on the other side of the corridor. But the scale of the open lab and segregation of lab and office environments was something that WSU was getting a lot of push back from the users who were looking at those spaces.”

In brainstorming with Josh Meyers from Jacobs Consultancy, Tarrytown, N.Y, the team decided on alternating bands of open and closed labs and offices as a way of achieving a smaller scale of open labs. This approach would bring daylight and views deep inside the building, and create research “neighborhoods” with visual connections between zones and promote a sense of collegiality. Support spaces paralleling the open labs and the linear equipment corridors connecting the neighborhoods would facilitate movement while providing a designated location for noisy, heat-producing equipment that also requires standby power.

As most of the building’s research teams conduct live animal studies, mainly with rodents, access to research animals was a program priority. The team addressed this need by locating small, satellite vivaria on each of the four floors above grade.

“This was a very important aspect of the program,” says Evans. “We placed satellite vivaria on each floor so they would be directly adjacent to the research labs and the researchers working in them. But the critical implication it had for the design of the building is that those satellite vivaria needed to have direct access via a service elevator to the central basement-level vivarium, which connects to the adjoining Biotechnology Building vivarium and shares its highly automated cage wash facility.”

The most fundamental strategy the team implemented, according to Evans, was in designing the lab support spaces for a variety of functions to allow changes in their use over time. “WSU held steadfastly to the concept of flexibility, including not identifying the final locations for the research teams, which helped to prevent customization of the space for any one researcher’s particular preferences,” says Evans. And this, in the end, produced a highly flexible space versus customized space that could be easily adapted to meet any research team’s needs.

At a more detailed level, in the open labs, the team custom designed two types of overhead service carriers to provide the moveable lab benches with utilities and linear fixtures for ambient lighting when needed. The carriers’ lightweight aluminum extrusions and tension cables minimize obstruction of daylight and support the airy character of the labs and offices.

The theme for the VBRB building is “discovery happens everywhere”. And as a firm, SRG Partnership strongly believes scientists are extremely creative and benefit from opportunities from unstructured interaction, according to Evans. So, in response, the team created a variety of spaces for collaboration and brainstorming outside of the labs.

“Research on the sociology of buildings seems to indicate that when given a choice, researchers will gravitate towards the kind of space they feel most comfortable and desire to be,” says Evans. “This, in turn, increases the frequency and quality of interaction.”

The light-filled circulation spine, according the Evans, is a natural choice for many informal collaboration areas as it encourages movement between the VBRB and adjacent science complex, and is both a physical connection and means to promote interaction between wide ranges of scientific disciplines. The spine incorporates multiple versions of informal areas for casual encounters, quiet reflection and study. The east stair tower is also a significant feature on the exterior of the building’s most public face, and serves as a dramatic symbol of the connections and collaboration taking place inside.

The VBRB represents a new model for lab design by applying complementary interior design features in public zones and research neighborhoods alike. Evoking natural light, views, exposed structure and integrated work elements enhance human responses through all spaces. The consistency between the different zones strengthens the sense of an integrated research community.

Perhaps the most impressive feature is the dramatic two-story Science Forum. “This is by far the biggest space for collaboration,” says Evans. “And it was one that came about from a desire to create a more public venue, one that could be used for a wide range of activities and could also create a heart to the facility.”

The VBRB’s Science Forum creates a signature gathering place. The VBRB’s Science Forum creates a signature gathering place. The forum creates the signature gathering place for WSU’s entire six-building research complex. It draws together researchers and staff from within the VBRB and from the adjacent buildings for meetings and presentation, both formal and informal.

In the design process of the VBRB, a rigorous analysis of climate, energy use, daylighting and water conservation was integrated with the function requirements of a contemporary lab building. Collaborating with the Energy Studies in Buildings Laboratory at the Univ. of Oregon, the team used computer simulations and physical models to test, re-test and validate design solutions.

The building faced issues with solar glare, as the site gets quite a bit of sun, according to Evans, so solar shading was a major aspect of climate that affected the building. The open lab and office zones enhance daylight penetration, providing natural light in all regularly occupied spaces. As WSU prohibited the use of external shading devices and interior shades, especially roller blinds and shades, due to concern over snow accumulation, magpie nesting and maintenance issues, the team needed to go back to the drawing board on a solution. Months of study for the south-facing glazing yielded an innovative solution of specially glazed transom lights and fixed/operable internal shading devices that optimize light transmission while preventing sunlight infiltration and uncomfortable glare.

“We have worked with the Energy Studies in Buildings Laboratory for over 20 years,” says Evans. “And they have an artificial sky chamber, which allows you to place a physical building model in the chamber and actually see how the sun behaves on it at different times of the day and the year. So, we placed our physical model of the VBRB in this chamber to see how the sun would strike the building throughout the day and determine what elements or combination of elements would work best.”

The material palette of the building’s exterior was driven by the existing Biotechnology Building, which consists of brick, metal panels and glazing, which had established the vocabulary for the research and education complex that will eventually grow to five buildings or more. The team worked with these materials to construct a highly insulated and air-tight building envelope. Faced with a very cold and dry harsh climate, the envelope minimizes air infiltration and other obstacles that often contribute to poor building performance.

As Washington State has a policy to not pursue USGBC certification, the building didn’t receive LEED accreditation for its sustainable aspects, says Evans. However, the building was designed to a LEED Silver standard, and the team placed much emphasis on the energy performance of the building.

Facing the challenges of extreme climate conditions, intensive energy demands and a modest $56.5 million construction budget, the design team’s commitment to research and sustainable strategies successfully achieved ambitious energy savings, maximum natural daylight, user-friendly systems and low-maintenance/lifecycle efficiencies. The predicted energy use intensity is 220 kBTU/sq. ft/yr, 42.5% less than the Washington State Energy Code.

Numerous energy reduction strategies make the VBRB exemplary for its building type, such as a runaround glycol heat-recovery loop to mitigate the extreme climate. Low-temperature radiant systems were incorporated to minimize ventilation air, as well as accommodate future alternative heat sources. Following an analysis of lab equipment loads, the team decoupled ventilation and cooling to optimize air change rates. For space cooling, they opted to use chilled beams where high equipment loads warranted.

On the west elevation, the Science Forum’s unique exterior symbolizes the innovative spirit of WSU’s College of Veterinary Medicine and the 21st-century research taking place within. Highly visible from the greater campus and community, this expressive beacon provides the campus with a continual interplay of light, shadow and color.

“We were looking for a way of activating the façade,” says Evans. “And the west elevation that encloses the Science Forum was something that we wanted to make more dynamic, but it was a difficult task in terms of sun exposure because the afternoon sun blazes against it.”

Looking for something that would activate this relatively solid portion of the façade and protect it from the sun, but also provide an interesting and dynamic quality, the team chose to incorporate vertical dichroic fins. These fins reflect and refract sunlight onto the metal panels with different colors throughout the day, a technique designed to dynamically respond to changing solar angles and times of year. Exact conditions of the feature were extensively studied, and the results not only animate the façade, according to Evans, but also achieve a special effect on the summer solstice.

Ames Lab Expands

The U.S. Dept. of Energy (DOE)’s Ames Laboratory is now the home to a dynamic nuclear polarization (DNP) solid-state nuclear magnetic resonance (NMR) spectrometer that helps scientists understand how individual atoms are arranged in materials. Ames Laboratory’s DNP-NMR is the first to be used for materials science and chemistry in the U.S.

To obtain this detailed information about materials’ structure and dynamics, solid-state NMR monitors the response of atomic nuclei to excitation with radio frequency waves.

“The frequency at which nuclei respond creates a unique spectral ‘fingerprint’ of their local environment within a material,” said Marek Pruski, Ames Laboratory’s lead scientist in solid-state NMR.

These “fingerprints” are especially useful in understanding the structure of non-crystalline materials—that is, materials that do not display regular crystalline structure amenable to diffraction studies. But, solid-state NMR is a challenging business. Because it operates at the low-energy end of the electromagnetic spectrum, the population difference between energy levels involved in NMR transitions is exceedingly small—only a few spins per million effectively generate the NMR signal.

In the last few years, several approaches involving ‘hyperpolarization’ of nuclear spins have emerged that are poised to revolutionize NMR spectroscopy. Chief among these is dynamic nuclear polarization (DNP). In short, DNP-NMR relies upon excitation of the unpaired electrons by microwave irradiation and subsequent transfer of the resulting spin polarization to the material’s nuclei, resulting in a much stronger response from these nuclei than is possible in conventional solid-state NMR.

“This instrument will allow us to improve the sensitivity by up to 100 times, and thus take data 10,000 times faster,” said Pruski.

Commercial DNP-NMR systems only became available in the last few years. Pruski and his Ames Laboratory colleague, Takeshi Kobayashi, collaborated with research groups in Europe to demonstrate how useful the DNP-NMR will be for materials research at Ames Laboratory.

“We have solid evidence that the DNP-NMR is a game-changing technique,” said Pruski. “Remarkably, DNP-NMR is still emerging. There’s great potential for its further development, and we are looking forward to making these advances. Most importantly, however, we want to use this new capability within several Ames Lab’s research programs to study complex metal hydrides, novel heterogeneous catalysts, biological nanocomposites, thermoelectrics and other energy-related materials.”

DuPont Hospital Expanding in Delaware

Healthcare system Nemours has kicked off the 450,000 sq. ft. expansion of the Alfred DuPont Hospital for Children in Wilmington, DE. The $250 million project, designed by architect FKP Architects, incorporated extensive input from families and well as evidence-based design.

“In our planning, we talked to parents and listened to children to find out what they would wish for most in a hospital. We asked our caregivers what would help them continue to deliver the very best care.

These thoughts and ideas helped inspire the design of what will become our new space — an environment to promote physical, emotional and spiritual healing of children.

Opening in October 2014, we are creating a children's hospital like no other in the region, giving our patients and families the promise of even better days to come.”

Best in Healthcare Design: AIA selects 8 Projects for National Healthcare Design Awards

Projects showcase the best of healthcare building design and health design-oriented research.

American Institute of Architects, August 01, 2014

The American Institute of Architects Academy of Architecture for Health has selected the recipients of the AIA National Healthcare Design Awards program. The AIA Healthcare Awards program showcases the best of healthcare building design and healthcare design-oriented research.

Projects exhibit conceptual strengths that solve aesthetic, civic, urban, and social concerns as well as the requisite functional and sustainability concerns of a hospital.

Recipients were selected in four different categories:

Category A: Built, Less than $25 million in construction cost
Category B: Built, More than $25 million in construction cost
Category C: Un-built, Must be commissioned for compensation by a client with the authority and intention to build
Category D: Innovations in Planning and Design Research, Built and Unbuilt

Jurors for the 2014 National Healthcare Design Awards include: Eric Goodfriend, AIA (Chair), Mahlum; Roger Call, AIA, Herman Miller for Healthcare; Jim Lennon, Lennon Associates; James C. Lord II, AIA, KGA Architecture; Mark Patterson, AIA, SmithGroupJJR; Mark Tortorich, FAIA, Stanford University and Shane Williams, AIA, Array Architects.

Category A

Legacy ER – Allen

Allen, TX

5G Studio Collaborative

Legacy ER operates a hybrid program offering urgent and 24/7 state-licensed emergency care services within a freestanding building. Conceptualized as a potent reflection of the organization’s identity, the architecture captured the duality of the emergency medical professionals' character, projecting outwardly the knowledge, skill, precision, and decisiveness necessary for the competent practice of emergency medicine and expressing inwardly the gentle, empathic, and humanistic qualities of the persons beneath the robe, realized simply through montaging sharply folded exterior robe of zinc and softly sculpted interior plastered planes. Points of admission of natural daylight and views create apertures that elucidate intersecting tectonic moments.

Lightwell: Greater Boston Orthodontics

Waltham, MA

Merge Architects

A hundred-year-old storefront and warehouse on Main Street in Waltham was gutted, creating an open plan orthodontic clinic – including reception and treatment areas flanked by semi-private offices, tooth-brushing stations, exam rooms, and a staff coffee area. The double-height treatment space is framed by an 18-foot-tall backlit translucent wall curving down in section to frame and light the open treatment area. CNC-cut plywood ribs skinned with thin polycarbonate panels funnel light from skylights above. The front waiting space is defined by a custom seating area and digital media bar, wool felt applied to walls, a custom light pendant, and bright custom wall graphics to provide way-finding.

Category B

Lancaster General Health Ann B. Barshinger Cancer Institute

Lancaster, PA

Ballinger

The new 100,000 square foot Ann B. Barshinger Cancer Institute is developed around a progressive model for cancer care and employs an interdisciplinary and patient-centric approach. Focused on regeneration and reconnection to living systems, the building’s radial form derives from an existing elevated, curvilinear arrival / parking court which has become a central courtyard healing garden. The expanded oncology program is arrayed around the garden on two levels. Glazed skins and multiple points of access provide a continuous dialogue between interior and exterior, creating a visually open environment that reduces anxiety and stress for patients and their families.

Mount Sinai Hess Center for Science and Medicine

New York, NY

Skidmore, Owings & Merrill LLP

Envisioned as a place of discovery and healing, the striking Mount Sinai Hess Center for Science and Medicine is shaped by its translational research mission and urban context. Located in Upper Manhattan, the center places researchers, clinicians, educators, and patients in an integrated environment with state-of-the-art technology. The 420,000 square foot facility is specifically designed to foster multi-disciplinary interaction through a network of formal and informal settings. The primary design objective was to craft a flexible environment that would be inspiring and supportive for employees while gracious and dignified for patients and their families. Inside, natural light and a warm, simple material palette puts cancer patients at ease.

Rush University Medical Center New Hospital Tower

Chicago, IL

Perkins+Will

As part of Rush University Medical Center’s 10-year, $1 billion Campus Transformation Project, Perkins+Will planned and designed a new 840,000 square foot state-of-the-art hospital building. Crowned by a butterfly-shaped bed tower designed to minimize steps between staff and patients, the new hospital is comprised of 304 acute and critical care beds, 72 neonatal intensive care beds, and 10 labor and delivery beds. The emergency department contains one of the country’s few bioterrorism preparedness facilities, and is designed to handle large-scale health emergencies. The hospital is one of the largest in the world to be certified LEED Gold.

Category C

Children’s Hospital of Richmond Pavilion (CHoRP)

Richmond, VA

HKS, Inc.

At the gateway to the medical campus, the Children’s Hospital of Richmond Pavilion consolidates existing pediatric clinics into a compact vertical urban pavilion. The facility is dedicated to providing comprehensive healthcare for children and adolescents and contains a surgery level, three levels of pediatric clinics, a faculty/research floor, and seven levels of parking. Adjacent to some of the city’s most important civic structures, the design establishes a signature identity that embodies VCU’s objective of becoming the region’s premier pediatric academic medical institution. Drawing inspiration from natural elements that are unique to the City of Richmond, the design is intrinsically tied to its location. Themes of sky, water, and forest bring nature to the heart of this urban campus.

Category D

Cincinnati Children's Family Pet Center

Cincinnati, Ohio

GBBN Architects

The Family Pet Center expands the hospital’s pet therapy program with a 250-sf pavilion and lawn areas that accommodate patients whether on foot, in a wheelchair or on a stretcher. In this 8’ by 10’ enclosure, kids reunite with their own pets. Positive effects begin with anticipation days in advance, the visit itself, and the lingering effects of memories or storytelling afterwards. Based on research on the healing benefits of Animal Assisted Therapy (AAT), this pavilion addresses the medical needs of the children and the physical dynamics of pets. Especially for cancer patients, who deal with high levels of stress, pain, and long hospital stays, AAT contributes to recovery by improving the quality of life for patients.

GHESKIO Cholera Treatment Center (CTC)

Port-au-Prince, Haiti

MASS Design Group

The first permanent facility in Port-au-Prince, the CTC provides an aggressive model for cholera treatment, while creating a healing space that promotes a dignified patient experience. Both the CTC’s layout and placement of amenities optimize staff and patient flow. The design tackles unique site conditions, including the lack of reliable piped water and lack of sewer system connection, by providing off-the-grid services. The roof collects rainwater, which is stored in cisterns, chlorinated, and then used for showers and sinks. The facility also decontaminates waste on-site and is designed to achieve 99.99% removal and inactivation of Cholera vibrio and other pathogenic organisms. The façade blends the use of the most advanced technology, using parametric modeling to optimize apertures for daylighting, ventilation, and privacy, with deploying analog techniques for local fabrication. The CTC will not only establish new standards for cholera treatment, but also new standards for quality construction in Haiti.

AROUND THE WORLD

EMD Millipore to Supply Samsung's Plant

EMD Millipore has been contracted to supply raw materials to the Samsung Biologics plant where ingredients for BM-S’ anticancer monoclonal antibody Yervoy (ipilimumab) are made.

Few additional details of the 10-year supply deal have been released and EMD, which operates as Merck Millipore outside the US and Canada. According to a media statement EMD will ship unspecified raw materials to a facility in Songdo, Incheon, which is a hub for the South Korean contract manufacturing organization’s (CMOs) protein production operations.

Samsung Biologics, a joint venture formed by Samsung Electronics and Quintiles in 2011 , describes the Incheon facility as a one-stop shop capable of producing bulk drug substances and drug products.

The facility houses a cell culture hall with six 5,000L stainless steel bioreactors, an upstream suite, downstream processing and fill/finish areas as well as a fully functioning R&D laboratory.

At present the only drug substance confirmed as being made at the site is the active ingredient for Bristol Myers-Squibb’s anticancer monoclonal antibody Yervoy (ipilimumab), which Samsung produces for markets outside the US under a deal signed in 2013.

In 2011, Samsung teamed up with Biogen Idec to form Samsung Bioepis, a biosimilar development-focused joint venture that is also based at the Incheon facility.

Later that year the Incheon facility began making trial supplies of a candidate Rituxan (rituximab) biosimilar, however, production halted when the research was put on hold in 2012 for unspecified "internal reasons."

Since then Samsung has announced it has been contracted to make drug substances Swiss pharmaceutical giant Roche – which co-markets Rituxan with Biogen Idec.

More recently, Merck & Co said it had contracted Samsung Bioepis develop and commercialize an insulin glargine biosimilar at the site, building on an initial agreement signed in 2013.

In addition to the existing Incheon facility, Samsung is working on a 150,000 liter cell culture-based manufacturing plant, which will also be supplied with raw materials by EMD Millipore.

Merck Serono Breaks Ground in China

Merck Serono, the biopharmaceutical division of Merck, held a groundbreaking ceremony for its new pharmaceutical manufacturing facility in Nantong, China. The new facility, which will be the Group's second-largest pharmaceutical manufacturing facility worldwide, will focus on the bulk production and packaging of Glucophage^®, Concor^® and Euthyrox^®, Merck Serono's leading brands for the treatment of diabetes, cardiovascular diseases and thyroid disorders, respectively. These medicines are referenced in China's essential drug list, making Merck Serono the first and only multinational company in China to dedicate a large scale green-field investment to the production of drugs on the list, comprising medicines that address public healthcare needs and must be available at all times.

The new pharmaceutical manufacturing plant is located in the Nantong Economical Technological Development Area (NETDA), in the Greater Shanghai region (Yangtze River Delta area). Based in NETDA's BioSpark zone, a high-tech industrial park designed to accommodate life science enterprises, the plant represents an investment of € 80 million and will be Merck's largest manufacturing facility outside of Europe. The new facility will cover an area of 40,000 square meters (430,400 sq. ft.), with a possible 20,000 square meters (215,200 sq. ft.) extension. The construction of the site is scheduled to be completed in 2016, with commercial production starting in 2017. The site is designed to comply with the highest international standards in terms of quality, as well as environment, health and safety. The preservation of the environment is a critical consideration in the facility's construction, with a maximization of resource efficiency and minimized waste generation in the course of the manufacturing process.

"We firmly believe that complying with the highest quality, environment, health and safety standards is a natural commitment to the communities where we operate, as well as a prerequisite to ensuring the availability of high-quality medicines for patients," said E. Allan Gabor, President and Chief Executive Officer of Merck Serono China. "By building our new facility in the great city of Nantong, we are committing our resources to the clear objective that our drugs be made more readily available for hospitals, doctors and patients in China. This emphasis is part of a greater goal to promote not just better access to medicines, but better access to health for every person in this country. This is a key goal for China, and this is Merck Serono's commitment."

Baxter Opens its First Biologics Facility in Asia

Baxter International Inc. announced the formal opening of its first advanced recombinant biologic facility in Singapore, and expansion plans for a new recombinant protein processing suite.

The current suite supports the processing of ADVATE [Antihemophilic Factor (Recombinant)]1, the market leading full-length recombinant factor VIII (rFVIII) worldwide for the treatment of patients with hemophilia A. The second suite will initially process RIXUBIS [Coagulation Factor IX (Recombinant)]2, a recombinant factor IX (rFIX) protein for the treatment of adults with hemophilia B and, when operational, will be the primary global commercial processing facility. It will also support production of the company's investigational extended half-life recombinant FVIII treatment BAX 855 upon regulatory approval.

The announcement strengthens Baxter's leadership in hemophilia and underscores its commitment to increasing access to therapy and improving standards of care for hemophilia patients globally. In total, the establishment of the facility and new investment will have created 450 biopharmaceutical jobs by 2015 in Singapore.

"As a long-standing, established leader in the global hemophilia community, Baxter has focused efforts on improving standards of care for people with hemophilia," said Ludwig Hantson, Ph.D., president of Baxter BioScience. "The opening of the Singapore facility reinforces our continued commitment to expanding access to advanced, high quality treatments for patients around the world."

Baxter's expansion of its biologics footprint in Singapore reinforces our position as a leading biologics hub. This facility will support Baxter's growth in the global market and Singapore celebrates its opening. Singapore Economic Development Board (EDB) will continue to invest in talent development, supporting infrastructure and new technologies to support the biologics sector," said Mr. Yeoh Keat Chuan, managing director at the Singapore Economic Development Board, who officiated the opening ceremony.

The Singapore facility received regulatory approval from the European Medicines Agency in January 2014 for the production of ADVATE2. This allows the facility to process and supply ADVATE to the European Union, Iceland and Norway. The biologics facility in Singapore currently employs more than 400 production staff and expects to reach 450 by 2015 to support the second processing suite. The facility is the third location in the world supporting ADVATE processing, making this the only recombinant factor VIII treatment processed at three separate sites and providing unprecedented security of a triple-source capability.

Speaking at the opening of the facility, Jean-Luc Butel, corporate vice president and president of Baxter's International operations said, "Singapore's biotech industry has seen tremendous growth in recent years and Baxter is proud to have been a part of this journey. Baxter is grateful to the Singapore Economic Development Board for their support in establishing this facility and for its commitment to collaborations that advance access to quality healthcare. As we have invested in training our employees to support this state-of-the-art technology, we remain committed to partnering with the Singapore Economic Development Board and other government agency partners to elevate the quality of the healthcare workforce in Singapore."

Last month, Baxter International sold its vaccine business to Pfizer for $675m (€474m). Baxter told BioPharma-Reporter.com the sale could be attributed to a strategic decision “to enhance the focus of Baxter BioScience on our core areas of expertise as [it] prepares to become an independent global biopharmaceutical company in 2015.”

Merck Millipore Invests in France Facility

Merck Millipore announced a €12 million investment in its Molsheim, France facility. This investment will expand Merck Millipore's Ready-To-Use (RTU) Media manufacturing capabilities, better provide security of supplies for customers in the region, and sustain the heipha/Hycon product lines including contact and settle plates (ICRplus plates) and Agar strips for RCS® systems which are used in monitoring ambient air and compressed gases.

"We are committed to providing our customers with a reliable supply of products, including Ready-To-Use Media, which this investment in Molsheim will help to ensure," said Udit Batra, President and CEO of Merck Millipore. "Both Molsheim and heipha Eppelheim (Germany) sites will continue to support the increasing demand from our customers. This investment signifies our long-term dedication to Merck Millipore's Lab customers in this region and around the world."

This investment - which leverages Merck Millipore's core-competencies in media development and experience in media production technology - includes the extension of the manufacturing capacity space for RTU Media, a new clean room, and two additional production lines similar to those existing in Eppelheim, where RTU Media will also continue to be manufactured. In addition, current research and development laboratories across various scientific areas of expertise will be centralized to form an Innovation Center to develop solutions for future customer needs.

The increased manufacturing capacity will serve global market demand, and will ensure sufficient capacity to support the market growth. Merck acquired the heipha/Hycon product lines in 2011 as part of its purchase of Biotest AG which expanded the division's offerings in industrial microbiology.

Molsheim has been an important location for Merck Millipore since the facility opened in 1972. Approximately 1,030 employees are based in Molsheim. In addition to ongoing R&D activities, this site manufactures products across Merck Millipore's BioMonitoring, Lab Water, and BioPharm Process Solutions Business Fields.

Carbogen Amcis Takes Over Swiss Plant

Carbogen Amcis has signed a long-term lease for an ADC unit in Vionnaz, Switzerland

Carbogen Amcis has expanded its operations in light of unrelenting demand for antibody-drug conjugate (ADC) services by signing a long-term lease for a facility in Switzerland.

Cabogen Amcis, a contract manufacturing organization (CMO) owned by India-based Dishman Pharmaceuticals and Chemicals, signed a long-term lease agreement with chemicals and biotech firm Bachem to take over a high-containment unit in Vionnaz, Switzerland.

The facility is fully equipped for the development and small scale cGMP manufacture of highly potent drugs and drug-linkers - one of the main components of an ADC. It will help fulfill growing customer demand for ADC development and manufacture.

“In the last 18 to 24 months, the ADC market gained momentum, well beyond the demand we have experienced in the last 10 years, spurred by large pharma and small biotechs,” said Dr. Alan Fischer, Director of Technology.

“Clinical results have showed that ADCs can recognize and target cancer cells leading to their death with fewer side effects for the patient,” and was the main driver in both this expansion and an investment last year which saw the firm set up a dedicated clean room and clinical supply suite at its plant in Beubendorf, Switzerland.

The Vionnaz plant will complement Bubendorf, which caters to larger cGMP manufacture projects and, according to Fischer, supports the coupling of biological material and the drug-linker moiety in an aseptic environment.

The Vionnaz facility includes a process development laboratory, a dedicated QC laboratory and two production units fitted with reactors up to 30 L, as well as equipment for lyophilisation and chromatography.

Carbogen Amcis has over 200 customers on its books and therefore needs to be flexible with its chemistries and philosophies, especially for ADCs. “Therefore, we use equipment fit for purpose, depending on the project and customer needs,” Fischer said.

This includes single-use technology which, like other biomanufacturers, Carbogen Amcis is implementing alongside more traditional systems.

“For example, we have single-use equipment, bags, and reaction containers besides fixed installations like isolators, glove boxes, laminar flow benches, walk-in hoods and freeze dryers (with single use Lyogards, injection vials and syringes)”.

“Tangential flow filtration and chromatography are supported by a mix of fixed installations (like pumps) and single project use columns (like the Biotage system for example), membranes and tubing.”

UK to Invest in Genomes Project with Illumina

The four year project will allow scientists to do pioneering new research to decode 100,000 human genomes.

The UK is set to become the world leader in ground-breaking genetic research into cancer and rare diseases, which will transform how diseases are diagnosed and treated, thanks to a package of investment worth more than £300M.

The landmark project is on a scale not seen anywhere else in the world and is part of the Prime Minister’s commitment to ensure the NHS as well as the UK’s research and life science sector is at the forefront of global advances in modern medicine.

Sequencing the genome of a person with cancer or someone with a rare disease will help scientists and doctors understand how disease works. The project has the potential to transform the future of health care, with new and better tests, drugs and treatment. It is expected to provide a lifeline to thousands of families affected by rare genetic diseases and cancers.

The Prime Minister has pledged that the UK will map 100,000 human genomes by 2017.

Now, as world leading research organizations join forces, the 100,000 Genomes Project has reached a major milestone in a package of new investment.

The Prime Minister is unveiling a new partnership between Genomics England and the company Illumina that will deliver infrastructure and expertise to turn the plan into reality. As part of this, Illumina’s services for whole genome sequencing have been secured in a deal worth around £78million.

In turn, Illumina will invest around £162million into the work in England over four years, creating new knowledge and jobs in the field of genome sequencing. The investment will not only help the life science industry to thrive, but potentially create opportunities for talented UK scientists to lead the world. It will also pave the way for all NHS patients to eventually benefit from this exciting new technology.

This research puts the NHS at the forefront of scientific discovery. This is in line with the Prime Minister’s vision for the NHS to be the first mainstream health service in the world to offer genomic medicine as part of routine care.

Prime Minister David Cameron commented, “This agreement will see the UK lead the world in genetic research within years. I am determined to do all I can to support the health and scientific sector to unlock the power of DNA, turning an important scientific breakthrough into something that will help deliver better tests, better drugs and above all better care for patients.

The Wellcome Trust has invested more than £1 billion in genomic research and has agreed to spend £27 million on a world class sequencing hub at its Genome Campus near Cambridge. This will house Genomics England’s operations alongside those of the internationally respected Sanger Institute.

The agreement will place Genomics England at the heart of one of the world’s most vibrant genomic science and technology clusters, and allow scientists to work with world-class researchers from the Sanger Institute, the European Bioinformatics Institute, and biotechnology companies based on the same site.

The Medical Research Council has also earmarked £24 million to help provide the computing power to make sure that the data of participants will be properly analyzed, interpreted and made available to doctors and researchers securely.

NHS England has started the process of selecting the first NHS Genomics Medicine Centers. Successful centers will help to progress this ambitious project by inviting cancer and rare disease patients to take part to have their genome sequenced. NHS England has agreed to underwrite an NHS contribution of up to £20 million over the life of the project.

The cash injection – and new partnerships – will mean excellent progress can be made on the 100,000 Genomes Project. It is expected that around 40,000 NHS patients could benefit directly from the research. Ultimately this work will pave the way for genomics-based medicine to become part of everyday practice throughout the NHS.

Participation in the project will be based on consent, and people’s data will be strictly protected through Genomics England’s secure data services.

Life Sciences Minister George Freeman said, “Genomics England’s ground breaking partnership with Illumina confirms Britain’s position as a world leader in the field of genetic medicine. This project will help us map genomes on an unprecedented scale and bring better treatments to people with cancers and rare diseases for generations to come.

“This is a momentous day for the UK to push the boundaries of medical science and create the first comprehensive national program for genomic healthcare." commented Jay Flatley, CEO of Illumina. “Illumina is committed to partnering with Genomics England as they look to implement vital changes in the way healthcare is practiced. This project confirms the UK as a leader in the global race to implement genomic technology and create a lasting legacy for patients, the NHS and the UK economy.”

Alvogen Acquires Dream Pharma of Korea

North America generics manufacturer Alvogen has bought Dream Pharma of South Korea. Privately owned generics drugmaker Alvogen has bought South Korea's Dream Pharma for US$187m in cash, strengthening its position in the Asia-Pacific region. Dream will be acquired through the US company's Asian subsidiaries and, on completion, will create one of the largest generic pharmaceutical companies in South Korea, says Alvogen.

The transaction is subject to regulatory approval and is expected to close in the fourth quarter of this year. The deal will add a complementary portfolio of more than 100 products to Alvogen's existing business in the region. Dream currently has a 35% market share in obesity products in Korea. This is Alvogen's third acquisition in the Asia-Pacific region. The company bought Kunwha Pharmaceuticals of Korea in 2012 and this year merged its Asian operations with Lotus Pharmaceutical of Taiwan. There is currently no overlap between Kunwha’s product portfolio in the Korean market and that of Dream, the company says.

'Dream is an excellent business and we are looking forward to collaborating with its high-caliber team as we work to fuel regional growth and to gain scale in the Korean market and a broader product offering,' says Robert Wessman, President and CEO of Alvogen. 'Alvogen’s business continues to grow from strength to strength in Asia-Pacific and our commitment to the region is yielding clear results. This transaction further underlines our ability to act as a powerful industry consolidator and demonstrates the momentum we are building towards becoming one of the top five players in the Asia-Pacific market.' Alvogen aims to build a hiqh-quality product portfolio in Korea, Taiwan, Thailand, China, Japan and Vietnam. The company currently has commercial operations in 11 Asia-Pacific countries.

Western Australia launches New Plant Energy Research Center

The University of Western Australia said it has officially launched a new research center at its campus in Perth that will pursue molecular, genomic, and cellular research aimed at understanding and improving plant energy use.

Funded with AU$26 million (US$24.3 million) from the Australian Research Council and AU$14 million from industry and academic partners, the ARC Centre of Excellence in Plant Energy Biology (PEB) will seek to improve sustainable plant yield by optimizing the efficiency of energy capture, conversion, and use in plants.

Researchers at the PEB will seek to define the complex system that determines energy efficiency in plants by discovering "gatekeeper cells" and epigenetic controls that regulate it, and to develop ways to manipulate these activities to boost efficiency and yields. The center has three core research themes, including projects targeting gene variants and epigenetics, energy metabolism and signaling, and gatekeeper cells and specialization. To conduct these projects, the PEB includes a range of research platforms for next-generation sequencing, molecular profiling, proteomics, metabolomics, bioinformatics, and other applications.

The PEB is a collaboration between UWA, the Australian National University, the University of Adelaide, and La Trobe University. It houses 10 chief investigators, 110 staff members and students, and involves eight partner investigators in the US, Germany, Finland, Sweden, and China.

The center also works with industry partners, including Agilent Technologies, the Grain Research and Development Corporation, Photon Systems Instruments, and others.

ARC centers of excellence are generally funded for up to seven years, enabling them to undertake comprehensive research programs and short-term projects.

Redbiotec Expands Vaccine Production

Redbiotec has selected GE Healthcare’s single-use processing offering to aid development of its Herpesvirus vaccines which use viral antigen complexes and virus-like particles.

Cytomegalovirus is a member of the Herpesvirus family, and there have been many attempts to apply traditional approaches such as attenuated viruses or single viral antigens to develop a vaccine, yet these efforts have failed to show sufficient efficacy in the clinics.

However, Redbiotec, a Zurich, Switzerland-based biotech firm developing vaccines against Cytomegalovirus using its proprietary rePAX assembly and expression platform, is challenging these approaches by using conformational viral antigen complexes as well as virus-like particles (VLPs).

“VLPs are true virus ‘mimics’ – they are recombinantly built out of the same proteins as the real pathogen and contain only the immunologically relevant antigens,” said Redbiotec's Andreas Jurgeit. “When presented to the body’s immune system, they are recognized like the real pathogen but they are not infectious. Redbiotec could for the first time show that it is possible to resemble CMV as a VLP and that VLPs can be optimized and produced to assure an optimal immune response.”

To progress its programs and scale its production from prototype to GMP-compatible large scale bioreactors, the company has chosen single-use technology, and more specifically partnered GE Healthcare for its single-use Wave bioreactor and ReadyToProcess filtration system.

“GE’s solution is not just well integrated but remains flexible enough to adopt it to a variety of different products,” Jurgeit said.

“Besides in-house applications, Redbiotec could show that the processes developed can be readily transferred to external partners using the same platform. This is especially useful to on-demand scale production capacities in short time frames with limited investments.”

Telstar Expands Laboratorios Pisa in Mexico

Telstar has supplied a set of autoclaves for the sterilization of large-volume parenteral solutions and isotonic liquid products to the Latin American pharmaceutical firm Laboratorios Pisa. The autoclaves have been installed at the Mexican group’s plant in Tlajomulco, Guadalajara, Mexico.

This supply contract for multiple pieces of equipment, which was delivered in December 2013, is to be extended by the addition of further autoclaves during 2014. The super-heated water autoclaves developed by Telstar for Laboratorios Pisa include control systems which can compensate for the pressure differences occurring between the inside of the container and the autoclave chamber during the heating and cooling phases. This ensures that the processes occur at controlled temperature and that the physical integrity of the container is retained at the end of the cycle.

Telstar is also supplying Laboratorios Pisa with several seven-effect water stills, each with a capacity for up to 12,000 liters/hour of distilled water (WFI); some of which are in full operation and a further two now in the process of manufacture. The stills operate without requiring any cooling water. The seven columns provide more enhanced utilization of the heating energy and as a result in the last condensation phase no cooling water intake is required.

According to Telstar, this represents a significant financial saving considering such large production volumes. The autoclaves and water stills developed for the Guadalajara plant are complemented by steam generators, each with a capacity for 1,000 kg/hour of pure steam.

The supply contract is to be extended by the addition of further autoclaves during 2014. During the course of this year, Telstar will also supply steam sterilisable freeze dryer capacity for the production of injectable products at the plant in Tlajomulco. With a freeze-drying surface area of 19.8m2, each piece of equipment has the capacity to freeze-dry a total of 33,000 vials every 40-hour cycle over 15 cycles a month. Furthermore, two steam autoclaves for terminal sterilization of blisters and culture media will be supplied to the plant located in the industrial area of Guadalajara, which Laboratorios Pisa uses for developing process improvements.

Laboratorios Pisa is a leading pharmaceutical and medical devices manufacturer in Latin America. It was founded in 1945, and supplies medicines and medical equipment to the public and private health and hospitals market, particularly solutions-for-injection, formulas for artificial nutrition, oral rehydration, medicines for cancer, anesthesiology and antibiotics.

CPI Announces Investment into Biologics Factory of the Future

The Center for Process Innovation (CPI) has announced an investment of £20 million ($34 million) to create a Biologics Factory of the Future, £10 million ($17 million) of which is awarded by Tees Valley Unlimited Local Enterprise Partnership, as part of Local Growth Fund and their Growth Deal. Due to open in 2017, the new facility will allow organizations to develop and test medicine-manufacturing technologies that can be directly applied in the new personalized therapeutic supply chains.

The announcement comes as part of a £379 million ($645.8 million) investment into the region from the government’s flagship Local Growth Fund, which is designed to create jobs and ensure that every part of the country shares in economic growth. Located at Central Park, Darlington, the new facility will locate and integrate alongside CPI’s £38 million ($64.7 million) National Biologics Manufacturing Center, which is currently under construction on the same site and due for completion in 2015.

The provision of medicines to patients is changing from “one size fits all” to a personalized approach. This will have a significant impact on the established medicines supply chain, in that it is currently configured to deliver large batches of a single therapy to treat multiple patients with the same disease. DNA sequencing technologies are facilitating a more thorough understanding of causative mechanisms of diseases, enabling the differentiation of single diseases into multiple subtypes on the basis of underlying genetic factors. It is intended that CPI will enable the development of the process technologies and facility designs to deliver personalized medicines. It will achieve this through integration and simplification of process technologies to enable production at a much smaller scale and with change over between products.

CPI is the process industry element of the UK government’s national manufacturing strategy, the High Value Manufacturing Catapult, a network of seven technology and innovation centers tasked with stimulating growth within key manufacturing sectors throughout the UK.

Penn Pharma's New Manufacturing Suite Operational

In 2013, Penn Pharma revealed plans to invest a further £3million to expand its large-scale commercial manufacturing capabilities at its site in South Wales. Less than 12 months later, Penn is proud to announce that this new large-scale suite is now fully operational. This investment is in addition to the £14million previously invested by Penn when expanding its site with a purpose-built contained manufacturing facility which opened in September 2013.

The new large-scale manufacturing suite includes granulation, tableting and coating capabilities enabling Penn to increase overall capacity and address the growing market need for large-scale commercial outsourcing.

With over 0.5 billion doses of capacity now available on site ranging from 1kg to 300kg scale for non-potent and 1kg to 120kg scale for potent molecules, Penn provides expert scientific support for customers. Penn is able to manage the life cycle of a product from the early stages of development, through all stages of a clinical program and on to full commercialization. It is this “molecule to market” offering from Penn that delivers true speed to market for a global client base.

Heritage, experience, quality of service and reliability is why Penn Pharma has become a trusted outsourcing partner for many global pharmaceutical companies and is recognized by the regulatory agencies across Europe, the USA, Japan and South America.

The recent investments ensure that Penn is able to continue to meet current and future demands of both its existing and new clients.

West Pharmaceutical Services opens New Plant in India

To support growth in Asia, West Pharmaceutical Services has dedicated its manufacturing plant in the Sri City Special Economic Zone (SEZ) in Chennai, India. In June 2012, West signed a 99-year lease on 72,800 sq meters (about 783,600 sq ft) of land in Sri City and started construction in August 2012 on a 15,300 sq m (about 164,700 sq ft) facility for manufacturing seals used in primary packaging of injectable medicines.

“West is experiencing a very exciting period of growth and business expansion in Asia and we are proud to open our first facility in India,” stated Donald E. Morel, Jr., West’s Chairman and Chief Executive Officer in a press release. “With more and more pharmaceutical customers establishing operations in India, our new plant will help West meet market demand and further establishes the company’s presence in this growing and dynamic market.

“On behalf of West’s Board of Directors, I would like to thank the many representatives of the Indian government for their support throughout the planning process," he continued. "This new facility in Sri City will allow West to continue to satisfy the needs of our customers, who are serving a growing number of patients in India and the Asia Pacific region.”

West's new facility will serve its pharmaceutical and biopharmaceutical customers in India and the wider Asia Pacific region.

“This investment is important to our strategy of partnering with customers in India and the Asia Pacific region to help them provide medicines to patients more efficiently, reliably and safely,” stated Warwick Bedwell, President, Pharmaceutical Packaging Systems, Asia Pacific Region. “With the facility complete, we anticipate a reduction in lead times for supply to our customers in India. By leveraging our global sourcing activities and process engineering expertise, we expect to be able to carefully manage the overall costs of production.”

Future plans include expanding production to include West’s elastomer component business.

West already operates a plant in Singapore; two plants in Qingpu, China; and sales offices in Australia, China, India, and Singapore.

West also owns 25% of Daikyo Seiko, Ltd, Tokyo, Japan, which is involved in pharmaceutical packaging and medical device components. The West/Daikyo relationship was formed in 1973 and includes joint marketing agreements and technology transfer and licensing agreements.

RB to Build Consumer Health R&D Center

Consumer health and hygiene company RB plc, formerly called Reckitt Benckiser, has revealed that it will establish a research and development center in the north of England.

The company will invest £100 million to build the facility as part of plans to grow its global consumer health business.

The availability of effective self-medication is a critical part of the growing socio-economic need to help people manage their health, commented Rakesh Kapoor, RB Global CEO.

Located at its existing site in Hull, the Centre of Scientific Excellence will be one of six major R&D facilities operated by RB around the world. It will serve as the global technical innovation hub for products such as Nurofen and Strepsils.

In a statement announcing its investment, RB said that it chose the Hull site following a review that considered RB's other R&D locations. The decision reflects the UK's consumer health expertise as well as the UK government's positive attitude towards encouraging innovation, science and technology, it said.

To help fund the project, RB has been granted £6 million from the UK Regional Development Fund. Design and planning work for the new building is under way and construction work is expected to start early next year. The center, complete with state of the art consumer health laboratory facilities, will be fully operational by early 2018.

RB's health, hygiene and home brands include Nurofen, Strepsils, Gaviscon, Mucinex, Durex, Scholl, Lysol, MegaRed, Dettol, Veet, Harpic, Bang, Veja, Mortein, Finish, Vanish, Calgon, Air Wick and French's.

SGS Life Science Services to Expand Shanghai Facility

SGS Life Science Services announced plans to expand its Shanghai, China, cGMP chemistry and microbiology laboratories to 2000-m2 (16,140 sq. ft.)by Q2 2015 and will offer new services from the facility, including a new biotechnology laboratory for cytotoxicity testing, cell-based assays, plus endotoxin and ELISA testing.

The current 1500-m2 facility provides services for method development and validation, testing of raw materials, APIs and finished products, as well as testing of traditional Chinese medicines.

The expansion program, which is due to commence in August 2014, will also see the introduction of packaging testing, including extractables and leachables; an inductively coupled plasma mass spectrometer, for USP<233> Elemental Impurities, will also be located within the laboratory.

Other new capabilities at the Shanghai site will include a dissolution lab for generic drug stability studies, a mycoplasma lab focused on the biological market, and a highly active compound (HAC) testing laboratory to meet growing market demand. In addition to new office space, a drug compatibility study lab, designed to meet regulatory requirements, will also be introduced.

Citing figures from China’s National Development and Reform Commission, we were told the pharmaceutical industry in China has seen a Compound Annual Growth Rate (CAGR) of 22% over the past ten years.

The investment in the facility will therefore service overall market demands in China, and “given the high quality requirements for a cGMP lab, there are few competitors in China that can offer and meet such high standards for this market,” SGS said.

On top of the additional services listed above, SGS will begin packaging testing - including extractables and leachables – as well as offer generic drug stability studies, a mycoplasma lab focused on the biological market, and a highly active compound (HAC) testing laboratory.

SGS has 21 laboratories worldwide offering services to international pharma companies, so we asked how regulations in China differed to those in Europe and the US.

“Typically, for multinational customers, they need the services in China to meet the same level of compliance in US and Europe. When offering these services in China, they must also comply with Chinese local regulations,” SGS said.

“The Shanghai lab has implemented, and has been operating both compliance systems in the lab for several years, and the new investment will also follow the same compliance levels to meet both local and multinational requirements.”

Scotland, Kenya to launch Tropical Livestock Genetics Center

Scientists in Scotland and Kenya will work together in a new international center focused on studying livestock genetics to improve the health and productivity of tropical farm animals, The Roslin Institute said.

A joint effort between the University of Edinburgh, Scotland's Rural College (SRUC), and Kenya's International Livestock Research Institute (ILRI), the Centre for Tropical Livestock Genetics and Health will develop technologies to help farmers in developing countries identify the animals for breeding that will boost the economic value and quality of their livestock.

The research teams in both nations will study genes that provide disease resistance and enable some breeds to thrive in a warm, arid, climate, and they will aim to characterize new diseases that emerge and track outbreaks.

"Modern genetic approaches offer new opportunities to identify livestock suited to the diverse and demanding conditions under which African smallholder farmers work," ILRI Director General Jimmy Smith said in a statement.

The site in Scotland will be at the University of Edinburgh's Easter Bush Campus, where the Roslin Institute, the Royal School of Veterinary Studies, and Scotland's Rural College, are located.

The Kenyan side of the center will be housed at the ILRI, in Nairobi, and will involve researchers from the institute's LiveGene livestock genetic program and the Biosciences eastern and central Africa Hub.

Geoff Simm, a professor and vice principal of research at Scotland's Rural College, said the alliance "has the potential to transform our international efforts to help improve livestock genetics, enhancing food security but also reducing the environmental impact of global livestock production."

Alcon Opens Ophthalmic Pharmaceutical Manufacturing Plant in Singapore

Alcon, the global leader in eye care, officially opened the doors to its new state-of-the-art ophthalmic pharmaceutical manufacturing facility in the Tuas Biomedical Park in Singapore. This new facility allows Alcon to be closer and quickly respond to its growing base of customers and patients throughout Asia, who rely on the Alcon portfolio of products for healthy vision.

“The need for quality eye care is increasing rapidly across Asia, as the population grows and ages,” said Roy Acosta, Area President, Alcon Asia-Pacific. “With the opening of this new manufacturing facility, Alcon is making a strong investment in the future of our business in Asia, and ensuring that our innovative products are readily available to those who need them.”

Construction on this 330,000 square foot facility began in 2009, and represents an investment of approximately S$200 million. The plant produces ophthalmic pharmaceutical products which address eye conditions such as glaucoma, dry eye, allergies and bacterial infections.

“Alcon has more than 20 manufacturing facilities around the world, which use state-of-the-art technology and adhere to the strictest quality standards,” said Acosta. “We are proud to transfer those same capabilities to serve our customers right here in Asia with locally manufactured products.”

Alcon already has experience in operating a manufacturing plant in Singapore. In 2005, the company opened a contact lens manufacturing facility in the Tuas Biomedical Park, to meet the growing demand for DAILIES® contact lenses. Singapore has proven to be an attractive manufacturing environment for Alcon.

“Singapore’s robust biomedical presence, and the highly skilled and knowledgeable workforce made it easy to choose Singapore for our new site,” said Christopher Snook, Country President Novartis Singapore and Head Novartis Group Country Management. “With the opening of this facility, we deepen our relationship with Singapore and strengthen the foundation for the long and very successful future Novartis sees in Singapore.”

“Alcon’s first ophthalmic pharmaceutical manufacturing facility in Singapore further strengthens our position as a global biomedical hub. To support this growing sector, Singapore will continue to work with companies to develop dedicated infrastructure, industry-ready talent and new manufacturing capabilities. We look forward to deepening our partnership with Alcon and Novartis to create good jobs and exciting careers in Singapore,” said Mr. Yeoh Keat Chuan, Managing Director of the Economic Development Board.

The products manufactured at the new Alcon facility address some of the most widespread eye care needs in the region, such as glaucoma.

“Glaucoma is a group of eye diseases that lead to progressive damage of the optic nerve, and is projected to affect nearly 80 million people worldwide by 2020. If left untreated, it leads to irreversible blindness,” said Professor Tin Aung, Executive Director, Singapore Eye Research Institute. “In Singapore, glaucoma is a leading cause of blindness, and is expected to become an even more serious problem in the future.”

To ensure that each product manufactured is of the highest quality, Alcon adheres to the strictest of regulatory and statutory requirements. Through a comprehensive quality management system, Alcon is able to test and monitor all manufacturing processes, and all of its products pass rigorous inspections prior to shipment.

Currently, the facility employs approximately 150 associates, and is expected to continue to grow as production increases.

ReNeuron Opens R&D, Manufacturing and Headquarters Facility

ReNeuron Group plc, the leading UK-based stem cell therapy company, has signed an agreement with the Welsh Government to lease a landmark building at Pencoed Technology Park, near Cardiff, South Wales.

A key element of ReNeuron’s £33 million funding in 2013 was support from the Welsh Government and the Welsh Life Sciences Fund, allied to the relocation of the business to a new state-of-the-art facility in South Wales. This move will bring together ReNeuron’s world class research and development activities, GMP cell manufacture and allied corporate functions in one location, providing operational synergies as the company’s therapeutic candidates move through clinical development to future market approval. The company envisages the creation of up to 70 further jobs to be based at the site as cell manufacturing comes on-stream and builds over the next two years and beyond.

ReNeuron plans to commence the relocation of its operations to this site in April 2015, when the conversion of the existing building is expected to be complete. The ground floor of this facility will provide the company with more than 25,000 square feet of state-of-the-art research and development laboratories, GMP cleanrooms designed for automated cell culture, and office accommodation, with scope to expand further if required in the future.

When licensed for GMP cell manufacture, the facility will provide for ReNeuron’s late-stage clinical and initial commercial product requirements, from 2016 onwards.

The cost of converting and fitting out the building will be borne by the Welsh Government as part of the above-mentioned financial support package.

Edwina Hart MBE, Minister for Economy, Science and Transport in the Welsh Government, said:“I am delighted that plans are now well underway for ReNeuron’s relocation to Wales. Life sciences is one of our priority economic sectors and regenerative medicine is fast becoming an emerging sub-sector for Wales thanks to the presence of some world-class researchers. We have ambitious plans to grow this sector and build on our existing strengths. Attracting a company of the caliber of ReNeuron is central to this strategy. Their pioneering work is renowned internationally and the decision to move to Wales has created interest around the world.”

Michael Hunt, Chief Executive Officer of ReNeuron, said, “We are delighted to have signed an agreement to lease this landmark building in South Wales, which marks a further significant step in ReNeuron’s business development strategy.

When complete, we believe the building will house the UK’s most advanced commercial cell

therapy manufacturing facility and we are delighted to continue to work with the Welsh Government to bring this important project to fruition. Taking full control of the manufacture of our cell-based therapies is a key value driver for our business, reducing risk and enabling considerable future cost savings through manufacturing efficiencies and downstream economies of scale. Combined with the recent success we have achieved in developing off-the-shelf cryopreserved cell therapy candidate.

China's Sinovac Gets Grant to Build Vaccine Plant

Chinese vaccinemaker Sinovac Biotech has won a grant from the Chinese government to build a production facility to manufacture its vaccine against hand, foot, and mouth disease (HFMD). The awarding of the grant is a good omen that the government will approve the company's vaccine, which was submitted last year for approval.

The ¥60 million ($9.6 million) "free government grant" will be used to build a dedicated facility for its enterovirus 71 (EV71) vaccine. The company will get ¥20 million up front and the balance when it meets the criteria of the grant, it said. Those criteria include the plant meeting China's GMP requirements, that it be capable of producing 20 million doses of EV71 vaccine, and that the company commercializes the vaccine in China.

"From 2007 to 2013, over 9 million cases of HFMD have been reported in China with approximately 2,700 reported fatalities," Sinovac CEO Weidong Yin said in a statement. "This epidemic situation represents a significant unmet medical need for the EV71 vaccine. With the government support for building out the dedicated production capacity, Sinovac is poised to provide the EV71 vaccine to help address this potentially fatal childhood disease for which no commercialized vaccine and no EV71 specific treatment exist."

While based in and focused on China, Sinovac is also approved to sell some of its vaccines in other countries, like Mexico. It is the only supplier of the H5N1 pandemic influenza vaccine to the Chinese government-stockpiling program. It submitted its EV71 application to the China Food and Drug Administration in May 2013, and the vaccine is currently under technological review by China's Center for Drug Evaluation.

Pexco expanding Mexico Manufacturing

The expansion, designed to support specifically its growing medical division, will include a new building and manufacturing space with a dedicated medical manufacturing cleanroom environment adjacent to its current operation.

Pexco plans the expansion to be production-ready by August to bolster its medical device manufacturing capabilities in the Tijuana region and America's West Coast.

“This expansion, coming on the heels of our acquisition of Spectrum Plastics last year, further underscores the focus and commitment of our business to the medical plastics market," Pexco President Neil Shillingford said. "Pexco has been in medical plastics for over 50 years and the Baja California region remains a strategic center for medical manufacturing if not the capital of medical device manufacturing in North America. It is a necessary investment to support our customers, their needs and growth, and the continued success of our Mexicali operation for medical tubing, profile extrusion, and other value-added services. We are thrilled to be able to conduct it.”

Pexco has had a manufacturing presence in Baja California since it acquired the Multitube extrusion operation in May 2011 and claims to be the only independent local Mexican medical plastics extruder in the Tijuana medical manufacturing cluster zone. The company currently manufacturers from a 17,000 square-foot facility featuring a Class 8 cleanroom and 10 production lines. The expansion will add approximately 31,500 square feet of production and warehouse space to the current footprint with a 7,600 square foot clean room for the company’s medical division.

Part of Odyssey Investment Partners LLC and based in Atlanta, Ga., Pexco designs and develops custom and specialty plastics products focusing on niche, high value-added end markets. It provides standard and specialty parts and components to manufacturers and end-users in the aerospace and defense, medical, and industrial markets. Pexco operates five Class 8 and one Class 7 clean rooms, and operates 11 facilities in the United States and Mexico.

AstraZeneca, MRC to Create New Drug Discovery Facility

AstraZeneca is teaming up with the Medical Research Council (MRC) to create a research facility at AZ’s new R&D center in Cambridge, U.K. The center, dubbed the AstraZeneca MRC U.K. Centre for Lead Discovery, will be located within AZ's new site at the Cambridge Biomedical Campus.

AZ and MRC say, per the collaboration, academic researchers at the facility will receive access to over two million molecules from AZ’s compound library, in addition to the firm's high-throughput screening facilities. The MRC will receive, assess, and select the best scientific proposals from a range of therapy areas and diseases; it plans to fund up to 15 screening projects per year at the new center. AZ will have the first option to enter a negotiation to license any drug discovery programs of relevance to areas of interest to the firm resulting from the research. If AZ doesn't use this option, the researchers are free to negotiate with other parties.

The Cambridge Biomedical Campus site where the new center will be built is currently scheduled for completion in 2016 and was the product of a £330 million (around $548 million) investment in March of 2013.

"This major strategic alliance with the MRC is the first of its kind," Menelas Pangalos, AZ's evp, innovative medicines and early development, said in a statement. "It will further AstraZeneca’s aim of creating a truly innovative and collaborative research environment at our new site in Cambridge, where our teams will work side by side with world leading MRC scientists."

McIlvaine Company

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