The Icahn institute for Genomics and Multiscale Biology at Mt. Sinai is opening a new next-generation sequencing facility in Branford, Conn. The facility will be equipped with eight of Thermo Fisher Scientific's Ion Proton systems and eight Ion Chef systems, along with the Torrent Suite Variant Caller and customized AmpliSeq panels.

Researchers at Mt. Sinai and Thermo Fisher collaborated to develop a custom AmpliSeq panel consisting of 26,000 amplicons that cover 700 genes known to increase the risk for inherited genetic diseases, cancer, cardiovascular disease, obesity, and other disorders.

The Mt. Sinai team plans to use the Ion Proton as part of its Resilience Project, a research project to better understand the genes and other factors that may protect individuals from developing rare, catastrophic diseases.

Robert Sebra, director of technology development and an assistant professor of genetics and genomic sciences at Mt. Sinai, said in a statement that the Proton's "low per-sample cost, robustness across sample types, rapid end-to-end data generation, and the breadth of the AmpliSeq targeted custom panel for screening hundreds of targeted genes in a single sequencing assay indicated the platform as a highly efficient system for addressing the large volume and diversity of samples we intend to sequence in our new NGS lab."

Eric Schadt, the founding director of the Icahn Institute for Genomics and Multiscale Biology, also said in the statement that the researchers plan to develop "a wide range of clinical tests to be run on the Proton" at the new sequencing facility, including an Ion AmpliSeq Cancer Hotspot Panel, which he said recently gained approval from the New York State Department of Health.

"As we scale up to processing large volumes of samples, we expect to rapidly advance our translational research findings in major disease areas such as cancer, rare inherited disorders, and characterization of risk across a broad spectrum of common human diseases," he added.

Akorn Breaks Ground on Expansion

Akorn Inc. has broken ground on a project that will add 40,000 square feet to its plant. The company recently bought a neighboring property to accommodate the expansion.

Akorn is also remodeling and modernizing equipment as part of an $18 million project to increase production. The Decatur-based maker of generic pharmaceuticals employs 435 people and says the expansion could create more jobs.

Decatur has struggled with high unemployment in recent years due in part to layoffs by other manufacturers. The state Department of Employment Security says the unemployment rate in the area was 9.4 percent last month. That's down from 12.5 percent a year earlier.

Pandemic Vaccine Facility Dedicated in Texas

Government officials from Texas and the US Department of Health and Human Services joined representatives of Texas A&M University, Texas A&M Health Science Center and GlaxoSmithKline to dedicate a national pandemic influenza vaccine manufacturing facility in Bryan, Texas.

Construction of the 100,000-sq-ft Pandemic Influenza Vaccine Facility is scheduled for completion by the end of 2015, to be followed by start-up and validation phases that are expected to be complete by early 2017. When fully functional, the facility is expected to have the capacity to produce the bulk antigen needed for up to 50 million adjuvanted pandemic influenza vaccine doses within four months of a declared influenza pandemic and availability of acceptable virus seeds.

The Pandemic Influenza Vaccine Facility and the adjacent Viral-based Vaccine Facility, which recently entered final design development, are part of the Texas A&M Center for Innovation in Advanced Development and Manufacturing (CIADM), one of three such national centers for innovation supported by the U.S. Department of Health and Human Services and the only one housed at an academic institution.

CIDAM was founded on a $285 million public-private partnership between the US Department of Health and Human Services, and collaborating academic, commercial, and State of Texas stakeholders. Key objectives include performing advanced research and development, ensuring domestic manufacturing capacity, enabling FDA approval of products, and mentoring the next generation of public health professionals through education, training and outreach, according to an organization statement.

University of Alabama Opens New High Tech Cleanroom

The engineering department of the University of Alabama in the US has opened a new cleanroom, which is officially known as the Microfabrication Facility, or MFF. The lab is an expansion and relocation of the original facility, which was launched in January 2007. It is directed by Dr Subhadra Gupta, UA professor of metallurgical and materials engineering.

The state-of-the-art, 7,111 sq. ft. facility was previously housed in two other sites on campus before finding permanent space in the North Engineering Research Center. It will be used for research into computer memory and solar panels, among many other applications. The lab is open to researchers across campus, and features three cleanroom bays: one 510 sq. ft. Class 100 bay; and two 863 sq. ft. Class 1000 bays. The technology being used to create transistors is photo-reactive, and sensitive to ultraviolet light, so light filters for ultraviolet light pull out much of the blue light portion of the visible light spectrum too, resulting in a yellowish tinge. 'What we are doing is making tiny devices, and these can be applied toward solar cells, they can be applied to semi-conductor chips, they can be applied toward the guts of a computer disk drive and other unique and interesting things like that,' said Dr Gupta.

Cubist Opening New International Headquarters in Zurich

With resistant bacterial infections resulting in an estimated 25,000 deaths in the European Union and 23,000 deaths in the United States annually, the issues of rising antibiotic resistance and the lack of treatment options have raised alarms with world leaders. As the call to action grows louder, Cubist Pharmaceuticals Inc. announced the official opening of its international headquarters in Zurich, Switzerland, reinforcing its commitment to global public health. Located in a growing biopharmaceutical hub in Switzerland, the company’s international operations complement the Cubist’s corporate headquarters in Lexington, Massachusetts in the United States.

To address the urgent need for new antibiotics, during 2014 Cubist expects to invest approximately USD 400M on antibiotic R&D, and is focusing its late-stage pipeline on addressing serious and potentially life-threatening healthcare-acquired bacterial infections. Led by Patrick Vink, senior vice president and general manager of International Business at Cubist, the company’s international operations will focus on preparing for the launch of potential new antibiotics in Europe during 2015.

“Dangerous superbugs know no geographic boundaries. Cubist has never been more committed—nor better positioned—to lead the battle against superbugs. We are one of the few companies globally to take on the challenge of antibiotic resistance, and this expansion enables us to continue to address the growing medical need,” said Vink. “We selected Zurich for the location of our international headquarters due to its proximity to other markets, access to top talent, and stable business climate, as well as its position as a thriving and growing biopharmaceutical hub.”

Bruno Sauter, deputy minister of Department of Economy and Labor of the Canton of Zurich, commented: “I am excited to welcome Cubist to Zurich, and look forward to the Company’s support of our commitment to create jobs and grow our innovation economy, including in the healthcare area. Cubist’s focus on the vital need to provide doctors and patients with new medicines to treat serious and potentially life-threatening infections is a great example of the type of mission-driven organizations we aim to attract to and nurture here in Zurich.”

Cubist’s international expansion follows its strong performance in 2013, when the Company generated full year total net revenues of $1.1 billion. Cubist has increased its global employee base to approximately 960, up 35% from 2012, when the Company introduced the Building Blocks of Growth, its five-year strategic goals. Approximately three out of every four employees at Cubist are focused on the research, development, commercialization, and support of antibiotics. The company anticipates a significant employee presence internationally, and expects to have around 200 internationally-based employees, of which approximately 50 will be based in Zurich. Cubist is focused on creating new jobs in Zurich and throughout Switzerland, including in medical, regulatory, and commercial capacities, as well as other support functions.

Smithsonian Institution Opens LEED Platinum Lab Facility

The Smithsonian Institution opened the doors of its greenest building to date on Friday, Sept. 19: the Charles McC. Mathias Laboratory on the campus of the Smithsonian Environmental Research Center in Edgewater, Md. Designed to be the first Leadership in Energy and Environmental Design Platinum building in the Institution, the Mathias Lab will emit 37% less CO2 than a comparable lab that does not meet LEED-certification standards.

Before the new Mathias Lab, almost two-thirds of SERC’s office space and one-fourth of its lab space were housed in trailers. The disjointed environment hindered communication and the kind of experiments scientists were able to do.

“The new lab provides us flexible space for future cutting-edge research,” said SERC Director Anson “Tuck” Hines. “Biogenomics, conservation biology, global change—these are all at the forefront of environmental science today. The new lab gives our scientists the ability to explore new territory in a more sustainable way.”

Building a sustainable research laboratory is more difficult than building a sustainable home, office space or school, largely because research environments are highly energy intensive and typically consume three-to-four times as much electricity as other buildings. However, research efforts on climate change, invasive species and conserving the Chesapeake Bay are vital to preserving healthy ecosystems throughout the rest of the world. The challenge for lead architect Howard Skoke of EwingCole was to enhance these research projects while slashing their environmental footprint.

On the south side of the lab, this 4.65-acre constructed wetland acts as rain garden to filter stormwater. The wetland also receives irrigation as part of the lab’s system to recycle 100 percent of its water.

The finished lab’s reduced carbon footprint comes from a substantial reliance on renewables. A geothermal well field with 250 wells provides a highly efficient heat exchange for the lab’s HVAC system, while a 352-kilowatt array of solar panels provides water heating and covers 15 percent of the building’s annual electricity expense. Energy efficiency also received a boost from passive solar lighting, a result of its open interior design and large windows, as well as automated lighting controls and strong insulation. In total, the Mathias Lab will save an estimated 42 percent on energy costs each year compared to a lab without LEED certification.

The lab will also recycle 100% of its water through innovative interconnection of systems. All domestic “gray water” will go to a wastewater treatment plant on the SERC campus within walking distance of the lab. From there, it will be sent back to the lab for reuse in fire protection, irrigation and the water-closet supply. Some of the water will nourish the 4.5-acre constructed wetland on the lab’s south side. Three cisterns will capture rainwater to irrigate the wetland, which will filter stormwater and provide a living habitat for native plants and animals.

The majority of the project’s $57 million funding came from Congress. Construction began in May 2011 with the addition of 69,000 sq. ft. of new laboratory and office space. Renovation of the existing 23,000-sf laboratory completed the project in fall 2014.

“Mac Mathias would have loved this building as much as the research that is going to go on inside it,” said Sen. Ben Cardin (D-Md.). “This new lab will dramatically advance research efforts on conserving the Chesapeake and understanding climate change. Highly energy efficient, heavily reliant on renewable energy sources and quite beautiful, the lab is a statement on how the built and natural environments can continually complement one another.”

“As a strong supporter of the Smithsonian Environmental Research Center, I’m pleased that this new sustainable research facility will provide men and women at the forefront of environmental science with the space needed to conduct their critical work,” said Congressman Steny Hoyer (D-Md.). “Throughout my career, I’ve been proud to support investments in research and innovation, and I look forward to joining the SERC team as they open the new Mathias Lab.”

EwingCole was the design firm for the project. The general contractor was Hensel Phelps Construction Company.

LCMC Health announced Investment in the New Orleans Business Alliance (NOLABA)

“With University Medical Center coming on line in 2015, LCMC has a vested interest in the biomedical corridor and its development," said Greg Feirn, CEO of LCMC Health. The New Orleans biomedical corridor encompasses 1,500 acres spanning the downtown and mid-city areas of New Orleans, and will be anchored by University Medical Center and Southeast Louisiana Veterans Health Care System currently under construction.

“In 2010, we launched the New Orleans Business Alliance as a public-private partnership, charged with leading a coordinated economic development effort for our city,” said Mayor Mitch Landrieu. “With a 9.6-percent increase in sales tax and new businesses from all over the world locating to New Orleans, we have proof that we get more done when we work together."

Baxter’s Boom

Baxter International’s footprint keeps getting larger. In addition to the dots on this map, which each represent operations employing 50 or more, the company operates 65 BioLife plasma centers across the United States.

Baxter’s investment in Opelika, Ala., will eventually mean 200 new jobs in addition to the current payroll of 170.

Baxter International Inc. announced in August that it plans to expand its state-of-the-art manufacturing facility in Opelika, Ala., to help address the growing global demand for dialyzers, a critical component used in hemodialysis therapy (HD), a life-sustaining therapy for patients with end-stage renal disease.

Baxter will invest nearly $300 million in the Opelika site to add 230,000 sq. ft. and several production lines. The company currently employs about 170 people at the facility, and anticipates it will begin hiring an additional 200 workers in 2016 to support the expansion.

"In addition to supporting a greater number of patients having access to therapy, the expansion is an investment in the communities where our employees live and work,” said Robert L. Parkinson, Jr., chairman and CEO of Baxter. The collaboration with Governor Robert Bentley, Mayor Gary Fuller and the many other local officials was a key component of our expansion plan."

Currently, there are nearly 2 million patients worldwide with end-stage renal disease (ESRD) receiving HD therapy. A growing population with diabetes, blood pressure issues and other key causes of kidney disease, means the incidence rate of ESRD and the need for dialysis is also growing by an estimated six to seven percent annually around the world, says Baxter. For many patients with ESRD, HD therapy is performed to remove waste and excess fluids from the body by processing their blood through an artificial kidney (the dialyzer). Clean blood is then returned to the body after the filtering process is complete.

Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, cancer, infectious diseases, kidney disease, trauma and other chronic and acute medical conditions. Baxter had 2013 sales of $15.3 billion and has approximately 61,500 employees.

While the Opelika area is more well known for its automotive cluster, it’s also home to another life sciences expansion by Pharmavite, which last year announced a $16-million, 54-job expansion. Other life sciences investments in the state since early 2013 include Innovative Health Products’ $12-million, 245-job investment in Russellville and Turner Medical’s $5-million, 25-job investment in its medical devices site in Athens in Limestone County.

Illinois–based Baxter has liked the South ever since it established its second manufacturing plant in Cleveland, Miss., in 1950. Two years ago it revealed that it really liked the South by choosing a site near Covington, Ga., for a new manufacturing complex to support plasma-based treatments. The Opelika site sits about a two-hour drive from the new Georgia location.

“As of June 2014, all electricity, natural gas, water and sewer connections at the site are complete,” says Baxter. “Steel construction, roofs and exteriors of the buildings are also nearly complete. The construction team is currently focusing on mechanical, electrical and plumbing installation in preparation for opening the Central Utilities Building.” There are approximately 1,500 contractors on site on a daily basis.

“The integrated campus includes three main manufacturing components, as well as support components such as warehouse and utilities buildings, administrative facilities and laboratories,” explains Baxter. “The initial phase of development is approximately 1 million total gross sq. ft. The timeline on the project spans several years with commercial production scheduled to begin in 2018.

The Baxter products that will be manufactured at the Covington facility include immunoglobulin therapy for patients with immune deficiencies and albumin products, which are primarily used as plasma-volume replacement therapy in critical care, trauma and burn patients.

Baxter expects capital investments at the site to exceed $1 billion by the time the facility is fully operational in 2018. The project is expected to create a total of 1,500 full-time positions in Georgia and more than 2,000 jobs in total across multiple U.S. locations. “As of June 2014, there are approximately 200 full-time permanent Baxter employees in Covington with a goal of having 300 Baxter employees on-board by the end of the year,” says the company. “Hiring focus for the balance of 2014 will be in Maintenance, Manufacturing, Quality, Quality Control Lab, and Validation.”

Halfway around the world, Baxter announced in early August the formal opening of its first advanced recombinant biologic facility in Singapore, and expansion plans for a new recombinant protein processing suite, which process products for hemophilia A and hemophilia B, respectively. When fully operational, the new suite will be the primary global commercial processing facility for the hemophilia B protein therapy.

The establishment of the facility and new investment will have created 450 biopharmaceutical jobs by 2015 in Singapore. The biologics facility in Singapore currently employs more than 400 production staff.

"Baxter's expansion of its biologics footprint in Singapore reinforces our position as a leading biologics hub,” said Yeoh Keat Chuan, managing director at the Singapore Economic Development Board. “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.”

“Singapore's biotech industry has seen tremendous growth in recent years and Baxter is proud to have been a part of this journey,” said Jean-Luc Butel, corporate vice president and president of Baxter's International operations. “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."

Evonik to Open Global Innovation Center in Alabama

Evonik Corp. intends to open a global Innovation center for medtech research and development at the company’s Birmingham, Ala., facility.

The multimillion-dollar project will create up to 25 high-paying jobs, adding to Evonik’s current roster of 100 local employees. Housed at Evonik’s campus off Lakeshore Parkway, it is Evonik’s first innovation center in the United States devoted to medical devices and technology, expanding the German-based company’s health care capabilities.

“Alabama ranks fifth in the nation for medical technology job creation,” said Alabama Gov. Robert Bentley. “Evonik Corp. will expand its footprint in Birmingham to now include research and development of medical devices and technology, and create 25 new jobs. I appreciate Evonik’s commitment to Alabama and look forward to a continued partnership.”

Evonik’s medical devices Innovation Center will expand the company’s local core competencies in medical technology and biomaterial research. The center will focus on current and future customer needs for its specialty chemicals and sustained drug delivery systems (biomaterials and polymers) and develop new system solutions for medical technology.

Evonik chose Birmingham because of the company’s existing presence, the experience base in the region, strong educational institutions nearby and a business friendly atmosphere, according to company and state officials.

“Great innovation drives profitable growth. Last year, Evonik spent $540 million on research and development to offer innovative products. We are very excited to be part of what we see as a new innovation and technology sector in the Greater Birmingham region,” said Sanjay Gupta, Evonik vice president and regional head, corporate innovation strategy and management.

Alabama is an emerging regional leader in creating medical technology jobs. According to U.S. Cluster Mapping, developed and maintained by Harvard School of Business, between 2008 and 2010 nearly 1,600 new medical technology jobs were created in seven Southeastern states – more than half were created in Alabama, ranking the state fifth nationally for medical technology job creation.

“The Evonik Innovation Center project in Birmingham demonstrates the depth and sophistication of medical technology research taking place in Alabama,” said Secretary of Commerce Greg Canfield. “Alabama is a state that offers companies skilled workers, a business-friendly environment and a support system that can make them successful. But Alabama also offers the kind of talent needed to make research and development bear fruit for companies like Evonik.”

Having Evonik’s first U.S. R&D center focused on medical devices and technology in the Birmingham region can be a game-changer for the community, said Steven Ceulemans, vice president of innovation and technology for the Birmingham Business Alliance. “Birmingham’s innovation ecosystem is well suited to support Evonik’s goals in medical technology,” Ceulemans said. “With local innovation centers such as the University of Alabama at Birmingham, Southern Research Institute and Innovation Depot, the resources and human capital are easily accessible.”

Germany-based Evonik is a specialty chemicals company active in more than 100 countries worldwide. It operates a facility in Mobile, Ala., that produces hydrogen peroxide and other chemicals.

Ag-Bio Firm NewLeaf Symbiotics Grows

Agricultural biotechnology firm NewLeaf Symbiotics said that it has raised $17 million in Series B financing.

Proceeds will be used to accelerate the St. Louis-based firm's R&D program, move production from pilot to commercial scale, and launch its first biological products, it said.

NewLeaf develops beneficial plant bacteria and uses genomics technology to discover and analyze plant/microbe interactions. It is looking to launch plant biologics based on a family of bacteria called pink-pigmented facultative methylotrophs to improve crop health and protection.

In December, the company acquired bioinformatics consulting firm Intuitive Genomics to develop bespoke solutions for analyzing and interpreting genomic data.

Otter Capital led the round with participation from existing investors RockPort Capital, Open Prairie Ventures, and Pangaea Ventures. NewLeaf previously closed a $7 million Series A financing round in January 2013.

Wisconsin Energy Institute Lab Design

What are the new design ideas and features that help meet flexibility goals in a lab design? What new lab features help researchers focus on their science goals? They’re generally features and designs that bring resources to researchers without additional expenditure. Functional and flexible casework can also be pleasing to the eye with simple lines, and heavy duty to withstand heavy use.

The lab casework used in Wisconsin Energy Institute (WEI) was not previously off-the-shelf casework. It was specifically designed for WEI and users beyond by Hamilton Scientific. The results were beautiful and the users love it.

Ceiling interface panels (CIPs) are replacing full overhead service carriers in the ceilings of some labs. The idea is new and very flexible. A few years ago, the motivation was to eliminate the heavy service carrier in lab ceilings because they cost the client a lot of money just to provide a rack in which to run utilities, take up space and collect dust in an environment where it’s hard to clean. Some designs provided a simple 2-by-2 tile that introduced utilities in random locations.

But why just add CIPs randomly without regard to the rest of what is located on the ceiling? In WEI, the CIPs were integrated into the simple 2-by-2 ceiling grid. It was designed and specified to incorporate 1-by-2 panels centered over the full length of each lab module. The CIPs were directly attached to the ceiling since the weight is much heavier than a simple 2-by-2 ceiling tile, but it is flat, clean and an attractive design element in the ceiling.

The 1-by-2 panels are perforated, so utilities aren’t connected until needed. They’re outfitted with locking, quick disconnect plugs in order to simplify the ceiling attachment point in the high 10-ft lab ceilings. Blank panels are inserted in locations like aisles where utilities wouldn’t be located in the future.

The contemporary casework design at WEI was developed in response to user’s requests for ease of access to the utilities while still providing movable casework that can accommodate traditional wet lab benches, engineering racks or table-mounted gloveboxes, bioreactors or other specialized equipment.

The perimeter of the labs on Levels 2 through 5 are generally fixed cabinetry with shared storage for the research teams. The center, or “dance floor” in each of the large, open labs is generally designed in efficient 18-ft-long islands that provide space for whatever the users want to locate here, including their lab workspaces.

There are fume hoods in some of the islands, and there are several pieces of equipment with fixed exhaust. Other than these fixed attachment conditions, the layout has been designed to provide fully flexible and reconfigurable islands. Moveable carts have been designed and built to incorporate the utilities needed for equipment or just for computers.

The lab utilities incorporated into the moveable carts include compressed air, vacuum, natural gas and special gases 1 and 2. All are available on the lab work cart at the user interface level. There are vertical power outlets on each cart, including one circuit per side, with two duplexes above the bench, one below. One 208-V outlet is integrated into a cart below the bench at each island.

The mobile cabinets were specified with lockable casters so users could move them wherever they were needed and then create a stable worksurface. They provide a horizontal surface in unusual places.

These are 6-ft-wide movable carts that can support 1,200 lbs on the benchtop (additionally reinforced with steel). The design intent for each of these units was to accommodate three fermenters and associated CPUs, chillers, etc. Other special features include 29-in clearance for tall equipment, and 13 duplexes/cart including two below the bench. Note that five of the extra duplexes are provided using the horizontal raceway at the back. One of the key complaints often heard when scientists comment about their new buildings is the lack of foresight into the emerging power needs. This didn’t happen at WEI. Power and data were clear priorities.

Dr. Yaoping Zhang, the project lead of GLBRC Fermentation Lab in WEI Level 4, says, “we like the moveable carts which give us the flexibility to move our equipment to different locations in the lab. Depending on the lab’s current needs, these very sturdy carts can have different kind of utilities incorporated. On the moveable carts for the bioreactors in my lab, we ordered heavy-duty and heavy-powered carts, since we put bioreactors, computers and other equipment on the table and shelves. The adjustable shelves allow us to put different sizes of bioreactors (up to 44-in height). There are four Ethernet ports on each cart for communication between bioreactors and computers. We also have three gas lines installed on each cart, which we can run different gases for fermentation experiments. These gas lines can be easily connected or disconnected to the ports of main gas lines on the ceiling interface Panels.”

These units were the brainchild of Pete Heaslett, of the Univ. of Wisconsin Facilities Planning & Management Div. They’re the same unit as the moveable cart, but without the bench top.

The intent of these units is to bring specific lab utilities down into equipment islands that are used for equipment and that have no other casework, without occupying much of the premium floorspace in the lab island. This permits floorspace to be dedicated to gloveboxes, biosafety cabinets and analytical equipment, as required.

Note Hamilton Scientific designed these units so they were properly weighted and, therefore, wouldn’t tumble over without the benchtops mounted on them. Hamilton Scientific designed them so users can add benchtops later if a benchtop is needed.

WEI had little need for island sinks in the labs because the current and potential future layouts were designed to accommodate sinks around the perimeter.

Two sinks were exceptions to this perimeter condition. These sinks make use of Wisconsin State Law that allows "island venting" for plumbing so no vertical pipes for venting or water are required to extend up through the ceiling within the island. The water lines and vent stacks run under the floor until it connects with a vertical stack.

These are viewed as movable when the plumbing beneath (water, drain and vent) is disconnected so that the sink can be relocated and replaced with some other piece of casework with more ease than if it were permanently located.

A key scientist and principal investigator in WEI, Dr. John Ralph, had the following to say about the design: “Researchers in the chemistry labs in particular have been extremely pleased with the convenience and functionality of these arrangements. Quite honestly, movability has not (yet) been an issue as the lab is considered quite stable and functional, but having the flexibility designed in is likely to be a huge asset in the future. The hoods in particular are a highlight of one of the labs; they function well and add to the safety of the lab and the building. Overall, the design is pleasing and functional—it’s something of a showcase for visitors.”

Ampio Pharmaceutical Opens New Facilities

Ampio Pharmaceutical announced the opening of its new headquarters, manufacturing and research facility in Englewood, Colo. It’s designed to manufacture and package 10 million doses per year.

“This advanced, labor-efficient, pharmaceutical drug manufacturing facility will be fully operational this summer, right on schedule, to produce the first batches of AmpionTM necessary to accommodate the company's BLA application to treat osteoarthritis-of-the-knee,” said Michael Macaluso, Ampio's CEO.

FDA approval for manufacturing to proceed came one week later on July 30.

Natoli opens R&D Site

The Natoli Engineering Company has opened an pharmaceutical research institute to look for answers to enduring formulation problems in solid oral dosage.

The Natoli Institute for Industrial Pharmacy Research and Development was built at Long Island University, US, in partnership with the Arnold and Marie Schwartz College of Pharmacy and Health Sciences.

“The facility features traditional solid dosage formulation equipment, as well as the technology to measure the physical and chemical properties of tablets,” said Chuck Kettler, Director of Natoli Scientific.

The site has suites for studying formulation, compression, and coating of drugs. Work will concentrate on long-time problems the compression of tablets, the development of formulations for new and existing molecules, and the tablet press measurements needed for proper delivery formulation.

The laboratory can be used by undergraduate and graduate students looking for solutions to formulation problems, as well as providing resources to the tableting customers. Outsourcing will include studies into tablet disintegration, sticking and picking, bioavailability, and formulation and feasibility.

Natoli’s pharmaceutical work includes making tools for pill manufacturing, as well as conducting tablet design for clients.

University to open New Cleanrooms

George Washington University researchers and faculty will move into the Science and Engineering Hall's approximately 500,000 sq. ft. facility in December, in advance of the building’s scheduled opening at the start of the spring 2015 semester.

Alex Weller, an 11-year Division of Operations staff member, will serve as building manager and facilitate the move-in process.

“In 2011, the university broke ground on a vision for an interdisciplinary research facility with state-of-the-art research space,” Senior Vice Provost for Academic Affairs and Planning Forrest Maltzman says. “This vision is months from becoming a reality. Science and Engineering Hall will inspire a new generation of faculty, researchers and students to explore their chosen fields of study, work together in ways they never could before and push the boundaries of innovation and discovery.”

Weller, who has been working with the SEH project team since its inception, will oversee day-to-day operations of the complex interdisciplinary space, which includes wet and dry laboratories, collaborative teaching areas, lounges, and an aquatic suite.

SEH also includes a three-story high bay, an area with a strong wall and floor that is reinforced to handle the stress of large-scale experiments. Researchers will also make use of a nano-fabrication cleanroom for designing and manufacturing nano-scale devices, an imaging suite for producing high-resolution images, and a greenhouse.

“We are thrilled to be included in the Science and Engineering Hall, which will give Milken Institute SPH researchers world-class laboratory space and equipment, and the ability to push forward on a number of global public health problems,” say Michael and Lori Milken Dean of Public Health Lynn R. Goldman. “We look forward to working across disciplines to accelerate the search for improving the health of communities.”

SMHS Dean and Vice President for Health Affairs Jeffrey S. Akman said that the space also will benefit the university’s health and medicine research.

“SEH will enable more opportunities for research and discovery in health and medicine,” Dr. Akman says. “In the new space, the School of Medicine and Health Sciences will expand its research capabilities in the area of translational science, building bridges between the lab and the clinic to deliver novel therapies to patients.”

SEH was designed to encourage interdisciplinary partnerships, Weller says. To that end, departments and schools will be arranged in “research neighborhoods” that place laboratories and office space for different disciplines next to each other around a central, spiraling staircase.

The facility, which is lit naturally by an expanse of glass windows, will put research on display in glass-enclosed laboratories. It also features a multi-chamber cleanroom for researchers who need an isolated, sterile environment for developing, manufacturing, and testing devices.

SEH also boasts a basement-level aquatic suite for the Department of Biology and an imaging suite.

Novartis to build New Development Center

With a lead chimeric antigen receptor program holding on to a breakthrough drug designation at the FDA and Penn's Carl June grabbing headlines for the data his team is seeing among cancer victims, their big pharma backer Novartis ($NVS) is contributing $20 million to build a new, 30,000-square-foot research center at the university that will concentrate on developing a wave of new immuno-oncology drugs.

The center--to be added at the rear of the Perelman Center for Advanced Medicine on Penn Medicine's University City campus--will have a staff of about 100 specialized workers in the field. Novartis's contribution will cover part of the total cost of the center.

The Center for Advanced Cellular Therapeutics (CACT) is to be built on the Penn Medicine campus in Philadelphia, where they will be genetically reengineering patients' T cells with chimeric antigen receptors to make them much more efficient cancer cell killers. Novartis licensed in the work, which has been racing against a rival team at Seattle-based Juno Therapeutics to bring in the first approval in the field.

Juno and Novartis and all the researchers involved are also engaged in a nasty legal battle over the technology used in CAR-T treatments.

"The past five years have been a time of explosive, exciting progress in the field of cancer cellular therapy," said June in a statement. "The results we've seen among the leukemia patients we've treated using our 'hunter' cells have accelerated our expectations for the potential of these new therapies. Today, many of those brave patients are thriving, and through our work in the CACT, we hope to offer that chance to patients with many other types of cancers."

Slated for completion in 2016, this new facility will double the amount of space dedicated to CAR-T work at Penn. The university says that the expanded team will focus on vaccine development, assay development and correlative studies of blood and other biospecimens to examine how trial participants respond to the therapies they receive.

Novartis CEO Joe Jimenez has been an enthusiastic advocate of all things related to Penn and CAR-Ts. In an interview with Forbes earlier this year he essentially vowed to hand over a blank check to the investigators to hurry their work along. And in addition to the work at Novartis and Juno, Kite ($KITE) and other biotechs have been following up with a burst of new programs of their own.

Pfanstiehl Gearing Up for Potent API Expansion

Pfanstiehl is aggressively investing in its potent API contract manufacturing capabilities at its US-based cGMP facility located north of Chicago.

This expansion has taken the form of new state-of-the-art equipment, updated permanent and flexible containment solutions, open development and manufacturing capacity, top tier technical and business development personnel, as well as a new collaborative culture focused on delivering customized solutions to clients from early development / toxicology through drug commercialization.

Pfanstiehl is focused on building on its nearly century-old heritage by encouraging prospective clients to 'Rediscover Pfanstiehl'. As the first company worldwide to obtain the prestigious SafeBridge certification for potent compound handling and manufacture, Pfanstiehl is well-positioned to address the growing market need for elite-level manufacturers of cGMP drug substances, which includes highly potent linker-toxins that play a critical role in an ADC platform.

Matt Tower, Pfanstiehl's new director of business development and SAFC alumnus, believes that Pfanstiehl's timing could not be better. "I'm thrilled to be a part of the rediscovery, growth, and success of Pfanstiehl's API / HPAPI offering," he said. "Today's successful pharmaceutical and biopharmaceutical companies demand a perfect blend of speed, quality, communication, and flexibility from their drug outsourcing partner. We feel Pfanstiehl is well positioned to meet and exceed these expectations."

With the globalization of the industry, API sourcing experts are increasingly challenged with the often daunting task of selecting manufacturing partners from around the world, while trying to gain an understanding of the supply chain and regulatory complexities that apply by region and often by molecule. The global regulatory environment, now more than ever, dictates that these critical actives not only function properly, but are manufactured under cGMP, are derived from a supply chain with the appropriate level of traceability and transparency, and are manufactured safely, sustainably, and economically.

Since shedding Ferro in April of 2013, Pfanstiehl has been reinvesting in its two core businesses; highly potent APIs and high purity cGMP-produced injectable grade formulation components. Long-known for its first-in-class process chemistry expertise, Pfanstiehl is focused on delivering superior quality, technical and service excellence, and innovative customer solutions.

GE Healthcare to open U.S. Life Sciences HQ in Massachusetts

GE Healthcare Life Sciences will open a new US headquarters for GE Healthcare Life Sciences in Marlborough, Mass., according to a statement released by the firm and the Massachusetts Life Sciences Center.

The 160,000 square-foot facility is expected to open in the spring of 2015. GE said that it will invest $21 million in the site, which will house 500 GE Healthcare Life Science employees, including more than 220 new jobs. It said that the currently unoccupied space will be transformed into state-of-the-art labs, customer application facilities, and office space, and it will complement GE Healthcare Life Sciences' existing manufacturing facilities in Westborough, Mass.

The new headquarters will consolidate GE Healthcare Life Sciences' US East Coast presence and include employees from across the life sciences business, including research, bioprocessing, medical imaging, in vitro diagnostics, and services.

This is the first time that GE has established a US headquarters for the life sciences business, according to a GE spokesman, with operations previously spread among sites in New Jersey and Massachusetts. He said GE Healthcare Life Sciences' global headquarters remain in Amersham, UK.

"Our new facility in Massachusetts will position us for continued innovation and competition in such a fast-paced, innovative industry," Kieran Murphy, president and CEO of GE Healthcare Life Sciences, said in the statement. "We will 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."

GE Healthcare Life Sciences generates around $4 billion in annual revenues from the sale of research tools aimed at accelerating molecular medicine, as well as for basic research of cells and proteins, drug discovery, cell therapies, and regenerative medicine.

The Massachusetts Life Sciences Center is a $1 billion state-funded effort to support life sciences research, development, and commercialization in Massachusetts.

Wisconsin Health Care Campus Achieves Water Conservation

The University of Wisconsin Hospital & Clinics incorporates a number of water sustainability measures.

The University of Wisconsin Hospital & Clinics (UWHC) will soon open UW Health at The American Center. Referred to as a health care campus, the 42-acre site includes a 492,000-sq-ft hospital, a universal care center, and a wellness campus, representing a unique approach for the Madison, Wis.-based health care provider to serve a growing patient population and establish a service point separate from the main UWHC campus.

The three-wing facility is designed to be U.S. Green Building Council LEED for Healthcare Silver and to promote the city’s goal of reducing water use. From a base design that would have used 17.6 million gal/year, the selection and right-sizing of mechanical systems and facility equipment reduced the total water demand to 11.7 million gal/year. Of that number, more than half of the building’s water use (6.1 million gal/year) will be with second-generation (reuse) water.

This water reuse enabled the project’s stormwater management ponds to be designed to a reduced water infiltration level, supporting site design objectives and making it easier to secure approvals for the stormwater management plan. When the building opens in 2015, UWHC will avoid purchasing 12 million gal/year of potable water that the base design would have used.

“We practice our mission of advancing health both within our facilities and in the communities we serve,” said Ralph Turner, UWHC vice president of facilities and support services. “The water-conserving design of UW Health at the American Center illustrates this, partnering with our host city to meet the water needs of our growing community without increasing groundwater withdrawal.”

The facility incorporates a number of sustainability measures, including the following design elements that work to reduce building energy demand and water use:

•Heat recovery chillers for base load heating and cooling
•High-performance window glazing and roof
•High-performance chiller plant with optimized chilled water plant, and six cycles of concentration
•High-performance boiler plant with stack economizers
•Efficient lighting, daylight harvesting, and lighting controls
•Comprehensive HVAC controls to setback unoccupied airflows in operating rooms, imaging, and outpatient spaces
•Chilled water cooled imaging equipment
•High-performance central kitchen with variable air volume (VAV) hoods, end-skirts, efficient appliances, water-cooled freezers, and efficient hood layout.
•Design elements that reduce water use and, consequently, reduce building energy demand, with a premium placed on reducing potable water use include:
•Chilled water cooled sterilizers (207 gal of quench water avoided per cycle, 15 gal evaporated in cooling tower per cycle)
•A system of interconnected ponds that receive and naturally filter water from air handling units, roofs, lawn, and parking areas
•A cooling tower and landscape system that use water from the site’s interconnected ponds
•Landscape design with minimal irrigation needs
•An isopropyl alcohol liquid pool cover to reduce pool evaporation by 40% and reduce dehumidification and makeup water heating
•Efficient water fixtures and devices.

In addition to the direct energy and water savings from these systems, reducing cooling loads on the main chillers reduces heat rejection and consequently evaporated water, drift, and blowdown. Reducing heating loads on the steam boilers reduces blowdown. For nearly every energy savings, there is a complementary water savings, and vice versa.

Even with relatively low water and sewer rates, the design of this building was able to offer the building’s owner a payback of less than three years for many of the water use reduction-and-reuse elements of the building design.

AtriCure plans Headquarter Building

When AtriCure Inc. opens its new headquarters 18 months from now, the new space will have added room for mock laboratories and training centers to educate customers how to use its surgical products.

There will be extra room to grow, and expanded manufacturing floor space to add greater production capacity than what the company does now, according to executives.

AtriCure, which makes medical devices used in heart surgery, starts construction this month on the new 85,000-square-foot office, manufacturing and research building on Innovation Way in Mason. By the time it opens in late 2015 or early 2016, approximately 200 "well-paid" employees will move to the building from AtriCure's current offices in West Chester Twp.

They include advanced manufacturing workers, engineers, marketers and other administrative employees.

In Mason, AtriCure will join high-tech neighbors such as Luxottica Group, L-3 Cincinnati Electronics, Lindner Center of HOPE and Seapine Software.

Mason city officials are planning for more development of retail, hotels and other amenities to provide services to companies in the Western Row Road, Innovation Way and Interstate 71 area where AtriCure is building, which is being referred to as the OakPark District.

"Not only do we like to attract innovative companies in the City of Mason, but we also like to be a part of that ecosystem particularly in biohealth," said Michele Blair, economic development director of Mason. "That's a really strong focus of ours."

The move from Butler to Warren County to state-of-the-art facilities is key to AtriCure's next stage of growth. Founded in 1994 as a small technology startup, the bioscience manufacturer has grown to a $100 million revenue business. It makes surgical ablation devices with indication from the U.S. Food and Drug Administration for the treatment of atrial fibrillation, a heart disease that affects an estimated more than 5 million people globally, said Chief Executive Officer Mike Carrel.

"This new facility is necessary for us to meet the demand," Carrel said prior to a groundbreaking ceremony Tuesday, Aug. 26, at the 10.5-acre construction site.

Since Carrel joined the company in 2012, AtriCure has grown from $70 million in revenues. Sales are projected to exceed $100 million for 2014. Employment has grown during the last two years from about 225 workers to more than 300 worldwide including satellite offices in Amsterdam, California and Minnesota. All but about 25 workers are based in the U.S., according to AtriCure spokesman Troy May.

"We want to attract the best and we're creating an environment that will attract the best people," Carrel said.

Ashland expands HPC Production at VA plant

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.

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

Xellia plans to Invest in Raleigh Plant

Xellia has agreed to invest $100m in equipment, retain staff and create 40 full time jobs at the plant it bought in Raleigh, North Carolina in return for business incentives.

The Danish API and finished dosage form maker – in which Novo Nordisk’s holding company is majority shareholder – bought the facility from Fresenius Kabi in July. The acquisition moved them closer to US customers and enhanced its network.

In the weeks since, Xellia has agreed a deal with the City of Raleigh that will allocate 50 percent of paid property taxes to Xellia Pharmaceuticals on a yearly basis for five years.

CEO Carl-Aake Carlsson said, “The acquisition of the Raleigh plant was undertaken prior to the award of any incentive. Our subsequent application for the business incentive was not guaranteed as it required review and approval from the City of Raleigh.

He reiterated that: “The opportunity to apply for a business incentive is of course an attractive prospect but we were committed to developing the Raleigh site from the beginning.”

Under Fresenius’ ownership the facility produced anti-infective drugs and housed extensive freeze-drying capacity, which is one area that could benefit from the $100m investment according to Carlsson.

“We intend to invest significantly in expanding the existing freeze drying capacity at the site but will also consider increasing our capabilities with other injectable product technologies” he said.

If it does decided to invest in injectables Xellia will join other services firms like Hospira , PSC Biotech , DPT and AMRI , which have all been trying to build in the space following the collapse of former sector leader, Ben Venue.

The issue of business incentives has been in the headlines of late after authorities in Hopkinton, Massachusetts decided not to ask Lonza to pay back taxes after the firm decided to shut down its facility in the city.

Carlsson does not expect any problems with Xellia’s incentive deal because “the terms of the business incentive are based on the level of investment that Xellia makes in the site and the meeting of set milestones, therefore we do not envision a situation where taxes would need to be repaid.”

Taylor Floyd, from the Raleigh office of economic development, told us "there is not as of yet a contract in place to formalize this agreement, so the particulars are not available."

Reed-Lane opens Dedicated Serialization Suite

Reed-Lane, Wayne, NJ, a contract packaging provider that serves leading Rx, OTC, and generic drug manufacturers, has completed a dedicated Serialization Suite allowing the company to provide track-and-trace services down to the unit level. The new suite – Reed-Lane’s first for such purposes – debuts with the installation of an Optel Vision TrackSafe^™ system. The initial installation of the line was completed in July 2014. Validation is projected to be completed by the first quarter of 2015, and pilots with company customers shortly thereafter.

The line’s configuration allows Reed Lane to serialize individual cartons; aggregate cartons to cases; aggregate cartons to bundles; aggregate bundles to cases; aggregate cases to pallets; or rework previously serialized items according to customer needs. The Optel TrackSafe line at Reed-Lane’s Serialization Suite comprises the following stations:

A Carton Tracker Pharmaproof Station that incorporates a VideoJet Wolke M600 Dual Head Printer for applying serialized data directly to cartons, and an Optel High-Resolution Commissioning Camera for carton-level serialization.

A Bundle Aggregation Pharmaproof Station that aggregates serialized cartons within bundles utilizing two high-resolution commissioning cameras from Optel Vision. Here, serialized labels are applied with a Domino M-Series Print & Apply Labeler and commissioned with an Optel High Resolution Camera.

A Case Aggregation Pharmaproof Station where serialized cartons or bundles are aggregated within a case using an Optel Ultra High Resolution 15.8 Mega-Pixel Camera installed on a 3M Case Sealer. Serialized case labels are applied with a Domino M-Series Print & Apply Labeler and commissioned with an Optel High Resolution Camera.

A Line Master / Pallet Aggregation Station that aggregates cases to pallets via a serialized pallet label printed from a Zebra ZM400 Printer and commissioned with a Datalogic Magellan 1100i Table Top Scanner. A Datalogic PowerScan M8500 Hand Held Scanner is available for commissioning and decommissioning items as needed.

“The new Serialization Suite provides Reed-Lane with a dedicated space to showcase its track-and-trace services – capabilities that are, understandably, getting higher and higher on the priorities lists of major pharmaceutical manufacturers,” said Patricia Elvin, President of Reed-Lane.

The new Serialization Suite is the latest in a slew of recent upgrades at Reed-Lane aimed at addressing developing customer needs, including the installation of its fifth bottling line, two integrated Uhlmann blister/carton lines, a high speed ampoule labeler and a secured property providing a 30% increase in warehousing space.

DPT Laboratories acquires Meda Pharmaceuticals Lakewood, New Jersey

DPT Laboratories, a contract development and manufacturing organization (CDMO) with a specialized focus on semi-solid and liquid dosage forms, announces the acquisition of Meda Pharmaceuticals’ Lakewood, New Jersey, facilities.

The acquisition reflects the organization’s recent growth, allowing DPT to expand its footprint in Lakewood by adding two buildings totaling 90,000 square feet of space. The real estate meets the organization’s current need for additional cold storage and a larger state-of-the-art analytical laboratory. “

The Meda Pharmaceuticals space allows us to meet the needs of our clients today and beyond,” said Gene Ciolfi, vice president and general manager, Lakewood site operations. “We are also in a better position to explore additional opportunities to further our capabilities from development through commercialization.”

As part of the acquisition, DPT will also absorb Meda Pharmaceuticals’ employees to continue the manufacturing of MUSE, its urethral suppository product. “

We look forward to transitioning Meda Pharmaceuticals’ personnel to the DPT team,” Ciolfi commented. “Their experience and continued dedication to quality complements our commitment to outstanding client service.”

DPT’s current Lakewood location is one of the organizations established Centers of Excellence. This center provides state-of-the-art aseptic processing suites and filling equipment for small-volume parenterals, ophthalmic preparations, preservative-free nasal sprays and sterile ointments.

DPT is a contract development and manufacturing organization (CDMO) helping pharmaceutical companies achieve clinical and commercial success. With five cGMP-compliant facilities in San Antonio, Texas and Lakewood, New Jersey, DPT applies a Quality by Design (QbD) methodology to investigate your product, and discover and deliver the optimal solutions from development through commercialization. We bring vast experience in resolving development and manufacturing challenges in sterile (aseptic) and non-sterile semi-solids and liquids. From drug preformulation and formulation, to analytical method development and technology transfers, to production and distribution, DPT is your partner all the way through full-scale worldwide commercialization.

Grand River opens Second Manufacturing Facility

Grand River Aseptic Manufacturing (GRAM) has opened an additional facility for high-quality parenteral contract manufacturing in Grand Rapids, MI. The new 28,000-sq.-ft. facility will house the company's finishing operations, inspection services, storage and a substantially larger lab.

Mr. Tom Ross, GRAM President, said, “We are very excited to celebrate our expansion in Grand Rapids. GRAM began operations in December 2010 at our facility on 140 Front Avenue in Grand Rapids and we have outgrown that 11,400 square foot facility. Our cleanroom, lab and offices will remain at 140 Front Avenue and represents a significant amount of capital investment. As our company has signed new customers and hired many new employees, we were looking for the right space to handle future growth. Importantly, we now have room to grow and can add new cleanrooms in our new facility.”

Mr. Ross added, “In 2013, GRAM had 25 employees and today we have over 50 highly trained and educated technical staff dedicated to exceptional pharmaceutical services. We appreciate the support of our investors, employees and the West Michigan community as we expand our role in the life sciences effort in our state. The ribbon cutting is an opportunity for GRAM to celebrate with all stakeholders of the company.”

Bayer CropScience plans Further Growth in the U.S.

Bayer CropScience sees a positive long-term market development in North America and is committing significant resources to spur further growth. "We see future growth driven by increasing and sustained demand from customers for improved seeds and innovative crop protection products," said Bayer CropScience CEO Liam Condon at the official inauguration of the company's new integrated R&D site in West Sacramento, California.

"We are investing heavily in R&D infrastructure such as laboratories, greenhouses, and breeding stations as well as new production capacities and seed processing facilities," Condon explained. He said that the company aims to grow faster than the U.S. market. Bayer CropScience plans to invest close to US$ 1 billion (EUR 700 million) in Capital Expenditures (CAPEX) in the United States between 2013 and 2016, mainly to ramp up research and development and to expand a world-class product supply of its top crop protection brands.

These expenditures are part of a global investment program Bayer CropScience started last year, with a total CAPEX for the period 2013 to 2016 of EUR 2.4 billion (approximately US$ 3.3 billion). Bayer CropScience seeks to better leverage its full research and development capabilities by consolidating and expanding its global R&D organization. "Our integrated West Sacramento site represents a major step forward in our efforts to enhance our vegetable seeds and biological crop protection innovation efforts," said Dr. Adrian Percy, Global Head of Research and Development at Bayer CropScience. "The investment into this state-of-the-art facility creates an environment where our researchers and experts can find the best possible conditions to discover solutions that growers across the globe can depend on to produce high-quality food in a sustainable manner."

The new West Sacramento site, which also serves as the global headquarters of Bayer CropScience's Biologics Business, has the capacity to house up to 300 employees. The approximately $80 million facility is situated on 10 acres of land and features a 100,000-square-foot building and a 35,000-square-foot pilot plant to support research and development of biological crop protection products, as well as a 30,000-square-foot Vegetable Seeds research building. The facility will also include a 2,000-square-foot greenhouse and five acres of nearby land for future greenhouse space.

In addition to building its R&D network in the U.S., Bayer CropScience is also investing significantly in the production capacities of its crop protection products. "Along with capacity expansions at our Muskegon, Michigan, and Kansas City, Missouri sites, the construction of our new plant in Mobile, Alabama for the production of our herbicide LibertyT will contribute significantly to our future growth plans," stressed Condon, who pointed out that the increased production of LibertyT will help U.S. growers fight weed resistance, a key challenge for U.S. farmers.

"The single biggest investment item in the U.S. is our planned capacity expansion of LibertyT herbicide. This is a strong signal to the market as LibertyT is the only non-selective herbicide that controls glyphosate resistant weeds," said Jim Blome, president and CEO for Bayer CropScience LP and Head of Crop Protection for the North American region. "Two-thirds of our planned investments in the United States between 2013 and 2016 are intended to expand our production capacities. This includes measures to further optimize our supply chain in order to increase flexibility and thrive despite market volatility," Blome added.

Bayer CropScience is also investing constantly in its Seeds business. In June 2014, the company announced plans to expand its North American and global Seeds headquarters in Research Triangle Park (RTP), North Carolina. The RTP site has experienced significant operational growth in recent years, and approximately $200 million will be invested through 2016. "The construction of greenhouses as well as the necessary infrastructure and land development represent our continued commitment to growth in RTP," said Blome.

The overall RTP investment program includes further important projects, for example, the construction of the Development North America facility dedicated to Crop Protection and Environmental Science research; renovations to Bayer CropScience's North American headquarters, scheduled to be completed in 2015; construction of the 6,000 square-foot North American Bee Care Center; and the purchase of 70 acres of land to accommodate future growth, which includes a new 29,500 square-foot greenhouse.

Bayer CropScience also plans to invest approximately $90 million in its Cotton Research and Development Laboratory in Lubbock, Texas. Founded in 1998, the company's global cotton headquarters is focused on providing cotton growers with the products and solutions they need to meet the world's growing demand for fiber. With a staff of around 120 experts, Bayer CropScience operates two breeding stations, a seed processing plant, a quality assurance lab, a seed warehousing facility, and a state-of-the art research and development lab.

Complementing this, the company also invested $17 million in the expansion of its Memphis Research and Development site, bringing total greenhouse capacity to 76,000 square feet. Located in the heart of the Mississippi Delta, a world-class group of scientists, researchers, technicians, and agronomists with a specialized set of skills is developing high quality cotton and soybean varieties as well as trait innovations. Their aim is to support Bayer CropScience's growing global cotton and soybean seed businesses through molecular breeding and other innovative technologies.

Fujifilm Diosynth Biotechnologies expands Cell Culture Manufacturing Capacity

FUJIFILM Diosynth Biotechnologies has announced continued expansion of its cell culture manufacturing capabilities with the addition of two 2000L single-use bioreactors. One each of these is being installed at the company's sites in Research Triangle Park (RTP), NC, USA and Billingham, UK.

The new reactors will complement the range of vessels at both sites, adding further flexibility for customer requirements. Each site currently operates 1000L single-use bioreactors with 250L to 1,000L operating volumes, with an additional 200L single-use bioreactor in the UK, and a 2000L stainless steel train in RTP, which has been in place for a number of years manufacturing a range of products.

"The addition of these two new bioreactors will meet the demand we are seeing for a 2000L platform, and offer a cost-effective, low-risk route to market through 'scaling-out' from early phase to commercial manufacture" says Mr. Steve Bagshaw, Chief Executive Officer, FUJIFILM Diosynth Biotechnologies. He adds "Being similar to our existing bioreactors means they will fit seamlessly into our facilities. Having identical single-use operations on both sides of the Atlantic offers our customers flexibility and easy access to global markets. Combined with the expertise of our process development scientists to produce high-titer cell lines, our focus on single-use bioreactor technology for cell culture processes is world class."

The company has over 15 years' cell culture manufacturing experience with significant single-use facility expansions in the last three years at both sites. The facilities have been inspected by key regulatory authorities and utilize both traditional platforms as well as the latest single-use technologies. The new 2000L bioreactors are expected to be operational by November 2014 in the US and in the UK in January 2015.

Mr. Bagshaw concluded "With these expansions, FUJIFILM Diosynth Biotechnologies is able to deliver a significantly enhanced, full life cycle 'Gene to GMP' service for our customers".

Life Pack Labs poised to Help Medical Device and Pharmaceutical Manufacturers

Life Pack Labs is a new package testing company created through a joint venture between MOCON Inc. and Life Packaging Technology LLC. The new firm aims to work with pharmaceutical and medical device companies as well as related suppliers to improve time-to-market and reduce costs, the company reported in a news release.

MOCON manufactures technology to evaluate package permeation, headspace, and integrity, and Life Packaging Technology provides package engineering services.

Life Pack Labs will be headquartered in Vista, CA, and is expected to open Q2 2015 with ISO 17025 certification, it shared in the release. Packaging and life science industry professionals with multidisciplinary expertise will be available to help manufacturers design, develop, test, validate, and troubleshoot packaging, the company shared.

StartX-QB3 Labs Expands

StartX-QB3 Labs, a life science laboratory to help early stage medical and hardware technology firms transition from academia to industry, has launched. The 2,000-square-foot facility is jointly operated by StartX, a non-profit technology accelerator program affiliated with Stanford University, and QB3, an institute supporting scientific innovation at the University of California, San Francisco, UC-Berkeley, and UC-Santa Cruz. StartX-QB3 Labs is housed in StartX's complex in Palo Alto, Calif., and has been designed to support up to 20 life science startups. It will be outfitted with equipment including fume hoods, a molecular biology core, a tissue culture core, an autoclave, a glasswash, workbenches, and a hardware prototype room. Among the firms that have signed up for use in the space is Nirmidas Biotech, a Stanford spinout developing biosensing technology, which recently raised $2 million in seed funding.

BioConsortia opens Headquarters and R&D Laboratories

BioConsortia opened its headquarters and R&D laboratories in Davis, Calif. The microbial consortia for improving plant traits and increasing crop yields said it has developed technology that links plant phenotype with high-throughput microbial screening and DNA sequencing, facilitating the rapid discovery of teams of microbes that improve fertilizer performance and plant growth, "and positively impact many other crop traits from abiotic stress tolerance to enhancing plant metabolite expression." The new R&D labs contain microbiology and molecular biology labs, growth chambers, and genomic analysis resources.

American Airlines Cargo builds Pharmaceutical Handling Facility

American Airlines Cargo has started construction on a pharmaceutical handling facility in Philadelphia, PA.

The 25,000-sq-ft facility is designed for a range of temperature-sensitive products being shipped in and out of the Northeast pharmaceutical corridor of the United States

Included within the new building will be 6000 sq-ft for controlled room temperature (CRT) passive shipments at +15 C and +25 C. A 3000-sq-ft refrigerated area will be available for shipments that need to be maintained in a +2 C to +8 C environment. A deep frozen area will be available for shipments that need to be kept at -10 C to -20 C, with powered charging stations for up to 30 electronically controlled units.

The facility is expected to be completed in the fall and will be equipped with technology to monitor products with proactive alarming and will be validated to 0.25°C. Backup power generation is designed to ensure product protection in the event of a power failure, the company reports.

The opening of the Philadelphia pharmaceutical facility will coincide with the rollout of a ExpediteTC cold chain program across the American Airlines network.

Tamworth Facility for Midland Fertility Completed

A Midlands-based design and construction company has handed over new laboratories and a clinical suite to Midland Fertility.

Cleanroom Design and Construction (CDC) held a ceremony to mark the completion of the facilities at Ventura Park Road, Tamworth.

As the principal contractor, Hagley-based CDC, in partnership with the Midland Fertility board of directors, fully designed, installed, commissioned and validated the state of the art laboratories within the new premises.

JM Coull completes Multiple Lab Renovations at Northeastern University

JM CoullJM Coull recently completed renovations to six labs in the Egan Research Center at Northeastern Univ. The project marks JMC’s latest project at the university, where the company has been working for more than 10 years. The project scope called for complete gut renovations of Labs 157, 160, 216, 230, 231 and 464. The labs included fume hoods and emergency showers and eye wash stations. JMC extended the existing nitrogen line from the building’s loading dock tank farm to Lab 231 and provided future tees and valves for other labs. Lab 216, the largest of the spaces, features an aluminum and glass storefront to support Northeastern’s “Science on Display” initiative.

Sanovas Moves Biotech Operations

Sanovas, a California-based life sciences accelerator is relocation to biotech-ready, 29,000 sq. ft. facility in San Rafael. The company plans on developing minimally invasive surgical products allowing physicians to diagnose and perform therapeutic procedures in spaces as small as one millimeter in diameter. The new facility includes R&D labs, operating rooms and light-industry warehouse space.

Memorial Sloan Kettering Plans Precision Oncology Center

With a little help from Sloan Kettering Institute chair Marie-Josée Kravis and her husband, philanthropist Henry R. Kravis, the Memorial Sloan Kettering Cancer Center (MSK) is launching a new program that it says will reshape clinical trials and speed up translation of molecular discoveries into routine clinical practice. Dubbed the Marie-Josée and Henry R. Kravis Center for Molecular Oncology (CMO), the new center will support development of individualized cancer therapies and diagnostics. The couple donated $100 million toward its founding.

The CMO, according to MSK, will include around 20 labs and support over 100 MSK faculty and staff. It will also contain two next-generation sequencing (NGS) facilities, one of which will sequence patient samples in real time, while the other focuses on discovering new genetic alterations and therapeutic targets. MSK says new lab space is currently under construction, and it is buying new instrumentation for generating and analyzing large-scale genomic data for the new center. MSK hopes the CMO will not only bring together existing researchers, but recruit new ones as well.

MSK has big plans for the CMO: Sloan Kettering hopes to use it to analyze over 10,000 patient tumors in its first year alone and ultimately aims to offer molecular analysis for all cancer types for every patient at MSK. The CMO will profile archived tumor specimens and tissues from trials with NGS and other technologies, then correlate the molecular information of each tumor with clinical outcomes to get a better view of how genetic alterations affect tumors and come up with personalized treatments based on this knowledge. One of the CMO's cornerstones, MSK adds, will be "basket studies", Phase I trials where patients whose tumors test positive for certain mutations regardless of cancer type are offered new therapies. The CMO will also analyze the tumors of exceptional responders, or patients who experience a sustained response to treatment in a trial where nearly all the other participants do not.

"Throughout the course of my involvement at Memorial Sloan Kettering, I have been deeply impressed by the dedication, experience, and competence of the physicians and scientists who are working to unravel the complexities of cancer," Marie-Josée Kravis, who has also been a member of MSK’s Boards of Overseers and Managers since 2000, said in a statement. "Henry and I are delighted to support this exciting new initiative, which offers such hope to people around the world."

Texas A&M Center Adds Mobile Cleanrooms

Walker Barrier Systems, a producer of isolation and containment equipment, has built and delivered the first of eight mobile cleanrooms for the Texas A&M Center for Innovation in Advanced Development and Manufacturing (CIADM).

The Texas A&M Center for Innovation is home to the National Center for Therapeutics Manufacturing (NCTM), which provides a facility for the development and production of vaccines and therapeutics for use in clinical trials. The addition of eight new mobile clean rooms to the NCTM will increase the development and manufacturing capacity of the CIADM.

The Walker Barrier Systems mobile clean room design will allow the NCTM to manufacture clinical grade materials at increased levels of compliance. Walker Barrier Systems units are built to support a wide range of processes and platforms that will be required by CIADM to manufacture biosecurity medical countermeasures.

Construction of the mobile cleanrooms began in May 2013, and all eight are expected to be in operation at the NCTM in 2014. The first unit was delivered in January 2014.

Grand River Aseptic Manufacturing Plans Expansion

Grand River Aseptic Manufacturing (GRAM), a CMO for aseptic pharmaceutical filling, received $9.8 million in capital to expand its facilities, which will create life science jobs in West Michigan. Municipal Employees’ Retirement System (MERS) of Michigan, a nonprofit organization, led the $9.8 million investment round, supported by other Michigan and Indiana-based investors.

“We are delighted with the strong investor response, especially by MERS,” said Tom Ross, GRAM president. “Their considerable support, in combination with the backing from many private investors in our community, is a strong indicator that we’re headed in the right direction. This funding enables us to expand our capabilities, improve our facility, and advance our customer reach, all while creating more highly technical, high-paying jobs in West Michigan.”

Rest of the World

Allele Raises Money to Expand

After subsisting mostly on Small Business Innovation Research grants and sales of laboratory reagents over the past 15 years, San Diego-based Allele Biotechnology & Pharmaceuticals says it has raised $7 million in its first round of institutional funding.

Yuan Capital, a private equity firm with offices in Beijing and Hong Kong, led the Series A round, according to the company. Joining the deal was Yifang Ventures, an early stage venture firm led by Eric Xu, who co-founded Baidu, the Chinese-language search engine.

“It’s not quite the same as a typical Series A,” says Jiwu Wang, who started Allele as a postdoc in molecular biology at UC San Diego. “But it’s an important step for us. It gives us the ability to move faster with our iPS [induced pluripotent stem cells] technology.”

Wang said Allele will use the new funding to expand its production of Allele’s proprietary stem cells for potential cell therapy programs, cell-based assays, and customer stem cell banking. More recently, Allele says it has focused on emerging applications that use stem cell-based therapies in areas such as neural diseases.

3M Purification opens New Laboratory in Antwerp, Belgium

3M has extended its global network of validation laboratories serving the pharmaceutical and life sciences industries by opening a new facility in Antwerp, Belgium. European customers now have enhanced access to services that help confirm compatibility between equipment and manufacturing processes.

3M now has seven validation laboratories spanning Europe, the Americas, North Africa and Asia producing technical studies and data packages for 3M Purification products as used in customers’ processes, to ensure process integrity and to demonstrate regulatory compliance. The portfolio of services covers microbial challenge testing, product integrity testing, chemical compatibility testing, and particle release testing, as well as test design, execution, and full documentation. '

The on-going investment in 3M’s global network of validation services demonstrates the company’s commitment to providing the best possible support for customers using our high-quality filtration products,' said Lynne Deakin, Field Applications Specialist – Life Science Process Technologies, 3M Purification Division.

The validation services available from 3M’s global network of laboratories includes challenge tests such as Brevundimonas diminuta retention testing using customer process fluids under simulated processing conditions. Mycoplasma clearance testing using Acholeplasma laidlawii and Mycoplasma orale retention testing are also available, and are increasingly important as M.orale now accounts for more than 40% of cell culture mycoplasma contamination events. 3M’s validation laboratories are also able to assess the chemical compatibility of the company's products with customer fluids under expected operating conditions, taking into account the composition of the end product or intermediate chemicals, product materials, as well as duration and temperature of product contact. Particle release testing is also available for applications that require capture and identification of particles from the process stream under operational conditions.

Foster Delivery Science to Build Facility For Manufacturing Drug Delivery Polymers

The facility is expected to be completed by May 1, 2015 at which time it will be registered with the Food and Drug Administration (FDA) to allow for processing active pharmaceutical ingredients (APIs).

Foster's new 32,000 square foot (2,973 sq. meters) facility will be dedicated to HME processing of highly regulated materials and operate according to the controlled Good Manufacturing Practice (cGMP) regulations designated by the FDA. These materials are used for improving bioavailability and release rates of oral dose pharmaceuticals, as well as local delivery of APIs in implantable devices. Foster will offer custom drug/polymer blends in powder form for tablet pressing, or extruded into rods, film or fiber for a wide range of drug delivery applications.

The new facility will include a 1,200 square foot (111 sq. meters) ISO Class 7 cleanroom for processing materials and a 3,500 square foot (325 sq. meters) cGMP warehouse for storage of APIs, raw materials, intermediates and finished products. A comprehensive quality control lab will provide in-house material characterization, including microscopy, thermal analysis, spectroscopy, chromatography and non-sink dissolution testing.

"We are one of the few companies dedicated to HME processing of APIs. Our success in formulation development, process development and manufacturing of custom drug/polymer blends has exceeded our expectations and currently available space," said Tony Listro, Managing Director of Foster Delivery Science. "The new facility will allow us to increase our services in manufacturing of clinical supplies and larger production volumes."

ProBioGen plans Expansion

ProBioGen AG announced that it will be investing €20 million to double its workforce in Berlin. ProBioGen develops novel biotechnological processes for the production of biopharmaceutical drug substances to treat serious diseases. The company specializes in cell line and process development up to GMP contract manufacturing and develops technologies to improve biotechnologically active substances. ProBioGen plans to exploit its internal potential for the development of production cell lines, process engineering, and GMP manufacturing of biopharmaceuticals.

"Together with our parent company, we will continue to expand and invest in Berlin," stated Wieland Wolf, CEO, in a press release. "With an investment of around 20 million Euros, we will strengthen our market position, add two additional disposable 1000L bioreactors and, within the next two years, will double our staff from currently 75 highly skilled and dedicated employees."

Hospira plans Investment in Australia

Hospira has invested 15m AUD ($14m) in a Victoria injectables plant it says will continue to make drugs for export despite the economic downturn and strong Australian dollar.

The facility, in Mulgrave about 10km southeast of Melbourne, manufactures cancer drugs and other specialty injectables for both the local and international market. This investment will add a new filling line set to be operational in March next year.

The plants VP of operations Andrew Hodder said Hospira is the largest supplier, by volume, of injectable generics in Australia and “is bucking the manufacturing trend” in the country with continual expansions such as this filling line.

Hospira spokesman Ken Griffin said Victoria, the state in which the Mulgrave site is located, has been hit particularly hard by a manufacturing down turn and events such as the entire car industry closing down have had repercussions across the drug world.

“Australian generic medicines manufacturers are being impacted by a domestic medicines pricing policy which drives rapid price cuts to publicly funded medicines. In some cases this has seen the price of some medicines reduced by over 90% in the space of several years,” he said.

“Coupled with the high Australian dollar and high cost compared to other global locations, the Australian environment has been particularly challenging.”

However, “not only is Hospira still in Victoria, it is investing 15 million in its site to increase its competitiveness and increase its export profile,” he continued.

Hospira’s response to the economic conditions has not all been good news with 34 staff members of the site’s 600-strong workforce losing their jobs in April this year. “This was part of a process to increase the efficiency of our operations which meant the closure of a filling room,” said Griffen.

Hospira is a member of Australia’s Generic Medicines Industry Association (GMiA) which is spearheading a campaign to bring together pharma firms with the Departments of Industry, Health and Trade to identifying opportunities and address barriers in the Australian drugmaking industry.

This Medicines Manufacturing Taskforce (MMT) “would allow the Australian government to review the issue of medicines manufacturing from the perspective of health, industry and trade policies,” Griffen said.

“The country recognizes that medicines manufacturing is a valuable industry but this is not reflected in all policies implemented by these departments [and] the Taskforce would review the policy settings required to ensure a successful world class medicines manufacturing industry in Australia.”

Earlier this year, German-owned medicinal product firm Fresenius Kabi invested $47m in a new plant in Melbourne, while in 2013 Mumbai-based firm Cipla announced Victoria would be home to its first regional office outside India. The state of Queensland also received a boost with DSM Biologics – now merged with Patheon to form DPx Holdings - opening Australia’s first contract biomanufacturing facility last year.

ILS Completes Work on New Laboratory

ILS has completed the building work on its new state-of-the-art laboratory in Shardlow in the UK, following a fire in February 2013. It is now fitted out with all-new equipment, including four automated plate inoculating robots for Food Microbiology.

The Pharmaceutical Chemistry Section has moved into the new laboratory premises and the validation/qualification process to comply with cGMP has been completed on the installed instrumentation. As such this new laboratory facility is now open for business. The Pharmaceutical Microbiology department has started the relocation of non-sterile testing into the new laboratory. Testing in the new laboratory will commence once the equipment has been validated/revalidated and signed off as ready for operational use.

Work continues on the validation and qualification of the instruments and systems for the new Pharmaceutical Microbiology Laboratory and the Food Microbiology Laboratory. Having the opportunity to redesign the facility and the laboratory work ‘Process Flow’ will allow ILS to pass on the benefits of fast and on-time delivery to customers coupled with increased quality and economies of scale, enabling it to provide a service of the highest scientific standards and remain at the forefront of contract laboratory testing, the company says. 'We would like to take this opportunity to thank you for your patience, ongoing support and commitment to ILS during the redevelopment process. We are currently planning a celebratory event to showcase our new facility; the event will also be an excellent opportunity for our customers to familiarize themselves with our capabilities,' say Lorraine Bater, Operations Director, and Stewart Neithercut, Head of Business Development. 'This is a major milestone achieved following the challenges and frustrations we have encountered over the last few months. The recovery process has been extensive; we would like to thank our staff and colleagues in the industry for their extraordinary dedication, hard work and support during this difficult and challenging period.

Ireland plans New Hub

The Irish Government announced plans to invest €5m ($6.4m) in an “industry-focused” pharmaceutical manufacturing technology centre at the University of Limerick, in a bid create a hub for process innovation.

The centre – which is the latest of 15 sites set up by Enterprise Ireland and IDA Ireland – is designed to foster the development of technologies that will help Irish drugmakers compete on costs according to Limerick University research vice president, Mary Shire.

“Ireland has one of the best reputations globally in pharmaceutical manufacturing and it’s important that we continue to support the sector so we attract further investment and retain existing investments” she said.

Dr Shire explained that providing drugmakers and academics with a centre at which they can collaborate on things like process analytical technology development will help “reduce cost and thus enhance competitiveness.”

This was echoed by center director Chris Edlin who said the site was a response to the negative impact patent losses and competition from low cost regions have had on drug making in Ireland.

He explained that: "There was a real fear that unless our manufacturing industry could start competing on costs by becoming more innovative and knowledge-based work would start to go elsewhere."

Dr Edlin said that, in light of this need, the new centre will focus on expanding the use of PAT and data analysis to improve processes, explaining that this work will be carried out by an eight strong team of researchers.

While it is a Government project, development of the new centre is being supported by an industry consortium involving big firms like Pfizer, GSK, Eli Lilly, MSD and BMS, smaller firms such as Alkermes, Allergan, Astellas and Gilead and various local suppliers.

Donal Coveney, managing director of active pharmaceutical ingredient (API) and excipient firm TopChem said: “The major commercial impact for member companies will be the access to technology generated by the research team.”

“The implementation of these technologies will lead to improved competitiveness, increased or retained employment and more secure future prospects for the companies involved.”

Companies involved in the project will be offered access to any IP developed at the centre according to Edlin, who explained that they can either license access to a particular information or take greater control by choosing to fund further development.

Edlin, who has a background in the competitive world of pharmaceutical drug discovery, also said he is confident the centre combined with the collaborative approach to manufacturing present among Irish drugmakers will benefit the industry.

“One eye opening thing is that companies in Ireland are very collaborative,” he said, adding that “everybody recognizes the need to innovate and this approach will pay dividends.”

New Facility makes Ottawa a Centre for Medical Devices

The federal government is pledging millions of dollars toward a new facility aimed at making Ottawa a national hub for getting Canadian designed and produced medical devices to market.

The government announced it will invest $14.9 million in the Medical Devices Commercialization Centre, which stems from the University of Ottawa’s Medical Devices Innovation Institute and will initially be housed at the University of Ottawa Heart Institute.

The not-for-profit centre’s mandate will be to help get medical devices to market quickly and efficiently by creating a collaborative network to remove roadblocks to commercialization for devices designed and produced in Canada.

“With this national centre, Canada is well positioned to reap the benefits of the $335 billion worldwide market for medical devices,” said professor Dr. Tofy Mussivand in a statement. Dr. Mussivand, who also serves as director of the university’s Medical Devices Innovation Institute, said the centre will also stimulate innovation.

The university issued a release saying the centre would assess “clinical need and market demand” to help develop new products while enhancing Canada’s performance in the multibillion-dollar global market.

“Research is about creating knowledge but also about putting this knowledge at work for Canadians,” the university’s vice-president, research, Dr. Mona Nemer said in a statement. “By bringing together key stakeholders from universities, colleges, hospitals, industry and government agencies, we can create incentives and remove barriers to the commercialization of medical devices.”

The government announced funding for four other commercialization centers, with a price tag of $68.1 million.

Ottawa will also be getting a Centre of Excellence in Next Generation Networks.

Baxter Growth & Investment

Baxter’s investment in Opelika, Ala., will eventually mean 200 new jobs in addition to the current payroll of 170.

Conwed expands Capacity in Belgium

Conwed, the leading plastic netting manufacturer in the world, manufactures a full line of feed spacers specifically designed for reverse osmosis applications, has decided to expand production capacity at its plant in Genk, Belgium.

Reverse Osmosis (RO) is a critical part of the world’s water supply. By 2025, nearly 1 billion people will lack access to fresh, drinkable water. It is clear that RO will play a major role in alleviating water scarcity, but there will be a strong push for greater efficiency and cutting energy costs while boosting product water output. Frequently known as scrim, mesh, net or netting, feed spacers act as one of the layers of wound materials in reverse osmosis filters and provide vital separation between the membranes to achieve superior filter performance.

The Global Innovation and Technology team at Conwed, led by James Kidwell, is devising and testing new ideas and developments in feed spacers. “We believe the next generation of improved RO feed spacers can lead to increased performance and energy efficiency," he says. "Pressure drop, membrane damage and biofouling are a concern for both membrane manufacturers and RO plant operators. We believe the next leap in RO filtration efficiency could come from the feed spacer”.

Conwed is focusing on the RO feed spacer market following increasing demand for RO filters worldwide. Existing RO plants expanding their water treatment capacity and new plants around the world are becoming operational confirm the growing need for drinkable water. “We proactively took upon ourselves the challenge of understanding how feed spacer design evolution may impact filtration efficiency. We want to become the innovation leader in RO feed spacer development,” says Chris Hatzenbuhler, CEO at Conwed.

All Asia, Africa, Middle East and Australia customers, serviced by Conwed European Headquarters, will benefit from the expanded production capacity installed. “We’re delighted with this investment in our European plant. Increasing our feed spacer production capacity confirms our commitment to the reverse osmosis industry. Our ability to customize netting configurations and our in-house testing capabilities make us the partner of choice for RO filter developers,” says Stefan Tielen, General Manager at Conwed Europe.

Merck Millipore invests in Manufacturing Capabilities in France

Manufacturing Merck Millipore, the life science division of Merck KGaA, is to make a €12m investment at its Molsheim facility in France. The investment will expand the company'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.'

The investment also includes extending the manufacturing capacity space for RTU media, a new cleanroom, and two additional production lines similar to those already used 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 Centre to develop solutions for future customer needs. The company says the increased manufacturing capacity will meet current and future global market demand. Merck acquired the heipha/Hycon product lines in 2011 as part of its acquisition of Biotest which expanded the division's offerings in industrial microbiology.

The Molsheim facility opened in 1972 and employs approximately 1,030 people. In addition to ongoing R&D activities, the site manufactures products across Merck Millipore's BioMonitoring, Lab Water, and BioPharm Process Solutions business areas.

Synthon sells Czech Plant to Mercachem

Synthon has consolidated its Czech API capabilities through the sale of a laboratory and pilot scale plant in Prague to CRO Mercachem.

Approximately 20 active pharmaceutical ingredients (API) are manufactured from the plant in Prague to support Synthon’s pipeline, but these will be transferred to the nearby facility in Blansko, the firm says, as it sells the site to European contract research organization (CRO) Merachem.

“The decision to divest our small-scale operations (laboratory and pilot scale operations) in Prague is purely based on our strategic decision to concentrate our Czech API capabilities in one location in the country,” said Fabienne Douven, a Synthon spokesperson.

The firm’s site in Blansko is “a fully integrated drug substance site,” she added, which houses its own pilot plant and commercial manufacturing facilities, dedicated to Synthon’s own product portfolio, as well as an R&D centre. Synthon has a second API plant in San Lorenzo, Argentina.

The deal will see workers at the plant joining Merchachem, a Dutch firm which describes itself as a CRO. However, Merchachem confirmed it will not supply Synthon, but rather use the site instead to bolster its API services for its own customers in Europe, the US and Japan.

“At our main site in Nijmegen [The Netherlands] we have a small scale GMP-facility for APIs for clinical trials,” said Mercachem Managing Director Frank Leemhuis.

“At the site in Prague we can now produce larger quantities of these materials and hence we can support our clients with API supply at later stages of development, typically until after Phase II clinical studies.”

He added Mercachem will only produce small molecule API’s from Prague and has all necessary equipment for producing and handling such products.

The acquisition is the first outside The Netherlands for Merchachem and will help cope with increased demand from customers for “high quality services and a desire to have early stage GMP productions ‘under the same roof,’” Leemhuis said.

“The acquisition of the Prague facility also nicely fits into our strategy to broaden our services portfolio toward commercial manufacturing of small volume API,” he continued.

Furthermore, the Prague facility has been FDA inspected and has a GMP certificate from the Czech authorities.

ProBioGen invests in Mammalian Manufacturing

Research ProBioGen, a specialist in the development and manufacturing of complex therapeutic glycoproteins and viral vaccines, is to planning to double its workforce and invest €20m at its site in Berlin, Germany.

'With an investment of around €20m we will strengthen our market position, add two additional disposable 1000L bioreactors and, within the next two years, will double our staff from currently 75 highly skilled and dedicated employees,' said CEO Dr Wieland Wolf.

ProBioGen is developing novel biotechnological processes for the production of biopharmaceutical drug substances to treat serious diseases on behalf of pharmaceutical and biotech companies. The service spectrum ranges from cell line and process development up to GMP contract manufacturing. In addition, the Berlin scientists develop innovative technologies to improve biotechnologically active substances and have created an extensive portfolio of proprietary rights for optimized biopharmaceutical manufacturing. Licenses have recently been granted to a number of global pharmaceutical companies, including Boehringer Ingelheim and Novartis.

Molecular Profiles expands Liquid Capsule Manufacture

Molecular Profiles has expanded its capsule-filling services from solids to liquids with investment in equipment at its UK site.

The contract development and manufacturing organization (CDMO), bought a BD3000 capsule banding machine from Italian firm Dott. Liquid-in-capsule formulations are favored over powders and semi-solids when drug compounds are particularly potent or poorly soluble.

The Columbia Laboratories subsidiary also added a second capsule-filling machine to quadruple capacity and increase weight accuracy and fill weight range.

Liquid-in-capsule formulations are used when drug compounds are particularly potent or poorly soluble.

Capsules are popular in early phase trials, where dosage flexibility is needed. “We can manufacture for relatively small scale early stage trials and also now have the enhanced capacity that allows us to scale up to Phase III,” said Rob Harris, Chief Technical Officer.

Molecular Profiles uses both gelatin and HPMC (hydroxypropyl methylcellulose, a semi-synthetic polymer) capsule shells, depending on clients’ drug formulation.

Harris told us that “cultural sensitivities” – religious and moral objections to animal excipients – are one of the reasons for increased interest in gelatin alternatives such as HPMC.

But zoonotic diseases are not an issue for the gelatin supply chain, he said:

“All excipients and actives are now provided with a BSE/TSE [bovine/transmissible spongiform encephalopathies] statement, which confirms either that no materials of animal origin were used during the manufacture of the product, or that the animals from which the product was derived were healthy.”

Additionally, clients can specify preferences for porcine- or bovine-derived gelatin.

HPMC shells come with their own pros and cons: the capsules contain less water than gelatin, so can offer an advantage if APIs (active pharmaceutical ingredients) are sensitive to water. They also avoid the osmosis associated with gelatin capsules, which can draw out water from the casing and make shells brittle.

“The slight disadvantage with HPMC capsules is that they take longer to disintegrate compared with gelatin capsules,” Harris told us.

This is the latest investment by Molecular Profiles after the company purchased GMP hot melt extrusion (HME) technology earlier this year for processing poorly soluble molecules.

China, France collaborate on Virus Lab

China and France are jointly constructing a top-level biosafety lab in Wuhan, Hubei province, which will facilitate scientific research into dangerous viruses such as Ebola, according to French ambassador to China Sylvie Bermann.

She made the remarks at the Sino-France Health Forum in Beijing, adding that the lab will play an important role in both countries' capacity in outbreak control and prevention.

The two countries have launched a partnership in epidemic control and lab testing of the virus in the global combat against Ebola outbreaks in West Africa, "And that opens a new era of bilateral collaboration, particularly in international emergency response," said Ma Xiaowei, vice-minister of China's National Health and Family Planning, during the forum.

Health officials and industry practitioners from both countries also discussed potential cooperation in fields such as hospital management, responses to an aging society and chronic disease intervention.

Chen Zhu, vice-chairman of the Standing Committee of the National People's Congress and a former minister of health, said he expects China and France will keep deepening their cooperation in the fields of public health and medical care.

"The cooperation is also a boost to the advancement of medical science worldwide," said Chen, who has trained in France.

Telstar supplies Laboratorios Pisa with Upgrades

Telstar has supplied a set of autoclaves for sterilization of large volume parenteral solutions and isotonic liquid products to the pharmaceutical firm Laboratorios Pisa.

The autoclaves have been installed at the Mexican group's pharmaceutical plant in Tlajomulco, Guadalajara, Mexico. The supply contract for multiple pieces of equipment, which was delivered in December 2013, is to be extended by the addition of further autoclaves this year.

The super-heated water autoclaves developed by Telstar for Laboratorios Pisa, which can perform faster and more energy-efficient sterilization cycles, are characterized by their large capacity.

Each autoclave has been specially designed for use in the sterilization process of large batches of parenteral solutions. The new set-up includes control systems, which can compensate the pressure differences occurring between the inside of the container and the autoclave chamber during the heating and cooling phases. This system ensures that the processes occur at controlled temperatures and that the physical integrity of the container is retained at the end of the cycle.

Telstar is also supplying the Laboratorios Pisa plant in Guadalajara with several seven-effect water stills, each with a capacity for up to 12,000l/hr of distilled water (WFI); some of which are in full operation, and a further two which are now in the process of manufacture. The seven-effect 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, which results in a significant financial saving across such large production volumes.

The autoclaves and water stills are complemented by steam generators, each with a capacity for 1,000kg/hr of pure steam.

Freeze-drying 500,000 vials/month of solutions-for-injection

Throughout this year, Telstar will supply steam sterilisable freeze dryer capacity for the production of injectable products at Laboratorios Pisa's plant in Tlajomulco, Guadalajara. 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.

Two steam autoclaves for terminal sterilization of blisters and culture media manufactured by Telstar will also be supplied to the Guadalajara plant.

EMD Millipore expands in Japan and Opens New Location in Tokyo

EMD Millipore announced the opening of a new Biomanufacturing Sciences Training Center (BSTC) facility in Tokyo. The state-of-the-art facility is designed to help biopharmaceutical companies develop manufacturing processes and find solutions to processing challenges in collaboration with engineers from EMD Millipore.

“We recognize that our customers in Japan face tremendous pressure to reduce development costs and identify production efficiencies. The new BSTC is designed to recreate an actual manufacturing environment allowing customers to operate equipment, evaluate processes and conduct training,” said Udit Batra, President and Chief Executive Officer of EMD Millipore. “Our goal for this facility, now the ninth of its kind for EMD Millipore, is to enhance the customer experience by delivering innovation, quality products, and comprehensive technological support – all major components of our product and service portfolio offering.”

Through the simulation of manufacturing process with leading-edge products, EMD Millipore’s Biomanufacturing Sciences Training Centers allow customers to test equipment and devices, evaluate manufacturing processes, and conduct operator training. This extensive training helps biopharmaceutical companies expedite system implementation and enhances the efficiency of manufacturing process development, while also providing quality assurance validations compliant with GMP standards and various regulations, thus lowering the risk when introducing new systems.

The new facility in Japan comprises a Pilot Scale Zone equipped with EMD Millipore’s Mobius ® series of single-use components for everything from culture to filtration and purification, allowing for total demonstration testing from upstream to downstream processes. There is also a Process Development and Application Test Zone for various types of testing for process development and optimization, a Seminar & Training Zone, and a Gallery Zone with displays of EMD Millipore products. Staff membrs with expert knowledge provide multifaceted support to client companies for biopharmaceutical manufacturing.

EMD Millipore has BSTC facilities in nine major regions including Japan, U.S., Germany, France, Singapore, China, South Korea, India, and Brazil. These centers provide universal instruction to partners around the world, allowing clients to receive the same training in any region, even if they move their manufacturing process to other countries. EMD Millipore has invested €1.3 million in the project, which will relocate the existing center in Yokohama, Kanagawa Prefecture into a larger facility.

Merck KGaA Breaks Ground on Facility in China

Merck KGaA's biopharmaceuticals division held the groundbreaking ceremony for its new pharmaceutical manufacturing facility in Nantong, China, on Aug. 27, 2014. 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, the company's brands for the treatment of diabetes, cardiovascular diseases, and thyroid disorders, respectively. These medicines are referenced in China's essential drug list, and Merck KGaA's biopharmaceutical division is the first and only multinational company in China to dedicate a large-scale, green-field investment to the production of drugs on the list, the company said in a press release.

The construction of the site is scheduled for completion in 2016, with commercial production starting in 2017. The site is designed to comply with the highest international standards in terms of quality, environment, health, and safety. The preservation of the environment is a crucial consideration in the facility’s construction. The company notes it plans to maximize resource efficiency and minimize waste generation in the course of the manufacturing process.

Synthon sells Czech Plant to Mercachem in API Consolidation

Synthon has consolidated its Czech API capabilities through the sale of a laboratory and pilot scale plant in Prague to CRO Mercachem.

“At our main site in Nijmegen [The Netherlands] we have a small scale GMP-facility for APIs for clinical trials,” said Mercachem Managing Director Frank Leemhuis.

He added Mercachem will only produce small molecule API’s from Prague and has all necessary equipment for producing and handling such products.

“The acquisition of the Prague facility also nicely fits into our strategy to broaden our services portfolio toward commercial manufacturing of small volume API,” he continued.

Furthermore, the Prague facility has been FDA inspected and has a GMP certificate from the Czech authorities.

Ajinomoto Althea gains EU GMP Certification

Ajinomoto Althea, Inc. has received its European GMP certificate from the Medicines and Healthcare products Regulatory Agency (MHRA) following an on-site inspection on June 19, 2014 that resulted in no critical or major observations. The certification allows the company to test commercial drug product for the European market.

"Althea is proud of this important regulatory milestone. We are well known for our impeccable regulatory track record in the US and now are very pleased to expand our commercial testing capabilities for European clients," said David Enloe, president and chief executive officer of Althea. "Knowing that our testing and quality processes meet both the stringent FDA and EMA quality requirements really signifies a great accomplishment by our team and supports our leadership position in the CMO market."

Althea provides manufacturing services including cGMP bulk manufacturing filling in vials and syringes, microbial-based biologics manufacturing, Crystalomics crystal suspension technology, process development, in-process and release testing analytics, equipment qualification, and validation.

Orion opens New Facility

Orion has finalized construction of its new manufacturing facility of hormonal gels and solutions. The demanding project was carried out exactly to the planned schedule, fulfilling all the set criteria for the quality of the new premises and processes.

The new facility provides almost 6,000m² (64,560 sq. ft.) of space for the manufacturing and packaging of hormonal gels and solutions as well as space for technical and utility systems supporting the production. Fully validated, the area was already been put in to use in late July and the first batches manufactured in the facility have been released.

Future plans include the installation and validation of the next new filling and packaging lines later this year. The space also offers new possibilities for new contract manufacturing customers, so Orion' s professional team welcomes new projects to the department.

The range of other contract manufacturing capabilities available from Orion include manufacturing, packaging and testing of small volume parenterals, conventional tablets, creams, ointments and liquids, cytostatic tablets and capsules. Our sites are all located in Finland and products from our sites are exported to all major markets, including the EU, US, JPN, Latin America and Australia.

Phase 2 opens Medical Device Contract Manufacturing in Tijuana

Phase 2 Medical Manufacturing, Inc. selected Tijuana as the site for a new offshore medical device contract manufacturing facility.

The initial search began in Costa Rica. While Costa Rica is well known for its medical technology industry, Phase 2 felt that they could not manage costs as well for their customers because of increased real estate prices and scarcity of skilled labor.

"Our medical device clients told us off-shore or near-shore, lower-cost labor would be important when it came to medical product outsourcing in the future,” said Adam Prime, CEO of Phase 2 Medical Manufacturing. Add higher shipping costs and 18-day shipping times, and Phase 2 Medical began to look elsewhere to complete their medical assembly and medical packaging businesses. After hearing good things about cost, an abundance of skilled labor and the willingness of the economic development agency to work with new companies, Prime and his team began to seriously consider Tijuana, Mexico.

When it comes to medical product outsourcing and medical device manufacturing, lower cost and close proximity to the U.S. are big deals for us,” Prime said. “Tijuana meets both those criteria.”

By the end of the year, the company expects to employ 20 people in its Tijuana plant. It has a staff of 170 in New Hampshire.

Eurofins plans Four Labs to Support Food Testing

Eurofins is planning to add 100,000m2 (1,076,000 sq. ft.) of laboratory space in the next two years to maximize synergies and optimize efficiencies across the businesses.

The firm is setting up four laboratories in different US cities to support the growth in food testing activities.

More than 40,000m2 (430,400 sq. ft.) is planned to come on stream in 2014 to serve clients including Nestlé, Unilver, PepsiCo, Coca-Cola and Kellogg’s.

It has also finalized the move of its southern US food testing hub into a new site with double the capacity at the University of New Orleans campus in Louisiana.

One-off costs from integrations, reorganizations and discontinued operations, and other non-recurring costs totaled €8.8m in its half year results compared to €4.5m for H1 2013.

However, temporary losses and other costs related to network expansion, start-ups and new acquisitions in significant restructuring dropped to €9.2m from €10.4m last year.

Dr Gilles Martin, CEO, said revenue growth continues to be strong and organic growth in the first half of the year was over 8.5%, excluding acquisitions in significant restructuring.

“We are optimistic that a significant portion of our restructuring programs has now been addressed, which should gradually unlock further profit expansion,” he said.

“Overall, acquisitions made in 2014 thus far are highly profitable and should not require significant restructuring.”

Eurofins is in the final stages of the construction of a large site in Vejen, Denmark, where five small and mid-sized laboratories will be combined.

In Benelux, the group is evaluating the combination of several small laboratories into two large sites in The Netherlands and Belgium.

In Germany, it is shifting several multi-building or multi-location laboratories into a large, single-site campus in Hamburg. In Sweden, it is combining two laboratories into one larger site in Uppsala.

Revenues in H1 were €644m, representing an increase of 12.8% (15.5% at constant currencies) on organic growth of over 6.5%.

Excluding acquisitions in significant restructuring, organic growth was over 8.5%.

The continued strengthening in the food testing business is underpinned by increasing market volumes and ability to gain market share due to large past investments, said Eurofins.

The bioanalytical testing market remains buoyant in the US, which accounts for 23% of the group’s total revenues.

In France, continued growth in food testing from market share gains and contract wins such as a three year agreement with Burger King to provide the fast-food chain with a food safety control program, mitigated the impact of the ongoing IPL restructuring during the period.

The group’s businesses in the UK also recorded good organic growth in H1 2014, despite strong comparable results in the previous year, which included the horse meat scandal.

Examples of laboratories outsourced to the firm include the Austrian Research Institute, Raisio Group and Cranswick, Mondi and Danone.

Blueprint Genetics plans Growth

Next-generation sequencing-based clinical diagnostics firm Blueprint Genetics announced it has raised $3.9 million to fund its international expansion.

It is unclear if the $3.9 million figure is the amount the Finnish firm raised in the most recent financing round or if it is the total amount raised since its founding.

Venture capital firm Inventure and Finnish foundation Avohoidon Tutkimussäätiö (Outpatient Research Foundation) were new investors in the financing round. Previous investors in the company included Tekes, the Finnish Funding Agency for Innovation, as well as angel investors.

Based in Helsinki and founded in 2011, Blueprint develops clinical-grade NGS-based tests using a targeted sequencing technology developed at Stanford University. Its first products were launched in 2013 aimed at inherited cardiovascular diseases.

It currently provides testing for more than 60 hospitals in 10 countries and is launching an office in the US, it said, though it provided no further details. In addition to establishing a base in the US, Blueprint CEO Tommi Lehtonen said in a statement that the firm plans to expand its test menu to include additional disease categories.

Stem Cells API Development by European Biobank

A German biobank has made stem cells available to active pharmaceutical ingredient (API) firms in a bid to support industry drug development efforts.

The Fraunhofer Institute for Biomedical Engineering (IBMT) in St. Ingbert, Germany and its partners began building a library of pluripotent stem cells in January with the idea being to collect from patients with specific diseases or genetic mutations.

Eight months on and the project – which is known as the European Bank for induced pluripotent Stem Cells (EBiSC) – is now ready to start supplying the collected stem cells to drug developers.

Long term the plan is to base the biobank at sites in Cambridge, UK and Sulzbach, Germany. However, at present cells are being stored by IBMT according to project leader Julia Neubauer, who said expertise in this area was what led the organization to be involved.

She explained that IBMT scientists are responsible for freezing the cells and automating cell cultivation, adding that for efficient long-term storage of functional stem cells they have to be cooled down to temperatures of below 130 degrees Celsius in a controlled way.

“Cells don’t like being removed from the surface they are grown on, but that’s what people used to do in order to freeze them. Our method allows the cells to stay adherent,” Neubauer said, citing the ‘extremely gentle’ freezing process developed the IBMT team.

The organization also had to come up with a way of safely accessing the frozen cells according to Neubauer, who said: “It’s just like when you go to your refrigerator at home – it’s not a good idea to leave the door open too long.”

Solving the problem involved collaborating with industrial partner Askion GmbH with which IBMT developed hood that protect the other samples whenever the cryotank is opened.

The next stage of the biobank project is the development of ways of culturing sample cells into usable stock to order.

IBMT is currently assessing methods involving cell growth in stirred tank bioreactors as well as a separate automated approach involving robots according to Neubauer, who said: “By the time the project is completed we’ll know which is the better method for what we’re trying to do.”

Synexus to acquire Helderberg Clinical Trials Centre

Synexus has acquired the Helderberg Clinical Trials Centre near Cape Town's international airport.

In its release dated Aug. 27, the company said Graham Ellis, who founded the Centre, has been appointed Medical Director and will continue as the Centre Manager.

Christophe Berthoux, CEO of Synexus, said: "This is yet another new development that we have put in place to meet the increasing demands of the pharma industry for our high quality professional services. Our order book is at a record high and continuing to grow.

"We have long recognized the vital role South Africa has to play in global clinical trials as this addition to our portfolio and continued investment in the region is testament to that. South Africa provides access to a large patient pool, excellent medical infrastructure and the training of the medical staff at all levels is of a very high standard. There is also a high public awareness of the benefits of clinical trials which speeds up recruitment and overcomes the lengthy regulatory process. These are all key factors in ensuring the success of a clinical trial."

Lab Innovation around the Globe Highlighted in S-Lab Awards

Eleven labs in locations as far afield as Atlanta to Auckland and Cambridge to Catalonia have been named winners of the highly coveted S-Lab Awards for Laboratory Improvement and Innovation. They are:

New Building, Research (Joint) – Medical Research Council Laboratory for Molecular Biology. New Building, Research (Joint) – Oklahoma Medical Research Foundation Research Tower. New Building, Teaching and Mixed Use – Engineering and Computing Building, Coventry University. Refurbished Laboratory –

University of Auckland, New Zealand, Chemistry Undergraduate Teaching Laboratories. Laboratory Effectiveness – University of Sheffield, Professional Technician Training Program. Making a Difference – University of Nottingham, Technical Focus Group. Environmental Improvement –

University of Leeds, Environmental Improvements in the Priestley Teaching Laboratory.

Best New Product – University of Southampton, StarStream.

Laboratory Based Teaching and Learning – University of York, Green Chemistry Centre of Excellence.

Virtual Laboratory, Teaching and Learning – La Trobe University, Australia,

Supporting Remote Laboratory Learning.

Virtual Laboratory, Data & Informatics – West Middlesex University Hospital, Integrating Field and Laboratory Clinical Data.

A further seven entries were highly commended. The entries covered a range of topics, including best practice design of new and refurbished lab facilities, the importance of technical support, application of lean production principles to lab practice, better chemical and sample management, sharing of equipment, environmental improvement actions, more effective use of freezers, and the growing impact of IT within both research and teaching.

S-Lab Director Peter James said: 'The 2014 Awards – which attracted entries from around the world – show that laboratory design, management and operation are changing in response to new knowledge and technologies, competitive, financial and other pressures, and user expectations. The result is better research and teaching, more cost-effective operation – which can create more resource for actual science – and reduced environmental impact.'

The Awards are supported by many leading professional and higher education bodies. They were presented at a prestigious ceremony preceding the Supporting World Class Science conference at King’s College, London (2-3 September). This will have presentations from many of the 58 shortlisted entries. It provides a forum for science managers, estates and facilities, technical support, specialist services, suppliers and others to hear about the lab innovations and to network with a wider range of lab and facilities managers and designers.

Orion opens New Facility

Harlan Labs expands Presence in Australia and Southeast Asia

Harlan Laboratories, Ltd. has appointed Invenium Pharmacology as its exclusive agent for Harlan’s Contract Research Services (CRS) to strengthen its local presence in Australia, Southeast Asia and New Zealand in the pharmaceutical and chemical industries. Anthony Bishop will serve as the primary contact in the region.

“There are great growth opportunities for Harlan CRS in this region,” said Ciriaco Maraschiello, director of strategic initiatives and director of drug discovery and translational medicine at Harlan CRS. “Working with Anthony Bishop and Invenium Pharmacology, we can provide the expertise that companies and organizations in this region need—at a local level.”

Merck targets Italian Production Site for Investment

Merck KGaA plans to invest €50 million ($68.5 million) in its Italian pharmaceutical and biotech production site in Bari, Italy. The new facility in Bari is to be commissioned in 2017 for the sterile filling and packaging of liquid drugs into syringes, vials, and ampoules.

Within Merck Serono’s global biotech production network, the Bari site is part of fill & finish operations alongside the facilities in Darmstadt, Germany, and Aubonne, Switzerland. According to Merck officials, the drugs produced within this global network are seeing long-term growing demand, especially those that treat infertility.

“To make Merck fit for the future, we are investing in modern, expanded production capacities,” said Karl-Ludwig Kley, chairman of the executive board of Merck, making reference to the company’s “Fit for 2018” transformation and growth program.

Baxter opens its First State-of-the-Art Biologics Facility in Asia

Singapore-Based Facility Enhances Baxter's Global Capabilities to Support the Treatment Needs of Hemophilia Patients Worldwide

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.

"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."

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 (21,520 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.

AstraZeneca designs New U.K. Global R&D Center

AstraZeneca revealed its proposed designs for its new global R&D center and corporate headquarters in Cambridge, U.K. The facility, which will be located on the Cambridge Biomedical Campus (CBC), includes the global center, an R&D enabling building and an energy center. Key features of the site include: high-tech labs separated from other work spaces by glass walls to promote ‘visible science’; a number of open spaces and thoroughfares to encourage collaboration; and environmental efficiency with a low energy design and the largest ground source heat pump in Europe.

The new site will bring together AZ’s small molecule and biologics R&D activity. The CBC will be the new U.K. home for biologics research and protein engineering carried out by MedImmune, AZ’s biologics arm. MedImmune already employs 500 at Granta Park, to the south east of the city. “With our combined AstraZeneca and MedImmune portfolios we are already uniquely positioned to explore the promise of combination therapies in transforming the way patients are treated,” said Dr. Bahija Jallal, executive vice president, MedImmune. AZ expects to begin the build of the new site in early 2015.

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