Andrew Natale, a University of Colorado research assistant, works to cast gels for analyzing proteins inside a lab at the Jennie Smoly Caruthers Biotechnology building on the University of Colorado's East Campus in March 2013. This year, CU is requesting $20 million in state capital construction funds to add a fifth wing to the building.

The University of Colorado is hoping to soon add a fifth wing to the biotechnology building on the East Campus with help from state capital construction funds.

CU is requesting $20 million in state funds for fiscal year 2015-2016 for the proposed fifth wing, which campus officials say is needed to provide classroom and learning space for growing numbers of biochemistry and engineering students on the Boulder campus.

The campus has said it will commit $8 million for the new 57,000-square-foot wing.

Gov. John Hickenlooper's current budget request includes $281.6 million for capital construction and information technology projects. If that request is approved by the Joint Budget Committee and then the Legislature in the spring, CU-Boulder's biotechnology wing likely would receive funding.

CU also is hopeful state funds will come through to continue a visual and performing arts project on the Colorado Springs campus.

"We would be thrilled if they funded the governor's request, which includes those two important projects for CU," said Todd Saliman, chief financial officer for the CU system.

Construction on the initial four-wing, 343,000-square-foot Jennie Smoly Caruthers Biotechnology Building on CU's East Campus finished in 2011 and was financed with $163 million in campus, federal and private donor funds.

In 2013-2014, the state allocated $6 million to complete shelled teaching labs, classrooms and unfinished laboratory and office areas in the building.

This year, the campus appropriated $4 million to design the proposed academic wing, which planners want to add to the northwest side of the building at Colorado Avenue and Innovation Drive.

Once completed, the biotechnology building will be a leader in expanding academic offerings on East Campus, CU officials said.

"As the university continues to develop East Campus, it's migrating from what used to be a research park to a true extension of the main campus," said Steve Thweatt, vice chancellor for administration. "The need for educational spaces on East Campus has become more and more apparent."

The academic wing is likely to house CU's biochemistry and chemical and biological engineering programs, which are located in aging and inadequate facilities on the main campus, according to planning documents.

A proposed "active learning classroom" will allow faculty and instructors to do more hands-on and interactive teaching, according to planning documents.

The biotechnology building currently houses the BioFrontiers Institute, a hub for interdisciplinary research in science, math and engineering led by Tom Cech, who shared the 1989 Nobel Prize in chemistry.

If state funding comes through, Thweatt said construction on the new wing could begin in the spring or summer of 2016.

Vetter Development Service Chicago Planning for Clinical Syringe Projects

Vetter has announced its US early-stage development site located at the Illinois Science and Technology Park in Chicago, has completed the next step of its expansion with the addition of a third cleanroom.

Clinical syringe projects are now being accepted at the facility, which can handle preclinical through to Phase II projects.

The site offers the resources needed for efficient early-stage clinical manufacturing including chemical analysis, microbiology labs, material preparation and compounding functions.

The facility includes three cleanrooms, followed by visual inspection capabilities and GMP storage.

With the addition of the third cleanroom, filling of single-chamber syringes are available with a maximum filling speed of 3,600 units per hour, and batch sizes as large as 25,000 units.

The line is constructed as a restricted access barrier system (RABS), offering various filling pumps depending upon unique characteristics of the product, as well as fully automated tub processing.

The two existing cleanrooms, operational since 2011, provide fully automated vial filling for batches of up to 10,000 liquid or lyophilized vials, as well as semi-automated filling for manufacturing prefilled syringes, cartridges and vials in small batch sizes.

The new cleanroom expands on the company's strategy to offer its customers an early platform access to drug development.

Vetter offer biopharmaceutical companies the opportunity to utilize final packaging material, depending on individual product characteristics and planned launch strategy in early development phases.

Vetter managing director Peter Soelkner said: "The newest cleanroom, which performs clinical manufacturing of syringes, is a demonstration of Vetter's consistent approach to staying ahead of the market.

"For many indications, prefilled syringes provide advantages that will become even

more important in the future of drug delivery.

"With our Chicago site, we can now offer our customers filling of this delivery system from early in the drug development process, affording them an innovative approach and an early advantage in today's highly competitive markets."

The first customer products in development were recently transferred from the early-stage Chicago facility to Vetter's European sites for further Phase lll development and subsequent commercial production.

This shows the effectiveness of the company's up scaling approach concept, as well as its acceptance by customers.

Several additional product transfers from early development in the US through to late stage development in Europe are planned for next year.

Avid Bioservices Announces Expansion of cGMP Manufacturing Capacity

Avid Bioservices, the contract-manufacturing subsidiary of Peregrine Pharmaceuticals, has initiated an expansion of its biomanufacturing capacity for clinical and commercial manufacturing services. The new production facility will more than double the company's current manufacturing capacity and will use a flexible modular cleanroom design and single-use technologies.

The capacity expansion will take place within an existing 40,000-ft2 warehouse located adjacent to the company's current campus in California. The new cGMP facility will accommodate multiple single-use bioreactors of up to 2000 liters, downstream processing suites, and dedicated support utilities that will allow for the production of a variety of biological products.

The new cGMP facility is expected to be ready for cGMP production in mid-2015.

"As one of the early adopters of single-use technology, this expansion allows us to build upon our expertise in what is now a common mainstream practice for biologics production," said Steven King, president at Avid.

"This will truly be a cutting-edge facility utilizing a leading trend in biomanufacturing in terms of flexibility and efficiency," said Robert Garnick, PhD, head of regulatory affairs at Peregrine. "We have been pleased that the design, the flow, as well as equipment and timelines, have all been well received by leaders and experts in biomanufacturing. We look forward to having this facility build upon our exemplary inspection and audit record that Avid has achieved from multiple regulatory agencies."

Romaco Opens North American HQ

Romaco North America has opened its new headquarters in Hamilton, NJ. The new site serves as a local base for sales, customer service, spare parts, rebuilds, pre-installation inspection and line integration for tableting and packaging technology. The Romaco brands include Kilian, Siebler, Noack, Promatic, Macofar, Unipac and Bosspak. The location also will include a demonstration lab for packaging and tableting machine trials.

Charles Ravalli, who is responsible for all Romaco Group activities in North America, will oversee operations. Mr. Ravalli has more than 35 years of experience in the packaging industry, including a 22-year tenure as chief executive officer of Oystar USA and Hassia USA, and prior to that, with Bosch and Perry Industries.

Other key Romaco executives will continue their roles at the Hamilton facility, including national sales manager Paul Walencikowski, and Bill Crozier, who oversees sales for Romaco’s Kilian line of tabletipresses.

“The opening of our Hamilton location allows Romaco’s dedicated packaging and tableting professionals to focus on servicing our customers in North America. The Romaco Group’s – Beyond Technology tag line is regarding the expectations of our machinery, people and services bringing long-term value to our customers. This is a key to our continued growth in North America,” said Mr. Ravalli.

Biosciences Partnership Building in Phoenix

The Biosciences building will be a ten-story building spread across an area of 245,000 square feet.

The University of Arizona (UA) College of Medicine in Phoenix broke ground on a new research facility named Biosciences Partnership Building on the Phoenix Biomedical Campus, a major bioresearch and education hub in downtown Phoenix, Arizona, US in October 2014.

Construction of the new research building, located immediately north of the UA's existing Health Sciences Education building in Phoenix Biomedical Campus, near 7th Street and Fillmore, is expected to be completed by the end of 2016.

The construction is sponsored by the UA and the city of Phoenix. Opening of the new building is scheduled for 2017.

Biomedical research will be housed in the building, as well as laboratory facilities to conduct research into partnerships with industries on key medical areas including neuroscience, cardiovascular and thoracic science.

The project is expected to create 500 jobs during construction and 360 permanent jobs upon commencing operations.

The facility is the first antibiotic-free and animal-free cell culture media and supplements manufacturing facility in the pharmaceutical industry.

Construction of the biosciences building was approved by the Arizona Legislature's Joint Committee on Capital Review in 2010.

The ten-story, 245,000ft² building will expand research facilities at the University of Arizona Medical Campus, while paving the way for innovative therapeutic discoveries to improve lives. The research focus will be on areas including neurosciences, healthcare outcomes, cancer and precision medicine.

The research facility will provide faculty to teach the next generation of health professionals. It is expected to create employment opportunities in the field of research, while providing opportunities to specialized technicians and other support staff.

Biosciences Partnership Building is part of a larger expansion project underway at the Phoenix Biomedical Campus. In 2012, Health Sciences Education Building was opened at the campus and construction is ongoing for the 220,000ft² cancer center at Dignity Health St. Joseph's, which is scheduled for completion in 2015.

Additionally, the Phoenix Biomedical Campus already houses four health science colleges including the Mel and Enid Zuckerman College of Public Health, and the colleges for nursing and pharmacy.

Arizona State University's School of Nutrition and Health Innovation is located in the Arizona Biomedical Collaborative 1 building. Plans are in place to build another building between the Arizona Biosciences College (ABCI) and Translational Genomics Research Institute.

"The ten-story, 245,000ft² building will expand research facilities at the UA Medical Campus, while paving the way for innovative therapeutic discoveries to improve lives."

Total investment for the construction of the Biosciences Partnership Building is estimated at $136m. The investment is from the stimulus plan for Economic and Educational Development bonds approved by the Arizona legislature in 2008, for the construction of the Health Sciences Education Building and campus improvements.

California-based CO Architects and Ayers Saint Gross of Phoenix designed the biosciences building. A joint venture of DPR Construction and Sundt Construction are the construction managers for the research building project.

The aim of the state of Arizona and city of Phoenix is to develop PBC as a major biosciences hub and premier academic health center in the region. Once fully developed, the campus is anticipated to create an economic impact of up to $2bn every year.

The PBC, which includes the Biosciences Partnership Building, is spread across 28 acres with various bioscience and education projects. Plans are in place for the construction of more than six million square feet of biomedical-related research, academic and clinical facilities.

Phoenix Biomedical campus follows the environmental sustainability policies set by the UA and Northern Arizona University (NAU). An internal team known as PBC Green Team was formed in August 2009 to understand local sustainability practices, define the framework for a campus sustainability plan, periodically assess the sustainability efforts on the campus and suggest improvements and initiatives.

Sustainability initiatives adopted on the campus include recycling of light ballasts, paper, cardboard, glass bottles and aluminum cans, use of energy efficient fixtures and systems, use of sustainability products, and waste reduction programs.

The Rockefeller University Campus Expansion, New York

A two-acre extension at Rockefeller University campus will be named the Stavros Niarchos Foundation – David Rockefeller River Campus.

Located in York Avenue, New York and established in 1901, Rockefeller University is the first biomedical research institute established in the US.

The university announced plans to launch an expansion of its campus along the East River in November 2014.

The proposed expansion includes construction of a new research facility containing bio-medical laboratories and other facilities. The extension will be named Stavros Niarchos Foundation - David Rockefeller River Campus as it is being funded by the Stavros Niarchos Foundation and American philanthropist David Rockefeller.

A new building will accommodate bioscience laboratories and serve as a replacement for the current ageing lab facilities that are no longer suitable for modern science.

It will enable scientific collaboration both in the university and with the outside community, and also provides venues for public programs to spread scientific information to a wider audience.

Project background and master plan for the Rockefeller campus expansion

The master plan for the campus and design of the new laboratory are developed with the objective of making Rockefeller University one of the world's leading biomedical research institutions.

Flexible and collaborative space is required at the university to encourage collaboration between various research disciplines. The infrastructure at the campus has become outdated and poses a challenge to conduct modern bio-medical research.

The university appointed architects to analyze, recommend and develop a master plan that maintains the current scale of scientific environment and fosters intellectual interaction.

Rockefeller University wants to maintain a low profile structure and will utilize existing air rights over Franklin D Roosevelt Drive (FDR) for the structure.

The expansion aims to bring scattered areas or offices of the campus under one roof and provide new connections to the existing building and infrastructure. The new structure will serve the existing population by providing modern bio-medical research space.

The design of the extension project further extends sloping topography of the campus towards the east, and the building will have a green roof which regenerates the natural landscape of Rockefeller University.

Laboratory designs incorporates latest trends and caters to specific needs of the university. It offers maximum flexibility for changes in the layouts, maximum horizontal connectivity and importance to soft spaces such as lounges, informal congregation areas, seminar rooms and food and beverage spaces.

Key features of the building include low height and horizontal floor plates with large areas, ensuring accommodation of multiple laboratories adjacent to each other and allowing researchers to interact easily with their groups.

"The proposed expansion includes construction of a new research facility containing bio-medical laboratories and other facilities."

The 160,000ft² expansion at the university campus will be developed in a two-acre site, increasing the total area of the campus to 16 acres.

Expansion includes a two-story building, a single-story interactive conference center and a single-story building with recreation facilities. The main focus of the project is to construct a research building with a small part devoted to a health and wellness center.

The new research building will be a long, horizontal, two-story structure extending from the south end to the north end of the university campus. It will feature state-of-the-art laboratories, administrative space, conference halls, dining rooms and an outdoor amphitheater. It will accommodate 26 laboratories and 440 research staff.

The building will have a green roof with two glass pavilions, one each for offices and the cafeteria. It will be best visible from the west, in sync with existing contours of the campus and will remain invisible from other directions.

As part of the expansion, the university will also invest $8m in repairs and improvements for East River Esplanade, which is adjacent to the campus. Located between FDR Drive and the East River, the esplanade is one of the few green spaces in the area popular for walking, running and biking.

Improvements at the esplanade will include rebuilding a crumbled sea wall, landscaping upgrades, new paving and benches, a designated lane for bikes and installation of a 5ft-high acoustic barrier to reduce traffic noise from FDR drive.

Rockefeller University will also establish a $1m endowment fund for its maintenance.

The project received a $150m grant, $75m each from the Stavros Niarchos Foundation and David Rockefeller.

New York-based Rafael Vinoly Architects designed the extension project. Rafael Vinoly and Mathews Nielsen Landscape Architects designed the repair and improvement plans for East River Esplanade with inputs from community stakeholders.

FEI and Oregon Health & Science University Install a Complete Correlative Microscopy

FEI and Oregon Health & Science University (OHSU) announced an expansion of their Living Lab for Cell Biology agreement that includes the installation of a complete correlative microscopy workflow in the new Collaborative Life Sciences Building (CLSB) on OHSU's campus. This expansion adds a new instrument, the FEI CorrSightTM, to the OHSU-FEI correlative light and electron microscopy suite.

FEI's CorrSight is an advanced light microscope that integrates multiple sample preparation protocols for correlative experiments and enables researchers to observe live cell dynamics using visible light microscopy and quickly fixes those cells for follow-on light and electron microscopy when a targeted event or structure is identified. The CorrSight system completes OHSU's correlative microscopy workflow and will be used by researchers to develop correlative light and electron microscopy (CLEM) assays for high-content drug screening applications.

The OHSU/FEI Living Lab is part of the OHSU Center for Spatial Systems Biomedicine (OCSSB) that combines physics, biomedical engineering, chemistry and biology to study how cancer cells and other diseases develop in the body. The multidisciplinary Center for Spatial Systems Biomedicine is part of the OHSU School of Medicine and the OHSU Knight Cancer Institute.

"Establishing the OHSU/FEI Living Lab with FEI in 2011 equipped us with high-performance tools to visualize cell and tissue structures at levels of detail that were not possible before, with a specific mission to explore how cancer cells function differently as they spread from the site of origin to other parts of the body. With the installation of the new CorrSight microscope, we will now have a complete correlative workflow that will allow us to better understand complex diseases, such as HIV and cancer. In the near term, we will contribute to the OHSU Knight Cancer Institute goals of enabling early detection of lesions destined to become lethal cancer, developing low toxicity treatments to prevent or keep early lesions from becoming lethal and developing effective strategies to better manage advanced cancers," said Joe Gray, Ph.D., director of the OCSSB and associate director for translational research for the OHSU Knight Cancer Institute.

"Among the advantages of the expanded Living Lab instrumentation is the ability to view living samples and preserve those cells in a fixed position for observation with both light and electron microscopy," Gray said.

Peter Fruhstorfer, vice president and general manager of Life Sciences, FEI, added, "Over the past several years, imaging technologies have made their first steps toward usage in automated high-content screening environments for unsupervised discovery. The rich variety and wide field-of-view of light microscopy, when combined with the exquisite detail offered by electron microscopy, enables researchers to find and analyze molecular-scale structures and events as part of a drug discovery process. An automated combination of these techniques could be a powerful tool for high-content screening of candidate compounds."

"A working protocol will be defined, enabling a known specific cell sample type to be run through an entire workflow during demonstrations," Fruhstorfer added. "The workflow will involve multiple steps, leveraging the live cell imaging capability of the complete set of instruments, as well as the scientific expertise of OHSU and FEI researchers and staff."

The goals of the expanded OHSU/FEI Living Lab collaboration include: improvements in image acquisition speed, automation, data handling, improved image analysis, more challenging electron microscopy (EM) sample preparation protocols, and three-dimensional EM acquisition. Development of high-content screening workflows for biologically-relevant problems also will be explored.

In addition to the CorrSight system, the CLSB facility includes several other microscopes from FEI that complete the correlative microscopy workflow, such as: Titan Krios™ transmission electron microscope (TEM) - the world's most powerful commercially-available TEM; a Tecnai™ T12 TEM; and a Tecnai with iCorr™ fully-integrated light/electron TEM; and a Helios NanoLab™ DualBeam™ focused ion beam/scanning electron microscope (FIB/SEM) for sample preparation and 3-D studies of cell structures. FEI's MAPS software enables correlation between the electron microscope images and an image from any other microscope within the facility.

Establishing the OHSU/FEI Living Lab has provided the OHSU and FEI team with a forum to regularly share feedback on the instrumentation as well as the experimentation. FEI and OHSU are also establishing the first correlative workflow demonstration showcase at the CLSB facility, which is jointly owned and operated by OHSU, Oregon State University and Portland State University. Using this workflow, researchers are able to start from live cell imaging, continue to fixing cells and then go to high resolution electron microscopy, all working from one software platform.

Kaiima Bio-Agritech Establish Subsidiary in St. Louis

Kaiima Bio-Agritech, an Israel-based genetics and breeding technology company, announced in late November it had established a wholly owned subsidiary in St. Louis to lead its North American activities, and had appointed former Dow AgroSciences, Monsanto and Donald Danforth Plant Science Center leader Sharon Berberich to head those operations.

“We chose St. Louis as the base of our US operations because of the region's unique ecosystem that combines an entrepreneurial environment with strong plant science research and commercial activity,” she said We are specifically excited to work with BioSTL, an organization committed to nurturing business relationships in the region, with a new initiative that focuses on St. Louis-Israel collaborations.”

Eurofins Scientific Opening Microbiology Laboratory

Des Moines, Iowa–based Eurofins Scientific announces the opening of a microbiology laboratory in Garden Grove, Calif., early this month, the fourth microbiology lab development this year in North America for the global food testing firm, which acquired SF Analytical Laboratories in New Berlin, Wis., in November. The Garden Grove site will be co-located with CAL Science, an environmental laboratory acquired by the Eurofins Group earlier this year. "The addition of the Garden Grove laboratory aligns with Eurofins' strategy to provide clients with the necessary testing for importing and exporting their products close to vital US commercial ports including those in Southern California," said the company.

JunoPacific Expands Manufacturing Capabilities in Minnesota

JunoPacific Inc., a medical device design, development, and manufacturing company, celebrated the opening of a new facility with a large open house for customers, employees, and honored guest, U.S. Rep. Erik Paulsen (R-Minn.).

Located northwest of the Twin Cities in Anoka, Minn., the facility has more than 60,000 square feet of design, development, and manufacturing space. Additionally, the facility has more than 18,000 square feet of cleanroom space for manufacturing and assembly of all classes of medical devices from disposables to implantable products. Specific sections of the building are also dedicated to silicone molding and 3-D-printing capabilities.

“It’s wonderful to see the significant investment made by JunoPacific in the continually growing medical device expertise here in the Minneapolis area,” Paulsen said. “It is a pleasure to participate in recognizing this significant milestone for the community and for JunoPacific.”

Paulsen has been a champion of medical device tax repeal efforts in the House of Representatives and one of the medical device industry’s most vocal advocates.

The new facility currently employs more than 125 people and is expected to grow by 25 to 50 percent in the next two years, according to JunoPacific officials

U.S. Rep. Erik Paulsen (second from right) stands with JunoPacific officials during recent grand opening of a newly expanded manufacturing facility near the Twin Cities in Minnesota.

JunoPacific also has three other facilities in the Midwest and West Coast.

“We are excited to celebrate the opening of this new facility with our dedicated team members and valued clients, and are greatly appreciative of Congressman Erik Paulsen’s support of the medical device industry,” said JunoPacific President Kern Bhugra. “We look forward to leveraging the state-of-the-art capabilities of this facility, along with the medical device expertise provided by our teams here in the Twin Cities and in Silicon Valley, to further enhance the delivery of medical device solutions for our clients.”

The open house was also celebrated by executives from Cretex Companies Inc. JunoPacific is part of the Cretex Medical group of companies which provide turn-key injection molding, precision machining, stamping, assembly and engineering services for the medical device industry. Cretex Medical is made up of five medical device engineering and contract manufacturing firms: JunoPacific, RMS, RMS Surgical, Meier, and Spectralytics.

Prefab Elements Saved Colorado Hospital Millions in Construction

Using prefabricated elements in the construction of the new Saint Joseph Hospital in Denver—scheduled to open Dec. 13—cut 72 workdays off the construction schedule and resulted in $4.3 million in savings, according to a study by University of Colorado Boulder engineers.

The study, by Matthew Morris and doctoral student Eric Antillon, both of the Department of Civil, Environmental and Architectural Engineering, is one of the first to try and quantify the full costs and benefits of using prefabricated elements in a large-scale construction project. The study was done in partnership with Mortenson construction, which built the new 831,000-square-foot Saint Joseph Hospital.

Developers often choose prefabrication to save time on a project. But because the process of building a unit — like a bathroom or an exterior wall panel — off site can be more expensive up front, due largely to the cost of transporting the finished products to the job site, the overall financial benefits haven’t been well understood.

“The direct cost of the actual units is more expensive — in this case 6 percent more expensive — but the cost savings come from indirect costs related to time savings,” said Morris, an instructor of construction engineering and management. “If you save three months on the schedule, that’s three months when you don’t have to pay for all the things you need to run a job site. This reduces your cost of big-ticket items such as supervision, equipment and your field office.”

For the Saint Joseph Hospital, Mortenson construction chose to prefabricate the exterior wall panels, the bathroom pods, the headwalls in patient rooms, and the utilities that run above hospital corridors by bundling them into prebuilt racks.

Prefabrication is an especially efficient technique in hospitals or any large building where the same type of unit has to be built over and over again, such as dorms or barracks, Morris said. At the Saint Joseph hospital, the need to have hospital rooms with standard equipment and private bathrooms allowed Mortenson to prefabricate 440 bathroom units and 376 patient room headwalls.

“This isn’t the solution for every project,” Morris said. “It takes a particular type of project with repetitive work and an owner and a design team that are willing to be completely onboard.”

Aside from allowing a project to be completed more quickly, prefabricating units offsite can also improve the safety of the job site by decreasing the number of different trades people who need to work in the building at any one time, reducing elevated work and providing a controlled environment.

For example, when utilities are traditionally installed in hospital corridors, a number of different subcontractors have to install cables, air ducts, piping and drywall overhead. Aside from the difficulty of working above your head, this causes congestion in heavily used hallways that can lead to accidents. In all, Morris and Antillon calculated that using prefabricated utility racks in the corridors along with other prefabricated units avoided seven safety incidents on the job site.

Even with the impressive cost benefits calculated in the study, Morris said it may be possible for builders like Mortenson to save even more time in the future by perfecting the sequence of work. In the case of the Saint Joseph Hospital, some prefabricated elements moved the project forward so quickly, that the workers responsible for the next phase of the project weren’t always ready to immediately get started.

It may also make sense in the future to only partially prefabricate some units before installation, which could help the workflow, Morris said.

“Fine-tuning is the next step,” he said. “Now we know that prefabrication saves time and money and increases quality and safety. The next steps include developing best practices, training project teams and continuing to drive out inefficiencies.”

REST OF WORLD

Roche will Establish Diagnostic Manufacturing Facility in Suzhou

Roche will establish a CHF 450 million (about $467.2 million) diagnostic manufacturing facility at China’s Suzhou Industrial Park, the pharma giant’s eighth worldwide and first in the Asia-Pacific region.

The facility—set to become fully operational by 2018—will focus on producing immunochemistry and clinical chemistry tests and will grow its workforce to more than 600 people “over the next several years,” Roche said.

“The new manufacturing site will enable us to meet the growing demand for our diagnostic products, ensuring our continuous contribution to the health of people in China and the Asia Pacific region,” Roland Diggelmann, COO of Roche Diagnostics, said in a statement.

Roche now employs more than 4,000 people in 15 countries across the Asia-Pacific region, where it has had a presence for 40 years. In China, Roche became the first foreign-based pharma giant to open a drug-discovery research center in 2004 at Zhangjiang Hi-Tech Park.

This year, the region has generated the fastest growth for Roche Diagnostics, with first-half 2014 sales rising 15% over the first six months of 2013, to CHF 877 million ($910.4 million). Asia-Pacific sales growth reflected in part demand for professional diagnostics.

“The sales increase in Asia–Pacific was also influenced by increasing sales in China (+24%) coming from governmental healthcare investments, public demand and the division’s expanding presence and wide portfolio,” Roche stated in its Half-Year Report 2014, covering January-June results.

While a Roche sales office in Hangzhou was “visited” earlier this year by local authorities investigating the practices of multinational pharmas, the company has not experienced the official wrath visited upon GlaxoSmithKline, which in September was fined almost $500 million by a Chinese court that meted out prison sentences to five of its former executives.

Roche also strengthened its Asia-Pacific presence last year by launching a partnership with Ascletis to develop and commercialize Roche’s investigational small-molecule NS3/4A protease inhibitor danoprevir in China for Hepatitis C virus. Ascletis agreed to fund and oversee development, regulatory affairs and manufacturing of danoprevir in greater China—including Taiwan, Hong Kong, and Macau—in return for an undisclosed amount of development and commercial milestone payments from Roche, plus royalties.

New Cell Therapy Manufacturing Centre to be built in Stevenage, UK

A new £55m cell therapy manufacturing center in Stevenage, Hertfordshire, UK, is set to create 150 jobs. The firm Cell Therapy Catapult is planning to build the manufacturing center on the Stevenage Bioscience Catalyst campus. Forecasts suggest that firms using the center will generate £1.2bn of revenue by 2020 (80% through export).

UK Business Secretary Vince Cable said cell therapy 'is at the very cutting edge of medical research, and is using our own cells in the fight against life-threatening diseases including cancer. This state of the art facility in Stevenage will ensure Britain can be a real leader in this industry'.

The UK Cell Therapy Manufacturing Centre, expected to open in 2017, will be managed by the Cell Therapy Catapult and will be used for the manufacture of late phase clinical trial and commercial supply of advanced medicines including cell and gene therapies. Keith Thompson, CEO of the Cell Therapy Catapult said: 'This facility will complement the existing UK capability, enabling companies to operate at the scale needed for Phase III clinical trials, and we look forward to working with global scientific and medical communities to assist in their research into products that have the potential to address many unmet medical needs.' GE Healthcare also welcomed the announcement of the new center. CEO Kieran Murphy said: 'The clinical science in cell therapy is making significant strides, and there is no doubt about the consensus: this is set to revolutionize medicine. 'The toughest nut for cell therapy companies to crack is to scale-up manufacturing and subsequent distribution of these therapies so they are affordable and accessible to patients globally; this manufacturing center will help companies to crack that nut.'

GlaxoSmithKline Manufacturing Facility Expansion, Boronia, Australia

The latest machinery to be installed at the Boronia site will be used for manufacturing advanced aseptic packing of sterile pharmaceutical liquids.

GlaxoSmithKline (GSK) announced the expansion of its manufacturing facility in Boronia, in the outer eastern suburbs of Melbourne, Australia, in November 2014.

The expansion will introduce the latest machinery, which will be used for manufacturing advanced aseptic packing of sterile pharmaceutical liquids.

By investing in innovative manufacturing processes to increase production at its Boronia manufacturing facility, the pharmaceutical company aims to cater to the needs of emerging markets such as China, Turkey and Brazil where demand for low cost, accessible treatments for asthma is high.

The project involves an investment of a $31m ($25.7m) and is expected to be completed by January 2016.

The new facility will be located at GSK's existing factory in Ulverston factory in Morecambe Bay.

Expansion includes high-speed Blow-Fill-Seal (BFS) machinery, which constitutes one quarter of the total investment, while the remaining investment will be allocated to the expansion of the facility, in order to accommodate new machinery and other process equipment, as well as staff training.

The new machine will be the second Rommelag machine and 11th BFS machine to be installed at the Boronia manufacturing site. The machine will run six days a week and requires four highly skilled manufacturing operators.

Capacity of water for injection (WFI) facility and additional batch holding tanks will also be increased to facilitate the expansion.

The newly installed BFS machine will be used to manufacture advanced aseptic containers for unpreserved, sterile pharmaceutical products. It will be dedicated to producing Ventolin (salbutamol sulfate) nebules.

BFS technology requires less human intervention as the entire process of forming a container, filling and sealing occurs continuously in an enclosed area inside a machine. It is a preferable technique to manufacture sterile pharmaceutical liquid dosage forms.

Rommelag 4010 machine uses the latest rotary technology to produce continuous output instead of a shuttle output. It is different from existing machines at the site and offers advantages including increased output, reduced waste production and less space consumption.

The new machine produces two and a half times more output than the old shuttle machine. Layout of the new machine demands less space for the clean room and reduces construction costs. It produces 30% lesser polymer waste, compared to conventional machines.

Boronia manufacturing facility is GSK's biggest manufacturing site producing sterile and non-sterile liquid pharmaceutical products. The facility has been manufacturing BFS products for 25 years and is also GSK's Centre of Excellence for BFS technology.

The unit manufactures medicines for a range of conditions including migraine, herpes, epilepsy, smoking cessation, hypertension, anti-virals, pain relief and asthma.

Environmental impact is a key consideration for all manufacturing processes at GSK. The company is working towards achieving a global carbon neutral value chain by 2015 and the Rommelag machines contribute to year-on-year reductions across waste, water and energy.

The current investment is part of a series of investments made by GSK in Australia and the UK.

Earlier expansions included an investment of a $60m for increasing BFS capacity at the site, installing state-of-the-art equipment across other manufacturing sites in the UK and the establishment of two new facilities in the UK, designed to utilize latest technologies.

AstraZeneca R&D Center and Corporate Headquarters, Cambridge, United Kingdom

British-Swedish pharmaceutical and biologics company AstraZeneca intends to build a new global R&D center and corporate headquarters on the Cambridge Biomedical Campus (CBC) in Cambridge, UK, in 2015.

The project is part of the company's strategic move to establish global R&D centers in the UK, US and Sweden to improve its pipeline productivity and biopharmaceutical innovation.

AstraZeneca will invest approximately £330m ($500m) to build the facility, which is expected to employ approximately 2,000 highly skilled employees.

Construction of the facility, which will be AstraZeneca's new global corporate headquarters, is expected to be completed by 2016.

The facility was commissioned to produce the active pharmaceutical ingredient (API) rosuvastatin calcium for the worldwide supply of the once-a-day dyslipidaemia treatment Crestor.

The new facility on the CBC will occupy approximately 11 acres and benefit from the central Cambridge location and strong infrastructure links. The project includes the construction of a global R&D center, an R&D enabling building, and an energy center.

Features of the global R&D center will include high-tech labs with glass walls to enhance visibility, a number of open spaces, as well as pathways to encourage collaboration within the company and CBC campus.

The R&D enabling building will host operations to support AstraZeneca's scientific work including regulatory affairs and commercial units. The energy center will be equipped with power generators, heating and cooling systems, IT and other telecommunications systems.

AstraZeneca's small molecule and biologics R&D activities and protein engineering capabilities carried out at MedImmune, the biologics arm of the company, will be consolidated in the new facility.

Scientists from AstraZeneca and MedImmune will work together to advance science in core therapeutic areas.

The new site will become the company's biggest center for oncology research. It will also conduct research on respiratory, inflammation and autoimmune diseases, cardiovascular and metabolic diseases, as well as conditions of the central nervous system.

The center will also accommodate a number of pre-clinical research capabilities of the company. Other global functions will join the R&D teams at Cambridge upon completion of the building.

AstraZeneca unveiled designs for the proposed new global R&D center and corporate headquarters in July 2014. The shape of the new building is inspired by historical colleges in central Cambridge, which are typically designed with less height than traditional colleges and includes enclosed central courtyards.

The entire building will be constructed in a single loop to provide short connections. It will feature modern and innovative workspaces to ensure collaborative working.

The roof of the building will replicate a saw-tooth roof, which continues through the façade and aims to unite the visual aspect of the building.

A proposed two-story disc structure of a unique oval shape creates an uninterrupted protected walk along the building. The disc will have laboratories and other amenities with a porous ground floor, and provides a spatial feel by framing a central courtyard.

A courtyard will be open to the public and feature three main entrances to the building, while the center of the courtyard will have large trees and green lawn providing places for recreation and informal meetings.

The building's internal design elevates visible science in a synergetic environment. Laboratories are separated from work and other spaces by semi-transparent partitions.

The first and second levels of the building will have a ring area overlooking the central courtyard, leaving a large number of spaces and arrangements, while the roof will bring natural light into deep floor plates.

AstraZeneca campus on the CBC will comprise a north and south plot. During the first phase of construction, the R&D center and corporate headquarters with a central courtyard will be built on the north plot, while the R&D enabling building and energy center will be constructed on the south plot.

The next phases include the development of a series of buildings on the south plot with an enclosed park, similar to the courtyard on the north plot. Consistency in design throughout the north and south plots will unify all buildings.

AstraZeneca is obtaining Building Research Establishment Environmental Assessment Methodology (BREEAM) Excellent status for the proposed site. The site will feature labs that adopt best practices in low energy design and the largest ground source heat pump in Europe, while the majority of the buildings on the site will have green roofs.

AstraZeneca selected Swiss architect firm Herzog & de Meuron Basel to design the new facility in November 2013.

Command Medical Products' Nicaragua Manufacturing Plant Expands Cleanroom

Command Medical Products, Inc. has doubled cleanroom manufacturing space in its Managua, Nicaragua facility. Construction completed on the additional ISO Class 7 cleanroom (Class 10,000) and the room was certified operational in November, 2014. With this expansion, additional space is available for use in device assembly, ultrasonic welding and packaging operations. R.F. Welding will also commence in this room once installation and qualification of the new capital equipment is completed in Q1 of 2015.

"Command has experienced tremendous growth in 2014. Expanding our cleanroom capacity in Nicaragua and optimizing our operations in both Florida and Nicaragua has allowed Command to meet increased demands and also plan for continued growth in 2015," says Stephanie McGee, Director of Sales and Marketing.

Stelis Biopharma Builds Facility in Malaysia

Stelis Biopharma began construction of its customized, multi-product biopharmaceutical manufacturing facility at Bio-Xcell Biotechnology Park in Nusajaya, Johor, Malaysia, the company announced in a Dec. 3, 2014 press release. Stelis Biopharma is a wholly owned subsidiary of Strides Arcolab.

The construction and fit-out of the facility is expected to be completed in 24 months, and commercial operations are targeted to begin mid-2017. The 140,000-ft2 facility will incorporate single-use bio-processing technology with both mammalian and microbial manufacturing suites. When complete, it will be one of the few regulated-market approvable facilities in the region with end-to-end capability including sterile fill-finish across all formats. The facility will also house an R&D unit to conduct scale-up and process development studies. At peak operations, the facility will employ 180 people.

Biocon Planning New Biomanufacturing Plant in India

Indian drugmaker and biosimilars pioneer Biocon has told the Chief Minister of Andhra Pradesh it intends to set up a new biomanufacturing plant.

According to a release from the Andhra Pradesh Government reported by a number of Indian media outlets , Biocon’s Managing Director Kiran Shaw met Chief Minister N Chandrababu Naidu at his residence Sunday to inform him of plans for a new manufacturing facility in Vizag in the next six months.

A company spokesperson said: “Biocon has been planning to set up a Bio-manufacturing facility at Pharma-city SEZ [Special Economic Zone] in Vizag.” No specific details are being provided at this stage.

The company has already launched two proprietary monoclonal antibody drugs – Alzumab (Itolizumab) for psoriasis and Biomab (Nimotuzumab) for glioma – but the firm is also investing in insulin products through construction of a $200m facility in Malaysia set to open next year, and biosimilars.

Earlier this year, Biocon and Mylan became the first companies to launch a biosimilar in India following approval of their version of Roche’s Herceptin in December 2013. Known as Canmab, the drug is “a testament to our significant investments in state-of-the-art research tools,” Biocon said in its annual report and despite being criticized by patient groups over its cost, is the world’s lowest priced trastuzumab.

Alzumab and Canmab are manufactured at the firm’s 200,000 sq. ft. facility in Bangalore, one of the largest biomanufacturing plants in India, and also the site of a training academy the firm has set up in order to address the shortage of biotech workers in the country.

Furthermore, Biocon operates a third-party contract manufacturing subsidiary, Syngene, which – along with Kemwell – is one of two firms offering India-based biomanufacturing services to Western firms.

Siegfried Acquires Hameln Pharma

Siegfried Group will acquire the Hameln Pharma in Germany, consisting of Hameln Pharmaceuticals GmbH and Hameln RDS GmbH, with effect from end November 2014. Hameln Pharma is active in the development and production of sterile liquid pharmaceutical products for international pharma companies; the Siegfried Group will therefore considerably strengthen its sterile filling segment.

The acquired companies are located in the city of Hameln in the vicinity of Hanover in Germany and employ a workforce of approximately 500. Under terms of the acquisition agreement, Siegfried will take over the entire staff.

To date Hameln Pharma was a part of the privately held Hameln Group. For 2014, Hameln Pharma expects sales of approx. CHF 85 million. The purchase price amounts to CHF 60 million.

The Hameln Group with its remaining subsidiaries will in future focus on their worldwide business activities with their own brand of injectable pharmaceutical finished products. The research and development site in Slovakia will also remain in the possession of the Group.

Hameln Pharma is an attractive complement for Siegfried

Hameln Pharma was founded in 1950 and goes back to the “Raths-Apotheke” in Hameln, family-owned since 1890. The company began focusing on the production of parenteral products in 1970. It produces sterile liquid drugs filled in ampoules or vials for international pharmaceutical companies.

The focus of its activities is on the production of demanding compounds, such as anesthetics. To supplement its core business of contract manufacturing, Hameln Pharma offers a portfolio of accompanying services ranging from product and method development to dossier compilation and registration services.

Siegfried CEO Rudolf Hanko: “The family-owned company looks back on a history of more than 100 years and, from both a technical and a cultural point of view, represents a perfect fit with the Siegfried Group, which celebrated its 140th anniversary last year. The new location significantly supplements our activities in the field of sterile filling.

Our industry is in an intensifying consolidation process. Siegfried wants to and will play an active role in this.”

Hameln Pharma’s production plant is very modern. In 2008, Hameln Pharma´s new sterile facility was put into operation, which in 2009 has been awarded the internationally renowned “Facility of the Year Award” in the category Operational Excellence. Thanks to the sterile facility, the combined company now has at its disposal an innovative, efficient and flexible production plant capable of producing sterile drugs under conditions for the entire world. In the future, Siegfried will continue to invest in these technologies at both of its sites - Irvine and Hameln - and in the coming years move forward especially the production of vials in Hameln.

With this acquisition, Siegfried has implemented its Transform strategy regarding both forward and backward integration. In 2012, Siegfried acquired Alliance Medical Products, Inc. in Irvine, California, active in a comparable market segment as Hameln Pharma.

In October 2014, operating approval was granted for the new chemical production plant for active pharmaceutical ingredients in Nantong, China. This Siegfried site has a chemical-pharmaceutical capacity of over 300 cubic meters. At its headquarters in Zofingen, Switzerland, Siegfried is currently building a chemical production plant with a capacity of 100 cubic meters which from mid-2015 will replace older and less efficient facilities.

McIlvaine Company

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