AAF International held a ribbon cutting ceremony on May 22, 2014 commemorating its new ISO 4, 6, and 7 cleanroom for HEPA filter manufacturing in its Columbia, Missouri facility. Hiroo Yoshioka, Senior Executive Officer and board member of AAF's parent company Daikin Industries Ltd, Peter Kurto, AAF Chief Executive Officer, and Bob McDavid, Mayor of Columbia, were in attendance along with other state and local government officials, to celebrate the inauguration. Peter Kurto stated, "The official opening of the cleanroom and our exciting new product launch highlight AAF's mission to be a world class air filtration solution provider, innovative technology leader, and supplier of choice. We thank the mayor and city of Columbia for their support of this project as we build for AAF's and Columbia's future."

The new cleanroom will contain four core process steps: media pleating, filter assembly, testing, and packaging. All cleanroom areas are designed, constructed, and validated following the international standards as defined in ISO 14644: Cleanrooms and associated controlled environments.

The quality of a HEPA filter directly affects process performance and output quality of critical cleanroom environments, such as those found in the pharmaceutical and microelectronic industries. Even the smallest contamination can make the difference between success and failure. This means that not only the efficiency of the HEPA filter needs to comply with performance specifications, but also contamination of the HEPA filter itself has to be eliminated. AAF recognized the importance of this and constructed the new cleanroom for its U.S. HEPA manufacturing facility.

As a member of Daikin, AAF has the ambition to be the number one preferred supplier of clean air solutions. Kurto stated, "The new cleanroom is dedicated to Mr. Yoshioka, a Daikin board member, who was instrumental in initiating this cleanroom. The new cleanroom facility exemplifies the positive development of our organization and strengthens AAF's leading position in the high-end air filtration market." In addition to the Columbia, Missouri plant, AAF has also implemented various improvements to its other manufacturing locations. These improvements enable AAF to deliver the highest quality levels in terms of process, product, and the environment.

Additionally, AAF launched Impress Technology during the event. Impress is the latest generation of embossing and pleating technology delivering advantages not seen in other filters. Impress Technology offers the most energy efficient, low pressure drop technology available. Embossed, reinforced V-pleat geometry offers smoother airflow, with higher dust holding capacity. Several products designed with Impress Technology will be introduced in the upcoming months.

AAF International, based in Louisville, Kentucky, has more than 3,000 employees, 22 manufacturing facilities, and 5 R&D centers worldwide. AAF designs, develops, and manufactures air filtration solutions for commercial, industrial, cleanroom, transportation, and nuclear power applications. AAF also provides inlet air cooling and sound attenuation solutions for high-speed rotating machinery. For more information visit www.aafintl.com.

AstaReal Technologies Opens Astaxanthin Production Facility

AstaReal Technologies, Inc. opened its new production facility in Moses Lake, Washington. The new 59,000 sq. ft. factory will produce natural astaxanthin, an antioxidant supplement that helps fight signs of aging and supports joint and skeletal health. It is expected to begin production by this July, initially employing approximately 45 people.

The company said it has been producing natural astaxanthin in Gustavsberg, Sweden, and decided to build an additional factory in response to increased global demand. The new factory will have more than double the production capacity of the existing Swedish facility and will more than triple the AstaReal Groups' total production capacity.

“The increased capacity will allow AstaReal to offer a stable supply of natural astaxanthin to its customers in the United States and around the world. The factory site in Moses Lake has ample space for further expansion,” according to company officials. “The City of Moses Lake in Grant County was chosen after a global search and is a perfect match for AstaReal Technologies' new factory. Moses Lake offers a stable supply of pure water and renewable electrical energy, two resources that are critical to the success of the new facility.”

"AstaReal is honored to be a community member of Moses Lake, Grant County and Washington State, and expects the community will experience significant growth and development which it hopes to contribute to," said Mitsunori Nishida, President/CEO of Fuji Chemical Industry.

Company officials explained, “research shows that astaxanthin may be effective in helping to maintain cardiovascular health as well as supporting the body in its fight against metabolic syndrome conditions. The number of studies exploring astaxanthin's potential benefits has greatly increased during the last decade, to include research areas such as eye health, hypertension, diabetes, and nonalcoholic steatohepatitis.

"We see the 21st century as the era of anti-aging," said Nishida. "We believe that natural astaxanthin will play a key role in the advancement of anti-aging and lifestyle disease research."

AstaReal Technologies' parent company Fuji Chemical Industry Co., Ltd. was established in 1946, and is a global pharmaceutical company focusing on three main business areas including; the production and sales of high performance pharmaceutical products, synthesis and manufacturing of active pharmaceutical ingredients and bulk products, and the production and sales of nutraceuticals.

PCI Opens North American Clinical Facility

PCI has completed a North American storage and distribution facility for clinical trial materials on a 97,000 square foot site. The site was constructed to support growth in PCI’s clinical trial services business, which includes drug development and manufacturing, laboratory services, packaging and storage services, global logistics, as well as client supporting consultative services for executing global investigational studies. PCI features these services at facilities across North America and Europe, and distributes clinical trial supplies through a network of global depots to deliver investigational medicinal products (IMP) to investigational sites around the world.

The new facility features storage for investigational supplies at controlled room temperature, as well as expansions of its cold chain storage capacity including conditions at 2-8°C, -20°C, and -80°C. In addition, the facility is a DEA registered site for schedule II – V controlled substances. Special consideration was given to management of returned investigational products, a service where PCI supports clients with management of investigational study materials returned from clinical trial sites across the globe including preplanning, on-site processing at receipt, detailed reconciliation, multi-year storage, as well as certified destruction where designated. PCI has dedicated over 8,000 square feet of the new facility for this regulatory segment of the business.

According to the company, the opening of this facility highlights a significant ongoing investment in clinical trial services. In August 2014 PCI announced the acquisition of Penn Pharma, a provider of drug development and drug manufacturing services located in Tredegar, in the UK. Subsequent to that acquisition, PCI announced in September 2014 the acquisition of Biotec Services International, located in Bridgend, also in the UK. Biotec is a provider of clinical trial services with specialization in controlled temperature management services ranging from +25°C to -196°C. The addition of the two companies brings PCI’s global footprint to 16 facilities across North America and Europe, with over 2,900 employees.

“These ongoing investments in our clinical trials business continue to allow us to grow our presence in this market and at the same time keep our focus on the significant importance of each package we prepare and each shipment of investigational study material we manage,” says Bob Misher, senior vice president of PCI Clinical Trial Services.

DPx Holdings Expands Patheon's NC Facility

DPx Holdings B.V. and its business unit Patheon, a provider of contract development and commercial manufacturing services to the global pharmaceutical industry, will expand its operations in NC. The company plans to create 488 jobs in Greenville by the end of 2019 and invest $159 million to increase the site’s capabilities as well as modernize the site and develop energy efficiency programs at the facility. The investment will also make the Greenville site home of Patheon’s North American sterile facility as well as boost growth for its Pharmaceutical Development Services (PDS) offering, which will be built out at the site.

Patheon contracts with large and small pharmaceutical and biopharmaceutical companies to develop, manufacture and distribute its drugs and therapies. DPx Holdings’ U.S. headquarters is located in Durham and the company also has a manufacturing facility in High Point. The company currently has more than 1,680 employees in NC, including more than 1,000 at its Pitt County facility. Globally the company has over 8,000 employees at more than 20 locations. The expansion will address Patheon’s need for additional manufacturing and development capacity.

“We are committed to our work with local and state government officials as well as academia to provide the best opportunities to build sustainable and successful manufacturing and product development operations in Greenville. We appreciate the support and collaboration of the Governor’s office and the Grenville Chamber of Commerce to establish a world class operation in Greenville,” said Franco Negron, senior vice president of the contract manufacturing business for North America at Patheon.

SGS Completes New Carson, CA Lab

SGS Life Science Services has completed its fifth North American Life Science Services lab in Carson, CA. The new GMP/GLP facility houses 6,000 sq.-ft. of dedicated lab space and 2,000 sq.-ft. of office space. The lab will provide microbiological testing and bioanalytical services and will initially employ seven scientific staff, with room for expansion.

Dr. Marcella McSorley is Quality Assurance manager at the Carson site, and Pojaman Zunggeemoge is the facility’s microbiology manager.

“This strategic expansion to the West Coast will provide local support to the well-established Californian pharmaceutical and biotechnological community,” commented Jeff McDonald, chief operating officer, SGS North America. “The laboratory complements our existing bioanalytical offer and we look forward to welcoming existing and new clients to visit this state-of-the-art facility in October.”

Thermo Fisher Scientific Opened Center of Excellence

Thermo Fisher Scientific officially opened its $85 million, 350,000-square-foot Niche Diagnostics Center of Excellence in Fremont, Calif. The facility will be used for the development and manufacture of tests for therapeutic drug monitoring, drugs of abuse screening, and other purposes, and employs more than 500 workers.

Novo Nordisk Newly Acquired Plant in New Hampshire

Novo Nordisk announced plans to hire up to 90 people at its newly-acquired manufacturing facility in West Lebanon, New Hampshire.

Novo bought the 180,000 square-foot plant from CMO Olympus Biotech in August. The facility will produce products for the treatment of hemophilia in the US, including the long-acting recombinant factor VIII, N8-GP for those with hemophilia A.

The additional employees will add to the 130 facility personnel currently employed at the site who have expertise in manufacturing and facility operations, engineering, development, quality assurance, quality control, validation, and operational excellence.

"We're pleased to be bringing this site back to life, and make it a part of Novo Nordisk's growing network of manufacturing sites," said Steen Weber Jensen, corporate VP, Novo Nordisk. "Our long-standing commitment to patients and families affected by hemophilia means we have to continuously improve how we supply our medicines, and this new site will give us new, vital capacity."

The site was set to close on the same day that Novo stepped in and bought it. Terms of the acquisition were not announced but Olympus said back in March that it was reducing the price of the plant to a “nominal value.”

According to Olympus, the plant houses two mammalian cell culture suites with fixed and single use platforms as well as an area dedicated to process development activity. Each suite offers independent cell culture equipment trains and dedicated areas for product recovery and purification. Downstream areas can support an array of column chromatography and filtration processes including affinity, ion exchange, hydrophobic interaction, gel filtration, ultrafiltration, and diafiltration. Clinical aseptic fill capacity was recently introduced at the site using barrier isolator technology.

"Novo Nordisk is making a long-term investment in the Upper Valley, and we're glad that New Hampshire is a part of the company's manufacturing division," added Peter Gariepy, vice president and site manager for the West Lebanon plant. "The community can look to Novo Nordisk to be a cornerstone for the foreseeable future."

Meanwhile, Novo Nordisk announced last week that it has been served with a subpoena by the office of the US Attorney for the District of Massachusetts requesting documents regarding potential manufacturing issues within certain production units located in Kalundborg, Denmark.

“Novo Nordisk is cooperating fully with the US Attorney in this investigation. At this time, Novo Nordisk cannot determine or predict the outcome of this matter or assess the consequences thereof. In addition, the company cannot predict how long the investigation will take or when it will be able to provide additional information,” the company said in a statement.

Headquartered in Denmark, Novo Nordisk is a global health care company with more than 90 years of innovation and leadership in diabetes care. The company also has leading positions within hemophilia care, growth hormone therapy, and hormone replacement therapy. Novo Nordisk employs approximately 40,000 employees in 75 countries, and markets its products in more than 180 countries. For more information, visit novonordisk.

Pharma Firm to Establish Operations in VA

A Chinese pharmaceutical ingredients maker is planning to invest $22.5 million to establish operations in Virginia, creating 376 jobs.

UniTao Pharmaceuticals LLC has purchased the Boehringer Ingelheim plant that's slated to close by the end of the year.

Officials say the project is a result of the governor's Asia trade mission. UniTao is a subsidiary of Shanghai-based Tenry Pharmaceutical Co. Ltd.

Virginia successfully competed against California and China for the project. McAuliffe approved a $1 million grant from the Governor's Opportunity Fund for the project.

The company also will be eligible to receive a major business facility job tax credit and sales and use tax exemptions on manufacturing equipment.

New BSL-3 Public-Safety Lab Opens in Vermont

The project’s Building team is tested by this facility’s complex mechanical system and air exchange requirements.

Vermont’s state-of-the-art public safety facility includes unique biosafety labs that rely on complicated mechanical systems to control air exchanges, and in some cases require zero air leakage.

The Vermont Department of Health and the University of Vermont in late October held ribbon-cutting ceremonies for a 60,000-sf public health laboratory that is nearly twice the size of the 62-year-old lab it replaces. The laboratory will be used to perform a wide range of analyses to detect biological, toxicological, chemical, and radiological threats to the health of the population, from testing for rabies, West Nile, pertussis and salmonella to water and food contaminants.

The new $31 million facility, located at the Colchester Business and Technology Park, took 18 months from its notice to proceed to its completion. It is distinguished by highly specialized Biosafety Level 3 and Animal Biosafety Level 3 (BSL-3 and ABSL-3) laboratories, as well as high-performance building enclosure, mechanical, electrical, plumbing and fire suppression systems to conduct specialized laboratory work.

That mechanical system accounted for about 40 percent of the project’s total cost, and posed the biggest installation challenge for Vermont-based PC Construction, the contractor on this project, according to Matt Cooke, PC’s senior project manager. “The building’s ‘penthouse’ is all mechanical, and the facility is jammed-packed with air recovery and exchange equipment.

He says that “to make everything fit,” PC and the Building Team did extensive BIM modeling That team consisted of HDR (architectural design), Scott & Partners (exterior envelope), Krebs & Lansing (civil engineering), Zero by Design (energy consultation), as well as the State of Vermont Department of Building and General Services and the university (owners).

PC Construction has built a number cleanrooms in the past, but nothing as elaborate as this facility, which includes one of the few BSL3 labs in the country, says Cooke. He notes that some of the lab space requires zero leakage, so everything—including the electrical boxes and windows—needed to be sealed. Cooke adds that what also makes the facility unique are its “systems and automated controls” for the anterooms and air exchange machinery.

The building sits on a foundation supported by 180 H-piles that are driven to depths of between 70 and 90 feet. The original plans called for piles that would only need to be 60 to 65 feet deep. “But once we got out there and started drilling,” Cooke says PC found that the geological survey hadn’t sufficiently taken into account the location of underground rocks, which dictated far-deeper piles.

The facility design called for its six flue-gas stacks to be 75 feet above ground, which required FAA approval and a non-reflective coating due to their height and proximity to Burlington International Airport

Cadence Expands Rhode Island Facility

Cadence Inc., a Staunton, Va.-based manufacturer and supplier of advanced products, technologies and services to medical device, life-science, automotive, and industrial companies, has expanded its facility in Cranston, R.I.

In the medical device sector, Cadence has worked with OEM partners to developing, manufacture and assemble cutting and piercing components and assemblies used in spine; trauma; joint repair, reconstruction and replacement; laparoscopy and arthroscopy; and sports medicine.

The company recently celebrated the grand opening of the new 34,000-square-foot expansion with a ribbon cutting ceremony on Thursday, Oct. 30. The new expansion adds to the existing 43,000-square-foot plant.

“This is a very exciting time for the Cadence Rhode Island team. The need for this facility expansion is the direct result of the talent, hard work, and commitment of our employees to making us a better company every day and our business is seeing the favorable results of their efforts,” said Brian Plummer, vice president of manufacturing at the Rhode Island facility.

The expansion creates space for new precision machining, laser processing, and automation equipment. The Rhode Island facility is currently staffed by 150 full-time employees and intends to continue adding jobs over the next several years, according to Cadence officials.

Cadence employs more than 475 people worldwide. In addition to Staunton and Cranston, the firm has facilities in Pittsburgh, Pa.; Sturgeon Bay, Wis.; Plymouth, Mass.; and the Dominican Republic.

Grand Opening of Sandoz U.S. Headquarters

Lt. Governor Kim Guadagno today joined executives from Sandoz, Inc. to celebrate the grand opening of its new U.S. headquarters. The Partnership for Action, which includes the New Jersey Business Action Center (BAC) and Economic Development Authority (EDA), assisted in bringing this project to fruition.

"This project is one more example of the State's ability to attract and retain businesses while creating quality, sustainable jobs," said Lt. Governor Guadagno. "In addition to its contributions to New Jersey's position as the Medicine Chest of the World, Sandoz has breathed new life into a facility that has been vacant for more than a year. That brings an added boost to the tax base and strengthens the local economy through job creation."

Sandoz, previously located in West Windsor, is the generic pharmaceuticals division of Novartis and a global leader in the generic pharmaceutical sector. Prior to making the decision to stay and grow in New Jersey, Sandoz considered a location in Pennsylvania. The BAC worked in collaboration with the EDA to help cultivate this project, providing ongoing customer service support.

The EDA awarded Sandoz a Grow NJ award worth $9.1 million over 10 years. The award encouraged the company to lease the more than 154,000-square-foot property that was vacated in 2013 when its previous tenant expanded to a nearby location. The relocation and expansion will retain 292 existing jobs as well as create 70 new full-time positions. Sandoz executives plan to make an estimated capital investment of $15.2 million.

"Sandoz's decision to expand in New Jersey helps to illustrate how the Economic Opportunity Act is effectively working to stimulate growth in targeted industries, including life sciences," said EDA CEO Michele Brown.

Sandoz employs more than 26,500 employees across more than 160 countries, offering a broad range of high-quality, affordable products. With $9.2 billion in sales in 2013, Sandoz has a portfolio of approximately 1,100 molecules, and holds the #1 position globally in biosimilars as well as in generic injectables, ophthalmics, dermatology and antibiotics.

New Jersey's life science industry is a thriving and crucial part of the State's economy. A recent report by BioNJ and EY (formerly known as Ernst & Young) found that the estimated annual expenditures by the industry are $30.1 billion. Since the 2012 report, the number of biotechnology companies operating in New Jersey has increased by 12 percent from 340 to 379 companies. Overall, the life sciences industry directly employs and indirectly supports a total of 212,556 jobs in the state.

Biosciences Partnership Building in Phoenix

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.

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

The ten-storey, 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-storey, 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 centre 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 aluminium cans, use of energy efficient fixtures and systems, use of sustainability products, and waste reduction programs.

Catalent Expands Highly Potent and Cytotoxic Clinical Packaging Capabilities

Catalent Pharma Solutions, a global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, has commenced to expand its highly potent and cytotoxic clinical drug packaging capabilities within its 450,000 sq. ft. Kansas City, MO campus.

The expansion will increase the available packaging space for highly potent compounds adding two large packaging suites, a sampling lab, and space for various storage conditions. Segregated and separated from non-potent manufacturing operations, the new 6,000 sq. ft. facility is capable of handling SafeBridge Category 3, 4 and cytotoxic compounds. Completion is expected in January 2015.

Catalent already has several highly potent and cytotoxic drug packaging suites in its clinical supply facility in Bolton, UK, providing end-to-end clinical supply solutions from clinical supply management, comparator sourcing and primary packaging to storage and distribution globally.

“Customer demand for specialty clinical packaging has grown as the proportion of highly potent molecules in drug development pipelines increases,” commented Gerry Hepburn, chief operating officer, vice president and general manager of Catalent’s Clinical Supply Services business. “Industry-wide clinical packaging capabilities are insufficient to support future demand and this expansion will provide our customers with the necessary capacity and expertise to develop and commercialize potent and cytotoxic compounds.”

Environmental Hall, The Nicholas School of the Environment, Duke University

As one of the world’s premier schools for the study of environmental science and policy, the Nicholas School of the Environment attempts to understand the Earth, its inhabitants and the environment as an integrated whole by addressing the critical issues of climate change, energy, water quality, ecosystem management and conservation and human and environmental health. Environment Hall, the School’s new front door, mirrors this mission by employing low-energy sustainable building systems aimed at reducing the project’s environmental impact and serving as a teaching tool for the School and its community. This is reflected by the project goal of LEED Platinum certification with a targeted energy reduction of 40 percent over the baseline ASHRAE 90.1 (2004) building.

The building’s systems include solar photovoltaic power generation, solar hot water, chilled beam cooling system, daylight harvesting, high-performance glazing, water-efficient fixtures, green roofs and rainwater harvesting. The building consists of a simple glass box housing a south facing “thermal” corridor which utilizes related temperature criteria to reduce the building’s energy use and buggers the adjacent classrooms and offices from direct solar gain. Environment Hall includes faculty and departmental offices, advanced computing labs and classrooms, a reading room and environmental art gallery all wrapped in a high-performance exterior envelope specifically tuned to the site.

Bristol-Myers Squibb and Lonza Expand Manufacturing Agreement

Bristol-Myers Squibb Company and Lonza have announced a multi-year expansion of their existing biologics manufacturing agreement. The contract expansion will include the production of commercial quantities of a second Bristol-Myers Squibb biologic medicine at Lonza’s mammalian manufacturing facility in Portsmouth, New Hampshire. Financial terms were not disclosed.

Biologic medicines that treat serious diseases are an integral part of Bristol-Myers Squibb’s specialty care portfolio and R&D pipeline. Bristol-Myers Squibb and Lonza have been collaborating since 2003 to produce commercial supplies of a biologics medicine marketed by Bristol-Myers Squibb worldwide. Currently, Lonza also produces clinical supplies of an investigational biologics medicine for Bristol-Myers Squibb.

“Our expanded relationship with Lonza is an important example of our global manufacturing strategy to meet anticipated demand for our commercial biologics portfolio and prepare to bring our late-stage clinical assets to patients by supplementing our in-house manufacturing capabilities,” said Lou Schmukler, president, Global Manufacturing & Supply, Bristol-Myers Squibb.

Lonza’s development and manufacturing facilities offer proven expression systems and established platform processes for streamlined scale-up throughout the clinical pipeline. In addition to its state-of-the-art Portsmouth facility, Lonza offers three additional clinical-to-commercial mammalian production facilities in Tuas, Singapore; Porrino, Spain; and Slough, United Kingdom.

"We are pleased to extend our relationship with Bristol-Myers Squibb for the commercial production of their innovative drug substance,” said Marc Funk, COO of Lonza’s Pharma & Biotech Segment. “This reinforces Lonza’s mission to support life-saving medicines by being a reliable supplier of drug substance for our customers with high-quality commercial GMP manufacturing services delivered to the market.”

AROUND THE WORLD

Bristol-Myers Squibb to Open New Biologics Facility in Ireland

Bristol-Myers Squibb (BMS) announced on Nov. 14, 2014 that it plans to open a large-scale biologics manufacturing plant in Cruiserath, Ireland. The new facility will house six 15,000-L bioreactors, a purification area, and a laboratory/office space, and will be built on the grounds of the company’s existing bulk pharmaceutical manufacturing plant.

The project is estimated to be a $900-million investment, based on the cost of a similar plant that was recently constructed in Devens, Massachusetts. The change of facility type has larger implications about the development strategies of some pharmaceutical companies that have historically focused on small-molecule production.

BMS boasts a 50-year manufacturing presence in Ireland. The construction will support 400 new jobs in the industry, and according to Prime Minister Enda Kenny T.D., the BMS plant opening will help Ireland “secure recovery” so that the country can attract new jobs and investments.

B-MS has a robust and growing portfolio of approved and investigational biologic medicines across multiple therapeutic areas including oncology, virology and immunoscience. Biologics comprise more than half of B-MS’s research and development pipeline.

The 30,000m2 (321,000 sq. ft.) project will house six 15,000-litre bioreactors and a purification area as well as office and laboratory space. The plant will be built on the grounds of the company’s existing bulk pharmaceutical manufacturing plant.

Once complete the facility will employ approximately 350 to 400 scientists, engineers, bioprocess operators, quality specialists and other skilled professionals, and the construction program is expected to create about 1,000 jobs. The completion of the facility, including commissioning and validation, is expected to take approximately four years and is estimated to be operational in 2019.

'Our investment in this new facility reflects the strength of our business and the increasingly important role that biologic medicines will play in Bristol-Myers Squibb’s future,' said Lamberto Andreotti, chief executive officer, Bristol-Myers Squibb. 'For 50 years, Bristol-Myers Squibb has maintained a significant manufacturing presence in Ireland, and we look forward to building on that legacy through this significant expansion of our manufacturing capability.'

Wuxi Manufacturing has Two New Facilities on the Way

With biologics declared as its main driver over the next few years, CDMO Wuxi is seeing rapid manufacturing growth and planning two new facilities in the next two years.

The company is looking to triple manufacturing capacity with its building projects, which include a $100m large scale research and commercial small-molecule manufacturing facility in Changzhou City, and its largest commercial manufacturing facility in WuXi City in 2015.

“Our rapidly expanding pipeline of early and late stage products is leading us to build the new facilities in Changzhou City. Upon completion of the entire product over several years the site will triple current manufacturing capacity,” Ge Li, chairman and CEO of Wuxi said.

With a 500-member team developing biologics, the company now boasts of “one of the largest biologics development operations” among all CDMOs, Li said.

“A key source of growth in biologics over the next several will be biomanufacturing,” Li added. “We are making plans to build biological commercial manufacturing facilities to meet the strong demand that we are seeing.”

He also expects a substantial uptick in small molecule manufacturing jobs. The company currently manufactures a portfolio of 11 Phase III products, and also recently passed its first US FDA inspection at its API manufacturing plant.

“The largest incremental revenue came from small-molecule manufacturing, which grew from 25.9 to 26.7 percent on total company revenues,” Li said. “Biologics had nearly as large incremental revenue contribution and it grew from 4.8 to 8.7 percent of the total company revenue.”

All three of Wuxi’s business segments had their highest quarterly revenue ever – with manufacturing seeing 23 percent growth, China lab services seeing an 18 percent increase and US lab services seeing a 11 percent rise.

In order to capitalize on this growth, Wuxi is ready to double its capital expenditures -- from $56 million last year to $95 million to $100 million this year. The expenditures “will grow even higher next year, as we take full advantage of the many business opportunities in front of us,” Li said.

He also highlighted the company’s acquisition of XenoBiotic Laboratories, a company with capabilities in DMPK/ADME and bioanalytical services, with operations in both the US and China.

But he downplayed the company’s joint venture with PRA Health Sciences and MedImmune, saying it won’t likely be profitable until next year.

GSK Australia will Expand its Boronia site in Australia

The expansion will include the introduction of the latest high speed ‘Blow-Fill-Seal’ machinery to advanced aseptic packing of sterile pharmaceutical liquids. The latest Blow-Fill-Seal machine will be dedicated for the manufacturing of Ventolin (salbutamol sulfate) nebules, a prescription medicine used to treat or prevent bronchospasm in people 4 years of age and older with reversible obstructive airway disease. The investment will allow the facility to meet increased demands from emerging markets such as China, Turkey and Brazil where patients look for low cost asthma treatments.

Blow-Fill-Seal manufacturing has been a focal point for GSK’s Boronia facility for more than two decades and the new Blow-Fill-Seal machine is expected to become operational in Boronia in January 2016.

A GSK spokeswoman said that there will be no new staff added as a result of the latest investment. The Boronia site currently employs around 320 staff.

Praised by British Prime Minister David Cameron and Australian Prime Minister Tony Abbott, who met in Sydney recently for the G20 Leaders’ Summit, the new tech is one in a series of investments GSK has made to strengthen its manufacturing capabilities in both Australia and the UK.

These include a previous investment of $53m (€42m) in Boronia to advance the site’s Blow-Fill-Seal capability, new equipment across a number of sites in the UK and the establishment of two new UK-based facilities specifically focused at harnessing innovative technologies and supporting the business’s growing pipeline.

The company spent $328m (£200m) on the two sites last year to add capacity to produce GSK’s respiratory device, the Relvar Ellipta Inhaler, as well as active ingredients and formulated drugs. The UK investments have helped to add more than 1,000 new jobs, the company said.

Geoff McDonald, VP and General Manager Pharmaceuticals, GSK Australia mentioned the company’s concentration on respiratory, adding, “Our focus and expertise in this area has allowed us tremendous insight into patient needs across the world. Investing in improved presentations and manufacturing innovation is just one way we can continue to address these.”

But GSK’s track record in emerging markets has been tenuous. Last year, the company pulled out of China after four GSK doctors were detained for bribing doctors to receive preferential treatment.

SGS Life Science Services Announces Expansion of Glasgow Laboratory

SGS Life Science Services has announced the completion of its expanded facility in Glasgow, UK, for the testing of cell banks for vaccines, gene and cell therapies, monoclonal antibodies and other recombinant protein based biological medicines.

The new laboratory adds an additional 500 m2 (5,380 sq. ft.) and will be adjacent to SGS’s existing center of excellence for viral safety, now totaling 1,124 m2 (12,094 sq. ft.), with the enhanced capacity and capability in cell culture testing.

Employing more than 45 scientific and quality personnel, the lab will offer a full range of validated bioanalytical methods to support the manufacturing, biopharmaceutical stability and lot release of drug product, including host cell protein, endotoxin, ELISA, western blotting and residual impurity testing. These methods are now accessible via a new web-based tool at SGS Bio/Analytical Methods page.

Scientific expertise and Surface Plasmon Resonance (SPR) BiaCore T200 equipment located within the facility will facilitate off the shelf and customized binding kinetics, and potency measurement of monoclonal antibodies and other recombinant protein-based biological medicines.

The new laboratory will also offer nucleic acid sequencing technologies and enhanced real-time PCR platforms to support viral safety and genetic stability assessment of cell banks for vaccines, gene and cell therapies. In addition, to meet pharmacopeial requirements, SGS will undertake validated PCR assays for detecting mycoplasma contamination during drug product manufacturing.

“As the pharma industry becomes increasingly focused on large molecule biologics, so we are increasing our service capacity and capabilities in this area,” commented Archie Lovatt, Scientific Director at SGS Life Science Services. “This is a rapidly expanding field where much broader and highly specialized testing expertise and equipment are required, to establish the safety of novel human therapies and vaccines, and one which we see as key to our strategic growth.”

Earlier this year, in January, SGS Life Sciences announced that it was officially launching its new service offer for the integrated formulation and stability testing service for biologics from its 7,000 ft2 laboratories in Wokingham, UK.

With 21 laboratories offering contract analytical and bioanalytical services, SGS leverages its wholly-owned global network, present in North America, Europe, and Asia, to deliver harmonized solutions to large pharmaceutical and biotechnology firms.

In addition to testing services for the bio/pharmaceutical market, SGS also provides clinical trial management (Phase I to IV) and services encompassing data management and statistics, PK/PD modeling and simulation, pharmacovigilance and regulatory consultancy.

Oberg Costa Rica Receives ISO 13485

Oberg Costa Rica, an Oberg Industries company located near San Jose, Costa Rica, recently achieved ISO 13485:2003 certification from the British Standards Institution. ISO 13485:2003 is the internationally recognized quality standard for the manufacture of medical devices.

“This important certification formalizes the processes we use every day to provide quality solutions for our customers and positions our company well for future growth,” said Brian Stewart, director of quality and continuous improvement for Oberg Industries.

Headquartered just north of Pittsburgh, Pa., Oberg Industries is a diversified manufacturer with more than 800 employees worldwide specializing in the production of precision machined or stamped metal components and precision tooling. In addition to Pennsylvania and Costa Rica, the company also has manufacturing in Mexico.

As part of Oberg’s manufacturing excellence policy, the company established a quality management system to ensure that all medical device products made in Costa Rica as well as the United States are inspected by qualified staff at each step of the manufacturing process, according to company officials.

Oberg Medical, a subsidiary of Oberg Industries, was established to focus on manufacturing medical devices such as orthopedic implants, instruments, assemblies, and endoscopic surgical components. Oberg Medical expanded its medical device manufacturing at a new facility in Costa Rica two years ago.

“We are exceptionally proud of the Oberg Costa Rica team for their efforts and contributions that were essential for achieving this certification in a relatively short period of time,” added Stewart.

Lombard Medical Gains FDA Clearance for Expanded Manufacturing Facility

Lombard Medical, Inc., a medical device company focused on Endovascular Aneurysm Repair (EVAR) of abdominal aortic aneurysms (AAAs), announced that the US Food and Drug Administration (FDA) has cleared the way for manufacturing to commence at Lombard Medical's new cleanroom operation in the UK. The larger facility expands Lombard Medical's global operating footprint and production capabilities to meet increased worldwide customer demand for the company's Aorfix endovascular stent graft for AAA repair.

The 10,000-square-foot facility at the existing manufacturing site, located in Didcot, Oxfordshire, expands the maximum manufacturing capacity at Lombard Medical and will now house more than 80 production employees in total.

CEO Simon Hubbert said, "With recent Aorfix regulatory approvals in hand and commercial launches under way in the US and Japan, the world's two largest stand-alone markets for AAA repair, we needed to increase our manufacturing capacity substantially. The expansion and regulatory clearance of our cleanroom facility is a key operational milestone for Lombard Medical as we focus on growing the commercial traction of Aorfix and building out the organization for future growth."

The Company has received formal approval from all applicable regulatory bodies for its new cleanroom. The FDA approval was received at the end of October with approval from other regulatory bodies earlier in 2014, including the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan and TUV Rheinland in the European Union.

Lombard Medical, Inc. is a medical device company focused on device solutions for the $1.4 billion per annum abdominal aortic aneurysm repair market. The Company's lead product, Aorfix, is an endovascular stent graft which has been specifically designed to solve the problems that exist in treating complex tortuous anatomy, which is often present in advanced AAA disease. Lombard Medical, Inc. is based in Oxfordshire, England with US commercial headquarters in Irvine, CA and is registered in the Cayman Islands.

Roche to Make Products in China

Roche is to establish a new diagnostic manufacturing facility in China, investing 450 million Swiss francs ($463 million) over the next three years.

The Swiss-based biotech company said that its new manufacturing site will help meet the growing demand for diagnostic tests in China and the Asia Pacific region.

Located at Suzhou Industrial Park, the facility will be the eighth Roche Diagnostics site worldwide and the first in the Asia Pacific. It will produce immunochemistry and clinical chemistry tests, which are essential for clinical laboratory testing.

Roland Diggelmann, COO of Roche Diagnostics, welcomed the expansion of the company's diagnostics operations in China to include manufacturing. "Roche is committed to investing in China and the Asia Pacific region. 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," he added.

Moreover, with the new manufacturing site located close to the company's existing China operations, "we can further increase our market responsiveness and contribute to the overall competitiveness of our business," Diggelmann said.

As it grows over the next few years, the new site will build a workforce of over 600 employees. It will be fully operational by 2018.

Roche Diagnostics has had a presence in the Asia Pacific for 40 years. It employs over 4,000 people across 15 countries in the region.

Sartorius Opens New Application Center

Sartorius announced on Oct. 30, 2014 that it opened a new application center at its offices in Shanghai. The 2600-ft2 center will be used to demonstrate products, complete trial runs, and run training sessions.

Customers can test the latest products from Sartorius in cell cultivation, media and buffer preparation, sterile filtration, cross-flow purification, membrane chromatography, virus clearance, and aseptic processing. Laboratory customers can visit the center to see instruments and consumables: balances, moisture analyzers, pipettes, water purification systems, filters, and products for microbiological testing and quality control.

“Our application center is not just a showroom for our extensive range of lab and bioprocess products. We invite our customers to gain hands-on experience with our technologies during training and demonstration. By doing this, we can demonstrate the benefits of the high degree of seamless integration of the newest state-of-the-art technology for biotech manufacturing,” said Dr. Jörg Lindenblatt, the senior vice-president of sales Asia/Pacific for Bioprocess Solutions, in a press release.

Novo Nordisk Builds New Labs in Denmark

Novo Nordisk announced an investment of approximately $130 million in new laboratories at the company's R&D campus in Måløv, Denmark. Construction has started, and the new laboratory facility is expected to be ready for occupation in early 2016. The Diabetes Research House facility will accommodate approximately 350 employees.

"The new lab facility will provide an environment for cutting-edge diabetes research within biotechnology and protein chemistry," said Mads Krogsgaard Thomsen, executive vice-president and chief science officer of Novo Nordisk.

The company announced in a separate press release that it would be hiring up to 90 people at the manufacturing plant in West Lebanon, NH that the company acquired from Olympus Biotech earlier in 2014. The facility will produce products for the treatment of hemophilia in the US, including the long-acting recombinant factor VIII, N8-GP for those with hemophilia A.

"We're pleased to be bringing this site back to life and make it a part of Novo Nordisk's growing network of manufacturing sites," said Steen Weber Jensen, corporate vice-president, Novo Nordisk. "Our long-standing commitment to patients and families affected by hemophilia means we have to continuously improve how we supply our medicines, and this new site will give us new, vital capacity."

The Danish firm is expanding in other parts of the world, too: In September it announced plans to establish a new obesity research unit in Seattle, WA. That announcement came a little over a week after the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 14–1 to recommend approval of Novo Nordisk's obesity candidate Saxenda for chronic weight management in adults with obesity or overweight with comorbidities, as an adjunct to diet and exercise.

WuXi PharmaTech Launches Office in Israel

WuXi PharmaTech (Cayman) Inc., an open-access R&D capability and technology platform company with operations in China and the U.S., has established a representative office in the Tel Aviv area of Israel.

The new office will promote WuXi's platform of R&D services to local customers, and will also collaborate with Pontifax, a healthcare-dedicated venture capital firm based in Israel, to invest in promising local technologies that can potentially advance WuXi's capabilities.

"We welcome WuXi's presence in Israel and believe the new representative office will be mutually beneficial to WuXi and the Israeli biotech industry," said Tomer Kariv, chief executive officer of Pontifax.

"We are excited to establish a presence in Israel and to contribute to one of the most dynamic healthcare innovation ecosystems in the world," said Dr. Ge Li, chairman and chief executive officer of WuXi PharmaTech. "We value the expertise that Pontifax has developed in Israel's biotech industry and look forward to working closely with them to help many of their portfolio companies and other startup companies. This step advances WuXi's mission of helping entrepreneurs in the global life sciences industry to realize their dreams of developing innovative products to benefit the world's patients."

SGS Gains cGMP Accreditation at Livorno Site

SGS Life Science Services has been awarded cGMP accreditation for its new analytical lab at its Livorno, Italy facility.

Its first in Italy, the new lab will focus on analytical quality control testing, IT compliance and validation. The Livorno site also provides facilities qualification, calibration and validation services, and has an analytical chemistry lab that opened in 2013.

The 1085m² (11,675 sq. ft.) lab employs 25 staff and is ISO 9001 accredited. The cGMP accreditation enables the Livorno GMP lab to demonstrate whether or not individual batches of raw materials, or regulated product, are manufactured according to the highest quality standards.

“The investment in the new laboratory and its cGMP accreditation adds significantly to our existing offer and will enable us to conveniently serve the microbiological and chemical testing needs of our clients in the important Italian market, where many multinational pharmaceutical firms and API manufacturers are located,” said Marco Benvenuti, business manager, SGS Life Science Services.

Irvine Expands into Asian Market

Irvine Pharmaceutical Services, Inc. will open a new analytical facility in Hangzhou, China. The new 115,000-sq.-ft. facility will expand Irvine's service offerings into the Asian market and is scheduled to be fully operational in 1Q15.

Chief executive officer and founder, Dr. Assad J. Kazeminy said, " Irvine is responding to the rising needs of large multi-national pharmaceutical companies that are looking for contract organizations overseas that include robust cGMP quality infrastructure and technical expertise. Irvine will now have a local presence and a strong understanding of the local market to offer the region high quality analytical support."

Irvine provides cGMP contract development and manufacturing services including parenteral manufacturing (liquid and lyophilized), preformulation/formulation development, analytical development, biopharmaceutical development, stability storage, analytical chemistry, structural chemistry, microbiology, and drug delivery device testing.

ILS Opens New Facility Europe

International Laboratory Services (ILS) has made considerable progress with its new state-of-the-art facility in Shardlow, Derbyshire, UK, following a fire in February 2013. The pathogen laboratory, quality control laboratory and media preparation sections have now moved into the laboratory, which is fitted with all-new equipment.

All media will now be produced in house, giving greater flexibility to meet the changing requirements of customers, removing out of stock issues and giving greater management over quality control and quality assurance, the company says.

Greater capacity in the pathogen and quality control laboratories will provide an enhanced, more responsive and flexible service to meet the needs of customers. Having the opportunity to redesign the facility and the laboratory work ‘Process Flow’, has allowed ILS to pass on the benefits of fast and on time delivery to customers, coupled with increased quality and economies of scale, enabling the company to provide a service of the highest scientific standards and remain at the forefront of contract laboratory testing.

'We would like to take this opportunity to thank you for your patience, ongoing support and commitment to ILS during the redevelopment process,' say Lorraine Bater, Operations Director, and Stewart Neithercut, Head of Business Development. '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. The recovery process has been extensive; we would also like to thank our staff and colleagues in the industry for their extraordinary dedication, hard work and support during this difficult and challenging period.'

HOK Breaks Ground on Research Complex for LG in Seoul

The design encourages communication and collaboration among LG’s business units.

HOK’s team joined South Korea President Park Geun-hye, LG Group chairman and executives, and hundreds of guests to unveil the design and break ground for a new 11.8 million-sq. ft. research and science campus in Seoul.

This will be the largest research complex in western Seoul and the center for LG’s next-generation research and development. Located in Seoul’s Magok District, the LG Science Park provides facilities to support innovative research and industrial prototyping.

When it is complete, employees from 10 different LG business groups will move to the landscaped urban campus. HOK designed phase one of the master plan and six of the laboratory and office buildings totaling 8 million sf.

“Based on the wide range of science accommodated and the emphasis on sustainable design, the new LG Science Park will be a unique campus in the global research community,” said Larry Malcic, HOK’s Director of Design in London. “The architecture, planning, and landscaping reflect the LG brand by being innovative and rational, elegantly simple and beautifully detailed.”

Planned around the company’s vision for highly collaborative, interdisciplinary research, LG Science Park provides flexible buildings and laboratories for virtually every type of science. HOK’s design provides high-quality facilities that will attract and retain leading research scientists from across the world. The design encourages communication and collaboration among LG’s business units.

A public greenway bisects the site from north to south, connecting the campus to a public park. The master plan also creates a new linear park running east to west through the site, forming extensive swaths of greenery and encouraging public access to the parks.

Intersecting the parks at the heart of the campus is an Integrated Support Center (ISC) housing shared campus facilities. Designed for LEED Platinum certification, the ISC features a welcome center, LG exhibition and conference spaces, sports and recreation facilities, a children’s nursery, a VIP suite, and offices.

Each LG business unit has its own main entrance and lobby. Building elevations are framed with natural stone and in-filled with glass and stainless steel panels to create a variety of facade treatments that provide views to the parks and minimize solar gain. In the lower ground level, under the linear park, a dining facility accommodating 11,000 people links buildings and shared facilities. A three-level basement provides a connecting service corridor, support spaces, a central utility plant and parking for 4,200 cars.

Sustainable design strategies for the LG Science Park include self-shading facade treatments and the use of innovative technologies, such as algae panels and footfall harvesting to generate power. Flat roof surfaces accommodate photovoltaic panels and vegetated roofs, while ground-source heat pumps provide heating and cooling.

HOK provided architecture, interior design, laboratory planning, landscape architecture, master planning and urban design services. HOK worked in association with Korean practices Gansam Architects, Chang-Jo Architecture and LG Toyo Engineering; engineering consultants WSP (structural and civil engineering); and Vanderweil Engineers (mechanical, electrical and plumbing services).

ROQUETTE Expands Excipient/API Services

ROQUETTE has opened a new pharmaceutical Application Development Center at its site at Lestrem, France, expanding its services for excipients and active ingredients to the pharmaceutical industry.

The 800 m2 (8,608 sq. ft.) lab offers compression, film coating or granulation, as well as the development of new galenic forms, one of the company’s latest innovations. ROQUETTE has developed an excipient for orodispersible tablets, a new form that melts directly in the mouth without the need for water, providing immediate action for the patient. The company will also provide expertise for pharmaceutical formulation.

ROQUETTE generates plant-based raw materials to develop and offer numerous galenic forms to patients: syrups, drinkable solutions, tablets, capsules, powders, etc. The excipients produced by ROQUETTE are designed to facilitate industrial production and cover a broad range of pharmaceutical applications.

Guillaume Fichet, director of the ROQUETTE Lestrem site, said, “The creation of this new Application Development Center on the Group’s largest site at Lestrem enables synergies with all of the Group’s research laboratories and production units at the site. Its ambition however is global. Located at the heart of Europe, this Application Development Center is in direct contact with the three other major regions of the Group (North America, Asia and India) and will serve our pharmaceuticals customers throughout the entire world.”

GSK Invests in Facility at Jurong, Singapore

Manufacturing GlaxoSmithKline (GSK) is investing £19m in its first continuous manufacturing facility in Singapore, marking an important milestone in the UK pharmaceutical company's long-standing partnership with Singapore’s Economic Development Board. When completed by the end of 2015, the new facility will become operational in the first quarter of 2016 and produce one of GSK’s key respiratory active pharmaceutical ingredients (APIs).

By adopting continuous manufacturing, the company will produce the API more quickly, while maintaining the same high-quality standards. Continuous manufacturing requires fewer manual interventions than batch production, where each stage of the production process is taken sequentially, with hold times required at each. The flexible nature of the production process means the volume of API produced can be adapted according to demand. There are also a number of environmental benefits from this technique, which will help to reduce the Jurong site’s carbon footprint by more than 50 percent.

Roger Connor, President of Global Manufacturing and Supply at GSK, said: 'The decision to invest in Jurong was straightforward; the site offers exceptional technical expertise and is recognition of the fantastic support we have had over the years, and continue to receive, from the Economic Development Board (EDB) and other Singaporean government institutions.'

Yeoh Keat Chuan, Managing Director of the Singapore Economic Development Board (EDB) said: 'The pharmaceutical sector is important for Singapore's economic growth and competitiveness, contributing 17 percent of our manufacturing output in 2013. Through continued investments in technology and talent, we are committed to maintain Singapore as the best-in-class pharmaceutical manufacturing location globally. GSK’s decision to build a continuous processing facility, its first in the world, is aligned with Singapore’s vision and efforts in where we want to grow the industry.'

Johnson & Johnson Unveils Asia Pacific Innovation Center in Shanghai, China

Johnson & Johnson Innovation has launched the Asia Pacific Innovation Center in Shanghai, China, with satellites in Singapore, Australia and Japan.

The new centre will boost Johnson & Johnson Innovation Centers network in worldwide life sciences hotspots, and will feature local science and technology experts, and deal-making capabilities.

Asia Pacific Innovation Center head Dong Wu said: "The Asia Pacific Innovation Center plans to build on the company's track record of collaboration in the region and advance the most promising science.

"It will play a key role in sourcing early stage science in the region for the development of new medicines, medical devices, and consumer products."

"The new centre will identify and develop early stage opportunities across pharmaceuticals, medical devices and diagnostics, and consumer healthcare products."

The new centre will also identify and develop early stage opportunities across three areas including pharmaceuticals, medical devices and diagnostics, and consumer healthcare products.

Johnson & Johnson China chairman Jesse Wu said: "The Asia Pacific Innovation Center supports our larger goal to address China's specific healthcare needs, invest in local capabilities, and increase our external collaborations."

Additionally, Johnson & Johnson Innovation and Janssen-Cilag have partnered with James Cook University in Australia to enhance the hookworms ability to regulate the human immune response, allowing their survival in a human host for the benefit of people suffering with Crohn's disease and ulcerative colitis.

Janssen Australia and Johnson & Johnson Innovation extended an existing collaboration with the University of Queensland (UoQ) to determine peptides as potential treatments for pain, and develop a more targeted approach to pain management.

A broad collaboration was also launched by Johnson & Johnson Innovation with China Pharmaceutical University on several projects across its consumer and pharmaceutical businesses.

Janssen research and development (R&D) and Johnson & Johnson Innovation launched a R&D collaboration with Peking University to determine agonists and antagonists for G protein-coupled receptors (GPCRs) to help develop novel CNS medicines.

Johnson & Johnson Innovation and Janssen R&D teamed up with Zhejiang University to clarify the physiological and pathological role of human lactate receptor GPR81 in the regulation of metabolism and metabolic syndrome.

The new Asia Pacific Innovation Center will launch a regular presence in the Suzhou BioBay incubator with more than 400 companies in the areas of drug discovery, biotech, in vitro diagnostic (IVD) medical devices and nanotech.

Roche’s Giant R&D Site

Over the next ten years, the drugmaker will build a four-tower R&D cluster on its current Basel site, as well as an office building for 1,700 workers, a logistics centre for energy and GMP, and renovation of its 77 year-old building designed by Swiss architect Otto Salvisberg.

The research centre’s high-rise towers (132m, 72m, 28m and 16m) will be located in the middle of the site to protect living conditions for neighbors – with the facility’s perimeter reserved only for low-rise buildings.

The R&D hub is planned to open around 2022, and a neighboring in vivo research facility is expected by 2018. Office buildings will be in use by 2021.

The mammoth 3bn Franc figure is in addition to 550m Francs ($579m) already spent on an office that is due to open towards the end of 2015. When 3,000 Roche staff move into the building, another 6,000 will remain in rented properties spread around Basel.

The ten-year plan is to bring all workers onto Roche’s existing industrial site at Grenzacherstrasse, Basel. One consequence is “eliminate[ing] the need to build over green zones", said Jürg Erismann, head of the Basel site.

"Instead, Roche will be making more efficient use of those parts of the site that have already been developed but cannot be expanded.”

He added sustainability is a top priority for all the construction: “The energy used in Building 1 will be only one fifth of the amount consumed in 40-year-old Building 74, which is due to be replaced as part of the site development project."

Roche said the makeover will create “an attractive workplace” but kept quiet on whether the facilities will have any Google-style perks for employees.

“Roche already offers highly attractive working conditions; with the new R&D centre we make sure that R&D lab and office spaces provide cutting edge research technology and infrastructure as well as a working environment which fosters communication and collaboration between the different disciplines involved in R&D,” said Engels.

The site will have a “modern mobility” design to encourage public transport and bikes and to keep car use to a minimum.

BioSilta New UK Headquarters

The UK beats Finland for business opportunities according to the CEO of microbial growth system developer BioSilta, who said moving the firm to St. Ives, Cambridgeshire has improved its access to larger markets.

BioSilta makes a reagent-based microbial growth platform designed to increase protein yield in lab-scale bacterial and yeast expression systems.

The firm's approach is to use combinations of long chain polysaccharides and an agent that controls the rate of glucose release to ensure that optimal growth conditions are maintained in culture vessels.

BioSilta was founded in Oulu Finland in 2007. However, in recent months the firm has been trying to expand its business globally through its deal with Sigma-Aldrich and a fundraising round and relocating to the UK is the next step in that effort according to CEO Bob Penney.

“The UK is better for our business for many reasons,” Penney said, citing the larger domestic market, proximity to North America customers and the fact that shipping “to Europe and USA is significantly lower than in Finland” as advantages.

Proximity to customers is important for BioSilta according to Penney who said “Having not had a commercial team in the company before now, the awareness of our products and company is low.

“To this end we are focusing on achieving this in Europe and the US. We have hired a commercial team in Europe who are now gearing up our marketing and sales activities to create awareness through a variety of activities, including conferences, seminars, and promotions.

“We are also recruiting a commercial team in the USA to the same in North America. We see the home market as being important to establish ourselves in first for credibility but the US offers a larger market, which we need to credibly serve.”

In addition, to being BioSilta’s headquarters the UK site will house warehousing, logistics, order processing and commercial sales, marketing and technical support functions. The Finnish site will now function as an R&D and QC center.

Sorin Group Expands Manufacturing in Germany

Italian cardiovascular device company Sorin Group is broadening its footprint in Germany.

The company has expanded its Munich manufacturing facility to “accommodate growing worldwide demand for state-of-the-art cardiopulmonary technology,” according to a release from the company.

Sorin recently held an opening ceremony and formal dedication of the new facility, which included tours for officials, customers and employees.

The expansion will increase the size of the current facility by 25 percent to approximately 11,000 square meters (118,000 square feet), including offices, laboratories and training facilities. The manufacturing floor space extension will allow the production capacity of heart-lung machines (HLM) and auto-transfusion systems (ATS) to be significantly increased and it will enable the in-house manufacturing of heater-cooler systems.

The company’s Munich facility produces advanced cardiopulmonary systems, including hundreds of HLMs, ATS machines and blood-gas monitoring devices each year.

In addition to its German plant, Sorin Group operates facilities dedicated to cardiopulmonary bypass systems in Denver, Colo., and in Mirandola, Italy. In 2013, the company also started a manufacturing project in China to better serve the growing demands of the growing Chinese market.

“The expansion of our Munich manufacturing plant marks another milestone for Sorin Group as we focus on further strengthening our leadership in the cardiac surgery arena,” said Michel Darnaud, president Cardiac Surgery Business Unit. “The Munich expansion follows the recent delivery of our 10,000th heart- lung machine to Brigham and Women’s Hospital (in Boston, Mass.) earlier this year.”

HLMs help sustain a patient undergoing an open-heart surgery procedure, providing blood oxygenation and circulation (extracorporeal support) to the brain and major organs while the patient's heart and lungs are temporarily bypassed. Every year, more than 1.5 million patients worldwide suffer from cardiac disease requiring extracorporeal support from these systems.

ATS allows collection, processing and reinfusion of autologous blood during and after surgical interventions in many applications, including cardiac, orthopedic, vascular, obstetrics, trauma and others, as well as preoperative sequestration of whole blood components.

Sorin Group also offers HLM accessories, data management systems and disposable perfusion circuits as well as blood management systems, cannulae and other advanced cardiopulmonary products designed to enhance the exceptional results achieved by surgical teams.

McIlvaine Company

Northfield, IL 60093-2743

Tel: 847-784-0012; Fax: 847-784-0061

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