The Houston-based pharmaceutical company had new executives and a new $65 million war chest from investors, paving the way for a growth plan focused on specialty drugs. But that meant moving its headquarters to a state with a labor force that could help it build a new senior management team from the ground up.

"That led us to decide it's got to be New Jersey," said Terry Novak, the company's chief operating officer. "That's where the pharmaceutical talent pool is."

It's a glimpse at the new makeup of New Jersey's life sciences industry, a change that's now translating to commercial real estate. With growth now concentrated in smaller specialty firms, biotech groups and mid-tier pharmaceutical companies, experts say space needs have evolved from the sprawling, suburban research campuses of Big Pharma's heyday to a smaller but steady stream of office leasing.

Pernix opened its new 6,400-squarefoot headquarters in Morristown last month, four months after installing its new executive team. The lease has given the company the space it needs for about a dozen more front-office positions, Novak said, with room to grow as it acquires new products as well as much-needed access to New York City.

Pernix is not alone. Last year, life sciences companies accounted for a quarter of all office leases in northern and central New Jersey, totaling 1.6 million square feet, according to Steven Jenco, JLL's director of suburban tri-state research. The trend continued through the first half of 2014, making life sciences the most active of any industry group tracked by the brokerage.

In May, New York-based Actinium Pharmaceuticals opened its first New Jersey office, a 5,200-square-foot space in the Metropark section of Edison. CEO Kaushik Dave said the office could house nearly 20 employees as Actinium expands its product pipeline.

And experts say many pharmaceutical firms still see New Jersey as a headquarters location, as Pernix does, even if their manufacturing and research operations are elsewhere. Aside from the workforce, C-suite executives are drawn to the state's proximity to Manhattan's financial markets and its transportation infrastructure.

That's exactly why there are so many "nerve center operations" located in New Jersey, said Dean Paranicas, president and CEO of the Healthcare Institute of New Jersey.

"All of those factors combine to make this a good environment in which to invest, grow and expand," said Paranicas, whose trade group represents life sciences companies in the state. "Our companies like the proximity to each other - they collaborate, they work together, they draw from a very broad and deep talent pool."

Brokers and developers can only hope the interest stays high - enough to help transform many of the large pharmaceutical campuses that have been left behind by Big Pharma and are now slated for redevelopment.

Glenmark to Build U.S. Manufacturing Plant

India-based Glenmark Pharmaceuticals has announced plans to set up a new oral solid dosage manufacturing facility in North Carolina.

After the oral solid unit is set up, the 100,000-square foot facility will expand to set up manufacturing units for injectables and topicals.

“Our plan to set up a new state-of-the-art manufacturing facility in the US underlines the fast paced growth the company has witnessed in a short span of 8 years in the US market and our long term commitment to the country,” said Glenn Saldanha, chairman of Glenmark. “The US is a key strategic market for Glenmark and it is important for us to have a manufacturing base here to serve our growing business in the country.”

The company plans to make investments at the site over the next five years to set up all three manufacturing units.

The company expects to start manufacturing activity by the end of the current fiscal year and the facility will be dedicated only for the US market. This is Glenmark’s first manufacturing facility in North America, and adds to its 14 plants in India, Brazil, Argentina and Czech Republic.

Glenmark currently operates in North America through its subsidiary Glenmark Generics, which has a portfolio of over 90 products authorized for distribution in the US in niche segments like dermatology, hormones, controlled substances, oncology, and modified release products. The company has nearly 70 ANDAs pending for approval with the US FDA.

The company has a significant presence in branded generics markets across emerging economies including India.

Clinical Sciences Building, Cincinnati, Ohio, United States of America

Cincinnati Children's Hospital Medical Center

The construction of a new 15-storey clinical science building at Cincinnati Children's Hospital Medical Center (CCHMC) began in June 2012. The new facility is being constructed next to the existing research centre known as S Tower, which is located on the Burnet campus in Cincinnati, Ohio, US.

Scheduled for completion in mid-2015, the new building will be used for conducting translational research.

The new research centre will be a 15-floor tower with a total floor space of 425,000ft². The tower will be known as T Building and will accommodate new laboratories, a research imaging facility, a research-focused outpatient clinic, offices and supporting infrastructure. It will have 11 floors dedicated to research, including wet and dry laboratories, a data centre, dining facilities and meeting rooms.

The building will be integrated with the existing research facility that opened in 2007 by CCHMC, and will subsequently increase the centre's paediatric research space to a total area of roughly 1.4 million square feet. The new building will provide a physical link between discoveries in laboratories and animal models, as well as the application of patient care in the clinical locations.

The new facility will be able to accommodate approximately 1,500 top researchers and clinicians and be used as a translational research centre for developing evaluating breakthrough discoveries. Clinical staff will also use it to apply these discoveries to improve the health of children.

The building is designed to promote collaboration across disciplines and interactions among basic, translational and clinical investigators. Two floors will be dedicated for the laboratory, which features a transparent design that not only draws natural light into the building, but also enables views throughout.

"Scheduled for completion in mid-2015, the new building will be used for conducting translational research."

A collaborative space, known as Beehive, will connect the research centers located in the two towers. A rooftop respite garden will be built on the top floor terrace and sunshades will be built on the southern façade of the T building.

Cincinnati Children's Hospital Medical Center's board of trustees approved the construction of the clinical sciences building in May 2012. Ground breaking was held in June 2012 and the facility is expected to be opened for operations by mid-2015. The installation of the windows and the façade began in October 2013.

Construction is being carried out using building information modeling, a three-dimensional digital model that eliminates waste and adds efficiency to the building.

The design for the clinical sciences building was provided by GBBN architects in collaboration with Geier Brown Renfrow Architects and HDR, while the general construction contract was awarded to Messer Construction.

Pioneer Glazing and Cladding was awarded with a contract to provide design and installation of curtain wall, windows, skylights, sunshades, as well as the structural and point-supported glass walls for the facility.

The total estimated investment for the construction of the clinical sciences building is approximately $180m. It is being financed through a combination of operating cash, investments, future operating cash flows and private donations.

Huntsman Cancer Institute Expansion

Huntsman Cancer Institute (HCI) is a part of the University of Utah campus in Salt Lake City, US. Construction of the primary children's and families' cancer research centre began at the institute in June 2014 as part of fourth phase of expansion. The new facility will carry out cancer research on children and families, as well as to develop new advanced therapeutics to improve survivorship.

The facility is expected to double the research space in the HCI, upon completion in 2016.

The HCI has 231,118ft² of on-site research space, state-of-the-art clinical laboratories spread over an area of 442,000ft² and an additional 12,746ft² on-site research space located at satellite locations. The new cancer research centre will add an additional 220,000ft² of research space to the Institute in the fourth phase of expansion.

The new research centre will have a six-floor building with a total floor space of 22,000ft². It will extend from the existing HCI building's south-east corner of the research wing. It will be facilitated with laboratories to study various aspects of cancers that are the leading cause of death in children with leukemia, sarcoma and brain cancers.

The expansion also includes addition of a biotechnology centre, which will house the latest and advanced genetic sequencing and imaging equipment.

The estimated investment for the expansion of the research centre is approximately $105m. It is being funded by the Church of Jesus Christ of Latter-day Saints, the Jon M Huntsman Family, Huntsman Cancer Foundation, Intermountain Healthcare, and Utah state.

The first three phases of HCI construction were completed between 1999 and October 2011. Jon M Huntsman Research Centre, a four-storey research facility spread over an area of 231,000ft², was completed in 1999 as part of the first phase construction. Three floors of the building are dedicated to accommodate research laboratories and one floor for outpatient clinics.

A Cancer Specialty Hospital spread over an area of 286,000ft² was added during the second phase expansion. The hospital with 50 in-patient rooms was opened in 2004.

The third phase involved 156,000ft² expansion in the north-east corner of the cancer hospital. It was designed by Architectural Nexus and built by Okland Construction. The expansion added a number of new features and services to the hospital. The cancer hospital now has 50 inpatient rooms, 30 outpatient rooms, four operating rooms, expanded Cancer Learning Centre and personalized medical clinics, new imaging technologies including intraoperative MRI, new centers for breast health and advanced therapeutics, and an expanded Wellness-Survivorship Center.

The construction contract of the cancer research centre was awarded to Jacobsen Construction, a company based in Utah, while Architectural Nexus provided the design.

The HCI is a six-storey building with a built-up area of 673,000ft². The first floor houses the Linda B And Robert B Wiggins Wellness and Survivorship Center, which serves the physical and emotional needs of patients, cancer survivors and other patients. The floor also includes outpatient clinics which provide cancer care in a supportive environment.

The second floor is occupied by the Wayne A.Reaud Center for Infusion and Advanced Therapeutics. The centre has 55 infusion stations and offers chemotherapy treatments.

The third floor houses introperative MRI (I-MRI), a new technology used to capture the images of tumors in the middle of the brain surgeries. The third floor also has Cleone Peterson Eccles Center, which provides breast cancer treatment.

Bone Marrow Transplant (BMT) unit with 25 rooms is located in the fourth floor. The unit treats cancers including leukemia, lymphoma and multiple myeloma. Intensive Care Unit (ICU) is located in the fifth floor of HCI building.

Fujifilm Diosynth Biotechnologies Continues Expansion of R&D Facilities

Fujifilm Diosynth Biotechnologies has announced continued expansion of its process development capabilities with the investment of over $5.6m in new laboratories and equipment at both its Billingham, UK, and Research Triangle Park (RTP), NC, US sites.

This includes the first TAP ambr250™ automated bioreactor system for microbial fermentations to be commercially installed in a CDMO at the company's Billingham, UK site. This investment further demonstrates the company's commitment to use High Throughput technology and design of experiments to benefit its customers by rapid development of robust scalable processes for their biopharmaceutical production.

Also at the UK site, three laboratories have been upgraded and refurbished to accommodate the latest equipment, including new robotic chromatography platforms.

At the company's RTP, NC site, four new process development labs have been added along with new equipment to allow greater flexibility for client project execution. This new equipment and expanded laboratory floor space for both process design and analytical support have significantly increased the development capacity for customer projects at the site.

Dr Mark Carver, senior VP, R&D and innovation, Fujifilm Diosynth Biotechnologies said: "The purchase of this latest equipment, and upgrading of our laboratories across the business, keeps us at the forefront of technology for the development of robust and cost-effective manufacturing processes for biologics.

"Our ambr15 system has been working continuously since its installation in our mammalian cell culture laboratories 15 months ago, and we look forward to broadening our offering also to microbial fermentations by running multiple, single-use fermentations on this firstly-introduced ambr250.

"All of this new equipment, combined with the experimental design expertise of our highly trained scientists will allow us to produce 'high throughput scale down' data for better process understanding, enabling our customers to proceed more quickly to larger scale manufacture.

"This investment forms part of our ongoing innovation activity and our commitment to lead the global Biologics CDMO industry through the continuous innovation of technologies, service delivery and quality for the benefit of our customers and their patients."

IPD Contract for Cancer Center

Partners share the risk and reward of extreme collaboration on this LEED Silver project, which relies heavily on Lean principles.

The new Lawrence + Memorial Hospital Cancer Center will allow patients to receive comprehensive oncology services in a single location. Medical oncology, radiation oncology, GYN oncology, hematology, and coagulation disorders are focuses. Special features include infusion bays with individual temperature controls, heated chairs, and television sets. The LEED Silver facility includes an on-site lab and pharmacy.

For its Waterford, Conn., Cancer Center, a comprehensive treatment facility affiliated with Dana-Farber Community Cancer Care, Lawrence + Memorial Hospital decided to try something new: true three-party Integrated Project Delivery.

The contractual agreement covered L+M, architecture/engineering firm TRO JB, and construction manager Suffolk Construction, with programming, design, and construction all informed by Lean principles.

To further extend the collaborative theme, this three-party project management team invited three trade partners to participate in an incentive compensation layer, involving a pool consisting of at-risk potential profits.

TRO JB, Suffolk, and three handpicked HVAC/plumbing, electrical, and site work subs would participate in the ICL. If the project came in over budget or exceeded the schedule, the ICL profit pool would be tapped to pay the penalties. If the facility came in under budget or ahead of schedule, the ICL group would get the profit pool plus 50% of the savings, with the hospital pocketing the remaining savings.

Bronze Award - Project Summary

Lawrence + Memorial Hospital Cancer Center - Waterford, Ct

BUILDING TEAM

Submitting firm: Suffolk Construction (GC/CM)
Owner/developer: Lawrence + Memorial Hospital
Architect, MEP/FP: TRO JB
Structural: Simpson Gumpertz & Heger
Civil: DiCesare-Bentley Engineers

GENERAL INFORMATION

Project size: 47,000 sq. ft.
Construction cost: $24 million (IPD contract value $34.5 million)
Construction period: May 2012 to September 2013
Delivery method: Tri-party integrated project delivery

Early collaboration on the design, schedule, budget, and quality goals was a must for making the plan work. Using 3P (Production Preparation Process) Lean design and pull planning tools, the Building Team was able to make key decisions efficiently. Input from about 70 Cancer Center stakeholders—including administration, medical staff, support staff, patient advocates, and partners from Dana-Farber—was solicited in an intense three-day 3P charrette, which resulted in schematic draft floor plans.

Only minor changes were needed after this point, testifying to the effectiveness of the event. (The most significant contract alteration, requested by L+M as a value-added item, was a geothermal well field system that will pay for itself in just a few years.)

A co-location center set up in two of L+M’s hospital conference rooms was made available to the Building Team for the duration of the project. This home base proved crucial to ensuring efficient communication and also provided a convenient setting for stakeholder evaluation of mockups.

As a result of the collaborative efforts, the overall project schedule was reduced by six months, and the facility came in $1.2 million under budget. Actual construction was completed in only 10 months, meeting a “stretch goal” previously set by the client. Streamlined front-end decisions played an important role, including an RFI process that was 80% shorter than the client had previously experienced.

Building Team Awards judges were impressed with the participants’ ability to weigh wants and needs and craft a facility that achieved ambitious goals. The client has engaged Suffolk and TRO JB for a second IPD contract, this time to renovate a three-story medical office building. As with healthcare itself, new ideas about delivery are proving indispensable to positive outcomes.

SGS’s New California Life Science Services Facility

SGS Life Science Services, the leading pharmaceutical analytical and bioanalytical contract solutions provider, announced two senior appointments at its new North American Life Science Services GMP/GLP laboratory in Carson, California, which is due to open in the third quarter of 2014.

Dr. Marcella McSorley joins SGS as Quality Assurance Manager, and will have a key role in the implementation of a robust quality management system at the new site

In another new role at the site, SGS has also appointed Ms. Pojaman Zunggeemoge as Microbiology Manager. Ms. Zunggeemoge will focus on the practical management of the Microbiology Department at Carson and ensure the on-going compliance with SOPs. She joins SGS from Grifols Biologicals, Inc., where she was QC Microbiology Supervisor, responsible for the adherence to cGMP protocols, company specifications and procedures within the Microbiology Department.

The 7,500 square foot Carson facility will be SGS’s first for the Line of Business on the West Coast, and will offer microbiological testing and bioanalytical services in a GMP/GLP controlled environment. This facility represents SGS’s fifth North American Life Science Service site and complements the existing network in Fairfield, NJ, Lincolnshire, IL, West Chester, PA, and Mississauga, ON.

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.

Pharmatek Launches New API Manufacturing Program

Pharmatek, a contract development and manufacturing organization, has launched a new API-in-capsule manufacturing program. The program is designed to address manufacturing strategies that will lower development cost, shorten timelines, and increase capsule throughput for API-in-capsule productions.

As part of the program, Pharmatek has developed two new cGMP manufacturing suites designed specifically for API-in-capsule productions. The suites include humidity control and inert gas systems, which contribute to a stronger manufacturing process for API-in-capsule productions. In addition, Pharmatek has implemented operational systems to further address efficiencies, including new project teams, updated batch records, extended shift operations, redundant equipment and change parts, and on-demand inventory management.

Pfizer Opens New Site in Cambridge, MA

Pfizer Inc. announced the opening of a new 280,000 square-feet Research and Development (R&D) hub in Cambridge, Mass. The new Pfizer facilities in Kendall Square bring together 1,000 colleagues from three area locations and position Pfizer in closer proximity to leading academic institutions, hospitals and patient organizations.

“Our new Kendall Square presence in Cambridge represents an important milestone in Pfizer’s approach to creating a sustainable R&D engine that is designed to yield a flow of innovative therapies year after year,” said Mikael Dolsten, M.D., Ph.D., President of Worldwide Research and Development at Pfizer. “Having all of our Cambridge-area researchers working closely together in one of the world’s most exciting biomedical ecosystems will allow us to continue our efforts to grow our external collaborations and has the potential to help speed the translation of scientific knowledge into potential medical breakthroughs across areas of unmet need such as lupus, inflammatory bowel disease, kidney disease, type 2 diabetes, muscular dystrophy and Parkinson's disease.”

Led by Pfizer Group Vice President of BioTherapeutics R&D, José-Carlos Gutiérrez-Ramos, Ph.D, the new laboratory facilities, located in the heart of Kendall Square at 610 and 700 Main Street, respectively, are leased from the Massachusetts Institute of Technology (MIT). Pfizer scientists will work in state-of-the-art lab space on a range of clinical programs across several therapeutic areas, including inflammation, immunology, rare disease, cardiovascular and metabolic diseases, and neuroscience.

In addition to the new Cambridge R&D hub, Massachusetts is home to Pfizer’s research and manufacturing site in Andover and is the global headquarters for Pfizer’s Centers for Therapeutic Innovation (CTI) in Boston. By establishing collaborations with institutions working on novel and cutting-edge research, CTI’s model is designed to build an innovative network for drug discovery, with the goal of bringing new, targeted therapies to patients quickly.

AAF International Inaugurates Cleanroom Facility for HEPA Filter Manufacturing

North America AAF International, based in Louisville, Kentucky, US, held a ribbon cutting ceremony May 22 to commemorate its new ISO 4, 6, and 7 cleanroom for HEPA filter manufacturing at its Columbia, Missouri facility. Hiroo Yoshioka, Senior Executive Officer and board member of AAF's parent company Daikin Industries, Peter Kurto, AAF Chief Executive, and Bob McDavid, Mayor of Columbia, attended the event along with other state and local government officials.

'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,' said Kurto. '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 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 built the new cleanroom for its US HEPA manufacturing facility.

Kurto added: 'The new cleanroom is dedicated to Mr. Yoshioka, who was instrumental in initiating it. The new 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.

AAF also launched Impress technology during the event. This is the latest embossing and pleating technology, which is said to offer the most energy efficient, low pressure drop technology available. Embossed, reinforced V-pleat geometry offers smoother airflow, with higher dust holding capacity, the company says. Several products designed with Impress technology will be introduced in the coming months.

Total Facility Solutions Opens Hygienic Fabrication Center

Total Facility Solutions (TFS), a specialty contractor and services company focused on critical process infrastructure, completed the company’s first certified hygienic fabrication facility dedicated to the US life science market. Located in Burlington, North Carolina, the facility will provide hygienic and high-purity piping fabrication, stainless-steel skid fabrication, and field installations.

Off-site fabrication in a controlled environment has the benefits of cost-effectiveness and minimizing the number of people at the construction site area, which makes the site safer, notes the company. “Moving man-hours from a customer site to a regional fabrication facility helps us streamline our work,” said Joe Cestari, TFS president, in the press release. “Reducing congestion in the facility also reduces risk to safety, quality and schedule, all while meeting the stringent hygienic standards of the life science market.”

John Edward Porter Neuroscience Research Center, MD

John Edward Porter Neuroscience Research Center at Bethesda, in Maryland, was opened and dedicated to the public in March 2014. The facility is situated on the western campus of the National Institutes of Health (NIH). It was named in the honor of former congressman John Edward Porter.

The new facility brings together the neuroscientists located across ten institutes in the NIH at one place to foster collaboration among scientists to encourage new approaches in the understanding of the nervous system in health and disease. The facility was developed by the National Institutes of Health (NIH).

The interdisciplinary biomedical research facility features a total floor space of 500,000ft² spread over five floors in two buildings connected by a glass atrium. The facility includes open laboratory space, offices, shared resources and other facilities.

The facility accommodates more than 800 scientists in 85 laboratories from ten different institutes including the National Institute of Neurological Disorders and Stroke (NINDS) and the National Institute of Mental Health (NIMH). It includes closed wet laboratories that are designed to provide support for 28 principal investigators from seven scientific institutes of the NIH.

The basement of the building features a vivarium with more than 20,000 research animal cages. The second floor features a vertical vivarium, vibration stable core areas, hot and cold rooms, imaging suites, and associated scientific staff offices. It also features an advanced MRI suite for high-resolution.

Facilities at the Neuroscience Research Center include a four storey sky-lit atrium, a cafeteria, and a suite of conference and seminar spaces. It also includes public areas for scientific symposia.

The construction of the Neuroscience Research Center was completed in two phases. Phase I of the construction began in 2001 and was completed in 2004. The second phase of building construction began in November 2010 and was completed in March 2014. The phase II construction added a 320,000ft² building.

Phase II building of the research facility was designed by Perkins+Will architects. Whiting-Turner Construction was awarded general construction contract worth $156.36m.

Jacobs Engineering provided the program management services. Cagley & Associates was selected as structural engineer, and Affiliated Engineers Metro provided mechanical, electrical, plumbing and fire protection services.

The other contractors involved in the phase II construction included Johnson Bernat & Associates for electrical infrastructure works, William H Gordon Associates as civil engineer, and Wiedlinger Associates for blast resistance. Jordan Honeyman provided landscape architecture, Debra Gilmore provided lighting, Lerch Bates offered vertical transportation, and Miller Beam & Paganelli provided acoustics and audio-visual equipment.

NIH received $500m in federal funding for construction of the second phase of the Neuroscience Research Center. The funding was provided as part of federal Recovery Act proclaimed by US President Barack Obama in 2009.

The research centre was built to achieve LEED gold standard. The building was designed to feature environment-friendly systems such as solar panels on phase I and phase II buildings, and geothermal energy system, which will make it 25% more energy efficient compared with other conventional laboratory buildings.

The building also features an atrium, ground source heat pumps, chilled beams, and LED lights. It was constructed as part of the American President Obama's federal initiative for more energy efficient buildings.

West Pharmaceutical Services installs Conveyor in Cleanroom

America West installs an Impulse sanitary electromagnetic vibratory conveyor in its ISO 5 cleanroom West Pharmaceutical Services, a supplier of packaging and delivery systems and components for parenterally administered medicines, has replaced a belt conveyor in an ISO 5 cleanroom with Impulse, a sanitary electromagnetic vibratory conveyor from US company Symetix. As the first Impulse to be installed in any cleanroom, it helps West maintain the highest product quality and improve production efficiencies.

'It is absolutely necessary that the equipment in the cleanroom [does] not have an impact on the product or room’s particulate levels,' said Tim Miller, Principal Project Manager at West. 'We spoke with several suppliers and considered various systems. We chose to work with Symetix because of the quality of the company's technology and its expertise in the pharmaceutical industry. We selected Impulse to ease line clearance and cleaning.' Impulse is an electromagnetic vibratory conveyor built completely from stainless steel.

Compared with belt conveyors, vibratory shakers are inherently more sanitary because they eliminate product contact with moving parts and present a flat-bed surface that is easy to clear and clean. The Impulse conveyor has no sliding or rotating parts to wear and no belts or bearings to fail. The energy-efficient electromagnetic drives are oil-free and offer low maintenance with no moving parts.

The sanitary design makes Impulse suitable for use in a cleanroom. Symetix is the pharmaceutical group of Key Technology, a manufacturer of process automation systems. Symetix offers worldwide sales representation and maintains demonstration and testing facilities at Key’s headquarters and manufacturing divisions in Walla Walla, Washington, US, and at Key Technology in Beusichem, the Netherlands.

Illumina to Build Facility in San Diego

Illumina will build a new 150,000-square-foot facility in San Diego to house manufacturing and logistics, the company said.

When completed, the new space will add about 300 new "high-wage" jobs to the current 1,500 workers already employed by the firm, a spokesman for Illumina said. The new facility will be located at the company's headquarters campus, he added.

The immediate occupants in the space are anticipated to be groups from Illumina's reagent and manufacturing operations, and the company is targeting basic LEED certification, Gold or Silver level.

"We are deploying highly efficient electro-mechanical systems in the fit out, using best-in-class design to enhance energy conservation," the spokesman said. Completion of the space is anticipated by early in the second quarter of 2016.

According to a statement from the office of San Diego Mayor Kevin Faulconer, Illumina would be eligible to receive a $1.5 million tax rebate. San Diego will retain about 30 percent of Illumina's sale tax revenues as well as the current level of sales and use tax generated by the company, or about $1.3 million annually in the most recent year. After the $1.5 million tax rebate cap is reached or the term of the 10-year agreement has expired, San Diego would receive 100 percent of Illumina's tax revenue.

The agreement is scheduled for a vote by the City Council for the week of July 21.

Promega to Break Ground for New Processing and Manufacturing Facility

Promega Corporation will break ground for a new processing and manufacturing facility near its primary campus in Fitchburg, Wisconsin on July 10.

The new processing and manufacturing facility will initially work with processing, packaging, staging and shipping. In addition, the floor plan will allow for potential expansion of manufacturing and logistics operations to meet growing business needs in the future.

Most Promega products are temperature sensitive and require specialized temperature controlled facilities and equipment to hold the inventory stock for daily processing. Inventory will be pulled from designated locations, processed, packed and shipped out to customers worldwide. Raw materials and other inventory needed to process product will be received and housed at the facility, and used on-site or distributed to other Promega facilities as needed.

Micro Mold Expands Class 10,000 Cleanroom

Micro Mold Co. Inc. & Plastikos Inc. of Erie, Pa. has begun a facility and equipment expansion of over 17,000 ft2, with the heart of the medical expansion being an ISO 7 (Class 10,000) injection molding cleanroom that will accommodate eight brand new medical molding machines.

Plastikos’ medical expansion will also include a separate ISO 7 assembly and packaging lab, as well as corresponding medical production support departments (e.g. maintenance, toolroom, quality, general office and meeting room space, etc.). The new ISO 7 cleanroom will be one of the largest Class 10,000 cleanroom available in the injection molding industry.

Plastikos’ total production capacity is projected to increase by over 30% once the medical expansion is fully equipped and staffed. The target completion date for the project is slated for Q1 of 2015.

“We are very excited to announce Plastikos’ Medical Expansion project, which marks a new and exciting chapter in the Micro Mold & Plastikos story,” says Philip Katen, President and General Manager of Plastikos. “Our fiscally conservative, organic growth strategy has enabled us to make the necessary capital investments throughout our history to support the growth of our customers in their respective industries. And we view today’s investment as part of the commitment that we make to those customers, who create the exciting new opportunities ahead for our team.”

Plastikos & Micro Mold have a number of new medical projects that will come on-line during the remainder of 2014 through 2015, which spurred the cleanroom expansion. Plastikos is a custom injection molder that works closely with its sister company, Micro Mold, on high precision mold design and fabrication, engineering, and production services for small, tight-tolerance applications. The two companies have partnered with customers and OEMs to push the engineering and technical limits of the plastics industry in medical, electronics, aerospace, automotive, defense, and telecommunications, among other markets.

Grand River Aseptic to Expand in West Michigan

A group of Michigan and Indiana based investors, led by the Municipal Employees' Retirement System (MERS) of Michigan, has invested $9.8 million in Grand River Aseptic Manufacturing (GRAM), a contract manufacturer of sterile injectable pharmaceuticals that offers services for aseptic vial and syringe filling. The company plans to use the funds to expand its range of services and hire additional staff. "We are delighted with the strong investor response, especially by MERS," said GRAM president Tom Ross. "Their considerable support, in combination with backing from many private investors in our community, is a strong indicator that we're headed in the right direction. This funding enables us to expand our capabilities, improve our facility and advance our customer reach, all while creating more highly technical, high-paying jobs in west Michigan. We have a great company, fantastic employees and a bright future," he said.

GRAM offers services including sterile product development and manufacture, lyophilization, terminal sterilization, vial and syringe filling, as well as analytical and microbiological services.

RUCDR Infinite Biologics Received CLIA Certification

The unit of Rutgers' Human Genetics Institute of New Jersey also received a Clinical Laboratory Improvement Services license from New Jersey. RUCDR, which calls itself the world's largest university-based biorepository, said it plans to provide clinical-grade diagnostics for a range of diseases, and will use genetic and genomic technologies to develop tests for diagnosing and managing several types of cancers.

Lake Superior College, Health and Science Center

The new addition to the single building campus of Lake Superior College, Duluth, Minn., provides future-oriented facilities for the Health and Science programs while consolidating the widely dispersed areas into this building. Growing out of the bedrock, the building adds 34,000 sq. ft. and remodels 5,500 sq. ft. of the existing 307,970 sq. ft. facility on the main campus. The new building combines student-centered teaching labs and open lab space on campus for health, nursing and science programs. Hands-on learning is provided through simulation labs with adjacent lecture classrooms for the allied health sciences, including nursing, medical assistants and radiology. Labs and classrooms for the sciences, including Earth, chemistry and physics, are located at the other end of the classroom wing. Adjacent instructional and lab classrooms provide maximum flexibility. The vacated spaces within the existing facility provide opportunities to address the shortage of general classrooms and general-use/support spaces.

The Health and Science Center, a LEED Silver building, is constructed on the hill behind the main building. A glass-enclosed walkway connects the existing building on the main circulation, second level. This location for the addition achieves several goals: campus expansion to the north as proposed in the master plan; protects Miller Creek and provides visibility for this program on campus. The new addition capitalizes on the natural site and the views toward the St. Louis River and Lake Superior.

The budget was $14,000,000

Project team included Ross Barney Architects, Chicago (design architect); LHB Engineers and Architects, Duluth, Minn. (architect of record, MEP/civil/structural engineer, landscape architect); Shaw-Lindquist (GC).

NIH to Fund New Pediatric Cardiac Genomics Centers

The National Institutes of Health will award up to $2.3 million next year to fund research centers that will join the Pediatric Cardiac Genomics Consortium, an initiative that targets the genetic causes of human congenital heart disease and seeks to connect genetic variants with clinical outcomes.

The funding, provided by the National Heart, Lung, and Blood Institute and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, will support up to five such centers in joining the consortium, NIH said.

The PCGC initiative was created in 2009 to establish a consortium of multidisciplinary research teams and scientific core facilities that would study genetic variants involved in CHD and eventually translate those findings into improved therapies, prevention strategies, and risk stratification. It is one part of NHLBI's three-pronged Bench-to-Bassinet Program (B2B) program. The PCGC provides the B2B with genetics and genomics researchers, while the Cardiovascular Development Consortium provides basic scientists and the Pediatric Heart network provides clinical and observational study experts.

NIH said the PCGC's multi-center approach had enabled the consortium to accumulate the largest collection of data and DNA from patients with CHD.

The research projects the new PCFC centers may pursue include, but are not limited to, determining if specific genetic variants are associated with relevant clinical outcomes; testing the hypothesis that variants in cis-regulatory regions or modifier genes contribute to CHD pathogenesis; studying the extent to which gene-environment interactions contribute to CHD; and using human induced pluripotent stem cells from CHD patients to determine the mechanistic steps that translate genetic variants into CHD.

KBR to Construct Oral Solid Dosage Production Facility for Purdue Pharma

KBR announced that KBR Building Group, a subsidiary within KBR's Services Group, has been awarded a contract by Purdue Pharma Manufacturing L.P. to build a new Oral Solid Dosage manufacturing plant in Durham, N.C. The 188,000-square-foot, steel-framed facility is being constructed on a 51-acre site in Treyburn Corporate Park in Durham, NC.

Production areas will feature cleanroom spaces with epoxy flooring, and epoxy painted walls and ceilings. The building will also house administrative offices, laboratories and associated support areas, such as dining, conference, and training areas.

"KBR Building Group has provided construction services to Purdue Pharma Manufacturing L.P. in the past, and we look forward to serving this important client again," said Mitch Dauzat, KBR Services Group President. "KBR Building Group specializes in constructing facilities for the life sciences and pharmaceutical sectors and this award reinforces our leadership position in this market."

CSHL plans New Quantitative Biology Center

Cold Spring Harbor Laboratory said it has received a $50 million donation from the Jim and Marilyn Simons Foundation to establish a new research center focused on using quantitative biology to interpret genomic research data from a variety of diseases and disorders.

The Simons Center for Quantitative Biology will incorporate applied mathematics, computer science, theoretical physics, and engineering into basic research and studies of illnesses such as cancer, autism, bipolar disorder, and depression.

CSHL said it has recruited Adam Siepel from Cornell University to chair the Simons Center beginning in September. Siepel is currently associate director of the Cornell Center for Comparative and Population Genomics and director of the school's PhD program in computational biology.

Siepel's research at Cornell has focused on developing computational methods for identifying functional elements of eukaryotic genomes, mostly mammalian, based on comparative sequence data.

"The pace of modern science and the vast amount of data being generated, both in genomics and imaging, has necessitated an expansion of our research to include scientists with expertise in quantitative analysis," CSHL President Bruce Stillman said in a statement.

New Lab to Speed Michigan Water Testing

A new laboratory at Lake St. Clair Metropark in Harrison Township aims to speed and improve the process of testing water at beaches in Michigan.

The Macomb Daily of Mount Clemens and The Detroit News report the lab opened this week in Harrison Township following years of work to improve testing. The lab is part of a pilot project designed to help state officials plan for future water monitoring.

The Huron to Erie Alliance for Research and Training Freshwater Center, also known as the HEART lab, is a joint venture that includes Wayne State Univ., Macomb Community College, the Metroparks system and Macomb County. It’s getting $100,000 in state funding.

A subject of interest for the lab is testing for E. coli bacteria, which can shut down swimming at beaches, as well as monitoring other contaminants.

Grifols opens Plasma Production Plant

Grifols, a leading producer of plasma-derived medicines headquartered in Barcelona, Spain, has opened a US$370m North Fractionation Facility (NFF) in Clayton, NC, in the US, where it will almost double production capacity of plasma from 3.2 to approximately six million liters a year by 2015. The NFF will be fully operational next year and employ more than 200 people.

Grifols' products are used to treat rare, chronic diseases such as neurological disorders, immune deficiencies, hemophilia and genetic emphysema. The company is the largest private employer in Johnston County, NC with a total of 2,300 employees across the State.

The company also has a corporate office and manufacturing facilities in Los Angeles, CA, testing labs in San Marcos and Austin, TX and 150 plasma donation centers across the US. Additionally, the company has manufacturing facilities in San Francisco, CA producing antigens for immunological diagnostics, as well as the Grifols Academy of Plasmapheresis, an education and training facility headquartered in Glendale, AZ. Grifols employs more than 9,600 people in total in the US, representing approximately 73% of its 13,200 employees worldwide. Sales in the US reached €1.71m in 2013, or 62.3% of the company's total turnover.

The US has always been one of the company's most important markets 'As a leading healthcare company, one of Grifols' main goals since being founded in the 1940's has been to advance the plasma industry,' said Victor Grifols, President and CEO of Grifols. 'Today, I take great pride in our pioneering spirit that has allowed us to build the world's largest and one of the most innovative plants producing plasma medicines.' He added that the US has always been one of the company's most important markets and investment of more than $7bn since 2001 in the country demonstrates its long-term commitment to growth.

The NFF was recently named the 2014 Facility of the Year for Project Execution by the International Society for Pharmaceutical Engineering (ISPE). The 155,000ft2 facility features technologically advanced systems and processes to ensure the highest standards of product quality and high production capacity in plasma fractionation. The company will invest more than €600m in its American and European plants over the next two years Fractionation is the first step in the production of plasma-derived drugs, which involves subjecting plasma to various changes of temperature and chemical conditions, causing each of the proteins with therapeutic properties to separate out. These proteins have to be purified and formulated before they can be used as medicines. The medicines manufactured by Grifols from plasma include immunoglobulin, for the treatment of primary immune deficiency and a neurological disorder called chronic inflammatory demyelinating polyneuropathy (CIDP); factor VIII, for the treatment of hemophilia A; albumin, to re-establish and maintain blood volume; and alpha-1 antitrypsin for the treatment of genetic emphysema.

Grifols said it would invest more than €600m in its manufacturing facilities in the US and Spain over the next two years. A substantial portion will go towards the expansion of the albumin purification plants in Los Angeles, CA and Clayton, NC, and also towards a new warehouse at the Clayton complex, while construction of a new alpha-1 antitrypsin purification area in the Parets del Vallès, Barcelona complex is one of the main projects in Spain.

Rutgers University Breaks Ground for Chemistry and Chemical Biology Building

New Jersey Governor Chris Christie and Rutgers University President Robert Barchi marked the start of a new era of science education and research as they joined with state officials and members of the university to break ground for the new home of the Department of Chemistry and Chemical Biology (CCB).

The four-storey, 145,000ft2 facility will provide teaching, laboratory and support space that will enable the U.S. university to expand and accelerate its research into drug design, alternative energy, biomaterials and nanotechnology. It is expected to be completed in Autumn 2016, when Rutgers will celebrate its 250th anniversary.

The US$115m project is funded largely by the 2012 Building Our Future Bond Act. The new classrooms and labs are key to enhancing the high quality science education at Rutgers. More than 5,000 Rutgers students take chemistry courses each semester.

In addition, the CCB building will allow the university to build upon its tradition of collaborative research with leading academic labs, government organizations and private industry in New Jersey and around the world. ‘This remarkable new building befits a premier research institution,' said Barchi. 'Rutgers ranks first among US universities in federal funding for chemical research. Our chemistry and chemical biology faculty are world leaders in discovery and innovation, and our students go on to successful and distinguished careers in the pharmaceutical, chemical and healthcare industries in New Jersey and beyond.' Core facilities in the CCB building will include a microscopy suite, a Class 100 chemistry cleanroom as well as optical spectroscopy, nuclear magnetic resonance spectroscopy and X-ray crystallography laboratories.

The facility’s modular design and versatile infrastructure will allow reconfiguration of labs and classrooms to respond as technology evolves and the needs of students and faculty change. Common areas are designed to promote collaboration. The new building will be located adjacent to the Wright-Rieman Chemistry Complex on the Busch Campus. The first building in the complex was opened in the late 1940s and additional facilities were built in the 1960s and 1970s. In the last decade, 75% of Rutgers’ peer institutions have invested in new chemistry facilities. The CCB building will enable Rutgers to compete better for top-notch faculty and the best and brightest students. The research at the new CCB building will be matched by the cutting-edge sustainability features of the building itself.

Besides conforming to New Jersey energy mandates and guidelines, Rutgers seeks to achieve a Leadership in Energy and Environmental Design (LEED) Gold certification for the building by reducing its energy usage. Numerous green features are designed into the project, including windows that maximize natural light and manage heat gain, advanced air handling and exhaust systems, construction materials made with a significant percentage of recycled content, and native vegetation to encourage biodiversity and reduce the need for irrigation

Auer Precision Stamping Increases Cleanroom Capability

Auer Precision Stamping Inc., a provider of medical device contract manufacturing services, has installed additional ISO 14644 Class 7 cleanroom capacity. This addition doubles cleanroom square footage allowing Auer Precision to expand production capacity for thin film and polymer based medical devices.

“Controlled environments are critical for the materials we convert and products we supply. Adhesives are present in the manufacturing processes and require clean environments to alleviate any exposure to foreign particles,” says Auer’s President, Brent Bollong.

Auer Precision Inc. has the capability of manufacturing high quality, particle free parts in ISO 14644 Class 8 to Class 5 cleanroom environments.

Auer Precision Stamping is located in Mesa, AZ.

Sterigenics International Expands

Sectors Sterigenics International, an outsourced contract sterilization services specialist, will invest more than US$10m to expand operations in Atlanta and Dallas in the US and in Petit-Rechain, Belgium as a result of increasing customer demand.

The Sterigenics Atlanta facility, located for more than 20 years in Smyrna, Georgia, will add a 30-pallet ethylene oxide chamber, increasing processing capacity 2mft3 a year. An additional aeration room will accommodate the increased production. Sterilization of medical products, validation capabilities and SteriPro lab services are offered at the site.

The Sterigenics Dallas facility, located in Grand Prairie, Texas, will increase ethylene oxide processing capacity by 3mft3 a year. Here, pre-conditioning and aeration rooms will be expanded, with completion by January 2015. Sterigenics has operated at the site since 2003 and offers sterilization of medical products, validation capabilities and SteriPro lab services.

Petit-Rechain, Belgium is one of Sterigenics largest locations, offering ethylene oxide sterilization, SteriPro lab services, validation and cycle development capabilities. The company will install a 32-pallet chamber at this facility, bringing the total number of chambers to 14. The new chamber will add 2mft3 of additional ethylene oxide processing capacity and will be operational by the end of the year.

Headquartered in Deerfield, Illinois, Sterigenics International has 40 facilities across the Americas, Europe and Asia, offering outsourced contract sterilization services, primarily to the medical device, pharmaceutical, food safety and high performance/specialist materials industries.

Entegris Opens New Facility in Bedford

Entegris Inc., a Billerica-based materials and solutions provider to the microelectronics industries, inaugurated its new i2M Center for Advanced Materials Science (“The i2M Center”) in Bedford, Massachusetts. The facility is the company’s flagship innovation center for developing filtration and specialty coatings technologies, which are used to maximize production yields in the world’s most demanding and challenging microelectronics manufacturing environments.

Representing an investment of more than $55 million, the i2M Center will focus on R&D and manufacturing for filtration media, metal membranes, electrostatic clamps (E-Chucks) and proprietary advanced, low-temperature coatings.

“i2M stands for ‘ideas to market’ and we intend for this facility to be our flagship innovation center for solving very difficult materials science challenges,” Bertrand Loy, President and CEO of Entegris, said. “Our customers run extremely complex manufacturing processes and the i2M Center reflects our commitment to developing truly innovative solutions to support their process advancements. As a global company serving global customers, we evaluated a number of locations for this new building. We chose Massachusetts because it is at the epicenter of some of the best engineering talent in the world.”

Approximately 100 professionals will work at i2M Center, many of whom hold doctorates and advanced degrees in material/separation science and chemical engineering. Entegris has approximately 350 employees in Massachusetts and approximately 3,500 employees worldwide.

Entegris reported on April 30, 2014 that it completed the acquisition of Danbury-based ATMI for $1.1 billion

UFP Technologies expands Cleanroom

UFP Technologies Inc., a producer of custom-engineered components, products, and specialty packaging, has expanded its manufacturing operations in Georgetown, Mass. The addition of a new cleanroom and high volume production equipment broadens UFP Technologies’ medical manufacturing capabilities. Using foams, plastics, composites, and natural fiber materials, the company designs and manufactures a range of solutions primarily for the medical, automotive, aerospace and defense, and packaging markets.

The new ISO Class 8 (Class 100,000) certified cleanroom will house a custom built high volume line to support its growing line of components manufactured from medical-grade thermoplastic polyurethane (TPU). The TPU components offer a high degree of puncture resistance and flexibility to provide a robust sterile barrier protection. UFP Technologies now has a total five clean environments in Massachusetts.

“Our customers rely on us to continually innovate our manufacturing technologies to meet stringent medical device requirements,” says Mitch Rock, Vice President of Sales and Marketing. “Investing in a new cleanroom facility and advanced manufacturing equipment allows us to be a valued partner to them.”

UFP Technologies has seven manufacturing facilities throughout the country that are ISO 13485:2003 certified which house multiple ISO Class 8 (Class 100,000) and ISO Class 7 (Class 10,000) cleanroom facilities

Bayer CropScience Building New Greenhouse in RTP

Bayer CropScience, a maker of crop pesticides and genetic traits to improve soybean, corn and other crop seeds, announced that it will invest $29.6 million in the expansion of its North American and global seeds headquarters in Research Triangle Park. The investment includes the construction of a 29,500-square-foot greenhouse.

This is the latest investment in the campus made by company, which is a subsidiary of the Germany-based Bayer AG. “We voted for RTP, and it’s been very good for us and we’ll continue to do that,” said Jim Blome, president of Bayer CropScience LP.

The company opened a new, $20 million greenhouse in the summer of 2012 at the campus, it finished a $16.1 million renovation and construction of buildings for its crop protection and environmental science research last year, and has started a $33 million renovation of its headquarters that’s expected be completed in 2015.

The 29,500-square-foot greenhouse will replace two smaller, older greenhouses on the campus that have been operating for more than 30 years.

Blome said the construction will be the first development of the 70-acre property near its existing campus that the company bought for $6.2 million in December 2012.

Like the old greenhouses it will replace, the new structure will be used for the company’s soybean, corn and other crop biotechnology research, he said.

According to a news release, the greenhouse will be built to accommodate seed trait research, providing dedicated and isolated space for insect testing, nematode trait research, and the capability of “groundbreaking plant disease research. It’s an update reflecting the size, scale, and growing capacity of our biotech business,” Blome said.

The project is scheduled to begin in the late summer of this year and to be completed late next year. To accommodate staff growth, the project will also increase campus parking by 200 spaces and provide a new security hut.

To date, Bayer CropScience has about 700 employees based in the greater Research Triangle Park area.

Blome also said the company is looking to consolidate its Triangle workforce onto the RTP site.

The company has another facility in Morrisville that was the former location of Athenix Corp., a biotech company acquired by Bayer CropScience. Traits developed at the former Athenix facility in Morrisville are put into plants in RTP. “We still have that facility, and over time, we want to move those scientists over onto this RTP site,” he said. “We have future ideas, but nothing concrete to express.”

In addition, the company has shifted its global headquarters for seed research in the Research Triangle Park. The company moved its seed headquarters to RTP in 2012 from France. Blome said the shift was more about focusing new hires in RTP.

And the $16.1 million's worth of renovations were completed at the site in what Blome said was the last step in migrating the company’s headquarters from Kansas City, Missouri. About 40 employees moved from a business group from Stilwell, Kansas.

The company kept a global manufacturing in Kansas City, Missouri, that employs 750 people. Bayer Corp.’s agricultural business was based in Kansas, City, Missouri, before 2002.

The company's RTP operation is the result of the 2002 merger of Bayer's crop protection division with Aventis CropScience.

BioOutsource targets Biosimilars Testing with New U.S. Lab

US demand for biosimilars testing will grow substantially in the next few years according to BioOutsource, which expects to generate half of its revenue in the country by 2019.

The Scotland-based biopharma testing firm announced plans to set up a laboratory in Massachusetts, citing its expanding US client base as the main driver for the investment.

Spokesman Mitch Scanlan said, “The US is our fastest growing market where we have tripled our revenues and client base in the last 18 months and we expect this market to represent 50% of our total sales within the next 3-5 years.

“The new facility is being set-up predominantly to support Biosimilars, but we also plan to offer additional services that will support our Biosafety customers” he said.

The US biosimilars market has not taken off as well as had been expected in 2010 when the government created an abbreviated approval process as part of the Affordable Care Act (ACA), also known as Obamacare.

The main issue has been a lack of clear guidance from the US Food and Drug Administration (FDA) on biosimilars, specifically how developers should go about proving their drugs are similar to the originator product.

This lack of guidance has already seen some potential major players scale-back their the efforts. In 2013, for example, Lonza and Teva dissolve their biosimilars joint venture citing US regulatory uncertainties.

In May this year the FDA finally moved to address this problem by issuing draft guidance on biosimilarity, but whether this will be enough remains to be seen.

BioOutsource related, "The FDA is drip-feeding biosimilar guidelines in draft form which is less than ideal to encourage the industry. However what is clear is a key requirement for analytical comparability assessment which BioOutsource are able to provide."

BioOutsource has not chosen a site for the new laboratory. However, Massachusetts was the “logical choice” according to Scanlan, who said that: “Boston is already home to several of our US clients [and] our local sales office was also established there in 2013.”

Scanlan also said: “We will be refurbishing an existing facility rather than a new build construction,” which is an approach that a number of other biopharmaceutical services firms have adopted to accelerate geographic expansion.

The firm also describes itself as an active member of the Massachusetts Biotechnology Council (MassBio) and cites this as another reason for choosing to set up its services base in the State.

However, while efforts to expand its US client base are a major part of the expansion plan, they are not the only focus according to Scanlan.

“We are focused on a global market and we believe the new lab will accelerate growth and open up opportunities across North and Latin America.”

Intertek Expands Immunochemistry Centre

Intertek, a leading quality solutions provider to industries worldwide, is to expand its immunochemistry facility in San Diego with a move to a larger centre of excellence. The move to the new facility, which spans 46,000ft2 of laboratories, offices and sample storage, is scheduled for completion in September 2014. It will provide expanded support for Intertek’s customers in preclinical and clinical drug development, by enabling Intertek’s bio analytical experts to provide more effective delivery of its services through the significant upgrade in capacity and throughput.

In particular, the new facility will provide an enhanced operating structure for the evaluation of novel large molecules/proteins-based drugs or antibody therapeutics, antibody-dug conjugates (ADCs), vaccines and biosimilars.

Intertek has been providing Good Laboratory Practice (GLP) compliant immunochemistry services to global pharmaceutical clients to support their preclinical and clinical studies for more than 20 years and the new facility will form a key part of the company’s network of state-of-the art GLP-compliant laboratories.

In addition, current expertise in the development and validation of quantitative ligand-binding assays including pharmacokinetic (PK), immunogenicity, and biomarker immunoassays will be enhanced. The cell-based assay capabilities will also be expanded and additional functional areas added to provide a more comprehensive support to the pharmaceutical industry.

“Bioanalysis plays an important role in the development of a biologic drug, helping to develop safe and more efficacious drugs. With the expansion in San Diego, we will build on our current world-class immunochemistry capability to deliver solutions for the global biopharmaceutical industry’s growing requirement for superior bio analytical expertise,” said Chetan Parmar, Senior Vice President of Intertek Life Sciences.

Working alongside the San Diego facility, the European GLP and cGMP immunochemistry laboratory is located in Manchester, UK to provide complete and global bioanalytical and analytical support for large molecule drug development from discovery to market approval.

Intertek’s global network of regulatory pharmaceutical centers of excellence are located in the US (El Dorado Hills, San Diego and Whitehouse, New Jersey), in the UK (Cambridge and Manchester), Switzerland (Basel) and Australia (Melbourne).

REST OF WORLD

Onyx Invests in Continuous Flow with API Demand

UK API-maker and contract research organization (CRO) Onyx Scientific is installing equipment for continuous flow manufacturing to offer customers an alternative to batch manufacturing.

Denise Bowser, Commercial Director, said the company has spent £80,000 ($137,000) on equipment for its premises in Sunderland, northeast England citing customer demand for flexibility during process development.

Pharmaceutical clients ask for continuous flow during product R&D, she said, for “a wider range of conditions for certain experiments,” particularly surrounding hazardous reactions. “For us it’s a good thing to have the technology to give the clients full availability.”

She added that continuous flow would make better use of the company’s space, give quicker output, and provide greater flexibility in compound manufacturing.

Continuous flow manufacturing – a technique that aims to lower costs and waste by integrating all stages of production – is “a very small area,” Bowser told us. The majority of Onyx’s API manufacturing will continue to be batch work, she said; “we’re just giving our clients further scope for developing using different techniques.”

The equipment purchase comes as part of a wider investment initiative, with Onyx announcing it is increasing its GMP manufacturing capacity with extra vessels, following increased demand for GMP API manufacturing services for drug development.

The company reported a 45% rise in solid-state chemistry-related revenues last year, which it said was driven by early stage campaigns.

In May this year, it completed an API manufacturing deal for US firm Neuronascent, producing a 1kg consignment for use in the neurology company’s marketing authorization submission to the US Food and Drug Administration.

As well as its Sunderland-based laboratories, Onyx has access to seven API sites in India for technology transfer, pilot-scale work, and manufacturing for Phase II through to commercial.

USFDA approves Novasep Facilities

Novasep has received the regulatory nod to manufacture a kinase inhibitor new molecular entity (NME) following pre-approval inspections at two facilities in France.

The US Food and Drug Administration (FDA) inspected Novasep’s Chasse-sur-Rhone and Pompey sites last month and has certified the contract manufacturer to produce a new molecular entity (NME) already approved in the US.

The NME is for a small molecule kinase inhibitor – a type of enzyme inhibitor which stops phosphorylation and can therefore help treat certain cancers and inflammatory diseases – but the firm was unable to disclose further details due to client confidentiality.

However, Sophie Baudouin, Marketing Director at Novasep, said that on top of acknowledging the sites’ cGMP, the approval “positions Novasep as a top tier leader providing services to the Pharmaceutical industry.”

She continued: “To have the technologies and the capacity to produce is not always enough either,” adding the firm’s “level of compliance with regulations, proven over the years” was also a key in being selected by the client for this project.

The API and late-stage intermediates will be made at the Chasse-sur-Rhone site, which has multi-step pilot and commercial scale production workshops, Baudouin said, offering “specialized technologies such as ozonolysis, low temperature, enzymatic reactions, metal catalyzed coupling reactions” on top of conventional synthesis technologies.

Pompey will be used for the last purification step, she continued, using Novasep’s industrial chromatography platform designed and produced on site.

In 2013, Novasep’s Le Mans, Mourenx (both in France) and Leverkusen (Germany) were also subject to successful FDA inspections .

GSK’s New Biopharmaceutical Plant, Ulverston, United Kingdom

GlaxoSmithKline (GSK) unveiled plans for the construction of a new biopharmaceutical plant in the UK. The new facility will be located at GSK's existing factory in Ulverston factory in Morecambe Bay.

The facility will specialize in developing biopharmaceutical medicines. It will manufacture medicines for treating a wide range of diseases that include cancer, autoimmune, and hereditary ailments, and is expected to create 250 jobs.

The first phase of construction of the plant is expected to take six years to complete to make it ready for operations by 2021, when the second and third phase will be launched for construction respectively.

The master plan for the new biopharmaceutical plant was prepared by Devereux Architects in collaboration with the PM Group.

The facility is designed to retain most of the existing trees and banking around the site wherever possible, and will create new trees and mounds around the site's edges. It will follow eco-friendly designs to protect the biodiversity in and around the proposed development area.

The vaccine manufacturing plant of GSK in Dresden, Germany, mainly produces the company's seasonal influenza vaccine Fluarix for its biologicals division.

GSK's existing factory in Ulverston, built in 1948, produces penicillin and other antibiotics. An extensive feasibility study was conducted by GSK in 2011 for selecting site for the construction of a new biopharmaceutical plant in the UK.

In March 2012, GSK decided to build the proposed plant at the existing Ulverston factory as part of the £500m investment for further expansion of UK facilities. The total investment allotted for the construction of the new manufacturing facility is £350m ($580m).

The investment decision for the Ulverston facility was taken after the introduction of 'patent box' scheme by the government. The scheme was intended to support and invite more investment in the UK, creating an attractive environment for the pharmaceutical companies to discover and produce new products and avail lower tax rate benefit.

The new facility will enable the discovery of new medicines and their production in the UK.

The plant will have odorless production buildings with hospital-like internal conditions. It will have quiet operation, low level of truck traffic servicing the site, and no visible emissions. It will have a sophisticated closed, clean and sterile equipment with controlled reactors cultivate cells, organisms and cleanroom facilities to produce large quantities of the biopharmaceutical products.

The production will be free from unintended contamination of naturally occurring microbes. Sophisticated equipment will be installed to further process, purify and stabilize the bulk product.

Products developed at the facility will be frozen and stored until formulation and dispensing into the final dosage form.

Construction of the new biopharmaceutical facility is expected to be completed in three phases. The first phase of construction is expected to start in 2015 and will be completed by 2021. It will involve construction of a new production building, office space and associated landscaping. It will also include rationalization of the existing wastewater treatment plant at the existing plant.

A new access will be built to the factory, a new roundabout will be created and alterations will be made to the highway located adjacent to the factory. A new car park and an emergency access road will also be constructed.

The new car park will have 299 spaces, including 15 disabled. It will also include an additional provision for bicycle parking.

The second phase of construction will involve development of the second phase of production building, relocation of the sports facilities to the West Site, and landscaping along Pulman Road.

Phase three of construction will involve establishing a third phase production building, final car parking, and landscaping

CPI’s National Biologics Manufacturing Centre, Darlington, United Kingdom

Construction of the National Biologics Manufacturing Centre (NBMC) at Central Park in Darlington site, UK, began in April 2014. The facility will be used for conducting research on biologic products by promoting collaboration between academia, the National Health Service (NHS) and the industry.

The facility is expected to be ready for operations by 2015 and will be managed by Centre for Process Innovation (CPI).

The new NBMC will have a total floor space of 5,000m² (53,800 sq. ft.) and will be equipped with flexible laboratory and pilot plant areas. It will help companies of all sizes in the biologics market to produce, demonstrate, prototype and scale-up the next-generation of biologic products, as well as processes and technology. It will also help companies based in the UK to develop a competitive foothold in the growing biologics market.

It will manufacture medicines for treating diseases that include cancer, autoimmune, and hereditary ailments.

The facility will have dedicated space for Good Manufacturing Practices (GMP) process, analytical and technology development, and clean rooms to carry out research. It will also be facilitated with state-of-the-art lab equipment. It will be designed to feature flexible, open-plan areas and will house offices, meeting rooms and spaces for training and conferencing.

It is being developed with £38m ($64m) investment by the government as part of the 'Strategy for UK Life Sciences' program initiated in 2011, which promises an investment of £310m towards the support of discovery, development and commercialization of innovative medicines.

The facility will be strategically located at Darlington as it will be in close proximity to East Coast Mainline for transport facilities. It will also be close to the existing pharmaceutical companies and relevant universities located north of England.

NBMC's construction is expected to create new jobs for the region and will also help enhance the local economy, as well as the competitiveness of the UK biologics sector.

The NBMC will be used for developing biopharmaceuticals and biologics using biotechnology. Production of biologic products needs to have biological foundations such as cells, bacteria, yeast and others to perform precise development processes. The new facility will be equipped with all such tools, facilities and technology for the development of innovative biologic medicines.

Construction on the National Biologics Manufacturing Centre started in April 2014 and is scheduled to be complete by March 2015.

The design and build contract valued at £38m ($64m) was awarded to Interserve Construction, a company based in Darlington, in March 2014.

The Centre for Process Innovation (CPI), based in the UK, provides guidance to companies to develop new products and processes from concept to finished product. It uses applied knowledge in science and engineering together with sophisticated development facilities. It enables clients to develop, demonstrate, prototype and scale-up the next generation of biologic products and processes.

CPI was made part of the High Value Manufacturing Catapult (HVMC) network, which consists of seven technology and innovation centers, in 2011. The HVMC was established in the UK to access the best manufacturing talent and facilities.

Biological medicines account for 10% to 15% of pharmaceutical market and constitute more than one-fifth of new medicines launched in worldwide every year. The new facility at Darlington will help the UK expand its contribution to the high value and high quality production of biologic medicines in the global market.

AstraZeneca Reveals Plans for Cambridge Site

AstraZeneca revealed the proposed designs for its new Global R&D Centre and Corporate Headquarters in Cambridge in the UK. The plans for the new facility, which will be located on the Cambridge Biomedical Campus (CBC), include designs for the Global Centre, an R&D Enabling Building and an Energy Centre.

Key features of the site include:

Science at the heart – the high technology labs on the site will be separated from other work spaces by glass walls to promote ‘visible science’, ensuring scientific innovation is the primary focus for all staff, both in R&D and other functions.
Fostering collaboration –the site will feature a number of open spaces and thoroughfares to encourage collaboration not only within AstraZeneca, but also with the wider scientific community within the CBC and beyond.
Reflecting the character of the City – the unique characteristics of Cambridge’s historic center has influenced the shape of the buildings. The site will be low rise and will include a central courtyard reflecting the colleges of Cambridge University.
An environmental build –AstraZeneca is seeking Building Research Establishment Environmental Assessment Methodology (BREAAM) Excellent status for the site, which will feature labs that represent best practice in low energy design and the largest ground source heat pump in Europe. “Green Roofs” will also be installed across the majority of the site.

Mene Pangalos, executive vice president, Innovative Medicines & Early Development at AstraZeneca said: “We are very excited to be able to reveal the plans for our new site in Cambridge. Our aim is to create an open, welcoming and vibrant center that will inspire our teams and partners to push the boundaries of scientific innovation.”

The new site will bring together AstraZeneca’s small molecule and biologics research and development activity, opening up opportunities to exploit the promise of biologics and small molecule combinations. The CBC will be the new UK home for biologics research and protein engineering carried out by MedImmune, AstraZeneca’s biologics arm. MedImmune already employs around 500 people at Granta Park, to the south east of the city.

“With our combined AstraZeneca and MedImmune portfolios we are already uniquely positioned to explore the promise of combination therapies in transforming the way patients are treated,” said Dr. Bahija Jallal, executive vice president, MedImmune. “Our new Global Research Centre in Cambridge will see AstraZeneca and MedImmune scientists working side by side to advance science in our core therapeutic areas. This will support and strengthen our focus on combining the expertise across our business to develop new ways to treat patients and tackle the significant unmet need that exists in areas such as oncology.”

Stefan Marbach, senior partner at Herzog & de Meuron, the architects selected to design the new site in Cambridge, said: “In designing the new building we made reference to the historical colleges in central Cambridge, which are typically low-rise buildings enclosing a central courtyard. The building's proportions draw on this, as well as the open public access to the courtyard. The whole structure is connected in a single loop, providing short connections within the building and modern, innovative workspaces that support collaborative working. The ‘saw-tooth’ roof, which carries on through to the facade, aims to unify the appearance of the building and give it a distinctive character.”

In advance of the new site coming online in late 2016, around 70 AstraZeneca staff have already relocated to interim facilities in Cambridge, at the Melbourn Science Park, Cambridge Science Park and Granta Park. By the end of 2014 approximately 300-400 AstraZeneca staff will have relocated to the city, to cement important relationships with other members of the Cambridge life science community.

Pangalos continued: “As we carry on our work to get the new site up and running, our focus is on continuing to build important relationships with partners in the local bioscience community. With up to 400 staff relocating to the city by the end of the year, and with the range of exciting collaborations we have underway, Cambridge is already an important part of our innovation footprint here in the UK alongside our sites in the North West, which will continue to be important elements of our UK presence.”

BGI, University of Birmingham Create UK Environmental Omics Centre

The Centre will seek to protect environment, health and global biodiversity by analyzing the toxicity of compounds more efficiently than has been achieved before.

BGI has signed a ground-breaking agreement with the University of Birmingham that will create the Joint Centre for Environmental Omics (JCEO) between the two institutions.

Located on the University’s Edgbaston campus, the JCEO will specialize in automated ultra-high-throughput sample processing in a facility jointly operated with the BGI China National GeneBank (CNGB). The Centre’s work will provide comprehensive and timely data on the effects of thousands of high priority chemicals, advanced materials and their mixtures on biological systems.

BGI, based in Shenzhen, has more than 5,000 employees including over more than 1,000 bioinformatics specialists who are working on solving the globe’s most pressing research questions and societal challenges.

Over 60,000 synthetic compounds are used by industry and found in domestic products across the world, for which there is a paucity of information on their potential environmental and health effects. The knowledge gap can be addressed by applying the rapid technological improvements in DNA sequencing and computing power that are transforming the possibilities for regulatory toxicology. These scientific advancements will be crucial to the work of the JCEO, which aims to reduce the uncertainty about compound health risks and help industry fulfil the requirements of European legislation such as REACH and the Water Framework Directive.

John Colbourne, Professor of Environmental Genomics, University of Birmingham and Co-Director, JCEO, said: “Together, REACH and the Water Framework Directive can positively transform environment and human health protection, as long as science can provide robust and cost-effective toxicity tests to be used by industry, policy makers and regulators”.

Xin Zhou, Deputy Director, CNGB and Co-Director, JCEO added: “In collaboration with industry and government scientists, the JCEO will allow the European Union and beyond to ‘industrialize’ knowledge for advancing regulatory science and its applications that will, in turn, lead to a unique mass-scale predictive, quick and relatively inexpensive diagnoses of environmental health concerns”.

BGI will staff the JCEO with laboratory technicians and bioinformaticians, who will collaborate with scientists at the University of Birmingham and international partners on a variety of projects.

Dr Yong Zhang, Assistant President, BGI said: “Considering the scale of current environmental health problems, and realistic future projections, we are calling-out to researchers all over Europe and the UK to collaborate with the JCEO in response to international research challenges, so as to maximize the growth of this shared knowledge”.

The signing took place between Professor Sir David Eastwood, Vice-Chancellor, University of Birmingham and Dr Yong Zhang, Assistant President, BGI in front of a gathered audience in the University’s Senate Chamber on Thursday 3 July.

Sidra, Illumina Ramping Up High-throughput Genomics Center in Qatar

Sidra Medical and Research Center and Illumina said that Sidra will house a high-throughput genomics center at its facility currently under construction in Doha, Qatar.

The new center aims to undertake population studies and gene sequencing for the Middle East and North Africa regions, the partners said. One of the first projects out of the center will be the creation of the Arab consensus genome, intended to enable a deeper understanding of genetic variants that contribute to the health of the Arab population.

Under the partnership, Sidra, Illumina, and Alliance Global, Illumina's partner in the Middle East, will work together to ramp up operations at the new center over the next year. The center will initially focus on high-end applications, including human whole genome sequencing for rare genetic diseases and population studies using Illumina’s HiSeq X Ten Sequencing System.

"Implementing genomic medicine in and around Qatar requires an Arab reference genome set that will provide an in-depth knowledge of genetic variations in the population group," Sidra Chief Research Officer Francesco Marincola said in a statement. "The new level of sequence-based knowledge of genetic variation will allow us to implement genomic medicine systematically and on a large scale. This will help Sidra to lead the way in personalizing medical treatment and delivering the highest level of care to women and children."

Aptuit to Upgrade Cytotoxic Manufacturing Facility in Glasgow

Aptuit, a US-headquartered supplier of early to mid-phase drug development services, is to invest US$1m at its facility in Glasgow, Scotland. The investment will finance an upgrade in the site's sterile cytotoxic liquid and lyophilized drug product manufacturing capabilities. This upgrade, which will address the industry's current need for capacity in cytotoxic GMP clinical supply, will be operational by January 2015.

The installation of an autofiller with Restricted Access Barrier Technology (RABs) will enable larger batch sizes for liquid and lyophilized drug products, increasing capacities from 2,000 units to more than 9,000 units, Chief Executive Jonathan Goldman said. Additionally, the new equipment will achieve greater sterility assurance and operator protection. David Stevens, Senior Director and Site Head at Aptuit Glasgow, said cytotoxics offer a real opportunity for Aptuit. 'It is expected that biopharmas will be increasing their cytotoxic injectable outsourcing over the next few years, driven by the robust demand for oncology and other high potency drugs such as Antibody Drug Conjugates (ADCs) and IV fluids requiring a quick onset of action,' he said. 'Our substantial experience with ADCs adds to the distinct advantage that clients have in working with us in this key area.'

The company has also appointed Paul Overton as Executive Vice President, Business Development and Marketing, making him responsible for all of Aptuit's sales and marketing activities. Overton previously led the Global Sales, Marketing and Program Management team at Huntingdon Life Sciences and grew the business significantly year on year. He was instrumental in developing late stage discovery and translational sciences partnerships for the company. Before his association with Huntingdon, Overton held key leadership positions at Covance Laboratories, LCG Biosciences, Origin Pharmaceutical Services and Cambridge Life Sciences. Overton will be based in the UK, reporting to Goldman, and will join Aptuit's Executive Committee.

Waters, Chinese Pharmacopeia Establish Joint Open Laboratory

Located in the laboratory building of Beijing Zhendong Guangming Drug Research Institute, the new facility is over 400m2 (4,300 sq. ft.).

Waters Corporation announce an agreement with the Chinese Pharmacopoeia Commission (ChP) to establish a Joint Open Laboratory.

Scheduled to open before the end of 2014, the new Joint Open Laboratory will focus on in-depth research of pharmacopoeia standards, development of testing methods, methods validations and basic and advanced technical training of pharmacopoeia detection methods. Both the ChP and Waters® expect the laboratory to become one of the national technical support centers in the field of Chinese pharmaceutical standards.

"Waters is very excited about our new collaboration with the Chinese Pharmacopeia Commission," said Art Caputo, President of the Waters Division. "I am confident that this new Joint Open Laboratory will make positive contributions to assuring drug quality control in China, it will quickly become an international leader in the field of traditional Chinese pharmaceutical standards."

At the collaboration agreement signing ceremony in Beijing, Secretary General Zhang Wei of the ChP pointed out that "the ChP-Waters Joint Open Laboratory cooperation would become another milestone of the development of the ChP. This cooperation not only meets the needs of ChP’s own development, but also meets the demands of enhanced pharmacopoeia standards and improved public drug safety."

The laboratory will be outfitted with a full complement of Waters chromatography and mass spectrometry technologies, including (but not limited to) a range of ACQUITY UPLC^® systems, ACQUITY UPC2^® System, Xevo^® tandem quadrupole and time-of-flight mass spectrometers, and a Natural Products Application Solution with UNIFI^®.

PRA Adds Large Molecule Capabilities to U.S. Laboratory

PRA, a leading clinical research organization, announced that in addition to offering full-service bioanalytical capabilities in its Assen, The Netherlands, laboratory, it will add immunochemistry services in its Lenexa, Kan., laboratory. PRA is now the only company in the world with full-service bioanalytical capabilities near its clinics to support rapid results from Phase I clinical studies in both the U.S. and Europe, facilitating complex and adaptive study design.

"By expanding our services to large molecule bioanalysis, we can now support all types of clinical trials," said Chad Briscoe, Ph.D, PRA executive director, Science & Innovations, Bioanalytical Laboratories. "It is an important addition to our services because the contribution of large molecules in drug research and the development of biosimilars have increased rapidly over the past few years."

PRA's Early Development Services group is committed to the highest standards of clinical excellence and scientific expertise. With more than 1,000 staff, 500 beds, eight clinics and two laboratories, it is the most comprehensive early development organization in the world. From its state-of-the-art facilities, the group provides the pharmaceutical and biotech industries with the unique scientific environment required for complex compound development and testing in both healthy volunteers and patients. In addition, PRA's harmonized laboratory facilities in The Netherlands and the U.S. are situated close to the clinical facilities and are configured to fully support all clinical study requirements.

Colorcon Opens Major Facility in India

Colorcon announced that it has completed a major expansion of its South Asia production facility in Verna, Goa, India. The Goa site operates under schedule M of the Indian FDA and IPEC guidelines, with Colorcon accredited to the latest ISO 9001 standard.

Colorcon provides film coatings, modified-release technologies, functional excipients and tablet-design services to the pharmaceutical industry. The Goa plant is one of six Colorcon manufacturing plants dedicated to film coatings. These plants are strategically located close to key customer centers in India, China, Europe, North America and Japan.

Subodh Priolkar, regional managing director for South Asia, said during the opening event that the investment would enable Colorcon to continue to meet the needs of its customers through security of supply and short lead times.

Martti Hedman, CEO of Colorcon, added that India is one of the fastest growing pharmaceutical markets and is also the most important production cluster of generic medicines for global markets. “Colorcon is investing heavily in India to support its customers during both development and manufacture,” Hedman said. “Speed to market, cost to produce and consistently high product quality are our customers’ strategic objectives.”

GEO Begins Construction of New Production Facility in Hythe, UK

GEO Specialty Chemicals, Inc. (GEO) has begun construction of a new production facility at its Hythe UK site, designed to serve the fast growing contact lens and personal care markets.

The new facility will enhance and extend GEO's existing manufacturing capabilities, especially in products for silicone-hydrogel contact lenses, and has been specifically designed to meet the needs of the contact lens and personal care industry, including operating to cGMP standards.

"This investment builds on our acquisition of Hythe in 2011 and underlines our commitment to growth in the contact lens and personal care industry and to the Hythe site," said CEO and President Kenneth A Ghazey.

GEO offers a range of products and services to the contact lens and personal care industry, including high purity specialty monomers for conventional and silicone-hydrogel lenses, tinting systems, and tailor made, ready to use blends. With on site R&D laboratories and pilot plant facilities, through to full scale production equipment, GEO is an established development partner for contact lens and personal care manufacturers.

"The new facility builds on our long-standing expertise in supplying the contact lens and personal care industry. Our customers expect a high quality, first class experience all the way from product development to product delivery, and this purpose built facility will make sure we continue to deliver that," said Nick Liptrot, Managing Director of GEO Specialty Chemicals UK.

Glenmark Pharmaceuticals opens New cGMP-compliant Manufacturing Facility

The manufacturing facility will supply material for clinical development of its multiple mAbs in development, as well as to supplement Glenmark’s existing in-house discovery and development capabilities, which includes a biologics research centre with 69 employees.

Glenmark spokesman Jason D’Souza told us that the facility will only be for Glenmark’s mAbs and none of the space will be contracted out. This facility has been commissioned and is approved by Swiss Medic, the regulator in Switzerland, he added.

The company’s most advanced mAb candidate - GBR 500 – is intended to treat Crohn’s Disease and other inflammatory indications, has been licensed to Sanofi and is currently in Phase II development. A potential chronic pain mAb - GBR 900 – is currently in Phase I development, while the company’s third candidate - GBR 830, an anti OX-40 antagonist - is scheduled to enter the clinic later this year.

The facility has been designed to use single use bioreactor systems and also houses a suite for manufacturing cell banks. The facility is fully compliant with quality, environmental and safety standards for manufacturing clinical trial material.

Michael Buschle, president of biologics, said: “This state of the art manufacturing facility is a testimony for Glenmark’s commitment to growing its R&D and manufacturing facility in the canton of Neuchâtel. The manufacturing facility would help us bring these antibodies to the clinic faster and position Glenmark as a leading innovative pharmaceutical company.”

The company has six other manufacturing facilities, including four in India, one in the Czech Republic and one in Brazil. It also has six R&D centers.

In about 10 years, Glenmark’s biologics research center has filed several patents on novel biologic entities.

The scientists at Glenmark have also invented a technology platform to manufacture bispecific antibodies, known as BEAT, which the company is developing in addition to the mAbs.

The proprietary bispecific antibody platform allows the antibodies to be manufactured from a stable CHO cell line using standard processes. Built-in purification technology facilitates manufacturing to commercial scale, and the platform offers regular antibody pharmacokinetics, as well as a low immunogenicity profile.

West Opens Plant in India

West’s new pharmaceutical packaging facility in India will reduce supply lead times for its Asia-Pacific customers, the company says.

Construction of the plant - located in the Andhra Pradesh State of India - began in 2012 and West announced it has formally opened the facility which is set to become West’s first manufacturing site in India, producing seals used in primary packaging of injectable drugs.

A West spokesman said the plant formed part of the firm’s strategy of partnering with customers in the region. “By opening our first facility in India, we will meet market demand for our primary packaging for injectable medicines in a very dynamic emerging region.”

Though the company expects the plant to attract new customers in both India and the broader Asia-Pacific markets, it will also be used to benefit current customers, he continued.

“When the Sri City facility opens, we anticipate a reduction in lead times for supply to our customers in India and the greater Asia-Pacific region. By leveraging our global sourcing activities and process engineering expertise, we expect to be able to carefully manage the overall costs of production.”

The 15,300m2 (164,628 sq. ft.) facility lies on 72,800m2 (783,328 sq. ft.) of land leased in the Sri City Special Economic Zone (SEZ), about 55km north of Chennai. The SEZ status encourages companies from different industries to invest in Sri City through benefits such as tax exemptions, self-certification, and a solid infrastructure set up.

This site becomes the third plant operating as part of West’s Asia-Pacific network. West opened an injection molding facility in Shanghai, China, in 2009 but said at the time differences in regulations and cultural practices made the whole process “very tedious.” A second Shanghai plant opened last year , joining West’s Singapore operations in Asia.

As for the challenges in constructing and opening a plant in India, West said: “Every country has opportunities and challenges in terms of how we operate our plants,” but “we have had a good experience in getting our operation up and running in India.”

He continued: “Given the substantial global footprint we have at West, we have developed best practices for plant operations and we will be employing those in India, so that we can best meet our customers’ needs.”

India’s Cipla to invest in UK R&D

Mumbai-based drugmaker Cipla has announced it will invest “up to £100m” ($171m) in drug development in the UK.

The company’s commitment to invest in its US subsidiary over several years was agreed following a trade visit to India by George Osborne, Chancellor of the Exchequer for the UK.

Cipla said it will fund the launch of “a range of drugs in the areas of respiratory, oncology and antiretroviral medicines as well as research and development, clinical trials and further expansion internationally and in the UK.”

Its decision “shows the UK's international strength and attractiveness in this sector as well as its growing importance in Cipla’s long term strategy,” said the company’s Chief Financial Officer, Rajesh Garg. The company was pleased with the UK government’s “proactive support,” he said, and said it viewed the UK as “a key hub in our global footprint.”

A treasury spokesman said Cipla had not yet established full details about the R&D areas the £100m will be spent. He added, “This is an excellent announcement for us, as it underscores the attraction of the UK as a cutting edge hub able to attract top investment.”

Part of the purpose of the visit was to strengthen the two countries’ economic ties, said the spokesman, “which are very strong at the moment.”

Kemwell's Plant Approved with European Inspection

An oral solid dose manufacturing plant in Bangalore, India operated by CMO Kemwell Biopharma has passed a customer-prompted audit by European regulators and had its cGMP status renewed for the next three years.

The India-headquartered contractor announced it had passed the audit, explaining that it was performed as part of the European Medicines Agency's (EMA) evaluation of a drug being developed by an unnamed top ten global pharma company.

Karan Bagaria, Kemwell vice president of corporate development, said that the audit was conducted in February and that the Bangalore site makes “general pharmaceutical products.”

The inspection was a joint effort by inspectors from the Federal Agency for Medicines and Health Products, Belgium and the Medical Products Agency (MPA), Sweden under the European Union’s centralized marketing authorization procedure

This was reiterated by Bagaria, who explained that: “The facility is approved by US FDA and we have approval from Health Canada and TGA based on the EMA approval.”

Renewal of the Bangalore site’s cGMP status follows just a few months after Kemwell installed commercial-scale lyophilisation capacity at its neighboring biopharmaceutical drug substance production plant.

The Bangalore site produces oral solid dose drugs for more than 80 markets around the world according to Kemwell chairman and managing director, Anurag Bagaria, who said the cGMP renewal is key to the firm’s business.

“Kemwell understands the need to maintain high quality standards and to deliver products to our customers on-time. Through an unwavering commitment to continuous improvement, we supply products to over 80 countries worldwide with an assured level of quality and value.

“This positive audit underscores the high standards Kemwell upholds in contract manufacturing of products for commercial use and for products under development in compliance with rigorous international standards.”

Sectors Ci Medical Technologies to Expand Europe Manufacturing

Sectors Ci Medical Technologies (formally Classic Industries Europe), a global operator that employs over 500 people worldwide, has had a UK operation in Middleton in Teesdale, County Durham since 2009, where it designs and manufactures injection-molded components for the medical and pharmaceutical markets. Now the firm, which is on course to turn over £4.5m in the coming financial year, is bursting at the seams in its UK headquarters, prompting it to secure funding to pave the way forward for its expansion.

The company, which specializes in cleanroom manufacturing, operates a highly automated facility. Its current Class 7 cleanroom has a footprint of 175m2, and the company also has two portable Class 7 cleanrooms.

John Pearson, chief operating officer of Ci Medical Technologies, said: 'We’ve outgrown our current premises and so we’re expanding the size of our UK operations and anticipate a 25% increase in turnover over the next two years.' The company employs 50+ staff locally but hopes to increase the workforce in the coming months. Its US parent has been operating since 1971 and has also been providing contract design, technical assembly and logistics services, using advanced technology and engineering expertise.

BenQ Materials Expand for Medical Products

Taiwan-based polarizer maker BenQ Materials will expand the production capacity for medical care products at its factory in Suzhou, eastern China, and establish a factory in central Taiwan to make medical care products.

The company said the China and Taiwan plants are scheduled for completion by the end of 2014 and the second half of 2015, respectively.

While polarizers account for over 90% of its consolidated revenues, BenQ Materials has extended production to silicon hydrogel soft contact lenses and medical care products such as hemostatic sponge for sale under the own brand MiaCare, company chairman and CEO ZC Chen said.

BenQ Materials has marketed MiaCare contact lenses in the Taiwan and Malaysia markets and will tap the Singapore market in fourth-quarter 2014 and then China in 2015, Chen indicated.

Hospira Completes Acquisition of Orchid's API Manufacturing and R&D Facility

Hospira has completed the acquisition of an active pharmaceutical ingredient (API) manufacturing facility and an associated research and development (R&D) facility from Orchid Chemicals & Pharmaceuticals Ltd., an Indian pharmaceuticals company, for approximately $218 million, after settling prior advances of approximately $30 million.

"Hospira's acquisition of the Orchid API facility will support supply continuity of key beta-lactam antibiotic products, improve our cost position and pave the way for future API development," said Dr. C. Bhaktavatsala Rao, president and managing director, Hospira India.

"We're committed to the antibiotics space, and with our new colleagues from Orchid, we will continue to bring high-quality, lower-cost products to patients around the world." The acquisition enables Hospira, already a leader in certain critical antibiotic injectable products, to vertically integrate into the beta-lactam antibiotic APIs (penems and penicillins), and is also expected to improve Hospira's cost position in this therapeutic space.

In addition, backward integration into these beta-lactam APIs will improve the company's security of supply. Beta-lactam antibiotics represent a class of drugs with a wide spectrum of antibacterial activity.

The API manufacturing facility -- which is located in Aurangabad, India -- has capabilities for manufacturing sterile APIs and employs approximately 665 employees including chemists, engineers and technicians.

Hospira's purchase also includes an associated Orchid R&D facility based in Chennai, India, that will be directed primarily to beta-lactam and other API development with approximately 110 scientific personnel.

Post deal, Orchid retains its cephalosporin API business and facilities, and also certain non-antibiotic, non-sterile businesses and facilities it owns. Orchid will continue to supply Hospira with cephalosporin APIs.

The transaction between Hospira and Orchid, announced in August 2012, has received all necessary regulatory and legal approvals.

New Zealand Announces High-security Biocontainment Lab

The National PartyPrimary Industries Minister Nathan Guy says a new $65 m high-security biocontainment laboratory announced in Wallaceville is another demonstration of the Government’s commitment to biosecurity.

“The new facility will replace the existing high security laboratory and continue more than 100 years of animal disease diagnostics at the site,” says Guy. “The existing laboratories and skilled personnel have an essential role in responding to disease outbreaks, protecting public health and providing international trade assurances about New Zealand’s animal disease status. While these current labs have a good service record, they are now reaching the end of their design life. This new, fit-for-purpose laboratory facility will be equipped to current international standards, and have better capacity to deal with a large-scale emergency situation, in the unlikely event one should occur.

Guy continues, “Primary industries form the backbone of New Zealand’s economy, with over $20 b of exports coming from animal products. A major disease outbreak could halt trade, which could only be resumed through extensive laboratory testing. Many of our trade relationships are also dependent on ongoing surveillance and investigation work, such as that currently undertaken at the site on a day-to-day basis.”

MPI has commissioned an international company, Merrick, to design the facility. Merrick have designed and built a large number of similar secure containment facilities around the world.

The laboratory is designed to integrate two separate laboratories if NZ has a serious animal disease outbreak and maximum testing capacity is required to help manage the problem. Some examples of diseases that could be tested at the facility include Foot and Mouth disease, Anthrax, Brucella and Avian Flu.

“I’ve made biosecurity my number one priority. A world-standard diagnostic laboratory such as this is a necessity, not a luxury,” says Guy.

There are no live animals held at Wallaceville, and no live animal testing carried out there. This will continue to be the case when the new laboratories are built.

Preparative work is expected to begin on the site next month, with construction planned to begin early next year.

New Lab designed for High-altitude Medical Research

Jizhen Mountain is the second highest mountain in Guangzhou, China, with an altitude of 1,175 meters. An international laboratory for high-altitude medical research has been established in Xining City, capital of northwest China's Qinghai Province.

The lab is a joint project by Qinghai Univ. and the Univ. of Utah. Scientists from the two universities have been partners in academic exchange, personnel training and research collaboration since a cooperative agreement in April 2010.

The lab will contribute to research and cooperation on high-altitude medicine between the two sides, according to Michael Hardaman, vice president of the Univ. of Utah.

High-altitude medicine focuses on the prevention and treatment of altitude illness as well as other health issues affecting travelers, adventurers and residents in high mountainous regions of the world.

Parx Plastics Tech Start-Ups in Europe

Dutch start-up Parx Plastics, a bio innovator in antibacterial plastic technology, was selected as one of the top three tech start-ups in this year's Tech All Stars competition, organized by the European Commission.

Spearheaded by Dutch Commissioner Neelie Kroes, the European Commission selects the top start-ups from across the EU in an attempt to promote entrepreneurship.

Rotterdam-based Park Plastics, founded in 2012, made it to the final in London where it presented its technology during The Founders Forum in front of attendees including Richard Branson (Virgin), Chad Hurley (YouTube) and Reid Hoffman (Linked In). By applying biomimetics and nanotechnology, Park Plastics has developed a method to make an intrinsic change to plastic, resulting in a mechanical/physical property that acts against bacteria and micro-organisms. The patented Sanipolymers technology does not use chemicals, biocides, heavy metals or nano-particles. Instead, it makes use of zinc, which is one of the body's most abundant trace elements.

The company's research facilities are in Bologna, Italy. 'The technology is fully biocompatible, it is not toxic and it does not leach out of the materials and yet it kills 99% of the bacteria and micro-organisms that are on the surface of a product within 24 hours,' said Parx Plastics’ CTO Michele Fiori. Each of the three finalists received €20,000 worth of credits on Google Platform services.

Large-scale Commercial Manufacturing Suite Operational at Penn Pharma

In 2013, Penn Pharma revealed plans to invest a further £3m to increase large-scale commercial manufacturing capabilities at its site in South Wales. This new suite is now operational less than 12 months after first announcing the plans. This is in addition to the £14m previously invested by Penn expanding its site with a purpose-built contained manufacturing facility which opened in September 2013.

The new manufacturing suite includes granulation, tableting and coating capability. This investment allows Penn Pharma to increase capacity for both current and future clients and improve its ability to service the growing market need for large-scale commercial outsourcing solutions.

'We continue to grow and invest in new technology and our people,' said Penn Pharma Chief Operating Officer Mark Dean-Netscher. 'The decision to invest in additional capacity ensures we are able to offer our clients leading-edge technology across all manufacturing areas, continuously improve our service offering and exceed our clients’ expectations by offering the best possible service.'

Penn Pharma has been providing pharmaceutical services for more than 35 years. It has twice won the prestigious Queen’s Award for Enterprise in recognition of the work it provides to export markets including the EU, the US, South America and Japan. Penn has also received global recognition by winning the ISPE Facility Integration of the Year Award 2014 for its new contained manufacturing facility as well as being awarded three CMO Leadership Awards for Innovation, Productivity and Regulatory and going on to win the overall category winner for Innovation.

Medichem opens API Plant in Malta

The Spanish active pharmaceutical ingredient (API) firm’s new facility in Hal Far will make high potency drug actives for clinical assessment and commercial supply and is expected to be fully operational in the second half of the year.

Medichem CEO Ervin Veszprémi cited growing demand from generic drugmakers for HPAPIs adding that: “Our expansion to HPAI field will allow Medichem to offer a broader product portfolio to our customers.”

The firm also highlighted Malta’s patent laws as an important part of its decision to set up the facility, explaining that its “legal and intellectual property (IP) framework allows Medichem to offer first-to-market opportunities to its customers worldwide.”

Malta’s attraction as an API production hub is dependent on two factors: the small size of the market, which means that comparatively few drug patents have been registered in the country; and its broad interpretation of legislation covering research and development.

Fujifilm Diosynth Biotechnologies expands Capacity in UK

The firm – the pharmaceutical contracting arm of Japan’s Fujifilm – has installed a TAP ambr250 automated bioreactor system for microbial fermentations at its site in Billingham, UK.

Fujifilm already has experience using TAP’s technologies according to spokesman Mark Douglas, said that this coupled with the system’s automation capabilities were key to its bioreactor choice.

“For us, the TAP ambr250 was the leading platform - the nearest competitor is not automated and the use of disposable bioreactors, along with automation, in the ambr 250 makes this system very efficient and simple to set up and run. In addition, the bioreactor format of the ambr250 makes it inherently scalable.

Douglas added that: “We are very happy with the performance of the ambr15 in our mammalian development group - this was a factor in our decision to acquire the TAP ambr250.”

The system was developed by Sartorius Stedim Biotech's TAP Biosystems division, which has worked closely with Fujifilm during the installation Douglas continued.

“TAP has been great. They built the system on site and carried out SAT. They also provided detailed on-site training and were, and are, highly responsive to our questions and requests for support as we establish the system as part of our process development offering.”

The UK expansion is the first since October last year when Fujifilm installed an Xcellerex system at the facility.

Now, as then, the addition in new technology was not driven by the demands of any particular customer said Douglas.

“This is more driven by our desire to consolidate our position as a leader in process development and LPC studies. We are investing in systems that fit closely with our DoE driven approach to process design and application of HTS to increase efficiency - and speed. This is something we want to offer all customers.

He added that: “We are strongly committed to growth and, the investments we are making in leading edge technology need the best scientists and engineers for value to be realized - we are always on the look-out for good people.”

Fujifilm has also set up four new labs at its facility in Research Triangle Park in North Carolina, U.S.

Rentschler Expands Manufacturing Capacity

The Laupheim, Germany-based CMO (contract manufacturing organization) Rentschler Biotechnologie has invested €24m ($33m) to build a twin stainless steel bioreactor system.

The two 3,000 L stainless steel bioreactors will mainly target market supply at the company’s site in Laupheim, Germany, and are expected to be operational in early 2017.

The company defended its investment in stainless steel, as opposed to single-use, by noting that manufacturing in stainless steel “is far from being outdated,” especially for market supply and late clinical phases.

The twin-bioreactor system is designed for running two main bioreactors in parallel with one shared downstream processing unit to provide higher throughput while reducing labor costs. The system will integrate with the existing 3,000 L GMP line and will more than double the production capacities for cell culture-derived proteins at Rentschler.

What’s unique is that the twin system will allow the company to run cell culture processes in fed-batch mode with a high output in a single suite.

“The expansion will strengthen our global competitiveness and increase our market awareness of being a CMO partner of first choice all the way down from early clinical trials up to approval and market supply with a wide range of manufacturing technologies to offer,” said Frank Ternes, Chief Business Officer at Rentschler.

The expansion comes as the company doubled its capacity last month by adding a 2,000 L single-use bioreactor to its German facility, which it expects to go live in the first quarter of 2015.

In the last few years, Rentschler has been heavily investing in other single-use technologies, according to the company.

Telstar Develops High Containment Barrier Systems

Telstar has developed two high containment barrier systems for the Korean Komipharm Pharmaceutical, one of the largest producers of products from anti-cancer drugs in human oral dosage form to veterinary medicines in Asia.

The systems, one for API Sampling and the other for QC Sample Handling will be used in Komipharm's new facility, built in the South Korean city of Cheongwon, Chungcheongbuk-do.

The purpose of the systems is to provide a high level of containment to protect operators during the manufacturing process using APIs (active pharmaceutical ingredients). In addition, the systems will be used in research in the biotechnology field aimed to develop vaccines by genetic technology.

Specifically designed for handling hazardous products, these containment systems run at negative pressure to the surrounding room providing operator protection during the manual product handling process and environmental protection for the product by virtue of the standard ISO 7 classification inside the Isolator.

This project has been carried out by the Technology Centre for Barrier Isolation Systems of Telstar, located in Dewsbury (UK).

The two containment barrier systems developed by Telstar have been specially designed to handle APIs during pharmaceutical manufacturing and analytical testing of product containing raw arsenic. One of the Isolator systems is for API Sampling and the other for QC Sample Handling.

Both systems are based around the Telstar standard containment range to optimize cost efficiency, thus minimizing design and assembly hours. Because of the standard design, the routine maintenance and every day running procedures are simplified and more cost efficient. Additionally, many of the featured parts are common, versatile and inter-changeable, which enables the client to avoid the over stocking of spares.

The development of the isolator design took into account aesthetics, ease of cleaning and general maintenance together with operator safety / efficiency. Integration of internal equipment is made possible via simple glands and tri-clamp connections. The forethought of including a spare port provides provision for future add-on services and can also be used for DOP testing of filters during annual service.

The API Sampling Isolator includes single sided operator access to the main working chamber with mobile frame and onboard main control panel. Seimens PLC/HMI, materials transfer chamber for continuous batch processing, an integrated weigh system, integral Telstar glove tester, safe change HEPA filtration, contained transfer port, vacuum system and temperature/RH monitoring, are specifically attributed to this process Isolator.

The addition of double sided access within its main working chamber, graphic data management for critical data storage via a modbus link, sockets to power a density tester, friability tester, hardness tester, sieve shaker, moisture detection and PH meter, completes the main characteristics specifically attributed to the QC Sample Handling Isolator.

The barrier containment system supplied to Komipharm stands out by its simplicity regarding the base design and control system, coupled with optional accessory enhancement to offer flexibility and adaptation if required in the future. Ergonomically trialed base designs were employed ensuring suitability of the final design to the required operations. Whilst providing cost savings this approach ensures that a high containment solution with operator comfort of equal priority is achieved.

A close working relationship was key in surmounting differences with the client in regards to both time zones and culture. Regular communication and face to face meetings together with willingness to adapt: revising the project scope and accommodating new requirements were paramount to the success of the project. Establishing this close working relationship resulted in seamless incorporation of project changes and ensured any issues or concerns were quickly resolved without determent to the budget or equipment delivery.

This project has culminated in Telstar expanding its market base, of containment equipment using barrier containment technology into South Korea. Face to face meetings with Telstar was crucial in understanding our initial requirements together with special attention to particular details paramount in arriving at a fixed project scope, according to Kyung Seok, Kong, General Manager at Komipharm's new facility in Cheongwon, Chungcheongbuk-do.

Telstar, part of the azbil Group, is an international leader in the development of high-technology solutions for the pharmaceutical and biotechnology industries. Acknowledged as the only company able to develop and provide integrated process systems for the biopharmaceutical industry with in-house sterilization, freeze-drying, containment and clean air technologies, Telstar invests 3% of its turnover in research, development and innovation of its technologies and equipment

McIlvaine Company

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