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

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

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

Baxter Transitions Biopharma R&D to a New Hub in Cambridge

Baxter International plans to set up a new global R&D center in Cambridge, Mass, for Baxalta, its biopharmaceuticals spinoff, which is expected be formally incorporated next year and headquartered in northern Illinois.

The six-floor building at 650 E. Kendall Street in Cambridge is in the heart of the biotech district and near the Massachusetts Institute of Technology (MIT), said company spokesman Brian Kyhos.

Baxalta will be the primary tenant and will eventually occupy three and a half floors, according to Kyhos, and will lease approximately 200,000 square feet of space.

Work at the center will focus on advancing a pipeline focused on hematology and immunology drugs, as well as areas such as gene therapy and biosimilars.

“As we anticipate the spinoff as an independent biopharmaceutical company in 2015, we determined that creating a new R&D and innovation hub would enhance and accelerate our ability to deliver new treatments for patients,” Kyhos said.

“The biotech community around Cambridge includes more than 130 other biotech companies, 90 start-ups, 30 research and academic institutions and more than 14,000 biotech professionals who may be potential partners to help us advance our patient-centric platforms and leadership in clinical development, trials and testing for new and emerging therapeutics,” he added.

Approximately 400 employees will work at the center, including researchers from California and Europe as well as business development, oncology and biosimilars teams.

“Cambridge will be the new home for all of our human development programs and trials,” Kyhos continued, adding that “staff supporting early research and non-clinical activities, as well as our entire process development organization, will remain in Austria.”

Dr. John Orloff, vice president and global head of R&D for Baxter BioScience, predicted that the new center to increase R&D collaboration and efficiency.

“It will connect the company directly to a rich pool of talent in new and emerging biotech areas, and strengthen our ability to drive programs forward in cooperation with current and future partners," he said.

The company will soon start to transition work to the new facility.

“We will take over some temporary space within the next month, and implement a thoughtful and measured transition plan to fully occupy the building within the next two years,” added Kyhos.

Legacy Pharmaceutical Packaging Relocates to New Production Facility

Legacy Pharmaceutical Packaging, St. Louis, MO, a contract packager serving the global pharmaceutical industry with bottling, blistering, pouching, unit-of-use, compliance and secondary packaging services, has completed its move into a modernized 190,000-square-foot production facility. The new plant, which also will serve as the company’s headquarters, is more than twice the size of its previous facility, making room for a variety of additions and upgrades to Legacy’s production and customer servicing capabilities, including ten new packaging lines.

This spacious facility also contains a new Drug Enforcement Administration-approved Schedule II vault that can hold up to 300 pallets of product. The DEA vault fully meets federal regulation code 21CFR 1301.72, the governing specification for pharmaceutical applications. The plant has Verified-Accredited Wholesale Distributor status, which pertains to Legacy’s enhanced abilities to prevent potentially counterfeit drugs from entering the U.S. drug supply. To gain VAWD accreditation, wholesale distributors undergo a rigorous review of operating policies and procedures, licensure verification, surveys of facility and operations, background checks and screening.

Legacy’s new headquarters will also house a state-of-the-art 1,500-square-foot training facility which provides a dedicated area to train equipment operators and packaging specialists without interrupting day-to-day operations.

“The new facility exemplifies our commitment to anticipating and investing in our customers’ future needs,” said Brad Rayner, Executive Director of Sales & Marketing for Legacy Pharmaceutical Packaging. “This marks the largest infrastructure upgrade and expansion in Legacy’s history, leaving us well-positioned for further growth to both our client portfolio and overall service capabilities.”

Crown Bioscience Expands U.S. Translational Research Center

Crown Bioscience, Inc. will open its new U.S. Research Center at the David H. Murdock Research Institute (DHMRI) in Kannapolis, NC, in 3Q14.

The new center will combine Crown’s existing cardiovascular and metabolic disease (CVMD) services with a new U.S. expansion of Crown oncology services. The CVMD business features several in vivo models including a collection of spontaneously diabetic monkeys, along with the addition of oncology services providing access to Crown’s collection of immune-oncology models. These include: Western patient-derived xenografts in humanized mice, murine tumor models, GEMM and autografts of spontaneous mouse tumors (MuPrime™).

The Kannapolis site will also offer new immunology technologies, including flow cytometry and immunoassays, and will also be able to access unique mouse strains available in the U.S.

Dr. Jean-Pierre Wery, president of Crown Bioscience, said, “The opening of a new center at DHMRI marks an important milestone for Crown. In addition to increasing our capacity for running Western patient derived PDX studies and trials, it presents the opportunity to expand and develop our new immunotherapeutic translational technology platforms. Relevant preclinical models to recapitulate clinical treatments are desperately needed and the Research Center will provide partners with a range of immunotherapy research platforms for preclinical drug development, including platforms of mouse and human immunity.”

Ashland Opens Pharmaceutical Center of Excellence in Wilmington

The new facility in Wilmington, Delaware will focus on drug development and bioavailability enhancement, and expands Ashland's global network of pharmaceutical research and development centers. The facility also offers formulation and contract development for solid dispersions and oral solid-dosage forms. To support early stage proof-of concept-studies, capabilities include spray drying, hot-melt extrusion and potent-compound processing suites.

"A key commitment is to be close to our customers. One way of accomplishing this is by investing in leading-edge facilities and laboratories," said Luis Fernandez-Moreno, president, Ashland Specialty Ingredients. "These investments help drive growth by enabling us to deliver innovative solutions to customers and improve our competitive position. With this facility, we will provide our North American customers with unparalleled expertise and service in enhancing their pharmaceutical formulations."

"Research and development (R&D) dedicated to drug development and bioavailability enhancement is essential to the future success of the pharmaceutical manufacturing industry," said Jim Mish, group vice president, Consumer Specialties, Ashland Specialty Ingredients. "Emerging manufacturing processes, such as continuous manufacturing by spray drying or hot-melt extrusion, is one component of this equation. Excipients science is another. At our new center of excellence, we will be combining our expertise in process technology along with our knowledge in materials science to further support the quality, safety and efficiency of oral solid-dosage forms."

"The Ashland Pharmaceutical Specialties research and development team takes a customer-focused approach to R&D. Roughly 70 percent of our current R&D projects involve working directly with our customers on a collaborative basis," explained Tom Dürig, senior director, Global Pharmaceutical R&D, Consumer Specialties, Ashland Specialty Ingredients. "We provide customized training on product applications to our customers. Additionally, our team can provide technical assistance for specific requests from customers. Superior technical service forms an important part of our offering and this distinguishes Ashland from our competitors. The products we manufacture are supported by a global network of research and application scientists and technically trained salespeople."

The grand opening event in Wilmington was followed by an educational symposium featuring leaders in drug delivery and bioavailability-enhancement enabling technologies and a pharmaceutical equipment vendor showcase.

Ashland Specialty Ingredients offers comprehensive and innovative solutions for today's global pharmaceutical and nutraceutical industries. Having served these markets since the 1950s, Ashland offers an unparalleled excipient portfolio and a global R&D team focused on all of the major formulation trends. The opening of this pharmaceutical center of excellence in Wilmington is part of the company's commitment to serving this need and reinforcing its market leadership as a specialty chemical company.

This center of excellence expands Ashland's global network of R&D and technical support facilities dedicated to the advancement of consumer products. It is another major investment following the opening of a pharmaceutical center of excellence in Hyderabad, India, earlier this year and a personal care center of excellence in Mumbai, India, in 2012. Ashland Specialty Ingredients has 10 centers of excellence around the world.

DPT Acquires Meda Pharma's NJ Facilities

DPT Laboratories recently acquired Meda Pharmaceuticals’ Lakewood, NJ facilities, expanding its footprint in Lakewood with two buildings totalling 90,000 sq.-ft. of space. The acquisition provides additional cold storage and a larger analytical lab. DPT will also absorb Meda’s employees for the continued manufacture of MUSE, a urethral suppository product.

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

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

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

Argos Begins Construction on New Biomanufacturing Facility

Personalized immunotherapy developer Argos Therapeutics has broken ground on a new 100,000 square-foot biomanufacturing facility in Durham, North Carolina.

The facility is expected to create more than 230 jobs and will include proprietary equipment for the automated manufacturing of products via its Arcelis platform. AGS-003, the company's lead oncology product candidate, is currently being evaluated in a Phase III clinical trial for the treatment of metastatic renal cell carcinoma.

Randal Goller, Director of Facilities at Argos, said, “The Arcelis technology platform can be leveraged to manufacture personalized therapies for any cancer or infectious disease and integrates readily into current treatment paradigms.

“The proprietary technology uses RNA isolated from a patient disease sample to program dendritic cells, derived from the patient’s white blood cells, to target the entire disease-antigen repertoire. The activated, antigen-loaded dendritic cells are then formulated into the patient’s plasma and administered as an injection into the skin to produce the desired patient-specific immune response.”

The company said that this one facility could serve all of its expected patients in North America, and that because it’s automated, the company “avoids ramp up problems experienced by Denderon.”

And what’s unique about the manufacturing process is that it “does not require any bioreactors or any type of large stainless steel vessels,” Goller said. “The automated cGMP manufacturing facility will house approximately 40,000 square feet of cleanrooms.”

Argos received approximately $9.5m in incentives to build the facility from the State of North Carolina, Durham County, the city of Durham, and the North Carolina Biotechnology Center, for the development and implementation of the facility, which will support automated production of the company's Arcelis-based personalized immunotherapy product candidates for the treatment of cancer and infectious diseases.

As far as how the company plans to manage all of its new space, Goller told us that no contract manufacturing is anticipated at this time. The facility “will be a flexible modular design (multi-product/multi-function) to support manufacturing for 2,500 patients per year at commercial launch and scalable to 10,000 patients per year.”

“The Arcelis technology platform overcomes many of the manufacturing and commercialization challenges that have impeded other cancer immunotherapies,” he continued. “Automated processes will allow a single commercial facility to serve all of North America at a significantly reduced cost of goods and can be used to treat any cancer with the same manufacturing process and equipment.”

The Keith Corporation of Charlotte, N.C., will construct the facility.

Insight Genetics Doubled Laboratory Space

Insight Genetics has doubled its laboratory and office spaces in Nashville, Tenn., to more than 5,500 square feet. Eric Dahlhauser, chairman and CEO of the molecular diagnostics firm, said that the added space will allow Insight Genetics to grow and advance its companion diagnostics and clinical trials services and programs. He added that the company is growing its R&D operations, including those in next-generation sequencing, while enhancing its laboratory services and ramping up its test pipeline.

Weill Cornell Belfer Research Building, New York

The Weill Cornell Medical College at Cornell University opened a new translational research building in its premises in January 2014. The research building is named after Robert Belfer, a former American billionaire and a current member on the Weill Cornell Board of Overseers, who along with his wife donated $100m for the new research facility.

The Weill Cornell Belfer Research Building is situated near the ambulatory care building of the medical college on 69th street in New York City, USA. The new research building is an international hub accommodating global network of scientists and physicians engaged in translating medical research discoveries into therapeutic approaches for treating major infectious and chronic diseases.

The research building has 18 floors with a total floor space of 480,000ft2. It has 13 floors dedicated for clinical research. The total laboratory floor space in the building is about 455,000ft2. The building also has three floors dedicated for academic programmes and two floors for offices, conference rooms and classrooms.

The building accommodates translational bench-to-bedside medical research facilities targeting diseases such as cancer, cardiovascular disease, neurodegenerative diseases as well as Parkinson's and Alzheimer's, and other global health and infectious diseases.

It houses 16 programme areas, several well-equipped laboratories, and principal investigator office suites.

The new building has doubled the research space at the Weill Cornell medical college. It hosts more than 30 scientists from abroad, as well as provides additional research space for scientists and physicians from the Weill Cornell Medical College.

"The design of the research building incorporates open floor plans to facilitate communication and collaboration between scientists as well as encourage interdisciplinary research."

The design of the research building incorporates open floor plans to facilitate communication and collaboration between scientists as well as encourage interdisciplinary research. The building has a glass façade that provides the interior areas with natural sunlight.

The building was built as part of Weill Cornell's $1.3bn Discoveries that Make a Difference Campaign. The total cost of the project was $650m.

The project received more than 38 donations and gifts apart from the $100m donation from Robert Belfer and his wife Renée. The Chairman of the Weill Cornell Board of Overseers Sanford I Weill and his wife, Joan, contributed $135m for the construction of the research building, which was part of the historic $250m pledge made in 2007.

The Starr Foundation donated $75m, and Corinne and Hank Greenberg provided $25m for the project.

Ground breaking for the construction of the research building was held in 2009. The building was topped out in November 2011. It was in final stages of construction by the end of 2013.

The building construction employed Building Information Modelling (BIM) method. The environmental sustainability and energy efficiency features of the building make it a strong contender for Leadership in Energy and Environmental Design (LEED) silver certification.

Contractors involved with the design and construction of the research building

The research building design was provided by the New York-based architectural firm Ennead Architects. Tishman Construction was appointed as the construction manager.

The double curtain wall for the building was provided by Permasteelisa Group. The scope of the contract included providing 15,800m2 of curtain wall including single and double wall facades, sunshades, screen walls, zinc panel system, ribbon windows, skylights, and storefronts.

Rutgers University Chemistry and Chemical Biology Building

Construction of a new Chemistry and Chemical Biology (CCB) building began in June 2014 at the Rutgers University's Busch campus in New Jersey.

The new facility, expected to be opened for operations in Fall 2016, will expand research and science education at the university.

The CCB building construction is expected to be completed with an investment of $115m. The majority of the funding came through an $82m grant under the Building Our Future Bond Act 2012, which was passed by New Jersey State Legislature. The remaining $33m will be contributed by Rutgers University.

Located on the south campus of the University at Buffalo in New York, US, it houses the School of Pharmacy and Pharmaceutical Sciences of the university.

The CCB facility will be a four-storey building with a total floor space of 145,000ft². It is being constructed adjacent to the Wright-Rieman Chemistry complex. The first floor of the building will comprise of seminar, office and instructional space. The second, third and fourth floors will accommodate laboratories and related office spaces. Infrastructure and equipment will be located in the building's penthouse and basement levels.

The facility will have modern laboratory and specialty research core facilities that can enhance innovative research in drug design, alternative energy, biomaterials and nanotechnology. It will augment collaborative research as it features flexible labs, modern instructional space and a layout that facilitates the informal interaction and collaboration needs of a scientific community.

It will also have dedicated space for smart classrooms for high quality science education. The classrooms will be facilitated with sophisticated technology to support teaching and learning.

The CCB facility will be equipped with latest technology to enhance the research and provide the catalyst for extraordinary discovery. It will be equipped with transmission electron microscopy (TEM), scanning electron microscopy (SEM), atomic force microscopy (AFM) and helium ion microscopy (HIM).

It will include Class 100 chemistry clean rooms, as well as optical spectroscopy. It will also feature a nuclear magnetic resonance spectroscopy and X-ray crystallography laboratories.

The CCB building broke ground for construction in June 2014 and is slated to be completed before the end of 2016. The building was designed by Flad Architects. The general construction contract was awarded to Worth Construction.

Lend Lease Construction was contracted to provide project management and construction services, Langan Engineering was contracted to provide civil engineering services, and RG Vanderweil Engineers was awarded mechanical engineering services contract.

Concord Engineering, as commissioning agent, will provide Owner documented verification for the CCB building.

The new CCB building will be constructed to obtain Leadership in Energy and Environmental Design (LEED) Gold certification. The building will feature eco-friendly green designs such as windows to maximise natural light and manage heat gain, as well as advanced air handling and exhaust systems.

Construction materials such as steel, concrete and others used for the building will be largely made with recycled content. Native vegetation will be encouraged for biodiversity and to reduce the need for irrigation.

Clinical and Translational Research Building, University of Florida

The University of Florida started construction of a new clinical and translation research building at its Mowry Road, Gainesville campus in Florida in May 2011. The new facility was inaugurated in August 2013.

The facility serves as headquarters for clinical and translational science at the university. The project was sponsored by University of Florida (UF) and the NIH National Center for Research Resources.

The facility is a hub for expanding research network, which connects all 16 colleges within the Florida university campus as well as Shands HealthCare and the North Florida / South Georgia Veterans Health System.

The design for the new clinical and translational research building was provided by Perkins+Will architects. The facility was constructed on a 2.57 acre site located in the University of Florida campus.

The building has two wings, which are connected with a hub on the east side. It has a two storey glass-walled atrium-lobby at the centre. The building also features a garden.

The new clinical and translation research building has a total floor space of 120,000ft², which includes 40,000ft² ageing institute complex in the south wing, and 80,000ft² clinical and translational sciences institute in the north wing.

All the clinical research spaces are located in the ground floor. The administrative, support spaces and offices for staff and researchers are located respectively in second and third, fourth and fifth floors of the building.

The new facility has a clinical and translational science institute, Institute on Aging, UF clinical research centre and department of health outcomes and policy. It also has department of biomedical informatics, department of epidemiology, department of biostatistics and geriatric research.

The Institute on Aging is a one-stop facility that makes it easier for mobility-restricted older adults to take part in clinical trials and strengthen connections among existing UF research centres including the Claude D. Pepper Older Americans Independence Center, the CTSI and the Cognitive Aging and Memory Clinical Translational Research Program. It also includes a geriatric medicine multi-specialty clinic.

The facility also has an array of other research departments, as well as sophisticated conference, training and reception areas.

The new clinical and translational research building broke ground for construction in May 2011. The building was topped out in May 2012. It was opened in August 2013.

The building was designed by Perkins + Will architects. The building construction contract was awarded to Skanska. Mechanical and electrical engineering support was provided by Moses and Associates.

Other key contractors involved in the construction of the building were AEI, SEG, Siebein and Associates, Brame Architects, Williams-Scotsman and Brentwood Company.

The cost of construction of the building was about $45m. It was financed with $15m under the American Recovery and Reinvestment Act of 2009 by the NIH National Center for Research Resources. The University of Florida contributed $30m for the construction of the 80,000ft² facility.

The new building was constructed with environmentally sustainable features. It was aimed to achieve LEED platinum certification. The building has solar panels and systems. It uses rainwater for flushing toilets and irrigation. The designers increased the thickness of glass in the facility to keep out the noise of a power plant situated adjacent to the facility.

Wistar Institute’s Biomedical Research Facility Expansion, Philadelphia

The Wistar Institute is the first biomedical research institute in the US and Philadelphia's first NCI-designated cancer centre. It opened a newly expanded biomedical research building named Robert and Penny Fox tower in September 2014. The building is named in honour of Robert A Fox, a member of Wistar's Board of Trustees for 40 years and his wife Penny Fox, who raised more than $150,000 for the 'Building Wistar, Changing the World' campaign.

The Robert and Penny Fox tower is located on Spruce Street in the University City of Philadelphia. It connects the entire Wistar Institute's campus by linking the original facility built in 1894 and the newly renovated cancer research building, built in 1975.

Ground breaking for the construction of the research building was held in September 2011 and construction was completed in 2014.

It will focus on bringing therapeutic improvements through lower dose submicron non-steroidal anti-inflammatory drugs (NSAIDs).

The research building has seven floors with a total floor space of 89,700ft² and five floors are used exclusively for 15 laboratories. The floors are flexibly built with open floor plans, which can be easily configured to meet changing research needs. Each lab can accommodate up to four principal investigators and other staff, and is equipped with advanced apparatus and facilities.

Other state-of-art technologies include DNA sequencing and array technologies, imaging technologies, chemistry facilities, mass spectrometry and high power computational tools to conduct advanced research.

The expansion aimed to upgrade the old building with new, modernised infrastructure and to make space for new research laboratories for researchers to carry out collaborative research in cancer, genetics and vaccine development.

The project created 380 construction jobs and is expected to create 100 new research and administrative jobs at the Wistar Institute.

The expansion also included the construction of a new 22,000ft² vivarium, which is double the capacity of the previous one, with 7,000 cages.

A new public entrance has been created to the Wistar Institute on Spruce Street. A new 200-seat auditorium named Sarah and Matthew Caplan Auditorium was also constructed to host scientific symposia and public events.

Visitors to the auditorium pass through a new sun-lit atrium and the building hosts public spaces, enhancing the institute's accessibility to the community.

Other new facilities include tissue culture rooms, equipment alcoves, fume hood alcoves, and a shared cold room. High-efficiency, energy saving heating, cooling, electrical and data systems are incorporated in the building.

The total investment for the construction of the Robert and Penny Fox tower was approximately $100m. The Commonwealth of Pennsylvania funded an $18m grant under the Redevelopment Assistance Capital Program and a loan of $55m was provided by the Citizens Bank. The 'Building Wistar, Changing the World' campaign raised $35m towards the construction of the project.

The biomedical research building was designed by Ballinger, an architectural firm based in Philadelphia. The scope of work included providing master planning and conceptual design for the project. L F Driscoll was appointed as the construction manager.

PCI Opens North American Clinical Facility

PCI has announced the completion of a brand new North American Storage and Distribution facility for Clinical Trial materials. The 97,000 square foot purpose built site was constructed in support of the growth PCI has experienced in its Clinical Trial services business, which includes drug development and manufacturing, laboratory services, packaging and storage services, global logistics, as well as client supporting consultative services for executing global investigational studies. PCI features these services at facilities across North America and Europe, and distributes clinical trial supplies through a network of global depots to deliver IMP to investigational sites around the world.

PCI’s new state-of-the-art facility features expansive storage for investigational supplies at controlled room temperature, as well as expansions of its Cold Chain storage capacity including conditions at 2-8°C, -20°C, and -80°C. In addition, the facility is a DEA registered site for Schedule II – V Controlled Substances. Special consideration was given to management of returned investigational products, an essential service where PCI supports clients with meticulous management of investigational study materials returned from Clinical trial sites across the globe including preplanning, on-site processing at receipt, detailed reconciliation, multi-year storage, as well as certified destruction where designated. PCI has dedicated over 8,000 square feet of the new facility for this important regulatory segment of the business.

The opening of this facility highlights a significant ongoing investment by PCI in Clinical Trial services. In August 2014 PCI announced the acquisition of Penn Pharma, a leading provider of drug development and drug manufacturing services located in Tredegar, in the United Kingdom. Penn partners with clients in pre-clinical and clinical phases, as well as commercial manufacturing of drug product. Subsequent to that acquisition, PCI announced in September 2014 the acquisition of Biotec Services International, located in Bridgend, in the United Kingdom. Biotec is an emerging provider of Clinical Trial services with specialization in Controlled Temperature Management Services ranging from +25°C to -196°C. The addition of the two companies brings PCI’s global footprint to 16 facilities across North America and Europe, with over 2,900 highly trained associates.

Bob Misher, Senior Vice President of PCI Clinical Trial Services, noted “Clients trust PCI with lifesaving medicines. These ongoing investments in our Clinical trials business continue to allow us to grow our presence in this market and at the same time keep our focus on the significant importance of each package we prepare and each shipment of investigational study material we manage. These medicines are literally lifesaving for patients around the globe, and we appreciate the gravity of our responsibilities as well as the trust with which our clients have extended to us. It is an exciting time for PCI and we are very grateful for the opportunity to continue the growth we have experienced.”

Jackson Laboratory for Genomic Medicine Opens

The Jackson Laboratory for Genomic Medicine officially opened on the campus of the University of Connecticut Health Center. The center's research will focus on the genetic causes of diseases and the development of treatments and prevention. It has hired 150 employees to date and anticipates hiring 300 researchers, technicians, and support staff within a 10-year period. Plans for the 183,500-square-foot facility were first announced in late 2011 with a proposed total capital and research budget of around $1.1 billion over 20 years, including $291 million from the state to build, outfit, and operate the facility.

Aastrom Biosciences Moving from Ann Arbor, MI

Aastrom Biosciences, a longtime Ann Arbor biotech company, is moving its headquarters to the Boston area and changing its name.

Formed in 1989, the company went public in 1997 amid a flurry of investor interest in biotech.

The company raised more than $40 million in a stock sale in September.

The publicly traded company, which has been pursuing adult stem cell therapies and personalized medicine for a quarter of a century, plans to rename itself Vericel Corp. following its move to Cambridge, Mass.

The firm said that it would maintain its Ann Arbor manufacturing operations.

It was not immediately clear how many employees the move would affect. The company had 190 employees as of June 30, according to a Securities and Exchange Commission filing.

"The proposed name change and plan to move our headquarters to Cambridge are the next steps in the transformation of Aastrom from a clinical-stage company to a fully integrated, commercial-stage specialty biologics company," Aastrom CEO Nick Colangelo said in a statement.

Formed in 1989, the company went public in 1997 amid a flurry of investor interest in biotech companies.

The move comes less than a month after Aastrom raised $40.3 million by offering 15.7 million shares of its stock at a price of $2.55. The offering boosted the company's liquidity amid concerns about its cash flow.

"The new corporate name reflects our leading position in the cell therapy market, and our expanded presence in the vibrant Cambridge biotechnology community will increase our access to both talent and technology as we continue to grow our company, maximize the potential of our two U.S. marketed products ... and bring our late-stage product candidates ... to market," Colangelo said.

Texas A&M University Adding Mobile Cleanrooms

The Texas A&M University System has agreed to a non-exclusive license for XOMA Corp.'s design of a manufacturing facility. The technology relates to a flexible arrangement of mobile cleanrooms (MCRs) within the manufacturing facility with each MCR providing a portable, self-contained environment that allows for drug development. The A&M System will use MCRs for certain government programs at The National Center for Therapeutics Manufacturing facility, a multidisciplinary workforce education institution and biopharmaceutical manufacturing center, located at Texas A&M University in College Station, Texas.

"This announcement is the culmination of years of collaborative work begun when Texas A&M assembled a small group of world leading experts to solve the manufacturing challenges essential for biosecurity," says Dr. Brett Giroir, Executive Vice President and CEO of the Texas A&M Health Science Center. "This team included Dr. Patrick Scannon and other XOMA experts, who developed concepts that have now been uniquely implemented by Texas A&M through our pioneering biomanufacturing facilities, including the Texas A&M Center for Innovation sponsored by the U.S. Department of Health and Human Services. The MCR technology is an important component of our vaccine and medical countermeasure technologies that may be important for responses to Ebola and other emerging diseases."

"This license validates our flexible manufacturing design as it will be in practice initially at a well-known educational facility," says Patrick J. Scannon, MD, PhD, Founder and Chief Scientific Officer of XOMA. "Mobile cleanrooms have the potential to transform the industry because of their 'plug and play' design, which offers benefits of easy scalability and reduced clean-out and set-up times. In addition, they offer the potential to respond to possible threats in locales where pharmaceutical or biologic manufacturing facilities are otherwise not available."

The flexible manufacturing facility design allows MCRs to connect to a central supply of utilities such as air, water, and electricity. This arrangement facilitates flexible design and eliminates change-over downtime. When MCRs are not in use, they can be moved to cleaning/refurbishing areas and prepared MCRs can be "plugged in" for manufacturing.

CSL Behring Launches Capacity Expansion

CSL Behring announced a multi-year, $450 million two-site global capacity expansion. This expansion strengthens CSL Behring’s global manufacturing capabilities with production capacity increases of albumin at its Broadmeadows facility in Melbourne, Australia and plasma intermediates at its Kankakee site in Illinois, U.S. The company says the cross-functionality that is enabled by the capacity expansions will allow it to leverage its global manufacturing network, helping to optimize the manufacturing efficiencies of immunoglobulin and albumin. Of the $450 million investment, $240 million will be for Kankakee and $210 million for Broadmeadows.

“As a global science-based company with decades of experience and insight, we are uniquely positioned to serve patients with rare and serious diseases. Providing innovative treatments to save and extend lives is an important part of our patient care, including ensuring we have the capabilities and capacity to meet patients’ growing needs. Our latest production expansion means the critical base material for our leading therapies will continue to be available - enabling us to deliver on our promise to patients around the world,” said chief executive officer Paul Perreault.

At Broadmeadows, the new facility will become an integral part of CSL Behring’s global supply chain and expand its albumin manufacturing capacity. Albumin is a plasma expander that quickly makes up for blood loss in accident victims, and that is also used to treat burn patients. About 200 jobs will be created during construction in Broadmeadows, and 190 manufacturing jobs will be in place when the new facility is fully operational. The new facility will comprise two manufacturing modules. Construction of the first module will begin in the next several weeks and will take about four years to complete. Broadmeadows currently has 650 employees.

At Kankakee, the expansion will increase the production of plasma intermediates. CSL Behring uses plasma intermediates to make albumin and also immunoglobulins. The expansion is expected to be complete in 2017, at which time 300,000 square feet will have been added to the site.

CSL Behring is set to commence operations in its newly expanded 140,000 square foot facility, which also recently was approved by the US FDA.

The expansion will allow CSL to significantly increase plasma processing and albumin production capacity at the Kankakee, Illinois, facility. CSL said the expansion is necessary due to the growing demand for its immunoglobulins and albumin.

CSL’s EVP of Global Operations and Planning Mary Sontrop said that the intermediate paste produced in Kankakee is sent to CSL Behring’s other manufacturing facilities where it is used to make therapies for the treatment of immune deficiencies, bleeding and other medical disorders. Albumin is a plasma expander that quickly makes up for blood loss in accident victims, and that is also used to treat burn patients.

The new facility will use the same technology as CSL Behring’s manufacturing facility in Bern, Switzerland.

Sontrop added that the expansion in Kankakee is part of the company’s multi-site expansion plan, which includes the expansion of its manufacturing facilities in Broadmeadows, Australia; Bern, Switzerland; and Marburg, Germany.

“In today’s competitive market, we continually explore the latest technology that’s available, and evaluate how it can make our operations and physical plant more efficient to meet patients’ growing needs. Increasing Kankakee’s ability to fractionate plasma and produce albumin and intermediate paste is an important step for our global operations,” Sontrop said.

Nypro Expands Manufacturing Footprint in Massachusetts

Nypro, a Jabil company, has opened its new manufacturing plant in Devens, Mass.

The new facility will offer a full selection of Nypro Healthcare services—from product development, mold design and build, to injection molding and automated assembly—for single-use and electro-mechanical Class I, II and III healthcare devices. This additional operational space increases Nypro Healthcare’s clean-room space by 60 percent in Massachusetts. The company is headquartered in nearby town of Clinton.

The 200,000-square-foot facility features a state-of-the-art training area, metrology lab, a fully digitized machine shop, environmentally controlled chambers, and a 60,000-square-foot, Class 8 clean room. The facility will employ 50 professionals in the next 12 months and is projected to continue to expand, with the goal of adding another 50 positions within two years.

“The opening of the new Devens facility emphasizes Nypro’s commitment to its customers and community,” said John Witkowski, general manager, Nypro Healthcare, Clinton. “By delivering high-end, new product development technologies we help our customers produce advanced new devices. This expansion demonstrates Nypro Healthcare’s continued drive for growth and enhanced capabilities.

With this move, the Massachusetts-based company, whose demand had exceeded the capacity of its Clinton headquarters, according to company management, will be able to produce hundreds of thousands of additional medical devices daily, while maintaining the close connection to the technical resources in Clinton.

Through a network of 25 facilities, Nypro Healthcare also provides product development services, in addition to expertise in processing, tooling, packaging, quality engineering, procurement and supply chain management.

With 25 dedicated facilities in 11 countries and more than 8,000 employees worldwide, Nypro Healthcare is a business unit of Nypro, a Jabil Company, a global healthcare design and manufacturing services provider. Jabil is an electronic product solutions company, providing comprehensive electronics design, manufacturing and aftermarket product management services to global electronics and technology companies.

DPx Holdings to Acquire Gallus BioPharmaceuticals

DPx Holdings B.V., privately owned by JLL Partners and Royal DSM, is pleased to announce that it has reached a definitive agreement to acquire all shares of Gallus BioPharmaceuticals, LLC, a leading contract manufacturing company specializing in biologics and current portfolio company of Ridgemont Equity Partners. Following the transaction, Patheon’s biologic drug substance business, a unit of DPx Holdings, will span four facilities in Europe, Australia and North America and include 550 employees globally.

DPx Holdings is the parent company of Patheon, DSM Fine Chemicals and Banner Life Sciences. The Patheon pharma services business provides commercial manufacturing, pharmaceutical product development services for a full array of solid and sterile dosage forms, and biologic and chemical drug substance development and manufacturing. The addition of Gallus BioPharmaceuticals makes Patheon a leading provider of process development as well as clinical and commercial scale manufacturing of mammalian cell culture derived products. Patheon can offer its customers a broad array of disposable manufacturing technology, as well as commercial scale production, throughout its global network.

“We are pleased to expand our biologics business with the acquisition of Gallus BioPharmaceuticals,” says Jim Mullen, CEO of DPx Holdings. “This transaction is in line with our strategy. We can now further support the needs of our customers with biologics projects by providing flexibility, leading technology solutions, commercial operations and an expanded footprint with two U.S. sites.”

Once the transaction is complete the two Gallus sites in St. Louis, Mo. and Princeton, N.J. will be the first Patheon biologic drug substance sites in the U.S. and will complement the two existing sites in Groningen, the Netherlands and Brisbane, Australia. Three of the four global sites each have nearly three decades of mammalian cell culture experience, while the fourth site in Brisbane was opened within the last year and is considered a facility of the future for biologics. Together these sites will support Patheon’s ongoing growth in biologics and will continue to support the needs of Patheon’s customers in this growing segment of the industry. In addition, Patheon will be able to leverage its expertise in disposable technology to expedite manufacturing as well as expand its capabilities in mid-scale flexible manufacturing.

“This is an exciting time as we join a world-class company and expand our offerings as one global team specializing in biologics,” says Mark R. Bamforth, president and CEO, Gallus BioPharmaceuticals. “We have built deep commercial and clinical manufacturing and process development capabilities that are highly complementary to Patheon’s biologics organization. We look forward to the ongoing success and growth by combining our knowledge, skills, technical expertise and capabilities to serve customers’ product needs.”

Subject to receipt of regulatory approvals, the transaction is expected to close in the fourth quarter of 2014. Wells Fargo Securities served as lead financial advisor to Gallus, with William Blair & Company and Frontier Management, Inc. serving as co-advisors. Goodwin Procter LLP served as legal advisor to Gallus, the Gallus management team and Ridgemont Equity Partners. Skadden, Arps, Slate, Meagher & Flom LLP served as legal advisor to DPx Holdings.

PSC Investments Announces Acquisition from Morgridge Institute

PSC Investments, a subsidiary of California based PSC Biotech Corporation, is proud to announce the acquisition of a high potency sterile injectable facility from the Morgridge Institute for Research (MIR), a private research institute affiliated with the University of Wisconsin-Madison. The contract manufacturing operation will be named BioTechnique and will be a newly formed subsidiary of PSC Biotech.

The 37,000 square foot sterile injectable fill finish facility, located in Madison’s University Research Park was constructed in 2008 by Mentor Biologics, Inc. and later conveyed to MIR.

PSC Investments partnered with Steve Mixtacki, Chief Financial and Operating Officer of the Wisconsin Alumni Research Foundation (WARF), an affiliate of MIR, who said, "PSC has been a pleasure to work with, and we wish them much success at 5501 Research Park Boulevard”. Additionally, PSC Investments was very pleased with the outcome of the acquisition. “This was a great team effort from PSC Investments to help drive future growth potentials for PSC, and more importantly, help meet the high demand for cytotoxic and high potency fill-finish contract manufacturing services of sterile injectable products”, stated Raphi Hanessian, Managing Director of PSC Investments. The acquisition was financed with an SBA real estate loan from East West Bank in partnership with the CDC Small Business Finance team.

The recent acquisition of the pharmaceutical manufacturing facility will allow BioTechnique the opportunity to provide specialized filling services for cytotoxic, high potency, biologic, and other sterile injectable drugs. The injectable facility is state-of-the-art for filling and finishing high potency compounds and was designed to meet the highest safety levels for manufacturing personnel, as well as to minimize cross contamination, and be compliant with current Good Manufacturing Practices (cGMP) for sterile injectable manufacturing.

BioTechnique will be customer ready for sterile liquid and lyophilization fill-finish production in 2015.

When fully operational, BioTechnique is expected to employ over 100 technical professionals in Madison, Wisconsin.

UFP Technologies Opens New Cleanroom in Massachusetts

UFP Technologies Inc., a producer of custom-engineered components, products, and specialty packaging, has expanded its manufacturing operations in Georgetown, Mass., where the company is headquartered. The addition of a new cleanroom and high-volume production equipment broadens UFP Technologies' medical manufacturing capabilities, according to the company.

The new ISO Class 8 (100,000) certified cleanroom will house a custom-built, high-volume line to support the company's 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, company officials said. UFP Technologies now has a total of five clean environments in Massachusetts.

"Our customers rely on us to continually innovate our manufacturing technologies to meet stringent medical device requirements," said Mitch Rock, vice president of sales and marketing. "Investing in a new clean room facility and advanced manufacturing equipment allows us to be a valued partner to them."

UFP Technologies has seven manufacturing facilities throughout the United States that are ISO 13485:2003 certified and house multiple ISO Class 8 (Class 100,000) and ISO Class 7 (Class 10,000) clean-room facilities. The company also manufactures products for other industries, including aerospace and automotive.

Millstone Medical Outsourcing to Break Ground for Headquarters Expansion

Millstone Medical Outsourcing broke ground on July 28 for an expansion project that is slated to add 40,000 square feet to the company's headquarters in Fall River, Mass.

The expansion, expected to be complete in the first quarter of 2015, will add 8,000 square feet of Class 10,000 cleanroom to the facility, as well as multiple ultrasonic clean lines. Yielding a 200-250 percent increase in production capacity, the project will allow Millstone to "continue its growth and permit the organization to meet the increasing demands of its customers," according to company officials.

“We are thrilled about this expansion,” said Brad Schwarz, chief operating officer of Millstone Medical Outsourcing. “The influx of programs we have seen over the past few years is astonishing. Doubling our capacity and strengthening our partnerships, this expansion will provide us the additional space and capabilities required to meet more of our customer’s post-manufacturing needs.”

Millstone Medical Outsourcing is a provider of customized outsourcing solutions to the medical device industry—primarily in orthopaedics. The company offers advanced inspection, sterile and non-sterile packaging, loaner kit processing, and distribution services to device and product manufacturers worldwide. Privately held Millstone also has a facility just outside Memphis, TN, in Olive Branch, MS.

Medbio Adds to its Manufacturing Capacity

Officials at Medbio Inc., a medical device contract manufacturer based in Grand Rapids, Mich., say it's time for more room.

The company will be expanding its facility on southeast side of Grand Rapids.

“We are very excited to be expanding our facility," said John Woodhouse, director of sales and marketing. “We want to ensure we have the clean-room space for our projected growth."

The addition will be built by Pinnacle Construction and will not interrupt daily operations at Medbio, Woodhouse noted.

Medbio will add 20,000 square feet to the facility, including a 12,000 sq. ft. cleanroom for the assembly and packaging of medical devices.

“We will be moving assembly and packaging into the expansion, opening space for additional molding presses in the existing cleanroom,” said Woodhouse.

Medbio specializes in custom injection molding and assembly, and currently molds implantable, disposable, diagnostic and instrumentation components for the orthopaedic, cardiovascular, ophthalmology, neurology and biotechnology sectors.

RSSL Opens New Laboratory

Sectors RSSL (Reading Scientific Service Limited) has opened a new £1.5m pharmaceutical development laboratory, based in the University of Reading JJ Thompson building. The company says the 6,000 sq. ft. laboratory is further evidence of its significant growth in recent years.

The expansion will enable RSSL to increase its capacity and service offerings to the pharmaceutical, biopharmaceutical, healthcare, food and drinks sectors. The new laboratory follows the completion of a 10,000 sq. ft. extension in March 2012, the addition of 44 new jobs, and a program of laboratory refurbishments. It is expected to boost jobs in the local area, resulting in a further 20 roles across the whole business over the next three years. The positions will be at all levels from experienced PhD qualified scientists through to school leavers, who are given the opportunity to enter a career in science as a trainee scientist, which allows them to work across both food and pharmaceutical laboratories.

Alan Gundle, Managing Director of RSSL, said: ‘The new facility is part of a long-term development program to solidify Reading’s place at the heart of innovation and research in the UK and globally. ‘We are incredibly excited about the new laboratory and the breadth of expertise that will come from working across a range of disciplines and we appreciate the University of Reading’s positive approach to accommodating a growing scientific organization.

Renaissance RX Expanding Operations in New Orleans

Pharmacogenetic testing firm Renaissance RX is expanding its operations in New Orleans with an $8 million investment, the company and Louisiana Economic Development announced.

The expansion is expected to create at least 425 new direct jobs and 407 new indirect jobs in the greater New Orleans area. Renaissance, founded in 2012, currently has 80 employees in the region and more than 800 across the country.

The firm will consolidate its business into a 30,000-square-foot building.

Louisiana is providing the company an incentive package that includes a $925,000 performance-based grant to defray the costs related to the expansion of its headquarters and laboratory. The grant will be paid in five annual instalments of $185,000. Renaissance also will receive the workforce solutions of LED FastStart, a recruiting and training program, and is expected to participate in the state's Quality Jobs Program, which provides a cash rebate to companies that create well-paid jobs and promote economic development.

Renaissance RX uses gold-standard real-time PCR to provide pharmacogenetic testing, according to its website. It also has a toxicology business that uses liquid chromatography tandem mass spectrometry for quantitative urine drug testing.

REST OF WORLD

SGS Completes Glasgow Expansion

SGS Life Science Services has completed the expansion of its facility in Glasgow, UK, for the testing of cell banks for vaccines, gene and cell therapies, monoclonal antibodies and other recombinant protein based biological medicines. The new lab enhances capacity and capabilities for cell culture testing, adding 500 m² to SGS’ existing centre of excellence for viral safety, which now totals 1,124 m² (12,094 sq. ft.).

The lab employs approximately 45 scientific and quality personnel, and will offer a full range of validated bioanalytical methods to support the manufacturing, biopharmaceutical stability and lot release of drug product, including host cell protein, endotoxin, ELISA, western blotting and residual impurity testing.

The facility is equipped with Surface Plasmon Resonance (SPR) BiaCore T200 equipment to facilitate off the shelf and customized binding kinetics, and potency measurement of monoclonal antibodies and other recombinant protein-based biological medicines.

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

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

J&J Launches Asia Pac Innovation Center

Johnson & Johnson Innovation has opened its Asia Pacific Innovation Center in Shanghai, with satellites in Singapore, Australia and Japan. The Center will identify and develop promising early-stage opportunities across the company's three areas of focus: Pharmaceuticals, Medical Devices and Diagnostics and Consumer healthcare products.

"We are excited to launch the Asia Pacific Innovation Center which builds on the momentum of our Centers in London, California and Boston. Our goal is to collaborate with the best minds in the region to advance new technologies and deliver transformative solutions for the people of China and Asia Pacific at large, and throughout the world," said Paul Stoffels, MD, Johnson & Johnson chief scientific officer and worldwide chairman, Pharmaceuticals.

To date, the Innovation Centers have established more than 80 collaborations, including the following six new alliances in Australia and China.

A collaboration with James Cook University will explore new approaches in autoimmune disease. The research seeks to harness the ability of hookworms to regulate the human immune response for people with Crohn's disease and ulcerative colitis.

Janssen Australia and J&J Innovation have extended an existing collaboration with University of Queensland (UoQ) on a spider venom project to identify peptides as potential treatments for pain.

J&J Innovation has established a broad collaboration with China Pharmaceutical University on several projects across its consumer and pharmaceutical businesses. The projects include research around a novel antibody-drug conjugate to treat solid tumors as well as collaborations to explore new functional foods for improved health.

A collaboration with Peking University aims to identify agonists and antagonists for G protein-coupled receptors (GPCRs) to help develop novel CNS medicines.

A collaboration with Zhejiang University will explore the physiological and pathological role of human lactate receptor GPR81 in the regulation of metabolism and metabolic syndrome such as dyslipidemia, obesity, and diabetes.

Additionally, J&J has established a Partnering Office at BioBAY in Suzhou, an incubator with more than 400 companies in the areas of drug discovery, biotech, IVD, medical devices and nanotech. The office will serve as an extension of the Asia Pacific Innovation Center to work with academics and entrepreneurs on a more local basis.

SEPPIC Opens New Packaging Line

SEPPIC, a leader in the global market for vaccine adjuvants, has commenced operations at its new €6m production unit for vaccine adjuvants and injectables in Castres, France. The ultramodern facility puts it at the cutting edge of technology, SEPPIC says, adding that it is now the only company producing large quantities of sterile pharmaceutical excipients and packaging them in pouches with volumes as great as 200 L.

SEPPIC will eventually be offering sizes up to 1,000 L. SEPPIC meets pharmaceutical industry standards through its sterile manufacturing process and aseptic packaging line. Public health and access to uncontaminated foods are issues that will grow in importance over the coming years, it says, especially since the world population is expected to grow by 34%2 between now and 2050. As animals carry 60% of all human pathogens, animal health and veterinary vaccines will be critical to the protection of human populations. The facility at Castres will initially be producing animal vaccines — mainly offerings from the MONTANIDE range that target foot-and-mouth disease, avian influenza and Newcastle disease. 'We regularly invest in pharmaceutical operations at the Castres site. The new production unit allows us to expand our vaccine adjuvants business,' said Armelle Levieux , Chairman of the Management Board of SEPPIC. 'We are maintaining our lead by offering the pharmaceutical industry high-volume sterile packaging and a wider product range.'

Telstar Builds High Containment Lab for Medichem

Telstar has completed the construction and installation of a modular R+D laboratory and kilo lab at the Medichem production centre in Hal Far, Malta for the manufacture of Highly Potent Active Pharmaceutical Ingredients (HPAPIs). The facility consists of a production room and a laboratory, both under negative pressure relative to adjacent rooms and the exterior to ensure user protection.

Telstar carried out the project management of the facility under an EPC (Engineering, Procurement and Construction) arrangement. The architecture, HVAC system, distribution of utilities and services, the provision of heating and cooling water, and the inside furnishings were included in the scope of this project. Telstar undertook the construction engineering phases, which relied on direct client involvement, the purchasing of materials and the construction, which required continuous supervision of materials quality and workmanship to achieve approval and validation of the facility.

The modular laboratory is a single structure that comprises nine rooms grouped in four areas: a production area, which includes two 15-litre reactors, a filter dryer and a microniser; an R+D laboratory; a technical area (to house the air handling unit, hydraulic installation, electrical and control cabinets, vacuum system, etc.) and staff changing rooms for entry and exit. The modular approach enabled the entire system to be assembled and qualified in the Telstar manufacturing facility in Estonia The HPAPIs will be produced in a GMP environment and with containment levels of 40ng/m3. The modular approach enabled the entire system to be assembled and qualified in the Telstar manufacturing facility in Estonia. From the operational standpoint, this had advantages in terms of availability, control and access to construction materials and manpower without relying heavily on the supply capacity in Malta. It has also resulted in considerable cost savings as a consequence of the limited time staff spent travelling in addition to reducing implementation time on site.

The modular facility was installed, commissioned and validated in its final location at the Medichem premises in Malta within one month. Telstar says if conventional construction techniques had been used it would have taken six months to complete. Since the facility is modular, Medichem can modify it and even relocate it if required in the future.

The laboratory fulfils the high containment and maximum safety specifications required when operators handle highly active ingredients. For example, air extraction from the rooms uses Bag-In/Bag-Out (BIBO) safe change filters to eliminate the risk of cross-contamination and to protect the operator during filter changes. An emergency shower has also been provided at the exit, which the operator can use in the event of a hazardous spill. In addition, the kilo lab ATEX 3G classification for all the equipment in the room (including switches, push buttons, light fixture, power outlets, etc.) protects against explosions that are a risk when flammable solvents are being processed.

Finally, Telstar has included an innovative system for distributing breathable air. Breathable air connection points have been installed in all the rooms so that, in the event of an emergency, the operator has access to a safe supply of air stored in cylinders placed outside the module.

Medichem is an independently-owned API manufacturer, headquartered in Barcelona, Spain with more than 40 years of experience in this market. The company, which has two FDA inspected plants (Spain and Malta) and three R&D centres located in Spain, Malta and China, has more than 250 people working at various locations (Spain, Malta and China) and delivers products to more than 60 countries (US, the European Union and Japan, among others). Medichem has a sister company, Combino Pharm, which manufactures, develops and markets generic pharmaceutical products. Both companies also offer contract manufacturing services (API and FDF).

IDT Biologika Completes Biologics and Vaccines Facility

IDT Biologika has completed construction of a large-scale production facility in Dessau, Germany dedicated to filling and lyophilization of biologics and vaccine products. The facility utilizes a sterile liquid filling line engineered to handle as many as 24,000 vials per hour. The facility was designed and commissioned to be used for a range of advanced biomedical technologies required in medium to large clinical stage and commercial stage volumes and is certified to biosafety levels (BSL) 1 and 2 for live vaccines.

Specialized manufacturing capabilities include drug substance and drug product services for live recombinant and non-recombinant vaccines and, in separate units, fill-and-finish capabilities for other biologics and small molecule drugs including cytotoxics. All products produced in the facility can be manufactured in the form of liquid or freeze-dried (lyophilized) presentations.

Also, an automated loading and unloading freeze-dryer system now in place for live recombinant and non-recombinant products along with a freezer-dryer shelf capacity of 40m², equal to at maximum 178,000 vials per batch.

“Expanding our capabilities within a further multipurpose facility, IDT Biologika now offers one of the most dynamic facilities designed for biomedical products manufacture,” said Dr. Ralf Pfirmann, chief executive officer. “With the completion of this facility, we are equipped to manufacture up to 100 million vials per year of freeze-dried and liquid presentations. Our capacity planning and facility designs appear to be on target, as we gear up to accommodate the development, testing and manufacture of vital vaccines and other biological products for our partners in the biopharmaceutical industries.”

CSL Behring Plans Expansion of Illinois, Australia Sites

CSL Behring said it will spend $450 million over several years to expand its global manufacturing capacity at two sites—one each in the U.S. and Australia.

The company said it will carry out a $240 million increase in its production capacity for plasma intermediates manufactured at its Kankakee, IL, site, as well as a $210 million albumin capacity increase for its Broadmeadows facility in Melbourne.

Plasma intermediates made in Kankakee are used in making albumin and also immunoglobulins. The expansion is expected to be completed in 2017, at which time 300,000 square feet will have been added to the site.

The expansion follows FDA approval to start operations from a previous expansion of Kankakee's manufacturing operation that added 140,000 square feet to the facility.

CSL Behring also plans to start construction “in the next several weeks” on the first of two planned new manufacturing modules to be built at Broadmeadows over the next four years.

About 200 jobs will be created during construction in Broadmeadows, and 190 highly skilled manufacturing jobs will be in place when the new facility is fully operational. Broadmeadows currently has 650 employees.

“Our latest production expansion means the critical base material for our leading therapies will continue to be available—enabling us to deliver on our promise to patients around the world," CEO Paul Perreault said in a statement.

Kankakee and Broadmeadows are two of four sites where CSL Behring produces plasma and plasma intermediates. The other two facilities are in Bern, Switzerland, and Marburg, Germany. Earlier this year, CSL Behring said it intended to build a leading-edge recombinant production site in Lengnau, Switzerland where the company plans to produce proteins to treat immune deficiency diseases.

Lilly to Close One of Three Manufacturing Operations in Puerto Rico

Eli Lilly announced plans to conclude production and pursue a sale of one of its three manufacturing plants in Puerto Rico. The manufacturing site, located in Guayama, Puerto Rico, will remain in operation until the end of 2015. All of the approximately 100 full-time non-contracted employees currently working in Guayama will be offered employment at Lilly's Carolina (Puerto Rico) location.

"The decision to conclude operations at Guayama is based upon the evolution of the company's pipeline, which includes a growing insulin and biologics portfolio, coupled with a less capacity-intensive small molecule portfolio," said Paul Ahern, Ph.D., senior vice president of Global Active Pharmaceutical Ingredient and Dry Products Manufacturing. "The utilization of the site has been impacted by patent expirations on the medicines produced there. As we assessed our long-term capacity needs, the company made the business decision to conclude manufacturing at the site."

"Our employees at Guayama have demonstrated strong, sustained performance throughout the years and have produced lifesaving medicines for patients around the world," said Maria Crowe, president for Lilly's Global Manufacturing Operations. "For nearly 50 years, Puerto Rico has served as a major manufacturing location for Lilly, and it will remain so in the future. We have talented and experienced colleagues in Puerto Rico, and we are pleased to be able to maintain employment opportunities for the Lilly employees affected by this decision."

As a result of this action, the company expects to record a charge of approximately $170 million (pre-tax) or approximately $0.16 per share (after tax) in the fourth-quarter of 2014.

While Lilly will initiate efforts to sell the Guayama site, the company will continue to invest in two manufacturing plants at Carolina. In November 2013, Lilly announced a $200 million investment to increase capacity in its Carolina-based insulin active ingredient manufacturing plant. In July 2014, Lilly announced an additional $40 million in investments to increase capabilities at its Carolina-based drug product site as part of a rebalancing of Lilly's oral solid dosage network.

Lilly began manufacturing operations in Puerto Rico in 1965 and employs approximately 1,600 employees on the island.

WuXi PharmaTech Acquires XenoBiotic Labs

WuXi PharmaTech Inc. has acquired XenoBiotic Laboratories, Inc., a provider of bioanalytical, drug metabolism, and pharmacokinetic services to the pharmaceutical, animal health, and agrochemical industries. Financial terms were not disclosed.

The acquisition expands WuXi's Lab Testing Division in bioanalytical and DMPK/ADME services, specifically for radio-labeled compounds, expands LTD's presence in North America, and provides access to new agricultural and animal health customers.

XBL has 150 employees and operates a 45,000-sq.-ft. research center in Plainsboro, NJ, and a 36,000-sq.-ft. facility in Nanjing, China. The company is FDA- and USDA-registered, New Jersey-licensed for work with radioisotopes, USDEA-licensed for conducting research with Schedule 1-5 controlled substances, and AAALAC-accredited.

"My colleagues and I are very excited to join WuXi, a global leader in providing drug discovery and development services to the global biopharmaceutical industry," said Dr. Jinn Wu, president and chief executive officer of XBL, who has been appointed vice president and chief scientific officer of LTD. "We will continue to provide our services to our current clients while also offering expanded services to WuXi's clients."

"We are very pleased to have XBL join the WuXi team," said Dr. Ge Li, chairman and chief executive officer of WuXi. "Dr. Wu has spent the past 27 years building a solid organization and reputation within the industry. This business combination is an important step in WuXi's development of a comprehensive, integrated platform of R&D services to help our customers discover and develop drugs more efficiently and cost-effectively."

West Expands Global Manufacturing Ops

West Pharmaceutical Services, Inc. is expanding its global manufacturing operations with a new site in Waterford, Ireland that will produce packaging components for insulin injector cartridges and other packaging components. Once operational, the new site could add as many as 150 new jobs and will also support future expansions.

Construction is planned to begin in early 2015 on the 44-acre site, which will be a center of excellence for West's elastomeric sheeting used to package insulin for use in pen injectors. Future plans include additional manufacturing space for the company's injectable component product lines for injectable and dosage forms. With these expansions, the plant can accommodate between 250 to 300 jobs and an investment of approximately €100 million.

"With diabetes emerging as one of the fastest growing diseases globally, our pharmaceutical customers are expanding their production lines for injectable insulin. To meet this growing demand, we are announcing an expansion today that will help us address this need and continue to serve this critical patient population," said Donald E. Morel, Jr., West's chairman and chief executive officer. "In the future, we intend for this site to be a center of excellence for advanced packaging components to meet the needs of our customer base for a range of sophisticated injectable therapies."

SGS to Open New Lab in France

SGS Life Science Services is opening a new 2,000-m2 (21,520 sq. ft.) facility in Villeneuve la Garenne, France, replacing an existing lab in Clichy, and increasing Quality Control service throughput and support for R&D. The new lab will be completed in 2Q15.

The services currently offered at Clichy, including analytical chemistry, microbiological analysis, stability studies and method development services, will be transferred to the new site, along with additional services for biopharmaceutical analysis, including amino acid analysis and mycoplasma testing. The company is also investing in contained hoods to safely handle biologics, as well as walk-in stability testing chambers for small molecules. The site will be accredited to comply with cGMP regulations.

“This investment is a significant step for SGS and its positioning within France, one of the three largest bio/pharmaceutical markets in Europe,” said Paul Beyou, director of Life Science Services, Clichy, “We see the site as being an important strategic tool to keep in step with the small molecule quality control market and begin to address the biologics pipeline within the country, underlining SGS’s ability to evolve along with the needs of our customers.”

Boehringer Ingelheim to Expand Manufacturing in Germany

Boehringer Ingelheim is investing more than €100m ($126m) at its Dortmund, Germany site to expand production capacity for its Respimat inhaler, which is the third time in the past four years that the company has made a capacity-expanding investment at the site.

The added capacity will allow the company to produce 44m units of the inhaler per year, and will create approximately 100 new jobs on the site where Boehringer manufactures the inhaler.

In July, the US FDA approved Striverdi Respimat (olodaterol) inhalation spray to treat patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema that are experiencing airflow obstruction.

Boehringer previously expanded capacity at the Dortmund facility in 2012, when it invested €85m to expand the plant and added another 100 jobs. That additional funding went to new cleanrooms and production equipment.

In 2010, the company invested another €70m to expand production capacity citing high demand for the inhaler.

“The Respimat is a success story – for Boehringer Ingelheim and for the patients,” said Wolfgang Baiker, member of the Board of Managing Directors at Boehringer Ingelheim responsible for Operations. “We want to continue this success story. The Respimat inhaler will also in future be the inhalation device for applying our respiratory medications.”

Boehringer Ingelheim acquired the plant when it bought microtechnology company STEAG microParts GmbH in September 2004 and integrated it into Boehringer. There are now more than 550 employees working at the Dortmund facility.

In addition to the €100m expansion, Boehringer Ingelheim is investing €72m at the company headquarters in Ingelheim, Germany, where the inhalers are filled with the relevant API and then distributed worldwide. In May 2013, the API site was hit with an FDA warning letter for particles and cGMP violations.

Herzog & de Meuron Unveils Basel Campus for Roche Healthcare

Herzog & de Meuron has revealed its plans to redevelop the Basel campus of Swiss pharmaceuticals company Roche, adding a 205-metre-high tower and a research centre.

Construction is already underway on the first new building for the Roche campus – the corporate headquarters of the research-focused healthcare company. Herzog & de Meuron's redesign will create modern and sustainable office and laboratory facilities.

The first building, which staff will begin moving into in 2015, will comprise four blocks, ranging between 16 and 132 metres in height. It will contain 950 office and 950 laboratory workstations.

With approximately 50 storeys, a 205-metre-tall office tower will accommodate 1,700 employees and will be ready for occupation by 2021.

"With the Roche area development plan, we see a basic principle of our work realised, and that is densification," said a statement from Herzog & de Meuron, whose recently completed projects include a biologically filtered bathing lake and a Brazilian gymnasium.

"This is relevant for the entirety of Basel, even for all of Switzerland, as well as for the current national discourse regarding urban sprawl," added the Swiss firm.

The development will also include the two-year renovation of a historic office building designed by Swiss architect Otto R Salvisber in 1937, involving the preservation of its original facade.

Herzog & de Meuron will overhaul the site infrastructure and landscaping – adding a logistics centre focused on sustainable energy consumption, upgrading existing buildings, replacing the old underground car park, and integrating use of public transport and bicycles.

"The planned consolidation of the existing industrial site will eliminate the need to build over green zones," said Jürg Erismann, head of Roche's Basel and Kaiseraugst operations.

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

"Sustainability is a top priority for all our construction projects," he added.

"For instance, assuming a comparable number of workplaces, the energy used in Building 1 will be only one fifth of the amount consumed in 40-year-old Building 74, which is due to be replaced as part of the site development project."

The investment is planned for the next ten years, as the office and laboratory buildings on the site will not meet current day requirements, said Roche.

Roche CEO Severin Schwan said: "Roche is committed long-term to Switzerland and to Basel in its dual role as corporate headquarters and one of our most important sites worldwide.

"The entire value chain is represented in Basel. Employees from all parts of the company are making a vital contribution to Roche's innovative strength, and we want to provide them with an attractive work environment."

Roche intends to invest CHF700m ($734m) to upgrade existing buildings and for the infrastructure, including a logistics centre for energy consumption, safety, good manufacturing practice (GMP) guidelines and other requirements.

Roche Basel and Kaiseraugst site head Jürg Erismann said: "The planned consolidation of the existing industrial site will eliminate the need to build over green zones."

Myriad Opens Analysis Lab in Europe

Myriad Genetics announced that it has established a European laboratory that will offer its Tumor BRACAnalysis CDx test to guide treatment with PARP inhibitors, namely AstraZeneca's olaparib.

According to Myriad, testing will be conducted in the company's lab in Munich, Germany and will be widely available throughout Europe.

Myriad announced the establishment of its European lab on the heels of an announcement this morning by the European Medicines Agency's Committee for Medicinal Products for Human Use, which recommended marketing authorization for olaparib as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer.

According to Myriad, an estimated 22 percent of all ovarian cancer patients carry a deleterious germline or somatic BRCA mutation and thus may benefit from olaparib therapy.

"BRCA mutation screening is critical in ovarian cancer patients to identify the subset of women who might benefit from PARP inhibitors," Colin Hayward, Myriad's European medical director, said in a statement. "Tumor BRACAnalysis CDx testing is the best method for screening ovarian cancer patients because it detects both germline and somatic mutations, significantly increasing the total number of patients who may benefit from this life-saving drug."

At the European Society for Medical Oncology's annual meeting in Madrid, Spain last month, researchers from Myriad and MD Anderson Cancer Center described a study comparing germline BRCA mutation testing against the more comprehensive Tumor BRACAnalysis CDx, which revealed that the latter was able to pick up 44 percent more deleterious markers in women with ovarian cancer.

In addition to olaparib, Myriad is also studying BRACAnalysis as a companion diagnostic with other drug developers in 13 Phase III studies covering six different indications.

Myriad hasn't provided a timeline for when it plans to launch the test in the US, but has said it intends to launch in line with olaparib's approval by the US Food and Drug Administration. The company submitted its first premarket approval module with the FDA for BRACAnalysis as a companion diagnostic for olaparib in April.

West Pharmaceutical Services Packaging Plant, Sri City, Andhra Pradesh, India

West Pharmaceutical India Packaging opened a new manufacturing plant at the special economic zone (SEZ) in Sri City, an integrated business area, in India. It is situated in the state of Andhra Pradesh, near the border of the neighboring state Tamil Nadu. The inaugural ceremony of the plant was held in July 2014.

The manufacturing unit is a part of West Pharmaceuticals' global supply chain, and produces seals used for the primary packaging of the company's injectable drug products. The unit is expected to create more than 250 jobs.

West Pharmaceuticals signed a 99 year lease on a 72,800m² (783,328 sq. ft.) site in the special economic zone (SEZ) of Sri City in June 2012. The ground breaking ceremony marked the beginning of construction of the new compression moulding facility and was held in August 2012.

The plant is located at Kodambakkam near Chennai, on the eastern side of India.

Phase 1 included construction of metal seal assembly and compression moulding facility which produces metal and elastomeric pharmaceutical components for primary packaging of medicines. The facility has a built-up area of 15,300m² (164,628 sq. ft.) and the initial production of the plant's metal components began in the first quarter of 2014.

The packaging components facility is expected to produce high-quality standard elastomeric components by the first quarter of 2015 and will be equipped to produce ready-to-sterilise components by 2016. Construction of phase 3 is expected to be finished by 2023 and will expand the built-up area of the plant and the office to 37,700m² (405,652 sq. ft.).

Manufacturing facility of injectable drug and medicine products

The manufacturing unit produces seals used for the primary packaging of injectable drug products produced by biopharmaceutical companies in India and Asia Pacific region, as well as for the injectable medicines produced by West Pharmaceuticals. The unit also produces metal and elastomeric packaging components for injectable medicines. It will also produce ready-to-sterile components in future.

West Pharmaceutical Services built the new Indian pharmaceutical packaging components plant as part of its growth and business expansion plans in Asia.

India is witnessing entry of growing number of pharmaceutical companies as the market is growing and dynamic. The new plant is expected to help West Pharmaceutical meet demand in India and also establish a firm presence in the country's market.

The new plant in Sri City is West Pharmaceutical's first unit in India. It has been built for reducing the lead times of supply to the customers in India and also to reduce the overall production costs. Sri City has been selected due to the availability of the land, utilities, labour, and logistics and also because of the SEZ benefits.

West Pharmaceutical Services designs and manufactures packaging and delivery components for parenterally administered medicines such as injections. It supplies products to biopharmaceutical, pharmaceutical and medical device companies across the world.

West Pharmaceutical has already established its presence in Asia Pacific with one plant in Singapore, two plants in China and sales offices across a number of Asian countries including Singapore, China, India and Australia.

The inauguration ceremony of West Pharmaceutical Services’ manufacturing unit in Sri City, India, was held in July 2014.

Scion Laboratory Renovation, Rotorua, New Zealand

This project presents an architectural response for a leading research organization that was seeking to enhance their research capability. It involves the renovation of an existing research and analytical testing lab for Scion, a forestry research facility in Rotorua, New Zealand.

The previous lab building comprised a series of small individual working spaces and made for inefficient workflows, a lack of flexibility and didn’t comply with current lab design standards or regulations. A central corridor which the laboratories opened onto was a major circulation route which connected different parts of the campus and posed a safety risk as there was no separation between lab and non-lab activities. This layout supported an individualized and self-directed research approach which was no longer desired by the organization.

The architectural response took inspiration from the new developments that the organization was undertaking. It sought to provide a new context for lab research from within the existing fabric of the facility which enabled the collaborative approach that was being sought.

The result is a research facility that has been transformed from a lab containing numerous small individual rooms into open-plan spaces, which support collaborative research practices previously difficult to achieve. Contemporary standards of laboratory design have been introduced within a context of organizational sustainability.

Waters and Chinese Pharmacopeia to Establish Joint Open Laboratory

Waters Corporation (Milford, Massachusetts) entered into an agreement with the Chinese Pharmacopoeia Commission (ChP) to establish a joint open laboratory. Scheduled to open before the end of 2014, the laboratory will focus on in-depth research of pharmacopoeia standards, development of testing methods, method validation, 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 Chinese pharmaceutical standards.

The Joint Open Laboratory will be located in the laboratory building of Beijing Zhendong Guangming Drug Research Institute (Beijing, China) and will be more than 1300 square feet in size. It will be outfitted with Waters’ chromatography and mass spectrometry systems, including, but not limited to, a range of Acquity UPLC systems, Acquity UPC2 systems, Xevo tandem quadrupole and time-of-flight mass spectrometers, and a natural products application solution with UNIFI software.

Sterigenics International Expansion in U.S. and Europe

Sterigenics International, an outsourced contract sterilisation 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. Sterilisation 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 sterilisation of medical products, validation capabilities and SteriPro lab services.

Petit-Rechain, Belgium is one of Sterigenics largest locations, offering ethylene oxide sterilisation, 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 sterilisation services, primarily to the medical device, pharmaceutical, food safety and high performance/specialist materials industries.

Rhythmlink International Expands with New Cleanroom

A US$1.4m investment at US medical device manufacturer Rhythmlink will include a world class automated packaging line in a new 1,500ft2 ISO 8 Certified, Class 100,000 cleanroom. The new facility is expected to create an additional 50 new jobs over the next five years.

When Rhythmlink was founded 12 years ago, it started out manufacturing its medical devices at a facility in China. Now the company is expanding its design and distribution headquarters in South Carolina to include manufacturing. With growing labour and cost of living increases in China, it is the right time to move production to the US, and Rhythmlink product made in the USA will be available for sale in mid to late 2015. 'As Rhythmlink continues to grow, we keep looking for ways to stay competitive,' said Michael O’Leary, chief operating officer. 'After careful analysis, it made sense to take some of our production processes out of our facility in China and move them closer to home.' Automation is integral to bringing overseas manufacturing to Columbia and to meeting growing demand; it will allow Rhythmlink better quality control, customer service and improved ability to bring products to market faster. This project will reduce costs and allow the company to compete in existing markets and enter new markets more quickly. Rhythmlink International is a medical device manufacturing company specialising in devices that help connect patients to machines to record or elicit physiologic information. It also offers custom packaging, custom products, private labelling and contract manufacturing services.

Escatec Doubles ISO Class 7 Cleanroom

The new Future Lab for MOEMS production Escatec has nearly doubled the size of its ISO Class 7 cleanroom to meet increasing demand for miniaturised, multi-function components and ‘smart materials/systems’. The Switzerland-headquartered provider of contract and manufacturing services is also increasing staff numbers to accommodate the expansion. The company has added new equipment for material preparation, components creation and assemblies and a new 'Future Lab’ will offer advanced state-of-the-art R&D, custom designs, specialized prototyping, and novel process development to provide leading-edge LED solutions.

A dedicated workspace next to the cleanroom has also been added for 'hands-on' design work with Escatec's partners. Wolfgang Plank, Director of the MOEMS department at Escatec, said: 'SSL is the main light source in every new microelectronic device, with the market offering many different products. However, highly-integrated, ultra-miniature, high-power, specific colour/radiation LEDs for special uses are hard to source because the volumes are just not there compared with standard products.

As a specialist in pioneering the use of LEDs, Escatec has built up an extensive, reliable sourcing network for base materials, from dies to custom glues and from silicones to special semiconductors to create modules and assemblies. This enables us to offer customers almost limitless possibilities for custom solutions to suit most requirements, volumes, and price points. 'Doubling our Class 7 cleanroom will enable us to bring in the latest equipment to provide a world class MOEMS service for an increasing number of customers.'

Tergus Grows Manufacturing Capabilitie

Tergus has acquired cutting-edge equipment that will aid in manufacturing topical pharmaceutical supplies for clinical trials. The company, currently working from a state-of-the-art facility at Research Triangle Park area of Durham, North Carolina, delivers topical pharmaceutical formulation, analytical R&D, IVRT testing and manufacturing. Tergus has a stellar, 18-year track record of successfully providing comprehensive services as well as regulatory guidance, documentation and support.

“We are excited to be furthering the functionality of our cGMP clinical supplies manufacturing operation,” said Vijendra Nalamothu, PhD, CEO and co-founder of Tergus. “Our clients are our objective; this new equipment will ensure that our clients are getting the best we can provide through the entire process of research, development, analysis, testing and manufacturing. The goal is to deliver clinical supplies on a fast track to meet client’s clinical study requirement and tight timelines.”

The new machinery includes four different turboemulsifiers, ranging from 2 kg to 150kg capacity, a microfluidizer processor and several packaging equipment pieces. This top-of-the-line equipment will enhance the company’s manufacturing as well as deliver the most positive outcomes. From mixing stable creams and emulsions to achieving uniform particle size reduction to package the product in multiple configurations, these machines will guarantee accuracy and efficacy in producing supplies for clinical trials.

Tergus offers topical pharmaceutical formulation, analytics, In Vitro Release Testing (IVRT), skin biology and clinical supplies manufacturing GMP laboratories. The company also has several banks of IVRT and skin penetration cells and advanced clean-room environments Tergus Pharma’s services range from formulation through testing and manufacturing. The company leads the pack in topical pharmaceutical services.

Sanofi Sets Up R&D Hub in Booming Shanghai

French pharma giant Sanofi has opened a major new R&D center in Shanghai with plans to employ 1,400 staffers while bringing together the drug development work being done in a dozen different Pacific Rim countries. Sanofi's fifth big R&D hub will integrate work being done on biopharmaceuticals, rare diseases, vaccines and animal health. And highlighting the center's new role as a central dealmaking spot, Sanofi also put out the word on two new research partnerships that will be coordinated in Shanghai.

Sanofi says it will now work with the GPCR Institute on new diabetes "breakthroughs" while collaborating with ZAI Lab on respiratory ailments.

The move underscores Shanghai's emergence as a global crossroad in the research and development of new drugs. It's home to a number of big R&D operations which represent pharma's ongoing effort to build a big presence for themselves in the booming Chinese market. J&J ($JNJ) has been putting together the last of its global deal-making teams in Shanghai, while Merck ($MRK) has promised to follow suit as well.

Even after GlaxoSmithKline ($GSK) was hammered by allegations of widespread corruption, the multinationals haven't stepped back from China. Sanofi's move here indicates that there's still room for growth as China helps foster the first generation of biotechs to take root in the country. And it also highlights Sanofi's preference for doing R&D outside of its home base in France, where company officials have been frustrated by low productivity and a backlash from unions as well as government officials to their plans to trim the research staff in France. Sanofi also has a major R&D hub in Boston, which has been growing steadily.

"Integrating all our R&D activities in the region, the Asia Pacific hub will operate as one to accelerate the introduction of innovative solutions to the region while driving Sanofi's global efforts to improve health across the world," says Frank Jiang, head of the new R&D center, in a statement. "We are excited to enhance our ability to capture opportunities from this dynamic region with greater flexibility to respond to changing needs."

Monsanto Launches Mexico Center for Developing GMO Corn

Global seed technology giant Monsanto said it has launched a global center in Mexico for developing new hybrid and genetically modified strains of corn, part of the company's push to boost output of the planet's most widely produced grain.

The center, based in Tlajomulco de Zuniga on the southern fringe of the western city of Guadalajara, will be used to centralize development of Monsanto's corn seed research, mainly for the U.S. market, the company said.

"The aim is to create new varieties tolerant to diseases and the stresses that affect maize cultivation all over the world due to growing negative conditions caused by global climate change," the company said in a statement.

A Monsanto official did not immediately respond to a request to detail how the project is related to the company's existing efforts to expand beyond pilot plantings of genetically modified corn in Mexico, or how much it is spending on the new center.

Scientists say modern corn comes from teosinte, a tiny wild grain native to southern Mexico.

U.S.-based Monsanto is among several multinational agricultural firms seeking permission for widespread planting of corn that harnesses genetically modified organisms (GMO) to boost desirable characteristics of the staple crop in Mexico, where the issue is highly controversial.

Proponents of GMO corn say studies show that output will rise and costly inputs such as pesticides and fertilizers will fall, and say that GMO crops have proven safe for human consumption.

Critics contend that large-scale plantings will contaminate native strains of the grain and harm biodiversity. They also point to toxins that protect GMO corn against pests that may be linked to elevated insect mortality, which could undermine pollination.

Last year, in a victory for opponents of GMO corn, a federal judge in Mexico City ordered a temporary halt to the government's ability to issue any new GMO corn permits.

The judge's order remains in effect.

Hikma: API facility bolsters our oncology pipeline

Hikma has opened a new API facility in Jordan to support its oncology pipeline.

The new facility is located in Amman, Jordan and is an extension to an existing active pharmaceutical ingredient (API) site, adjacent to the company’s headquarters.

The site was inaugurated last week by King Abdallah of Jordan and will produce the raw materials for Hikma’s pipeline.

“Currently we’ve 5 oncology APIs in the development pipelines,” Hikma spokesman Ben Atwell was able to tell in-Pharmatechnologist.com, though he did not reveal more information about the new site or how it would support Hikma’s API network.

In 2011, the firm invested $33m (€23m) in a joint venture with Indian API and intermediate firm Unimark Remedies in order to develop specialized APIs.

Recently the firm has been focusing on the sterile injectables market, having rebuffed offers to sell its ‘lucrative’ business last year to Amgen and Novartis, and buying Ohio-based Bedford Labs – and subsequently troubled manufacturer Ben Venue Labs - for $300m in May.

McIlvaine Company

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