KVK-Tech Inc, a developer, manufacturer and marketer of specialty pharmaceuticals, has agreed to acquire a 57-acre site in Pennsylvania to expand its U.S. production capacity.

The facility, owned by defense contractor Lockheed Martin, was formerly used to make satellites for the U.S. military but defense spending cuts mean that it has been earmarked for closure since 2013.

KVK will purchase the 460,000 square feet of office, lab and high-tech manufacturing space on the Newtown Bypass in June. Lockheed Martin will continue to occupy the site until the end of 2015 as it winds down its operations. Then, in January 2016, KVK will start adapting the space to make generic pharmaceuticals for the U.S. market, including oral solid dosage forms such as tablets and capsules.

KVK-Tech CEO and President Anthony Tabasso said that the company will retain its existing manufacturing sites in Newtown -- an 84,000 square foot facility on Terry Drive and 24,000 square foot facility on Pheasant Run -- where the company employs about 200 workers.

"We expect to create quality jobs here over the next several years as we continue to manufacture high-quality pharmaceuticals exclusively in the U.S.," Tabasso added.

No financial details of the sale have been disclosed, pending a final settlement agreement between KVK and Lockheed Martin.

H3 Biomedicine New Research Facility

H3 Biomedicine, the American subsidiary of Tokyo-based company Eisai, has a new research facility in Cambridge, in the state of Massachusetts, USA. The new facility is located at 300 Technology Square in Cambridge's Kendall Square. It focuses on developing new drugs to fight various types of cancer.

The Cambridge facility endeavors to gain insights into the molecular basis of cancer. It targets the genetics of cancer and develops drugs using advanced chemistry.

With the new facility, H3 Biomedicine will be able to deliver personalized drugs for oncology patients.

Eisai will provide $200m in research funding to H3 Biomedicine and access to its drug development resources. It will also support clinical development of the drugs discovered.

The location of the facility is an added advantage as it is home to the world's leading biotechnology clusters, academic and scientific institutions. The facility leverages the intellectual capital of the Greater Boston area.

The facility uses chemical synthesis technologies, such as diversity-oriented synthesis and cell-based screening methods. The diversity-oriented synthesis technology is based on high-performance liquid chromatography.

The approach used at the facility helps in generating compounds in small numbers against therapeutic targets. About 15,000 compounds are expected to be produced at the facility annually.

H3 Biomedicine's approach closes the gap between genomics and small molecule development. It is unique and more effective than the patient-based drug development approach. In the patient-based approach, a drug with known molecular targets is matched to a patient with a specific therapeutic target which is derived from large clinical trials.

According to the World Health Organization, cancer is the leading cause of deaths across the world and by 2030 it is expected to cause nearly 12 million deaths. The new facility will ensure a steady stream of anti-cancer compounds is produced to tackle this growing disease.

Drug molecules developed at the facility are expected to be highly effective in treating target population. This approach is also expected to reduce the time and cost needed to develop drugs, thereby enabling faster delivery of new therapies to patients.

The world's leading scientists, such as Stuart Schreiber and Todd Golub of the Broad Institute of Harvard and MIT, will be instrumental in the research carried out at the facility. The scientific approach used at the new facility is based on the work carried out by the two scientists.

The first phase of the Cambridge facility is spread over an area of 24,000ft². It includes labs for chemical synthesis, bacterial and tissue culture and genome analysis.

Construction of the first phase of the lab space was completed in July 2010. H3 Biomedicine plans to expand the facility up to 48,000ft².

The facility includes open office space with glass frontage, a common room / coffee break area and four modern seminar rooms. Equipment installed at the facility includes a walk-up mass spectrometer and a 400-MHz Bruker NMR machine.

Safety at the facility is maximized by splitting fume hoods into two. All evaporation equipment is enclosed in ventilation hoods. Ethylene glycol is circulated in the hoods to cool reactions.

Every researcher at the facility is provided with a laptop and access to Eisai's databases and resources.

The Richmond Group was contracted to construct the facility.

University of Maryland has New Health Sciences Research Facility III (HSF III)

Construction of a new biomedical research facility known as Health Sciences Facility III (HSF III) began at the University of Maryland campus in September 2013. The research facility is being built by replacing Hayden Harris Hall located at the university campus in Baltimore, US. It will house a state-of-the-art collaborative research space upon its scheduled completion by the end of 2017.

The HSF III facility will continue to complement along with HSF I and HSF II facilities, which were constructed in the University of Maryland Baltimore (UMB) campus in 1995 and 2003 respectively.

The facility will provide employment to approximately 3,000 people during the construction phase and about 600 research scientists when it opens in 2018.

The new HSF III facility will have a ten-story building with a total floor space of 428,970ft² (39,853m²). It will be occupied by the schools of medicine, dentistry and pharmacy to carry out advance scientific discovery and breakthroughs to address the most critical disease categories.

It will consist of two towers housing wet and dry labs that will be connected by a glass atrium with bridges across allowing for easy movement between the lab areas. The lower level will be equipped with a four modality imaging core, while the first floor will accommodate a nano-medicine and synthetic chemistry suite, and a Class 10,000 clean room. The top floor will include a vivarium that can house about 17,000 rodent cages, and varying species up to the size of non-human primates.

Approximately 70,000ft² of the floor space will be dedicated for open wet and support labs that can accommodate 92 principal investigators. The dry labs will include workstations and offices for computational research groups of up to 18 principal investigators.

Ground was broken for construction of the research facility in September 2013, with work slated for completion by December 2017 and operations expected to begin in January 2018.

Building information modelling (BIM) and integrated project delivery (IPD) methods will be employed during construction. A 4.5ft thick mat slab will be built to provide protection to the imaging center’s equipment from possible flooding.

HOK in collaboration with Design Collective was awarded the contract to provide architecture and interior design for the HSF III building. Jacobs provided the designs for laboratory planning and programming.

Barton Malow Company was appointed as the construction manager. Southland Industries was awarded the preconstruction and early mechanical construction contract. Its contractual scope includes preconstruction design, and installation of mechanical, plumbing and process piping services. It also includes the vivarium as well as administrative spaces.

The total estimated investment for the construction of the research facility is $305.4m. UMB will provide about $200m funding for the project, under the state capital improvement program. The University of Maryland Medical Centre will contribute $30m.

The new HSF III building will aim for LEED Silver certification. The building will include environment-friendly facilities such as a new chiller plant and a steam central plant. It will also include other eco-friendly systems such as rainwater harvesting and reverse osmosis. Fan-powered induction units and chilled beams will be provided in the lab spaces.

New Williamson Translational Research Building at Geisel School of Medicine

The Williamson Translational Research Building (WTRB) at the Geisel School of Medicine will accelerate the advancement of discoveries from research labs to patient care.

The construction of Williamson Translational Research Building (WTRB) at the Geisel School of Medicine was initiated in June 2013, and is expected to be completed by June 2015.

WTRB is located on the campus of Dartmouth-Hitchcock Medical Centre (DHMC) in the city of Lebanon in New Hampshire (NH). It is named after Peter and Susan Williamson, a well-known neurologist at DHMC.

The new facility will be equipped with research space and facilities for the collaboration of biomedical scientists and clinicians to accelerate advancement of discoveries from research labs into patient care.

The new translational research facility will be located in a six-story building with a total floor space of 166,000ft². It will include 39 wet laboratories, a pathology lab, a vivarium, a 200-seat auditorium, huddle rooms, and office space.

The facility will accommodate interdisciplinary teams of bench scientists, physician-researchers, health-care delivery researchers, and biomedical data scientists of the Dartmouth Institute for Health Policy and Clinical Practice.

In addition, the building will be clad with metal panels and glass curtain walls. It will also feature a large atrium and bridges connecting the WTRB to the main hall of DHMC and to the surrounding Borwell and Rubin buildings.

Dartmouth's Board of Trustees gave approval for construction of the WTRB in June 2012, and construction work began in June 2013.

Construction of the glass corridor, auditoria E, F and G, and mall connecting the WTRB with the main Medical Centre began in April 2014.

The design of the WTRB at Dartmouth Hitchcock Medical Centre (DHMC) was provided by HDR. Casali Group was contracted to provide project management services for the construction of the building.

ORW was awarded the contract to provide landscape design for the new WTRB. The landscape plan includes integration of native plant materials and a landscaped rain garden into outdoor spaces.

Simpson Gumpertz & Heger (SGH) was contracted to provide engineering services for the structures and building enclosures. RG Gosselin was contracted to supply concrete and provide excavation services.

The total estimated investment for construction of the WTRB is $116.5m. It will be partly met through a $20m gift donated by Peter and Susan Williamson to the Transforming Medicine Campaign in 2007.

DHMC contributed $20m for the project, while an additional $18m grant was awarded by the Geisel School of Medicine under the National Institutes of Health's Clinical and Translational Science Award (CTSA) program in October 2013.

The WTRB is being constructed with the aim of receiving Leadership in Energy and Environmental Design (LEED) silver certification.

Intertek to Expand and Relocate Its Bioanalytical LC-MS Facility

Strengthening clinical development support for pharmaceutical clients worldwide, Intertek has announced the expansion and relocation of its bioanalytical liquid chromatography– mass spectrometry (LC-MS) facility in El Dorado Hills, California to Intertek’s existing center of excellence facility in San Diego.

The relocation to the San Diego facility will be completed by June 2015. The increased laboratory capacity of the San Diego facility, which spans 46,000 square feet of laboratories, offices and sample storage, will benefit customers involved in preclinical and clinical small molecule drug development. This will be coupled with investment in new state-of-the-art mass spectrometers which will be operational at the new San Diego LC-MS facility prior to relocation and so avoid service delivery interruption.

Existing large molecule bioanalysis services from the immunochemistry laboratory in San Diego will be strengthened by expanded capability for bioanalytical LC-MS evaluation of biologic drugs such as proteins, antibody therapeutics or biosimilars as a result of the relocation and investment.

Chetan Parmar, Senior Vice President of Intertek Life Sciences, said “Expanding and consolidating our bioanalytical capacity will strengthen our capability to address the challenges our clients encounter during increasingly complex drug development programs and provide them with the right data for informed decision-making".

Intertek has been providing Good Laboratory Practice (GLP) compliant bioanalytical services to global pharmaceutical clients supporting their preclinical and clinical studies for over 20 years and the combined bioanalytical LC-MS/immunochemistry facility will be a key part of Intertek’s network of state-of-the art GLP-compliant laboratories.

Particle Sciences to Expand Sterile Manufacturing

North America Particle Sciences, Inc (PSI), a Bethlehem, PA, US-based provider of drug development services is expanding its sterile and aseptic manufacturing capacity generally and specifically for nano-milled drug products. The company's cGMP facilities include dedicated high potency suites, ISO 5 areas, six ISO 7/8 suites, attached warehouse, lyophilisation, and full stability and analytic support.

According to Mark Mitchnick, CEO at Particle Sciences, in 2014 the company initiated a record number of projects that are headed into the clinic; more than 50% were sterile and 50% required aseptic processing. 'Several years ago, most of clinic bound work was developed at PSI but we have seen a significant uptick in projects that were developed at our clients’ facilities and are now being transferred to us for manufacturing. This is especially true with some of our larger multinational clients,' he said. Mitchnick added that the company is incorporating a great deal of flexibility into this latest expansion by making intelligent use of both fixed and mobile isolator assets and coupling this with its existing ICH-compliant stability programs and GMP analytic services group. 'Of course, our formulation expertise remains at the core of our activities,' he said. 'Being uniquely capable of bringing complex projects from concept through to manufacturing meets a real need and offers a compelling value proposition to our clients. Last year we grew by 16% and expect positive things in 2015 as well.' Particle Sciences is an integrated provider of drug development services.

The company works with BCS II/III/IV molecules, biologics and highly potent compounds using a variety of technologies including emulsions, gels, micro and nano-particulates, drug/device combination products, solid solutions and others.

Xcelience to Expand Headquarter Operations in Tampa

Florida's Governor Rick Scott announced the expansion of Xcelience, an international contract development and manufacturing organization (CDMO) servicing the pharmaceutical and biotechnology industries. Xcelience will expand product development services and manufacturing operations in Tampa, creating 100 new jobs and retaining another 100 jobs. Xcelience will also invest $9 million in the region as part of the expansion.

Xcelience will increase capacity in their manufacturing facilities with a 6,000 square foot expansion at their 5415 W. Laurel Street location. In addition, Xcelience will expand its pharmaceutical development labs in a new 71,000 square foot headquarters at 4910 Savarese Circle in Tampa to support future company growth. The positions will include staff for pharmaceutical development, manufacturing, quality assurance and packaging.

“Tampa is a great place to build a base of scientific capabilities,” said Derek Hennecke, President & CEO of Xcelience. “The warm climate attracts a stable workforce, and the government at all levels is eager to help us grow and prosper. Our location puts us just a mile from the airport, making it easy for out of state clients to find us. Exciting things are coming down the pipeline for Tampa, for Xcelience, and the exciting new medical treatments we are developing with our clients.”

Xcelience provides preformulation, formulation development, analytical services, GMP manufacturing, small-scale commercial manufacturing, and global clinical supplies packaging and logistics to help companies move a drug into clinical trials. The company continues to be recognized as a leader in the industry and will be receiving six Leadership Awards at next week’s Life Science Leader CMO Award Reception in New York.

This project was made possible by the close partnerships between Enterprise Florida, the Florida Department of Economic Opportunity, CareerSource Florida and the Tampa Hillsborough Economic Development Corporation.

Millstone Completes Headquarters Expansion

Millstone Medical Outsourcing has wrapped up its 40,000-square-foot headquarter expansion. The Fall River, Mass., facility now has 15,000 square feet of Class 10,000/ISO 7-rated clean- room space with newly available dedicated sterile areas for new or existing clients and special projects.

The company broke ground on this project in July last year. The additional space gives the company a 200 percent increase in production capacity.

“The added capacity allows us to better serve our customers,” said Tom Williams, president of Millstone. “Our people and our quality system, coupled with the expansion positions us to support the rapid growth of our customer base for years to come.”

Millstone Medical Outsourcing provides inspection, sterile and non-sterile packaging, loaner-kit processing, and distribution services to medical device and product manufacturers. The company is privately held. In addition to its location in Fall River, Millstone also has a site in Olive Branch, Miss., not far from Memphis, TN.

Georgia Tech, Engineered Biosystems Building, Atlanta

Georgia Tech’s Engineered Biosystems Building will provide 218,880 sq. ft. of flexible interdisciplinary lab space for researchers collaborating in the fields of chemical biology, cell therapies and systems biology. A principle goal of the design is to foster interaction between chemists, engineers, biologists and computational scientists from two separate colleges: the College of Engineering and the College of Science. The building is developed with a highly utilized equipment corridor securely linking vertical circulation to every lab and support space while allowing wide transparency into research labs. The vivarium is located in the building’s basement, allowing for more transparent and publicly accessible spaces to occupy the ground level. Core facility access and expansion are critical to the success of interdisciplinary bioengineering facilities and have been carefully accounted. The vivarium incorporates a network of underground tunnels to enable future facility expansion. The project is seeking LEED Gold certification.

Project team included Georgia Institute of Technology (client/owner); Cooper Carry (architect/interior design); Lake|Flato (architect); Research Facilities Design (lab planner).

Norman Noble to Open Process Development Center in Florida

Norman Noble Inc. plans to open a new process development center in Naples, Fla. The new facility, dubbed the “5-Axis Micro Milling and Turning Process Development Center South” (PDC South), doubles the company's capacity for manufacturing orthopedic implant and device prototypes and represents a strategic expansion geographically for the Highland Heights, Ohio-based firm, according to company officials.

The facility, which is slated to open in April, will be outfitted with Swiss turning and five-axis vertical milling machines with a primary focus on orthopedic screw and plate manufacturing.

According to a press release from Norman Noble, the new facility will focus “special, but not exclusive, attention” on customers located in the Southern United States and on parts that can be manufactured entirely on a Swiss turning or five-axis vertical milling machine without also requiring ancillary finishing such as wire electrical discharge machining or laser cutting. In addition to its core Swiss turning and five-axis vertical milling functions, the PDC South operation will house laser marking, finishing and inspection equipment as well as a programming office.

Once process development for a part is completed at PDC South, Norman Noble will complete validation activities and mass manufacturing at its full-scale production facilities in Highland Heights.

Norman Noble process development centers support customers with ultra-precision micromachining of medical devices from initial prototype through all stages of U.S. Food and Drug Administration approval to full-scale manufacturing.

PDC South expands the company's network of process development centers and supports a higher volume of new projects that can be run concurrently, the company claims. The company’s process development centers provide prototype-manufacturing services in dedicated departments for each manufacturing method; design and testing services; design-for-manufacturability services; access to machining and finishing technologies especially projects involving exotic materials, including nitinol, magnesium, and bioresorbable materials; and process validation services and quality engineering support.

Established 69 years ago, Norman Noble is a family-owned and -operated company. In addition to manufacturing facilities in Highland Heights, the company also has a manufacturing site in Cleveland

Patheon Expands Comprehensive Active Pharmaceutical Ingredient (API) Services

Patheon has announced it has reached a definitive agreement to acquire IRIX Pharmaceuticals.

IRIX Pharmaceuticals, headquartered in Florence, SC, specializes in difficult-to-manufacture API needs for drugs from early and late development, through to commercial launch.

Patheon expects to close the transaction in the next 60 days.

The company secures additional API development and manufacturing services in the US, including high-potency (SafeBridge Class IV certified) and controlled substances (Schedule 1-4), helping to meet clients' needs.

IRIX has a well-established reputation for optimizing chemical processes and scale-up for commercial API manufacturing at sites in Greenville and Florence, SC.

DPx Fine Chemicals president Lukas Utiger said: "With this deal we expand our Patheon OneSourceTMintegrated offering and leverage years of operational experience and scientific excellence at IRIX to complement Patheon's existing API operations in Europe."

Patheon and IRIX will offer an array of cutting edge process technologies, including biocatalysis, homogeneous catalysis and microreactors, and can address a range of supply chain issues for clients.

IRIX CEO Guy Steenrod said: "This is a strategic deal that allows us to help customers solve complex challenges with comprehensive, integrated solutions."

Patheon and IRIX have excellent track records with regulatory authorities, and are widely recognized as leaders in quality.

Completion of the transaction is subject to customary regulatory review.

Patheon legal counsel was provided by Skadden, Arps, Slate, Meagher and Flom.

Wells Fargo Securities served as exclusive financial advisor to IRIX Pharmaceuticals, with legal counsel provided by Wyrick Robbins Yates and Ponton LLP.

The George Washington University Opens Science and Engineering Hall, Largest Building of Its Kind in D.C.

"I can't imagine a stronger statement about the importance of science and engineering to America's future than the placement of this extraordinary facility right in the heart of the nation's capital," said GW President Steven Knapp.

In opening the hall—the largest academic building dedicated to science and engineering in the nation's capital—the university also announced an in-kind grant of software licenses from Siemens, with a commercial value of $30 million, to enhance programs in the School of Engineering and Applied Science (SEAS) and strengthen a long-standing partnership between the technology company and the university.

During the last decade, GW's research funding has grown 80 percent, increasing the need for modern labs to further faculty members' cutting-edge experiments. Inside SEH, a nanofabrication lab allows researchers to build and work with devices that measure billionths of a meter in an intensely clean environment that ensures the room is free of contaminants as seemingly harmless as dust. An imaging suite shows researchers samples, such as minuscule cells, magnified by 1 million times, and can create 3-D reconstructions of them. And at three stories tall, a "high bay" provides enough height and concrete strength to test large structures and inform how buildings and bridges can be built to be more earthquake resistant.

SEH doubles the existing space for science and engineering disciplines on the university's Foggy Bottom Campus, and is now home to thousands of students and roughly 140 faculty members.

"Investing in the infrastructure to support science and engineering learning and research is critical, particularly given the fact that science, technology, engineering and mathematics careers are projected to increase substantially," said Nelson Carbonell, chairman of the GW Board of Trustees, who received his bachelor's degree in electrical engineering at GW. "Our faculty now have more resources to perform their groundbreaking research, and our students will be prepared to become leaders in STEM fields."

With SEH, students and faculty have even greater opportunity to pursue their passions for changing the world. Research conducted in SEH will advance human health, expand society's understanding of nature and create new solutions through technological innovation.

Students and faculty now will have access to Siemens' product lifecycle management (PLM) software, which is used throughout the global manufacturing industry to design, develop and manufacture some of the world's most sophisticated products in a variety of industries, including aerospace, automotive, medical, machinery and high-tech electronics. The PLM software will support student course work and research related to computer-aided design, engineering simulation, creative engineering design, digital manufacturing and manufacturing management.

Researchers at GW also have the advantage of working closely with other partners at influential scientific and technical organizations in the Washington, D.C., region, including the National Institutes of Health, NASA's Goddard Space Flight Center and Smithsonian Institution, among others. As GW's faculty members look for ways to improve everything from tissue regeneration and drug delivery to robotics and sustainable ecosystems, the work researchers conduct at SEH will have an impact beyond its walls. 

"We are excited that our Foggy Bottom neighbors are dedicating this state-of-the-art building to science and engineering, and that they are doing so in a way designed to encourage multidisciplinary research, which is so critical to solving today's complex challenges," National Academy of Sciences President Ralph J. Cicerone said. "Washington, D.C., has a long history of being at the forefront of scientific discovery so it is entirely fitting and appropriate that such a cutting-edge facility be located in the heart of our nation's capital."

Among the spaces in the building is a "teaching tower," made up of 1,000-square-foot teaching labs that are stacked at the center of the building from the third to eighth floors. Enclosed by glass on three sides, the tower includes labs for software engineering, circuitry and robotics. Specialty teaching spaces elsewhere in the building include labs for molecular genetics, biomedical engineering and environmental engineering. Outside of the building, students can connect lessons in instructional labs with real-world research at some of the most important scientific organizations in the nation's capital, a hallmark of GW's STEM education. A new career center housed within SEAS on SEH's second floor ensures that over the next decade, as STEM-related careers increase by 9 million, GW students are well positioned to be leaders in their fields.

In addition to providing space for SEAS and the Columbian College of Arts and Sciences, faculty and students from the Milken Institute School of Public Health and School of Medicine and Health Sciences will also move in as the seventh and eighth floors of the building are completed.

Kite Pharma Expands Clinical Manufacturing for T-Cell Therapies

Kite Pharma, a clinical-stage biopharmaceutical company focused on developing engineered autologous T-cell therapy (eACT) products for the treatment of cancer, announced on Feb. 19, 2015 that it entered into a lease agreement for a commercial manufacturing facility in El Segundo, California, which is adjacent to Los Angeles International Airport. Kite also recently secured a lease for a clinical manufacturing facility in Santa Monica, California. The two facilities will support the planned clinical trials of Kite's product candidates and will prepare Kite for the commercial launch and supply of its lead product candidate, KTE-C19, anticipated in 2017.

"We are committed to the rapid advancement of KTE-C19, which has the potential to address the significant, unmet needs of patients with aggressive, refractory B cell lymphomas and leukemia," said Arie Belldegrun, Kite Pharma's president and CEO, in a press release. "We are initiating pivotal studies for KTE-C19 in multiple indications and believe our new facilities will help ensure the timely completion of these studies as well as our commercial launch. We also expect the facilities to support clinical trials and potential commercialization of our other eACT-based product candidates, including both chimeric antigen receptor and T-cell receptor-based product candidates."

The Santa Monica facility has approximately 18,000 ft2 and will provide space for clinical manufacturing, research and development, and offices upon completion. In addition, Kite plans to continue to use its contract manufacturer to support clinical trials of eACT-based product candidates.

The El Segundo facility has approximately 44,500 ft2, with an expansion option for an additional 17,000 ft2. Kite anticipates the El Segundo facility will be operational to support the planned commercial launch of KTE-C19 in 2017.

Baxter's New Biopharma Baxalta to Have Headquarters in Illinois

Baxalta will have sales of $6 billion next year in global revenues when it breaks away from Baxter in mid-2015, and the company just announced it will do the bulk of this business from its new headquarters in Northern Illinois. The lease for the 260,000-square-foot Bannockburn location will reportedly last more than 10 years.

The new company, which will have a focus on bleeding disorders and immunology, will be led by future Chief Executive Officer Ludwig Hantson, PhD, the current president of Baxter BioScience. He said in a statement that the selection of the Illinois location is a “key milestone on our journey to become a leading, independent biopharmaceutical company.”

Hemispherx Upgrades New Jersey Plant

Hemispherx has installed a 600 liter bioreactor at its manufacturing facility in New Jersey and plans to seek approval to restart production of its alpha interferon product, Alferon N Injection.

Alferon was approved by the US FDA in 1989 for the treatment of certain types of genital warts, specifically those linked to cervical cancer.

However, the drug has not been on the market since 2008 after Hemispherx halted production when the cost of making it proved to be too high.

At the time the firm said labor expenses coupled with limited manufacturing capacity drove the decision.

Hemispherx spent $8m (€7.1m) upgrading the New Brunswick facility, replacing the six 100 liter reactors with a single 600 liter unit. The firm said the investment allowed to cut the manpower needed to make the drug by 80%.

It also said the new tech “improved cost efficiency, enhanced yields, real-time process monitoring, flexibility to tailor batch size for lean manufacturing, and improved operational safety as seen in other cutting edge pharmaceutical companies.”

Hemispherx plans to ask the US Food and Drug Administration (FDA) to re-affirm the amended Biologics Application (BLA) for the upgraded plant.

If approved by the agency Hemispherex said it plans to sell Alferon in the US and South American markets in partnership with distributor Armada Healthcare.

News of the expansion comes a few months after Hemispherx started testing Alferon and its other product Ampligen – a double stranded RNA therapeutic – against the Ebola virus in collaboration with the US military.

On November 3 the firm announced that tests by USAMRIID scientists show that Alferon "successfully protected human cells against the Ebola virus."

"The overall effect is to establish a framework for clinical interventions in both preventative and therapeutic settings of Ebola virus disease (EVD) by rational combinations of the two experimental products to treat Ebola" it said.

Last month the firm announced that, in animal studies, mice treated with Ampligen survived Ebola infection.

VWR Expands with New England Biolabs

VWR has expanded its distribution deal with industrial enzymes firm New England Biolabs (NEB) in its latest biopharma-focused move.

The agreement – terms of which were not disclosed – will allow VWR’s biopharmaceutical industry customers to access NEB’s products through its online portal and onsite services group.

NEB spokesman Andrew Bertera said: "The support and reach of VWR's sales team will help showcase our expanding portfolio of innovative products to a larger number of researchers" adding that "we are excited about the expanded access and ease of ordering this will provide to customers."

The firm discovers and makes enzymes for molecular biology applications, including recombinant and native enzymes for genomic research, genome editing, synthetic biology and sequencing.

VWR completed its IPO last October and the NEB deal comes a few months after the firm expanded into the single-use technology sector through the acquisition of Integra Companies and STI Components.

Massachusetts-based Integra Companies provides single use connectivity solutions including tubing, hoses and gaskets for high-purity environments for biopharma companies. Integra is ISO9001 certified and operates two ISO Class 7 cleanrooms.

North Carolina-based STI Components offers high-purity fluid handling components and custom engineered solutions in the Southeast US.

Last month the firm bought National Biochemicals (NBC), a full service raw material manufacturer and supplier to the biochemical industry, citing expansion of its biochemical manufacturing portfolio as the driver for the deal.

At the time CEO Manuel Brocke-Benz said: "We continue to make targeted, strategic investments that give VWR access to the high growth biochemical industry.”

Aprecia Leases Forest Labs Site as Production Hub

3D drug printing firm Aprecia Pharmaceutical has leased an old Forest Labs facility sold following the firm’s $28bn takeover by Actavis last year.

Aprecia announced the deal, explaining that the Forest facility in Blue Ash, Ohio will serve as base of operations for production of fast dissolve drug formulations using three-dimensional printing technology.

CEO Don Wetherhold said: "The facility has ample space to accommodate our proprietary manufacturing machines and equipment assemblies in the capacity necessary to achieve our projected commercial production volumes well into the future."

Aprecia says it will invest $25m in facility and create 150 jobs, which will earn it a 55% tax credit recently introduced in the State.

3D printing – also known as additive manufacturing – involves using a digital model to guide the successive deposition of material to form an object. The technique is being considered for a wide range of applications – from gun manufacturing to pizza production in space.

Drug manufacture is another potential use. In Aprecia’s case, 3D printing is an integral part of the firm's ZipDose delivery technology, which is designed to create tablets that dissolve and release their active pharmaceutical ingredients (APIs) much more quickly than existing fast-melt pills.

The US Food and Drug Administration (FDA) accepted the first drug that uses the technology for review in December.

Jennifer Zieverink, senior director of alliance management at Aprecia, said, "The product, of which we anticipate FDA approval, will be manufactured in the Blue Ash facility."

Aprecia signed a commercialization deal with inVentiv Health last June. According to Zieverink "inVentiv Health will serve as the sales force for ZipDose products for a contracted period of time, Aprecia will maintain title of the products.

The facility Aprecia is leasing was previously owned by US drugmaker Forest Labs, which build it for $45m in 2013.

The site was due to serve as a packaging, warehousing and testing facility for Forest, however, when the firm was bought by Actavis a year later it was deemed unnecessary and mothballed without ever being operational.

At the end of 2014 the site was sold to Cincinnati United Contractors for $14m.

Repligen Finishes Plant Expansion

Repligen has finished an expansion at its U.S. filtration system facility eight months after bolstering its offering in this area by buying a platform from Refine Technology.

The U.S. firm spent $4m (€3.2m) to add 11,000 square feet of manufacturing space for the alternating tangential flow system at the facility in Waltham, Massachusetts, which also has a dedicated assembly area.

Repligen began kitting out the facility for the acquired Refine Technology business in November in a project that also saw it spend $2m to overhaul existing equipment, add more cell culture areas and production space for its ELISA kits and OPUS chromatography columns.

The firm has also set aside a further 7,500 square feet for future expansion in a bid to “remain flexible and responsive to the needs of its biopharmaceutical customers and life sciences partners.”

This is in keeping with comments made by incoming CEO Tony Hunt, who replaces Walter Herlihy in May.

Hunt plans to expand Repligen’s business beyond Protein A through acquisitions in the biomanufacturing technology space according to the Boston Business Journal.

In a U.S. SEC filing in January, Repligen said its revenue for the 12 months ended December 31 will be about $63m (€55m), which would be an increase on the $47m it posted in 2013.

Protein A is used to capture monoclonal antibodies (mAbs) and is the product with which Repligen generates the majority of its revenue - around 75% - by supplying it to customers like EMD Millipore and GE Healthcare.

In 2013, around 15% of the firm’s revenue - $5.6m - came from the sale of bioprocessing technologies with the remaining 10% coming from royalty revenues from licensing agreements.

Last year, however, the proportion of technology revenue increased 27% “driven by strength in sales of products that we sell directly to end users including partial year sales of the ATF system” according to Repligen.

For 2015, the firm expects revenue to be in the $69m to $72m range and says that a full year of ATF sales will be a key growth driver.

On a more negative note, the proportion of revenue Repligen generates through tech sales is also likely to increase as a result of Pfizer's decision to pull out of a spinal muscular atrophy (SMA) accord earlier this month.

Repligen is due to announce its full year results in March.

Mack Molding to Expand Cleanroom Molding and Assembly Capacity

Officials with Arlington, Vt.-based Mack Medical/Mack Molding report that the company is investing $2 million to expand its cleanroom molding and assembly capacity to handle significant growth in the medical consumables market.

According to Jeff Somple, who recently was named president of Mack Molding, “while we’ve been involved in orthopedic disposables for some time, this marks our first foray into high-volume, single-use components for a Class III medical device. It’s a critical step that will open up a whole new market sector for us.”

To accommodate the work, Mack is building its third ISO Class 8 molding and assembly clean room at its headquarters plant, which will house four electric presses from the Japan Steel Works (JSW). It is scheduled to be certified by April 1, at which time Mack will begin validation runs, according to company leadership.

Beyond the main molding and assembly area, the clean room will include space for part conveyance from an adjacent soft-walled clean room that will house a robotically automated 500-ton press. Servo-controlled radiofrequency and ultrasonic welding systems will be installed, as well as automated particulate, temperature and humidity monitoring.

Mack is adding four electric presses, including two 44-ton vertical machines and 60- and 199-ton horizontal presses. From JSW’s “advanced” series, the machines feature a 62 micro-second servo control circuit that, according to Mack officials, “delivers high-speed performance with increased precision and reliable quality.”

Semi-automated equipment will be installed to support molding and assembly, which includes over-molding of extruded tubing. The presses will be vacuum-fed by a modular bank of dryers located outside the clean room.

In addition to this investment, Mack has two other ISO Class 8 clean rooms—a molding clean room with six electric presses and an assembly clean room that is used for non-sterile packaging of medical disposables, light sonic weld assembly, and temperature- and humidity-controlled functional testing. There is also a 24-hour white-room operation that houses four hydraulic presses dedicated to small part medical molding.

In addition to adding clean-room capacity and technology, Mack also has added its pool of medical device engineering expertise and realigned staffing to “better serve the needs” of its customers.

Mack Molding is a plastics molder and supplier of contract manufacturing services. Mack specializes in plastics design, prototyping, molding, sheet-metal fabrication, full-service machining and medical device manufacturing. Founded in 1920, Mack is a privately owned business that operates 11 facilities throughout the world.

Cynata Validates Stem Cell Manufacturing Process at Wisconsin Biomanufacturing Site

Cynata will now move to manufacture its GMP-grade Cymerus MSC product and expedite its clinical trial and collaboration programs.

Australian stem cell and regenerative medicine company Cynata Therapeutics is now set to scale up manufacturing of its mesenchymal stem cells (MSCs) for therapeutic use.

The company’s novel stem cell manufacturing process known as Cymerus has been successfully validated at Waisman Biomanufacturing’s Madison, Wisconsin-based facility after trials confirmed the stem cell manufacturing process is capable of producing MSCs for therapeutic application, consistently, efficiently and economically in a GMP production environment.

Cynata claims that the Cymerus process uses an effectively limitless starting material – a bank of induced pluripotent stem cells (iPSCs) – and a patent-protected process to derive MSCs for commercial use, which differentiates the company’s process from all existing methods of MSC production, which usually require a continuous supply of new tissue donations.

One of the major benefits of this manufacturing process is that Cynata expects to be able to produce all of its MSCs from a single iPSC bank, derived from a single blood donation. Therefore there will be no need to repeatedly source, screen, and test new donors and issues with donor-to-donor variability will not arise.

Cynata CEO Dr. Ross Macdonald said: “An equity research report compiled last year by respected biotech analyst Stuart Roberts saliently noted that should Cynata demonstrate an ability to make cells at industrial scale under GMP then it would be in a position to be a ‘genuine Stem Cell Revolutionary.’”

In addition, the use of an essentially limitless starting material means that it will not be necessary for Cynata to excessively expand MSCs in culture in order to generate the vast numbers of cells required to provide commercially-viable treatments for major diseases.

Macdonald said that one of the biggest issues facing regenerative medicine companies is how to produce enough stem cells consistently and economically for clinical and commercial benefit.

“Our international manufacturing partner has now confirmed our proprietary process can achieve this in a GMP manufacturing environment. This is a key requirement for pharmaceutical companies as they move to capture the opportunities presented by stem cell medicine. An abundance of stem cells clears a path toward low cost, cutting edge cell therapy,” he added.

Cynata will now move to manufacture its GMP-grade Cymerus MSC product and expedite its clinical trial and collaboration programs. A Phase I human clinical trial of the Cymerus stem cell technology is currently in planning stage, with discussions underway with regulatory authorities to ascertain and clarify the likely regulatory path. The proposed clinical study is intended to examine the impact of these manufactured cells on patients affected by graft-versus-host disease (GvHD).

The Cynata announcement comes as the European Commission has approved the world's first stem cell derived drug. Italy-based Chiesi's Holoclar (an ex-vivo expanded autologous human corneal epithelial cells containing stem cells) has been approved for moderate to severe limbal stem cell deficiency (LSCD) due to physical or chemical burns to the eye in adults.

inVentiv to Open Miami Phase I Clinic

inVentiv Health plans to open a new Phase I/IIA clinic in Miami, expanding its Phase I clinical services into the U.S. The new clinic is expected to begin studies in 2H15. The new site compliments inVentiv's clinical facility in Quebec, Canada.

The 65-bed Miami clinic, located in the University of Miami Life Science and Technology Park, will focus on studies including first-in-human Phase I, Phase I-in-patient and other Phase I trials such as drug-drug interaction, biosimilar, first-to-file and 505b2 trials.

“Phase I clinical research continues to become more complex, requiring rapid recruitment of unique patient and special populations,” said Riaz Bandali, president of the Early Stage business unit for inVentiv Health’s Clinical Division. “The location of the clinic in the U.S., specifically in Miami, will help provide broad patient access thanks to a large population and diverse demographic. This should enable us to better meet the needs of our clients as they navigate the complex regulatory environment of drug development and approval.”

Horizon Pharma Opens Chicago Office

Horizon Pharma plc, a specialty biopharmaceutical company headquartered in Dublin, has opened a new office in Chicago that will primarily house commercial, corporate analytics, and business development staff.

"More than 25% of our Illinois employees live in the City of Chicago and we felt it was important to establish a city presence in order to assist our employees in maximizing their personal and professional potential," said Timothy P. Walbert, chairman, president and chief executive officer, Horizon Pharma. "As one of the fastest growing biopharmaceutical companies in Illinois, a city presence offers access to top talent and easier access to the growing biotech and biopharma community."

Children's Hospital LA to Expand Center for Personalized Medicine

Children's Hospital Los Angeles said that it will commit $50 million in institutional funding to expand its Center for Personalized Medicine.

The funding, which was recently approved by the hospital's board of trustees, will be invested over the next five years. The hospital will seek an additional $50 million in philanthropic funding from the community to support the translation of research into the clinic.

The center will be part of the hospital's department of pathology and laboratory medicine, led by Alexander Judkins, who will also lead the center.

The new investment will go towards the areas of cancer, inherited diseases, and infectious diseases, with an initial focus on pediatric cancer. The hospital has already developed a sequencing test for the retinoblastoma gene, RB1, in eye cancer patients. Also, in late 2014, the center won a $1.05-milllion grant from the US Department of the Army to for a core facility to develop next-gen sequencing tests for childhood cancers.

"Our expansion will provide us with the opportunity to study genomic features of all new and recurrent cancers treated at CHLA and support our Children's Center for Cancer and Blood Diseases, led by Director Alan Wayne, in discovering causes and novel therapies for pediatric cancer," Judkins said in a statement.

As the program develops, it will expand to include other genetic conditions, such as epilepsy, autism, neurocognitive disorders, congenital heart disease, and cleft palate.

The center will also explore collaborations with other children's hospitals and with the Keck School of Medicine of the University of Southern California, its longtime research partner.

Enteris BioPharma Launches Contract Manufacturing

Enteris BioPharma, Inc. has announced the launch of contract manufacturing located within its 32,000 square foot, FDA inspected and cGMP compliant facility in Boonton, New Jersey.

Equipped to ensure cost-effective, high-quality production of API using microbial expression systems, Enteris BioPharma offers pharmaceutical companies a full array of services to meet their manufacturing needs, from pre-clinical to commercial scale.

Brian Zietsman, President and CFO of Enteris BioPharma, commented, “The initiation of our contract manufacturing business is an important milestone for Enteris as we seek to fully maximize the assets and expertise that we acquired when the company was launched in 2013.”

Housed within Enteris BioPharma’s 32,000 square foot facility is a fully integrated manufacturing plant for producing API at multi-kilogram capacity. The fermentation, purification and production support suite includes a 1,000 liter B. Braun microbial fermenter, 300 sq. ft. Millipore TFF membranes, an Alfa Laval disc stack centrifuge, a Rainee homogenizer, a complete downstream purification suite, multiple chromatography columns, a bulk tray lyophilizer and an explosion proof area for solvent handling and RP-HPLC. Enteris BioPharma’s manufacturing capabilities are strengthened by significant technical expertise that enables the company to offer end-to-end program support, ranging from small scale pre-clinical programs to commercial scale API manufacturing.

Paul Shields, Ph.D., Vice President, Operations of Enteris , remarked, “From fermentation to harvesting and downstream purification through to stability testing, process validation, QA and regulatory support, Enteris has the technological capability and expertise to meet a wide array of customer needs and project specifications. With the initiation of our contract manufacturing services, Enteris offers pharmaceutical partners the ability to manufacture recombinant peptide and protein products using microbial expression systems in an FDA inspected and cGMP compliant facility located in New Jersey.”

Israeli Biotech Company Evogene to Build R&D Facility in St. Louis

Evogene Ltd., a biotech company that has partnered with Monsanto for nearly a decade, has plans in place to build a 6,000-square-foot research and development facility at Bio-Research & Development Growth (BRDG) Park.

The project is estimated to cost $10 million and will broaden the company's existing predictive discovery and validation capabilities. The facility will serve Evogene's growing insect control activities and is projected to be fully operational by the end of 2015.

"Our choice to locate at BRDG Park on the Danforth Center campus, a world leader in plant science research, is one we are very proud of as we join this innovative community," said Ofer Haviv, Evogene president and CEO. "Being a company that is committed to the improvement of crop productivity, we share the Danforth Center's belief that plants hold the key to discoveries and products that will enrich and restore both the environment and the lives of people around the globe."

Evogene received incentives from the state to build the facility.

Amy Susan, a spokeswoman for the Missouri Department of Economic Development, said if the company meets strict job creation criteria, it could access up to $202,608 through the Missouri Works program.

James Presnail, previously senior research manager for DuPont Pioneer in Johnston, Iowa, will lead the facility as director of U.S. insect control for the company.

Evogene is based in Israel and was founded in 2002. The company went public in 2013, when it raised $74 million in an IPO.

Its deal with Creve Coeur-based Monsanto is focused on identifying key plant genes related to yield, environmental stress and fertilizer utilization in corn, soybean, cotton and canola.

Univ. of California, San Diego (UCSD) Muir College Biology Labs renovation

RBB provided programming planning, design and construction services for the interior renovation within the existing Biology Building at Muir College, built in 1967. The 9,500 sq. ft. building is a wet-lab research building supporting the Div. of Biological Sciences research. The third floor labs exclusively support biology functions, and were in need of renovation to upgrade functionality, improve lab efficiency and overall safety and encourage collaborative research. The scope includes complete renovation of lab spaces to provide an open lab configuration. Specific upgrades include fire/smoke detection and fire protection systems, HVAC, fume hood replacement, plumbing systems and upgrade of the electrical system including lighting and standby power, ADA compliance and all new interior finishes.

Project team: RBB Architects (architect and interiors); John A. Martin & Associates (structural engineer); DEC Engineers (mechanical engineer); Engineering Partners Inc. (electrical engineer); TBD Consultants (cost estimator); Davis Langdon (LEED).

Completion date: August 29, 2014

Pii Expands CTM Services

Pharmaceutics International, Inc. (Pii), a CDMO based in Hunt Valley, MD, has expanded its services to include clinical trial supply packaging. These services include primary and secondary packaging, labeling, clinical site distribution, reconciliation, storage and destruction of returned supplies. The company also offers QP services for distribution of supplies throughout Europe.

Steve King, Pii's senior vice president, said, "Our expanded services will enable our clients to consolidate their formulation development and clinical trial manufacturing, packaging, labeling and distribution needs within a single organization. As a result, our customers will experience a more streamlined and cost-effective process with access to a multitude of options for customized packaging solutions."

Charles River Plans to Re-Open Massachusetts Preclinical Site

CRO Charles River Laboratories is further exploring the idea of re-opening a preclinical site in Shrewsbury, MA, though it will be more than a year before the site is ready.

Charles River taking advantage of biotech growth, CEO says “We have significant interest from biotech clients to open Shrewsbury as we’re the closest CRO to many of them,” CRL CEO James Foster told investors in the company’s quarterly earnings call on Wednesday. The company now has a devoted team looking at the site’s re-opening, though initially the site will open for non-GLP (Good Laboratory Practice) services.

“Once it’s open, it’ll be more real to our clients and then we’ll assess the demand for GLP toxicology services, but that’ll be a second step that we won’t make until demand is ready,” Foster said. He estimated that it will probably take a couple of years “to hire staff, put back some of the equipment, validate equipment and train staff.”

The site, which included about 300 jobs, was previously closed in 2010 due to lack of demand.

The announcement comes as Charles River still has capacity to fill at other sites. Foster specifically mentioned space at the company’s preclinical site in Reno, NV, that still needs filling, as well as “small pockets of space in a few other areas that need to fill.”

And Charles River might not be done with M&A as Foster noted to investors in the call that the preclinical sector is ripe for further consolidation “based on input we have from conversations with other companies, and given the fact that consolidation appears to be predictable in our business. Like many service-providing businesses, there’s strength of scale and expectations from clients.”

Consolidation in the sector also appears to be playing to Charles River’s strengths as Foster told investors that the Covance-LabCorp merger is already providing opportunities as “movement of competitors to new ownership can be concerning to clients.” He added that the deal “bodes well for us to engage with additional clients.”

And as far as where pricing trends appear to be headed, Foster added that the “pricing environment feels slightly better,” and he said he remains “guardedly optimistic” that they’ll continue to improve.

“We’re not at the lowest price point most of the time,” Foster said, noting that clients seem willing to pay a premium for Charles River’s services. Meanwhile, Foster said the company is pushing for more strategic relationships with larger pharma and biotech clients. He said the company has reached out to the heads of all large pharma R&D heads “to expand current deals and get new ones” and that most of the clients appear poised to forge deals that span the breadth of Charles River’s product lines.

REST OF WORLD

Chicago-based AbbVie (ABBV) will expand its Operations in Puerto Rico

Chicago-based AbbVie (ABBV) will expand its operations in Puerto Rico to the tune of $30 million and 100 new jobs over the next two years, the company said, as it doubles down on the island as an increasingly source of manufacturing.

“This investment demonstrates our commitment to Puerto Rico as a key element of our global manufacturing network,” said Stephen Muldoon, vice president of engineering and operations for AbbVie, in a statement. “Our presence in Puerto Rico dates to 1969 and our patients benefit from our dedicated and talented local team”, added Muldoon.

AbbVie said it will expand its existing operations in the northern municipality of Barceloneta, which already houses two AbbVie sites. Local officials lauded the announcement as another sign that Puerto Rico is becoming a competitive force in the biopharmaceutical production world.

“AbbVie’s expansion in Barceloneta is very important for us, as this site is one of the world's most advanced biopharmaceutical facilities, contributing to our island's growing reputation as a biotech hub”, said Puerto Rico governor Alejandro García Padilla.

“AbbVie's growth plans in Puerto Rico as well as its approach towards innovation and advanced therapies, gives us additional capabilities within the very competitive biopharmaceutical industry,” he said. “Most important, their $30 million investment to expand their facilities is an encouraging expression of the company’s confidence in their future in Puerto Rico.”

AbbVie said it had worked closely with the Puerto Rico Industrial Development Company (PRIDCO) to help promote the expansion with incentives for job creation and infrastructure.

“AbbVie’s expansion reaffirms Puerto Rico as a global manufacturing powerhouse where talented people combine with pioneer technologies to create biopharmaceutical products that have a significant role in the lives of many people worldwide,” said Antonio Medina Comas, executive director of PRIDCO. “We are committed to continue advancing our industrial development agenda, enabling similar investment opportunities to protect and expand our manufacturing footprint.”

AbbVie has three manufacturing plants in the island and generates more than 1,000 direct jobs which create 13 unique products that support the therapeutic areas of immunology, virology and metabolic disorders.

Puerto Rico has a reputation as a biotech hub, partly driven by tax credits which historically have exempted manufacturing on the island from US taxes. AbbVie has been present in the territory since 1969.

But following a change in US law in 2010 which taxed offshore big earners, companies have started to pull out of the region. Novartis has announced it will close its Puerto Rican activity and outsource manufacturing and packaging to Eli Lilly by 2019.

Pfizer and Merck also plan to phase out many of their operations in Barceloneta by 2017.

Actavis bucked the trend last June with a $48m investment in solid dose and hormone manufacturing.

Puerto Rico’s utility costs and taxes must be controlled if the region is to retain pharma investment, said a regulatory expert.

New Research Institute of the McGill University Health Centre (RI-MUHC), Montreal

McGill University Health Centre (MUHC) and Research Institute of the MUHC (RI-MUHC) inaugurated a new research institute that was jointly built at MUHC's Glen, Montreal site in February 2015.

The Glen site, which is one of the most innovative academic health centers in North America, is located at the center of three vibrant neighborhoods of Montreal city, Notre-Dame-de-Grace, Sud-Ouest and Westmount in Quebec Province.

The new research institute is a part of MUHC's Redevelopment Project at the Glen site. It offers biomedical and research facilities, and features renovated labs and redesigned care units to facilitate fundamental research for establishing the MUHC as a world-class center of excellence in patient-centric medicine.

The current research institute at the MUHC will be moved to the new facility at the Glen site by the end of February 2015.

"The laboratories and clinical research facilities at Montreal General Hospital (MGH), which houses one-third of the research institute's community, will be modernized to provide better research facilities for the investigators at MGH."

RI-MUHC, with an objective to establish MUHC as a cutting-edge center of excellence, adopted a strategic plan which includes a new program-based framework that will guide its future research activities.

Construction of a new state-of-the-art research institute at the Glen site is the first step towards achieving this objective.

As part of the plan, the laboratories and clinical research facilities at Montreal General Hospital (MGH), which houses one-third of the research institute's community, will also be modernized to provide better research facilities for the investigators at the MGH.

Construction works at the site began in June 2010, and the research building was completed in the third calendar quarter of 2014.

The new research center, located in Block E on the south-east side of the Glen site, is a five-story building comprising two towers with a central atrium.

The facility is built-up with a total area of 450,000ft², and is connected to the hospital building by a suspended walkway.

Research activities at the new RI-MUHC are housed in two main centers, which include the Centre for Translational Biology (CTB) and the McConnell Centre for Innovative Medicine (CIM).

These two centers, along with other clinical research units at the site such as the Centre for Outcome Research and Evaluation (CORE), are expected to take research at the MUHC to the next level.

CTB, located in Block E on levels S1-3 of the research building, houses 110 biomedical scientists.

It conducts fundamental research and features 105 lab modules, 210 equipment alcoves, 29 equipment rooms, 18 freezer rooms, seven tissue culture units, seven radioisotope labs, 14 cold rooms, seven glass washing rooms, and a state-of-the-art technical platform.

The CIM, integrated with the hospital, is located on level four of blocks B and C of the Glen site. It will be used by more than 250 clinical and evaluative researchers to conduct research and clinical trials to discover new treatments.

In addition, it houses three clinical research pods with a total of nine beds (eight for adults and one for children), an imaging and functional platform, offices and support spaces.

The state-of-the-art equipment at the RI-MUHC includes a CT scan, a fluoroscopy machine, two nuclear magnetic resonance (NMR) spectrometers, mass spectrophotometers, and microscopes including confocal microscopes.

Technological platforms are equipped with clinical proteomics, immune phenotyping, cellular imaging and histopathology core facilities.

Other facilities for research staff include conference and team rooms, a large amphitheater with a capacity of 200 seats, staff locker rooms, lounges, kitchen, offices and student work rooms.

Spread across an area of 43 acres, the Glen site will bring ambulatory services and world-class teaching, research and patient care under one roof.

The site features new facilities for the Royal Victoria Hospital, the Montreal Children's Hospital, the Montreal Chest Institute, the Cancer Centre and the MUHC Research Institute. It includes 20 operating rooms, 154 pediatric and 346 adult single-patient rooms, space for visitors, and two parking garages to accommodate 2,859 vehicles.

The Glen site is scheduled for opening in April 2015.

The design-build contract for the Glen campus was awarded to McGill Health Infrastructure Group (MHIG), which is a consortium of SNC-Lavalin and Innisfree.

Under the 34-year public-private partnership (PPP), the consortium is responsible to design, build, finance and maintain the new Glen campus. The MHIG will maintain the campus for 30 years once it becomes operational.

The redevelopment project at the Glen site was jointly funded by the MUHC and MHIG. For the research institute, the MUHC invested a total of $320m, of which $220m was allocated for construction and design, and $100m for research equipment and personnel.

Funding was secured from the government of Quebec ($100m), Canada Foundation for Innovation (CFI, $100m), MUHC ($70m) and donation

Dr. Reddy’s Opens Center of Excellence in India

Dr. Reddy’s Custom Pharmaceutical Services (CPS) division has expanded its existing custom service facilities with a new formulation development laboratory in Miyapur, Hyderabad, India. The company says bringing together the existing API development team and the formulation teams at one location will accelerate project timelines, reduce costs and simplify licensing processes for CPS’ pharma customers.

With this expansion, the laboratories will form a Center of Excellence for fully integrated API and formulation development services, including pre-formulation studies, prototype formulation development, process development and optimization.

These development capabilities will are put in place to integrate CPS’ offerings of cGMP supplies for clinical trials, registration batches and commercial manufacture.

“This new Center of Excellence for formulation development services reflects our ongoing focus to better serve our pharma customers. Access to our integrated expertise and resources will bring their drug product to market in an even quicker and more cost-efficient manner than before,” said Anurag Roy, vice president, global business head at Dr. Reddy’s CPS.

GSK Picks Singapore for Asia HQ

GlaxoSmithKline is strengthening its presence in Singapore by establishing a new 15,000-square-metre (161,400 sq. ft.) global headquarters for Asia.

The drugs giant has signed an agreement with Boustead Development Partnership to develop and lease a new building located at the ‘one-north’ development in the Rochester Park area of Singapore, with construction expected to complete by the end of next year.

“Singapore excels in fostering talent, supporting business growth and offers an excellent base to access Asia. This is why we are making a significant decision to further increase our presence in Singapore as we continue to modernize and advance GSK,” said the firm’s chief executive Sir Andrew Witty explaining the decision.

The company, which stepped into the country more than 40 years ago, is expecting pharmaceutical, consumer healthcare and vaccine markets to grow “significantly faster” in key Asian territories than in the rest of the world.

Johnson Matthey built High Containment Facilities in Edinburgh, Scotland

The expansion was made by MacFarlan Smith, part of the Fine Chemical and Catalysts division of Johnson Matthey.

Macfarlan Smith provides and manufactures opiates, controlled substances and HPAPIs (highly potent active pharmaceutical ingredients).

This latest, self-contained facility contains isolators with a range of hastelloy and glass vessels. Powder transfers are mediated at the facility through split butterfly values with active valve wash stations. It also has a dedicated finishing room, QC lab and control room.

The investment was made to meet existing demand for potent products and will also give the company extra capacity for future orders, the company said.

Johnson Matthey said the site was designed to be a safe working environment, with controls in place to make chemicals with an occupational exposure limit less than 30 nanograms per m3.

“This new facility is a significant addition to our existing capabilities at our site in Edinburgh,” said Steve Barr, Vice President, Business Development Europe.

“It enhances our overall capabilities in high containment manufacturing and provides extra capacity to extend our range of high potency products and services. These facilities support Johnson Matthey’s broader assets for the manufacture of highly potent products including our US capacity in West Deptford, NJ and Devens, MA.”

Construction finished last month and the company is due to begin commercial manufacturing.

Johnson Matthey recently reported a decline in sales of bulk opiates and other pain management APIs in Q3 2014, year-on-year. However operating profits were up by half a million pounds to £96.5m ($145m) thanks to the sale of ingredients for ADHD drugs, the company said.

The firm bought an API manufacturing site in Annan, Scotland, from Bakhu Pharma in December. It has started a “multi-million pound” refurbishment of the site, which it plans to reopen in early 2016.

CureVac to build Plant with Gates Foundation Money

CureVac will build a manufacturing facility for mRNA vaccines after a $52m (€46m) Gates Foundation investment that also brings an IPO one step closer according to majority shareholder Dietmar Hopp.

The investment was announced today in addition to a Gates Foundation commitment to provide CureVac with funding to develop mRNA vaccines for several unspecified projects for viral, bacterial and parasitic diseases.

CureVac operates a clinical development facility in Tübingen, Germany.

A spokeswoman said: "The new, additional facility will also be located in Tübingen" explaining that "the current manufacturing facility can produce 150k doses per year of 14 different products simultaneously.

"With the additional GMP production facility that the investment by the Gates Foundation enables, CureVac plans to scale this up to 30mm annual doses" she said, adding that "It will thus be in a position to meet its clinical production and supply the commercial needs of the world market."

Work is expected to start on the plant next year and it is expected to be operational in 2018 or 2019.

Bill Gates said the backing was driven by CureVac’s tech, explaining that: “If we can teach the body to create its own natural defenses, we can revolutionize the way we treat and prevent diseases” adding that “technologies like mRNA give us confidence to place big bets for the future.”

The Gates foundation was accompanied by news that longstanding CureVac backer Dietmar Hopp has agreed to stump up an additional $24m through his investment vehicle dievini Hopp BioTech, which holds a 90% stake in the firm.

Hopp told Germany’s Capital.de that the Gates Foundation investment could also see CureVac go public.

A spokesman for dievini Hopp BioTech echoed this, telling us "deals like the Gates Foundation investment make IPOs more likely."

He stressed, however, that while CureVac is considered "IPO-able," no definite plans have been put in place.

CureVac has deals with a number of drugmakers, including Janssen, Boehringer Ingelheim and Sanofi Pasteur.

The firm has also received a European Commission (EC) grant to develop room temperature-stable mRNA vaccines for use in countries where refrigeration is problematic.

WuXi to More than Double US Cell Therapy Manufacturing with New Site

The facility is designed for cell therapy products that contain viral vectors such as chimeric antigen receptor T cell (CAR-T cell) therapies. CAR-T cells are T cells taken from a patient's body, engineered to target specific cancers, and then reintroduced into the body.

The site is expected to become operational by mid-2016 and it will provide single-source contract development and cGMP manufacturing capabilities to support growth in the cell therapy industry, which has come from the likes of deals by Kite Pharma and Cardio3 Biosciences . Specifically, the new facility will provide manufacturing capability and capacity to meet the rapidly expanding demand around clinical trials and commercialization.

"Cell therapies like CAR T cells offer important new treatment options for cancer patients, and WuXi aims to be at the forefront of this area of providing our partners with cutting-edge cGMP manufacturing capabilities and capacities," said Ge Li, Chairman and CEO of WuXi.

The site supplements the company’s existing 16,000-square-foot cGMP cell therapy manufacturing facility, as well as a 45,000-square-foot facility for the manufacturing of allogeneic and autologous cell-based therapeutics that is expected to be completed by mid-2015. The 45,000-square-foot site relies on single-use and disposable equipment, said Alan More, VP of cell manufacturing.

By 2016, WuXi's available manufacturing capacity in the US will be 206,000-square-feet, which would help meet the anticipated market needs of clinical and commercial production for cell-therapy companies. These facilities will complement the company's current fully integrated facility for biological safety and lot release testing in Philadelphia.

Ardmac to Deliver Cleanrooms at New Rayner Facility

Rayner, the UK’s only manufacturer of intraocular lenses, is moving to a new state-of-the-art facility in Worthing. This new world class manufacturing center will dramatically increase production capacity and expand innovative research and development. Ardmac is working alongside Morgan Sindall Group and TSL Projects to deliver 600m2 (6,456 sq. ft.) of cleanrooms at the new Rayner facility. The scope of works for the Ardmac team includes cleanroom architectural design, cleanroom walls and ceilings and emergency break out panels, as well as innovative interfacing with the M&E contractor with all details coordinated by the in-house design team to ensure a finer quality of finish. Alongside this, Ardmac is also installing fully flush integrated system doors, including oversized single swing doors for equipment access, and fully flush, bespoke glazing details for fire rated walls. This will include flush cleanroom grade on one side of the wall, with fire rated PBSC systems on the other. Project completion at the Worthing site is due in October 2015.

BAM Wins Life Science Facility Contract from Coventry University

The University of Coventry, UK has awarded the £37 million contract to build its flagship new Science and Health Building to BAM Construction.

The five-story, 120,000 sq. ft. (11,148.4m2) building on Much Park Street in Coventry’s city center is due for completion in 2017 and will bring together the Faculty of Health and Life Science’s teaching and research facilities into a ‘superlab’.

The modern multi-disciplinary facility will house world-class teaching and simulation facilities with state-of-the-art equipment and laboratories. A mock operating theatre, fully-equipped ambulance and a community house to test the latest assistive living technologies will be among the health simulation features.

A purpose-built laboratory for teaching and research in biological and analytic sciences will sit alongside a strength and conditioning room. A sports therapy clinic and facilities for food and environmental sciences will also be part of the complex.

BAM based in Shirley, Solihull, is part of BAM Construct UK, one of the country’s largest construction services organizations. The contractor built The Hub at Coventry University, which is the social center of student campus life, and also the new Severn Trent Headquarters building which it completed in 2010.

The Hub, completed in 2011, achieved a BREEAM status of excellent. The new energy-efficient building has been designed to meet the world-leading environmental rating system for buildings.

'There are many reasons for us to be pleased – we’ve been appointed to build a really significant and exciting structure, by a client we’ve enjoyed an excellent working relationship with before, in a city we know well and treasure. It builds on our long track record in Coventry and we’ll bring a first rate team to create an outstanding learning facility that the University can be proud of,' said Rod Stiles, Regional Director.

BAM Technical Services will also be involved in the project providing temporary works and BAM Plant will provide plant, machinery and electrical services installations on site.

Oxford-based AECOM is project manager for the scheme. The architect is the Birmingham office of Broadway Malyan.

Takeda Expands Pharma Operations in Singapore

Takeda Pharmaceutical Co., Japan's largest drug company, has expanded its Singapore operations by relocating its emerging markets business unit to the city-state from Zurich, executives said at an inauguration ceremony.

Taking up the whole fourth floor of the sprawling Biopolis biomedical complex, the company's new 1,300-square-meter (13,988 sq. ft.) office also houses all its other operations that were already in Singapore, such as R&D and vaccine development.

"Takeda's decision to relocate the central hub of its emerging markets business unit demonstrates its decision to propel the momentum of the emerging market business," said Giles Platford, president for emerging markets at Takeda Pharmaceuticals International.

He said the move "also emphasizes the importance of the Asia-Pacific region as a pillar of Takeda's long-term growth strategy."

As far back as 2008, Takeda had made Singapore its headquarters for Asian business outside of Japan. One of the focuses of its R&D activities in Singapore is the development of vaccines for dengue and other diseases prevalent in Southeast Asia.

With the relocation of the headquarters of its emerging markets business to Singapore, its office here will also oversee commercial activities over areas such as the Asia-Pacific, Latin America, the Middle East and Africa.

The total number of workers hired by Takeda in Singapore is expected to jump 50 percent to 200 as a result of the relocation and consolidation.

Christopher Weber, president and chief operating officer of the Osaka-based company, said it decided to expand its operations in Singapore because of the city-state's efficiency, location, talented workforce and ease of access to and from Japan.

Beh Swan Gin, chairman of the Singapore Economic Development Board, noted in his remarks at the ceremony that eight of the top 10 Japanese drug companies have established their regional headquarters in Singapore, with some expanding their R&D presence here.

Recently, Chugai Pharmaceutical Co. announced an additional S$276 million (US$204 million) commitment to its antibody engineering lab in Singapore from 2017 to 2022, making it one of the largest R&D investments in the city-state.

SAFC Dry Powder Media Manufacturing Plant, Scotland, United Kingdom

SAFC, a business unit of Sigma-Aldrich Corporation, has opened a new dry powder media (DPM) plant at its Irvine manufacturing facility in Scotland, UK, in January 2015.

The new plant features two separate manufacturing lines that produce ACF dry powder media in batches.

The expansion adds dry powder milling and blending capabilities to the Irvine plant, which is an established center of excellence for manufacturing liquid media, buffers and reagents for the biopharmaceutical industry.

In addition, the facility features dry powder cell culture media to produce large-scale bulk dry powder media and reagents. It is designed to cater to the growing biopharmaceutical industry in European and Asia-Pacific markets.

The validated new plant now serves as the European counterpart to SAFC's center of excellence for dry powder media, and reagent manufacturing in Lenexa, Kansas.

Facilities and technology at the dry powder media manufacturing plant

The new state-of-art DPM manufacturing facility features warehouses with temperature-controlled storage areas for raw material and finished goods. Warehouses will be continuously monitored using a Facility Monitoring System (FMS).

The facility has new formulation suites with humidity control to support product lot formulation from small to large scale. Rooms will be continuously monitored for efficient operation. All process rooms in the plant have dedicated heating, ventilation and air conditioning (HVAC) systems where appropriate, and are controlled environmentally.

All equipment hold validated cleaning processes, including clean-in-place processes for fixed equipment and pipe work, clean-out-of-place processes for wash room, and an automated intermediate bulk container washer.

The facility also features a purified water plant and distribution loop producing European / US Pharmacopoeia grade water. Clean, compressed air and clean nitrogen will be supplied and distributed throughout the plant.

Manufacturing facilities, processes and technology at the new plant are similar to those at the Lenexa facility to ensure consistency in production quality at both sites.

The entire construction work at the facility complies with US Food and Drug Administration (FDA) and EU current good manufacturing practice (cGMP) regulations, and also with local safety and environmental regulations.

The plant produces animal component-free (ACF) media, which is complementary to the liquid cell culture media, buffers and reagents already being produced at the site.

In addition, the plant features two separate manufacturing lines. Line 1 is a pin type mill with a conical, auger screw pre-blender and tumble post-blender, capable of producing ACF dry powder media batches from 750kg to 6,000kg.

SAFC's Irvine facility is an 11,000m² (118,360 sq. ft.) cGMP manufacturing facility featuring liquid production facilities, quality control laboratories, and temperature-controlled warehouses.

Core technologies at the plant include automatic aseptic filling of bottles and bags, validated steam-in-place (SIP) clean-in-place (CIP) and flexible manufacturing systems, as well as disposable systems, and a wide range of testing capabilities for raw materials and finished goods.

The plant manufactures custom and catalogue formulations, liquid media, reagents and downstream purification buffers of pack sizes from 5ml to 500l, and batch sizes up to 10,000l (bags) and 6,000l (bottles).

SAFC, which provides products and services for use in regulated pharmaceutical and biopharmaceutical applications, is one of the world's top ten chemical and biologics suppliers.

The company's product portfolio includes high-purity inorganic materials for high technology applications, raw materials and biologics safety testing services for biopharmaceutical manufacturing, and high-potent APIs and key intermediates for pharmaceutical manufacturing.

Gilead to Expand Operations in UK Capital

Gilead Sciences has committed S20m (€18m) to expand its presence in the UK and will double its workforce in the country.

The California-based company is investing $19.6m into the UK, expanding its operations in Uxbridge (about 20km Northwest of London) and R&D site in Cambridge, while setting up a commercial HQ in the center of London.

The plan was announced by London mayor Boris Johnson this week during a trade delegation visit to the US East Coast, where he described the investment as underlining “the growing importance of the life sciences industry in the UK as we look to ensure that this crucial sector becomes a key contributor to the capital's growth and health.”

Gilead's total workforce in the UK is set to be around 600, with two thirds being based in London.

The manufactures the hepatitis C drugs Sovaldi (sofosbuvir) and Harvoni (sofosbuvir/ledipasvir). Since the US launch of Sovaldi in December 2013, sales of the nucleotide analog have hit over the $10bn mark, while Harvoni – approved only in October – has brought in revenues of $2.1bn.

Samsung BioLogics to Expand New Songdo Plant

South Korea's Samsung BioLogics has pledged to be a big deal in biosimilars, but so far its biologics subsidiary has produced mostly operating losses for its parent. In anticipation of turning that around, the company will undertake a significant expansion of the biologics plant in Songdo, Incheon, that it opened in 2013.

The division of Samsung Group will invest about $700 million in an expansion of the facility, the Korea Herald reports. The project is slated to be completed in 2016 and by 2017 is expected to boost its annual capacity to 180,000 liters, placing it third behind Swiss contract manufacturer Lonza and Germany's Boehringer Ingelheim.

Samsung already does biologics manufacturing for Big Pharma players like Bristol-Myers Squibb ($BMY), Roche ($RHHBY) and Merck ($MRK). But in 2012, it announced a joint venture with U.S.-based Biogen Idec ($BIIB) to create Samsung Bioepis, which would develop, manufacture and market biosimilars. The venture, which the Herald says is 93% owned by Samsung, is working on 7 biosimilars.

When the deal was announced, Biogen CEO George Scangos said that he saw value in relying on another company for the manufacturing to lower manufacturing costs. Tae-Han Kim, president of Samsung BioLogics, has said that the company's manufacturing expertise should allow it to produce biosimilars at half the cost of the reference products.

Samsung Group is looking to its biologics subsidiary to provide its next boost of growth, but so far, the Herald reports, Samsung BioLogics has been unable to generate any profits. It says the unit last year had an operating loss of 146.3 billion won ($132.3 million), up 10 times from 12.2 billion won loss in 2011.

Patheon Adds New Filling Technology to Milton Park Facility

Patheon has added a new filling technology that significantly reduces the time needed for formulation development and stability testing at its facility in Milton Park, UK.

The Xcelodose 600 S Automated Encapsulator supports early phase development for oral dose products.

The technology adds to on-site services, from early development to life cycle management of both small and large molecules, as well as enhances Patheon's Quick to Clinic capabilities.

Xcelodose 600 S manufactures active pharmaceutical ingredients (API) in capsule form for Phase I through to pilot-scale Phase II clinical trials.

The technology fills API directly into the capsules, with no requirement of excipients, and can save up to six months of development time by reducing the need for formulation development and stability testing.

Xcelodose technology offers precision at filling speeds of more than 600 capsules per hour, and is ten times faster than manual filling methods.

Milton Park manager of formulation Dr. Jon Sutch said: "With this new technology, we can bring medications to trial more quickly for our customers."

Patheon's Milton Park facility focuses on the development and formulation of semi-solid, oral liquid and solid dosage forms at the earliest development phases, and aims to bring projects to clinical trials as quickly as possible.

G-CON Manufacturing Selected to Build ISO 5 POD for Instituto Butantan

G-CON Manufacturing has been selected to build an ISO Class 5 POD for Instituto Butantan, a biomedical research center.

Instituto Butantan, based in Sao Paulo, Brazil, ordered the POD for use in clinical production of recombinant BCG, a product intended to be an improved treatment for bladder cancer.

Instituto Butantan is purchasing a standard size POD that is 3.66m x 12.80m x 3.51m.

The POD is designed to provide approximately 312 sq. ft. of cleanroom space, with a custom configuration for the filling and finishing of the clinical product.

This POD will be the first project to be delivered internationally by G-CON.

G-CON will provide shipping, delivery and installation of the POD. The company is also working with Instituto Butantan on other opportunities for applying PODs to help meet their future manufacturing needs.

Expansion for Bioanalysis Studies at the International Pharmaceutical Research Center

AB SCIEX has announced that the International Pharmaceutical Research Center (IPRC) in Jordan is investing in two AB SCIEX Triple Quad^™ 6500 LC/MS/MS Systems in order to offer new capabilities for bioanalysis studies of Phase I clinical trial compounds. The sensitivity of the 6500 Systems will enable the IPRC to detect drug compounds or metabolites in human samples down to femtogram levels for the first time, as well as increasing significantly the IPRC’s daily sample throughput.

IPRC is a privately owned CRO that has been providing clinical services, including Phase I bioanalysis studies, for pharmaceutical companies worldwide since 1997. The CRO has been inspected by Health Authorities all over the world. It has conducted over 1,000 bioavailability and bioequivalence studies to date and has been relying on AB SCIEX mass spectrometry hardware and software for seventeen years. Its five teams of chemists run eight mass spectrometry systems for 24 hours per day, in order to process hundreds of thousands of samples per year.

“These two 6500 Systems will make a significant different to our capabilities as well as to our productivity,” said Dr. Isam Salem, Vice President, Operations, IPRC. “We will be able to provide Phase I clinical trials for inhaled drugs and hormones for the first time, thanks to the extreme sensitivity of the 6500 Triple Quads. They will enable us to determine with confidence whether or not inhaled drugs are absorbed into the general circulation, even at the femtogram level.

“It’s critical that we have absolute confidence in the quality and robustness of our data when submitting clinical trials results to the regulatory bodies,” added Dr. Salem. “We have always depended on AB SCIEX hardware and software systems. We have a long and collaborative relationship with the company, based on its excellent support and high quality instruments, which have never once let us down.”

The 6500 System with Ion Drive™ Technology increases the quantity of ions produced while enhancing the way ions are transmitted and detected, increasing the limits of quantitation.

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