The Princeton, New Jersey-based company’s initial plans for the Virginia site, which began with the construction of the steel frame in 2007, included the employment of about 550 scientists, research assistants, veterinarians and administrative professionals by 2014, according to a local news outlet.

The land where the unfinished lab sits is on the border of Prince William County and is in the center of the county’s “Innovation Technology Park,” which includes space for an FBI data center. The county refused to pay for the site’s demolition, according to another local news outlet.

Projects for the site were awarded about $3.5m (€2.57m) in state and county economic development grants. Thompson told us these funds - which she described as “incentives” associated with planned development of the site - were "never released to Covance.”

Officials in Prince William Economic Development department continue to help Covance market the site, according to local reports, because of its size and proximity to the I-66 highway, as well as Dulles International Airport.

Covance seems to be making a strong push to reign supreme in the CRO industry, which is constantly consolidating.

“Our [employee] turnover rate continues to be about half of the industry average… [And] our backlog is at all-time highs,” said an upbeat Joe Herring, CEO of Covance.

He highlighted Covance’s two largest strategic deals - $1.6B (€1.17B) with Lilly and $2.2B (€1.6B) with Sanofi - noting that they’re the biggest deals ever made by a CRO. The company also has the fastest growing late clinical trial business, Herring added.

The transition to a more central lab-centric approach comes as Covance recently partnered with NeoGenomics, which was its second genetics partnership in as many months.

Analysts seem bullish on Covance, as well. Windley upgraded the shares to "Buy" from "Hold" and raised his price target for the stock from $88.50 to $105. Covance is rated “Buy” by 17 other Wall Street analysts, which have set the stock on an average of $93.69 per share.

The destruction of this site comes as Covance is looking to strengthen its preclinical work. According to Windley, preclinical work represents about 18% of its bookings.

In late December, Covance also announced that its board approved a stock repurchase of up to $100m (€128m) of outstanding common stock.

In addition to its genetics partnerships from November and December, Covance also bought a genomics lab from Merck in 2009.

Smithers Pira Michigan Laboratory Achieves Accreditation

Smithers Pira, a worldwide authority on package, paper and print industry supply chains, announced that its distribution testing laboratory in Lansing, MI, achieved ISO/IEC 17025 accreditation through A2LA. The accreditation demonstrates to clients that Smithers Pira meets stringent, internationally recognized lab quality standards.

“Our goal is to ensure that our customer’s products are packaged so that their characteristics and performance during intended use are not adversely affected by transport and storage,” states Michael Kuebler, technical director at Smithers Pira. “Smithers Pira has worked with various companies to validate distribution performance for a range of medical and pharmaceutical products including tissue implant products, inhalers and medication.”

Smithers Pira provides independent, high quality testing and consulting services to ensure pharmaceutical and medical products meet ISO 11607, an international standard that is accepted in the European Union and is an FDA Recognized Consensus Standard in the U.S.

The Smithers Pira Distribution Testing Service Center features state-of-the-art technology and equipment to test, in accordance with ISO 11607, packaging for terminally sterilized medical devices:

Seal / Closure evaluation (7.3)
Physical tests for sterile package integrity (7.4)
Physical tests for packaging performance (7.5)

A variety of specific testing for seal strength, burst, pressure, dye penetration, vacuum, aging, distribution and storage, that fall within the categories listed above, can be conducted by the experienced technical team at Smithers Pira.

“This accreditation requires rigorous processes and procedures that ensure that our laboratory meets the highest standards for independent distribution testing accuracy and quality,” adds Jim Dowey, president, Smithers Pira. “This type of quality control system is critical for pharmaceutical and medical device companies to ensure that their products perform as designed after moving through the supply chain.”

In addition to a diverse service offering for the medical packaging market, the Smithers Pira Distribution Testing Laboratory in Lansing serves key industry verticals such as the food and beverage, consumer goods, electronics and automotive markets in North America with a wide variety of package testing services. Smithers Pira experts test to specific ISO, ISTA, ASTM and other industry standards and develop custom testing protocols to ensure that product packaging will not only hold up to the challenges of the supply chain, but will also find the ideal balance of packaging cost and durability.

AAIPharma Services Completes Expansion

AAIPharma Services Corp. has completed a multi-million dollar expansion of its cGMP parenteral manufacturing facility in Charleston, SC. The expansion includes three new suites designed and built by AES Clean Technology, and equipped with a Chase-Logeman monoblock FSAS, Lytzen ISO Class 5 depyrogenation oven, BMT Steripro cGMP steam sterilizer, and SP Hull pilot-scale lyophilizer with a production-scale lyophilizer, both with ControLyo technology.

AAIPharma doubled the facility’s sterile product development and production capacity and added redundancies to its major processing equipment. Validation is underway and the new suites will be fully operational by February 2014. Also, the new production-scale lyophilizer will more than triple the facility’s lyophilization capacity by late 2014.

“Some exciting features of the expansion include low line loss and in-line weight check capabilities, which are extremely important to our clients with high-value active pharmaceutical ingredients,” said James Fife, senior director of parenteral operations. “In the coming months, the pilot and production-scale SP Hull lyophilizers will be brought online affording seamless lyophilization cycle optimization and scale-up.”

SGS to Open New GMP/GLP Lab in CA

SGS is investing in a fifth North American Life Science Services lab in Carson, CA. The 8,000-sq.-ft. Life Science Services GMP/GLP lab will provide microbiological testing and bioanalytical services. The new facility will include 6,000 sq. ft. of dedicated lab space and 2,000 sq. ft. of office space. The facility is projected to open 3Q14 and will initially employ seven scientific staff, with room to expand.

“We are very pleased to undertake this project because it allows SGS to establish a West Coast, Life Science Services presence to address the California pharmaceutical and biotechnology market,” said Jeff McDonald, chief operating officer, SGS North America.

“This development permits SGS to leverage the bioanalytical testing expertise from the laboratory in Poitiers, France, where SGS has more than 700 validated bioanalytical assays to date,” added Anne Hays, executive vice president, Life Science Services.

SGS has 20 labs offering contract analytical and bioanalytical services and is present in North America, Europe, and Asia. SGS also provides clinical trial management (Phase I to IV) and services encompassing data management and statistics, PK/PD modeling and simulation, pharmacovigilance and regulatory consultancy.

Health Sciences Biomedical Research Facility Opens at UCSD

When the Univ. of California, San Diego (UCSD) embarked on the construction of its 196,000-sf Health Sciences Biomedical Research Facility, the priority was to support collaborative teamwork and a “project-first” approach to delivering an on-time, high-quality, high-performance building that met LEED certification goals.

The project team included McCarthy Building Companies Inc., as the builder, ZGF Architects, as the designer, and The ReAlignment Group as the facilitator. A high-performance teaming approach to construction of the Health Sciences Biomedical Research Facility was used not only for this project, but also to serve as the delivery model for successful teamwork on future construction projects at the university.

Located on a 3.3-acre site within the UCSD School of Medicine campus, the Health Sciences Biomedical Research Facility was built to achieve LEED Platinum certification. The building fits within the modern design context of the academic mall, with its exterior incorporating a combination of concrete, curtain wall, metal panels and terra cotta cladding. It encompasses wet labs, open lab space, lab support and administrative support space on five stories above ground, with a vivarium, core lab space and support mechanical, electrical and plumbing (MEP) systems located in the basement.

Distinctive design features include dynamic, computer-controlled exterior solar shading systems on the east, west and south facades, representing the most extensive use of this type of shading by any building in the UC system. UCSD will study how capturing natural light in this unique manner lends itself to enhancing students’ learning abilities and study motivation. Another important feature of the building design is the exterior structural concrete work done by McCarthy.

In response to San Diego County’s water shortage, the building’s design dictated extensive reuse of water for landscape irrigation, as well as urinal and toilet flushing. Particular attention was given to the build-out of the MEP systems to ensure optimum energy efficiency.

Some of the most technically challenging aspects of construction were the basement vivarium and highly MEP-intensive areas of the overhead construction. Building information modeling (BIM) was utilized extensively to help in the coordination of these spaces.

High-performance teaming was used for the UCSD project as a way to break down company silos, create horizontal competence in teams, unify disparate groups within the various organizations and focus on the project’s success first—before individual agendas or goals.

The decision to utilize this approach was made by UCSD well before construction began. This allowed the team to focus on the tasks at hand, forecast risks and opportunities, manage systems, encourage professionalism and collaboration and resolve inevitable conflicts. Like many complex lab projects, the UCSD Health Sciences Biomedical Research Facility wasn’t void of challenges; but through this approach, team members were able to overcome potential obstacles and take proactive steps to limit risks surrounding items such as cost escalation, uncertainties related to lab functionality, unique vivarium construction/material requirements and interdisciplinary trade coordination.

High-performance teaming benefited all project stakeholders—from UCSD and its lab management, research staff, construction and facilities personnel and university students, to the contractor, architect, consultants and subcontractors. By delegating authority, promoting leadership, developing appropriate feedback systems and anticipating and invoking necessary team expansion or team changes, the process drove all project participants to “project-first” thinking, allowing them to focus on what was ultimately best for the project.

The goal of high-performance teaming for the UCSD lab facility was to ensure clear, effective and efficient communication—and to focus on the project’s success over individual agendas.

Before embarking on high-performance teaming for the UCSD Health Sciences Biomedical Research Facility, The ReAlignment Group principal, Dan Faucher, assessed the attitudes of project participants to ensure they had the appropriate level of thinking, which the team identified as follows:

Level One Thinking is about personal safety—both physical safety and career safety. It’s important that one feels safe in a work environment in order to create the opportunity for a person to excel, contribute and take pride in the success of a project. The personal and professional needs of participants in any project have to be recognized and understood. Only in a productive, safe, Level One working environment can a person move up to and work at Level Two.

Level Two Thinking focuses on team and business outcomes and organization successes. Attaining business goals contributes to the company’s health, growth and longevity. Level Two thinking is the fundamental bridge between the individual and his or her employer, securing loyalty to the organization and fostering protection of the organization’s interests.

Level Three Thinking is the point where a person can begin focusing on the best interests of a given project. Contracts form where organizational interests overlap—at the project level. In order for people to process at Level Three, they must feel safe and secure at Levels One and Two. It’s only at Level Three that project-first thinking lives and thrives. Likewise, only project-first thinking allows for collaboration and trust in delivering the project.

The most important goal of high-performance teaming for the UCSD lab facility was to ensure communication was clear, effective and efficient. Complex lab projects require close coordination with end users, together with a deep understanding of technologies, systems and unique facility usage requirements.

Typically, communication follows the silo pattern, whereby answers to important questions are routed through the company rather than discussed at the appropriate level and then having a joint response sent to the next management level. The goal for this project was for this never to be the case. This became the main reason why the team embraced high-performance teaming.

For this project, the team established that communication appropriately reflecting both the job and the level of authority of the professionals on the project was critical to the project’s success. Rather than the typical vertical configuration of company teams, the project team was re-aligned and configured to reflect authority and responsibility to the project. Therefore, James Gillie, Director of Construction for UCSD; Robert Betz, Senior Vice President of McCarthy; Joe Collins, partner with Zimmer Gunsul Frasca Architects, LLP; various consultants and executive-level employees from several key subcontractors, including mechanical and electrical, formed an executive team to make decisions regarding the project.

Project managers for each company, the UCSD lab manager and mechanical/electrical systems experts from the UCSD facilities staff formed a separate team to focus on work at the lab project, forecast risks and opportunities, decide what recommendations to make to the executive team regarding risks or challenges that arose on the job and engage in the management of the construction. Other teams dealt with implementation on the project site, supervision of crews, inspections and so forth—all with the objective of maximizing the project-first effort of the project teams.

With the project for UCSD being Construction Management at Risk, with design-assist for the major subcontractors, the team handled the project through an integrated project delivery (IPD) approach. Lean construction theory also informed the team’s processes so that it was able to design new, more collaborative and reliable partnering models. With high-performance teaming, the team incorporated techniques and strategies learned from IPD and design-build to implement these five principles, which are promoted in the collaborative models:

1. Real project collaboration: “Projects are built by people.” Therefore, collaboration of all job participants working on all aspects of the project was crucial to the timely, cost-effective delivery. High-performance teaming at UCSD led participants to regularly focus their collaborative discussions on intermediate priorities and forecast risks (to mitigate them) and opportunities (to enhance them).

2. Increase the relatedness of project participants: Traditional approaches to construction can develop adversarial relationships; however, the team changed that paradigm on the UCSD Health Sciences Biomedical Research Facility by developing project relationships founded on trust and sustained by reliable performance. When conflicts and disputes arose, they were resolved quickly in an atmosphere of trust and openness, with conscious processes that allowed resolution at the lowest horizontal cross-organizational level.

3. Projects are networks of commitments: The fundamental building blocks of design and construction are commitments. Productivity in every industry, except construction, has improved 100% since 1960. One of the most common reasons construction productivity has actually decreased in that period of time is the lack of reliable commitments. Industry studies reveal that only 56% of what people say they will do in any week is actually performed. The team’s focus at UCSD was to increase the performance of people’s commitments in order to increase the productivity on the project while maintaining costs and the project schedule.

4. Project-first thinking: Rather than optimizing the parts of the project, the participants on this project optimized the whole project. The team found that high-performance teaming drove project participants to think about people first, enabling the project leaders to think in terms of the project’s best interests rather than the legalistic “rights” of the parties. Cross-organizational, horizontal teams were taught to work in unity and to elevate issues upward to obtain authority to solve problems and keep the project first.

5. Couple learning with action: What the team learned from the project every week was communicated to all participants so that any mistakes were not made again. Project success can be learned from a best-practices/lesson-learned scenario. Team members found that high-performance teaming fosters a robust feedback system that enabled continuous reflection and action on lessons learned.

Conclusion

Through the use of high-performance teaming, the UCSD facility garnered quantitative results on all aspects of the project—from performance enhancements and delivery of a high-quality project to accommodation of a fast-track schedule, maintenance of a safe jobsite and fostering of camaraderie amongst all team members. Given the success of this approach, high-performance teaming is a concept McCarthy looks forward to replicating on future lab construction projects in the region.

GATC to Provide Support for MolecularHealth's New Lab

MolecularHealth announced an agreement under which GATC Biotech will provide its laboratory information management system in MolecularHealth's new clinical laboratory.

GATC also will provide protocols, support, and training to MolecularHealth's staff. The deal, MolecularHealth said, will complement its next-generation sequencing offerings and its TreatmentMap oncology treatment decision support platform, which is anticipated to launch in the current quarter.

"GATC Biotech has decades of experience in sequencing technology and services, and a standardized, validated, automated process," MolecularHealth CEO Lloyd Everson said in a statement. "Their proven expertise will be invaluable to our team, as we work to provide personalized, actionable information to cancer patients and their medical teams."

Financial and other terms of the deal were not disclosed.

MolecularHealth separately announced the opening this week of its US headquarters and clinical lab in The Woodlands, Texas. The office and lab occupies about 7,000-square-feet of space, and the company expects to hire approximately 40 people in 2014, it said. The lab will be equipped with Illumina sequencing equipment and offer two tests, a gene panel of more than 500 known cancer genes, and whole exome sequencing of the tumor genome.

Ampio Pharmaceuticals Breaks Ground on Manufacturing Facility

Ampio Pharmaceuticals, Inc. has held a groundbreaking ceremony to announce the start of construction of its new state-of-the-art manufacturing facility for its lead drug candidate, Ampion, for the treatment of patients afflicted with osteoarthritis of the knee. Located in the Denver Metro area, the facility is expected to be ready for production of AmpionT in the summer of 2014 and should generate approximately 40 new jobs in the next two years.

"Bioscience continues to be a key industry in Colorado and an important part of our advanced industry growth," said Ken Lund, Executive Director of the Colorado Office of Economic Development and International Trade. "We are pleased that Ampio Pharmaceuticals has chosen to increase its employee base and capital investment in Colorado." April Giles, President and CEO, Colorado BioScience Association remarked "We congratulate Ampio Pharmaceuticals on their decision to locate their new manufacturing facility in the Denver Tech Center. Ampio Pharmaceutical's decision to grow their company in Colorado and to focus on innovative methods of treating patients with debilitating medical conditions has served the company and the community well." The construction of this manufacturing facility will accomplish a major milestone for the commercialization of Ampio's lead drug," said Michael Macaluso, Chairman and CEO of Ampio. "We are excited about the prospect of bringing a safe and effective medicine to patients whose quality of life has suffered due to osteoarthritis of the knee.

Having announced positive trial results for the initial pivotal trial (SPRING STUDY) late last year, and the start of the final pivotal trial (STEP STUDY) this week, we look forward to reaching commercial-scale production of AmpionT that would follow FDA clearance of the drug. The facility will have an annual production capacity of approximately ten million doses of AmpionT. More than 50 percent of the source material, human serum albumin or HSA, required to meet this capacity has already been secured through a long-term, non-exclusive, supply agreement as previously announced."

Strouse Cleanroom Now ISO 7 Certified

Strouse’s cleanroom has been certified to ISO 7/Class 10,000 standards by Atlantic Technical Systems. The cleanroom at Strouse has been operating at this ISO 7 level for several years and now has the official certification needed for demanding medical and electronics projects that require more precision and therefore follow very strict manufacturing guidelines.

This certification denotes a maximum particle count threshold that must not be exceeded. At ISO 7 standards there must not be greater than 352,000 air particles per cubic meter. The cleanroom was inspected for several days collecting air quality samples from all over the room. After going through rigorous testing the samples came back clean and Strouse was awarded ISO 7 Cleanroom Certification.

Manufacturing in the medical and electronics industries must be closely monitored for cleanliness. If adhesives are exposed to airborne particles they could promote the growth of bacteria and mold. This could shorten the shelf life of the materials as adhesives levels change. Medical products that are often applied directly to the skin or open wounds must be uncontaminated. With the ISO 7 Cleanroom Certification Strouse can certify that the products manufactured in the cleanroom meet this standard.

Over a year ago Strouse upgraded their cleanroom by installing humidity controls with an industrial dehumidifier. These efforts to continually invest in the company and new technologies are part of Strouse’s vision.

Strouse is a die cut adhesive manufacturer serving the medical, automotive, military, appliance, and renewable energy industry, with a quality management system currently registered to ISO 9001:2008 standards. The company is located in Westminster, Md.

Maryland's institutions continue to help the state's bio economy maintain a healthy constitution.

MedImmune’s headquarters is located in Gaithersburg, Md., one of AstraZeneca’s three global R&D centers.

MedImmune’s manufacturing facility expansion in Frederick, Md., was named the facility of the year in 2011 by the International Society for Pharmaceutical Engineering.

Brace Opens Facility

On Dec. 4 during a trade mission to Brazil, Maryland’s Gov. Martin O’Malley announced that Brace Pharmaceuticals, an investment company created by EMS S/A, Brazil’s largest domestic pharmaceutical company, has opened its U.S. headquarters in Montgomery County and plans to invest $200 million in the new operation.

Located in the Rockville Innovation Center, the company is focused on the late stage clinical development of pharmaceutical products with the potential for near-term commercialization. Brace invests in research and development companies’ efforts to successfully complete their clinical trials and seek FDA marketing approval. Brace recently entered into its first venture investment in a U.S. company with Gliknik, a Baltimore-based biopharmaceutical company that is creating new therapies for cancer and immune disorders.

DK Diagnostics Expands in Maryland

Governor O’Malley also announced that DK Diagnostics, a Sao Paulo, Brazil-based biotech company, is planning to expand its presence in Maryland, invest $1 million in the new operation and grow to 20 employees over the next two years. Founded in 2004, the company manufactures and markets a parasite testing kit called PARATEST. Currently, the company has four employees in an office in Frederick and recently began manufacturing the product in Maryland.

On Dec. 11, MedImmune, AstraZeneca’s global biologics research and development arm, and The Johns Hopkins University further reinforced the R&D environment in the state by announcing they have entered into a five-year, $6.5-million research collaboration. Each party will contribute funding, personnel and materials to address important scientific questions and exchange knowledge through joint research efforts, training programs and access to specialized knowledge, facilities and equipment.

“We believe this significant collaboration with Johns Hopkins University will create a new standard on how academia and industry can work together,” said Dr. Bahija Jallal, executive vice president of MedImmune. “Our partnership with this prestigious research university will leverage each organization’s strengths, advance research in critical therapeutic areas and strengthen Maryland’s presence as a growing hub in the bioscience industry.”

The joint research projects will focus on MedImmune’s therapeutic areas of interest, including cardiovascular and metabolic disease; oncology; respiratory, inflammation and autoimmunity; infectious disease and neuroscience.

“We look forward to working alongside a company that embodies our own commitment to novel research and to bringing the benefits of drug discovery to patients in need,” said Ronald J. Daniels, president of The Johns Hopkins University. “Our relationship with MedImmune will provide our scientists and students with new opportunities to play a leading role in advancing science and improving global health outcomes.”

“We are excited about the opportunity for our scientists to collaborate with MedImmune researchers to accelerate the development of new therapies to treat a variety of serious diseases such as multiple sclerosis, rheumatoid arthritis, chronic obstructive pulmonary disease and certain types of cancer,” said Landon King, executive vice dean of the Johns Hopkins University School of Medicine. “We believe that by working together to leverage the strengths of each organization, we can make significant advances.”

The initiative is one of several regional collaborations by MedImmune to actively work with leading research institutions and the state to advance Maryland as a top bioscience cluster, foster innovative science and ensure accelerated development of key medicines.

Northwestern Taps Perkins + Will to Design Research Center

Evanston, Ill.-based Northwestern University has selected architect Perkins + Will to design a $370-million, 600,000-sq-ft biomedical research center for its medical campus in downtown Chicago.

The Chicago-based firm was selected from a field of three contenders, including joint-venture teams Goettsch Partners and Ballinger, of Chicago and Philadelphia, respectively, and Chicago-based Gordon Gill Architecture, which partnered with Payette, a Boston-based architect.

The facility will be constructed on a site occupied by Prentice Women's Hospital, a 1975 structure designed by architect Bertrand Goldberg, designer of Chicago's Marina City, a pair of multifamily high rises constructed in 1964. Although preservation groups lobbied Northwestern to adapt the iconic Prentice for research uses, the university elected to replace the concrete-clad structure with a new facility it says will better serve the needs of university researchers.

Plans for the new structure include flexible floor plans and curved glass exteriors, though design work won't be finalized until the project undergoes permitting and further planning.

Northwestern spokesman Alan Cubbage said “the combination of the elegant design and the fuctionality of the floor plans were key” in selecting the Perkins + Will scheme.

“Perkins + Will has designed a building that will be both very functional and also have great internal spaces that will encourage collaboration among our researchers,” Northwestern Vice President Eric Neilson added in a statement. “It will support our research mission and help us attract the best faculty in the country.”

Northwestern expects to break ground on the project in 2015. It eventually plans to add another 600,000 square feet to the facility.

WSU's Pharma and Biomed Building Opens

Washington State University will officially open a new Pharmaceutical and Biomedical Sciences building, a $78.6 million facility that will house integrated drug, pharmacogenomics, genomics, imaging, and proteomics research programs and core labs.

The 125,000 square-foot facility in Spokane will also house the College of Pharmacy and will be home to much of the university's biomedical research programs, including resources and staff that are in the process of relocating to the building from WSU's campus in Pullman.

The building was funded through two allocations from the Washington State Legislature, including $35 million toward construction costs in 2011, and an additional $37 million in 2012.

Research programs will fill about 44 percent of the space, while teaching and administrative activities each will use about a quarter of the building.

"The new research cores will greatly expand our research capabilities on campus to include advanced imaging technology, mass spectrometry, and genomics research," WSU Medical Sciences Director Ken Roberts said in a statement.

The new building is a major step towards WSU's long-term goal of building up a health sciences research and medical education program in Spokane, said Phil Lazarus, chair and professor of pharmaceutical sciences at WSU.

The pharmaceutical program will place "a big emphasis on pharmacogenetics and pharmacogenomics, molecular epidemiology, and cancer risk assessment," Lazarus said.

This program, which will fill two of the building's five floors, also will pursue projects focused on drug discovery and delivery, developing novel targets, and systems pharmacology.

To support these and other biomedical research programs, WSU has built up several core facilities, including a genomics core to provide high-throughput sequencing, a proteomics core, and core labs focused on nuclear magnetic resonance imaging, flow cytometry and imaging, and a vivarium.

Lazarus said the school is weighing whether it wants to add an Illumina HiSeq or MiSeq instrument to its genomics core, and will decide soon which of these it will buy based on the program's research ambitions and requirements.

He noted that WSU's investigators also have access to the many resources and facilities available through the University of Washington's Institute of Translational Health Sciences, which is UW's National Institutes of Health-funded Clinical Translational Sciences Awards program.

"They have a lot of high-throughput facilities, and I'm not sure we need to repeat that," he told GWDN.

The mass spectrometry core is up and running now, and has been outfitted with triple quad and a time-of-flight mass spectrometers, Lazarus said, explaining that in the future he expects to see the proteomics program expand, which may include the purchase of a top-of-the-line AB Sciex mass spec instrument.

The program currently is looking to hire people specifically to serve as directors of these core facilities. They would serve as research-track staff members, not tenure-track faculty, he said.

As an example of the types of "highly translational" research the pharmaceutical program will pursue, Lazarus pointed to his own ongoing study. He is working on a multi-institute study of 4,500 women of the effects of an aromatase inhibitor called exemestane that is commonly used to treat breast cancer.

"Our project is to look at how exemestane is metabolized in the body, and are there specific genotypes in those metabolizing pathways which could affect toxicity and efficacy."

His team is working with its partners at Queens University, Harvard Medical School, and Pennsylvania State University to compare toxicity data, outcome data, metabolites, and genotypes.

On WSU's long-term ambition to create a health sciences research center in Spokane, Lazarus said the region is a natural fit for such a program because of its geography.

He said that tapping into the region's clinical resources will be "a major emphasis" of WSU's pharmaceutical and biomedical programs going forward.

"The biggest industry in Spokane, of all things, is the health industry. The reason is because between Seattle and Minneapolis … there are no big cities," said Lazarus. "We serve a fairly large area. [From] anywhere between the mountains outside of Seattle and inner Montana, people come here. We have several major hospitals with a lot of beds, and they get a large patient population. They are extremely enthusiastic about collaborations with an academic center."

Plexus Spends $3 Million to Triple Cleanroom Capacities

Plexus Corp. has made a $3 million investment to expand operations in its Boise Microelectronics Center of Excellence in Nampa, Idaho. This investment will triple the size of the ISO 7, Class 10,000 compliant, cleanroom facility and upgrade specialized manufacturing equipment.

"The expansion of our microelectronics capability not only increases our capacity to meet our customers' demands, but also includes equipment upgrades that enhance our service offering,” says Andy Edgin, Microelectronics Business Director. “With this investment, we are implementing continuous flow manufacturing methods directly within the cleanroom and increasing the speed and accuracy of our equipment to align with the latest microelectronics technologies. In addition to our investment in facilities and equipment, we continue to enhance our team's capabilities by adding talented engineering and technical resources that align with our product development engineers to offer a full suite of solutions. These changes will deliver significant gains in efficiencies and provide additional flexibility for our customers."

Plexus integrates product conceptualization, design, commercialization, manufacturing, fulfillment and sustaining services to deliver end-to-end solutions for customers in the America, European, and Asia-Pacific regions.

SMC Completes Cleanroom Expansion Project

SMC Ltd., a medical device contract manufacturer with locations in California, Wisconsin, Massachusetts, Ohio, Costa Rica, and India, has completed a 10,000-square-foot Class 8 cleanroom (Class 100,000) expansion project in its Santa Rosa, Calif., facility.

The expansion project converted existing white room manufacturing into a Class 8 cleanroom. The expansion also allows for increased assembly area in the existing Class 7 cleanroom allowing the firm to better serve customers' cleanroom needs. In addition, a 2,000-square-foot area has been dedicated to new product development and training.

“The 10,000 sq. foot expansion in California provides SMC customers with additional clean- room options allowing greater solutions for full device manufacturing and assembly,” said TJ Shadid, SMC's Santa Rosa facility manager.

SMC Ltd. is a global contract manufacturer offering design, molding services, and finished devices for the medical and pharmaceutical industries. The company’s facilities provide more than 600,000 square feet of space for high- and low-volume medical manufacturing. The Company’s medical operations offer ISO 13485, quality systems, white room, Class 7 and 8 cleanrooms with services including; design, engineering, thermoplastic molding (including 2-shot), LIM (liquid injection molding), project management, secondary operations, validation, micro molding, assembly, and kitting and packaging of finished devices.

Strand Partners with El Camino Hospital on Genomics Center

Strand Life Sciences said that it is collaborating with El Camino Hospital to establish the Strand Center for Genomics and Personalized Medicine at the Genomic Medicine Institute of the El Camino Hospital.

The aim of the center will be to accelerate the adoption of next-generation sequencing-based research panels and counseling services by physicians at El Camino Hospital and its partner clinics. El Camino's Genomic Medicine Institute is based in Mountain View, Calif., and is focused on bringing personalized medicine to the clinic.

Bangalore, India-based Strand said that it signed a letter of understanding with officials from El Camino to launch the new center. It said that the collaboration would bring genomic tests for cardiology, oncology, pharmacogenomics, and other personalized medicine applications to the community served by the hospital.

"ECH is focused on the practical aspects of clinical medicine, while Strand's expertise, as embodied by their tagline, lies in providing 'Algorithms for Life.' So it is a perfect marriage between partners with diverse expertise and a unified vision," Eric Pifer, chief medical officer of El Camino Hospital, said in a statement.

Catalent Expands Plant for Pharmacyclics

Catalent says it is creating dedicated space and possibly jobs at its Missouri facility in order to service a commercial contract for Pharmacyclics’ oncology drug Imbruvica.

The contract development and manufacturing organization (CDMO) has manufactured clinical supplies of Imbruvica (Ibrutinib)on behalf of Pharmacyclics for more than three years, a company spokesman said, and following approval from the US Food and Drug Administration (FDA) earlier this month, Catalent will now provide drug product capsules for commercial supply.

The drug is manufactured from Catalent’s Kansas City, Missouri, facility acquired in 2011 from Aptuit and as part of continued global investment the site will see the firm “building out dedicated space to accommodate the commercial volume” from this extended partnership.

“[Kansas City] provides a wide range of fully integrated support services from formulation development and analytical testing to clinical supply services as well as clinical and commercial manufacturing for oral dose forms,” and “the expansion is scheduled to be completed by the middle of 2014, and Catalent will announce further details in the near future.”

The agreement was reached after the 450,000 sq. ft. site underwent an FDA Pre-Approval Inspection that resulted in zero observations, the company said.

In a statement Heow Tan, Chief of Technical Operations at Pharmacyclics, said: “It is important that we work with a development partner with expertise in both clinical and commercial supply as well as US and worldwide GMP regulations, to ensure reliable quality supply to patients.”

“Catalent currently employs 334 workers in Kansas City, and it is likely that we will increase the number of employees to accommodate this and other recently announced programs at the site.” said the company.

Furthermore, the site has been strengthened by two other partnerships reaching regulatory approval announced in the last year. In December 2012 Exelixis’ Cometriq (cabozantinib) gained FDA approval, and a month later Aegerion’s Juxtapid (lomitapide) also got the thumbs up (and subsequently European Commission approval).

Caltech, LightLab: Resnick Sustainability Institute and Center for Artificial Photosynthesis

This complete renovation of a 30,000-sf, three-story, concrete, university computational center constructed in 1971 combines two new university centers for sustainability research into one 35,700-sf lab facility that includes: the Resnick Institute for Science, Energy and Sustainability, whose mission is to address challenges related to all aspects of energy; and The Joint Center for Artificial Photosynthesis, that seeks to invent a highly efficient photovoltaic panel.

The project had four significant challenges: a complete revamping of the function of the facility from a computer science space to a building full of wet labs; two distinct research centers, each constrained by the space; a very robust program desire accompanied by not enough funding; and a very tight schedule set by the U.S. Dept. of Energy, which partially funded the project.

The major architectural decisions included the following: removing the original overhanging concrete sunshades that served only to block much needed light and views; introducing a skylit atrium and stair to create vertical connectivity between the building’s researchers; building over an unused second-floor terrace to add 4,700 sq. ft. of research space; replacing a bulky entry bridge that separated the building from the surrounding campus with a light-filled pavilion for the education of school groups, informal lounging and social interaction and for special events; removing all of the existing partitions that had rendered the original structure a maze-like collection of small rooms, and created a well-proportioned set of spaces that combines communal workspaces, conference rooms and lounges with offices, labs and write-up spaces for the researchers.

Lab casework was designed to be flexible, and while California code requires that it be attached to the floor, it is easily picked up and moved elsewhere, making it easy to reconfigure and recycle them. The site reduces the two-year, 24-hr design storm run-off by 25% as compared to pre-development conditions, and provides TSS removal efficiency of 86% through a combination of mechanical filtration and bio retention. The site landscape design reduces irrigation demands by 52 percent.

The project achieved LEED Platinum. The coordinated use of BIM and other 3-D software, in addition to energy modeling and analysis programs such as Ecotect, was necessary to ensure that each proposed building system was carefully explored—not only with respect to performance, but also to dimensioning and sizing relative to available space (the 11-ft-high floor-to-floor height was a very restrictive restriction). Performance-wise, the traditional neutral dual-duct HVAC system proved, when innovatively utilized to specifically target fume hood energy usage, to be most effective—and this solution was backed up by energy analysis as executed by the design team.

Project team: John Friedman Alice Kimm Architects, Los Angeles, Calif. (architect); Jacobs Consultancy, Solana Beach, Calif. (lab planner); Buro Happold Consulting Engineers, Colver City, Calif. (MEP); Saiful/Bouquet Structural Engineers, Pasadena, Calif. (structural engineer); VCA Engineers, Solana Beach, Calif. (civil engineer); DPR Construction, Newport Beach, Calif. (contractor)

Cornell Univ., College of Agriculture & Life Science, Stocking Hall, Ithaca, NY

Built in 1921, Stocking Hall’s 48,000-sf building and its runway extension no longer met the expanding needs of the university’s Food Science program. The renovation of Stocking Hall and construction of a new food science teaching and research facility creates a new, integrated presence for Food Science on Cornell’s Ithaca campus. The four-year project, the first phase of which was recently completed, includes the full renovation of Stocking Hall, the demolition and replacement of the runway extension and the construction of a new 79,000-sf lab building and 23,000-sf dairy plant. The renovated portions of Stocking Hall house offices and teaching labs for food chemistry, microbiology and engineering. The addition includes advanced research labs for food biophysics, chemistry, functional foods and nutraceuticals, engineering, microbiology, food safety and milk quality improvement. Also included is a dairy plant, a teaching winery and a sensory lab testing suite.

In keeping with the university’s goal of becoming a carbon-neutral, “net-zero” campus by 2050, the project was designed to achieve LEED Gold. The energy-efficient building envelope and high-performance mechanical equipment in conjunction with the campus chilled water and steam distribution network will contribute towards reducing the building’s energy costs by over 44% annually compared to benchmark buildings. A sophisticated lighting control system automatically dims interior lighting based on available daylight and allows individual spaces to be centrally “tuned” to optimize lighting efficiency. All electrical loads in the building are sub-metered by space and type to allow the university to closely monitor energy use. Highly efficient plumbing fixtures will result in a significant reduction in the annual use of potable water compared to traditional plumbing fixtures, thereby saving both water and energy. Building materials produced locally with high levels of recycled content were utilized and only low-emitting paints, coatings, adhesives, sealants, composite woods and flooring systems were installed. Additionally, the project diverted over 75% of construction and demolition waste from landfills and into recycling programs.

The project also features a number of highly visible sustainable design elements including an 8,000-sf vegetated roof that insulates the building envelope while reducing water runoff and minimizing the “heat island” effect. Exterior sunscreens on south facing windows block solar gain while maximizing daylight and views. An electronic, interactive “dashboard” in the lobby highlights the building’s sustainable design features and allows visitors to monitor the building’s energy use in real time.

Because Stocking Hall is home to the cross-disciplinary Food Science Dept. the labs have been designed with the flexibility to support microbiology, chemistry and engineering. The modular special equipment rooms and fume hood alcoves at the center of the building can meet the needs of all disciplines. The bench zone at the perimeter provides flexibility with its open horizontal plan as well as with the alternating movable bench system. The overhead services facilitate the introduction of large-scale equipment within the open lab area.

Budget: $63 million

Size: 187,000 sq. ft. (105,500 sq. ft. addition, 81,500 sq. ft. renovation)

Project team: Mitchell/Giurgola Architects, LLP, N.Y., N.Y. (architect); Ysrael A. Seinuk, PC, N.Y., N.Y. (structural engineering); ME Engineering, PC, Rochester, N.Y. (MEP); T.G. Miller, PC, Ithaca, N.Y. (site/civil engineering); Jacobs Consultancy, N.Y., N.Y. (lab planner); Gilbane Building Company, Albany, N.Y. (CM)

The completion of the phase II Stocking Hall renovation is expected in August, 2014.

Center for Advanced Forensic DNA Analysis Opens

The Genome ID Group has established The Center for Advanced Forensic DNA Analysis in Greenville, N.C. The center is a joint effort of Pitt County, Greenville, and the NC Biotech Center and currently has 10 employees with plans to increase that number to 130 and expand within its 11,000 square feet building "in line with business growth," it said. The new center is a full service forensic genomics lab, and offers forensic analysis of biological evidence from crime scenes.

GlaxoSmithKline to Open Cambridge Office

The British pharmaceutical giant GlaxoSmithKline PLC, which in March closed the Cambridge headquarters of an anti-aging biotech start-up it had bought earlier, confirmed it plans to open a new research and development office in the city next year.

“Our intention is to have an office in Cambridge with a small staff,” Melinda Stubbee, a US spokeswoman for Glaxo, said. The global drug maker plans to hire a Cambridge research leader and find office space during the first quarter of 2014.

Glaxo will join multinational life-sciences companies such as Pfizer Inc., Merck & Co., Johnson & Johnson, Novartis AG, Sanofi SA, AstraZeneca PLC, and Shire PLC. All have set up shop or expanded operations in the Boston area in recent years to capitalize on university and hospital research and collaborate with the area’s cluster of biomedical start-ups.

Stubbee said Glaxo wants to be “a partner of choice and become a more integral part of the local Boston and East Coast ecosystem of venture capital, biotechs, and academic institutions.’’

The move in Cambridge, coupled with a plan to open a satellite office in San Diego, is part of a broader push to increase Glaxo’s presence in research hubs worldwide.

Glaxo paid $720 million for Sirtris Pharmaceuticals Inc. in 2008. Scientists at that Cambridge biotech were studying the anti-aging effects of a red wine chemical called resveratrol and trying to develop drugs that activated enzymes called sirtuins to fight age-related diseases. The nature of their work attracted widespread attention, but the company was not able to bring a product to market.

In March, the British drug company said it was pulling up stakes in Cambridge and folding the Sirtris operation into a research and development center in the Philadelphia area.

Even after that pullback, Glaxo has continued its partnerships with a number of biotechs and academic collaborators in the Boston area, including the Harvard Stem Cell Institute. It is also majority owner of Tempero Pharmaceuticals Inc., a four-year-old Cambridge company that is developing therapies for a variety of conditions, from inflammatory bowel disease and psoriasis to lupus, multiple sclerosis, and rheumatoid arthritis.

REST OF WORLD

Laboratorios Inibsa Gets New Capsule Filling Facilities

Laboratorios Inibsa has obtained authorization from the Spanish Health Ministry for its new capsule filling facilities, in accordance with EU-GMP (good manufacturing practices).

This investment will allow an increase in the production capacity for hard shield gelatin capsules, as well as improving the quality of the manufacturing process for finished products.

Due to the new equipment, IMA-ZANASI PLUS 48 E Inibsacanreach has a filling rate of nearly 48,000 capsules per hour with pellets or powder with a high-accuracy in the dosage weight.

Josep Lajara, supply chain director of Laboratorios Inibsa, said: "I hope that this will allow us to win more customers who have products in hard shield gelatin capsules, now that we can offer a process of filling, which brings together high-quality and competitive prices."

Harlan Labs to Open Research Model Facility in India

Harlan Laboratories announced the site of its first research model breeding facility in India. The new facility will be located in the Genome Valley Alexandria Technology Park in Hyderabad.

Harlan has provided research models to the Indian market for 10 years and has developed strong relationships with many leading life-science researchers. Opening a SOPF breeding facility in this market represents the next step in Harlan's continuing growth initiatives and commitment to the research community in India.

"Harlan supplies research models to more than 60 percent of the Indian research market and has a large concentration of customers in the Hyderabad-Bangalore region," said Stuart Frith, global vice president of business development. "Opening this facility will allow us to better serve our current customers and increase our global presence within the Indian market."

According to Joe Meyer, vice president of global commercial operations, Harlan Laboratories, the time is right for Harlan to open a research model production facility in India.

"Life science research in India continues to expand and the need for high-quality models continues to grow," said Meyer. "Having a physical presence in the region will yield numerous benefits to our customers, including having access to a consistent supply of high-quality models and improved animal welfare."

While Harlan's initial focus will be on providing SOPF-quality oncology models, the company will have the scalability in place to further expand model selection based on customer needs. Harlan is currently in the process of configuring the acquired space to meet its stringent biosecurity and production requirements. Shipments from the new facility will begin in 2014.

USP Inaugurates Expanded Shanghai Facility

The U.S. Pharmacopeial Convention (USP), a nonprofit global health organization that creates and promotes quality standards for medicines, herbal medicines/dietary supplements and food ingredients, marked the official inauguration of its expanded state-of-the-art laboratory and administrative facility in Shanghai, China.

“This is a tangible demonstration of the importance and value that USP and our counterparts in China place on assuring the quality of medicines, herbal medicines/dietary supplements and foods in China, the US and in all countries around the world,” said Roger L. Williams, M.D., chief executive officer of USP. Williams celebrated the official opening of the new Shanghai site with a delegation of USP volunteers and leadership staff, along with representatives from China, the US Food and Drug Administration (US FDA) and other local and international dignitaries. Volunteer representation came from USP’s Board of Trustees and standards-setting body, the Council of Experts.

Williams noted the inauguration marks the beginning of a week-long series of symposia, workshops and training programs in Shanghai, along with meetings concerning Memorandums of Understanding (MOUs), advisory groups and expert committees. This series of meetings will highlight issues such as global quality standards for medicines; rapid testing technology to detect counterfeit and substandard medicines and foods; food standards, food testing and issues related to food adulteration and contamination; and other presentations regarding food and drug quality standards.

These forums and educational programs feature presentations from experts drawn from different parts of the world, focusing on cooperative efforts involving USP, the Chinese Pharmacopoeial Commission (ChP), China’s National Institutes for Food and Drug Control (NIFDC) and the China National Center for Food Safety Risk Assessment (CFSA). Representatives of World Health Organization and the US FDA are also attending various events associated with the inaugural week.

Williams said the expanded USP site in Shanghai features 95,000 square feet of space for laboratory facilities which have been designed to not only address today’s challenges related to product quality, but also to evolve and grow as new issues emerge. Additional administrative space may be used for education, training and allied activities associated with USP’s core standards-setting work. In addition to Shanghai, USP operates laboratories in São Paulo, Brazil; Hyderabad, India; and at USP’s headquarters in Rockville, Md. (USA).

“Having a facility of this size and capability on the ground in China is extremely valuable, especially in a city like Shanghai, which has become a significant part of global pharmaceutical R&D and manufacturing,” said Williams. “This location will provide improved opportunities for USP to connect and communicate with Chinese-based manufacturers and regulators; expand training and technical outreach; work jointly on documentary and physical standards; translate USP’s compendia into Chinese; promote the value of visiting scientist programs and other cooperative efforts.”

Williams explained that the pharmaceutical industry and the pharmaceuticals market in China are both growing rapidly. China is also a large and growing force in the production of generic drugs. China’s regulatory and compendial leadership has expressed its commitment to advancing modern, relevant standards for medicines and foods, and USP has joined in this effort via MOUs with ChP, NIFDC and CFSA. Given USP’s role in law in the United States, where the current official versions of United States Pharmacopeia and the National Formulary are referenced and enforceable by the US FDA, USP has also worked closely with FDA and its staff in China to advance good standards for foods and drugs.

“We live in an ever-shrinking world, which makes the quality of products made and sold in China just as important as the quality of products made and sold in the United States,” Williams said. “The global flow of products means that quality issues can have a wide impact and having a facility in China allows USP to work more closely with developments in this important industry.”

Williams added that the expanded presence in Shanghai is another step forward in a relationship whose groundwork was laid nearly a century ago, with the first translation of USP standards into Chinese in 1923.

In recent decades, USP outreach to China has intensified, starting with a 1990 visit to ChP. The following year, Mr. Wang Ping (currently the Deputy Secretary General of ChP) became the first Chinese scientist to participate in the newly established USP Visiting Scientists Program and the years since have seen the relationship continue to evolve and expand.

In inaugurating its new facility, USP expresses sincere appreciation to its hosts in China, which reflect a broad array of government bodies both centrally and in the district city of Shanghai, together with representatives from manufacturers, academicians and many other stakeholders from civil society.

Belgian CRO Genae Opens Swiss Facility

Genae Associates has expanded its European reach by opening an office in Switzerland to offer clinical trials and research projects relating to medical devices.

The medical device focused contract research organization (CRO) - a privately owned offshoot of genae - is headquartered in Antwerp, Belgium, and this news announces a second European location for the firm.

According to CEO Bart Segers, the new site will organize clinical trials and research projects for clients, and will employ between five and ten full time staff members in the next few years.

“[The office] can act as intermediate and provide consultancy within the medical sector,” he said. Furthermore, “because of its mixed status as an operational and holding company, it may acquire, hold and manage participations in other entities.”

Located in Zurich, the second site is “ideally located,” according to Segers, due to the “clinical site proximity, both in Switzerland and abroad.”

Whilst the larger players in the outsourcing industry offer both a vast number of therapeutic areas and physical locations, the smaller firms are - according to some experts, such as Parexel’s Christian Buhlmann - being forced to adapt either through merging or by offering niche services.

However, we asked Segers if this was the case for Genae and how his firm dealt with the rise of multinational CROs.

“Genae differentiates itself by focusing on medical devices,” he said. “We collaborate with other CRO’s and ARO’s who appreciate this clear focus.”

Back in October the firm signed an agreement with Yale University’s Cardiovascular Research Group in order to cross-market platforms, share facilities and staff, and sharing and subcontracting monitoring regulatory, safety, core laboratory, data management and statistical analysis services.

Aesica Containment Facility, United Kingdom

Aesica, a supplier of active pharmaceutical ingredients, opened a new High Capacity Manufacturing facility at its Queenborough site in September 2013.

The facility was constructed with an investment of £30m, as part of an expansion plan announced in July 2012. The new facility covers an area of 10,000m2 (107,600 sq. ft.). It produces solid dose medication products for treating Type 2 diabetes in adults.

It will started production in November 2013. It implements Buck®Valve split butterfly valve technology for contained transfer of potent powders.

Located in Isle of Sheppey, Kent, England, the Queenborough facility was acquired by Aescia from Abbott Laboratories in September 2007. The deal, which included a five-year supply agreement with Abott Laboratories, tripled the workforce of the company, boosted capacity and took Aesica into secondary manufacturing.

The Queenborough facility received the US Food and Drug Administration (FDA) approval in 2012.

The new high-potency facility houses multiple suites for granulation, tabletting and blister packing. All the suites are equipped with appropriate heating, ventilating, and air conditioning (HVAC) and cleaning facilities. To avoid any occurrence of cross-contamination, the facility has a segregated unit constructed at a distance from the remaining facilities of the company.

The company says that the design and construction of the purpose-built facility is in conformance with environmental requirements. The new facility is equipped with security systems that ensure the production of Schedule II controlled drugs including opiates.

The multi-purpose Queenborough facility is designed in compliance with ISO14001 standards. It is equipped with a range of capabilities including production of solid dosage forms, anesthetics, and controlled medicines and packaging facilities that accommodate blister packs, sachets and bottles.

The facility has increased the company's formulation and packaging capacity of liquid and solid dosage forms. Its construction was started in August 2010 and completed in November 2011. Aesica invested €3m ($4.6m) on the construction.

The new facility allowed Aesica to expand its formulation offering in the growing market for contract manufacturing of high-potency drugs.

The Queenborough facility is equipped with a range of technologies including high shear granulation, low shear granulation, fluid bed drying, tray drying, blending, compression, bi-layer compression, tabletting with B&D tooling, film coating, liquid manufacturing, blister packaging, solid bottle filling, liquid bottle filling, sachet filling and capsule filling. Other technologies include those for control release, alcohol-based liquids and device assembly.

The high potency facility allows Aesica to develop Schedule II controlled substances, potent active pharmaceutical ingredients (API) and intermediates that are classified as Category 3 by Safebridge Consultants, Liverpool UK.

The facility boosts Aesica's the production capacity of Schedule II compounds. Aesica began production of Schedule II compounds in 2009 after the approval of its Cramlington, Northumberland facility. Compounds categorized as high potent are effective in treating a range of diseases at low doses.

The compounds, however, have to be produced in an environment equipped with appropriate safety measures.

The Queenborough facility specializes in the production of drugs containing APIs that require special handling needs including high potent medicines or controlled substances. It also manufactures a range of formulated products including anti-infectives, cardiovasculars, anti-virals, anaesthetics, anti-inflammatories, haematinics and hormones.

The products are manufactured in solid dosage forms, liquid dosage forms, anaesthetics and potent drugs. The facility can additionally perform packaging in bottles, blister packs and sachets.

The facility can operate at an annual wet granulation capacity of more than 500t, including low shear, high shear and fluid bed drying. Annual tablet production capacity including single, bilayer and film coating is more than 2bn.

The facility can additionally manufacture 1.5m liters of liquid at non-critical temperatures and up to 300,000l of liquid at critical temperatures every year. Blister packaging capacity of the facility is 90m packs per annum.

The facility can also pack 15m bottles of solids including tablets and granules and 14m bottle packs of liquids every year.

ScinoPharm Completes New Chinese API Plant

Taiwan-based API maker ScinoPharm has completed construction of a new $133 million (€96m) manufacturing and process development centre in Changshu, China.

The new facility will make active pharmaceutical ingredients for both the Chinese and international markets and – according to ScinoPharm - is the first plant in China built in accordance with manufacturing standards issued by the SFDA in 2010.

ScinoPharm's revenue figures indicate that the US is the API maker's biggest individual export market, followed closely by Ireland and Italy. Aside from Taiwan, ScinoPharm groups all of its other export markets together which makes it hard to tell how many APIs the firm sells in China at present.

Nevertheless, the firm clearly wants to build its business in China and sees the new facility – which has already received drug production licenses for 4 API products from the Chinese FDA – as a key part of this effort.

In a press statement the firm said that: “serve as the base for the company to develop its API business in China” claiming that it has already developed nine of the top 20 oncological products used in the country.

The site also complies with U.S. and EU current good manufacturing practices (cGMP) according to ScinoPharma, which said that the plant also gives it capacity to “quickly respond to the demands of the market.”

The construction of the new facility was accompanied by some significant changes at ScinoPharm, beginning in 2010 when U.S. generics and biosimilars firm Watson, now named Actavis, sold its 31 percent stake in the API maker.

Since then ScinoPharm has gone public, grown its API export business and signed several major manufacturing contracts, including the production of the APIs for Clinical Data’s antidepressant Viibryd and Supernus Pharmaceutical’s antiepileptic Trokendi XR.

And, earlier this year, the API maker took its first step toward developing its own range of drug products. In January the firm teamed up with delivery technology firm Foresee Pharmaceuticals to develop a range of peptide-based medicines.

Merck to Build German Plant

Merck KGaA subsidiary Allergopharma has begun construction on a €40 million ($55m) facility to produce products for type 1 allergies.

The site, in Reinbek near Hamburg, Germany will have an area of more than 6,000m2

(64,560 sq. ft.) containing cleanrooms for production, as well as plant engineering technology, and is being built - in part - to expand production of allergy therapies in new markets, including China.

The firm’s Allergen-specific immunotherapy involves administering increasing doses of allergens with the aim of improving the allergic response and is, according to Allergopharma, the only causal treatment for allergies to unavoidable allergens available.

“We want to fully exploit the potential of our business, whether in Emerging Markets or in rapidly growing and highly promising areas such as the global allergy market,” Stefan Oschmann, a Merck executive board member said.

“With this investment, which is largest in the history of Allergopharma, Merck is setting an important milestone to expand the Allergy business internationally and to secure the future of the Reinbek site.”

The facility is expected to be completed in 2016 and will employ, initially, 40 people.

Phillips-Medisize Expands Finland Plant and adds Cleanroom

Phillips-Medisize, a US-based contract manufacturer to the medical device, drug delivery and pharmaceutical markets, has started production at the 6,000m2 (64,560 sq. ft.) expansion to its site in Kontiolahti, Finland.

The site focuses on the production of inhalers, insulin pens, transfer devices and syringes.

The expansion includes 1,200m2 (12,912 sq. ft.) of Class 8 cleanroom manufacturing and assembly, and has space for further expansion for molding machines and assembly.

New high-speed automation lines enable the ramp up of multi-component, complex drug delivery devices from prototype to automated 24/7 mass production. The plant has multiple high-speed, fully automated assembly lines; fully automated printing lines; and several semi-automated lines.

Matt Jennings, President and CEO of Phillips-Medisize, said: 'The ISO 13485 multi-site QMS certified expansion brings our medical manufacturing square footage to over 92,900m2,

(999,604 sq. ft.) with 25,000m2 (269,000 sq. ft.) of cleanroom. This, coupled with extensive in-house tooling, state-of-the-art metrology, high volume automated assembly capabilities, innovative technologies, and creative people, upholds our mission to provide the highest level of satisfaction to our customers.'

Phillips-Medisize has annual sales of US$500m with 75% coming from drug delivery, medical device, primary pharmaceutical packaging, and diagnostic products such as disposable insulin pens, glucose meters, inhalation drug delivery devices, single-use surgical devices and consumable diagnostic components.

Alvotech 'Exploding' into Biosimilars with $250 Million Iceland Plant.

Alvogen has branched into biomanufacturing with plans to build a $250 million (€182m) facility in Iceland to produce biosimilar monoclonal antibodies.

The generic drugmaker has set up Alvotech in a bid to take advantage of market opportunities presented by antibodies coming off patent and the increasing interest in biosimilar drugs. The new organization will be based at a purpose built facility being constructed in the science park of the University of Iceland, in Reykjavik.

The first monoclonal antibody biosimilar was approved in Europe earlier this year and in preparation for this venture the firm has already secured key monoclonal antibodies in development which are going off patent from 2018, said Alvotech CEO Andreas Herrmann.

“While currently available biosimilars were taken up in Western Europe slowly, they were taken up very rapidly by East Europe and emerging markets,” he said.

Greater confidence in these drugs, cost pressures within the health care markets and the loss of exclusivity for a number of big products will, he continued, lead to the next generation of biosimilars being taken up much faster worldwide.

Alvotech broke ground in November, 2013 on a new 11,800 sqm (127,000 sq. ft.) development and manufacturing facility, where it will produce its own developed biosimilars, the first of which are already in advanced development stage (molecule names undisclosed). Located in the science park of the University of Iceland in Reykjavik, the site will provide Alvotech with a state of the art, fully vertically integrated biologics manufacturing plant.

The plant itself is set to be operational in early 2016 and will create around 180 jobs. Technology wise, it will house twelve 1,000L disposable bioreactors, as well as fill-finish capabilities for syringes and vials.

Alvogen already has some experience in biosimilars, being in partnership with Hospira and selling across the Central and Eastern Europe (CEE) region for the past few years.

“The creation of Alvotech further strengthens our capabilities as Alvogen will distribute Alvotech products in its markets,” Herrmann said.

However, he added, this would not restrict Alvotech’s business as the firm intends to work with partners other than its parent company including contract manufacturers and firms to whom it could out license its portfolio.

Iceland is a favorable location offering a strong regulatory system, low operating costs, a great talent pool, high quality standards and a convenient geographical location between the EU and US that is within easy reach of the rest of the world.

Alvotech is headquartered in Reykjavik. The “Land of Fire and Ice” may not have as many drug developers or research universities as Europe’s larger bioclusters such as in Germany and the United Kingdom, but Iceland has made some big splashes in biotech, the most familiar to Americans probably being the success of deCODE Genetics, which overcame bankruptcy protection from creditors to build alliances with big pharmas before Amgen snapped up the company for $415 million, in a deal announced in December 2012.

Alvotech and Alvogen say Iceland offers the advantages of a strong regulatory system, low operating costs, a great talent pool, high quality standards, and a convenient geographical location between the European Union and United States that is within easy reach of the rest of the world.

Patheon Expands Capabilities at UK Facility

Patheon is increasing solid dose capabilities at its European sites, with the latest investments being made at its UK facility, Milton Park.

This stand-alone early development center will now offer automated capsule filling, instrumented tablet compression and tablet coating capabilities as well as increased manufacturing capacity. These upgrades will include DoE and QbD enabled equipment and expansion of time-saving disposable technologies to include tableting.

The Milton Park facility will now have the capability to manufacture supplies for up to Phase IIb studies with seamless transfers to Patheon's recently upgraded Bourgoin, France, site for later stage clinical trials on compatible, scalable equipment.

Milton Park will also now offer a wider range of dose forms: capsules, oral liquids, suspensions, tablets, microtablets and multiparticulates, as well as controlled-release coating technologies.

This is in addition to established capabilities in high potency API handling, manual filling of up to approximately 10,000 capsules per batch, and the Quick to Clinic™ service offering for rapid results in early stage projects.

"This latest investment in Milton Park will enhance our flexible early development offerings with a wider range of dosage forms, technologies and capacity, all from one purpose-built facility," said Jon Sutch, manager of formulation and clinical trials manufacture, based at Patheon's Milton Park facility.

"It positions Patheon as Europe's strategic partner of choice for oral dose early development."

TxCell's Manufacturing Facility Approved

TxCell, a biotechnology company specializing in the development of personalized cell-based immunotherapies, has received manufacturing accreditation status of its cell-therapy production site in Besancon, France, from the French National Agency for Drug Safety (ANSM). TxCell develops antigen-specific regulatory T-cells (Ag-Tregs) for chronic inflammatory and autoimmune diseases.

The company’s manufacturing facility, located at the French National Blood Center of Bourgogne Franche-Comte region, is now authorized to produce biological investigational medicinal products in accordance with the European Union Directives 2001/83/EC and 2001/20/EC, as required for the manufacturing of Advance Therapy Medicinal Product (ATMP). The company will now be able to manufacture batches of Ovasave (its lead autologous Ag-Treg cell-based immunotherapy) for clinical testing in patients with Crohn’s disease. The 440 m2 (4,734 sq. ft.) facility includes 120 m2 (1,291 sq. ft.) of cleanroom suites of which 80 m2

(861 sq. ft.) are Grade B suits under GMP EU classification. TxCell has a manufacturing capacity of more than 20 cell therapy batches in parallel.

“This manufacturing accreditation from ANSM is a key milestone in the planned future development and growth of TxCell,” said Damian Marron, CEO of TxCell, in a press statement. “This is essential for scaling up manufacturing of TxCell’s lead product Ovasave for our forthcoming Phase IIb in refractory Crohn’s Disease. This in turn allows us to accelerate the development of all our innovative, personalized cell-based immunotherapies. These therapies target niche and orphan indications for which there are few or no treatment options and a high unmet medical need.”

Endress+Hauser Opens Plant in Brazil

The Endress+Hauser Group has strengthened its position in the South American market. The Swiss specialist for measurement engineering has invested more than €8m in a new production facility for flow, level and pressure measuring instruments in Brazil.

The plant in Itatiba, around 100km north of São Paulo, has now been inaugurated.

Endress+Hauser manufactures more than 2,000 products, many of which are available in millions of design variants.

"Regional production in China, India, the U.S. and most recently Brazil allows us to serve our customers anywhere in the world fast and flexibly," said Klaus Endress, CEO of the group.

"This concept eases logistics, reduces exchange rate risks and lowers business dependencies. At the same time, growth in the international markets also safeguards jobs in our European production centers."

Endress+Hauser has operated in Latin America's biggest country, Brazil, for over three decades. Development took off with the establishment of the Group's sales centre in 2003.

"Since then, annual sales have grown on average by more than 30%," says Carlos Behrends, managing director of Endress+Hauser Brazil. And he is convinced the company can continue to grow

"Thanks to local production, we will be able to strengthen our position in the Brazilian market even further," Behrends added.

The Itatiba site - situated about one and a half hours' drive north of the business metropolis São Paulo and only 30 minutes' drive from the country's biggest freight airport - has been chosen for logistical reasons. Endress+Hauser invested over eight million euros in the purchase and reconstruction of the building, as well as in plants and machinery. Modern infrastructure and production lines were installed on around 4,300m² (46,268 sq. ft.) of floor space.

The site is 18,000m² (193,680 sq. ft.) in total, offering plenty of room for further expansion. More than 20 people assemble, check and calibrate customized measuring instruments in the new plant, for the time being for customers in Brazil.

"This has helped us to significantly reduce delivery and lead times," said Rogerio Jeronymo, general manager of level and pressure device production. "Also, we gain plenty of experience when it comes to the special needs and requirements of our market, whether from the customers' side or with respect to national standards and regulations."

"All our equipment and processes comply with the standards of our parent companies in Europe, right through to ultra-precise calibration systems which are unrivalled in our industry," added Gustavo Lemos, general manager of flowmeter production. "We are the only producer of measurement engineering who manufactures in Brazil at this high level of quality. At the same time we can offer the most diverse product basket on the local market."

Successful FDA Inspection at Haupt Pharma Amareg in Regensburg, Germany

Haupt Pharma has successfully passed an inspection by the US Food and Drug Administration (FDA) at its site in Regensburg, Germany.

Haupt Pharma Amareg completed the audit for the four inspected solid and semi-solid, high-potent products, two of which were oncological products without receiving an FDA form 483. The inspection covered the full service of these products and included manufacturing and packaging, as well as development and analytics.

Haupt Pharma Amareg has extensive know-how in the contract manufacturing of various dosage forms. A core competence is the production of solid dosage forms with highly active substances. In this segment, the site is also a successful development partner with many international companies.

"The management board congratulates Haupt Pharma Amareg on its successful completion of the FDA inspection. This result once again confirms the high quality standards within the group," said Dr Karl Heinz Brücher, chief operating officer of Haupt Pharma.

"The outstanding commitment of the entire team in Regensburg has contributed to this positive result."

With six FDA-inspected sites in Germany and Italy, Haupt Pharma is able to deliver high-quality products for the demanding, highly regulated US market

SGS France Lab Cleared to Release Biopharma Batches

SGS has been cleared to conduct tests for the batch release of biopharmaceutical products at its laboratory in Poitiers, France.

The facility – which has provided analysis services since 1994 – was approved by the Agence National de Securitie du Medicament et des Produits de Sante (ANSM), the Government agency charged with ensuring the safety of drugs.

Following the approval the lab will offer analysis services for biopharmaceutical industry customers and compliment SGS’ facility in Clichy just outside Paris, which provides equivalent analysis services for small molecule drugmakers.

SGS Life Science Services’ executive VP, Anne Hays, said: “Bringing GMP to the Poitiers site allows us to offer cell-based assays for the testing of biologics, with some of the initial projects coming from companies developing biosimilars.

Hayes added that SGS also plans to start providing equivalent bioanalysis services at its facility in Carson, California in the US.

The approval follows just under 18-months after SGS established a cell-based assay laboratory at the Poitiers site, which was an investment designed to support a large unnamed pharmaceutical industry customer’s efforts to develop therapeutic antibodies.

The launch of new services at the Poitiers site also fits with SGS’ wider efforts to build in biopharmaceuticals testing in Europe, which began with the acquisition of Wokingham, UK-based M-Scan in 2010 and continued with the purchase of Glasgow, Scotland-headquartered Vitrology in 2012.

The planned addition of biopharmaceutical bioanalysis service at the Carson site would also fit with investments has made in recent years. In September 2012, for example, SGS doubled capacity at its laboratory in New Jersey citing demand.

SGS has set itself the target of being the world’s leading bioanalysis services firm for biopharmaceutical products – including biosimilars - by next year.

Telstar Develops Barrier Systems for Korean Komipharm Pharmaceuticals

Telstar has developed two high containment barrier systems for the Korean firm, Komipharm Pharmaceuticals, one of the largest producers in Asia of anti-cancer drugs in human oral dosage form and veterinary medicines. The systems, one for API Sampling and the other for QC Sample Handling will be used in Komipharm's new facility, in the South Korean city of Cheongwon, Chungcheongbuk-do.

The systems will provide a high level of containment to protect operators during the manufacturing process using APIs. Additionally, the systems will be used in biotechnology research aimed at developing vaccines by genetic technology.

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

The project was carried out by Telstar's Technology Centre for Barrier Isolation Systems, located in Dewsbury (UK).

AREVA Med Launches New Production Facility

AREVA Med has launched its Maurice Tubiana facility located at Bessines-sur-Gartempe, France, following administrative authorizations and completing technical testing. The facility began production to extract and purify lead-212 for medical use.

Lead-212 is a rare metal used in the development of treatments for certain cancers that do not respond to other conventional methods. Nuclear medicine is dependent on the availability of high purity isotopes and the production at the Maurice Tubiana facility will provide sufficient amounts of high-purity lead 212 for clinical development. Lead-212 is currently being used in an AREVA Med Phase I trial at the University of Alabama at Birmingham.

Patrick Bourdet, chief executive officer of AREVA Med, said, "This facility, completed thanks to AREVA's expertise in radiochemistry and nuclear facility design and the support of our partners, confirms AREVA Med's industrial development. This will allow us to accelerate the development of alpha radio-immunotherapy using lead-212."

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