The new Health Sciences Education Building at the Phoenix Biomedical Campus will provide interdisciplinary instruction space for the University of Arizona and Northern Arizona University’s pharmacy, medical, and health and human services schools. Los Angeles-based CO Architects and the Phoenix office of Ayers Saint Gross designed the 268,000-sf building to reflect the desert landscape. Two wings create a “canyon” and imprinted copper cladding on the lower floors shows images of the surrounding mountains. The project is pursuing LEED Silver with such features as regionally sourced materials, natural lighting, and an east-west orientation.

Nuclea, Clark University to Start Proteomics, Metabolomics Center

Diagnostics developer Nuclea Biotechnologies and Clark University will establish a new center to use proteomics and metabolomics methods in conducting biomarker research focused on cancer, Nuclea said.

The Pittsfield, Mass.-based firm will expand an ongoing partnership with Clark to establish a new Proteomic and Metabolomic Center on the university's campus in Worcester.

The center will bring together tools for sample preparation and mass spectrometry with Clark's established nuclear magnetic resonance imaging resource.

The large volumes of data generated from Nuclea's clinical repository and from scientific samples will be analyzed through a newly established computer cluster network at Clark and Nuclea's database.

Nuclea is focused on developing gene, protein, and antibody biomarkers and pharmacogenetic diagnostic assays that can predict which treatments will be effective for certain patients.

"The research being conducted at Clark, using the state-of-the-art equipment and technology, will lead to new biomarkers that will help doctors identify deadly cancers in hard-to-diagnose patients and prescribe the most effective treatments," Nuclea CEO and President Patrick Muraca said in a statement.

Shire Gains Advanced BioHealing

After completing its $750 million acquisition of San Diego-based regenerative medicine company Advanced BioHealing (ABH) on June 28th, Irish drug giant Shire is going on a minor hiring binge.

ABH plans to hire 50 new employees in San Diego, according to ABH CEO Kevin Rakin. The company now employs 256 people at its manufacturing and laboratory space on Torrey Pines Mesa where ABH makes Dermagraft patches, which are bio-engineered from human skin cells and used as grafts to treat diabetic foot ulcers.

The deal was strategic for Shire in several ways said Rakin. ABH is joining Shire’s Specialty Pharmaceuticals business, which enables ABH to also take advantage of the biologic manufacturing expertise in Shire’s Human Genetic Therapies business. While Shire also operates a major site in Switzerland and in the Philadelphia area, Rakin says the company gains a West Coast base with the ABH deal.

“They are a smart acquirer and a smart integrator,” said Rakin near his office in Westport, CT, home to an office of Canaan Partners, which helped to found ABH in 2006, and held roughly a one-third stake in the ABH. “They plan to use the ABH acquisition to network around the West Coast, and identify other companies and other technologies. So we are the cornerstone of a new business area for them.”

The deal proved to be a windfall for Canaan. The venture firm is realizing an extraordinary 15x return for its $15 million investment in ABH.

Sales of ABH substitute skin patches grew from $9 million in 2007 to nearly $147 million in 2010, and are expected to hit somewhere between $180 million and $200 million this year. ABH already has hired 151 employees so far this year, including 76 based in San Diego.

Washington University Opens Genome Center

Washington University in St. Louis has opened a new Genome Technology Access Center (GTAC) to provide researchers with DNA sequencing, microarray, and quantitative PCR services.

The new center, which is a separate entity from the university's Genome Institute, will provide high-speed genome sequencing and other services to scientists on a fee-for-service basis.

Based at the Washington University School of Medicine, the GTAC is staffed by a group of nearly 20 geneticists, molecular biologists, and informatics specialists who will prepare DNA samples for sequencing and analyze and interpret the genomic data. The center has already begun providing sequencing and analysis services to researchers at WUSTL and St. Louis University and to regional companies including Sigma-Aldrich, Pfizer, and Nestle.

The GTAC is providing sequencing on Illumina HiSeq 2000 machines, of which it has five, and it offers whole-genome sequencing and analysis projects, DNA and RNA characterization, and microarray and quantitative PCR tools.

"DNA sequencing has become the go-to technology in many fields," Jeffrey Milbrandt, the James S. McDonnell Professor of Genetics and head of the genetics department, said in a statement. "But not every scientist has the specialized training to prepare DNA samples, analyze the data and interpret the results. We saw a real need to fill these gaps and to expand access to the technology."

"We have the full range of technologies needed to perform genetic analyses," added Seth Crosby, the center's director and research assistant professor of genetics.

"Scientists don't have to know the details of a particular technology. We can walk them through the various options and help them select the best one based on the research questions they want to answer," Crosby said.

Acorda Therapeutics to Expand

Governor Andrew M. Cuomo announced that leading biotechnical drug manufacturer Acorda Therapeutics, Inc. will relocate to a new facility in the Village of Ardsley, potentially creating 190 new jobs.

Acorda will invest an estimated $36 million in the facility. Empire State Development (ESD) will provide Acorda with up to $5.2 million in Excelsior Jobs Program tax benefits as an incentive for job creation.

"Acorda Therapeutics's decision to expand its footprint in Westchester County sends another signal that New York is open for business," Governor Cuomo said. "This investment will strengthen New York's vibrant biotech industry and create new jobs in the Lower Hudson Valley. This is a sign of good things to come for our state as we work to revitalize New York's economy."

Acorda, one of several dozen biotechnology companies in the Hudson Valley, develops therapies for multiple sclerosis, spinal cord injury and related nervous system disorders. The company's new 139,000 square foot facility will be located in the Ardsley Park life science campus, owned and managed by BioMed Realty Trust, Inc. The company will relocate to the new facility from its current location in nearby Hawthorne, retaining 159 employees bringing total employment to nearly 350 employees.

Acorda's President and CEO Ron Cohen, M.D. said, "Based on successfully commercializing AMPYRA, a new therapy for people with multiple sclerosis, Acorda has grown significantly over the past several years. The Ardsley Park life science campus will have state-of-the-art laboratory and office space to accommodate our current and future needs. New York state, county and local government and economic groups were collaborative partners as we explored our relocation options and we are pleased to remain a part of Westchester County's growing biotechnology corridor."

Founded in 1995, Acorda Therapeutics is a biotechnology company that develops therapies for multiple sclerosis, spinal cord injury and related nervous system disorders. The company is commercializing and marketing AMPYRA, a potassium channel blocker approved as a treatment to improve walking in patients with multiple sclerosis (MS). Acorda also markets ZANAFLEX CAPSULES, a short-acting drug for the management of spasticity. The company's pipeline includes a number of products in development for the treatment, regeneration and repair of the spinal cord and brain.

EMA OK Shire Plant

Shire has received European Medicines Agency (EMA) approval for a new US plant, doubling purification capacity for its Fabry disease drug Replagal.

The new facility, in Lexington, Massachusetts, will purify the Replagal active pharmaceutical ingredient (API), agalsidase alfa, which Shire will continue to produce at its cell culture plant in Alewife, Cambridge.

Shire’s additional capacity will not have escaped the attention of French drugmaker Sanofi which bought US biotech Genzyme, producer of rival Fabry disease treatment Fabrazyme, earlier this year.

Genzyme has been working to correct a number of contamination problems with its manufacturing operations that cut Fabrazyme production levels, forcing the firm to ration supplies and recommend reduced dosages.

During this period some US Fabry disease patients asked the government to break Genzyme’s Fabrazyme patents arguing that, in certain cases, the reduced dosages resulted in increased pain and gastrointestinal problems.

In Europe, where Replagal has been approved since 2001, the EMA started recommending that Fabry patients who had not reacted well to the lower doses were switched to Shire’s drug.

All of which seems to have had a positive impact on sales. According to Shire’s most recently quarterly report revenue from Replagal increased 55 per cent in Q1 to $105m (€72.3m).

However, Shire spokesman Jennifer Mann said that while market opportunity was ‘an important factor’ in the company’s decision to develop the Lexington site it was not the only reason, explaining that: “It’s about providing increased flexibility of supply for patients."

Shire also plans to seek further regulatory approval to begin making its Gaucher’s disease drug Vpriv at the Lexington facility by the end of the year.

This approval, if granted, would be of interest to Genzyme given that its own Gaucher’s disease drug Cerezyme, production of which was also interrupted, has started to lose market share to Vpriv.

Aviagen Opens Facility

Alabama-based poultry breeding firm Aviagen has opened a new 15,000-square-feet diagnostic and research facility. Researchers at the new lab will conduct bacteriology, serology, molecular diagnostics, genomics research, and pathological exams.

Morphotek’s New Biologics Production Facility, USA

Morphotek, a subsidiary of Eisai Co, is constructing a new manufacturing plant for the production of biologics for early phase clinical trials. The new facility will be located in Welsh Road, Exton, Pennsylvania. It will be completed in 2011 with operations scheduled to begin in 2012. The $80m plant has been designed for LEED (Leadership in Energy and Environmental Design) certification by the US Green Building Council at the silver level or higher.

The company currently has 200 employees and will hire 30 to 50 people in 2012. Upon starting the production of its first drug, the company will construct a new manufacturing building in the area over the next three to five years.

The 60,000ft² facility will accommodate a biologics plant, a cGMP warehouse and loading dock area, and offices. The biologics plant will include ISO 5, 7 and 8 cleanrooms for cell culture, purification and formulation. A fill finish suite has also been planned for the future. The facility will additionally house a cold storage area, quality control laboratories and mechanical and process equipment rooms. An interior equipment platform and an interstitial catwalk system will be installed within the facility.

A fully transparent glass corridor will provide a complete view of the cleanrooms, manufacturing suites and the mechanical systems while in operation. The design will allow easy tour of the facility without dressing into cleanroom gowns.

"Construction of the facility has involved the demolition of three buildings."

The facility has been designed to use 30% less water and 33% less energy than a conventional building of a similar kind. To minimize glare and heat gain, the building shell will be incorporated with exterior solar shading devices, roof overhangs and high performance reflective glass curtain walls. Light shelves will be installed to maximize the interior day light and minimize solar heat gain.

Additional design features will include prefabricated and insulated metal wall panels, Pennsylvania bluestone accent and a white membrane roof that allows the building to reflect and convert 90% of the solar power into short wave radiation. To further minimize the usage of energy, an open floor interior design plan will be implemented together with energy saving devices including daylight and occupancy sensors on the lighting. The facility will be furnished with Greenguard indoor air quality certified systems furniture to minimize emissions.

Construction of the facility has involved the demolition of three buildings. Recycled and renewable building materials, including the remains from the demolished buildings, are being used for the construction.

Other sustainable features of the design include on-site energy generation and an aggressive construction waste management plan that diverts over 75% of construction waste from landfills.

The contract for the project's construction management has been awarded to HSC Builders & Construction Managers. Precis Engineering has been appointed to provide mechanical, electrical, plumbing (MEP), process engineering and commissioning services for the project. The company used Autodesk Revit MEP software to develop the engineering design.

The software is a new Building Information Modeling (BIM) tool with advanced 3D coordination features. It offers project visualization in real time at every phase of the design process, enabling the company to streamline its design and decision making process. A 3D animated video was also provided to demonstrate the look and functioning of the finished facility and its systems.

The contract for the project's architectural services was awarded to Exton based Arcus Design Group Architects. MacIntosh Engineering was chosen to provide structural engineering services while Re:Vision Architecture was appointed as the LEED consultant. Other contractors involved are Chester Valley Engineers for civil engineering and site survey, and CVE to assist in the LEED Certification.

Dendreon Gets FDA Nod for Drug Factory

Seattle-based Dendreon said that it has won clearance from the FDA to start manufacturing its immune-boosting drug for prostate cancer at a new factory in the Los Angeles area. The manufacturing plant OK, which was widely expected by analysts, means that Dendreon now has its first new location to produce its treatment outside its original commercial factory in New Jersey.

The company is also seeking FDA clearance for a third facility in the Atlanta, GA area, which the company is hoping will get the green light by a regulatory deadline of August 28. The new capacity is important to Dendreon because it has been unable to meet all the demand from patients for its drug, sipuleucel-T (Provenge), in its first year on the market.

Getting FDA sign-off on the factories isn’t trivial. Dendreon’s first-of-its-kind manufacturing process is complicated, in that it requires running a patient’s own cells through a proprietary system to “teach” the cells to recognize hallmarks of prostate cancer cells, so that when they are re-infused into the patient, they should be able to start fighting the cancer cells like a virus. Getting all three factories running on schedule is critical for Dendreon if it is going to hit its sales forecast of $350 million to $400 million in sales of the treatment this year.

MD Biotechnology Center Grants $1.8 Million to Nine Life Sciences Firms

The smartphone-like blood sugar meter that Bethesda-based Telcare has developed to improve care for diabetes patients has attracted financial investors who want to see the device move to market as quickly as possible.

That singular focus leaves little room in the budget to simultaneously create the company’s future products, said Chief Executive Jonathan Javitt. That’s where a recent grant from Maryland will prove useful, he said.

The Maryland Biotechnology Center doled out $1.8 million in grant money to nine life science firms that plan to commercialize university technology or have made steps to bring a product to market. This is the grant program’s second year and awards average $200,000 per recipient.

For the biotechnology industry, that’s a very modest sum. Companies often require millions of dollars to bring products under development through the regulatory process and out to the market.

Grant applicants were required to prove that the state’s small injection of cash could be used to attract additional money or would significantly advance the company’s products, said Judy Britz, executive director of the Maryland Biotechnology Center, which is housed within the Department of Business and Economic Development.

Indeed, that’s the case for Rockville’s 20/20 GeneSystems. The firm earned a $3 million grant from the National Cancer Institute in October on the condition it secure matching funds. The award from the biotechnology center contributed to that effort.

“The DBED award came at exactly the right time for us,” said chief executive Jonathan Cohen. “Essentially this $200,000 became $400,000.”

The nine awardees include:

NeuroNascent, of Clarksville, develops therapies for the treatment of depression and other neurodegenerative disorders.
Rockville-based Noble Life Sciences develops a tool to inform clinicians about which biomarkers indicate how a patient will respond to treatment.
Unither Virology, of Silver Spring, works on an antiviral drug.
Baltimore’s Paragon Bioservices established the stem cell consortium with the University of Maryland, Baltimore.
A & G Pharmaceutical, of Columbia, develops a test for breast cancer progression.
DioGenix, of Gaithersburg, develops a blood-based molecular diagnostic test for multiple sclerosis.
Rockville’s 20/20 GeneSystems develops a test to predict kidney and breast tumors.
Telcare, of Bethesda, created a blood glucose meter that uses cellular technology to offer real-time feedback and monitoring.
Plasmonix, of Baltimore, develops metal-enhanced fluorescent products.

Pfizer to Buy Back Akrimax Plant

US drug giant Pfizer has exercised its option to re-acquire a manufacturing facility in Rouses Point, New York from Akrimax.

Akrimax bought the facility in January 2008 from Wyeth, which had been trying to phasing out activities at the plant since 2005 following a drop in demand for its menopause treatment Premarin.

The original deal saw Akrimax lease manufacturing space back to Wyeth to allow it to keep making both Premarin and Effexor XR (venlafaxine). This arrangement continued following Pfizer’s $68bn acquisition of Wyeth in 2009.

Akrimax used its portion of the facility to manufacture prescription and over-the-counter (OTC) products in solid (capsule and tablets), semi-solid (creams and ointments) and liquid dosage forms, as well as controlled/sustained release and sterile injectables.

According to a number of reports Pfizer has agreed to re-acquire the facility after Akrimax’ plan to expand manufacturing operations falter as a result of over capacity in the market.

Akrimax decided to shut down its new business development department that was based at the facility.

Pfizer spokesman Chris said that Akrimax’ departure, which is due to take place in the next few weeks, will see around 60 of the 400 people employed at the facility lose their jobs.

Loder also told the local news website that while Pfizer intends to continue some manufacturing operations at the facility in the short term, the plan is to seek a buyer for the facility and, if none can be found, close the plant in 2013.

Scripps Health Breaks Ground in San Diego

Building on its legacy as San Diego’s leading provider of heart care services, Scripps Health celebrated the start of construction for the $456 million Scripps Cardiovascular Institute, a center for innovation that will bring together leading physicians and premier cardiovascular services to San Diego County.

“Our vision is to build the world’s finest cardiovascular institute right here in San Diego – providing the best in heart care for our community and serving as a destination for heart patients everywhere,” said Scripps President and CEO Chris Van Gorder. “Scripps Cardiovascular Institute will be a catalyst for collaboration, drawing on the clinical expertise of some of the nation’s most brilliant physicians and scientists, the most advanced technology and ground-breaking clinical research.”

Scripps Cardiovascular Institute is the cornerstone of a 25-year master plan that will transform the Scripps Memorial Hospital La Jolla campus and redefine health care in San Diego for the 21st Century. Scripps Health is replacing the existing hospital with three new hospital towers to meet state earthquake safety mandates. The first of these towers will serve as the “heart” of the Scripps Cardiovascular Institute. The seven-story, 383,000-square-foot building is scheduled to open for patient care in 2015. It will feature108 in-patient beds in private rooms, 60 intensive care beds, six state-of-art operating rooms, and as many as six cardiac catheterization labs with the most advanced medical technology.

Scripps Cardiovascular Institute will integrate the highly respected cardiovascular programs from throughout the Scripps Health system and Kaiser Permanente. The two non-profit health systems recently agreed to a 10-year extension of their 30-year partnership. Under the agreement, Scripps is the exclusive provider of cardiac surgery and interventional cardiology to the more than 500,000 Kaiser members across San Diego County.

Scripps Cardiovascular Institute will build on a legacy of Scripps breakthroughs in pioneering surgical procedures, landmark studies, genomic medicine and wireless technology to provide the most advanced treatment options available to patients with cardiovascular diseases. Every year, more than 55,000 patients receive their cardiovascular care from Scripps, making it the largest heart care provider in the region. And Scripps is the only cardiovascular program in the region consistently recognized by U.S. News & World Report as one of the best in the country.

The building design was developed with input from more than 200 physicians, nurses and clinical staff to ensure efficiencies that will foster exceptional care in a safe, comforting environment. Large expanses of windows will take advantage of natural light, and each private patient room features a visitor zone by the window to include family members as part of the healing team.

“The hospital incorporates evidence-based design principals throughout the patient care areas,” said Brent Eastman, MD, chief medical officer for Scripps. “Computerized room-level observation stations, a decentralized medication dispensing process, and decentralized nurse stations will allow caregivers to closely monitor patients and facilitate communication with family members.”

In addition, the design incorporates natural light, views of nature, reduced noise and a subdued color palette that studies show increases the patient’s sense of well-being and help in the healing process. Patient rooms will offer a variety of amenities, including wireless Internet access, LCD screen televisions and pullout couches so family members can stay comfortably overnight.

Situated 1,600 feet away, the new Central Energy Plant will be a cast-in-place concrete structure encompassing three levels, with two of the levels located below grade. The energy plant will provide air conditioning, heating, medical gas, steam, fuel storage, waste storage, and emergency generators for the new hospital tower.

Jacobs Engineering Group Inc. is serving as the construction management firm on behalf of Scripps Health. McCarthy Building Companies, Inc. has been retained as the design-assist general contractor and HOK Architects is the project architect.

Established on Prospect Street in downtown La Jolla in 1924 through the vision of Ellen Browning Scripps, Scripps Memorial Hospital La Jolla moved to its current location in 1964. The hospital provides care to more than 140,000 patients annually, is equipped with 389 beds, and has more than 2,400 employees and approximately 900 affiliated physicians.

Philanthropy has continued to play an important role in Scripps La Jolla’s growth. The hospital expansion will be financed by operating revenues, borrowing and community support. To date, $35 million in philanthropic gifts have been raised toward the $125 million fundraising goal for the first hospital tower, which includes naming opportunities.

The Scripps Cardiovascular Institute is part of improvements being made throughout the Scripps Health system. Projects include a new emergency department and critical care building, medical office building and parking structure at Scripps Memorial Hospital Encinitas; the new Conrad Prebys Emergency and Trauma Center, a new parking structure and central energy plant at Scripps Mercy Hospital San Diego; the new Scripps Proton Therapy Center and the Scripps Radiation Therapy Center. Other facility improvements include seismic upgrades and investment in new information technology.

Toxikon Expands Surgical Wing

CRO Toxikon is expanding its efficacy and surgical research services (ESRS) unit in Bedford, Massachusetts to bolster its preclinical services offering for drug and medical device developers.

The US firm is adding capacity for both small and animal models, a surgical wing and a bank of monitoring and imaging technologies in a project that is expected to be completed next month.

Company CEO Laxman Desai said the modifications are designed to provide Toxikon’s research and product development clientele with resources and scientific capabilities typically found only in academic settings.

This was echoed by Curtis Schondelmeyer, Toxikon’s director of preclinical veterinary services, who added that: “Our facilities are also equipped to handle multiple surgical stations to accommodate physician trainings and demonstrations.

“We can accommodate large groups and even provide remote visualization of procedures and surgeries within our facilities and around the world.”

News of the expansion comes just a few months after Toxikon revamped its brand identity by launching a new website, logo and attending numerous industry events.

Toxikon’s decision to expand also fits with the wider trend in the preclinical contract research sector that has seen a number of the firm’s industry peers seek to bolster their offerings.

In March preclinical research specialist Ricerca Biosciences teamed up with UK-headquartered Fulcrum Pharma in a partnership focused on improving the discovery and early-phase development of drug candidates.

And, in April , French preclinical CRO CIT snapped up Canada’s LAB Research and relaunched as CIToxLAB earlier this month with the aim of “create a global player at the service of the pharmaceutical, biotechnology and chemical industries.”

HWI Global Installing Upgrades at Memorial Hospital Gulfport, Mississippi

HWI Global, Inc., the Pittsburgh-based cleanroom design builder, reports constructing its Bio-Gard Germicidal Wall System as part of the ongoing Surgery Modernization project at Memorial Hospital in Gulfport, Mississippi. An HWI proprietary application, this interior specialty lamination is used on most of the Company's USP 797 pharmacy renovations and other Bio-Pharma makeovers. HWI reduces the potential of nosocomial infections putting the patient at far less risk when it expands its product line using the Bio-Gard Germicidal Wall System.

Deric Haddad, CEO, HWI Global, says: "Our Bio-Gard Wall System is the ideal solution for an Operating Room environment. For years we've talked about additional applications for the System -- from wet labs to nursing stations to bathrooms, and of course, operating rooms and surgical suites. At Memorial Gulfport, we ran into a situation where the architect and customer really took the time to evaluate the cost-effectiveness that our System would yield, not to mention the sanitary upgrade it would provide. It creates an aseptic surface condition that allows hospital maintenance personnel to sterilize rather easily, lowering the likelihood of human error. We hope to see more architects nationwide choosing our product is these specific arenas."

HWI's Bio-Gard was selected for this project by Blitch/Krebs Architects, a distinguished healthcare architectural firm headquartered in New Orleans, Louisiana. HWI has entered into a subcontract with Roy Anderson Corp Contractors, a Gulfport-based general construction firm.

Sisters Hospital Adding Cleanroom to Pharmacy

Sisters of Charity Hospital is working on installing a new pharmacy cleanroom at its St. Joseph Campus in Cheektowaga, NY, to better prep for IV medications.

The hospital has filed plans with the state Health Department for a $455,440 project to construct a pharmacy cleanroom for compounding. The project also includes installation of a new heating and HVAC system.

According to Catholic Health, upgrading the older HVAC equipment with new, energy-efficient systems also allows the installation of the negative pressure room for the pharmacy.

A time line for the project has yet to be determined. With limited construction, the project requires an internal review by DOH staff.

Watson Adding Manufacturing Capacity

Watson Pharmaceuticals has initiated a $44m (€31m) expansion of its Utah R&D and manufacturing plant for transdermal patches and topical gels.

Using the $44m Watson will retrofit 20,000 sq. ft. of existing space and add a further 17,000 sq. ft. of manufacturing capacity. Adding production capacity positions Watson to meet demand for its generic version of Lidoderm, due to launch in 2012, and other transdermal patches and topical gels in the portfolio and pipeline.

“This expansion not only supports our near-term product manufacturing and packaging needs, but also positions us to more efficiently meet anticipated future consumer demand for products that are currently in various stages of development”, said Paul Bisaro, president and CEO of Watson.

As well as launching new products, Watson also plans to introduce transdermal and topical drugs already produced at Salt Lake City, Utah “into select international markets”. To support these market expansions Watson is adding capacity that could allow it to triple annual manufacturing batch capacity.

At Salt Lake City, which is Watson's headquarters for global brands, 175 people work in product development and a further 200 are focused on manufacturing and operations. Over the next three to five years Watson plans to add 300 employees at the site.

“This expansion is more than just bricks and mortar. We are investing in the creation of skilled manufacturing, packaging and quality control and other jobs that will create opportunities for the population of Salt Lake City”, said Bisaro.

Expansion of the Salt Lake City follows the decision to make the Watson site in Parsippany, New Jersey the company's corporate headquarters. Before the decision the corporate headquarters was located in Corona, California.

HWI Global Awarded Clean Room Upgrades Contract for Duke Hospital Pharmacy

HWI Global, Inc., the Pittsburgh-based cleanroom design builder, announces a contract to upgrade the ISO classifications of the Department of Pharmacy, Duke University Hospital sterile compounding cleanroom located in the Davison Building within Duke's South Campus. Duke's Department of Pharmacy intends to upgrade the classifications of several of its critical zones to levels of cleanliness ten times cleaner than required.

HWI Global is expanding upon a seven-year relationship with Duke providing cleanroom construction and preventive maintenance. The Company will install the same type of Clean Room Upgrades in the South Pharmacy as contracted for in Duke's North Pharmacy late 2010. HWI's scope includes air-change renovations to hazardous, non-hazardous, and narcotic room compounding. The Company's plan is designed to exceed the regulations of Federal mandate USP 797 requiring hospital pharmacies to conduct compounded sterile preparations in ISO classified cleanrooms.

HWI Global's origins began at this same Duke University Hospital facility seven years ago. As the initial drafts of the Federal USP 797 mandate were first published in the late spring 2004, HWI Global was privately owned Haddad-Wylie Industries, LLC. At that time, as a subcontractor from New York-based Clean Room Depot, the Company designed, manufactured and constructed the 1,200 square foot aseptic modular wall system in place at the Duke South Pharmacy.

Under a direct contract with Duke in 2006, HWI created a Gown Room extension of the same modular facility. HWI subcontracted with Clean Room Depot in the summer of 2007 for the new 2,300 square foot pharmacy at Duke's North campus, furnishing and installing its proprietary Bio-Gard Germicidal Wall Lamination and heavy-duty rod-hung Utility Grid Ceiling System with integrated flush lighting. This product line with a new LED lighting mechanism is currently being developed further in a joint venture with Enigma Concepts.

Between 2008 and 2010, HWI held the preventive maintenance contracts for both the North and South Pharmacy clean rooms. In the latter part of 2010, the Company was awarded the North Pharmacy contract noted above.

Deric Haddad, CEO, HWI Global, "This particular cleanroom is very special to us because it is truly the foundation upon which HWI was built. Back when USP 797 first came to be, there weren't many prototype facilities in place to compare it with. We had a unique concept and definitely executed it well. Since then we've come up with many new methods and products. Specifically, we've developed numerous ways to do things cleaner and more efficiently. Our entire Preventive Maintenance Division was born out of the Duke project. Now we have annual contracts with the Cleveland Clinic, Mt. Sinai Medical Center, Philips Healthcare, The Timken Company, and several other medical device and industrial-based cleanroom customers. Looking back, we are so very proud to have performed services in 17 states and three countries, remembering that it all started at Duke."

REST OF WORLD

Phillips Buys Medisize

Phillips Plastics is to expand into Europe and add primary packaging contract manufacturing capabilities by acquiring Medisize.

Buying Finland-based Medisize for €99.8m ($138.7m) will give Phillips a stronger presence in Europe and add drug delivery devices and primary pharmaceutical packaging to its portfolio. The combined company will operate 19 production facilities across the U.S. and Europe.

Willem van den Bruinhorst, CEO of Medisize, said: "By combining our strengths, we are not only creating an industry leading portfolio of expertise and services, we are also enhancing to provide a wider range of technologies to serve our customers on a global level.”

Matt Jennings, president and CEO of Phillips, said: “Medisize has a world-class management team and European footprint, with demonstrated capabilities in high-volume manufacturing and high-speed automation that will strengthen Phillips’ service offering and global reach.”

Medisize is headquartered in Vantaa, Finland and employs 850 people. It is a contract manufacturer of medical devices for drug delivery and pharmaceutical packaging, as well as development and manufacture of single-use plastic products for anesthesia and intensive care from locations in Finland, the Irish Republic, the Netherlands, Sweden and the Czech Republic.

Across these sites Medisize employs 860 people and in 2010 generated sales of €127.8m. This includes sales from the drug delivery and pharmaceutical packaging units, as well as the medical and diagnostic devices and airway management systems units.

Phillips is considerably larger, with annual sales in excess of $250m and 1,500 employees at its 14 US facilities. A 120,000 sq. ft. plant in Menomonie, Wisconsin and 47,000 sq. ft. facility in New Richmond, Wisconsin are the most commonly used to serve Phillips’ medical clients.

The takeover is subject to approval from competition authorities and is due to close by the end of August. Medisize will retain its name and operate as Phillips’ European division, with van den Bruinhorst staying on as president.

Phillips operates four facilities with cleanroom capabilities in an ISO Class 8 environment.

Phillips said the deal would create a company with combined sales of just under US$500m (€357m), and makes Phillips ‘one of the medical industry’s largest and most complete global providers of outsourced medical design and manufacturing services’.

Wacker Adds Cleanroom at Burghausen Plant

Wacker has brought new high-purity silicone-elastomer production lines on stream in Burghausen and has expanded cleanroom capacity.

Wacker, a German chemical group, has started up several silicone polymer production lines at its Burghausen site, expanding production of high-purity specialist silicones, encapsulation and coating compounds, as well as UV-activated silicones for the medical, LED and electronics industries.

Wacker has added a new cleanroom facility at the site to meet the purity standards of pharmaceuticals, semiconductors, LEDs and other applications.

The new facility meets Wacker’s Clean Operations principles said Dr. Bernd Pachaly, head of the Engineering Silicones business unit. These include housing production, filling and logistics separately, accessed only through special airlocks.

Strict regulations also apply to the filling operations with special stipulations regarding clothing and hygiene, air and particle filters. The facility meets the ISO standard for Class 8 cleanrooms. Production steps are constantly monitored and documented.

The new clean operations facility produces Silpuran and Elastosil silicone elastomers for medical applications, as well as highly specialized Lumisil, Semicosil, and Wacker SilGel silicone products for encapsulating and coating electronic components. There is also a production line for UV silicones.

Roquette Announces Completion of Plant at Lestrem

Carbohydrates for injectable use are highly controlled pharmaceutical active ingredients that are essential in the preparation of large volume parenterals. These crucial life-saving medicines are taken for granted in all public health organizations and institutions.

The large volume injectable solutions prepared with these carbohydrates, mainly glucose solutions, are the sort of mass medication that is expected to be available everywhere and always of the highest quality. Poor quality or supply chain issues can lead to critical situations, which might endanger lives.

The paradox for carbohydrate producers is that these highly specialized and regulated ingredients are small scale when compared to the wider portfolio of products from the starch biorefinery industry, and organic growth is limited. This is further compounded by health suppliers, hospitals and clinics regarding them as commodities and as such a preferred target for price reductions.

Such a niche market is a challenging environment for investment. Roquette, however, decided to proceed with the investment as part of its long-term strategy to remain a responsible supplier in this demanding field. In fact, Roquette has pioneered the development of dextrose grades for the preparation of injectable and dialysis solutions over many decades and is the leader in the manufacturing of such carbohydrates in Europe.

This leadership position comes with a sense of corporate responsibility to ensure the continuity of these vital products and this in turn has lead to continuous investment and an identical facility in the US for international supply backup options.

The completion of the most recent investment phase at Lestrem on its injectable carbohydrate facility has just been announced. This major capital investment, which was approved in 2008, will support the increasingly sophisticated demands of the injectable industry in terms of quality. The facility will be of GMP standard, like the previous one, so that the integration into current production capacity will be seamless though 2011.

Such a major investment is a showcase for Roquette not only in terms of its manufacturing and engineering expertise but also of its understanding of the high quality required and proactive knowledge of changing European regulations to meet long-term demand for these life-saving medicines.

Sanofi Selling Site to Valeant

Valeant Pharmaceuticals is to buy a dermatology unit, including CMO and in-house production assets, from Sanofi.

Canada-headquartered Valeant has agreed to buy the dermatology unit, called Dermik, from Sanofi for $425m (€300m). Sanofi’s site in Laval, Canada, which includes the Dermik manufacturing plant, is included in the deal along with a portfolio of dermatology products.

"We are pleased to add another strong dermatology franchise to our growing operations in the US and Canada. Furthermore, the manufacturing facility will provide increased capacity for our future growth initiatives”, said Michael Pearson, chairman and CEO of Valeant.

Dermik uses the production plant for its in-house portfolio and to offer contract manufacturing services. The plant produces 70 formulations and more than 200 tablets, capsules, creams, and non-sterile liquids, generating revenues of $240m, including contract manufacturing sales.

Grindeks Opens Latvian API Plant

Grindeks has opened a 2,300 sq. m. (24,748 sq. ft.) API production plant in Latvia, that will boost UDCA sales to €10m ($14m) a year when at full capacity.

Construction of the €8.94m active pharmaceutical ingredient (API) facility in Riga, Latvia began in 2009 following collaboration between Grindeks and Germany-based Marenis Pharma. The plant is now completed and will begin boosting API business at Grindeks and adding to Latvia's growing export portfolio.

“Now, when Latvia has exceeded pre-crisis export volumes, it is very important to be able to find new products and niches, new markets and directions for further export growth”, said Valdis Dombrovskis, Prime Minister of the Republic of Latvia. The European Union gave Grindeks €3.9m towards construction of the plant.

For now Grindeks has hired 35 people to work at the plant, which uses an automatic management system to regulate production processes, control the microclimate and support the work of engineering systems.

By 2014 Grindeks plans to have moved into UDCA-based finished dosage forms. A two to three year plan has been created for the development and registration of the final dosage form. Entering the finished dosage forms market could add a further €10m in sales, claims Grindeks.

Vertical integration of manufacturing, bringing together API and finished dosage capabilities, is a strategic priority at Grindeks. Finished dosage forms account for the bulk of sales at Grindeks and generated revenues of €81.4m in fiscal 2010, up almost 20 per cent year-on-year. Russia and Georgia are key markets for Grindeks.

ESCATEC Adds ISO Class 5 Cleanroom

ESCATEC, the EMS innovator, has added ISO Class 5 sections to its ISO Class 7 MOEMS (Micro Optic Electronic Manufacturing Services) facility in Heerbrugg, Switzerland to address the growing demand for miniaturized electronics. They enable miniaturized electronics and sub-assemblies to be manufactured at levels of cleanliness and technological precision rarely available from a contract manufacturer. They are supported by the rest of the Group’s global operations that include the ability to ramp up to high volume manufacturing in Asia.

Pharmalucence’s Production Facility

Pharmalucence, Inc. has selected Integrated Project Services to provide architectural design, engineering and construction of its state-of-the-art pharmaceutical production facility in Billerica, MA.

Pharmalucence is a privately-held pharmaceutical business that is defying the current trend toward moving drug production outside of the U.S. Pharmalucence will build a new advanced aseptic manufacturing facility in Billerica, MA supporting creation of 25 to 30 new permanent

positions over the next two years.

Pharmalucence has initiated the first phase of its construction program to prepare for partial occupancy of the facility in late 2011. All phases of construction will be completed by mid-2012 with implementation of full drug manufacturing by mid-2013. This project has been partially

funded under the Massachusetts Recovery Zone Facility Bond program issued on the company’s behalf by MassDevelopment.

Teva Pharmaceuticals Expands in UK

A DRUGS company has been given permission to extend its warehouse in Runcorn despite residents’ objections.

The decision allows Teva Pharmaceuticals to build an extra 5,000 sq. m. (53,800 sq. ft.) of clean room and warehouse space at its site on Aston Lane North.

Halton Borough Council had received 23 letters opposing the plans.

Residents had complained that the extension would ruin their view and increase noise and light pollution. Some complainants said the construction would block the views of sunsets from their homes and reduce their property values. The 24-hour site has already prompted complaints about noise from residents.

Teva said the extra space and facilities will secure the site’s future for the next 10 years and drive business growth. It would also ensure the current number of jobs is sustained.

Planners received one letter of support for the project.

Halton Council’s development control committee approved the application..

No board members opposed the application.

Planning officers said the plans comply with guidelines on ensuring that buildings do not block daylight and that the nearby A56 Chester Road would buffer residents from increased noise.

Boehringer Ingelheim Extends Fill and Finish Capabilities

To round off its full-service capabilities for clients, Boehringer Ingelheim is expanding its capacities and capabilities in fill & finish for biopharmaceuticals at their state-of-the-art facility in Biberach, Germany, with a new filling line. The new line is available for contract filling of liquid and lyo vials from 0,5 ml- 100 ml. The expansion to a combination line for single and double chamber cartridges will be up and running in Q4 2012. To meet the customers' demand for clinical and commercial scale filling the batch sizes range from 6.000 - 110.000 ml for vials and 50.000 - 100.000 ml for capsules.

The new line with isolator technique represents one further step in Boehringer Ingeheim's "one stop shop" for contract development and manufacturing of biopharmaceuticals. With this state of the art technology Boehringer Ingelheim offers further excellence and solutions in the contract manufacturing business to its customers in addition to the existing capacities for lyophilization, vial filling and filling in pre-filled syringes. Customers' can rely on Boehringer Ingelheim either as a single supplier or they can also enter flexible at any step in the development.

Angel Providing GMP Stem Cell Production to ReNeuron

ReNeuron has inked a new deal with Angel Biotechnology to outsource stem cell GMP production services to the CMO.

Angel is providing manufacturing services in support of ReNeuron’s ReN001 stem cell therapy for stroke through to mid-2012. Both companies highlighted the contract’s work schedule flexibility, which is designed to help ReNeuron and Angel quickly respond as manufacturing needs shift.

“Critically, the new contract provides ReNeuron with guaranteed GMP (good manufacturing practice) manufacturing and non-GMP development slots over an extended period”, said Michael Hunt, CEO of ReNeuron.

Guaranteeing capacity allows ReNeuron to be “more efficient and flexible” with its planning, said Hunt, and makes its outsourced manufacturing model less risky. ReNeuron has consistently used partners, including Angel and NHS Blood and Transplant, to manufacture its stem cell treatments.

The value of the contract is private but Gordon Sheriff, chief operating officer at Angel, welcomed the “longer term contract”. Taking a longer term approach supports “the parallel development and GMP production of its primary products” and strengthens the relationship, said Sheriff.

ReNeuron has frequently outsourced work to Angel in recent years. In January 2005 a consortium, including ReNeuron and Angel, was awarded a £2.2m bioprocessing grant by the UK Department of Trade and Industry.

To support growth Angel signed a 15 year lease on a second GMP production plant in March. Opening the 1,661 m. sq, (17,872 sq. ft.) plant in Cramlington, UK will increase production capacity fivefold. Angel plans to start projects at the plant in the fourth quarter.

Gerresheimer to Invest in Czech Plant

Gerresheimer will expand its pharmaceutical packaging plant in the Czech Republic to meet growing demand for plastic systems and to further expand a key training hub.

The German firm said it will invest €12m ($17m) to double manufacturing and cleanroom space at the facility in Horsovsky Tyn and plans to hire an additional 75 staff to ramp up production capacity.

The plant produces inhalers, insulin pens, lancing devices and some of Gerresheimer’s diagnostic systems.

Company Spokesman Jens Kurten said: “Our plastic systems plant in the Czech Republic is among the most modern plants we have worldwide.

"It is a role model where a lot of our industrialization and production takes place for the first time for new products, where people from other plants worldwide are trained and then copy the production process in their plant.

Kurten went on to explain that the Horsovsky Tyn site had played a key role in the development of the insulin pen production facility that Gerresheimer opened in Indaiatuba, Sao Paolo, Brazil last year .

Gerresheimer’s plastic systems business has grown rapidly this year with revenue and for the first quarter increasing 11.4 per cent to €72.1m and 17.3 per cent to €14.4m, respectively.

This contrasts with the unit’s performance over the last few years, which have seen its revenue contribution fall from €346m in 2008 to €307.9m in 2010.

However, this decline is more a reflection of divestitures and a shift in the plastic systems unit’s focus than a decline in demand from the pharmaceutical sector according to Kurten.

“In recent years we have sold some parts of it like automotive (technical plastic systems) and some toothbrush business. If you consider this the division did high growth rates in recent years, 7.8 per cent last financial year."

Pfizer to Retain R&D Unit at Sandwich

US drug giant Pfizer will maintain a 350-strong research unit at its facility in Sandwich, Kent in the UK after revising its previous plan to find CROs to take over R&D operations.

The move is a turnaround for Pfizer, which announced its decision to cease all operations at the site by 2012 in February this year as part of an ongoing effort to integrate with Wyeth.

At the time Pfizer spokesman Andrew Widger said: “We intend to create novel and flexible partnerships to externalize R&D services that do not drive competitive advantage for Pfizer. Discussions around these partnerships are underway."

In May the Sandwich Economic Development Task Force confirmed this, explaining that Pfizer was in talks with a number of contract research organizations (CRO) about potentially moving to the Kent site and hiring some of the 2,400 staff currently employed there.

Now however the plan seems to have changed. According to a Press Association report, Pfizer said: "After a rigorous diligence process, Pfizer determined that retaining a portion of its pharmaceutical sciences operation at Sandwich presents the best solution at this time for Pfizer's business."

The firm added that the Sandwich unit will support the development of its mid and late-stage drug portfolio in concert with its Pharmaceutical Sciences centre is at its Groton, Connecticut, U.S.

Whether Pfizer will continue to seek CROs to develop the site remains to be seen.

Pfizer and ChemRar Collaborating on Russia

Pfizer Inc. said it will work with a Russian venture capital company to research and market new drugs in Russia and surrounding countries.

The New York drugmaker said it will work with ChemRar High Tech Center to explore research, development and marketing of drugs and vaccines to treat heart and metabolic illnesses, infectious diseases and cancer. It said those conditions are a high priority for Russian Federation health care system.

Pfizer and ChemRar said they signed a memorandum of understanding and did not disclose any financial terms. The partnership plans to seek technology transfer and licensing deals for drugs in Pfizer's pipeline of developing drugs.

Under the agreement, the companies can form other collaborations.

The agreement with ChemRar is Pfizer's second collaboration with a Russian company this year. In March, it announced an agreement under which Russian biotech drugmaker Petrovax Pharm will make a pneumococcal vaccine in the Moscow region.

Bausch + Lomb to Launch Pharmaceuticals Business in India

Bausch + Lomb has announced plans to launch a pharmaceutical business in India through a strategic agreement with Micro Labs, a leading provider of quality healthcare products. The partnership will provide Bausch + Lomb with high-quality manufacturing capabilities in the region that will speed the introduction of new prescription and over-the-counter medicines targeted at a wide range of eye diseases.

Through the agreement with Micro Labs, Bausch + Lomb aims to capture part of the rapidly expanding ophthalmic pharmaceuticals market in India which is expected to reach US$300 million by 2015. In addition to gaining access to world class manufacturing capabilities, Bausch + Lomb will establish dedicated sales and marketing teams, and deliver practitioner and patient education programs designed to improve the quality of, and access to, eye care.

"With as many as 76% of patients suffering from eye disease in India going untreated, Bausch + Lomb believes this is a critical time to enter the market with medicines and education designed to improve patient outcomes and overall quality of life," said Mr. Dan Wechsler, corporate vice president and global president, Bausch + Lomb Pharmaceuticals. "Today ophthalmic pharmaceuticals represent the fastest-growing segment of our business globally, and our collaboration with Micro Labs will enable us to enter one of the world's most vibrant yet underserved markets in the world with high-quality and dependable products that may help people see and live better." The companies will introduce up to six new pharmaceuticals eye drops including Moxisurge, Aquasurge, Aquasurge Max, Bromvue, Ketovue and Moxisurge-KT. Furthermore, the companies have also agreed to explore other areas of possible collaboration.

Bausch + Lomb began commercial operations in India in 1992 with its contact lens and solutions business before expanding into eye-related surgery products in 1996. Bausch + Lomb is the market leader for lenses and solutions in India and one of the fastest growing multinational corporations in Surgical Ophthalmology in the region.

"Bausch + Lomb is committed to improving the quality of eye care in India, and to helping doctors grow their practices and expand the range of offerings they provide," said Harish Natarajan, managing director, Bausch + Lomb India. "Our collaboration with Micro Labs will help us do both quickly and with quality."

Neuland Labs Expands Peptide Production Capabilities

Neuland Laboratories Ltd. has expanded its manufacturing capabilities for synthetic peptides. The company offers peptide production using standard sequential chemical peptide syntheses and segment condensation strategies, employing solid phase peptide synthesis procedures, as well as solution phase methods for shorter length peptides, and segment condensation and ligation techniques for very long peptides.

M.K. “Mike” Anwer, Ph.D., vice president of R&D at Neuland Labs, said, “Neuland’s extensive experience in producing a variety of synthetic peptides parallels their increasing use as therapeutics and diagnostics, in antibody production and as research tools. Our expanded service provides rapid access to commercial quantities of affordable, high quality peptides from a company with a 27-year track record of consistently achieving the highest regulatory standards in global pharmaceutical production.”

The Incredible Egg Opening Machine

Novartis Vaccines provides more than 20 vaccines to prevent viral and bacterial diseases and is dedicated to delivering on its promise of prevention through the research, development and production of innovative, safe and effective vaccines. The company’s new MARS (Marburg Site) facility in Marburg, Germany was designed and built to be the company’s “Center of Excellence” for modern vaccine production.

The company’s efforts to design and build a flexible vaccine manufacturing facility incorporating a state-of-the-art laser egg opening machine has resulted in the facility winning the Equipment Innovation award in the 2011 Facility of the Year award competition jointly sponsored by ISPE, INTERPHEX and Pharmaceutical Processing magazine.

The MARS Project integrated on to one site the manufacture of existing vaccine concentrates and the production of media, buffer and adjuvant products.

The project also integrated support functions, such as equipment cleaning and sterilizing, by centralizing the facilities at the Marburg site. Other accomplishment of the MARS Project included a new Quality Control building that consolidates the analytical and quality control functions for the Marburg sites. In the process of designing and building a state-of-the art vaccine facility, the company also seized upon the opportunity to enhance lean manufacturing techniques, to innovate processes and improve equipment design and operation, to ensure that the new buildings meet the latest sustainability trends and to create an excellent working environment for operations and QC staff with open views from all operating rooms to the country-side around the site.

The production facility is capable of manufacturing 20 million doses per year of rabies vaccine or 40 million doses per year of tick-born encephalitis vaccine or any combination of the two, utilizing two interchangeable production lines. The media, adjuvants and buffer production at the site supports all of the 20 vaccines within the Novartis portfolio.

The QC facility performs 35,000 to 40,000 analytical tests and more than 100,000 environmental and utility monitoring samples per year.

The warehouse serves an integral part of the production facility ensuring lean raw material and final product movement via a connecting spine. It has a capacity of 4,000 pallet spaces with chilled and ambient temperature storage.

The design leverages the revised requirements for live vaccine processing issued by the FDA in October 2007 and made effective in July 2008. The design and operating concept allows concurrent manufacturing of two different live vaccines on two segregated manufacturing lines in the same production area. The changeover procedure allows the facility to switch manufacturing from one vaccine to the other and also enables the facility to manufacture two vaccines either concurrently or in campaign.

This inherent flexibility allows the facility to respond quickly to health and market needs and reduces the cost of running dedicated facilities.

At the Marburg site a new process flow was implemented that enabled the facility to achieve a 10-fold increase in productivity. The basics of the process include:

Cell preparation: The upstream of the process is based on the infection of a suspension of chicken embryos fibroblasts with live virus. The cells and the viruses are incubated at controlled temperature for 5 days in single use cell factories and the virus suspension is harvested into a fixed stainless steel vessel.

Virus propagation: The harvest is then filtered in a second vessel in which the inactivation agent is added to the harvest and mixed. To complete the inactivation, a maturation step takes place in a third vessel.

Inactivation: A purification/concentration step by ultracentrifugation on sucrose gradients completes the process. The transfer between vessels and to the ultracentrifuges is with stainless steel lines.

From the harvest vessel to the ultracentrifuge, the bio-safety and the sterility of the product is ensured by a closed system. All transfers are driven by the automation system. Transfer lines and vessels are sterilized with clean steam (SIP), cleaning in place (CIP) by units dedicated to each of the two manufacturing lines.

It might seem odd and a bit old-fashioned in this modern age to consider that the manufacture of vaccines is still primarily based on eggs. But this is still the case in many facilities around the world. At the Marburg site the key to the dramatic production increase was the installation of a highly automated laser egg opening machine.

As mentioned above the production of TBE/rabies vaccine consists of three major production steps: preparation of the cell suspension; virus propagation and concentration of the inactivated virus.

In the first step of production, SPF (specific pathogen-free) eggs are used to produce cells for the next steps in the production flow. In the new MARS facility the process of opening of the eggs is performed using an industrial scale laser process under strict cleanroom conditions. The laser egg opener (LEO) automatically opens eggs in parallel while maintaining aseptic conditions. Within the new LEO handling system in the MARS facility, the pre-disinfected eggs are handled on trays with a capacity of 84 eggs with the potential to accommodate 3000 eggs/ hour. The trays are manipulated by the operator at the “front end” of the laser egg opener within a laminar flow tent. Transportation of the eggs through the egg opener is by means of a conveyor belt system controlled by optical sensors. These can detect tray position and occupation. This ensures that the laser is only distributed to the eggs present and not to the empty spaces. The layout of the trays and the conveyor system allows the opening of 4 eggs in parallel using 4 individual laser beams. The benefits of the LEO are: the elimination of cross contamination and increase process throughput contributing to the overall 10-fold productivity of the facility.

The opening of the eggs in the past was performed manually with the help of an “egg puncher” which operated pneumatically. The operator needed to manually open every single egg with this device. This older method is carried out under clean room classification and increases the risk of cross-contamination due to the contact and damage to the eggs.

In their selection of the Marburg site as a category winner, the judges mentioned several key factors that influenced their decision. Among them was the quick project execution of only 26 months, the impressive safety record of a 1.7 million man-hours with no lost-time incidents; and finally the innovative use and integration of the laser egg opening system which eliminated cross-contamination and increased processing efficiency.

BioMarin to Buy Pfizer Plant

Zacks Equity Research reports that BioMarin Pharmaceutical Inc. will acquire an integrated biologics manufacturing plant from Pfizer Inc., which will expand its manufacturing capacity to manage its product portfolio and its maturing pipeline. The plant, for which BioMarin will pay $48.5 million, is located in Shanbally, Cork, Ireland and is spread across 133,000 square feet.

The purchase price is almost five times less than the cost of building a new facility. BioMarin is expected to close the deal in the third quarter of 2011. Moreover, BioMarin will have to spend approximately $4 million annually to maintain the facility. The current manufacturing facilities have the capacity to manufacture protein products worth roughly $1 billion in revenue. With a maturing pipeline, the company will need additional resources to carry out its production activities. The acquisition of the Shanbally facility not only expands manufacturing capacity for BioMarin, it also diversifies manufacturing risk for BioMarin over two production facilities located in separate geographical locations. The company’s other manufacturing facility located at Novato, Calif., will continue to be used for producing its currently marketed drugs Naglazyme and Aldurazyme along with several clinical products.

The deal, which is expected to close in the third quarter this year, values the 133,000 sq.ft., Irish Medicines Board approved facility at $48.5m (€34m) which BioMarin said is one fifth of the cost of building and validating a new plan.

California, US-based BioMarin said that manufacturing activities at the plant will be tied to the results of a Phase III clinical study of N-acetylgalactosamine 6 sulphatase (GALNS).

The firm expects to start making GALNS in Shanbally in 2015 and said that in the meantime it will cost around $4m a year to maintain the facility.

Pfizer announced its intention to sell the Shanbally site, as well as others in Dun Laoghaire and Loughbeg, in May 2010 after buying Wyeth. The firm also said it would reduce its workforce at its solid dose plant in NewBridge, Kildare.

The Dun Laoghaire facility, which houses aseptic manufacturing lines, freeze-drying technologies and liquid vial filling areas, was bought by US biotechnology firm Amgen in March this year.

At the time Amgen said that it would continue to supply Pfizer with certain biologics products for an interim period, securing the jobs of 240 people that work at the facility.

BioMarin will not be involved in any supply deal according to spokeswoman Geraldine O’Conner who said that, under Pfizer's ownership, the Shanbally site produced small batches of candidate biologics for preclinical assessment and that this work will be transferred to a facility in Grange Castle on the outskirts of Dublin.

“The decision to exit the facility due to excess small scale mammalian cell based drug substance capacity in the Pfizer network, with availability of clinical launch and scale up capacity at our Grange Castle site.”

Sanofi Opens Vaccine R&D Site in Canada

Sanofi Pasteur has opened a new centre in Canada in an effort to streamline its global vaccine R&D operations.

The company, the vaccine production and development division of French drugmaker Sanofi, has invested $101m (€71m) in the new R&D unit, which is located on the firm’s Connaught campus manufacturing facility in Toronto.

Spokeswoman Nancy Simpson said: “The new R&D building allowed us to bring several operations, including 60 employees who were based at Sunnybrook Health Sciences Centre, under one roof.

“What the company did was to look at all R&D activity and rather than have two global sites doing the same type of work, we created centers of excellence, so for example, Toronto is the centre of excellence for analytical and bioprocess R&D.

Simpson added that: “We have a highly skilled workforce in Toronto, educated scientists with much experience. The company has been involved with R&D since its roots which go back to 1914, so it makes sense to continue to invest here on our Connaught Campus.

The province of Ontario contributed $14m to the project through its Biopharmaceutical Investment Program, which is part of the Next Generation of Jobs Fund, as part of an effort to secure manufacturing jobs in the region.

Nigeria: Taking Drugs Manufacturing to a Higher Level

The management of the company conducted the media and some of its shareholders on facility tour of the plant recently and explained what makes the facility a one of its kind in Central Africa.

The factory covers an area of 10,769 square meters (115,874 sq. ft.) with amazing facilities that meet global regulatory standards and specifications.

The ground floor consists of the Core and Noncore areas. The noncore area comprises the raw and packaging material warehouses, finished goods warehouse as well as the packaging hall, while the core area comprises the solid and liquid manufacturing areas.

The Solid manufacturing section comprises the raw material and Primary material packaging staging areas, 4 Dispensaries, 3 granulation suites fitted with state of -the- art equipment such as automatic paste maker, on line milling and Intermediate bulk container (IBC). Granulation is done in a close system ensuring that there is limited contact with personnel and product.

Within the Solid Manufacturing section, there are also seven compression booths with dedicated recirculating HVAC systems. Each compression machine is fitted with a Y chute, for feeding of granules via gravity, de-dusters and metal detectors. There is also an encapsulation machine and seven blistering machines fitted with non-fill device (NFD) for detecting missing pockets in the section.

In the Liquid Manufacturing section there are two manufacturing suites and hold areas and provision for three liquid filling machines.

The core area is made up of PCGI cleanroom panel walls, with double viewing flushed windows, epoxy floors with coving as well as GMP light fittings. Digital hygrometers and magnehelic gauges area are mounted in the area to monitor temperature, humidity and pressure differential in keeping with WHO, USFDA requirements. Other features of the core area include the use of pass boxes for transfer between core and non core areas, electronic interlocks and access controls which restrict unwanted movement within the factory.

The Packing hall within the non-core area consist of Seven blister cartooning lines, One Bulk tablet packaging line, One dry syrup packaging line and three liquid packing lines.

The Expansive Quality Control Laboratories is on the first floor, while the Quality Control Area contains the Chemical laboratory, Microbiological laboratory, Instrument laboratory and the Stability rooms. All these laboratories, according to Okafor, have their unique and specific functions.

These varieties of laboratories were installed primarily to ensure that all forms of tests and assessments can be conducted in one-stop laboratory without recourse to external help.

The first floor also has the Compliance section where the Documentation room and Sample Storage are located as well as the Technical Development section where the Pilot Production facilities are located.

The first floor also houses the expansive Training/Conference room with all the modern facilities for training fully installed to boost manpower development and capacity building

The man and material movement flow chart shows that there is a non-crossing flow pattern which essentially means that movement within the plant is unidirectional and separate for both personnel and materials. Also there is a separate entry and exit points for Core and Non-core production operatives.

There are also utilities such as a two ton per hour Boiler, 200cfu Air Compressors, 15,000 liter per hour water treatment plant, 2 forty TR Chillers and Cooling Towers.

All these facilities, Okafor said, have been put in place to meet internationally-recognized standards. The plant is billed for commissioning on Monday June 27.

Novartis Begins Construction of Manufacturing Plant in St. Petersburg, Russia

Novartis AG holds groundbreaking ceremony with Minister of Economic Development of the Russian Federation, E. Nabiullina, Governor of Saint - Petersburg V. Matvienko, and Novartis AG CEO Joseph Jimenez for new pharmaceutical manufacturing plant, deepening the company's commitment to becoming Russia's leading partner in healthcare reform

The Plant is part of Novartis USD 500 million multi-year investment addressing three core areas: local manufacturing, R&D collaborations and public health development in Russia

The facility expected to be complete by 2014, planned to manufacture innovative pharmaceuticals and high-quality generics, adding approximately 350 jobs for highly-qualified professionals in St. Petersburg

Basel - Novartis held a groundbreaking ceremony to announce the start of construction of a pharmaceutical manufacturing plant in St. Petersburg, Russia. The construction of this facility represents the most significant Novartis investment in Russia to date. This facility will further expand the company's capabilities to produce and deliver both innovative pharmaceuticals and high-quality generics to Russian patients.

The new greenfield facility will be built in the Novoorlovskaya Special Economic Zone (SEZ), located to the north of the St. Petersburg city center. Once completed and approved for commercial production, which is expected in 2014, the state of-the-art facility will use cutting-edge technologies to produce approximately 1.5 billion units per year. It will also be an attractive workplace for local talent, employing more than 350 highly qualified professionals who will have access to world-class training and development programs at Novartis.

"The establishment of the new Novartis manufacturing facility demonstrates our commitment to invest in the Russian healthcare infrastructure and to contribute to the long-term goals of improving healthcare in Russia, set by the government", said Joseph Jimenez, CEO, Novartis AG. "The plant in St. Petersburg is the latest step in our strategy to bring both innovative pharmaceuticals and low cost, high quality generics closer to patients and customers in Russia"

This facility is part of a USD 500 million five-year investment into Russian healthcare infrastructure announced by Novartis in December 2010. This comprehensive partnership addresses three core areas which are local manufacturing, R&D collaborations and public health development in Russia.

Novartis and its predecessors have been active in Russia since the 1860s, and the company is one of the key players in the Russian pharmaceuticals market. Novartis currently employs over 2,000 professionals in Russia across all business divisions, spanning Pharmaceuticals, Alcon, Sandoz, Consumer Health and Vaccines & Diagnostics.

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