W. R. Grace & Co. has earned Good Manufacturing Practices (GMP) certification of its facility in Baltimore, Maryland. The certification encompasses Grace’s Quality Management System that includes the standards, procedures and manufacturing operations used by the company in the production of pharmaceutical grade silica (commonly marketed by Grace under the SYLOID^® brand name).

The certification is a verification that Grace’s Quality Management System meets the requirements of the Joint International Pharmaceutical Excipients Council—Pharmaceutical Quality Group (IPEC-PQG) GMP Guide for Pharmaceutical Excipients. Pharmaceutical excipients are inactive ingredients (additives) used in drug formulations.

The certification included a two-day onsite audit of Grace’s Quality Management System and the company’s production, maintenance, laboratory and warehouse operations by International Pharmaceutical Excipients Auditing (IPEA), Inc. The audit was reviewed on February 22 by a panel of industry experts assembled by IPEA, Inc. which came back with a recommendation for certification. This is the first certification for conformance to Excipient GMP granted by IPEA, Inc. for a pharmaceutical excipient in the world.

“We are extremely pleased to earn this certification,” commented Greg Poling, Vice President, W. R. Grace & Co. and President, Grace Davison. “Our customers can be assured that we maintain the highest levels of quality. We continuously test ourselves and our business processes with this audit being an example of that dedication.”

Grace’s current manufacturing operations in Baltimore consist of ten production areas that produce hundreds of products from four general product lines: fluid cracking catalysts, hydroprocessing catalysts, polyolefin catalysts and silicas. Production processes include crystallization, mixing, filtering and washing, drying and calcination (high temperature drying).

Grace markets to customers in the life science, pharmaceutical, anesthesiology, forensic and biotechnology industries through Grace Davison Discovery Sciences, an established leader in silica chromatographic media and detector technologies. Products include liquid chromatography columns, detectors, instruments, accessories, bulk media and purification systems.

DPT Restructures Facilities to Create New Centers of Excellence

DPT Laboratories, Ltd., a pharmaceutical contract development and manufacturing organization, announced a restructuring of its facilities to create three new Centers of Excellence, each focusing on a different area of expertise.

DPT has established Centers of Excellence for Sterile & Specialty Products, Semi-solids & Liquids, and Research & Development to support clients' pharmaceutical development programs and manufacturing needs.

"We feel each of these Centers of Excellence will provide our clients with access to experienced personnel who are experts in their field and who will provide comprehensive development and manufacturing services," said Paul Johnson, President & COO of DPT.

DPT Laboratories in Lakewood, New Jersey, is home to The Center for Sterile & Specialty Products. This center specializes in the development and aseptic manufacturing of clinical trial material and commercial scale products to meet sterile requirements. The 175,000-square-foot site recently underwent a multimillion-dollar transformation to provide state-of-the-art aseptic processing suites and filling equipment.

The Center for Semi-solids & Liquids in San Antonio, Texas, will provide cGMP pilot, clinical and commercial scale manufacturing for prescription and over-the-counter products. The center also includes a dedicated cGMP aerosol and pMDI manufacturing facility. A multi-million-dollar investment was also made to this center to improve efficiency and increase capacity.

DPT's Center for Research & Development in San Antonio provides pharmaceutical development services to include pre-formulation and formulation development as well as analytical development services. This center will perform research and development activities and support technical transfers to the applicable manufacturing center of excellence.

"We are committed to excellence and investing in our future. Our goal is to provide our clients the most efficient and the best development and manufacturing services," said Johnson. "These strategic changes reflect our mission of providing enhancements to service, innovation, and technology for our customers as we move into our next strategic plan."

UGA Opens Nano-Bio Cleanroom

The University of Georgia opened its new nano-bio cleanroom on March 12. The facility cost $2.3 million and was built to engineer devices at the atomic and molecular level interface with biology.

Drug discovery, disease diagnosis and therapeutics, food safety, and bioenergy projects are planned for the new facility. It is a co-located with the Georgia BioBusiness Center. Project partners include the Savannah River National Lab, Emory University, and Georgia Tech.

SCHOTT Begins RTF Syringe Production in U.S.

SCHOTT’s Pharmaceutical Packaging business began production of ready-to-fill glass syringes at its manufacturing facility in Lebanon, PA. The company has invested more than $14 million in the new production capability, and will add 40 new jobs during the next year.

Syringe production capability at the 170,000-sq.-ft. plant will be 270,000 units per day. The company will move to 24-hour production within the next two years. With the addition of ready-to-fill syringes, all of SCHOTT’s pharmaceutical packaging products, which include vials, ampoules and cartridges, will now be produced in North America. SCHOTT will be the second company to produce ready-to-fill syringes in the U.S.

“We hope to increase the market share of domestically produced ready-to-fills, once we are fully operational here in Lebanon,” said Renard Jackson, Vice President of SCHOTT North America, Inc. and General Manager of its Pharmaceutical Packaging Division. “We’re delivering the same high quality standards our customers have come to expect.”

The company plans to further invest $30 million in the Lebanon facility in the future, and potentially employ 80 additional people.

HollisterStier and Draxis Pharma Successfully Complete cGMP Audits

Jubilant Organosys’ two contract manufacturing facilities in North America have successfully completed regulatory cGMP audits. HollisterStier Contract Manufacturing, based in Spokane, WA, completed a successful audit by the Japanese Pharmaceutical and Medical Device Agency (PMDA) for the review of a sterile injectable product for a client. Also, Montreal–based Draxis Pharma, successfully completed an audit by the FDA and Health Canada.

The PMDA revealed no significant observations, resulting in a recommendation to the MHLW that HollisterStier be listed as an approved manufacturing site for the client’s product. That facility was also recently approved by the European Medicines Agency (EMA) as a manufacturing site for this same product.

The FDA audit of Draxis Pharma included a comprehensive cGMP review of both sterile parenteral and non-sterile semi-solid manufacturing capabilities and a Pre-Approval Inspection for three client products. No observations were received from this audit. Recommendations for site approvals for the three new client products are expected. The audit of Draxis Pharma by Health Canada focused on a cGMP review of a dedicated packaging capability and revealed no significant audit observations.

Marcelo Morales, chief executive officer of both groups, said, "We are extremely pleased with the audit findings at both our HollisterStier and Draxis Pharma facilities. Maintaining a rigorous quality culture and robust quality systems, combined with effectively managing our clients' projects, assures the success of these projects in the global market place.”

Yakult to Commence U.S. Production in 2012

Japanese probiotics pioneer, Yakult Honsha, will commence manufacturing its little probiotic dairy bottles in the US for the first time in 2012, the company has announced, as it seeks to move into eastern seaboard US states.

Senior international operations managing director, Yoshihiro Kawabata, stated the company would build the facility in an as yet undesignated location to cater for forecast growth.

"We are planning to expand our business in the United States, starting sales of our products on the east coast, in the north and in other areas in the near future," Kawabata told Reuters.

Yakult’s probiotic drinks run a distant second to Danone’s DanActive drinkable and Activia spoonable yogurts in the US, but the company has been building a presence principally in west coast states of California, Hawaii and Arizona.

All of its US product is currently imported from a production facility in Mexico which also happens to be one of the company’s strongest markets outside of its Japanese base.

About half of Yakult’s sales occur in Japan, where the product has been established for more than 50 years, with another quarter coming from the Asia/Oceania area and the rest in the Americas and Europe. Sales have hovered around the 25 million bottles consumed per day level since 2005, according to the company’s 2009 annual report.

Yakult sells products in 30 countries and has stated it wants to expand to 45 countries in the short to medium term.

It has mainstream retail distribution in the markets where it is present and employs hordes of ‘Yakult Ladies’ to deliver personalized sampling at supermarkets and door-to-door.

The company is also expanding its operations in China where it already has two plants and plans to open a third and is set to post its first profit there, albeit modest.

Further Asian expansion in Indonesia and the Philippines, along with the Middle East, is also mooted.

While Yakult outsells Danone in Japan and some Asian markets, it has struggled in the US, as with Europe, against the might of Danone, which was the first to establish itself in both markets.

Danone’s probiotic brands helped drive a rapid expansion of the US and Canadian probiotic foods market that has seen it grow to be worth $1.77bn according to Euromonitor figures.

Euromonitor predicts the North American market for pro- and prebiotic spoonable and drinkable yogurts will grow to$2.78bn by 2013, and it will overtake the Asian market in value in 2012.

Fenchem Rolls Out Contract Manufacturing for Supplements

China’s Fenchem Biotek has announced the launch of a contract manufacturing service system for the dietary supplement market.

A spokesperson for the company said that, following positive customer feedback, the company is scaling up the pilot contract manufacturing services it previously offered to now officially launch the contract manufacturing service system.

“We can do the entire process for our customer, from raw materials sourcing, producing, packaging to shipment delivery,” said the company. “Our products include soft capsules, hard capsules and tablets. We have a variety of specification and shape of the mold, and a variety of mature product formulations and processes to ensure product quality.”

The company notes that quality and safety are guaranteed by adherence to quality standards and practices of GMP, HACCP and ISO certification.

Colorado Hospital Wins LEED Gold

The main building of the Medical Center of the Rockies in Loveland, Colo., is a 136-bed regional medical center offering a full spectrum of services, with specialties in cardiac and trauma care. Constructed primarily of brick, native sandstone, and 85,000 sq. ft. of metal panels manufactured by Centria, the 600,000 sq. ft. main building, by Denver-based HLM Design, is one of the few hospitals in the nation to receive LEED Gold certification

Dell Children's Medical Center Achieves LEED Platinum Status

The 169-bed facility is the first hospital to earn the coveted LEED Platinum certification (LEED v. 2.1) from the U.S. Green Building Council.

Hospitals are energy gluttons. With 24/7/365 operating schedules and stringent requirements for air quality in ORs and other clinical areas, an acute-care hospital will gobble up about twice the energy per square foot of, say, a commercial office building.

It is an achievement worth noting, therefore, when a major hospital achieves LEED Platinum status, especially when that hospital attains 14 of a possible 17 points for Energy & Atmosphere and 11 of 15 for Indoor Environment Quality.

Kudos, therefore, to Dell Children's Medical Center of Central Texas, a 169-bed, 503,000 sq.ft. children’s hospital and trauma center in Austin, which gained the coveted top spot in green certification (under LEED-NC 2.1) in early 2009, making it the first LEED Platinum hospital in the U.S.

Phil Risner, PE, LEED AP, the owner's project manager and building systems network engineer, said LEED Platinum was the hospital's goal from the outset because “being green” would have “real, positive effects on both the environment and our healthcare delivery capability.”

Interior hallway with skylights. More than 80% of nonclinical spaces in the 503,300-gsf facility have natural lighting. Dell Children’s was the first hospital to earn a LEED point for daylighting.

Wishing is one thing; executing is another. How the Building Team tackled the difficult energy and IEQ problems of such a facility may provide valuable instruction to AEC professionals facing similarly complex situations.

“We had three guiding principles,” recalls Joseph F. Kuspan, AIA, SVP and design director at Karlsberger, the Columbus, Ohio, firm that did the master plan and design for Dell Children's. “One, don't do dumb things to get LEED points. Two, anything less than a 12% return on investment is dumb. And three, we had to know if we were being dumb.” That is, before rejecting any strategy—roof-mounted wind turbines, for example—the team had to weigh it seriously to see whether or not it was truly viable.

A boon from Austin Energy

Dell Children's sits on 32 acres within a 700-acre brownfield redevelopment site that was once home to Austin's municipal airport. To provide power to the new facility, the local utility, Austin Energy, built an $18 million combined cooling/heating power (CCHP) plant. This increased the energy efficiency of the primary fuel conversion for the project from roughly 29% in a conventional power service model, to 75% efficiency.

The CCHP also saved $6.8 million in capital costs that would have gone to boilers, emergency generators, cooling towers, chillers, and the space necessary to house them. The bulk of the savings, $5.8 million, was plowed back into energy-conservation measures and other LEED initiatives.

Equally important to the sustainability of the project was its use of courtyards, which not only opened up the building massing (and played nicely into the project's pace-setting daylighting strategy), but also led to an interesting approach to the hospital's air handling units.

The $18 million combined cooling/heating plant, from Austin Energy, saved the hospital $6.8 million in chillers and other capital costs.

“The owner wanted the AHUs to be in enclosed spaces, not on the roof,” to simplify maintenance and extend their life expectancy, says Kuspan. Instead of doing the usual 10% space gross-up for the mechanical system, the designers put the air handling units in 2,000-sf “rooms” distributed across 15 locations. “We stacked those rooms and put five heat recovery rooms on the roof, because we didn't want to lose that 70° air on a 100° day in Texas,” he says. “That allowed some of the floors below to use that 70° air.”

Each “stack” of AHU rooms was also right-sized to meet the needs of the hospital department it served. One stack might serve a cardio OR, where the room temperature has to be jacked up from 60°F to 90°F in a matter of minutes following surgery, while another stack might serve administrative offices, where the room temperature would be fairly constant.

This innovation produced further benefits and cost savings, says Kuspan. It allowed for shorter duct runs, which enabled the Building Team to overscale the ducts to reduce air velocity and noise. “That kind of background noise can be a stress factor for patients, families, and staff in a hospital setting,” says Kuspan. The designers were also able to reduce the size of fan motors, thereby saving on initial cost as well as operating expenses.

The project's glazing also had to be fine-tuned to achieve a delicate balance between achieving energy savings in the hot Texas sun and not distorting the view to the outdoors. “The grid that was established in the [master] plan was on a 37-degree angle, which was great for some things but tough for sun control,” says Kuspan. Seton Healthcare Network wanted to avoid any hint of a “techy” look on the exterior; therefore, no applied exterior shading devices, no sunshades, no vertical blades, and definitely no motorized systems.

The team solves this problem by using high-efficiency, double-e coated glass high up on the walls and clearer glass, with low-level coatings, in what Kuspan calls “the sweet spot” from three to seven feet above the floor, where greater transparency was called for.

Perhaps the most commendable aspect of Dell Children's, though, is what the Building Team and hospital board didn't do. They stuck to their principles and didn't go overboard to look super-green. Design elements that could have added LEED EA or IEQ points but failed the “don't do anything dumb” rule or fell below 12% ROI didn't make the cut—things like active photovoltaics, roof-mounted wind turbines, vegetative roofs, natural ventilation in the lobby, charging stations for electric vehicles, and a biofuel fueling station for fleet vehicles.

Many other non-energy-related design elements were also scratched, things like denim wall insulation, waterless urinals, an on-site tertiary water treatment plant, pervious pavement and bioswales in the parking lot, a 500,000-gallon rainwater cistern, and recycled gypsum board. All were struck from the program, even though they might have added LEED points.

In some cases, otherwise popular sustainable design elements were ruled out by the owner. For example, interior light shelves were vetoed by the hospital because they were seen as dust collectors and a potential infection control threat. Even without light shelves, however, the Building Team was able to use the open spaces in the courtyards to daylight more than 80% of occupied administrative and nonclinical spaces. Perhaps more remarkable was their ability to get daylight into 35% of diagnostic and treatment areas. By using the LEED “alternative compliance path,” the project was able to earn the first LEED point for daylighting by a hospital.

Of course, not everything worked as planned. Motion sensors were used extensively to control lighting use, but this went a bit too far when the motion sensors in the on-call room kept turning the lights on every time the residents rolled over in their sleep. These motion sensors were quickly removed. Seton Healthcare's Risner and his staff also had to do a lot of fine-tuning to optimize all the mechanical systems.

By sticking to their guiding principles, however, the owner and the Building Team were able to produce a BMW project at a KIA price. “A lot of people think we must have had an $800 per square foot budget, that's just not true,” says Kuspan. The construction cost was somewhere between $280/sq. ft. and $305/sq. ft., depending on whether the $18 million for the cogeneration plant is included in the calculation.

“That's not an exorbitant cost per square foot for a project like this,” says Kuspan. Not when you get the kinds of bragging rights Dell Children's Medical Center has earned.

Twenty-five of the 54 points Dell Children's Medical Center earned in attaining Platinum designation under LEED 2.1 came in two categories: Energy & Atmosphere (14 of 17 possible points, including 10 for optimized energy performance) and Indoor Environmental Quality (11 of 15). To help reach these goals, Austin-based general contractor White Construction and the owner, the Seton Healthcare Network, selected Siemens Building Technologies to install and integrate a building automation and control solution in the 169-bed pediatric and trauma facility.

Siemens delivered its APOGEE suite of building automation and controls as part of a more extensive building system and energy management solution that also included fire detection, alarm, and emergency air handling system control. BAS implementation helped achieve two of three LEED Energy & Atmosphere prerequisites (Fundamental Building Systems Commissioning and Minimum Energy Performance). The control technology and its proper integration also helped earn five of the 14 EA points.

Indoor air quality is, of course, a critical aspect of the interior environment of any hospital, and Dell Children's was no exception. In the IEQ category, the BAS system and control helped achieve one of the two prerequisites (Minimum IAQ Performance), as well as its associated control, monitoring, and reporting of interior (and exterior) air.

Of the 11 IEQ points the project earned, four—for CO2 monitoring, controllability of systems, thermal comfort (under ASHRAE 55-1992), and thermal comfort (permanent monitoring system)—helped anchor this category for Platinum certification.

The BAS system provides the data handling capability necessary to properly monitor building systems and automate complex control functions. The system also monitors the incumbent operating conditions of energy-intensive systems, including the facility's underfloor air distribution, hot water generators, outside air-conditioning systems (for humidity and temperature conditions), and data center cooling units, as well as the MEP system's many pumps, fans, critical fire/life safety and smoke purge systems, and the 15,000-gallon therapy pool in the rehabilitation center.

The BAS system was configured to alarm in the event of equipment failure or ambient conditions straying from required setpoints, such as in the operation of critical air handler unit fans or operating/isolation room environmental conditions. The Siemens BAS closely monitors and controls the conditioning and use of outside air, as well as detecting and adjusting air-handling devices based on the predetermined night setback and other occupancy conditions.

On-site facilities engineers at Dell Children's can be alerted to a problem in real time via remote paging and notification software linked to their cell phones or pagers. Access and control are further facilitated through virtual private network access via the Internet or PDAs.

For Dell Children's, two local substations provide backup power, while an on-site emergency generator provides a third backup for all life/safety systems at the hospital.

The BAS automatically trends utility data on a regular basis. With the aid of this historical data, the hospital's facility managers can track costs, detect power spikes, and troubleshoot any equipment operating out of normal range. The hospital conducted extensive design-versus-actual load assessments on all energy-consuming systems—electrical use, chilled water, and steam—using the BAS system's monitoring capability and historical database. From this, it was determined that the facility recorded 32% less total energy use than expected in its first year of operation, despite higher than normal temperatures in Austin during that period.

Load management is also a critical factor in healthcare facilities. A unique aspect of the Dell Children's campus is its 4.5-MW natural gas turbine-powered combined heating and cooling power plant, which supplies all the electricity, chilled water, and steam required by the facility, making it more than twice as efficient as an equivalent coal-fired plant. The power plant provides 46% more primary energy than the conventional grid-to-substation-to-hospital power service model.

Thanks to the cogeneration plant, the overall building rating went from 17.2% to 61% above the applicable ASHRAE 90.1 energy-efficiency standard for facilities of this type

Merck Joins Biosecurity Vaccine Facility Coalition

Merck & Co has joined a coalition to build a vaccine facility which is capable of simultaneously manufacturing multiple products and can quickly switch in response to a crisis.

Bioterrorism and pandemic influenza have increased scrutiny of biosecurity in the US and the coalition, called 21st Century Biodefense (21CB), expects the government will allocate funds to ensure the nation is protected.

21CB will compete for this funding and use it to build a vaccine development and production facility. The plant would operate as a public-private partnership under the direction of the federal government, helping to keep production focused on threats to biosecurity in the US.

Discussing biosecurity President Obama outlined plans to create “a business model that leverages market forces and reduces risk to attract pharmaceutical and biotechnology industry collaboration with the US government”.

It is unclear exactly how and when this plan will be implemented. Consequently, 21CB is yet to establish a timeline for the vaccine facility but expects its initiative will create 1,000 jobs directly.

Non-profit health enterprise UPMC established the initiative and recruited GE Healthcare, Merck, Battelle and IBM. Merck will provide drug development and bioprocess advice, as well as training for facility staff, as part of a consortium of biopharmaceutical companies 21CB plans to establish.

The other partners each have expertise in specific areas of the operation. For instance, GE’s production equipment, consumables and manufacturing processes will be used at the site. In addition it will support the project with manufacturing design and developmental expertise.

Earlier in development Battelle is providing preclinical and other research services, such as product safety and efficacy evaluations to support submissions to the US Food and Drug Administration (FDA).

All these operations will be supported by IT infrastructure from IBM. 21CB claims the system will be able to handle very large volumes of data and scale quickly to shifts in demand levels.

New Nanobioscience Center Targets Personalized Medicine

The first center of the downtown Phoenix biomedical campus aims to change the way individuals are diagnosed and treated for the most deadly and debilitating diseases.

Diseases will be diagnosed more effectively and sooner through the work being done at the new Center for Applied NanoBioscience and Medicine at the University of Arizona College of Medicine - Phoenix in partnership with Arizona State University.

Led by internationally noted biochemist and physicist Frederic Zenhausern, PhD, MBA, the center, the first at the College of Medicine - Phoenix will focus on personalized medicine, changing the way individuals are diagnosed and treated for the most deadly and debilitating diseases.

"This world-class center is key to creating a thriving academic health center in Phoenix with cutting-edge research," said Stuart Flynn, MD, dean of the College of Medicine - Phoenix. "Dr. Zenhausern and his team have made impressive advancements in developing tools to help our future physicians practice personalized medicine and improve health care for all Arizonans."

With more than two dozen interdisciplinary researchers and support staff, the center will work to create new ways to diagnose disease, monitor health and build equipment by merging new technologies from areas so new they could prompt far-ranging options.

Among the center's goals is to develop novel molecular-based diagnostic tests that can be used by individuals and public health systems to facilitate personalized medicine, the emerging area that calls for using genomic and molecular data to better target health care to individuals. The practice will help determine a person's predisposition to a particular disease or condition and in treatment.

"Change in health care requires innovation in early diagnosis but also information, communication and overall medical practices," said Dr. Zenhausern. "The emerging molecular profiling of diseases is revolutionizing the future of medicine. Nanobiotechnology is a key enabler in providing unprecedented clinical tools to physicians and patients that will uncover the molecular mechanisms of diseases and drug therapies, helping to guide personalized treatment."

Much of the center's research focuses on combining physical sciences and molecular assay techniques from genomics and proteomics into device platforms that can be translated into improved systems to diagnose diseases more specifically and sooner for a better quality of life.

The center's infrastructure also provides a unique framework from discovery to large-scale prototyping and clinical validation that allows private industry and government research agencies to partner in developing these advanced platform technologies into compliant products.

The center already is working with the U.S. Food and Drug Administration for regulatory review of some of its technology initiatives. The center is also applying its nanotechnology expertise to address other great challenges in biosciences and also in energy systems.

Arena Completes Phase 3 Clinical Trial Program

Arena is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral drugs that target G protein-coupled receptors, an important class of validated drug targets, in four major therapeutic areas: cardiovascular, central nervous system, inflammatory and metabolic diseases. Arena’s most advanced drug candidate, lorcaserin, is intended for weight management, including weight loss and maintenance of weight loss, and has completed a pivotal Phase 3 clinical trial program. Arena submitted a New Drug Application for lorcaserin to the FDA in December 2009.

RTI Creates Genetic-Environment Center

In an effort to accelerate research to understand the complex relationships between genetics, genomics, molecular epidemiology and their interactions with environmental factors, RTI International has committed more than $2 million to form a new multidisciplinary research center.

The center, called Molecular Epidemiology, Genomics, Environment and Health (or MEGEH), will focus on addressing significant issues or questions regarding genetics and human health through interdisciplinary and translational research.

Since 2001, RTI International has been developing the core capabilities that laid the foundation for the new center, adding advanced capabilities in mass spectrometry, metabolomics, bioinformatics, biostatistics and high-performance computing.

Scientists working within the new center will employ "team science" to develop integrative approaches that better define disease states and states of wellness and susceptibility to disorders and disease. Working together, they will devise medical and public health interventions and policies that will promote implementation of personalized and preventive medicine.

Researchers at the new center represent specialties that comprise the entire range of RTI's research fields, including genetics, bioinformatics, proteomics, biostatistics, epidemiology, engineering and many others.

Washington U to Fund Genomic Data Center Expansion with $14 Million Stimulus Grant

Wash U's current genomic data center, a 16,000-square-foot facility that houses approximately 5,000 processors and more than 5 petabytes of disk storage, is nearly 90 percent full.

Washington University School of Medicine in St. Louis will expand its genomic data center and increase its computer data storage capacity using a $14.3 million grant the school will receive through the American Recovery and Reinvestment Act.

The grant, awarded by the NIH's National Center for Research Resources will double the data center to 32,000 square feet. The expansion will add staffers to the roughly 300 now working at the genome center, as well as generate about 200 construction jobs.

"My expectation is that we'd see an increase of somewhere between 20 to 50 people at the Genome Center" over several years, said Richard Wilson, the center's director.

He said the expansion will also enable the Genome Center to keep pace with the explosion in genomic data wrought by next-generation sequencing. The data center currently has about 5,000 computer processors with more than 5 petabytes of disk storage.

That capacity will increase, Wilson said, though it has not been decided how much. That answer will become known, he said, as the center assesses what new equipment comes onto the market, and what it will ultimately purchase. He said it was premature to project what that new equipment would cost, but did say it would not be a single immediate purchase. "It will take a couple of years to actually put all the gear in there," he said.

"You want to be able to respond to trends in sequencing technology development, and you want to also be able to take advantage of the trends in informatics hardware improvement and development. As we get closer to the point of actually starting to fill the building with gear, then we'll have a much better idea of which direction to go," Wilson said.

"The bottom line is, it gives us capability we know we're going to need for the next five to 10 years in terms of being able to sequence a lot more genomes, and to start to look at other diseases besides cancer and the other germline diseases we're looking at now," he added.

The Genome Center's major focus is on cancer and microbial communities at various sites on the body. The center is carrying out some initial investigation of samples of patients with metabolic diseases, such as diabetes, and visual disorders, such as retinitis pigmentosa and age-related macular degeneration, and some cancer-related syndromes.

Construction is set to start this fall and be completed in about a year. The addition will be designed to exceed the second-highest or "gold" rating of the Leadership in Energy and Environmental Design certification system for energy-efficient "green" buildings.

The current genomic data center, completed in 2008, was built to LEED's gold rating, and was the first green building to rise on the medical school's campus.

Institute for Systems Biology Gets $6 Million Donation

An anonymous California venture capitalist and philanthropist has agreed to donate $6 million over five years to the Institute for Systems Biology toward a planned expansion and move, the hiring of additional faculty, and unrestricted research support.

The Seattle-based non-profit, biomolecular research institute said in its announcement of the donation that proceeds from the gift would "facilitate ISB's move to a new building that will double space for research and core technology facilities."

ISB President Leroy Hood said the institute contemplated consolidating its two current Seattle sites into a single facility within the city that would be double its current 65,000-square-foot headquarters at 1441 North 34th St. ISB also occupies nearly 16,000 square feet nearby.

"I hope it will be on the order of a year, maybe a little longer than a year," Hood said in the interview, adding that the timing of a move was subject to several additional decisions that have yet to be made.

The consolidated facility, according to Hood, would be within the city's South Lake Union section, and accommodate additional research space and researchers: "My vision is, I'd like to grow us from 12 faculty to 20 or 22 faculty."

Part of the proceeds from the $6 million gift will go toward recruitment of additional faculty members, as well as providing unrestricted support for continuing research in areas that include the paradigm advanced by ISB and Hood that healthcare must evolve from being reactionary to being "predictive, preventive, personalized, and participatory" — what Hood calls "P4 medicine."

The donation also would fund support of research efforts toward "transferring new knowledge to society," as well as biofuels and global health studies. The study of the latter through systems biology is the focus on ISB's 9th annual systems biology symposium, to be held at the institute's headquarters on April 18-19.

"Visionary donors such as this wonderful friend of ISB understand the importance of unrestricted support in the pursuit of scientific ideas that can literally change the world," Hood said in the institute's announcement. "We are truly grateful."

Eyeing Prenatal-Testing Space, BioReference Labs Buys Regional Genetics Lab

BioReference Labs spent $5.5 million to acquire Lenetix Medical Screening

Laboratory, a privately held regional clinical lab located in Mineola, NY, that specializes in prenatal and genetic testing.

President Marc Grodman said the deal will "lay the groundwork for assuming a leadership role in the evolving area of prenatal testing, a specific area of testing that is the natural progression of the capabilities we have developed over the past few years."

He also said it "will enhance and help marry the core offerings of our Women's Health initiative and the strong technological expertise of GeneDx."

BioReference Labs currently offers two prenatal profiles, though they are both obstetric, not fetal, profiles, according to its website.

BioReference Labs disclosed the acquisition in its fiscal first-quarter earning release, which showed a 31-percent rise in total revenue. It said the buy included a down payment of $4.7 million and a "hold-back" of $750,000 designed "to insure the accuracy of the sellers' representations."

BioReference Labs said the acquisition will "enhance" its Genetic and Women's Health programs, and stressed that "because of its size, the acquisition will have minimal effect on current financial metrics."

Hawaii's Diagnostic Laboratory Services Expanding

Diagnostic Laboratory Services of Hawaii is expanding its main clinical-testing lab by moving into a $20 million renovated warehouse in December.

The lab's new 84,000-square-foot facility will be located in Halawa, which sits just north of Honolulu on the island of Oahu. The new space will be 10,000 square feet bigger than the lab's existing space in Honolulu.

“We are very excited about this warehouse space, which gives us the opportunity to remodel an entire building specifically for us, to include potential for future growth,” said Richard Okazaki, president and CEO of Diagnostic Laboratory. “We can now bring in new tests to meet physician and patient demand, something that would have been difficult if not impossible in the smaller space" it currently occupies.

Diagnostic Laboratory Services, Hawaii's largest locally owned clinical testing laboratory, employs around 600 people spread throughout 38 locations in the state, Guam, and Saipan, according to the report. It performs toxicology, pathology, and microbiology services.

Hyaluron Contract Manufacturing

Hyaluron Contract Manufacturing (HCM) is a leading scale-up process developer and aseptic filler of syringes, vials and custom containers from pre-clinical to commercial scale. HCM offers traditional filling as well as patented BUBBLE-FREE FILLING of pre-filled syringes and lyophilization of vials. HCM excels in process development scale-up of difficult formulations including: emulsions; viscous gels; suspensions, liposomes, and proteins. HCM is ISO certified, and has been inspected by the FDA for drug and medical devices.

Consortium Formed to Offer Tailored CMC Packages

Cambridge Major Laboratories (CML), Avantium, Xcelience and Beckloff have formed a consortium to offer tailored, client-focused CMC packages which are particularly suited to atypical compounds.

Drawing on the respective strengths of the specialized companies allows the consortium to offer a portfolio of services generally associated with larger businesses and, according to the partners, offers advantages over bigger rivals.

Kim Black-Washington, director, marketing and strategic at Xcelience, said that virtual and emerging pharmaceutical companies developing atypical compounds are underserved by current providers.

Fixed timelines and costs are unrealistic for these compounds, according to the consortium. Black-Washington believes they are better served by the Chemistry Playbook consortium’s bespoke developmental programs that focus on client needs and program execution.

The potential flaw in the consortium strategy is integration and communication. Larger, all-in-one chemistry, manufacturing and control (CMC) service providers often highlight how a single outsourcing partner can shorten timelines through close cooperation of in-house departments.

Chemistry Playbook has clearly considered this and Washington-Black believes systems are in place to ensure close cooperation between companies. For each client the consortium collectively creates a Gantt chart to define timelines, responsibilities and functional hand off.

This is accompanied by close communication between consortium project managers at each company. These individuals are already in contact with each other and communication will be maintained throughout a project using conference calls.

Washington-Black added that a client’s initial point of contact will depend of the service package they need. For companies without in-house CMC regulatory oversight Beckloff Associates would be the initial point of contact. In contrast, larger companies might not require Beckloff at all.

The consortium claims to cover drug development ‘from carbon to commercialization’. Each partner has a different strength: Beckloff’s is CMC regulatory oversight; CML’s is API production; Avantium’s is solid state characterization; and Xcelience’s is formulation development.

Glycos Scales Up Sustainable Lactic Acid Production

Glycos Biotechnologies, Inc. partners with ethanol companies, biodiesel companies and chemical companies interested in leveraging existing glycerin and cellulosic streams into alternative chemicals and fuels. The company can also support engineering and construction partners to collaboratively design and implement integrated biorefineries.

Glycos Biotechnologies has produced lactic acid in a pilot plant using its sustainable technique, successfully scaling up from a laboratory setting to provide an alternate source for the chiral synthon.

Production in a plant capable of outputting 150,000 liters of chemicals represents a validation of GlycosBio’s technology and a step towards its goal of globally commercializing the sustainable technology.

GlycosBio uses non-pathogenic microorganisms, which it claims have been used safely for years in pharmaceutical manufacture, to produce lactic acid from multiple non-sugar feedstock sources.

Paul Campbell, chief scientific officer at GlycosBio, explained: "Through the creation of biologically 'balanced' pathways inside the microbe we have been able to uniquely develop microorganisms that naturally produce the desired end-products."

The microorganisms are engineered to digest a certain feedstock and produce a particular chemical, such as lactic acid. Microorganisms are then grown in a bioreactor and they process the feedstock, such as crude glycerine, to produce a chemical that can then be isolated.

Separation and isolation of the desired chemical is performed using traditional equipment, making it easy to incorporate into existing infrastructure, according to GlycosBio.

Ending the reliance on sugar eliminates the risks associated with using a single source and provides chemical manufacturers with product flexibility, according to GlycosBio.

In addition to chiral synthesis lactic acid can also be used in the creation of lactate copolymer microspheres which are suitable for sustained-release drug delivery. GlycosBio’s technique can also be used to produce advanced ethanol and other specialty chemicals.

Now that the technique has been validated in a pilot plant GlycosBio is focusing on “securing additional commercialization partnerships around the world”, according to Rich Cilento, CEO of GlycosBio.

New Facility to Meet Pioneer Soybean Boom

DuPont and the state of Missouri announced DuPont business Pioneer Hi-Bred plans to construct a commercial and parent soybean seed production facility in New Madrid County, Mo. The $55 million project is one of many expansions Pioneer is making to ensure it meets rising demand for its products and helps farmers meet the strong global demand for grain.

Pioneer, which recently acquired 129 acres of land in Missouri’s New Madrid County, expects initial operation to begin fall 2011 after construction is completed. The new plant is expected to employ about 50 people once it is fully operational.

“This location strengthens our ability to bring new products to the market faster and to help farmers increase their productivity and profit,” said Paul E. Schickler, president – Pioneer Hi-Bred. “Our high-yielding Y Series soybeans have created even more demand for Pioneer soybeans, and this new facility will help ensure that growing demand is met.”

“As our economy continues to recover, it is critically important that high-tech, high-paying companies such as Pioneer invest in Missouri and create new jobs for our workers,” said David Kerr, director – Missouri Department of Economic Development. “Pioneer’s plan to build a new production facility in New Madrid County further demonstrates how a strong package of state tax incentive programs can serve as a powerful tool to help draw quality companies to Missouri, creating new jobs and moving our economy forward.”

“The Missouri Technology Corporation (MTC) is pleased to partner with the Department of Economic Development to bring this exciting project and new jobs to southeast Missouri,” said Jason Hall, executive director – MTC. “This project is a direct result of the work of the state and MTC, along with others, to strategically market Missouri’s strength in agricultural-biotechnology and to bring these next-generation jobs to all corners of the state.”

As the first Pioneer production facility in Missouri, the new plant primarily will serve soybean growers in more southern geographies in the United States. Pioneer also has a research facility in Miami, Mo., as well as selling corn, soybean, sorghum and wheat seed in the state.

The launch of the Y Series is the result of a proprietary matrix of traits and technologies Pioneer researchers have been developing and deploying to accelerate product development. Pioneer is employing its exclusive Accelerated Yield Technology (AYTTM) system and marker-assisted selection to boost the yield potential and improve the agronomic performance of these varieties. This harnesses the power of the Pioneer germplasm collection, strong bioassays, computing power and molecular breeding tools to drive genetic gain at unprecedented rates.

Missouri Technology Corporation (MTC) is a private, not-for-profit corporation, established by the Missouri General Assembly. It is charged with leading Missouri’s technology-based economic development strategy, including strengthening of the economy of the state through the development of science and technology; to promote the modernization of Missouri businesses by supporting the transfer of science, technology and quality improvement methods to the workplace; and to enhance the productivity and modernization of Missouri businesses by providing leadership in the establishment of methods of technology application, technology commercialization and technology development.

Pioneer Hi-Bred, a DuPont business, is the world’s leading source of customized solutions for farmers, livestock producers and grain and oilseed processors. With headquarters in Des Moines, Iowa, Pioneer provides access to advanced plant genetics in nearly 70 countries.

DuPont is a science-based products and services company. Founded in 1802, DuPont puts science to work by creating sustainable solutions essential to a better, safer, healthier life for people everywhere. Operating in more than 70 countries, DuPont offers a wide range of innovative products and services for markets including agriculture and food; building and construction; communications; and transportation.

Anderson Packaging Recognized for Lean Six Sigma Program

Anderson Packaging (Rockford, IL) has been recognized by the International Quality and Productivity Centre (IQPC) in its annual Process Excellence Awards competition. The company won the small-to-mid sized corporation category for the competition’s Best Process Improvement in a Manufacturing Project, following the submission of a detailed summary of its Lean Six Sigma project optimizing the company’s pharmaceutical bottle packaging lines. Anderson instituted its award winning Lean Six Sigma program companywide in 2004.

The award was received at the IQPC’s eleventh annual Lean Six Sigma and Process Improvement Summit in Orlando, Florida on January 21st. Anderson was recognized in the competition for its effectiveness in implementing improvements in the area of pharmaceutical bottling.

“This award is recognition of the efforts of many individuals at Anderson,” says Chuck Aubrey, VP, performance excellence, Anderson Packaging. “We maintain a culture of continuous improvement and the principles of Lean Six Sigma methodology are involved in every aspect of the business. It helps maintain Anderson’s competitiveness in the pharmaceutical packaging market, but ultimately it’s about delivering the best possible service and performance to our customers. The Lean Six Sigma program is delivering powerful and measurable results.”

The initiative was designed to deliver Anderson’s customers increased capacity and efficient turnaround of production orders, while furthering scrap minimization and downtime initiatives. The project encompasses more than ten production lines across multiple facilities. Anderson was able to achieve reductions in downtime for individual programs in excess of 30%, as well as increases in Overall Operational Effectiveness (OEE) for programs of 10%. In addition, for individual programs Anderson recognized scrap reductions approaching 40%. Project effectiveness was measured against ongoing performance metrics Anderson reviews with customers.

Acai Roots Plans Expansion after Brazilian Investment

California-based acai berry company, Acai Roots, claims it is poised for big expansion after a group of Brazilian investors invested a significant but undisclosed sum in the company’s business.

A spokesman for the company said, “I am not allowed to disclose the actual number, however, it is significant for the current growth we are experiencing.

“The investment will also cover product-development costs, it will be used to back-up our growing operations (logistics, distribution, sales, retail, etc), and at the same time it will allow us to provide marketing support to our brand.”

The spokesman added that the investment would not affect product quality. “In many cases, when companies partner with investors they change the formula of their products to make more profits, and this is not the case with Açai Roots. Marco Aurelio, the lead investor, believes in what we are doing and he wants to maintain our goal to deliver high-quality products.”

Açai Roots estimates the size of the U.S. retail market for açai products to range between $70-100m. If current trends continue, it expects the market to double every two years. In Brazil, the value of the açai market is estimated to be worth $1 billion.

The company, which produces a range of açai frozen pulp, açai freeze dried powder and capsules, açai liquid concentrate and energy shots, açai smoothies, and pure açaí juice, considers itself to be the number two brand in its market segment.

Aside from building business in the U.S., South America is an obvious region for further expansion. “We would love to be in South America prior to the 2014 World Cup in our homeland, Brazil,” said the company spokesman.”

Marco Aurélio added: "This is an idea that we have started to plant the seed. There is no reason to avoid this possibility.”

Rich in anthocyanin pigments that give it the berries their characteristic deep purple color, açai is associated with consumption of antioxidant pigments linked to reduced risk or prevention of cancer, diabetes, chronic inflammation, heart and vascular disease.

In addition to antioxidants, açai contains omega fatty acids, phytosterols and dietary fibers: nurtures a better digestive system. It is also a source of protein, calcium, vitamins A, E, and B6.

Açai Roots manufactures and distributes pure açaí berry products formulated by native Brazilians and pledges to respect sustainable harvesting methods and local communities.

ChromaDex Wins U.S. Government Contract

Phytochemical reference standards and contract testing services company ChromaDex has won a five-year contract to supply federal agencies with scientific services.

The new contract with the General Services Administration (GSA), which took effect on March 1, covers all aspects of food and dietary supplement testing, analytical method development and validation, contract research services, report and manuscript preparation and laboratory technique training.

CEO and co-founder Frank Jaksch said, “Any government agency that has need of… (our) analytical services can use this contract to purchase services… ChromaDex works with agencies such as: FDA (Food and Drug Administration), NIH (National Institutes of Health), NIST (National Institute of Standards and Technology), USDA (United States Department of Agriculture) and EPA (Environmental Protection Agency).”

The GSA contract is open-ended in that any company whose products or services match the requirements of the specification can submit a proposal. “There are 62 categories of commercial products and services that vendors may apply for a GSA contract under,” said the spokesman. “Known as schedules, these categories cover everything from industrial products, vehicles, computers and office products, to most categories of professional services.”

The five-year contract is reviewed annually and can be renewed for three additional five-year periods. To keep the contract in place, the company must achieve certain levels of sales to government agencies each year.

Government contracts with commercial firms provide federal agencies with access to over 11m commercial supplies (products) and services that can be ordered directly from GSA Schedule contractors, according to ChromaDex.

Jaksch said: “This long term supply contract enables government agencies to quickly and easily utilize ChromaDex services without going through lengthy competitive bid processes. We currently serve a number of government agencies, and this contract will make it quicker and easier for them to do business with ChromaDex.”

Covance’s R&D Partnership with Lilly Expands

Covance will provide US drug major Eli Lilly with bioproduct analytical testing services under an expansion of the firms’ year-old R&D collaboration.

The new agreement will see the U.S. contract research organization (CRO) take on responsibility for testing all of Lilly’s developmental biologics at its $15 million facility in Greenfield, IN.

Covance also said that it has offered employment contracts to around 20 Lilly staff to oversee the new analytical testing work.

Lilly and Covance have collaborated on drug R&D since August 2008 when the CRO bought the 600,000 sq. ft. Greenfield preclinical toxicology and discovery unit for $50m and taking on 264 additional staff.

The deal also guaranteed the CRO $1.6bn worth of drug development research and preclinical work of a 10 year period.

Covance said that in conducted nearly 4,000 studies for Lilly in 2009, ranging from discovery stage projects to Phase III clinical research and predicted that this number will increase as a result of the new agreement.

CEO Joe Herring said that: "In the first year, we've proven that we can help accelerate drug development timelines and improve efficiencies, enabling Lilly to focus on its core competencies in delivering better patient outcomes over the longer-term.”

Andrew Dahlem, VP of Lilly Research Laboratories (LRL) Operations, agreed and added that: “With the Lilly/Covance model, everyone on the team understands the end goal and their role in it, and because of this, has a greater sense of urgency and personal pride in advancing the molecule to the next stage."

Dow AgroSciences Adding More Than 550 Jobs

Dow AgroSciences LLC has released plans for a major, multi-year expansion that would add more than 550 jobs and dramatically grow the life sciences company's global headquarters in Indianapolis. The $340 million investment includes construction of a research and development complex with laboratories and a greenhouse as part of an effort to develop and commercialize products for the company's agriculture and related markets. It is billed as the largest jobs announcement by the company since its inception some 20 years ago.

Thermo Fisher Gets Ahura Scientific

Thermo Fisher Scientific has completed its acquisition of Ahura Scientific, a maker of Raman and FT-IR spectroscopy instruments. The acquired company will be integrated into Thermo Fisher's Analytical Technologies Segment.

Biotools Expands Personalized Medicines

Biotools said that it has spun out a personalized medicine tools firm called BlackBio. The new firm will use sequencing platforms, protein arrays, and other molecular tools in researching metabolic disorders, cancer, cardiovascular diseases, pharmacogenetics, and other areas.

Almac Radio-Labeling Facilities Expanded

The Almac Group, an integrated contract development and manufacturing organization supporting the international pharmaceutical and biotechnology industries, has enhanced its radio-labeling capabilities with a significant facility expansion. The new laboratories are the culmination of nearly five years of work by the Almac Group, since originally receiving a Carbon-14 license in 2005. They were opened by Dr. Ken Lawrie of GlaxoSmithKline and Chairman of the International Isotopes Society.

The opening of the facility follows Almac’s official accreditation for cGMP manufacturing and the securing an Investigational Medicinal Products (IMP) drug product-manufacturing license, from the Medicines and Healthcare Regulatory Agency (MHRA) in May 2009.

The expanded laboratories will include some 20 new workstations, 14 synthesis and a further 6 general workstations for chemistry and analysis. These facilities will be staffed by 20 dedicated radiochemists, including Dr. Sean Kitson who received the 2006 Wiley Journal of Labelled Compounds and Radiopharmaceuticals Young Scientists award for his work on the elaborate radiosynthesis of the Parkinson’s drug (R)-(-)-[6a-14C]apomorphine.

In addition, the expanded facilities will also feature a new, dedicated manufacturing finishing suite for the development of IMPs used in clinical trials and the final steps in Active Pharmaceutical Ingredients (API) manufacture. This will allow analytical chemists to carry out critical testing of a labeled IMP and undergo x-ray powered diffraction (XRPD) to determine the degree of polymorphism, all on the same site.

Commenting on the announcement, Almac’s VP, Operations Dr Rick Dyer, said: “Almac has started the New Year with a firm resolution to provide a clear pathway for pharma companies to meet the radio-labeling requirements in Phase 1 to Phase 3 clinical trials, signaling our intent to work very closely with the high quality servicing needs of the sector. Our capability to provide cGMP for final drug candidates, peptides, small molecules and advanced intermediates responds competitively to the demands of the market. Almac also now offers QP release.”

Worcester Polytechnic Institute Gets $6.6 Million Grant

The Massachusetts Life Sciences Center Board of Directors awarded a $6.6 million grant to Worcester Polytechnic Institute (WPI) to support the next phase of life sciences related development at Gateway Park in Worcester, MA. The grant leverages $25 million in private investment for the development of a new 80,000-square-foot life sciences facility anticipated to create 120 construction jobs and 142 new permanent jobs at completion.

The grant supports the development of WPI's Biomanufacturing Education and Training Center (BETC); a new incubator for Massachusetts Biomedical Initiatives (MBI); and expanded academic and research space, including new facilities for the Massachusetts Academy of Math and Science. The BETC is planning a 10,000-square-foot facility that will provide hands-on biomanufacturing training to support industry workforce development. MBI is planning to expand its incubator resources by developing a new wet-lab core facility to help more companies launch, grow, and provide jobs. MBI currently operates three life sciences incubators in Central Massachusetts (one of which is located in the first Gateway Park building) and has graduated 30 companies, creating 265 new jobs since 2000.

In addition to these programs, which will be housed in the new facility at Gateway Park, the expanded development will make available 40,000 square feet of additional lab and office space for commercial and academic uses, including workforce development.

"Gateway Park is a great example of a public-private partnership that is contributing to job creation and long-term growth in Massachusetts," said Lieutenant Governor Timothy Murray. "Today's approved funding will not only support the design, fit-out, and construction of a new wet lab at Gateway Park, but the funding will also lead to even further investment in the growing life sciences industry in the region and the Commonwealth."

"Significant growth in the life sciences is taking place in the Worcester area, thanks in large part to the more than $100 million in investments that the center has made in the region," said Dr. Susan Windham-Bannister, President & CEO of the Massachusetts Life Sciences Center. "This investment will help to accelerate that growth even further, while supporting a terrific project that will create jobs, provide training for a next generation of life sciences workers, foster the growth of new companies and advance scientific research."

"This grant from the Massachusetts Life Sciences Center will provide direct support in the Commonwealth's first Growth District here at Gateway Park for training in biomanufacturing, new business creation, and advanced research in life science applications," said WPI president Dennis Berkey. "We are grateful to the Life Sciences Center, its president Susan Windham-Bannister, and Governor Deval Patrick and his administration for their leadership and this investment in economic development and scientific and technological advancement in the heart of the Commonwealth."

"This is exactly the kind of investment envisioned by the Governor and Legislature when they crafted the Commonwealth's Life Sciences Initiative, and it will have tremendous leverage helping companies grow and add jobs here in Massachusetts," said Kevin O'Sullivan, MBI President and CEO.

"Gateway Park is an integral piece in the development of life sciences and biotech jobs not only for Worcester and Central Massachusetts, but for the entire commonwealth," said State Senator Harriette Chandler (D-Worcester). "This generous grant will play a tremendous role in the continued evolution of this revolutionary public-private partnership project in the heart of our city."

AIM Plastics Moves to Cleanroom Space

AIM Plastics Inc. moved equipment into a new, $4.5 million, 35,000-square-foot manufacturing center at its Clinton Township headquarters. The center includes a 6,000-square-foot cleanroom.

Medical work accounts for about 90 percent of business volume.

“We broke ground in October 2007, and construction began in 2008,” said Jim Jarrett, president of the firm's technology group.

The firm occupies 55,000 square feet now and is converting its adjacent 20,000 square feet into a technology center for in-house tooling and sampling.

As now configured, there are 20 presses in the manufacturing center, six in the cleanroom and five in the technology center.

New equipment includes a $200,000 Wittmann material-drying system, an ITW Trans Tech pad printer and three Arburgs: the firm’s second two-shot 110-ton hydraulic, a 450-ton hydraulic and a 150-ton vertical with a rotational platen.

“The new equipment is in place, calibrated and ready to go,” Jarrett said.

Acorn Industries Inc. of Livonia, Mich., is certifying the $250,000 clean room to Class 100,000 and Class 10,000 standards. For now, it will operate at Class 100,000.

In mid-2009, AIM acquired two Mitsubishi computer numerically controlled electric discharge machines, one sinker and one wire.

The firm employs 52 and had 2009 sales of about $9 million, a 10 percent jump from 2008 on top of AIM replacing revenue from the loss of an $875,000 medical account. Clinton Township is part of metropolitan Detroit.

REST OF WORLD

GVK Opens Ahmedabad Clinical Pharmacology Unit

Indian CRO GVK Biosciences hopes new clinical pharmacology unit in Ahmedabad will help boost patient recruitment to meet growing demand for clinical trials in the region.

The 110 bed, three ward unit, which will focus on conducting early-stage safety trials in health volunteers, boosts existing local capacity and is in the ideal location according to contract research organization (CRO).

“Ahmedabad was the most preferred and logical destination for expansion considering the volunteer pool accessibility and proximity to about 10 CROs and leading Pharma companies.”

GVK also said that, while a wide range of early-phase clinical trials will be carried out, one focus of the unit will be to increase the participation of women in research through the provision of dedicated “special housing facilities for female volunteers.”

Company president Manni Kantipudi said: “The opening of the new GVK BIO Clinical Pharmacology unit reflects our commitment to offer faster recruitment solutions to our customers,” and added that the first trial has already started.

Patient recruitment has been something of a focus for GVK so far in 2010, beginning in January when it became the latest member of the ResearchPoint Global Network (RGN)

At the time, Kantipudi explained that one of the benefits of the move was that the firm’s “existing clients will benefit from our ability to recruit patients across multiple geographies through RPG.”

Kendle Plans Facility in India

GVK is not the only CRO to be drawn to Ahmedabad in recent times. Earlier this month for example US firm Kendle unveiled plans to set up a major new facility in the region.

Quintiles Relocates Japan Lab

Quintiles has relocated its global central laboratory in Japan to meet rising demand from the local market and US and European pharmas keen to include the country in their clinical trial network.

Meeting local standards while ensuring global quality and harmonization has resulted in “huge growth” at the site in Japan, according to Alan Ong, vice president and general manager, Quintiles Global Central Laboratories Asia, and this has driven need for more capacity.

Quintile is gaining this capacity by moving its laboratory from Saitama to Tokyo. Ong explained to Outsourcing-Pharma that the site at Saitama was held back by space constraints and difficulties harmonizing testing platforms to increasingly exacting standards.

At the Tokyo site an area three times the size of Quintiles’ share of the Saitama laboratory, which is owned by Medca Japan, has been earmarked. Quintile has begun moving activities to the new wholly owned site and anticipates the majority of studies will be transferred by the fourth quarter.

The Tokyo site will initially focus on safety testing with additional services being added in response to demand and to harmonies the laboratory with the rest of the network, said Tom Wollman, SVP of Global Central Laboratories at Quintiles.

Steps are being taken to gain certification by the College of American Pathologists (CAP) at the Tokyo site. Ong explained that it is difficult to put an exact timeline on this process but Quintiles is aiming to gain accreditation by the third quarter.

An application will be filed by next month, after which CAP will give a definite scheduled date, and Ong is confident the site will be accredited. This belief is underpinned by Quintiles’ experience of working to the CAP quality system.

The Tokyo site has already received National Glycohemoglobin Standardization Program Level 1 certification for diabetes testing.

Quintiles’ Tokyo site began receiving clinical trial samples on March 1 and Ong said a number of new studies have begun at the laboratory. Discussions with sponsors are underway to switch Saitama studies to Tokyo, although those finishing this year will remain at the old site.

Furthermore, sponsors can request that studies remain at Saitama. Medca will operate the whole of the Saitama site, having also been space-constrained, and will remain as Quintiles’ third-party reference laboratory partner.

Porvair Opens New Cleanroom Facility

Porvair Filtration Group, a leading developer and manufacturer of novel, high performance sintered porous plastic materials and products for life science applications, has opened a new Class 100000 (ISO Class 8) clean room facility at its Wrexham, UK site.

The new cleanroom facility is part of ongoing investment to produce and package regulatory controlled materials and assembled products in a clean environment.

Porvair Filtration Group has over 25 years experience in providing innovative design, manufacture and assembly solutions that meet OEM customer requirements, as well as standards set by the regulatory authorities. Manufacturing of these specialist, high performance products is underpinned by an ISO 9001-2000 quality assurance program, cGMP practices and cleanroom environment to ensure products meet the stringent requirements of the Life Science industries.

To complement contract manufacturing for the Life Science market, Porvair Filtration Group has developed a new highly purified porous polymeric material - BioVyon. Chemically modified using novel technologies the resultant unique polymeric materials are being adopted by pharmaceutical, biotech, healthcare and analytical companies for filtration, separation, purification, diffusion and fluid transfer applications.

BioVyon standard materials are primarily polyethylene or polypropylene sintered porous plastic materials, made by proprietary cGMP processes with low extractable and particle shedding levels. Available in pore sizes from 5 to 100 micron (mean flow pore) the materials are available in sheet, roll, cut shapes or molded and, depending on the particular specification, these materials have regulatory approvals that meet FDA, WDA and USP requirements.

Biochips in Bangkok: Thailand's Sole Array Lab Plows Ahead with Ag-Bio Projects

Thailand's BIOTEC microarray lab has made progress since its inception two years ago, focusing on projects related to pathogen testing and agricultural research.

St. Jude Medical Plans Expansion in Costa Rica

St. Jude Medical, named FORTUNE Magazine’s “Most Admired Medical and Precision Equipment Company” in 2007 and 2008, has decided to set up manufacturing operations in San Jose, Costa Rica. The company will invest more than $40 million in a new 20,000-square-meter (215,200 sq. ft.) facility, which could potentially generate up to 500 new jobs by 2010.

St. Jude Medical will initially use its Costa Rica facility to expand production of the company’s heart valve portfolio. The global medical device company, based in St. Paul, Minn., USA, develops products for cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology and neuromodulation.

The construction of St. Jude Medical’s new plant began in December 2008 in Coyol Free Zone, Alajuela. The manufacturing process is expected to start in 2010, and the company expects to export products manufactured in Costa Rica in the second half of 2010.

“St. Jude Medical has chosen Costa Rica as an expansion site because of its robust business environment, talented workforce, and its strategic location in an area where we see strong growth potential,” said Michael T. Rousseau, group president of St. Jude Medical. “We appreciate the opportunity to do business in Costa Rica and look forward to a mutually beneficial relationship.”

St. Jude Medical’s product portfolio includes:

Pacemakers

Implantable cardioverter defibrillators (ICDs)

Cardiac resynchronization therapy (CRT) devices

Heart valve replacement and repair products

lectrophysiology catheters

Mapping and visualization systems

Vascular closure devices

Spinal cord stimulation devices

Boston Scientific Inaugurates Second Manufacturing Plant in Costa Rica

Boston Scientific inaugurates its second manufacturing plant in Costa Rica. Operations started in 2004 and today they have over 1,700 employees. The new plant located in Coyol, Alajuela is designed to house 2000 employees.

With US$65 million invested, this is the First manufacturing building in Latin America with a LEED-CI certification of “green building”

Boston Scientific Corporation, the largest company that manufactures the less invasive medical devices worldwide, inaugurated its second manufacturing plant in the country, with the capacity to house 2,000 employees and a construction investment of US$65 million.

In the end of year 2007, the company had 1.200 employees, that´s when they announced their intentions to double their operations in the country. The operation of Boston Scientific in Costa Rica has now over 1.700 employees.

The new plant is located in PROPARK Industrial Park in Coyol, Alajuela, and is an addition to the one established since 2004 in Global Park, la Aurora, Heredia.

Its technology and products are designed to reduce risks and traumas, cost, time of procedures and also pre and post operatory treatment. The company is currently producing in Costa Rica “biopsy forceps” and “snares” which are used to remove intestinal polyps.

“Thanks to our positive experience in the country, we are transferring to the new plant products and technologies of a higher added value. More than half of the total gastrointestinal endoscopy procedures that are currently being done worldwide use a device that has been manufactured by our people in a Boston Scientific plant in Costa Rica”, explained Jorge Perera, Vice-President of Operations and General Manager of Boston Scientific Costa Rica.

“With this growth we hope to also become a source of employment for the local towns and nearby communities”, stated Perera.

According to CINDE´s Director General, Gabriela Llobet, Boston Scientific has become one of the medical devices leading companies in Costa Rica, which nowadays counts with 28 established companies.

One of the most relevant facts of this new building is it´s design. This is the first manufacturing plant in Latin America to have a LEED-CI certification (Leadership in Energy and Environmental Design), that is awarded by the Green Building Council of the United States.

This plant is located in a land of 129,000 square meters (1,388.040 sq. ft.). The building has an industrial area of 32.000 square meters of construction (344,320 square feet).

This certification guarantees that the design and construction of the building use the latest technologies to minimize the impact in the environment and use of energy.

BSC´s new plant operates according to maximum resource and energy management criteria, as well as water consumption efficiency.

Roche Invests in Manufacturing Sites

Roche is investing about 190 Mio Swiss Francs at its production sites in Kaiseraugst, Switzerland, and Mannheim, Germany, to manufacture a patient-friendly device which might for the first time allow patients to self-administer biological cancer medicines. The production line in Kaiseraugst will provide the supply for clinical studies and market launch, and a full scale automated production line in Mannheim will deliver commercial supply to markets.

The new infusion-free device will deliver an innovative Herceptin (trastuzumab) formulation developed with Halozyme Therapeutics’s “Enhanze” technology. This Herceptin formulation together with the ready-to-use administration device allows for injection of larger volumes of medicines into the tissue under the skin. Medicines which are currently administered by infusion in a hospital could therefore be self-administered via a subcutaneous injection.

Today, breast cancer patients treated with Herceptin generally receive the drug as an infusion in a hospital; the infusion time is around 60 minutes. In contrast, subcutaneous Herceptin administration takes only about five minutes and means that patients with early HER2-positive breast cancer completing their one year of Herceptin therapy would have greater convenience of being able to receive treatment at their family doctor’s office or at home. It could also help to maximize the efficient use of hospital resources and reduce costs. Pat Yang, Head of Roche Pharma Global Technical Operations said: “We always strive to improve our products and manufacturing technologies, which in turn benefit our patients. This innovative formulation and the associated new device are designed to simplify patients’ lives. There is also hope that patients will experience fewer infusion reactions due to the slower absorption after subcutaneous administration."

A phase III trial investigating subcutaneous Herceptin is underway.

About Roche's cooperation with Halozyme

In December 2006, Halozyme entered into an agreement with Roche to apply Halozyme's proprietary Enhanze technology to Roche's biological therapeutic compounds. Roche has access to Halozyme's expertise in developing and applying Halozyme’s recombinant human enzyme, rHuPH20, to Roche biologics directed at multiple targets. Roche obtained a worldwide, exclusive license to develop and commercialize product combinations of rHuPH20 and Roche compounds resulting from the collaboration.

ICON Continues Asia-Pacific Expansion with Office in Manila, Philippines

ICON plc, a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, has announced that it will expand its footprint in Asia-Pacific with the opening of an office in Manila, Philippines. This announcement follows the recent expansion of ICON’s operations in Seoul, Korea and ICON Central Laboratories’ move to a larger laboratory facility in Singapore.

“With over 800 employees in 14 Asia-Pac countries and 13 years of successful operations in the region, Asia-Pacific is a key market for ICON,” commented Peter Gray, CEO at ICON. “Philippines’ large population, coupled with the country’s well-established network of hospitals, physicians and investigators has made it an attractive location for our clients, and one which we have supported for a number of years through home-based employees. Investing in local support and infrastructure through the office in Manila will ensure that we can support future client demand as they increasingly look to include Asia in their drug development programs.”

ICON has conducted a wide range of clinical studies across all therapeutic areas in Asia-Pacific, and has particular expertise in managing oncology, cardiovascular, CNS and metabolic disorder trials in the region. Current studies range from small local trials to pan-Asia-Pacific and large global programs and are supported by two fully-owned ICON central laboratories, strategically located in Singapore and Bangalore, India. ICON has a presence in 14 countries within the region – Australia, China, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, New Zealand, Philippines, Singapore, Taiwan, Thailand and Vietnam.

Patheon to Build Pharmaceutical Development Center in Bourgoin, France

Patheon, a global provider of drug development and manufacturing services to the international pharmaceutical industry, announced it has begun construction of a new pharmaceutical development center at its existing manufacturing facility in Bourgoin‐Jallieu, France. This new addition will enable the Bourgoin site to offer a full range of solid dose services as part of its Pharmaceutical Development Services (PDS) business.

“We currently provide our customers with solid dose Phase 3 and commercial supply from our facilities in North America. With this expansion we will offer the same services in Europe by the end of 2010,” said Wes Wheeler, Patheon’s CEO and President. “The investment reinforces our commitment to provide our customers with a full range of product development services from pre-clinical through late phase stages, on to commercialization.”

The state-of-the-art facility has been designed for the supply of late‐phase clinical trial tablet and capsule products, and will be capable of handling batch sizes up to 120 kg. It will consist of a new pilot plant and equipment designed to contain high potency products. Process trains will be scalable to commercial lines, offering clients the ability to produce Phase 3 and commercial product in the same location.

Nestle Opens a Global R&D Center in Santiago, Chile

Nestle has opened a global research and development centre for biscuits and cereal-based snacks, in Santiago, Chile.

The company said the centre will help lead its global research and development, with a focus on new products and the renovation of existing ones.

According to the company, R&D Santiago will bring together specialists from various fields, including nutrition, engineering, product development and quality control for the development of new technologies that will help to further reduce sugar and fat levels to make the biscuits lighter.

Nestle said it will also develop biscuits with bioactive ingredients to improve digestive health as well as fortified products to address local micronutrient deficiencies.

The centre will work closely with other Nestle R&D facilities around the world and will engage in local governmental initiatives and partnerships with universities such as the Pontificia Universidad Catolica de Chile and the Universidad de Chile. Nestle's global R&D network comprises 28 research, development and technology centers.

Nestle has seven production facilities in different parts of Chile, and the centre will work closely with its centre in Maipu to develop synergies in biscuit manufacturing.

Thermo Fisher Scientific Opens New UK Research and Manufacturing Facility

Thermo Fisher Scientific has opened a new facility in Runcorn, Cheshire, UK. Located at Tudor Road, Manor Park, it is a significant investment for Thermo Fisher Scientific in the North of England.

The new facility is the largest Thermo Fisher Scientific centre in the North of England and one of its biggest in the United Kingdom. Thermo Fisher chose the North-west of England as home for the new facility due to the strength of the region's academic, hospital, pharmaceutical and biotechnology industry sectors. The new facility has created approximately 60 new jobs, and the total workforce onsite is now more than 200. UK Trade and Investment worked closely with the North West Regional Development Agency to ensure that Thermo Fisher's requirements were met.

The new facility houses Thermo Fisher's Anatomical Pathology and Chromatography Consumables businesses. This includes products and services to improve the detection and diagnosis of cancer and advance research for drug development.

The new facility is also a manufacturing centre for Thermo Fisher's Chromatography Consumables business. These products are used in laboratories specializing in chromatography and mass spectrometry analysis. They enable detection, quantification and isolation of complex sample mixtures that are commonly encountered in pharmaceutical, environmental, biomedical, chemical, toxicology, forensics and food safety industries. The state-of-the-art technology developed in Runcorn enables the company to meet demands for more specific and sensitive yet robust testing to support its customers.

Kendle’s China Affiliate Gains ISO Certification

Kendle’s China-based affiliate has obtained ISO 9001:2008 certification and become the first global CRO to achieve the accreditation, according to the company.

The International Organization for Standardization (ISO) has granted the certification to Beijing KendleWits Medical Consulting, Kendle’s China-based affiliate. Receipt of the certification demonstrates compliance with quality management processes detailed by ISO.

“ISO 9001:2008 certification reinforces our ability to provide our customers with the highest-quality early- to late-stage clinical development services anywhere in the world”, added Candace Kendle, CEO of Kendle.

The contract research organization (CRO) believes receiving the certification reaffirms its strong position in China, which it regards as a key market.

Fresenius Opens Temp Controlled Facility in Austria

Fresenius Kabi has opened a temperature controlled, high-bay, fully automated warehouse near its manufacturing plant in Austria, according to its partner on the project.

SSI Schaefer, the company that planned, designed and installed the facility, explained that the warehouse has three temperature controlled sections, ranging from -15ºC to room temperature.

This range of temperatures makes the site, located in Graz, Austria, suitable for a variety of products. In addition, the warehouse includes an oxygen-reduced, fully automated high bay, a clean room for product sampling and a monitoring system.

The site forms part of Fresenius’ supply chain for bringing medicines into Eastern Europe and delivering products made in Graz to the rest of the world.

Lotus Breaks Ground on Beijing Pharma Complex

Lotus Pharmaceuticals has broken ground on a building complex, housing offices, R&D, production and storage, in Beijing, China.

The facility is part of Lotus’ efforts to achieve profitable growth and is predicted to help generate sales of $150m (€110m) in the first year after it is fully operational. This represents a significant leap over the $40m of net revenues the company generated in the first nine months of 2009.

Construction is expected to be completed in July and good manufacturing practice (GMP) compliance achieved by December. Until the facility is operational Lotus’ will outsource production of therapeutics to contract manufacturing organizations (CMO).

In June 2009 the Chinese government granted Lotus permission to build a nine-floor building complex with a maximum gross floor area of 20,353 sq m. (25,318 sq. ft.)With this approval in place, Lotus has now begun production after a year of planning the complex.

Lotus also has plans to develop a pharmaceutical park on 667,000 sq. m. (7,176,920 sq. ft.) of land that it has the rights to in Inner Mongolia. The land was acquired in December 2008 by Lotus’ contractually controlled subsidiary Beijing Liang Fang Pharmaceutical Company for about $26.3m.

In October 2009 Lotus stated it intends to start building the main body of its 33,350 sq. m. (358,846 sq. ft.) facility, which will be housed on a 133,400 sq. m. (1,435,384 sq. ft.) patch of land, at the site in 2010. The facility will house production, administration, storage and logistics capabilities.

Demand for drugs is increasing in Inner Mongolia and the five North-western provinces of China, according to Lotus, and the plans include a wholesale centre to meet the regions supply needs.

The remaining 533,600 sq. m. (5,741,536 sq. ft.) of land at the Inner Mongolia site will be sold or rented to other pharma companies. Lotus envisages that this will create a cluster of companies that “will find mutually beneficial ways of working together”.

China to Build Biologics CMOs in Asia

The Chinese government is supporting a $100m (€73m) project to build a contract biologics production facility in Beijing, which, by some measures, would be the largest in Asia.

China is keen to establish itself as a presence in the biologics sector and, in a similar way to Singapore, the government is prepared to use its finances and influence to ensure this happens.

Julius Li, the CEO of AutekBio, the contract manufacturing organization (CMO) leading the venture, said that the project turned to the Chinese government when capital dried up during the economic downturn.

Buoyed by governmental support AutekBio has outlined its plans. Li explained that the 60-70,000 sq. m. (753,200 sq. ft.) site will house manufacturing facilities producing biologics at scales ranging from preclinical to commercial.

The largest bioreactors at the site will be around 20,000L, some way short of the 80,000L capacity at Lonza’s site in Singapore, but Li believes the scope of the Beijing facility gives it a legitimate claim of being the largest contract biologics plant in Asia.

In addition to preclinical through to commercial scale manufacturing the site will also house process development. Completion of construction of these different capabilities will occur in phases in the coming years.

First, the pilot plant will begin operating at some point in 2010. This will be followed within three years by 1000L reactors. Finally, within four years the largest bioreactors will begin production.

When all these aspects are fully operational Li believes the site could employ up to 1,000 people. AutekBio is looking to recruit leaders from the US and Europe, citing the lack of experience China has in managing this type of operation, but other positions will be filled by locals.

Beijing alone produces a large number of life science graduates each year which can fill some positions and Li also hopes some Chinese people will return home from biotech jobs overseas.

Li strongly believes that Chinese engineers are the best in Asia, adding that many are already employed in Singapore. This combination of leadership with experience of managing biologics production and skilled operators is designed to ensure the site runs to international standards.

Achieving compliance with U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) current good manufacturing practice (cGMP) guidelines is integral to the sites plan.

Li hopes the site will serve a range of businesses, from large, multi-national pharmas to local firms, small biotechs to biogeneric producers, adding that many companies have already shown an interest.

China’s biologics roadmap

The Chinese government has been supportive of the project, offering favorable land prices, loans and training. This has come from local, as well as national, government, with Li explaining that Shanghai and Beijing both competed to house the production site.

Shanghai and Beijing, like many regions around the world, are keen to establish a biotech industry and Li expects competition to intensify in coming years. He explained: “It is my goal that 10 per cent of the world’s biomanufacturing capacity will be in China within the next 10 years.”

Beijing E-Town to Invest in the Largest CMO Project in Asia

AutekBio, Inc., SUMA Ventures and Beijing E-Town Harvest International Capital Management Corporation, a venture capital group from Beijing Municipal Government announced a joint investment of more than US$100m to develop a new contract manufacturing organization (CMO) for biopharmaceutical industry in China. This joint effort led by AutekBio represents strong interests from both private investment sector and government to establish world quality capability and capacity in biopharmaceutical manufacturing in China.

The new joint venture will build up a world class R&D and manufacturing center in southern Beijing to service international biologic developments, with combined volumes of bioreactors up to 20,000 liters in multiple production lines (trains).

"I am extremely pleased with this joint investment. This will allow us to build one of the largest biologic CMOs in Asia," said Julius Li, the CEO of AutekBio, Inc. "The newly established facility and company will provide, for the first time, manufacturing services in China fully conforming to the US FDA / EU EMEA cGMP standards, for the global biopharmaceutical needs."

According to Li, the facility will provide to the international biotech arena high quality yet cost efficient solutions in producing protein based medicines. The firm will also benefit from financial, regulatory and other supports from the Chinese government for the biotech industry.

Work Starts on £12 Million Biotech Facility at Wilton, UK

Construction work has started on the expansion of the Industrial Biotechnology demonstrator facilities in Wilton, Teesside. The Government has invested £12 million in the facility, which is to help develop novel and more sustainable manufacturing and process technologies at the chemicals complex.

The Wilton facility will be fully operational by the end of the year, giving companies improved access to the expertise and equipment to take advantage of the market opportunities. The market potential for chemicals made by industrial biotechnology is forecast rise to £12 billion in the UK alone by 2025.

The Government and One North East have earmarked £60 million through the Tees Valley Industrial Programme for the North East region. The funding comprises £30 million from the Government’s Strategic Investment Fund, and £30m from One North East.

Over £10m has been allocated in the first three months of the two-year Tees Valley Industrial Programme, specifically to support businesses, apprenticeships and energy efficiency programs. Up to £20 million will be invested in the Wilton International site. Regional development agency, One North East, has also earmarked £1.5 million to help strategic partners in the region to access the facilities at Wilton.

AuroSource Joins India’s $1.5 Billion CRAMS Sector

Indian generic drugmaker Aurobindo Pharma officially launched its CRAMS unit AuroSource, also unveiling plans for an R&D facility in Pashamylaram near Hyderabad, India.

The new division, which will provide medicinal chemistry and active pharmaceutical ingredient (API) development services at six facilities across India, is intended to capture a share of the country’s $1.5bn (€1.1bn) contract research and manufacturing services (CRAMS) sector.

AuroSource suggested that: “This is a critical time to enter the [CRAMS] market,” and added that Big Pharma’s adoption of outsourcing strategies as a key driver for development of the new business.

The firm also said that: “Impending reforms in the US healthcare market have exposed a need for contract manufacturing services.”

In other news, Aurobindo is set to sign several new generics licensing deals with several major global drugmakers according to Ramprasad Reddy, Chairman of Aurobindo.

He told expressbuzz that the firm, which recently signed a generics licensing agreement with US drug giant Pfizer, “anticipate to close deals with 2-3 multinationals over the next few months.”

Asian Hospital Launches Fully Integrated Operating Room

Asian Hospital’s Stryker Endoscopy Suite is equipped with state-of-the-art voice-activated devices and touch-screen command centers.

Asian Hospital and Medical Center is again at the forefront of delivering world-class patient care as it launches the Philippines’ first and only minimally invasive surgery integrated operating room suite.

The Stryker Endoscopy Suite is an advanced surgical operating room where all laparoscopic and endoscopic surgical procedures today can be best performed.

Dr. Orlando Diomampo, head of the Department of Surgery of Asian Hospital, said this state-of-the-art facility is another breakthrough in modern-day surgery from Asian Hospital.

“Minimally invasive surgery is one of the pillars in Asian Hospital. Through the years, we’ve worked very hard to develop and deliver this surgical expertise and to provide the best facilities and the latest technologies that would benefit our patients,” Diomampo said.

“The Stryker Endoscopy Suite reflects our commitment to giving only the most up-to-date technologies that complement our surgical expertise and procedures. This mirrors our vision of making Asian Hospital the Center of Excellence in minimally invasive surgery,” he added.

The Stryker Endoscopy Suite is a fully integrated operating room (OR) with the unique capabilities of interconnectivity to other units in the hospital such as pathology, radiology, doctors’ clinics, conference facilities, patient rooms, and even in other hospitals in the Philippines and abroad.

It is also equipped with state-of-the-art voice-activated devices and touch-screen command centers, which means the entire system is activated with a few verbal commands from the surgeon or the nurse to control all surgical equipment, OR lights, dictate notes and document findings using still pictures and/or motion video.

The suite also consists of the latest in technology of large-screen, high-definition LCD monitors, high-flow insufflators, and environment-friendly LED lights, all mounted on ceiling pendants and booms.

With its cutting-edge features, the Stryker Endoscopy Suite boasts of a number of benefits both for doctors and patients.

Dr. Miguel Mendoza, minimally invasive surgery section head, said, “With the interconnectivity feature, surgeons can conduct consultations during a surgical procedure and get them the information they need all at once.”

The LCD monitors present a vivid picture and better resolution, thus appraisal of the surgery becomes better. The LED lights do not emit heat like the usual OR lights, so the chance of burning the tissues when the surgeon puts the light inside the body cavity is negligible. The insufflators, meanwhile, provide the highest flow rate at 45 liters per minute.

Mendoza added: “Because of the wireless technology offered by the voice and touch-screen features and with the equipment all mounted on the ceiling, there’s no requirement for manual maneuvering in the room and no clutter of wires on the floor. This gives the surgeon and nursing staff greater mobility during the procedure, allowing them to focus full-time on the patient care, thus increasing the overall efficiency of the entire surgical team. The efficiency generated cuts operating time and allows faster turnover of cases, enabling the surgical team to do more surgery in a day or attend to other matters right away.”

For the patients, the combination of surgical expertise and a highly specialized operating room all translate to advantages that ultimately deliver excellent quality in surgical patient care — shorter hospital stay, significantly less painful recuperation period, faster recovery time, lower infection rate, earlier return to work and usual activities, and less visible scars.

“With the advent of machines and new technologies, it’s the goal of Asian Hospital to inspire, stimulate and train other surgeons to do minimally invasive surgery to be at par with all hospitals in the international community,” Diomampo said.

Harbin Pharmaceuticals Selects Warehouse Management Software

RedPrairie Corp. has announced that Harbin Pharmaceuticals has selected RedPrairie’s Warehouse Management solution to support its 30,000 sq.m. (322,800 sq. ft.) distribution center in Harbin City, Hulan District, China.

The warehouse handles up to ¥10 billion in products annually and supports more than 1300 outlets and 1000 wholesalers, including chemical medicine, traditional Chinese medicine, biological product, medical appliance healthcare, and daily use chemicals.

“We selected RedPrairie considering its practical and efficient team who are proficient in business process management,” says Xudong Wang, Harbin's general manager assistant. "The additional experience their project implementation team had in integrating with other major logistics management systems was also attractive, along with the sound post-sale service system they had in place. We expect the solution to help us relieve stock pressure, improve warehousing conditions, and make our operations more efficient overall.”

Harbin Pharma Company was particularly interested in the solution’s batch and lot management functionality, as well as its expiration date controls. In the future, the company plans to use RedPrairie’s solution to transition its internal logistics processes into a third-party logistics service for other related businesses.

“Harbin’s decision to select RedPrairie marks our company’s introduction to the Chinese pharmaceutical industry,” said Rod Talbot, RedPrairie Executive Vice President and Managing Director, Asia Pacific. “We look forward to building on our strategic partnership with Harbin and our other customers, as they achieve success with their expanding enterprises.”

Quintiles Continues Expansion in Africa

Contract services giant Quintiles has continued its expansion in Africa with a new clinical research services office in Nairobi, Kenya.

Quintiles Africa CEO Gillian Corken said the new site enables the firm to meet demand for trials outside its existing base in South Africa.

She explained the new office, which compliments a similar operation Quintiles recently set up in Ghana in West Africa, provides access to East Africa's large, ethnically diverse and treatment naive patient populations.

Corken went on to say that, although there are difficulties associated with trials in Africa, Quintiles’ approach is to minimize such problems by employing local staff who have knowledge of the regulations that govern studies in the region.

She also said that IT infrastructure improvements ahead of this year’s football World Cup in South Africa are further improving the situation.

Quintiles Expands Phase I Capacity

Quintiles has opened its expanded research facility in London, UK, increasing Phase I capacity and extending its capabilities in translational medicine. The expansion brings the total number of Phase I beds in London to 105 and globally to 385. Additionally, the company has plans to open a Phase I unit in Hyderabad, India, in late 2010. This facility initially will have 50 beds, with capacity for expansion to 100.

“Declining productivity in R&D means that the biopharmaceutical industry is under intense pressure to increase efficiency and overcome complexity,” said Eddie Caffrey, senior vice president, Global Phase I at Quintiles. “With our expanded facility in London and our planned facility in Hyderabad we will be better able to provide an integrated Phase I research solution that facilitates robust decision making early.”

Wacker Opens €18 Million Expansion of Biologics Site

Wacker Chemie AG has expanded its biologics production facility, adding GMP manufacturing capacity and a process development building in response to customer demand.

Faced with pricing pressures from emerging markets and rising demand for biologics, some chemical companies, including Wacker and Lonza, have expanded production for higher margin products.

Wacker’s expansion includes an €18m ($24.5m) investment in its biologics production facility in Jena, Germany. The final phase of the expansion, which doubled the capacity of the existing good manufacturing practice (GMP) production facility, officially opened.

Also included in the second phase of expansion is a new facility for product purification. Wacker claims the new site can achieve up to three times higher product yield per batch and meets US Food and Drug Administration (FDA) and European Medicines Agency (EMA) GMP standards.

The first phase of expansion, which began operating in 2009, added a laboratory building for process development and quality control. This has given Wacker “an ideal system” for process development and analytics, according to Thomas Maier, managing director of Wacker Biotech.

Maier explained that completion of the second phase allows Wacker to “optimize the entire process chain, from lab operations to industrial GMP production”, adding that customers “benefit from a full process and analysis package provided from a single source”.

The facility will use Wacker’s proprietary technologies, Esetec and Densetec, which can make biologics production simpler, more cost-effective and boost yields, according to the company.

Esetec uses the patented Escherichia coli (E. coli) K12 strain during fermentation to secrete recombinant proteins into the culture broth.

Taking this approach eliminates the refolding stage and facilitates cleanup of recombinant products, making production more cost-effective, according to Wacker.

This will be used in conjunction with Densetec, a high-cell-density process for fermenting E. coli. Wacker claims the combination of these technologies makes production more efficient.

Pharmadule Providing Modular Biotech Plant to Silcor

Pharmadule AB is creating a complete modular biologics production facility, which will be 80 per cent completed in its workshop before delivery, to Lithuania-based Silcor Biotech by 2011.

Fabricating much of the facility off-site allows Pharmadule to perform operations in parallel, which it claims can reduce construction timelines. Furthermore, creating the facility in Pharmadule’s workshop ensures a very high and predictable level of quality, according to the company.

Silcor will be aware of these benefits, having previously bought a facility from Pharmadule. The new biotech production facility will be made according to European Union and US quality standards and Pharmadule expects to deliver it to the site in Vilnius, Lithuania by January 2011. Under the terms of the contract, financial details of which were not disclosed, Pharmadule will design, fabricate, install and validate the facility. In its workshop Pharmadule can test run the plant at full scale before sending it to the site where it is assembled, commissioned and validated.

Pharmadule has previously signed contracts with Baxter Healthcare and AstraZeneca. The deal with AstraZeneca was for an expansion of the big pharma’s manufacturing facility in Wuxi, China, a region that Pharmadule is now targeting.

In February the company strengthened its presence in China by partnering with Morimatsu Group. The deal gives Morimatsu the right to produce Pharmadule’s modular facilities.

Lars Martinsson, CEO of Pharmadule, believes that “to serve the rapidly growing market in China, local presence is essential”, adding that Morimatsu has significant experience of producing pharma equipment in the country.

Morimatsu’s capacity in Shanghai, China supplements Pharmadule’s workshop in Tallinn, Estonia.

Clinical Reference Labs Establishes UK Location

Clinical Reference Laboratory Inc, (Kansas, USA) one of the world’s largest independent clinical testing laboratory operations, now offers its clients a completely integrated and optimized infrastructure to support their global clinical trials following the establishment of an additional laboratory in Cambridgeshire, United Kingdom, late in 2009.

With more than 18 years clinical trials experience, CRL Global Services brings together a network of clinical laboratories around the world to provide global logistics, consistent instrumentation, standardized laboratory safety-, and centralized biomarker testing. CRL Global Services’ integrated system supports early to late phase pharmaceutical drug development. CRL Global Services has achieved its integrated global presence following the set up of wholly-owned European operations in the UK and the implementation of its proprietary technology platform worldwide.

For the client, CRL Global Services’ system provides centralized global project set-up and management, centralized data management, reporting, and financial tracking. CRL Global Services also provides unique, web-based project information tools – Web-OASIS™ for investigators, and Trials-OASIS™ for sponsors.

This truly end-to-end structure delivers real benefits for clients with a lean infrastructure that is efficient and cost-effective so projects complete on time and on budget. Regional experts in all continents are available to CRL Global Services clients worldwide.

John Byerley, VP of Global Operations said: “We are very proud of the unique approach we bring to supporting our clients and their global clinical trials programs. Through our development of OASIS, and the integration of this web-based package with our central teams, we are able to ensure standardized, responsive services that deliver high value and high quality; essential characteristics for partnership with leading pharma companies in these tough economic times.”

Arnold Verbeek, PhD, general manager of Clinical Reference Laboratory – Europe Ltd, added: “We are confident that by using our own operations and applying our technology on a global scale CRL guarantees the best support and we are pleased when clients tell us that what we do -- our ability to make the non-standard, standard -- adds extra value. The result is that our clients commit to working with us long-term.”

Acai Roots Plans Expansion after Brazilian Investment

California-based acai berry company, Acai Roots, claims it is poised for big expansion after a group of Brazilian investors invested a significant but undisclosed sum in the company’s business.

A spokesman for the company told NutraIngredientsUSA.com: “I am not allowed to disclose the actual number, however, it is significant for the current growth we are experiencing.

Açai Roots estimates the size of the U.S. retail market for açai products to range between $70-$100 million. If current trends continue, it expects the market to double every two years. In Brazil, the value of the açai market is estimated to be worth $1bn.

In addition to antioxidants, açai contains omega fatty acids, phytosterols and dietary fibers: nurtures a better digestive system. It is also a source of protein, calcium, vitamins A, E, and B6.

Açai Roots manufactures and distributes pure açaí berry products formulated by native Brazilians and pledges to respect sustainable harvesting methods and local communities.

Institut Rosell-Lallemand Acquires DSM Probiotic Line

Dutch chemical company, DSM has sold its LAFTI range of probiotic strains targeted at immunity enhancement to the Institut Rosell-Lallemand but is to retain the dairy segment.

The Institut said the LAFTI range, which it maintains has proven survival in the GI tract, during processing and in food products, will complement its existing probiotics portfolio targeting gut health, immunology, as well as women’s and children’s health.

The DSM developed probiotic range includes the strains Lactobacillus acidophilus LAFTI L10 (L10), Lactobacillus casei LAFTI L26 (L26), and Bifidobacterium animalis lactis LAFTI B94 (B94), which have been in use in both dietary supplements as well as dairy applications over the past six years.

Oliver Clech, VP of Lallemand Human and Animal Nutrition, said that one of the LAFTI strains, Bifidobacterium animalis lactis, offers the French-Canadian company new areas of probiotic application such as sports health and athlete recovery.

And the Institut said clinical evidence supports the L10 strain with a human trial on 285 participants using the probiotic of diary origin indicating a reduction in cold and flu symptoms and a decreased reliance on medication.

Joseph Haddad, medical director of Institut Rosell-Lallemand, told this publication previously that the probiotics industry needs to invest more in R&D and state-of-the-art clinical trials to find out and support the most efficient strains. He said: “Some companies are already well positioned, but overall a lot of investment is still required.

“The challenge is really to demonstrate that the industry is not dealing with ‘simple good bacteria’ but that probiotics should be considered as living drugs, backed up by strong clinical evidence.”

NextPharma Invests to Expand Sterile Vial Area

NextPharma has invested €2.4 million (US$3.3m) to add capacity for solution and lyophilized vials of non-cytotoxic products at the sterile area of its facility in Braine-l’Alleud, near Brussels in Belgium.

The expansion adds to existing sterile capabilities covering ampoules, eye drops and cytostatics in vials, both solution and lyophilized forms. NextPharma claims clients have shown “considerable interest” in the expanded services which are due to be offered by the end of 2010.

Hermann Osterwald, managing director, NextPharma Technologies, contract manufacturing services, added: “NextPharma’s strategy for our Braine-l’Alleud facility has been to develop it as a centre of excellence for sterile development and manufacturing.”

Synthon Continues Latin America Expansion with Nafar Buy

Synthon has completed the acquisition of Mexico-based Nafar Laboratories, adding to its presence in Latin America which includes recent purchases in Chile and Argentina.

The acquisitions in Latin America are part of Netherlands-based Synthon’s emerging market strategy, which is also looking at opportunities in Eastern Europe and Asia Pacific.

Synthon believes there are benefits in acquiring companies which have a strong reputation in their home territory. This provides Synthon with an established presence in the country which can be enhanced by integrating the acquired business.

Nafar is a developer, manufacturer and distributor of generic drugs to the Mexican market. Its capabilities include the production and marketing of soft-gel formulations in Mexico.

PPD Opens Research Facility in Ireland

PPD, Inc. has officially opened its contract research facility in Athlone, Ireland, which includes an 18,000-square-foot analytical testing laboratory and clinical supplies business. The facility expands the company’s global scientific expertise, laboratory capacity and supplies network to meet growing client demand in Europe, Middle East and Africa for these services.

PPD will offer fully integrated product and analytical development services, including method development; validation; stability, release and quality control testing; and global clinical supplies services, including secondary packing, labeling and storage. The facility will also provide regulatory services, product licensing and marketed product support, including qualified person (QP) services for all drug dosage forms, with particular emphasis on inhalation and biopharmaceutical products.

The cGMP analytical testing laboratory conducts testing for clinical programs and marketed products spanning all phases of drug development and builds upon more than 20 years of PPD laboratory expertise. It joins the company’s scientific and therapeutic experience with state-of-the-art facilities and instrumentation to deliver comprehensive, best-in-class laboratory services.

“Expanding our laboratory operations into Europe enables us to continue to deliver on our strong history of providing quality work and customer service to our growing client base in this region,” said Magdalena Mejillano, vice president of laboratory services, PPD. “The Irish government, through IDA Ireland, has provided us strong support, and we continue to benefit from Ireland’s highly skilled work force and business-friendly climate. We are pleased to join Athlone’s strong, growing pharmaceutical and biopharmaceutical sectors.”

The facility represents PPD’s initial investment toward continued growth of its contract research operations in Ireland, having already expanded its medical communications safety call center operations into Athlone.

PPD has already hired 21 employees in Athlone and plans to create approximately 250 jobs at the laboratory to include Ph.D.-level scientists, analytical laboratory staff and other clinical development professionals. The company is investing up to $19 million (or €14 million) to develop the facility.

PPD has applied to the Irish Medicines Board (IMB) for manufacturer licenses to support both investigational medicinal products and marketed products and laboratory certifications for quality control of medicinal products. As of March 1, PPD’s license applications have been assessed, and the quality system and premises inspected by the IMB. The progression of PPD’s applications are under active consideration by the IMB.

Sandoz Opens Slovenian Biosimilars Production Plant

Lek has opened a 430m² modified protein manufacturing facility in Slovenia to produce epoetin alfa drug substance for use in the biosimilars marketed by its parent company, Sandoz.

Construction of the facility allows Sandoz to boost production of epoetin alfa, a drug originally marketed by a Johnson & Johnson subsidiary, which was among the first biosimilars to be marketed in the European Union.

To ensure supply of the drug Sandoz has invested $3.75m (€2.77m) into Lek’s site in Mengeš in central Slovenia. These funds have been used to build a 430m² (46,268 sq. ft.) production plant that will become a global supply point for Sandoz modified proteins.

Lek’s expertise in this field has been strengthened by the €45m investment Sandoz and parent company Novartis have made in biopharmaceutical development and production in Slovenia. This investment has led to Mengeš becoming one of Sandoz’ leading biopharmaceutical development and production centers, with particular expertise in cell culture and modified protein technology.

“Our endeavors in biopharmaceuticals will have an important impact on health systems going forward”, said Zvonko Bogdanovski, member of the Lek board of management.

Bogdanovski added: “Biologics are an increasingly indispensable part of modern medicine, but are very expensive due to demanding research and development. Biosimilars, pioneered by Sandoz, make these vital medicines accessible to more people.”

In total Sandoz and Novartis claim to have invested €900m in Slovenia over the past seven years. This includes a €13m packaging centre which opened last year to supply European markets.

Aspen Selling Brazilian Plant

South Africa-based Aspen Pharma is to sell its Brazilian oral solid dosage form manufacturing facility to Strides Arcolab after posting a 15 per cent drop in revenues from Latin America.

Aspen broke into the Latin American market through a series of transactions with India-based Strides but the Brazilian business suffered in the second half of 2009. In response Aspen has initiated a restructuring program which includes the sale of a facility back to Strides.

The Indian firm is poised to buy the site in Campos in south east Brazil for $75m (€55m). Regulatory approvals of the deal are yet to be issued but Strides has already been engaged to manage the facility and will assume the risks and rewards of the operation.

Construction of the site was finished in 2008 and since then it has been producing oral solid dosage forms, injectable penicillin and antibiotics. Aspen gained a control of the site in September 2008 when it increased its stake in Strides’ Latin American operations to 51 per cent. Since buying its way into Latin America Aspen has sought to increase its market share, particularly in Brazil. In 2008 Aspen recruited 150 experienced sales representatives to target Brazil but the following year noted that “the potential of this territory remains to be realized”.

The South African company is restructuring its operations in Latin America, selling the Campos facility and related products and altering business structures and sales teams to fit its new strategy. Aspen retains manufacturing facilities in Toluca, Mexico and Vitória, Brazil.

The sale of the facility in Brazil comes at a time when Aspen is strengthening its manufacturing presence in other areas of the world. Over the past 12 months it has acquired a production facility in Bad Oldesloe, Germany from GlaxoSmithKline and also strengthened in South Africa.

Operations are underway at a second oral dose facility and eye-drop suite at Aspen’s site in Port Elizabeth, South Africa and more expansions are in the pipeline. These include a hormonal suite, increased tabletting capacity and the addition of suppository and Dutch medicines capabilities.

BTS Opens Singapore Office

Bayer Technology Services (BTS) has set up a new Singapore office to provide the regions’ drug and chemicals producers with engineering consultation services and micro reaction technology.

Singapore’s manufacturing sector has been growing rapidly with, in terms of the drug industry, Novartis, Roche and Pfizer being just some of the most high profile firms to have invested there in recent years.

These trends were a key motivation for BTS’ new office according to company spokesman Arnold Rajathurai who said the firm had followed “potential customers towards this region.”

Dr Rajathurai explained that: “BTS is starting its South East Asia office … to have a closer look into the growing market in this area especially in pharmaceutical and chemical manufacturing.”

He went on to say that the new regional base will provide manufacturers with “engineering and other consulting services like energy efficiency checks and environmental technologies.”

BTS, which is a subsidiary of German drugmaker Bayer, already has an extensive network of engineering consulting offices, spanning Europe, South America, the US and the Middle East.

In Asia, BTS’ regional headquarters is in Shanghai, China that will managed operations at both the new Singapore office and the unit in Mumbai India that the firm recently set up.

Last month BTS’ Ehrfeld Mikrotechnik subsidiary signed a deal with Lonza under which it will act as exclusive worldwide manufacturer and distributor of the Swiss firms’ Development Mircoreactor and Advanced Production Microreactor platforms.

The technologies, which were recently awarded the Sandmeyer prize for industrial chemistry and the Profile in Sustainability award at Informex, have numerous applications in drug production, particularly in the biotechnology field

WuXi Collaborates with J&J to Bring GLP to China

WuXi PharmaTech is collaborating with J&J Pharmaceutical R&D, providing the pharma with toxicology services and receiving training to establish GLP at its facility in Suzhou, China.

The 314,000 sq. ft. facility in Suzhou in eastern China was completed in 2008 and currently performs non-good laboratory practice (GLP) toxicology work, as well as client-sponsored GLP validation studies.

Validation studies are one component of WuXi’s efforts to achieve GLP compliance. The company has initiated in-house GLP training and has now turned to Johnson & Johnson (J&J) Pharmaceutical R&D for additional support.

J&J Pharmaceutical R&D, a division of Janssen Pharmaceutica, will provide WuXi with training and other services to help establish the GLP quality system and technical capabilities needed to meet international standards.

This supports the “substantial progress” WuXi has made in training its technicians to perform GLP studies. By taking these in-house and external measures WuXi believes it can achieve its goal of offering GLP toxicology studies by mid-2010.

WuXi will reimburse Janssen for its support and supply the pharma with toxicology and other non-clinical services. An existing agreement between the companies was already in place and the new collaboration builds on this.

The deal with Janssen follows the approval of the Suzhou site by the Association for the Assessment and Accreditation of Laboratory Care International (AAALAC). This signifies that the site’s animal care and research practices meet accepted standards.

WuXi’s facility in Suzhou houses 108 animal rooms which are a key component of the company’s efforts to become a leading provider of non-clinical safety testing in China.

"This accreditation continues to demonstrate WuXi's ability to provide our global customers with high quality service in a regulatory compliant environment”, added Ge Li, chairman and CEO of WuXi.

Wuxi Plans Investments

WuXi PharmaTech posted an operating profit of $52m (€38m) in 2009 and is optimistic about 2010, when it will make investments in laboratory services and large-scale manufacturing to drive growth in coming years.

Full year and fourth quarter results reflected the trends seen at WuXi throughout 2009, with strong growth in China-based laboratory services and declining revenues from the manufacturing business.

WuXi expects China-based laboratory services to maintain double-digit growth in 2010 and this will be supported by an upturn in revenues from manufacturing services. Manufacturing struggled in 2009, with net revenues dropping 58 per cent, but WuXi retains faith in the business.

This is demonstrated by planned investments in 2010. WuXi indicated it will invest in large-scale manufacturing, China-based laboratory services and toxicology to drive growth in 2011 and beyond.

Expenditure on these improvements will affect operating income in 2010, although WuXi still predicts 10 per cent growth, and consequently the company is describing it as a “transition year”.

The short-term spike in expenditure is intended to equip WuXi to benefit from “trends favoring greater R&D outsourcing and offshoring and greater use of integrated services”, explained Ge Li, the company’s chairman and CEO.

Li added that demand for these offerings will continue to grow over the coming decade. More immediately, revenues from manufacturing services are predicted to grow by 70 per cent compared to 2009 underpinned by a large order in the first quarter and improving demand.

This upturn is expected to help total net revenues grow by up to 19 per cent. China-based Laboratory services is predicted to grow by up to 16 per cent and its US-based equivalent, net revenues from which were up two per cent in 2009, will achieve a single digit increase.

Asterand Gains GLP Accreditation at UK Laboratory

Asterand has gained GLP accreditation at its UK lab, enabling it to support regulatory submissions and furthering its goal of becoming a fully integrated human tissue service provider.

Tissue cross reactivity testing for therapeutic antibodies is the first good laboratory practice (GLP) service offered by Asterand. The contract research organization (CRO) believes it can use its expertise in this area to differentiate itself from rivals in the GLP preclinical field.

Karen Hildebrandt, marketing communications manager at Asterand, said that its initial offering will use its experience of “immunohistochemical studies and ability to source difficult to procure tissues through [its] independent network of collaborators”.

Furthermore, Asterand believes its approach to tissue cross reactivity testing can save clients time and money. The company will achieve this by offering clients a frozen tissue microarray platform for rapid pre-screening of therapeutic antibody candidates before GLP studies.

Asterand plans to add to its range of GLP services in the future. Expanding the range of GLP services offered from the Royston, UK site is a step towards Asterand becoming a ‘one-stop shop’ capable of meeting the changing needs of pharma companies.

Hildebrandt explained that clients have become increasingly interested in Asterand’s ability to perform GLP studies as “the current trend towards consolidation of suppliers within large pharmaceutical companies” has progressed.

Last month Asterand expanded its service offering by completing its acquisition of BioSeek. The buy gives it access to BioSeek’s BioMAP system which provides high throughput and high content screening using human primary cells.

This generates a unique signature of human biological response for active compounds. Hildebrandt added that there has been an “extremely positive” response from clients seeking to use the tool to guide lead selection and nomination of candidates for preclinical development.

FDA OK for Haupt Pharma’s Italian Antibiotics Plant

US FDA clearance for Italian antibiotics production facility is important for global growth says German contract development and manufacturing organization (CDMO) Haupt Pharma.

The site, in Borgo San Michele, Latina, now holds Food and Drug Administration (FDA) approval to make two sterile penicillin products for the US market.

“The US market has a great potential, it is important for us to be present. FDA approval also shows the high standards of good manufacturing practice at our company.”

She added that successful inspection “gives a positive signal to the market and potential customers who wish to target the US market and makes clear, that Haupt Pharma is a strong and competent partner.”

The facility, which was purchased from US drug giant Pfizer last February , also makes non-beta lactam antibiotics for pharma industry customers on a contractual basis, supplying 80 national markets.

The Latina plant is also approved by Italian authorities to produce generic drugs demand for which is likely to increase, according to Haupt’s spokesperson.

“[Although] the use of generics in Italian market is still not comparable to other markets such as Germany or UK…further growth is expected in the near future,” explaining that, according to a L’uso dei farmaci report, use of generics grew 12 per cent in 2009.

The Italian generics market has traditionally made up a smaller proportion of the nation’s total pharmaceutical sales than other European nations, owing to the extended national patent supplementary certificates in place.

This restricted the sale of generics in Italy for a long time after the product had come off patent in other European countries.

Consequently the market was valued at $809m in 2007, according to a report by Espicom Business Intelligence, which is less than in Portugal despite total pharmaceutical sales in Italy being six times as much.

However, the market is predicted to grow to $1.8bn by 2012 as big products come off patent and efforts to revise the laws covering generics gain pace.

Excella Teams with Atacama on PDG Tech

German contract manufacturing organization (CMO) Excella will provide pneumatic dry granulation (PDG) tablet making services through a new partnership with Finnish specialty pharmaceutical firm Atacama Labs.

PDG, launched by Atacama in 2007 , is an particle granulation method designed for use with moisture and heat sensitive active pharmaceutical ingredient (API) that are difficult to process with wet granulation or roller compaction techniques.

Under the new collaboration German CMO Excella, which provides development, clinical supply and commercial manufacturing services for cytotoxics and high potency APIs, will offer PDG to its customers.

Michael Tschope general manager of Excella’s pharmaceutical business described the PDG technology as “revolutionary in the sense that it offers significant advantages in terms of API treatability, development speed and costs.”

Recently appointed Atacama CEO Steffen Mittwich also stressed the benefits of the PDG technology, explaining that it can be used to process “almost any API into higher drug load tablets with good hardness and dissolution profiles.”

He added that such modifications can have a significant impact on a drugmakers revenue stream, explaining that they can be used to “extend the life cycle of expiring drugs, which can mean several more years of protected sales of a blockbuster drug.”

The deal with Excella follows just months after Atacama raised €2.3m through a private placement to further the development of the PDG technology.

Speaking at the time Mittwich said that the investment “enables Atacama Labs to move from the R&D phase into the commercial phase, and to launch the … PDG Technology for the traditional drug manufacturing field."

Helvoet to Build Parenteral Component Plant in India

Helvoet Pharma is to build a €14m ($19m) rubber parenteral packaging component facility in India to meet rising demand for products made to international quality standards.

The growth of the Indian generic market is driving demand for parenteral devices and this is now accompanied by rising quality standards. Helvoet Pharma believes this creates an opportunity for a company with an established reputation to set up a facility operating to international standards.

Currently there are two to three domestic companies producing components of a similar quality, said Jean-Paul Thans, vice president, sales and marketing at Helvoet Pharma.

Despite this competition Thans believes Helvoet will capture a share of the market. Thans stated that Helvoet’s reputation as a reliable, global supplier and use of the same standards and equipment in its Indian, US and European plants will attract business.

When the site is operational in 2012 it will employ 30 to 50 people and manufacture a limited range of very standardized products for use by domestic companies. The site and product portfolio may be expanded in the future.

This expansion could add price sensitive components for exportation to the rest of the world, according to Thans. By adding this capacity Helvoet would be able to reduce the production costs of components used by companies in Europe, the US and Asia.

Construction work on the facility, which will be located near Pune in Maharashtra state in Western India, will start in the third quarter. The facility will be housed in a newly developed industrial zone with a secure energy supply, good transport links and access to trained personnel.

Helvoet currently does around €2m of business with companies operating in India but these products are mainly for re-exportation. The new facility will be its first in Asia.

Sanmina-SCI Hungary Facility Achieves ISO Certification for Medical Devices

Sanmina-SCI Corporation, a global Electronics Manufacturing Services (EMS) company, announced that its Tatabanya, Hungary facility has received ISO 13485 certification for medical device manufacturing.

ISO 13485 is an internationally recognized standard developed to ensure that companies provide medical devices that consistently meet regulatory requirements. In order to obtain the certification, Sanmina-SCI demonstrated the ability to consistently meet strict requirements for quality management systems applicable to medical device manufacturing and related services.

"We are very pleased to have received the ISO 13485 certification which demonstrates Sanmina-SCI's commitment to maintain the highest medical device manufacturing standards in the EMS industry," said Gelston Howell, Senior Vice President of Sanmina-SCI's Medical Division. "Earning this certification represents a significant milestone for our European operations, plus reinforces our leadership position within the medical device market segment and our strategy to support customers on a global basis."

"Sanmina-SCI's Tatabanya manufacturing facility has more than ten years experience serving medical, industrial and telecommunications customers. Receiving this key certification for medical device manufacturing opens new opportunities for our strategic customers looking for lower-cost and quality solutions in this region," stated Dietmar Gunther, Executive Vice President of Sanmina-SCI's European Operations.

Sanmina-SCI's Medical Division leverages more than 20 years of experience with a large global network of FDA-registered, ISO 13485:2003 compliant medical design and manufacturing facilities in the EMS industry. The Medical Division offers medical device Original Equipment Manufacturers (OEMs) complete end-to-end manufacturing services from engineering and manufacturing to logistics and repair/returns management, specializing in a full range of medical devices, from small and medium-sized products, such as blood pressure monitors and prostate therapy systems to large equipment that includes CT scanners and ultrasound systems.

McIlvaine Company,

Northfield, IL 60093-2743

Tel: 847-784-0012; Fax: 847-784-0061;

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