Ranbaxy Laboratories is selling its 50 per cent stake in its Japanese joint venture (JV) to its partner Nippon Chemiphar (NC), allowing both companies to independently pursue their generic businesses.

The sale comes 12 months after Japan-based Daiichi Sankyo completed its $4.5bn (€3bn) acquisition of Ranbaxy. NC will now pursue its generics strategy independent of Ranbaxy, although the Indian business will continue to manufacture and supply its partner for some time.

This is intended to ensure a smooth transition and allow NC to continue serving the Japanese generics market, which, according to Reuters, Pfizer is believed to be considering entering in 2011.

Dow Forms Independent Protein Production Business

Dow has joined with Signet Healthcare Partners to form a new independent company which will use the chemical company’s Pfenex protein expression technology to accelerate development.

The new company, called Pfenex, will be based in San Diego, CA, and use Dow’s Pseudomonas fluorescens-based platform that optimizes protein production by using high throughput screening and parallel processing methodologies.

Using this platform Pfenex intends to become a biotech specializing in strain engineering and protein production. By focusing on these areas the company believes it can help accelerate the development of biologics and vaccines.

Dow will also contribute approximately 20 experienced employees, customer contracts and lists, trademarks and certain intellectual property to the venture. In return it will take a minority stake in Pfenex, as will Signet, a venture capital investor focused on the healthcare sector.

The move is part of Dow’s strategy of active portfolio management which it believes can maximize value. Dow is using this model to grow companies with novel technologies that have the potential for significant equity value.

It believes that Pfenex technology, which has been used by companies including Pfizer, fits into this category and the newly formed company has the attributes needed to succeed.

“Dow has invested in this business over the past five years”, explained Ken Van Heel, global director, Dow Venture Capital, adding that this has provided “the basis for an independent company with the potential for significant growth in this new independent business model”.

James Gale, managing director of Signet, added: “We are excited about Pfenex Expression Technology and the value of its protein expression system in surmounting barriers and shortening timelines in drug development.”

Financial details of the deal have not been disclosed.

Valeant Pharma to Acquire Laboratoire Dr. Renaud

Valeant Pharmaceuticals International said it will buy skin care products maker Laboratoire Dr. Renaud for 23 million Canadian dollars ($21.8 million).

Valeant said the Quebec, Canada company has $10.4 million in annual sales, and believes the purchase will increase Valeant's profit in 2010. The deal also includes a lease for a 45,000 square foot facility, which includes a manufacturing plant for topical drugs.

Valeant, which sells neurology and skin drugs, reported $220.3 million in revenue in the third quarter. The company sold off its overseas businesses in 2008.

Indian Drugmaker Dr. Reddy's Laboratories Expands Louisiana Plant

Dr. Reddy's Laboratories Inc., a generic drug manufacturer based in India, said that it will spend $16.5 million to expand its Shreveport production plant and create 73 new jobs.

Dr. Reddy's settled on Shreveport following a competitive inducement process involving domestic and foreign sites. The state is providing a $2.1 million grant to offset capital expenditures and Dr. Reddy's will receive a waiver of all city permit fees and a 2.75 percent rebate of local sales taxes the company pays.

The company currently has 161 jobs in Shreveport. State officials said the new jobs will average $37,000 annually, plus benefits. Projections call for $7.3 million in new state tax revenue and $5 million in local tax revenue over 10 years.

Dr. Reddy's said that the Shreveport plant is currently the largest producer of silver sulfadiazine cream, a topical burn remedy, and the second-largest producer of ibuprofen for the North American market. The expansion will enable the company to expand its product lines in Shreveport, officials said.

Gov. Bobby Jindal, who made the expansion announcement, said northwestern Louisiana had a growing health care, biotech and pharmaceutical industry that could create additional jobs.

Jackson Lab to Use Stimulus Funds for Bioinformatics Expansion

The Jackson Laboratory in Bar Harbor, Maine, will use a $2.1 million National Institutes of Health grant to bolster its bioinformatics team and facilities, and to hire other staff, the lab said.

Jackson Lab plans to use the funds from the American Recovery and Reinvestment Act to support the addition of three new stories to its existing bioinformatics facilities, and it plans to hire eight new faculty members, including four focused on bioinformatics.

The lab had initially announced the stimulus award in late September. The new staff members' areas of focus will include high-throughput genomics, computational statistics, and imaging, Jackson Lab's Chief Information Officer and IT Director, Scott McNeil, said in a statement.

McNeil described these as "fields with very high compute, storage, and bandwidth needs," and said that the lab is positioning for new cloud computing capacities.

The tools these bioinformatics programs develop will "be publicly available to researchers worldwide, helping them keep pace with the increasing amount of genetic data currently being generated," Jackson Lab said.

One focus, for example, will be mouse model characterization research coming out of the Mouse Genomes Project.

Jackson Lab said that the new grant brings its total stimulus funding to more than $5.8 million.

French Cell Chip Maker CYTOO Raises $4.7 Million, Opens U.S. Shop near Boston, MA

Looking to tap into demand for high-throughput, cell-based assays from North American customers, French startup CYTOO recently raised $4.7 million to help it establish a US subsidiary near Boston.

Founded last year in Grenoble, CYTOO currently sells CYTOO chips, which each comprises a 2 cm x 2 cm glass surface containing 144 micropattern arrays that provide 20,000 micropatterns per chip.

CYTOOplates, glass-bottom microplates in 96- or 384-well format, where each well holds an array of over 1,000 identical micropatterns, are expected to become available in April 2010. The chips and plates are available in a wide range of geometries and are used to normalize cell morphology and behavior and control cell organization for more reliable analysis, according to CYTOO.

According to President and co-CEO François Chatelain, CYTOO is ready to expand into the North American market to grow sales, attract customers, streamline logistics, and position the company for further rounds of financing.

Chatelain told BioArray News this week that there are several reasons for CYTOO's decision to set up shop in the US just 18 months after the company was founded. The first reason is the size of the US market. Chatelain said that market studies show that US customers could represent about 50 percent of the industrial market for cell-based assays and microtiter plates, in particular.

In a statement, the firm said that the US market for high-content screening assays is the "most mature" and was worth roughly $850 million in 2007.

In North America, though, CYTOO is also interested in working with talented scientists. "The US is where you find key opinion leaders," said Chatelain. "In this particular market, Europe is the follower, and France is even more of a follower," he said. Another reason for US entry is to make it easier to serve customers.

"It is much easier for US customers to order through a US company," said Chatelain. "Ordering to Grenoble created a lot of issues" for customers, he said, as some government-backed researchers had to justify the need to buy from a French firm and prove that there is no equivalent technology in the US.

Another reason for planting a stake in the US is the likelihood of additional investment. CYTOO will go through one more round of financing, he said. "This one we expect will be of larger value and that US investors will join the round," said Chatelain.

In addition to the $4.7 million the firm raised recently, CYTOO netted $1.5 million in seed funding last year. Investors include Auriga Partners, CEA Valorisation, Rhône-Alpes-Creation, and Expansinvest as well as private investors.

To lead its US operations, which will be called CYTOO Inc., CYTOO hired Bill Sharp as CEO. Sharp previously was president and CEO of Aruna Biomedical, a privately held stem cell technologies company, was chief commercial officer at BioProcessors, and served as vice president of business development at Cellomics.

Based in Framingham, Mass., the US office will focus on sales and marketing efforts, while CYTOO's operations will continue at its headquarters in Grenoble. "Not only do we want a subsidiary in the United States, we want our marketing to be directed from the US, because to address the worldwide market, US marketing is better, and is more universal or generic than French marketing," Chatelain said.

Currently, CYTOO employs 15 people in Grenoble and Framingham, and Chatelain noted that the firm's headcount has doubled since it began selling its CYTOOchips in April.

CYTOO's chips are competing in a market with a variety of different technology platforms, each of which offers users a different way of looking at cells. For instance, San Diego-based Biolog sells Phenotype Microarrays for high-throughput cell screening. Researchers at the VTT Technical Research Centre in Finland have also developed a miniaturized next-generation approach to microarray-based cell screening.

Chatelain said that CYTOO's platform differs from other approaches in that the cells on its arrays are normalized, allowing users to scan hundreds of cells without worrying about the differences between them. "Our main issue is raising awareness and getting people to move to buying the product and starting to use it. We don't have direct competitors," said Chatelain. "Nobody is offering a technology that can normalize cells, and the main problem in high-content screening is cell-to-cell viability," he said. "We are the only technology that can normalize cells so that cells look the same, all organized the same way."

CYTOO's CYTOOchips use micropatterns to control the shape of the cell on the surface, forcing the cells to behave the same way, Chatelain said. "Cells have limited points where they can anchor to the surface," he said. "We can normalize and control the inner structure of the cells. Everything is registered by micropattern and the cells behave the same way," he added.

CYTOO's chips have been on the market since April, and the original product was designed with individual researchers in mind. Chatelain said the firm has seen some demand from academic labs. But beyond academic research in cell biology, CYTOO wants its platform to be adopted by high-content screening groups within the R&D divisions of pharmaceutical companies. "We believe those two fields, those two segments talk to each other all the time and cross fertilize," he said.

To meet the needs of pharma customers, CYTOO is beginning beta tests on its microtiter plate format, which will make CYTOO chips available in 96 and 384 wells. He said the new products should become available in April 2010.

Covance Plans 30,000 sq.ft. Lab and Kellogg’s Partnership

Covance will add a 30,000 square foot lab for nutritional chemistry and food safety by the fourth quarter of 2010; that will, at least to begin with, occupy much of its time testing for Kellogg’s.

Covance and Kellogg’s – two companies that have worked together for more than 30 years – have signed a seven-year “strategic collaboration” , that will see Kellogg’s pay Covance $42m for work principally conducted at the new plant.

But the facility, which Covance corporate communications director, Laurene Isip, said was partly a response to food scares such as melamine and salmonella, would be able to accommodate other players.

“This is a good opportunity for us to tap into market needs for food safety,” Isip said of the plans that will see the state of Michigan and the city of Battle Creek inject about $4.3m into the project that is forecast to create more than 40 jobs. “The lab is open to anyone to use.”

The facility represents a “significant expansion of Covance's microbiological food safety testing capability,” the company said in a statement.

It is affiliated with the National Center for Food Protection (NCFP) in Battle Creek, a global food protection resource development and collaboration network initiated through the efforts of Battle Creek Unlimited, an economic development organization.

"We are excited to expand our contributions to improving and protecting the global food supply. Food safety is top of mind among consumers, manufacturers, regulators, and legislators amidst recent food safety outbreaks," said James Lovett, corporate senior vice president of Covance.

"We appreciate the confidence a high-quality organization like Kellogg's has placed in us, and we look forward to further growth through expanding our relationships with other valued clients in the region and through supporting the NCFP. We also look forward to becoming a more active participant in the Battle Creek community."

"We are pleased to have Covance, a market leader in nutritional testing, support NCFP's efforts," said Stephen Benoit, president and chief operating officer of NCFP. "Covance's involvement will help us establish the Food Testing Center for Excellence that will greatly benefit Michigan-based and other leading food manufacturers."

Vetter Dedicates New U.S. Facility in Illinois

Vetter Pharma International dedicated its new 24,000-sq.-ft. facility at the Illinois Science + Technology Park in Skokie, IL on Dec. 1. The new facility will focus exclusively on preclinical through Phase IIb projects and will fill very small quantities of product, required for early studies. Phase III projects will be transferred to the company’s German facilities for large-scale production. The Skokie site is expected to be operational by the end of 2010.

“For injectable drugs, collaboration early in development is essential,” said Peter Soelkner, Vetter's managing director. “What is the most user-friendly injection system for the patient? Should the compound be liquid or freeze-dried and reconstituted? What delivery system would best ensure multinational regulatory approval? Getting the answers right — the first time — speeds medications to market and to the patients that need them.”

The new facility is strategic to Vetter’s plan for worldwide growth. Founded 25 years ago in Ravensburg, Germany, Vetter employs 2,200 people. The Skokie site, Vetter’s first U.S. facility and its first outside Germany, will eventually employ 50 to 60 highly skilled professionals.

“Since nearly half of our customer base is located in North America, creating a U.S. facility was the logical next step,” said Mr. Soelkner. “Although we did consider several other U.S. biotech hotspots, including Boston and San Francisco, Chicago best suited our needs.”

Dell Children's Medical Center is World's First LEED Platinum Hospital

Dell Children's Medical Center of Central Texas, a member of the Seton Family of Hospitals, has become the first hospital in the world to receive the LEED (Leadership in Energy & Environmental Design) Platinum designation, given by the U.S. Green Building Council.

"Even before the first plans were drawn up, we set our sights on creating a world-class children's hospital, and becoming the first LEED Platinum hospital in the world was definitely part of that," said Robert Bonar, president and CEO, Dell Children's Medical Center of Central Texas. "Our motivation to pursue LEED Platinum was not just environmental. Being a 'green' hospital has a profound, measureable effect on healing. What's good for the environment and good for our Mueller neighbors is also good for our patients."

Dell Children's, which occupies nearly one-half million square feet on 32 acres that were once part of Austin's old Mueller Airport, opened in June 2007. Its environmentally-sensitive design not only conserves water and electricity, but positively impacts the hospital's clinical environment by improving air quality, making natural sunlight more readily available, and reducing a wide range of pollutants.

Inside the facility, sunlight reaches 80 percent of the available space. Outside, sustainable and indigenous building materials were used throughout the façade. A 4.3 megawatt natural gas-fired power plant produces 100 percent of the hospital's electricity, heating and cooling.

Dell Children's routinely plays host to visiting clinical, environmental and architectural experts from around the world, and features six interior healing gardens, each representing a distinct ecosystem within Dell Children's 46-county service area.

In order to achieve LEED certification, buildings are rated in five key areas: sustainable site development, water savings, energy efficiency, materials selection and indoor environmental quality. Listed below are some of the accomplishments in each LEED category:

Sustainable Site:

47,000 tons of Mueller airport runway material was reused on the site.
About 40 percent flyash instead of Portland cement in the concrete mix yields a drop in carbon dioxide emissions equivalent to taking 450 cars off the road.
Courtyards provide light to interior spaces; courtyard air intakes provide cooler air than rooftop intakes for air conditioning.
92 percent of construction waste was recycled on site.

Water Efficiency and Water Conservation:

Reclaimed water is used for irrigation, xeriscaped landscaping uses native plants which require less water.
Low flow plumbing fixtures.

Energy Efficiency and Energy Conservation:

Efficiency measures save enough power to fuel about 1,800 homes.
An on-site natural gas turbine supplies all electricity, 75% more efficient than coal-fired plants: links to the municipal grid and an emergency generator provides backup.
Converted steam energy from a heating/cooling plant supplies all chilled water needs.
Under-floor air distribution in non-clinical, non-patient areas requires less fan power than above-ceiling ducts.
Parking lot trees and reflective surface pavement and roof materials reduce the heat-island effect.

Indoor Environmental Quality and Lighting:

Most interior spaces are within 32 feet of a window.
Motion and natural light sensors shut off unneeded lights.

Conservation of Materials and Resources:

Use of local and regional materials saves fuel for shipping.
Special paints and flooring emit low levels of volatile organic compounds (VOCs).

Van Andel Institute Opens Expansion in Michigan

Van Andel Institute (VAI) cut the ribbon on its eight-story, $178 million, 240,000 square foot Phase II expansion. The expanded facility creates economic and scientific opportunity both for VAI and West Michigan's burgeoning life sciences sector and adds to the more than $1 billion investment in infrastructure already in place along Grand Rapids' Medical Mile. When operating at capacity, the expansion will support a $125 million annual research operation that expands the number of laboratories from the current 18 to more than 50, and provides the capacity for 550 additional jobs.

Phase II nearly triples current laboratory space and promises to significantly increase the Institute's capacity to impact human health through an expansion of its current basic and translational cancer research, and an expanded commitment to neurological diseases such as Parkinson's and Alzheimer's through an endowed chair and the new $4.2 million Jay Van Andel Parkinson Research Laboratory. This increased capacity is enhanced by a number of key partnerships including an alliance and affiliation agreement with the Translational Genomics Research Institute (TGen) of Phoenix, announced earlier this year, and expanded research opportunities provided by the new regional medical school, the Michigan State Univ. (MSU) College of Human Medicine, which opens in 2010 on an adjacent site.

"The buildings that rise along Grand Rapids' Medical Mile stand as a testament to our community's ability to unite and work together," says Chairman and CEO David Van Andel. "Now is the time to harness that ability to another challenge: to fill those buildings with the most capable individuals who will enable West Michigan to take its place as a leader among emerging life sciences sectors."

"The research and recruitment ability the Phase II expansion provides will have a dramatic impact toward understanding disease and improving patient care," says Jeffrey Trent, VARI President and Research Director.

The new facility also reflects VAI's dual mission of biomedical research carried out by Van Andel Research Institute (VARI) and science education undertaken by Van Andel Education Institute (VAEI). Phase II labs will be utilized by students of VAI Graduate School, a graduate program designed to prepare PhD scholars in cell and molecular genetics relevant to human disease, which matriculated its first students in 2007. Laboratory space will also be utilized by faculty of the MSU College of Human Medicine, which will include five research clusters: cancer, obesity, cardiovascular disease, arthritis, and neurobiology. The presence of the College of Human Medicine encourages collaboration with VARI researchers and provides a large boost to the region's development as a center of biomedical research and technology.

The Van Andel Institute building was designed by New York-based Rafael Vinoly Architects PC and intended to be constructed in two phases. The façade of Phase II mimics the cascading roofs and windows of the current Phase I building, which was completed in 2000 and evokes the rapids of the Grand River, which flows through downtown Grand Rapids. Rafael Vinoly's broad portfolio of award-winning work includes the Tokyo International Forum, the Kimmel Center for the Performing Arts in Philadelphia, and a much-publicized proposal for the World Trade Center site.

As in the case of Phase I, the glass roof design and open plan of Phase II offer abundant natural light, a unique open laboratory layout, and flexible laboratory and meeting spaces. The expansion also offers enhancements such as a 90-seat conference center and a 100-seat cafeteria, a demonstration lab for visitors to view research in progress, an interactive Discovery Wall, an expanded library, interior design that reflects the diversity of the Institute, and numerous "green" features.

Consistent with the region's emphasis on green building - Grand Rapids leads in the nation in per capita Leadership in Energy and Environmental Design (LEED) - certified buildings and ranks eighth in the nation in total number - Phase II will become one of just a handful of medical research laboratories in the Midwest to attain LEED certification. The new building and the construction process feature such energy efficient mechanisms as: photovoltaic panels to reduce energy demands during summer, a heat recovery system to reduce heating demand, low-flow water fixtures that reduce water usage by 30%, 33,000-gallon rainwater storage tanks to further reduce demand for potable water, the recycling of over 95% of construction waste, and the usage of locally-manufactured materials in the production process. Intelligent building design features include CO2 sensors throughout the building that detect the presence of people and automatically adjust room temperature.

The construction of Phase II provided more than 1,800 local building jobs between the project groundbreaking in April of 2007 and completion. The majority of the project team was composed of Grand Rapids-based businesses. In addition to Rafael Vinoly Architects PC, the Phase II project team included Owen-Ames-Kimball Co., The Hunt Construction Group, Culhane & Fahrenkrug Consulting, LLC, URS, Fishbeck, Thompson, Carr & Huber, Materials Testing Consultants, and CommTech Design.

Idaho Technology Lands $3.3 Million from DoD

Idaho Technology has won a $3.3 million grant from the US Air Force to further develop its FilmArray pathogen detection system and seek a CLIA waiver from the Food and Drug Administration, the company said.

The funding from the Defense Threat Agency (DTRA), on behalf of the US Air Force Assistant Surgeon General, Modernization Directorate, will be used to develop a rapid test for a number of pathogens that cause infectious diseases.

The FilmArray integrates sample preparation, PCR amplification, detection, and analysis utilities into one system that can detect more than 100 targets from one sample in less than an hour, the Salt Lake City-based firm said.

A Johns Hopkins University assessment of more than 200 instruments completed this spring found that the FilmArray was the only existing system that aligned with the needs of the Department of Defense's Epidemic Outbreak Surveillance objectives, the company said.

Cleanroom Facility Unveiled At College Of The Canyons

Providing a state of the art facility to train students interested in pursuing careers in the sciences and learning more about nanoscience and nanotechnology, College of the Canyons administrators officially unveiled the college's new Emerging Technologies Instrumentation Laboratory and Cleanroom facility.

The Emerging Technologies Institute at College of the Canyons was established to provide participants a basic understanding of the nanotechnologies and practical exposure to some typical tools used for their applications and an understanding of the many possible employment opportunities across a wide range of industries.

Located in Aliso Lab on the college's Valencia campus, the new laboratory and cleanroom facility houses an array of high-technology microscopes and measurement devices that will be used by students enrolled in the college's recently introduced General and Emerging Technologies Laboratory Technician program (GETLABTECH).

As a result, students will now be able to receive hands-on training and experience using some of the field's most technologically advanced equipment - including a scanning electron microscope, atomic force microscope, inverted fluorescent microscope, mask aligner, sputtering device, ellipsometer and profilometer.

"For a community college to have this kind of state of the art facility and technological capability is very unique," said Dr. Ram Manvi, dean of mathematics, sciences and engineering technologies at the college. "We really want to take advantage of this capability, build on it and make sure that our students are well prepared for the future by being adequately trained to use this type of equipment in their workplaces."

To help launch the new program and construct the cleanroom College of the Canyons received a two-year California Industry Driven Regional Collaborative (IDRC) grant totaling nearly $571,000, as well as a $1.38 million grant from the Department of Commerce/Economic Development Agency (DOC/EDA) Public Works and Economic Development Facilities Program.

Together those funds have allowed administrators to lay the foundation for the college's Emerging Technologies Institute and 14.5-unit GETLABTECH certificate program by developing and implementing curriculum, designing appropriate on-campus instructional and laboratory facilities, constructing the cleanroom area and purchasing furniture, lab tools and equipment for student use. During the fall 2009 semester, College of the Canyons began offering three new GETLABTECH courses. Additional courses are scheduled for the winter 2010 intersession and spring 2010 semester - with hopes of training approximately 300 students over the next eight years.

Novartis Opens Cell-Based Vaccine Plant

Swiss pharmaceuticals maker Novartis AG has opened the first U.S. plant to produce flu vaccines using cell cultures instead of egg-based methods, it said.

The new site in Holly Springs, North Carolina, is unlikely to ramp up output in time to produce vaccines for the current swine flu pandemic, but will be active from 2011.

Total investment in the facility, which was given a $487 million grant from the U.S. Department of Health and Human Services, was nearly $1 billion, Novartis said.

There are currently 191 employees working at the site, Novartis said. The staff number will go up to 350 when the plant is in full operation, it added.

With demand high because of the swine flu pandemic, companies are trying to find a more efficient way of producing vaccine than the slow method of cultivating seed virus in chicken eggs.

Novartis said once the plant is in full operation it will be able to supply 150 million doses of pandemic flu vaccine six months after a pandemic is declared.

The sale of flu vaccines from cell cultures is not yet approved in the United States, but Novartis is allowed to produce them there. The company said its agreement with the Health Department also includes funding for the development of such a vaccine.

Novartis said the plant could start producing pandemic flu vaccines in 2011, making it very unlikely it would produce any for the current swine flu pandemic. It is expected to run at full capacity in 2013, it added.

Novartis already operates a cell-based flu vaccines plant in Marburg, Germany.

Shares in Novartis were up 1.36 percent at 55.90Swiss francs ($55.27) on the Zurich exchange.

Flu Season, Ailing Economy Aiding Michigan Generic Manufacturer Perrigo

Record profits, job openings, shareholders making money; it's not what you might think in Michigan, home to the country's highest unemployment rate, but a century-old company is in robust health thanks to achy, thrifty Americans.

Perrigo Co., the nation's largest manufacturer of generic over-the-counter medications, reported more than $61 million in profit during its last quarter — a 60 percent spike from the same time last year. Its sales revenue hit $528 million, a 16 percent jump. It also adjusted its 12-month earnings forecast upward and boosted its shareholder dividend.

"We feel very good about what the potential is because, unfortunately, people still get sick," chief executive Joseph Papa said.

"We make over 40 billion tablets per year," he added. "That breaks down to every second, over 1,000 people take a Perrigo product."

With business expected to remain strong, the 122-year-old company wants to fill 60 positions with scientists, engineers and quality-control experts at its corporate headquarters and research and production site in Allegan, he said.

Although the state had the nation's highest unemployment rate in September at 15.3 percent, the health care and life sciences industries are thriving in southwestern Michigan. The region is home to Kalamazoo-based Stryker Corp., among the world's 12 largest medical device makers, and Michigan State University is building its new medical school in Grand Rapids.

Perrigo has a history of flourishing in tough times, said Daniel J. Farrell, a professor of management at Western Michigan University. Its store-brand products usually sell for 25 percent to 30 percent less than national brands.

Perrigo's growth also has been good for Allegan, a city of about 5,000 people about 140 miles west of Detroit. Allegan County's unadjusted unemployment rate was 13.1 percent in September. Allegan receives $1.1 million, or 38 percent, of its $2.9 million in annual property tax revenues from the company, whose facilities span said City Manager Rob Hillard.

"In terms of Perrigo's contributions to the community, it's vast from a tax-base standpoint," Hillard said.

Perrigo has 7,000 employees worldwide, up from 4,000 in 2003. There are 3,200 workers in Allegan and nearby Holland, where the company has production facilities.

Its primary markets and locations of manufacturing and logistics operations include the United States, Israel, Mexico and the United Kingdom. Much of its growth during the past decade came from its acquisition of pharmaceutical companies throughout the world, including Israeli drug giant Agis Industries Ltd. for $818 million in 2005.

Perrigo also has grown at home. In September 2008, the company agreed to pay $44 million for drug and vitamin maker JB Laboratories Inc. of Holland. A month later, Perrigo announced a $25 million plant expansion in Allegan.

Of the company's three business units, consumer health care is its largest with over-the-counter analgesics, cough and cold remedies, and gastrointestinal and feminine hygiene products. It also produces vitamins, dietary supplements and nutritional drinks.

Retailers contract with Perrigo to produce their bargain-priced store-branded medicines — and it controls 70 percent of the store-brand market, said Dan Willard, a company spokesman.

The company also markets certain products under its own brand, Good Sense.

Another unit makes generic topical prescription drugs, such as ointments, lotions and nasal sprays. The third produces ingredients that other drug makers use in manufacturing.

"All three of the businesses have done extraordinarily well and we've been very pleased with the results," Papa said.

For its first quarter of fiscal 2010, which ended Sept. 26, Perrigo reported net income of $61.3 million, up 60 percent from the same quarter last year, and sales revenue of $528 million, up 16 percent. The performance led the company to adjust its 2010 earnings forecast to a range of $2.35 to $2.45 per share, up from the previously expected $2 per $2.12 per share.

A few days before releasing its earnings, the company announced that it was boosting its quarterly dividend to 6.25 cents per share, up from 5.5 cents per share.

Research Revolution at Yale West Campus

By early next year, employees from three new core facilities are scheduled to complete their move to Yale’s West Campus, a 136-acre property which features state-of-the-art laboratories and the latest in life science technology.

At the center of the sprawling 136-acre West Campus are three buildings that will house scientists who are using three distinct technologies yet who share an underlying mission: transforming the way biological research is conducted at Yale.

"New technologies are creating an unprecedented amount of data and providing entirely novel ways to address scientific questions," says Michael Donoghue, VP for West Campus planning and program development. "The new cores opening up on the West Campus put Yale in a unique position to capitalize on these advances to answer some of the most fundamental questions in biology."

By January, the three core facilities — occupants of the largest acquisition in Yale's history — will be open and assisting scientists in the business of discovery.

Already, the technologies employed by the Yale Center for Genome Analysis, the Center for High Throughput Cell Biology and the Small Molecule Discovery Center have proved to be invaluable in dozens of Yale projects — such as shedding light on the genetic basis of autism, tracking key molecular pathways in inflammatory diseases, and discovering a new cancer drug. The new cores will only increase the computational firepower of bioinformatics systems and allow Yale scientists to conduct experiments that would not have been feasible just a few years ago.

These core facilities will help support the entire university, but will also be linked closely to five new institutes planned for West Campus. The institutes will be in microbial biology, chemical biology, cancer biology, systems biology and cell biology.

Shrikant Mane is representative of the directors charged with day-to-day operation of the new facilities. All are scientists whose love of research led them to learn the diverse and powerful new technologies that are quickening the pace of discovery in the life sciences. All are silent partners in labs throughout the university.

As a collaborator on several grants, Mane has provided the biotechnological support for projects that seek the genetic basis of autism and age-related macular degeneration; help test novel ways to repair the central nervous system; explore genes crucial to the evolution of the human brain; and look for genes involved in asthma, schizophrenia, bipolar disease, kidney disease and brain aneurysms.

A recent collaboration between Mane and Richard Lifton, chair of Yale's Dept. of Genetics, illustrates the power of the new technology and provides a glimpse of its potential clinical value. For the first time they made a clinical diagnosis using comprehensive DNA sequencing of all the protein-coding genes in the genome. The technology, which selectively analyzes the 1% of the genome that encodes for proteins, allowed the scientists to pinpoint mutations in the genes of a five-month-old Turkish boy that cause congenital chloride diarrhea, a rare birth disorder in which the gastrointestinal tract fails to properly absorb chloride and water.

For now, Mane says he plans to harness the power of 12 sequencers at West Campus to aid the work of Yale researchers. "We have no doubt that one day the technologies that are being employed at the new West Campus facility will pave the way for personalized medicine by providing critical insights into identification of genetic risk factors, diagnosis, prevention and treatment for a host of human diseases," Mane says.

While Lifton, Mane and others are pushing the limits of genomics technology, James Rothman, chair of the Department of Cell Biology, recently has his own vision for the Center for High Throughput Cell Biology. Rothman, one of the top cell biologists in the world who was recruited to Yale last year from Columbia Univ., wanted to create a center that married several distinct technologies that together would give scientists an unprecedented view of the inner workings of the cell.

In the summer of 2008 the center became the first of the three West Campus cores to open for business. Rothman recruited Columbia colleague Lars Branden to become director of the core. The facility, which employs 13 people, helps researchers assess how genes function in a cell by selectively silencing genes in highly automated, genome-wide screens. The latest in optical microscopes assess the effects of gene expression in living cells and the deluge of data is fed into banks of computers. The bioinformatics system helps researchers develop a picture of how those genes interact in living cells.

"We can do this for any field of biology you can imagine,'' Branden says. We want to be a hub of the Yale community's efforts to decipher complex biological processes."

While most of the individual and robotic technologies housed at the center have existed for years, Rothman envisions marrying the technologies in a way that will create something entirely new.

"The marriage of genomic, optical and bioinformatics screening technologies can shave years off research time as well as give scientists new insights into cell biology that will drive research forward," Rothman says.

By contrast, chemical screening is a well-developed technology that has been a key part of the drug discovery process for years. But it is rare for Univ. scientists to have easy access to such technology, says Janie Merkel, who runs the Yale Small Molecule Discovery Center, scheduled to open on West Campus in late November.

Using high throughput experiments capable of analyzing tens of thousands of possible future drugs a day, the five-person team at the center is in the business of looking for small molecules that affect many biological processes such as inducing or repressing the expression of genes, inhibiting the interactions of proteins or the activities of enzymes. In terms of medicine, this could mean using a chemical at the DNA, RNA or protein level to correct the behavior of diseased cells to simulate health.

The great potential of the technology for academic researchers was illustrated by the recent sale of the biotechnology company Proteolix, developer of a drug to combat multiple myeloma, to Onyx Pharmaceuticals in a deal potentially worth $851 million. The basis for the new drug, now in Phase II clinical trials, originated in the lab of Craig Crews, executive director of the Small Molecule Discovery Center.

Talecris Pours $268.7 Million into Production Plant in North Carolina

Talecris Biotherapeutics is expanding its manufacturing facilities in Clayton, NC, and expects to spend $268.7 million. The Clayton plant produces protein therapies that are used to treat a range of diseases including immune deficiencies, hemophilia, genetic emphysema, and chronic inflammatory demyelinating polyneuropathy.

To facilitate Talecris’ manufacturing expansion, the state has awarded the company a $250,000 grant from the One North Carolina Fund. In addition, the state Economic Investment Committee voted to award a job-development investment grant to Talecris.

Talecris currently employs approximately 4,700 people worldwide and is headquartered in Research Triangle Park, NC. The expansion will add another 259 jobs. Talecris has 11 approved products on the market, each of them derived from human plasma that is collected primarily from the company’s 71 plasma donation centers nationwide.

Emergent Buys Baltimore Production Plant

US biotech Emergent BioSolutions has bought a manufacturing facility from Maryland’s MdBio Foundation in a bid to expand its production infrastructure.

Emergent CEO Faud El-Hibri said that its new 55,000 sq.ft. Baltimore,MA, facility, which previously operated as a Food and Drug Administration (FDA) approved contract manufacturing plant, will provide a significant capacity expansion.

El-Hibri explained that: “[The plant] houses several suites capable of manufacturing multiple products at the same time,” adding that it also provides “the flexibility to conduct large-scale manufacturing of rPA while also producing other products in our pipeline.”

Emergent has also purchase land surrounding the facility, paying the city some $8.2m, suggesting that expansion is a possibility.

Vaccine producer Emergent plans to create up to 125 new development and manufacturing jobs at the site over the next three to five years.

In a press statement, Emergent COO Daniel Abdun-Nabi said: "The acquisition … reflects our commitment to both continually creating jobs and investing additional capital in the State of Maryland, where Emergent headquarters and one of its product development sites are located."

Emergent’s new plant, formerly known as the MdBio BioProcessing Center, has a significant history. Constructed in 1996, the facility was first occupied by New York headquartered contract manufacturing organization (CMO) Bio Science Contract Production (BSCP) corp.

In 2000, it was sold to New Jersey based generics manufacturer Cambrex, which operated the facility until the company’s acquisition by Swiss health care industry supplier Lonza in 2007.

The plant was taken over by the MdBio Foundation following Lonza’s decision to reduce capacity.

Icon Plans for Site at Hospital

Icon is currently planning to occupy over a third of the 100,000 sq ft redeveloped hospital in Manchester, UK, which is due to open in 2012 and will become a flagship site for the CRO.

Andrew Copestake, vice president and general manager, Europe at Icon Development, explained the market factors that led to Icon entering into a deal with the hospital.

Firstly, the incident at Northwick Park, UK, where some trial participants suffered multiple organ failure, has led to clients requesting studies are performed on hospital grounds, according to Copestake.

Since the incident the Medicines and Healthcare products Regulatory Agency (MHRA) has implemented new accreditation, increasing safety measures, but Copestake believes there is still a perception among clients that a hospital location is beneficial.

Consequently Icon entered into the deal with Manchester Royal Infirmary (MRI) and has established a good relationship, and geographic proximity, to the accident and emergency ward.

The contract research organization (CRO) also intends to work closely with MRI’s investigators and the hospital’s nurses and technicians may spend time at Icon’s site.

By taking these measures Copestake believes Icon will become an integrated part of the hospital, not just a tenant, which will potentially benefit the partners, as well as clients and patients.

The second primary driver behind the deal is pharma’s desire to perform Phase I trials in patients, as well as healthy volunteers. By performing translational medicine Icon can give clients early indications of the efficacy and safety of a product in people with the illness.

Several CROs are bolstering their capacities in this area, including Quintiles which entered into a similar partnership with a hospital to establish a translational research facility in London, UK.

Copestake believes the UK government is encouraging the National Health Service (NHS) to reach out to partners in industry to ensure its work has commercial applications and this has helped the CROs set up the deals.

The relocation in 2012 is part of a two phase deal that will initially see Icon occupy a 34-bed translational research facility in the grounds of MRI.

Icon moves into the site, which has been built to its specifications, next year but will hand it over to MRI when it takes a planned 35,000 sq. ft. of the main redevelopment in 2012. At this point Icon will also move its operations at Skelton House, Manchester, to the redeveloped site.

The project is a “major development” for Icon and after its completion it will look to build on its success. Copestake added that the UK has a great reputation for clinical trials and Icon now has a partner that shares its research agenda.

REST OF THE WORLD

London's Biomedical Research Institute Takes Shape

Plans for the UK Centre for Medical Research and Innovation are crystallizing. Details of a new £520-million (US$850-million) biomedical research centre in central London were revealed, giving some insight into its proposed scientific scope and architecture.

The UK Centre for Medical Research and Innovation (UKCMRI) will bring together four leading UK research institutes in one building on a 1.5-hectare site near London's St Pancras International rail station. The centre will accommodate the Medical Research Council's National Institute for Medical Research (NIMR), currently based in Mill Hill, just outside London, and Cancer Research UK's London Research Institute, which has laboratories split over two sites — one in central London and the other near Potters Bar in Hertfordshire. Also partners in the project are University College London and the biomedical-research charity, the Wellcome Trust.

Biologist and Nobel laureate Paul Nurse, president of the Rockefeller University in New York, is leading the scientific planning for the UKCMRI. He told journalists that the centre will aim to be a "magnet" for attracting and training the best young researchers from all over the world, with the hope that they will then move to other UK institutions. "UKCMRI will be a feeder for other research institutes in the UK," Nurse said.

The institute will have "no particular" research focus but will aim to cover all aspects of human disease by building on the science expertise of its partner organizations, including fields such as infectious disease and brain cancer. However, he proposed that research areas could, for example, include the use of stem cells to grow human organs in the lab. University College London will contribute research in non-biomedical areas including computer science, engineering and physics.

Animal research will be carried out at the institute, but pathogens, such as the Ebola virus, that require the highest level of biological containment, category 4, will not take place. It is not clear what will happen to the category 4 research, that is currently undertaken at the NIMR. A more detailed science plan will be developed over the next few years, Nurse said.

Clinical research will not be done in house — instead, UKCMRI scientists will collaborate with nearby hospitals and research centers. Translating that research into products and services will be something that is embedded in the institute's culture, rather than being an afterthought when research projects come to an end. But the building will not house biotech companies — one proposal that had previously been floated for the centre.

The centre will be an open-plan environment without "artificial departments", and will have communal break-out areas to encourage collaboration and discussion between the institute's researchers. It will also have networking and training centers that can be used by external researchers. Much of the front of the building will be glass, letting the public see researchers at work in their labs.

The building was originally estimated to cost £500 million, but the need to build an extra basement floor has added to costs. Nurse said that a definite figure for the building costs would not be available until the construction contract goes out to tender, but noted that the budget "will be tight".

The Medical Research Council will pay for 45–50% of the building costs, while 25–30% will come from Cancer Research UK, 20% from the Wellcome Trust and 5–10% from University College London.

If construction goes over budget they will seek to find savings, which may include starting operations with fewer than the intended 1,250 researchers, and building up their numbers over time.

He also added that no concrete plans are in place for how to choose which researchers at the partner institutes will move to the UKCMRI, but that staff will undergo a review and assessment to help inform the decision.

Planning permission for the building is expected to be submitted to the local council next year.

NRC Canada Opens New Brunswick Bioinformatics Lab

The National Research Council of Canada said that a new bioinformatics lab has opened at the University of Moncton in New Brunswick as part of a multi-partner initiative.

The NRC said it will provide workstations and software tools for researchers to use in bioinformatics projects with partners the Atlantic Cancer Research Institute and the University of New Brunswick.

"Collaborative research projects such as this increase the competitiveness of a region, creating a dynamic location where companies, government, and universities can network, invest and bring innovative technologies to market," NRC President Pierre Coulombe said in a statement. "This will result in new knowledge, new skills, new partnerships and new business opportunities focused on the priorities of Canadians."

The lab will support research into data analysis and mining, as well as knowledge discovery techniques, and tools that can be used in health, energy, and environmental research.

Czech Government Launches Four Major New Research Initiatives with EU Support

Toxicology, mechanical engineering, nanoscience and veterinary medicine are the subjects of four major new EU-funded research initiatives launched recently in the Czech Republic. The projects, which will share over CZK 2 billion (EUR 77 million), are financed under the Operational Program Research and Development for Innovation (OP R&DI), which receives EU support through the European Regional Development Fund (ERDF).

The aim of the OP R&DI is to strengthen research, development and innovation in the Czech Republic with a view to enhancing the country's economic growth and competitiveness, and to make the Czech regions attractive locations for research and related activities.

One grant recipient is Masaryk University in Brno, which has been allocated CZK 544 million (EUR 21 million) for its CETOCOEN ('Centre for the study of toxic substances') project. The money will allow the university to build a new pavilion for the centre and put together a research team comprising both Czech and foreign scientists with expertise in environmental science.

The project will focus on the development of new chemical and toxicological tools to monitor environmental quality, assess the impacts of man-made and natural toxins in the environment on human health, and model the behavior of these compounds. The team will create an open access environmental database and link it up to other epidemiological databases. They will also work closely with regional authorities and support regional development through the organization of an international conference or workshop and annual summer schools.

Another project is the NETME ('new technology for mechanical engineering') Centre at Brno University of Technology. As its name suggests, the NETME Centre's work focuses on research into advanced technologies for mechanical engineering. The CZK 768 million (EUR 30 million) grant will help the centre significantly enhance its research activities by allowing it to invest in state-of-the-art infrastructure and equipment. In addition, the new equipment will help the centre improve its education programs and ensure its research is applied in practice.

Elsewhere, the Technical University of Liberec has been allocated CZK 800 million (EUR 31 million) for the Centre for Nanomaterials, Advanced Technologies and Innovation. The funds will go towards the purchase of new equipment and devices to allow the centre's researchers to carry out top-level experiments in the fields of material research (with a focus on nanomaterials) and competitive engineering (notably in the areas of robotics, mobile devices and safe engineering subjects).

Finally, CZK 365 million (EUR 14 million) will go to the Centre for Advanced Microbiology and Immunology Research in Veterinary Medicine Research at the Institute of Veterinary Medicine in Brno. The main activities of this initiative will be the development of veterinary vaccines, the study of vaccination procedures and the immune response after vaccination, the development of diagnostic kits for the detection of contaminants in samples of biological origin, and the monitoring of the causes of infections in farm animals with a view to creating techniques to prevent them and control their spread.

The work will include the reconstruction of a number of the institute's buildings in order to make them more suitable for research and experimental work involving animals. The project will also fund the purchase of new equipment and enable the training of the team's workers.

The OP Ramp;DI is managed by the Czech Ministry of Education, Youth and Sports and has a total budget of EUR 2,436 billion. It received 44 applications in its first round of calls for proposals. The ministry is expected to release details of a further four projects slated for funding shortly; they are currently finalizing these projects' budgets. The projects were selected following a stringent evaluation process involving both Czech and international experts.

AlphaRx Establishes Headquarters in Hong Kong and R&D Facility in Shanghai

AlphaRx Inc., has selected locations in Hong Kong and Shanghai for its corporate headquarters and a new R&D facility respectively. This initiative will spearhead a major push into Greater China.

The R&D facility will be located in The State Biotech Pharmaceutical industrial base (Shanghai) which is situated on 740 acres of land in Zhangjiang High-Tech Park, Shanghai, also known as China's medicine valley. Established in 1996, the base is now home to 400 research-based companies including the regional headquarters of the world's leading pharmaceutical companies, and is commonly thought of as one of the largest and most successfully drug development centers within China today.

"The Shanghai government has offered business incentives to help the decision-making process," said Michael Lee, Chief Executive Officer and President, AlphaRx Inc. "Some of the incentives include financial assistance through various types of transactions, including grants, loan guarantees and interest subsidies which translate into substantial reduction in overall project development costs."

There will be no impact to AlphaRx's presence in Toronto, Canada which continues to serve as its headquarters in North America.

Mexico City Builds Hub for Medical Research

The government of Mexico City announced it will build a world-class center for biomedical and nanomedical research, called Campus Biometropolis. The center for medical research and development will be integrated with the National Autonomous Univ. of Mexico, a top Spanish-speaking university.

The research complex, scheduled to begin construction in 2010, has been designed by the internationally-acclaimed architectural firm, Foster + Partners, whose previous works include the Hearst Tower in New York City and Berlin's Reichstag building.

Campus Biometropolis, which will attract significant investment over the next several years, will become an engine for the transformation of Mexico's economy. Mexico has human resources and considerable infrastructure to position itself as the leading knowledge center for Latin America. It will attract medical tourism, deliver multiple medical services for the economy, and become a platform for clinical research.

This R&D cluster will look to attract pharmaceutical and biomedical companies and organizations from around the world. Given its close proximity to corporate laboratories, start-ups and public research institutions, it will provide fertile ground for R&D, and offer an environment to accelerate product development and commercialization. As one of the world's leading financial capitals, Mexico City is a suitable location for companies looking to access Spanish-speaking markets.

Campus Biometropolis will be sustainably designed and built, and will be composed of hospitals, laboratories and medical universities, as well as residential and retail areas. In addition, the complex will include a natural reserve and will become a model for green buildings and water conservation. This project is in accordance with plans to transform the city into one of the most environmentally-conscience and sustainable cities in the world.

The medical hub is at the core of Mexico City’s Mayor’s General Development Plan, which was designed to convert Mexico City into Latin America's knowledge economy. The five-year plan, launched in 2007, aims to create more equity for Mexico City's inhabitants by building a sustainable and inclusive city, promoting equality through better health, education and technology and improving the competitiveness of the Mexican capital.

CPL Biologicals Building Flu Vaccine Plant in India

CPL Biologicals Pvt. Ltd., a joint venture between biotechnology company Novavax Inc. and Cadila Pharmaceuticals Ltd., said that it is building a new flu vaccine manufacturing plant in India.

The 25,000 square foot facility is targeted to be running within four months, with 60 million vaccines doses expected to be prepared each year when operating at full capacity.

The plant, which is being paid for by Cadila, will also make other vaccines developed by CPL, based on Novavax technology.

Almac Adds Potent Containment Capabilities in Craigavon, Ireland

Addressing the continuing pharmaceutical market trend of manufacturing medication in smaller but more potent doses, Almac has successfully completed the design, manufacture and installation of state-of-the-art containment technology to facilitate the processing of potent compounds in its Product Development facility.

The company says that its in-house engineered containment solutions employ rigid and flexible film Isolator technology around the processing zones of equipment that require containment of airborne particulates. Extensive dust monitoring exercises have determined the effectiveness of these containment solutions; and demonstrate Almac can process compounds with an OEL as low as 30 ng per m3.

Almac has the capability to process batch sizes ranging from 0.1Kg to 100Kg, manufacturing development, clinical & small-scale commercial solid, oral dose products

Leeds Uni Opens £4m Process Development Lab

Leeds University in the UK has unveiled a new £4 million (€4.4m) laboratory designed to make smallscale process development “greener, cheaper and more effective.”

While innovative process development in the drug sector is still dominated by Big Pharma firms, in recent years the number of smaller-scale drugmakers seeking to industrialize their own products has increased significantly.

This trend has driven demand for cost effective process development capacity and expertise, as often, smaller firms lack the capacity to either set up industrial processes in-house or partner with contract manufacturing organizations (CMO)

The new Leeds facility is designed to meet just such demand. It houses analytical, batch and continuous processing equipment, a 20-50 liter, ATEX-compliant, testing and production facility, reaction hazard and process testing calorimeters and a suite of on-line PAT equipment.

In addition to process development projects, the new laboratory has the capacity to conduct contract manufacturing projects, which again is likely to be welcomed by drugmakers wanting small-scale production runs.

John Blacker, technical director of the Institute of Process Research and Development (iPRD) which operates the new laboratory, explained it will focus on creating “[innovative] processes for specific commercial challenges”.

Prof Blacker added that: “This will enable smaller companies to access chemical process and manufacturing R&D, thereby improving their competitiveness and green credentials without the conventional barriers of high research costs.”

iPRD was set up last year to forge closer links between research activities conducted at the University and the commercial demands of partners in the pharmaceutical and fine chemicals industries. To date, the group has signed around £5m of process development contracts in areas including catalysis, extraction and crystallization control, and has built up links with 12 pharma and chemistry firms which provide funding through a subscription scheme.

The other key role for the new laboratory will be as a training facility for students enrolled in the University’s School of Process, Environmental and Materials Engineering’s (SPEME) MSc course in chemical process research and development.

The course is designed to cover all aspects of chemical manufacturing, from initial design and catalysis through to process design, purification and waste management to give scientists the skills to help meet global, such as lower cost drugs, renewable energy and reduced environmental impact.

Cargill Chinese ARA JV near Completion

The ARA production facility owned by Cargill Alking Bioengineering, the joint venture between Cargill and Chinese company, Alking Bioengineering, will begin production in 2010.

The arachidonic acid (ARA) oil facility will serve global infant formula markets.

"The completion of this new facility will give Cargill the capacity to provide our global infant formula customers with ARA for years to come," said Marcelo Montero, president, Cargill Health and Nutrition.

"The production complex was designed to meet the strict requirements of the international infant formula industry and will give us the flexibility to serve our customers with additional, high-quality capacity as well as the potential for new product lines."

Cargill Alking Bioengineering have been involved in ARA in Chinese and other markets since 2004.

Servier’s Irish R&D and Manufacturing Plant Opens

French drugmaker Servier has opened a new €47m manufacturing and R&D facility in Ireland.

According to reports in the local media, the new plant in Arklow, County Wicklow, is the final stage of a €124m investment and infrastructure development program.

ENN reported that the 4,500 sq.m. (48,420 sq. ft.) facility will act as a centre for the company's R&D activities and has created 100 new drug development and manufacturing jobs.

Merck KGaA Plans €150m Clinical R&D Centre in China

Merck KGaA says China’s growing drug market is the key driver for the new €150m ($224m) clinical R&D hub it plans to set up in Beijing.

The facility, which will be operated by Merck Serono, will manage the German drugmaker’s clinical trial operations in the country and, according to spokesman Gangolf Schrimpf, will build on its existing presence.

Dr Schrimpf said: “[Merck} is keen to further develop in-house clinical research capacity in emerging markets,” adding that the firm already has 50 dedicated R&D staff in China.

Schrimpf went on to say however that, despite the new in-house capacity the centre will provide, “co-operation with local contract research organizations [CROs] is not out of the question,” explaining that Merck is currently involved in six such partnerships in the country.

He added that the centre will house biomarker, pharmacogenomics and bioanalytics capacity and is primarily designed to serve the growing Asian market, which was a key driver for the investment.

However, Schrimpf also stressed the centre’s role in Merck’s wider R&D network, which includes units in Germany, Switzerland and the US, citing the recent FLEX Erbitux study as an example of one that included patients from both Asia and Europe.

Merck Serono plans to access China’s R&D pool to staff the new facility, according to R&D executive VP Bernhard Kirschbaum who said the firm’s efforts to recruit locally will benefit both its operations in China and its global research capacity.

In all, Merck, based in Darmstadt, expects to create 200 new research jobs at the facility over the next four years.

The company said it will recruit researchers in China and that the organization there would become one of the key R&D hubs for Merck Serono worldwide, working closely with other R&D centers in Germany, Switzerland and the United States.

Merck said its Beijing team will lead drug development for China and other Asian countries, administer local clinical trials, and also participate in global clinical trials. The new center will also ensure the management of collaborations with research institutions in China and continue to look for partnerships with local academic institutions and companies, Merck said.

Merck in Germany is not related to the company of the same name in the U.S.

Millipore Buys Indian JV

Millipore has acquired the remaining 60 per cent of its Indian joint venture (JV) to drive growth in the country which it views, along with the other BRICS nations, as a critical part of its strategy.

Revenues from the Asia-Pacific region increased by 16 per cent in Millipore’s last quarterly results, accounting for 19 per cent of global sales, and gaining complete control of its joint venture is intended to help continue this growth.

“By establishing direct operations in the country, we will be able to more effectively execute our strategy and leverage our unique capabilities to accelerate growth and support our growing customer base in this dynamic market”, explained Martin Madaus, Millipore’s CEO.

Since the joint venture was established in Bangalore, India in 1988 the local market has undergone significant change and expansion. Millipore’s operation has adapted to this and buying the operation outright should allow it to more effectively meet the needs of the market.

Sudhir Kant, president of Millipore India, highlighted “drug discovery and development, the production of difficult-to-make biologics and vaccines and the cutting-edge fields of life science research” as areas which the company wants to see “more collaborative efforts”.

Millipore’s Indian acquisition forms part of its broader efforts to bolster its presence in BRICS nations, which consist of Brazil, Russia, India, China and Singapore.

India is a “critical part” of Millipore’s strategy in these key emerging markets, with the large generics market, which is looking to expand from small molecules into biologics, and the government’s $1.7bn (€1.1bn) investment in life sciences and biotech attracting the company.

Since launching the Indian operation has expanded beyond Bangalore, establishing offices in Ahmedabad, Hyderabad, Kolkata, Mumbai and Delhi. The Indian subsidiary employs approximately 300 people covering manufacturing, sales, marketing and an access services lab.

Financial details of the acquisition have not been disclosed.

Biologics Manufacturing Plant is Being Setup in Abu Dhabi

A $150m (€100m) biologics manufacturing plant is being setup in Abu Dhabi to produce therapeutics for the Middle East and North Africa, according to the Khaleej Times.

The United Arab Emirates (UAE), which Abu Dhabi is part of, has made sizeable investments and offered incentives to boost its pharma industry, in part to diversify its industry beyond oil.

Emirates Biotech Pharmaceutical Factory, a new company, will setup the facility to produce crystal insulin for diabetes, anti-cancers, vaccines, haemophilia A and growth factors.

The facility will employ 200 people and is aiming to hire UAE nationals from local universities and technical institutes. Emirates Biotech intends to export 80 per cent of products to Middle Eastern countries, with the remainder being sold in the UAE and other Arabian Gulf nations.

Edmonton Research Park Looks to the Future

When you think about the great technology centers of the world, Edmonton, Alberta, probably doesn’t spring to mind. Yet, a small cadre of dedicated and talented people are determined to put that city on the scientific map by building an advanced business incubator for biotechnology, energy, medical, and transportation research, development, and manufacturing.

Edmonton Research Park (ERP) is 88 acres of brainpower: A division of Edmonton Economic Development Corporation, it sits on a spacious and beautifully designed campus in South Edmonton. More than 1,500 people from some 55 companies work there.

The park is giving substance to dreams, recognizing that for an enterprise to succeed it must go through various stages of development and be provided with both a physical location and networking opportunities.

Stage one: incubation

The first thing you see when you drive into the research park is the award-winning Advanced Technology Center, a striking building that looks like a futuristic bunker set in a hillside. The ATC houses more than 30 startup companies in the first stage of their development. It is designed to ease the difficult early days of commercialization by offering flexible lease arrangements, common meeting rooms and administration facilities, as well as support from government agencies. Many of the companies which started out here now successfully operate both locally and around Canada. The modern, state-of-the-art offices are designed to house no more than nine people.

Stage two: Research Centre One – a business accelerator

For companies ready to move to the next level, the Research Centre One building provides a more flexible working environment, including space for wet labs, pilot manufacturing, and office space for 10 to 30 people. The 41,000 square-foot building also allows the construction of controlled environments.

A relatively recent addition to the stage-two stable of incubators is the Biotech Business Development Center. This multi-tenant wet-lab facility focuses on the hot field of biotechnology, currently a priority of the ERP. It accommodates companies — typically 30 to 50 employees — capable of generating income.

Stage three: independent sites

The park also has lots for lease or purchase for mature firms seeking to independently develop their own sites. The sites offer the advantage of working in a community of resident technology entrepreneurs, research organizations, and educational institutions. Resident companies include Schlumberger, Micralyne, Syncrude, C-FER, and Affexa.

The Edmonton Research Park has become so successful that it is bursting at the seams. According to Candace Brinsmead, vice-president of technology advancement, EEDC, “We only have four lots available, and there are negotiations going on for three of them. We’ll need to expand fairly soon. And we will be looking to the Southlands (85 acres of provincially-controlled land immediately south of the Research Park) to do that.”

“Because we see a boom coming in the technology sector, it will be a much more dense area than the Research Park is now,” Brinsmead predicts. “Right now, we have a zoning limit of two floors. We see that we’re probably going to have to go up to eight floors and have fairly dense office and lab space.”

And that’s only the beginning. ERP’s plan is to reach outside the Park by building networks throughout the innovation community within Edmonton, across the province, the country, maybe even the world.

“It’s a big vision, but it’s totally doable,” says Brinsmead. One of the immediate projects she is involved in is a new regional alliance between ERP; TEC Edmonton, a business accelerator; the National Institute for Nanotechnology; novaNAIT, a research and development arm of the Northern Alberta Institute of Technology; and the Northern Alberta Business Incubators.

To explain the alliance, Brinsmead says that, “Primarily we create space. Actually, we horse trade so we can work together — the five of us — to do what’s best for the tenant,” which is broken down into three parts:

At first, the tenant’s needs may be office space, lab space, or services like mentorship or help with commercialization. The regional alliance becomes one point of entry for the tenant or inventor who’s trying to move a new concept along the innovation chain.

“The second layer,” says Brinsmead, “is involvement with the product developers, the people who can help scale up. And, at some point, the third level will be the people who can fund some of these ideas.”

Brinsmead is confident that Edmonton has the wherewithal to become one of the top 10 research parks in North America, given its people, facilities and support — both public and private.

“If you look at the major research parks around the world, there are none, save Finland, that have the technology or the government support that we have,” she explains. “Instead of asking us to be profitable as soon as possible, the city wants us to create value. Build the technologies that will create the successful businesses that will contribute to Edmonton. And create the technologies that will save lives and protect our environment.”

Philippines University Gets P10-M Laboratory

The Department of Agriculture (DA) recently turned over a P10-million Tissue Culture Laboratory to the Western Mindanao State University’s (WMSU’s) College of Agriculture that aims to produce disease-free planting materials and mass produce planting materials in the Zamboanga Peninsula of the Philippines.

Agriculture Region 9 Executive Director Oscar O. Parawan Friday said the laboratory was turned over to the WMSU through Dr. Grace Rebollos for use at its College of Agriculture in San Ramon.

Rebollos also accepted all projects that were turned over to the College of Agriculture which include the Agriculture Forestry and National Resources (AFNR) facilities on Coco Sugar Processing, Rubber Nursery Area and Training Room.

Parawan said that the project was funded by Senator Edgardo Angara, who appropriated P10 Million in 2007 to DA under the Zamboanga Integrated Area Development Program (ZIADP) for the construction of the Tissue Culture Laboratory at the WMSU-CA.

Parawan added that “the laboratory will eventually enhance and develop the capacity and capabilities in biotechnology in the region.”

Parawan also asked the agriculture sector to make food available and affordable to people in this city and the region in general.

PPD Acquires BioDuro to Further Expand Its Outsourcing Capabilities in China

PPD is continuing its push into China with the acquisition of Beijing-based BioDuro. The announcement comes just a couple of weeks after PPD confirmed completing its acquisition of Excel PharmaStudies, one of the largest CROs in China.

Founded in 2005, BioDuro offers fully integrated services for the synthesis and optimization of novel compounds, with specialist expertise in medicinal chemistry, biology, pharmacology, drug metabolism, pharmacokinetics, and safety services. The company operates a 110,000-sq-ft laboratory in Beijing, and has some 600 employees. The Excel acquisition, meanwhile, has increased PPD’s capabilities in the areas of Phase II–IV clinical management, data management and biostatistics, and regulatory and quality-assurance services.

Once the BioDuro acquisition is complete, PPD will employ almost 1,000 people in China, which it claims will make it the largest CRO in the country to offer both clinical-development and discovery services.

David Grange, PPD’s CEO, says the acquisition of BioDuro will “position us well to provide services for the growing global discovery outsourcing industry and to be a full-service CRO of choice in China.”

In its third quarter strategic review at the end of October, PPD stressed the attraction of China as a marketing opportunity. In terms of recruiting for clinical trials, the country has vast patient populations as well as large, centralized hospitals and an improving regulatory and IP environment. Moreover, the country’s pharmaceutical market is growing at an estimated CAGR of 19.5% between 2008 and 2013. PPD estimates the number of open trials with sites in China rose from about 200 in Q3 2007 to over 400 in Q3 2009.

Schott Starts Mass Production of TopLyo Vials in Germany

Schott begins commercial scale production of its TopLyo vials in a bid to meet growing demand for packaging solutions for freeze-dried bio-drugs.

At present, up to 50 per cent of drugs in development include biomolecular elements such as proteins, polysaccharides and carbohydrates, and the market is expected to grow considerably in the coming years.

Unlike traditional small-molecule pharmaceuticals which are fairly robust, biomolecular drugs can be highly sensitive to changes in temperature and atmospheric conditions, usually requiring that they must by lyophilized for shipment.

However, while freeze-drying solves stability issues, this type of processing can increase the tendency of drugs to adhere to the interior surfaces of vials in which they are packaged, resulting in high-levels of overfilling and wastage.

Schott’s new TopLyo vials, showcased at AAPS 2009 last week, are coated with smooth 40nm thick hydrophobic layers designed to prevent adherence as company spokesman Gary Waller explained.

“Basically this is a combination of two process, the lyophilized bottom process that we’ve matched up with our plasma impulse chemical vapor deposition (PICVD) coating on the inside surface…”“

The primary market for TopLyo is any type of biopharmaceutical for which attachment and absorption to vial surfaces during production has hitherto been a problem.

Schott began commercial-scale mass production of TopLyo at its manufacturing facility in Muellheim, Germany on November 8 and estimates that the plant will produce up to six million units a year.

The vials, which are also designed to withstand sterilization processes and heat treatments of up to 300ºC, are currently available in 2ml and 10ml versions although Schott plans to roll-out a 6ml version later this year.

Azopharma Integrates Units, Expands Services

Azopharma Product Development Group has integrated its eight service divisions as part of an effort to streamline its approach to product development for small biotechs and large pharma alike, supporting both full development and specialty stand-alone projects.

The Azophrma Product Development Group — previously made up of Azopharma, APIcross, IQsynthesis, AniClin, Cyanta, ADMEQuant, AvivoClin, and Acromon — has been consolidated into three divisions: Azopharma Contract Pharmaceutical Services, AniClin Preclinical Services, and AvioClin Clinical Services.

Azopharma is focusing on its core services and has no acquisition plans for the near future. In the past year, Azopharma expanded despite the down economy, adding to its analytical services in Welwyn Garden City, UK and in Maryland Heights, MO, microdosing and central lab services to its pharmacology research facility in Daytona Beach FL, and more recently, new cytotoxic manufacturing suites for clinical trial materials at its (south Florida) Hollywood location.

Microdosing, a trend among pharmaceutical and regulatory agencies, allows companies to make “kill or carry” decisions with earlier pharmacokinetic and pharmacodynamic data in humans. In microdosing studies, drug substance is dosed sufficiently low not to have observable pharmacological activity, but to screen the ADME properties of several drug candidates. These studies have seen a big push from the FDA through its Critical Path initiative.

Cytotoxic compounds are becoming more prominent in the oncology drug realm. These compounds are difficult and dangerous to work with. With its three new manufacturing suites, equipment, and analytical instrumentation, the company is better positioned to support cytotoxic and highly potent compounds for development. Currently Azopharma is manufacturing two niche commercial products for clients: a cytotoxic product and a highly potent compound. With use of cytotoxics predicted to grow, the spokesman contended that the company is very interested in this smaller volume market.

Azopharma is also tapping into strategic partnerships. The group recently entered ones with Pharmanet to leverage complementary services through business development and co-promotion, and Immunregen, under which Azopharma provides development services in exchange for taking equity in the company.

Quay Pharma to Expand in 2010

Quay Pharma is investing nearly $4 million to move to a new purpose-designed factory and headquarters, allowing the company to greatly increase its development and clinical trial manufacturing capacities. The move is expected to create around 52 jobs in the next three years.

The new facility in North Wales, UK, is close to Quay Pharma’s existing premises in the Wirral, and brings together the company’s entire range of services — currently housed in two separate facilities — under one roof. The 40,400-sq.-ft. building, which is four times the size of its existing premises, will feature a variety of state-of-the-art equipment that will enable the company to meet increasing demand for its specialist capabilities, including formulation development, novel drug delivery design, analytical method development and clinical trial manufacture and packaging.

In particular, the expanded operation will provide the opportunity for the further development of Quay Pharma’s expertise in oral dosage form design and development, especially for new chemical entities that exhibit poor solubility and bio-availability, according to the company.

“Our extensive knowledge and experience can play a crucial role in the critical early stages of drug development and in recent years we have seen increasing demand for our services,” said Quay Pharma’s chief executive, Mike Rubinstein. “By creating this new advanced facility to our specific requirements, we will be able to offer an enhanced level of support to our clients.”

The move is planned for January 2010, and will be phased to ensure work on existing client projects is maintained throughout. The new facility is being part funded by a grant from the Welsh Authority Government.

Avantium, AMS Enter CSP Pact

Avantium, of The Netherlands, and Avant-garde Materials Simulations (AMS), of Germany, have entered into a collaboration for the further development and commercialization of Crystal Structure Prediction (CSP) with AMS’ GRACE software. Pharmaceutical companies can use CSP to predict the crystal structures of their drug compounds. CSP provides an essential approach to significantly reduce the risk of missing a more stable crystal form.

AMS will further develop the software to accelerate the calculations and broaden the range of compounds for which it can be used. AMS will also perform the predictions for third parties. Avantium will develop efficient experimental strategies to physically generate the predicted crystal forms and commercialize Crystal Structure Prediction as a stand-alone service or in combination with experimental programs.

CSP, as developed by AMS, is a breakthrough approach, showing for the first time that the reliable prediction of crystal forms is feasible. AMS in collaboration with the Institute of Pharmaceutical Innovation at the University of Bradford, UK, were the first participants ever to score a 4 out of 4 success rate at the 2007 CSP Blind Test.

“The scope of applicability and the accuracy of CSP will continue to improve rapidly,” said Marcus Neumann, managing director of AMS. “The next key challenge is to actually produce predicted but not yet observed forms by rational experiment design. With Avantium Pharma we have found the ideal partner to write the next chapter of the story.”

“The CSP technology is a great extension of our service portfolio,” remarked Guus Scheefhals, chief operating officer of Avantium Pharma. “The predictions will prevent overlooking the most stable crystal form, which will strengthen the IP position of our clients and will help to reduce the risk of crystal form inter-conversions in drug development.”

sigma-tau Group Acquires Enzon Specialty Pharma

Enzon Pharmaceuticals will sell its specialty pharmaceutical business, including its CMO operations, to the sigma-tau Group for $300 million plus an additional amount of up to $27 million based on success milestones. Enzon will also receive royalties of 5 to 10% on incremental net sales above a 2009 baseline amount from Enzon’s four marketed specialty pharmaceutical products through 2014.

Enzon’s specialty pharmaceutical business includes four marketed products: Oncaspar, Adagen, DepoCyt, and Abelcet, as well as the manufacturing facility in Indianapolis, IN which will be purchased by a U.S. subsidiary of Sigma-Tau Pharmaceuticals, Inc., based in MD. Sigma-Tau Pharmaceuticals will distribute the products in the U.S. market.

After the sale of these assets, Enzon’s businesses will consist of its royalties, Peg SN38 and our LNA and PEG technology platforms. “Enzon’s board is evaluating options to return most of the value of this sale to shareholders,” stated Alex Denner, chairman.

“sigma-tau is a great strategic fit for this business, as they have the presence and expertise to effectively market these products in all geographic areas,” said Jeffrey H. Buchalter, Enzon’s president and chief executive officer.

sigma-tau is a global R&D driven, Italian-owned pharmaceutical company dedicated, among other areas, to developing and commercializing medicines for rare diseases. This acquisition will expand sigma-tau’s current presence in the U.S. and in new therapeutic areas.

Marc Tewey, vice president, commercial operations of Sigma-Tau Pharamceuticals, confirmed that the company plans to continue the CMO business.

“sigma-tau is dedicated to providing novel therapeutics to patients suffering from rare diseases and other unmet medical needs,” said Claudio Cavazza, sigma-tau’s president. “Through the acquisition of Enzon’s specialty pharmaceutical business, we will increase our presence in the field of rare diseases with products of great value which are the result of an outstanding research activity. sigma-tau is determined to continue Enzon’s excellent work, especially in the field of rare diseases which is a particularly stimulating one as it aims at tackling life-threatening conditions which all too often affect the very young.”

Catalent, Endotis in Alliance

Catalent Pharma Solutions, Somerset, NJ, has entered into a strategic alliance with Endotis Pharma, Loos, France, for the development of oral formulations of synthetic oligosaccharides.

Using Catalent's drug delivery technologies, the two companies will collaborate exclusively to develop certain oral formulations of small-glycol drugs. Oral formulations of synthetic oligosaccharides will allow full exploitation of the therapeutic potential of small-glycol drugs, which to date are administered only intravenously or subcutaneously.

Catalent and Endotis are initially focusing on the preclinical development of Endotis' EP37151 compound. EP37151 is a first-in-class oral synthetic oligosaccharide anticoagulant which, as an indirect factor Xa inhibitor, acts via antithrombin activation. The companies expect to initiate a Phase I clinical trial program during the second quarter of 2010, and hope to have more oral anticoagulants enter development within the next year.

"This collaboration with Endotis, based upon a unique combination of complementary expertise, has been providing exciting results, proving that the various technical hurdles associated with the oral delivery of small-glycol drugs can be overcome," said Tom Stuart, group president of Catalent's Oral Technologies segment.

DSM, Galenix in Manufacturing Pact

DSM Pharmaceutical Products has entered a manufacturing alliance with Galenix of Saint Jean D'Illac, France, in which DSM will be the preferred commercial scale manufacturing partner for Galenix commercial products on a global basis.

DSM and Galenix will collaborate on business development opportunities co-marketing Galenix drug delivery technologies, based on the strength of Galenix in drug product development and clinical services and DSM in process development, scale up and commercial scale pharmaceutical manufacturing.

Pieter de Geus, DSM Pharmaceuticals' senior vice president, R&D stated, "These innovative drug delivery technologies enhance our offering in the field of pharmaceutical development services and complement our portfolio of drug delivery technologies. The collaboration with Galenix clearly demonstrates DSM's commitment to bringing improved drug delivery to markets globally."

Hans Engels, president of DSM Pharmaceuticals, added, "The alliance brings out the best of both parties. Combining innovative formulations with flawless transition into commercial products creates an attractive value proposition for any drug company."

Jerome Besse, chief executive officer of Galenix, commented, "This is truly a win-win situation. Galenix is privileged in working with DSM to generate value for our customers. The partnership fits with our strategic intention of expanding service offerings to the North America market, and also with DSM's expansion of sales & marketing focus in Europe."

No financial terms were disclosed.

Micromeritics and Surface Measurement Systems Announce Collaboration

Surface Measurement Systems Ltd., London, and Particulate Systems, a brand of Micromeritics Instrument Corp.,Norcross, GA, have signed a global strategic collaboration. The collaboration will draw on the combined knowledge and experience of both companies in the design and development of advanced analytical equipment for the characterization of particulate, porous, and complex materials. Working together, both companies will strengthen their ability to deliver customer-focused instrumentation solutions globally, according to a joint statement.

In the initial phase of this collaboration, Particulate Systems will have the exclusive distribution rights for key SMS products in selected regions of the U.S. as well as in South America, Central America, and the Middle East. These products include the DVS Dynamic Vapor Sorption systems that utilize dynamic gas flow and the gravimetric technique to produce high-resolution adsorption and desorption isotherms of water and organic vapors on essentially any solid material. In addition, SMS will extend its service and support for customers in the U.S. via the Particulate Systems’ extensive aftercare network. Particulate Systems will also have co-distribution rights to sell Surface Measurement Systems products in China.

Particulate Systems and SMS will begin organizing joint academic meetings, symposia, and other academic training programs to advance the development of particle and sorption technology starting in October 2009.

Preston Hendrix, president of Micromeritics, stated, “Collaboration between the two organizations enhances our ability to offer advanced analytical tools to guide research, resolve problems in production and QC, and to expand the understanding of material structure in general. Joining forces with SMS provides the customers of both companies’ additional options for solving their analytical needs.”

Dr. Daryl Williams, managing director and founder of SMS, added, “This new relationship builds on both a business and product synergy between our two companies which will allow us to provide total instrumentation solutions for many new research and development sectors.”

Drawing on Stelmi's experience as a specialist in rubber components for pharmaceutical primary packaging, the seminar will feature targeted presentations on the reduction of microbiological and particulate contamination in the production of rubber closures, with special emphasis on sterile components and visual quality.

Almac Adds Potent Containment Capabilities

Almac has the capability to process batch sizes ranging from 0.1Kg to 100Kg, manufacturing development, clinical & small-scale commercial solid, oral dose products.

Phase Forward Signs Multi-Year EDC Agreement with Quotient Clinical

Phase Forward has signed a multi-year agreement with Quotient Clinical to implement Phase Forward’s InForm Global Trial Management (GTM) electronic data capture (EDC) solution to support data collection, management and analysis for its clinical trials. Quotient Clinical will use Phase Forward’s Central Designer™ module to enhance eCRF design efficiency and improve workflow in the study development process for EDC trials.

“As an innovative provider of early drug development services, we want to ensure that our customers can take advantage of the benefits inherent in using EDC in Phase I trials, including access to high quality data within hours of collection, streamlined process efficiencies and rapid qualification of data,” said David Chalmers, Quotient’s vice president, Biometrics. “We selected InForm because of Phase Forward’s strong position in the marketplace and the company’s experience with Phase I trials.”

By supporting faster accessibility and greater visibility into trial data, the EDC implementation will help Quotient to expand its full-service, in-house Biometrics offering, according to the company. In addition, Quotient plans to offer customers on-line access to trial data, making it easier for them to track progress to date or to review summary reports.

“Quotient’s team is committed to continual expansion of its technical infrastructure to provide advanced services that help customers speed the development process,” said Steve Powell, senior vice president, Phase Forward. “The organization joins the growing number of CROs adopting our InForm product as part of a broader initiative to automate and streamline their Clinical Research Units.”

Vetter Adds U.S. Development Facility

Vetter will open Vetter Development Service (VDS), a technologically advanced customer service facility located in Chicago, IL. The site will allow the company to provide greater commitment and support toward the product needs of its North American customers, according to a Vetter statement. Vetter will be capable of aseptically filling very small quantities of products in the new facility, providing faster and more streamlined product delivery and customer service. Headquartered in Ravensburg, Germany, Vetter sees the new facility as a significant investment in Vetter Pharma International GmbH. The 25,000-sq.-ft. facility will open end of 2009.

With its new location in the heart of the U.S., Vetter can now process and test small quantities of materials by bringing the development process closer to key customers, enabling greater cooperation at the earliest stages of development and minimizing the need to transport products, according to the company.

The site is intended to facilitate a shorter time to market for Vetter's North American customers. Peter Soelkner, managing director at Vetter, remarked, “The opening of this new cutting-edge VDS facility shows Vetter’s firm, strategic commitment to the North American market by bringing the state-of-the-art technology to the heart of the U.S.,” said Peter Soelkner. “The support VDS delivers throughout the entire product development cycle can now start earlier, and the proximity to our customers will contribute to streamlining the process and delivering the final product faster.”

Toxikon Boosts Biologics Safety Program Services

Toxikon Corporation has expanded the offerings in its immunotoxicology department. To meet increased demand for biologics research, Toxikon has added flow cyctometry to its service offerings, which enables the direct analysis of cells to detect a variety of specifically labeled components.

Christopher Brynczka, Ph.D., head of immunotoxicology, clinical and histology services at Toxikon, remarked, “This is an opportunity for Toxikon to promote the development of our sponsors’ drugs and medical devices,” said Dr. Brynczka. “If there are findings related to immune function in other preclinical studies, a more extensive evaluation of immunotoxicology is often necessary.”

Immunotoxicology study designs examine the physiological functioning of the immune system and the impact treatment with a test article may have in normal function. “The flow cytometer is so powerful that you can detect virtually any entity or event that occurs within a cell,” said Dr. Brynczka.

A study published last fall by the Journal of the American Medical Association stated that almost 25% of biologic drugs approved in the U.S. and Europe since 1995 have been at the forefront of at least one safety-related regulatory action in the decade since initial market approval, while 11% of the biologic therapies within that one-quarter percentile have been issued a black box warning, the study revealed.

While all newly developed drugs carry risks, said a Toxikon statement, biologics are in a special class because they are derived from biological sources, including antibodies, enzymes and hormones.

The new equipment is just one of several additions Toxikon has added to its immunotoxicology department, offering everything from quantitation of splenic B and T cells to a full battery of host resistance models.

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