SGS Life Science Services has opened its newly renovated facility in Fairfield, NJ. The expansion has doubled the size of the facility from 15,000 sq.-ft. to 30,000 sq.-ft. and includes new lab space, expanded client accommodations, and new equipment.

The renovation includes new and modernized GMP/GLP compliant labs, increased ICH Zone 1 – 4 storage capacities, and expanded accommodations for client audits and planning sessions. Also, the company plans to invest in new equipment to broaden its service offering in extractables and leachables, as well as heavy metals testing.

John Pirro, general manager of the Fairfield site, said, “The facility has been designed to respond to the current and future needs of a changing bio/pharmaceutical environment. This investment will provide future capacity to service the growing needs of the bio/pharmaceutical market with expanded capabilities for stability and other project work.”

“The expansion at this site demonstrates our commitment to delivering excellent quality, the latest technology and best–in-class service to our customers to sustain long term partnerships,” said Anne Hays, executive vice president, SGS Life Science Services. “With outsourcing becoming an integral part of large multinational pharmaceutical companies’ strategies, we want to assure our clients that we can accommodate both their routine and complex bio/pharmaceutical analytical outsourcing needs, integrating the latest developments in regulatory compliance.”

SGS’s Life Science Services business unit provides analytical development, biologics characterization, biosafety and quality control release testing for the pharma, biopharma, medical device, chemical, and healthcare markets.

Phillips-Medisize to Expand

Phillips-Medisize Corporation has added cold chain storage to its existing capabilities. The new systems will be added to the company’s Menomonie, Wis., medical campus to support new business and future growth.

Cold chain storage regularly is used in the drug delivery and pharmaceutical markets to support life sciences products that require storage and handling between 2 and 8 degrees Celsius (35.6 and 46.4 degrees Fahrenheit). To complement this new capability, Phillips-Medisize has created an on-site analytical testing capability to perform incoming and final release batch testing (and the standard operating procedures to go with it). The new cold chain storage system reportedly will be able to hold temperatures constant to within positive/negative 0.5 degrees Celsius. The system also has redundant compressors and a full generator backup system.

“The addition of cold chain storage is a direct reflection of our continued focus on meeting our customers’ needs by investing in our facilities, processes, and people to continue to deliver quality, service, and innovation,” said company President and CEO Matt Jennings.

The U.S. Food and Drug Administration-registered Menomonie facility will need to expand to accommodate the new cold storage system. Phillips-Medisize plans a 25,000-square-foot expansion including a Class 8 clean room assembly space and infrastructure to support finished goods assembly and packaging of drug delivery and combination devices. Once the expansion is complete, the facility will have more than 200,000 square feet of purpose-built Class 7 and 8 clean room space, and also will have dedicated molding clean rooms, device assembly clean rooms, and drug handling and packaging clean rooms. The expansion is expected to be completed by April 2013.

Phillips-Medisize Corporation is based in Hudson, Wis., and offers services such as design development, prototyping and testing to the medical device sector.

Jackson Lab Expansion of Sacramento Facility

Jackson Laboratory said that it has begun a $27 million expansion of its Jax-West facility in Sacramento.

The expansion will enlarge the Jax-West mouse vivarium facility, which supplies genetically engineered mouse strains to West Coast research communities, from 115,000 square feet to 165,000 square feet, and will boost its staff from 132 to around 200.

Jackson Lab's headquarters in Bar Harbor, Me., handles orders for most of the rest of the US.

"To serve their role in research, these animals must be maintained and cared for in environments with limited bacterial and viral exposure," Jax Mice and Services Associate General Manager Kathy Vandergrift said in a statement.

Vandergrift also said that there are "significant biosecurity and redundancy benefits to balancing our production more evenly between our East and West Coast facilities. As our Sacramento facility expands, it enables us to distribute in an easterly direction over the Rockies and into the remainder of the United States."

CU-Boulder's Biotech Building Earns LEED Platinum Rating

The University of Colorado's biotechnology building has earned the highest possible rating for green construction, a feat that university officials are celebrating because of the difficulties in designing an eco-friendly research hub that also has complex safety requirements.

The Jennie Smoly Caruthers Biotechnology building, a 336,800-square-foot research and teaching complex, debuted last spring on the university's East Campus. CU officials announced that it has been designated with a Leadership in Energy and Environmental Design (LEED) platinum rating from the U.S. Green Building Council.

"When you take the size of the building and the complexity of the research equipment, it was a pretty tall order," said Moe Tabrizi, campus conservation officer.

Campus planners grouped the labs with similar functions near each other so they could share common lab equipment and maximize energy use. The building also has solar panels to help meet its energy needs. Other green features include energy-efficient freezer compressors and lab fume hoods, evaporative cooling and low-flow plumbing.

The building also has large windows to take advantage of natural daylight.

"That was a huge focus," Tabrizi said. "The folks who are doing research are spending extended hours in that building and we're able to reduce artificial lighting while giving them a sense of connection to the outside."

Overall, the building is 30 percent more energy and water efficient when compared to other buildings of similar size and function, according to CU.

It was important for CU to incorporate high-rated green features in the biotechnology building because research labs are five to seven times more energy intensive than other areas on campus, such as classrooms or offices, Tabrizi said. The features in the biotechnology building will help CU reduce its carbon footprint and save on energy bills.

The biotechnology building, located on Colorado Avenue and Foothills Parkway, houses more than 60 faculty and 500 researchers who are examining everything from cancer treatment to developing new biofuels.

The building is consistent with the Tuscan Vernacular, red-tiled roof architecture on the main campus.

"This project demonstrates that we can achieve a high-performing, technically complex facility that blends our Tuscan Vernacular -- or rural Italian -- style with the demands of cutting-edge, 21st century world-class research," said Paul Leef, campus architect, in a statement.

The building's designers took recommendations from Labs21, which is a program that aims to improve environmental performance of labs.

Swiss Pharmaceutical Roche Streamlining Its R&D

Swiss pharmaceutical Roche is streamlining its R&D activities, and most of the work was pegged to stream back to sites in Switzerland and Germany, and closure of its 1,000-employee site in Nutley, N.J., was part of the package. But so was the still-pending location of a pharmaceuticals translational clinical research center (TCRC) somewhere on the East Coast. After looking at some 50 sites, Roche last week announced it would bring 200 jobs to the new center at the Alexandria Center for Life Science – New York City, formerly known as East River Science Park.

The TCRC will be the mission-critical presence for Roche Pharma Research and Early Development in the United States. Located in the heart of the East Side Medical Corridor, the location provides Roche with critical adjacency to New York City's nine major academic medical centers and its numerous ongoing clinical trials. Roche has signed an 11-year lease and anticipates moving its TCRC team to the approximately 421,000-sq.-ft. (39,110-sq.-m.) West Tower of the Alexandria Center for Life Science, which is expected to be delivered during the fourth quarter of 2013. The company will be the anchor tenant of this new phase of the park's development, occupying approximately 60,000 sq. ft. (5,575 sq. m.) in the top two floors of the new tower.

"We looked at several great properties in New York and New Jersey and selected the Alexandria Center for Life Science for its unique location as well as the dynamic, vibrant, and thriving scientific atmosphere it offers," said Mike Burgess, M.D., acting global head, Roche Pharma Research and Early Development.

According to a release from the State of New York, Roche will invest $13 million in the project, and bring 235 jobs to the site by 2018. Empire State Development (ESD) has agreed to provide Roche with $6.6 million in tax credits from the Excelsior Jobs Program.

"We are honored that Roche, our longtime client tenant in the San Francisco Bay Area, has selected the thriving New York City life science cluster and the Alexandria Center for Life Science as its platform to substantially enhance its collaboration and translational efforts," said Joel S. Marcus, chairman, CEO and founder of Alexandria Real Estate Equities, Inc. "Roche's move is the latest in the trend of biopharmaceutical companies establishing a mission-critical presence in New York City in order to collaborate with the large concentration of first-class academic medical centers along the East Side Medical Corridor. A strategic presence in New York City enables more rapid translation of 'bench to bedside' therapies in key areas of oncology, neuroscience, cardiology, immunology, and virology with the result of substantially reducing the economic cost to society of these devastating illnesses."

Darien Wilson, director of public affairs for Roche, says the company's site search stretched from Boston as far south as D.C., with an original batch of 50 sites culled to 36 viable locations. Then it was down to two each in New Jersey and New York, followed by one site in each state. The New Jersey finalist was a new life sciences hub being developed in the New Brunswick area by a coalition including Rutgers University, Robert Wood Johnson Medical Center and others.

Roche's collaboration partners in the city include the Michael J. Fox Foundation, Columbia University, Memorial Sloan-Kettering, Mount Sinai School of Medicine and the Human Genome Center, with work ranging across therapeutic groups in virology, neuroscience and oncology.

Wilson says the work at the new center will not be research, but phase-one and phase-two development via clinical studies with patients. The East Coast scope of the site selection was defined in part by the wish to offer positions to existing personnel at the Nutley facility, she says, noting that 200 employees from Nutley will be transferring to the new center, but will continue to work from Nutley until the new facility is ready.

"Fifty will remain at a location in New Jersey for more corporate-related functions," she says, supporting both the translational work and the pharma business in the U.S. "We have not decided where they will be."

As for the 119-acre (48-hectare) Nutley campus, Wilson says Roche is soliciting bids from interested parties, and will work with a joint commission led by the mayors' offices in Nutley and Clifton, N.J., to find a suitable buyer and tenant for the site.

"We've gotten interest, but haven't moved on anything yet, as we're hoping to work with this joint commission," she says, adding that the campus will be fully owned and operated by Roche until that buyer is found.

The Alexandria Center for Life Science was developed by Alexandria in a strategic relationship with the City and State of New York. The first phase of development, which included the LEED-Gold Certified, 308,000-sq.-ft. (28,613-sq.-m.) East Tower, opened in late 2010 fully leased to a diverse selection of tenants including Eli Lilly and Co., whose wholly-owned subsidiary focused on oncology, ImClone Systems Incorporated, is headquartered in the building; Pfizer Inc.'s Centers for Therapeutic Innovation; New York University's Neuroscience Translational Research Institute; and Kadmon Corporation, LLC.

Silliker Opens New Solutions Center

Silliker’s new flagship food safety testing facility has opened its door in Illinois, as the company maintains its commitment to meet the food industry’s testing demands.

Johannes Burlin, President of Silliker North America, explained that awareness of food safety issues has increased for industry because of regulations like the Food Safety and Modernization Act (FSMA).

Safety is also increasingly in the public domain as more and more issues bubble over, he said, with the most recent example being concerns over arsenic in rice.

According to figures from the Center for Disease Control and Prevention, an estimated 48m people become ill as a result of foodborne illness each year, about 128,000 are hospitalized, and 3,000 die.

Consumers and the industry/regulators view food safety differently, said Burlin. For consumers, food safety is associated with a particular food or product. It is driven by recalls, he explained. For the industry, food safety is a matter of process, a matter of quality systems.

To meet the industry’s testing demands, Silliker celebrated the grand opening of its flagship laboratory for North America. The 71,000 square-foot facility in Crete, IL, will be home to about 200 employees eventually.

Construction on the $14 million dollar facility was completed in August 2012 and utilized advanced workflow design to maximize efficiency and to minimize any potential for contamination.

Burlin added that the company follows a central lab model built around centers of excellence. “We believe [the new Solutions Center] it’s the largest lab in the US dedicated to food safety,” he added.

The food industry is globalizing rapidly and the company’s business model is to provide ‘one Silliker’, he said. All of its services follow the same SoPs, the same quality systems, and this allows them to provide more services for our international customers.

“An important aspect for us is that we have a very good understanding of food, and we understand the matrix.”

According to the company, the Silliker Solution Center includes:

Expanded analytical chemistry capabilities
Advanced Nutritional Chemistry testing for composition and nutritional labeling
Increased profile of chemistry testing methods for current and emerging chemical contaminants
State-of-the-art microbiology testing and serology expertise
Enhanced capabilities for contract research programs including shelf life and challenge studies.

Philippe Sans, president and CEO, Mérieux NutriSciences said the new center is consistent with the company’s global strategic plan to provide the highest level of service from operations based on the latest technologies and instrumentation, combined with a dedicated team focused on operational excellence.

Catalent Biologics Facility Moves

Catalent Pharma Solutions announced its plans to expand its manufacturing capabilities in December 2011. It currently operates from a 43,000ft2 facility in Middleton, Wisconsin, US. Under the expansion plan, Catalent will relocate its operations to a 100,000ft2 facility in Madison, Wisconsin.

Construction of the new facility is expected to be completed by the end of 2012 with full operations commencing in 2013. It will quadruple Catalent's manufacturing capabilities and help generate innovative biologic products.

Catalent is expected to invest $29m in leasing and equipping the facility. It will receive $1m in job creation and job training tax credits from the state. The company is expected to hire 60 people for the new facility.

Catalent's Middleton facility is equipped with biopharmaceutical development and mammalian cell line engineering capabilities. It is also capable of carrying out protein production for clinical phase I-II trials.

The facility uses the patented GPEx (Gene Expression) technology used for producing stable mammalian cell lines. The technology enables current Good Manufacturing Practice (cGMP) production of biopharmaceuticals.

The Middleton facility also includes development laboratories and space for research and development and QC. It includes cGMP manufacturing suites featuring stirred tank bioreactors.

The facility was ideal during the initial growth stages of the company in the early 2000s. It is, however, aging and its size placed constraints on Catalent's bioprocess capabilities. Relocation was considered as the best solution to address these issues.

Relocation to Madison is part of several strategic initiatives being undertaken by Catalent to improve its product offerings. Increase in demand for cell-line engineering was one of the main reasons for the decision to relocate.

"The new facility will feature significant upgrades to Catalent's current process and manufacturing capabilities."In 2010, contracts requiring use of the GPEx technology doubled and are growing by nearly 20% every year. Competition is also increasing in contract manufacturing of biologics. Companies such as ShangPharma, Lonza and DSM are expanding their offerings in the field.

The increase in demand for Catalent's products and manufacturing capabilities, as well as competition from other companies, resulted in a need for more space and a robust infrastructure. The additional capacity provided by the new facility will help Catalent's customers bring their products to the market faster.

Catalent also recently partnered with Toyobo Biologics to increase its product offering in biologics.

The Madison facility was originally built in 2000 for the production of bone-scanning medical devices. It was later operated by GE Healthcare. Catalent will retrofit the facility to its standards.

The new facility will feature significant upgrades to Catalent's current process and manufacturing capabilities. It will help in optimizing its unidirectional process flow to increase production capacity. The facility will be equipped with three separate cGMP compliant production suites.

The Middleton facility currently uses 200l stainless steel bioreactors. The new facility will shift to the use of single-use bioreactors with capacity ranging from 50 to 100l. This will increase Catalent's production capacity for Phase I and II clinical trials.

Single-use bioreactors will help increase the number of batches produced. They will provide Catalent with greater flexibility in terms of cleaning and change-over. This flexibility will prove essential in an environment where Catalent has to work on different proteins supplied by several customers.

The increased capacity from stainless steel bioreactors will help Catalent to scale up its manufacturing capabilities according to customer requirements.

Catalent has already installed one single-use bioreactor at the Middleton facility. This will enable employees to familiarize themselves with the system.

The new facility will help in increasing the efficiency and output of the GPEx technology. It uses retrovector technology which enables transduction of targeted cells with accuracy. Any kind of complementary DNA can be targeted using the technology to generate a mammalian cell line of customer's choice.

The technology enables generation of stable mammalian cell lines in 4.5 months compared to 18 months using conventional technologies. It is more efficient and reduces expenses by halving development time.

UCSF Robotic Pharmacy

The University of California San Francisco (UCSF) has built an automated hospital pharmacy at its new medical centre at Mission Bay, San Francisco. The system is capable of dispensing medication automatically. It utilizes robotic technology to prepare and track medications.

The under-the-radar pharmacy system was introduced in March 2011 and to-date nearly 350,000 doses of oral and injectable medications were prepared without error.

UCSF believes the system will achieve the goal of improving patient safety and increasing the medical centre's efficiency. It plans to build robotic pharmacies at all of its branches.

The Mission Bay pharmacy currently dispenses medications to UCSF's hospitals at Parnassus Heights and Mount Zion in San Francisco. It will also dispense medications to a new hospital that UCSF plans to open at Mission Bay in 2014.

The Mission Bay facility is the second such state-of-art pharmacy in the world. The first is located at Cedars-Sinai medical centre in Los Angeles.

"The University of California San Francisco has built an automated hospital pharmacy at its new medical centre at Mission Bay, San Francisco. "UCSF initially planned to upgrade and renovate its existing pharmacy with an investment of $24 million. It later decided to develop a new robotic pharmacy for $15 million, not including the full automation cost.

The automated hospital pharmacy relies on a hub of automated robots to distribute medicine to patients. It enables UCSF to research various ways of dispensing medicine and relieves nurses and pharmacists from regular manual tasks. UCSF is able to train clinical pharmacists to focus on patients rather than drugs.

The pharmacists and nurses also get more time to discuss suitable drugs for a patient with physicians. This enables closer care and monitoring of patients.

Studies indicate that barcoding, computerized physician entry and development in medication-management reduce errors significantly.

The robotic pharmacy uses the pill-pick system to separate batches of pills into individual doses. The collected pills are bagged and stored. Pill-pick is a modular system with connected devices that automatically produce unit dose medicaments. The automated warehouse, where the dose medicaments are stored, is always ready to provide personalized therapy to patients.

"The under-the-radar pharmacy system was introduced in March 2011 and to-date nearly 350,000 doses of oral and injectable medications were prepared without error. "The physicians of UCSF send orders to the system electronically. The robotic system then picks the packages and dispenses the individual doses of pills. The system dispenses more than 10,000 doses per day.

The packed doses of the pills required by a patient are tied together on a plastic ring and barcoded for a 12-hour period. The nurses confirm the right medication for the patients through the bar code readers. The system also keeps record of the medication stock available in the pharmacy.

Three RIVA (Robotic IV Automation) robots fill doses of liquid medication into IV syringes and bags. The robots work in a protected germ-free environment where there is a less chance of the medication getting contaminated. The pharmacists also don't handle the drugs, so there is less risk of the medication being mixed.

Human pharmacists were appointed to check the work of robots. Once the phase-in is fully operational, the human intervention will be eliminated and doctors will start prescribing medicines directly through computers.

Switzerland-based Swisslog has developed the pill-pick robots for UCSF's medical centre.

Intelligent Hospital Systems, a medical device company has prepared the RIVA robots for dispensing doses of liquid medication.

Dome Construction constructed the robotic pharmacy building.

The robotic pharmacy has been awarded with LEED CI Gold certification for its sustainable building practices.

UCSF’s robotic pharmacy uses automated robotic technology to prepare and track medications.
The robotic pharmacy uses Swisslog’s system to bag and store individual doses.
The pill-pick robot is a modular system with connected devices that automatically produce and store unit dose medicaments.
The pharmacy's robotic system stores medicaments at the automated warehouse.
The UCSF robotic pharmacy uses three RIVA robots from Intelligent Hospital Systems.
The automated pharmacy relieves nurses and pharmacists from regular manual tasks.

Neurosciences Research Building, Indiana University, Indianapolis

Construction of a new neurosciences research building at Indiana University (IU) was initiated in August 2012, and is scheduled to be completed by 2014. It is located near 16th Street and Senate Avenue, near the IU Health Methodist Hospital. It is being developed jointly by Indiana University School of Medicine and Indiana University Health.

The facility will focus on expanding and strengthening the biomedical and life sciences research capabilities of the university. It will be also used for conducting a wide range of research in fields such as neurotrauma, addiction, epilepsy, dementias and pain.

Following the Indiana General Assembly's approval of the project, the Indiana state budget committee gave approval to the University for going ahead with construction, in April 2011.

"The Indiana state budget committee gave approval to the University for going ahead with construction, in April 2011."The new research building for neurosciences at the Indiana University will have a total floor space of 138,000 square feet.

It will provide enhanced research facilities for neuroscientists from numerous fields, such as psychiatry, neurology, neurosurgery, rehabilitation, radiology and pathology. The aim of the project is to provide patients with the best neurological care.

The facility will be connected to the 270,000 square feet ambulatory care and imaging centre, being built by the IU Health Neuroscience Centre with an estimated investment of more than $100m. The imaging centre is expected to be completed by the end of 2012.

The two facilities together will create a hub of expertise in neurosciences for researchers, doctors, patients and future physicians.

The space in the neurosciences research building will be allocated to interdisciplinary research teams for a flexible research with a disease oriented focus, rather than assigning the space on the basis of traditional academic departments.

"The two facilities together will create a hub of expertise in neurosciences for researchers, doctors, patients and future physicians. "The facility will welcome neuroscientists across the world from various disciplines, such as neurology, neurosurgery, psychiatry, rehabilitation, pathology and radiology. The cluster of multi-disciplines in one place will result in bringing fundamental advances in the research against various nervous diseases, such as Alzheimer's, spinal cord injuries, addiction and psychoses.

The research building will provide sophisticated and world class laboratory research spaces and facilities to the IU School of Medicine's scientists, the Stark Neurosciences Research Institute and those from the Institute of Psychiatric Research.

The Institute of Psychiatric Research will be the primary occupant of the building. It focuses on developing treatment for psychiatric disorders such as addictions, schizophrenia, anxiety, mood disorders, autism and Alzheimer's disease.

The Stark Neurosciences Research Institute focuses on applying advances in molecular, genetic and imaging technologies. Part of the institute will be relocated to the new research building. It will initiate collaborative research in the building through shared technical support and centralized analytical facilities. The institute aims to achieve these through flexibility in adapting to changes in programs and funding, and maximizing the performance of scientific instruments.

The neuroscience building at Indiana University broke ground for construction in August 2012. It is expected to be completed by 2014.

The exterior of the building will feature an efficient skin, composed mainly of glass. The interior of the building will be flexible so as to adapt to changes, and will have abundant natural light and other fundamental facilities. The building will follow a theme consistent with the entire neuroscience campus.

The research building was designed by BSA LifeStructures. The structural engineering support for the project is provided by TRC WorldWide Engineering. HKS Maregatti Interiors is the interior designer. Messer Construction was appointed as the general contractor and construction manager for the project.

The total investment for the construction of the facility is estimated at about $53m. The State of Indiana contributes about $43m through the issuance of bonds. The Indiana University and IU School of Medicine are contributing $5m each towards the project.

John and Editha Kapoor Hall, University at Buffalo

John and Editha Kapoor Hall is located on the south campus of the University at Buffalo in New York, United States. It houses the School of Pharmacy and Pharmaceutical Sciences of the university. It was built with an investment of $62m and replaces the former Acheson Hall chemistry building on the university campus.

The 147,000 square feet facility will mainly focus on research and development in the pharmaceutical sciences. It will provide education programs to pharmaceutical students, pharmacists and patients.

The location of the hall unites the pharmacy school with other health sciences schools of the university. It will revitalize the south campus of the university, which has been vacant for several years. More than 600 faculty, staff and students will occupy the building.

"It was built with an investment of $62m and replaces the former Acheson Hall chemistry building on the university campus. "Construction of the new facility is part of the UB 2020 strategic plan to expand the university and increase its economical impact on the region from $1.7bn to $3.6bn. A major part of this plan is the improvement of the north, south and downtown campuses of the university.

The John and Editha Kapoor Hall is the third major project being undertaken at the university. Other projects include Kaleida Health's Global Vascular Institute, the Clinical and Translational Research Centre and the Biosciences Incubator.

The project marks the first time a school has moved from the north campus in Amherst to the south campus. The university has already upgraded the campus, by adding new roofs, steam tunnels, electric systems, sidewalks and roadways.

It is also planning to renovate the Townsend, Wende and Kimball halls.

The facility is named after the alumni of the university, Dr. John Kapoor, and his wife, Editha Kapoor. Dr. John Kapoor received a scholarship from the university, which allowed him to complete his Ph.D.

In an act of thanks for the university's generosity, Dr. Kapoor made a donation of $10.8m to the School of Pharmacy. About $5m of this donation is being used towards construction of the facility.

The university received another $46m from the State of New York. The remaining project cost was met through funds raised from private donors and other sources.

John and Editha Kapoor hall was designed by architects, The S/L/A/M Collaborative. The architects were asked to transform the Acheson Hall, which has been unoccupied since 1994, into a facility that would support both pharmaceutical education and pharmaceutical research.

"Construction of the new facility is part of the UB 2020 strategic plan to expand the university and increase its economical impact."The facility is spread across four floors. The first and second floors include two lecture halls and two classrooms, a pharmaceutical care learning centre, a patient assessment suite and a model pharmacy. They also include meeting and study areas, computer labs, gathering areas, offices, conference rooms and a coffee shop.

The third and fourth floors form the main research hub of the school. They include educational labs, specialized pharmaceutical research labs, classrooms, conference rooms, lounges and offices.

The pharmaceutical research labs have facilities for sample processing, analytical research, molecular genetics, microbiology, bioinformatics, tissue culture, liquid chromatography-mass spectrometry and protein therapeutics.

They can also be used to process BSL3 cultures and radioactive samples. They have a semi-open design, which encourages collaboration between the researchers and reduces infrastructure by centralizing common facilities.

The former Acheson Hall was demolished to allow for the construction of the new facility. The demolition was completed in the summer of 2009. Groundbreaking for the new facility took place in September 2009. Construction was completed in May 2012 with the School of Pharmacy and Pharmaceutical Sciences moving into the facility.

The new facility has been designed with several environmentally sustainable features to gain LEED silver certification. The building materials resulting from the demolition of the Acheson Hall were reused for the construction. Certified woods and low emitting materials have been included in the building.

To improve the energy efficiency of the facility, water efficient plumbing, enhanced room temperature controls and air handling systems have been used. The design of the building allows natural daylight throughout the interiors.

Captek Increases Production

California-based Captek Softgel International, Inc. (CSI) has increased its softgel production capacity by up to 40% as the company responds to increased demand from the market.

Dave Wood, Captek CEO, said that the increase is due to dual factors: An increase in demand for the softgel dosage form as well as an increase in demand for more sophisticated products, such as multi-ingredients formulations and difficult-to-formulate products, that Captek specializes in.

“Many of our new opportunities are coming from established brands who are finding their current manufacturer does not align with their Quality Promise conveyed to their brand customers. Or their existing provider does not support their comfort level towards product failure or product recall risk.

“Our emphasis on building out our capacity at a very high level of GMP and regulatory compliance has made Captek a more attractive partner.”

The increase has been attained by successfully implementing a 24/7 production schedule. After gaining employee approval by majority vote, the production shifts were adjusted to support continuous manufacturing.

“In addition to the obvious creation of increased labor hours through expanded work shifts, continual manufacturing achieved when converting our operations to a 24/7 production operation allows Captek to complete a job once started without interruption on the encapsulation line,” explained Wood. “Supporting functional areas such as Quality Assurance, Quality Control, and R&D have also been expanded.”

It is also an example of Captek’s new ownership commitment towards heavy investment into its growth and business success, said Wood.

Since acquiring Captek in March 2011, the equity partners are said to have spent over $2 million in capital improvements.

Wood added that customers are seeking paste products at a certain quality level.

“With the growing trend toward ‘condition-specific’ formulations and the generalized health benefits of many natural food oils, we are seeing an increased interest in combination formulas that require a mixture of powdered materials with oils.

“Product formulations consisting of ‘multi-actives’ can pose a challenge for softgel manufacturers due to the potential for fill to gelatin shell interactions or not achieving proper suspension of the powdered ingredients within the formula matrix.”

Captek is headquartered in Cerritos, California.

SGS Opens Newly Expanded NJ Facility

Jubilant HollisterStier Launches Analytical Services

Jubilant HollisterStier’s contract manufacturing and services division, a subsidiary of Jubilant Life Sciences, has launched an analytical services unit that will provide lab method development and related analytical testing as part of its service offerings. The company will offer a full suite of testing capabilities, including raw materials testing, release testing, microbiology testing, laboratory method development and validation, impurities testing and stability testing and storage. These services will be available through its facilities in Spokane, WA, and Montreal, Quebec.

Marcelo Morales, chief executive officer, Jubilant HollisterStier, commented, “The launch of our analytical services offerings is a continuation of our strategy to be a leading provider of services to the Life Sciences industry. We are expanding our analytical capabilities to support a wide array of high-quality laboratory tests, aimed at further servicing our clients and partners.”

Cedarburg Hauser Doubles API Production Capacity

Cedarburg Hauser Pharmaceuticals (CHP) has doubled its API plant in a bid to meet client demand.

The factory in Grafton, Wisconsin, now houses a 100l Teflon reactor and a low-temperature chiller allowing it to perform cryogenic reactions. The expansion also includes a 500 gallon reactor, a reverse osmosis water system and an upgrade for its digital automation system.

Spokesman Bob Forner said: “The 500 gallon reactor significantly increases our capacity and gives us flexibility in our manufacturing plant. The 100L Teflon lined reactor and low-temperature chiller allow us to run reactions at -80°C, and also allows for corrosive reactions not able to be run in glass or metal.”

He said the plant – which currently makes steroids, prostaglandins, vitamin D analogs and compounds that are conjugated to polymers or peptides – will now work with potent and cytotoxic compounds. The target clients will be pharma firms throughout the product lifecycle, from clinical trials through to generics.

“More specifically, we have filed drug master files (DMFs) with the FDA for a schedule II opioid, fentanyl, two steroids, exemestane and oxandralone, and a prostaglandin, travoprost, among other compounds. We are also manufacturing a number of APIs at various clinical stages,” Forner added.

Cedarburg said the move was a result of increased demand for contract API manufacturing services.

Forner said the recent “boom” of cytotoxic and potent oncology drugs is one of the biggest reasons for the uptick.

He also told us many Western manufacturers are heading home for their ingredients after a “varied experience” with international low-cost manufacturers. And with new US Food and Drug Administration legislation over foreign inspection, the company believes this trend is on the rise.

“New provisions in Prescription Drug User Fee Act (PDUFA) 5 allowing the FDA to collect user fees for generic drugs will also require the FDA to inspect foreign manufacturing facilities every two years rather than every five years,” he said. “We expect this to have a positive impact on our generic API business.”

According to CEO Tony Laughrey, this expansion will not be the first in the near future. He said: “We will continue to invest in our business as we strive to be the premier contract API manufacturer.”

Forner said however that growing the product portfolio and increasing staffing levels will be the most immediate developments.

“Over the next year Cedarburg Hauser will look to build our business with a product portfolio of generic and new chemical entity products,” he said. “We also have plans to continue expansion through capital expenditure, as well as 15 to 20 operators, engineers and scientists over the next 12 months.”

Cambridge Major Adds Significant Capacity at US Site

Following continued growth in demand for larger scale Active Pharmaceutical Ingredient (API) manufacturing services, Cambridge Major Laboratories (CML) is announcing a significant expansion of its large scale API manufacturing facility in Germantown, Wisconsin. The expansion comes only three years after commissioning the new state-of-the-art facility, further validating CML’s business model of focused investment in US-based assets.

“We are very pleased to report that our faith in the “invest in the West” policy initiated a few years ago continues to bear fruit,” commented Brian Scanlan, President & CEO. “CML is very well positioned to support both increasing demand for our commercial products as well as our healthy pipeline of API’s in later phases of clinical development. By making these new investments, we show our commitment to support our loyal client base at the most critical point, when quality and timely delivery are imperative.”

The expansion will include significant additional reactor capacity as well as isolation equipment. Alongside capacity additions, CML has made additional investments in engineering controls to ensure the sustainability of the business. “Our Environmental, Health, and Safety commitments underpin all operations, and we have invested further containment capabilities with engineering controls across production trains. Additional containment capabilities will also be introduced into our European facility later this year,” added Scanlan.

Following the commissioning of the large scale API facility in 2009, CML has more recently invested in other supporting areas of the business, such as Solid State services and an expanded analytical offering. “CML is committed to becoming the long-term partner of choice for complex API development projects”, commented Roger McDonald, European Business Development Director. “Even clients in Phase I have the comfort of knowing they can potentially stay with us through product launch – plan for success!”

Pall Sets Up Systems with Avacta

Pall has opened a life science services center to allow drug makers to test its filtration, processing and purification technologies.

The new ‘center of excellence’ - in Westborough, Massachusetts – is intended to be a ‘proving ground’ at which Pall’s customers can assess the various single-use systems (SUS), tangential flow filtration (TFF) technologies, viral clearance and cell culture solutions, and chromatography systems the firm makes. The site will also act as a staff training location for Pall.

Ken Frank, president of Pall BioPharmaceuticals, said: “It will complement our new center in Menlo Park, California and serve as a technical hub for our Life Sciences business and operations in the northeast region of the United States.”

Pall’s systems business is in need of a shop window as sales have suffered of late. Earlier this month the firm reported that revenue from processing technologies was down 22 per cent for the fiscal fourth quarter.

At the time CEO Larry Kingsley said: "System sales were negative in the quarter as a function of a very large comparison quarter in FY11, our decision to pare certain unprofitable system sales, and lower capital commitment in some markets."

This continued the pattern seen in the third quarter when systems sales fell 60 per cent, though this was largely put down to the team dealing with problems at its then-new enterprise resource planning unit (ERP).

In other news, Pall announced that it has signed its third distribution deal with diagnotiscti tech firm Avacta.

Under the new agreement, the companies will sell and distribute Avacta's drug development tool "Optim" in India. The firms have sold the system in North America and South East Asia since 2011.

Pall has exclusive marketing and distribution rights to Optim in South Korea, Australia, New Zealand and Singapore where another of its centers of excellence is based.

Commenting on the deal Frank said: “This extension of our collaboration with Avacta in India complements our ForteBio technology and other initiatives, while adding to Pall's capability to provide high value, differentiated solutions to the developers and manufacturers of biomolecules for global healthcare needs."

Chicago Biotech Grows

Chicago's biomedical research industry finally may be putting on some weight.

Two university lab complexes, which together would employ hundreds of medical scientists, are nearing construction. They would complement a 34,000-square-foot facility at the Illinois Institute of Technology completed in mid-2011, where 80 scientists now work, and research space under construction at the University of Chicago within a massive hospital pavilion scheduled to open in February and a separate research center slated for a 2015 debut.

But the halting paths that these new centers are following help explain why Chicago lags behind smaller metro areas such as San Francisco, San Diego and Boston in biotech.

The just-funded research facility at the University of Illinois at Chicago, scheduled to open in 2015 in the Illinois Medical District on the West Side, was promised by the Legislature 10 years ago. Meanwhile, Northwestern University's plans to triple its lab space could be set back—or even dropped—if the city sides with preservationists and prevents it from razing the now-vacant Prentice Women's Hospital to make room for a new 1.2 million-square-foot structure in Streeterville.

While Chicago's biotech industry has “a lot going for us,” other states are outspending Illinois, says David Miller, chief executive officer of the Chicago-based Illinois Biotechnology Industry Organization. Massachusetts, for instance, has committed to spend $100 million a year on life sciences. “We're in a good position because of what we did in the past, but that position is eroding,” Mr. Miller says. One big reason is the state's massive debt load, which siphons funds from other uses.

Though biotech research often is promoted for its humanitarian benefits, its mercantile effects typically are more immediate and important. Government and private funding can pay faculty salaries and buy cutting-edge equipment. That, in turn, often boosts the quantity and quality of applications from instructors, researchers and students. The combination works to lift a school's reputation, creating a positive feedback loop.

In addition to saving lives, medical breakthroughs can create revenue streams, too. UIC's drug to treat HIV, Prezista, generated $14 million in royalties in fiscal 2012. Northwestern pocketed $575 million in 2007 from selling part of the rights to pain reliever Lyrica to New York-based Royalty Pharma in 2007.

Northwestern ranks 18th in medical research in the latest U.S. News & World Report tally. Rex Chisholm, vice dean of scientific affairs and graduate students at Northwestern's Feinberg School of Medicine, says the university's showing is good, but “we aspire to be at the very top.” To that end, it has pledged to spend $1 billion over the next decade on a biomedical facility that would house up to 300 more researchers, adding to its research staff headcount of about 4,000 at Feinberg.

With a new complex, Mr. Chisholm says, “I'm going to get better students; I'm able to do better research because I've got better talent.”

UIC is looking to invest $104 million on a 145,000-square-foot facility that will bring 81 new research jobs to campus. The university has more than 300 now, including adjunct and emeritus faculty. The state will underwrite $64 million of the expenses, after agreeing this year to come through with funds that were appropriated in 2002 but never released. The Advanced Chemical Technology Building would open as soon as 2015, the same year Northwestern hopes to debut its labs.

The decade-long delay in funding has hurt, says Lon Kaufman, UIC's vice chancellor for academic affairs and provost. “Have there been some areas we've not been able to explore? Surely,” he says. “There are situations where we went after certain faculty and were not able to attract them because we didn't have the facilities.”

As a result, UIC places 62nd in the country in medical research and 71st in biological science in the U.S. News ranking.

By comparison, U of C, which seems to be adding biomed research space every other year, ranks 10th in medical research. Half of the 10 floors at the medical school's new 1.2 million-square-foot hospital pavilion will be used for clinical research while the 265,000-square-foot William Eckhardt Research Center will house the Institute for Molecular Engineering.

IIT, which ranks 57th, according to U.S. News, finished renovating its engineering research building last year at a cost of $4.5 million, and the South Side university is in the early stage of raising money for at least one more research facility. “You can't in this day and age show a potential faculty member a dumpy space and expect them to come,” says David Mogul, interim chairman of the biomedical engineering department.

Teleflex Medical OEM Completes Expansion

Teleflex Medical OEM, a subsidiary of Teleflex Inc., marked the completion of the renovation and expansion of its facility in Jaffrey, NH with a ribbon cutting ceremony.

Teleflex Medical OEM provides custom extrusion services, interventional catheters and other medical devices. The company headquarters are located in Research Triangle Park, N.C.

Increased domestic and international demand for Teleflex Medical OEM’s brand of custom extrusions, catheters, and medical devices led to the need for increased capacity, company officials report. The multi-million dollar expansion adds 10,000 square feet to the Jaffrey facility, which includes additional research and development facilities and a larger, state-of-the-art extrusion center.

“This investment in the Jaffrey facility enhances Teleflex Medical OEM’s ability to incorporate our industry-leading innovations into the global marketplace, and accommodate our customers’ needs for technologically-advanced medical devices and custom-engineered extrusions,” said Greg Forrest, General Manager.

Teleflex Medical OEM anticipates an additional 25 new positions at the Jaffrey facility over the next several years. Currently, 318 people are employed at that location.

J&J Starting 4 Early Research Collaboration Hubs

Johnson & Johnson says it will set up four regional "innovation centers" in life sciences hotspots around the world to speed up early research.

The New Brunswick, N.J., health care giant wants to increase collaboration and investment across its businesses: prescription drugs, consumer health products and medical devices and diagnostic equipment.

Scientists, entrepreneurs and startup companies will get one-stop access to J&J technology and science experts, who can facilitate collaborations with the company's businesses.

The centers will be Boston, London, China and California, with that one including campuses in San Diego and San Francisco. They're expected to begin operating in the coming months.

Many drugmakers increasingly are doing collaborations like this, particularly with university researchers. That's because their own scientists haven't been creating enough new drugs to replace billion-dollar blockbusters getting generic competition.

Expansion for Charles River

Charles River has opened a new US biomedical diagnostic facility in a bid to boost its drug discovery and pharmacology business.

The plant – a 60,000 sq. ft. factory based in Wilmington, Massachusetts – will provide services in research model health monitoring, clinical chemistry, haematology, biomarker assay development and immunoassay services.

The facility will work with a range of biomaterials, including proteins, genes, metabolites, and cellular and microbial endpoints.

General manager of research animal diagnostic services Lisa White said that though there are some similar services on the market, it is the facilities “lean” design and broad range of services – from assay design and development to data analysis – which makes it special.

“The facility and operations are designed for lean operations including physical attributes; high-throughput, controlled environments, building monitoring and mechanical systems redundancy to provide an energy and space saving environment,” she said. “This allows us to provide high-throughput, cost effective assay determinations.

“We are a one-stop shop for all types of studies ranging from genetic models to therapeutic profiling.”

White added that the services would be targeted at both biopharmaceutical and academic clients.

In a statement, president and CEO James Foster also indicated the expansion makes room for further growth in research and development (R&D) services.

“Our new facility provides Charles River with additional capacity for growth, as well as the capability to utilize innovative technology platforms to advance the high-quality R&D services we provide our clients,” he said.

White also told us that the firm strongly believes molecular markers is key in the drug discovery field as researchers move from the age of “serendipitous” findings to “deterministic profiling.”

She said: “We are at an exciting time in biology and medicine that combines new platforms and informatics technologies to identify, and validate new biomarkers that help us unravel many unmet medical needs. Charles River is dedicated to be a partner in moving these new therapies forward.”

CSL Wins U.S. Government Contract

CSL Biotherapies, a subsidiary of CSL Ltd., has been awarded a contract by the U.S. Department of Health and Human Services to supply pre-pandemic and pandemic vaccine antigens and related services for the U.S. stockpile. The contract has a maximum potential value of $1.5 billion if all options are exercised under the contract.

CSL Biotherapies may manufacture and store bulk antigen for influenza strains with pandemic potential, as well as develop working virus 'seeds' for other manufacturers and to formulate, fill and finish bulk stored antigen.

"We are very pleased to again be working with the U.S. government on its pandemic preparedness efforts," said Dr. John Anderson, senior vice president of CSL Biotherapies. "CSL Biotherapies is committed to helping to protect the American public against the potential impact of an influenza pandemic. We are proud to contribute our 45 years of successful influenza vaccine manufacturing experience to the U.S. National Strategy for Pandemic Influenza."

ICON Expands Bioanalytical Labs

ICON has expanded its U.S. and UK bioanalytical facilities for biomarker and cell-based assay services. The company increased its bioanalytical labs in Whitesboro, NY and Manchester, UK, by 7,000 and 4,000 sq. ft., respectively. The expansions house dedicated immunoassay labs at each facility for biomarker testing and cell-based assays.

“We have expanded our bioanalytical facilities to provide the necessary scale to support the ever-broadening range of testing services required by our sponsors,” said Brian O’Dwyer, senior vice president of Global Bioanalytical Services, ICON Development Solutions. “In particular, the expansion of our dedicated biomarker testing laboratories allows us to support biomarker development programs across multiple testing platforms globally.”

Xcelience Opens New Drug Development Facility in Tampa

Xcelience LLC has announced the grand opening of a new 24,000 sq. ft. facility, located south of the Tampa airport.

The building will be dedicated to primary and secondary packaging, labeling, distribution and warehouse services. Xcelience serves national and international clients in the biotech and pharmaceutical industries, offering cGMP services from pre-formulation and formulation through clinical manufacturing and clinical supplies for phase I-III clinical trials. This is the company's second facility in the Tampa Bay area, and it will be audited and approved for domestic as well as European clinical trials.

The expansion also promises to open the door to more highly skilled jobs for the Tampa Bay Area. “At Xcelience, we work on several dozens of molecules, each of which has the potential to radically improve people's lives,” says Derek Hennecke, CEO and President. “We love being in Tampa, because through USF, UF and Tampa's growing biotech community, we have access to scientists at the height of their field. We don't have to go far to find people who thrive on the challenge of working with different molecules, upholding rigorous FDA standards while also demonstrating the agility to meet client parameters for speed, cost and efficiency.”

Xcelience has doubled its staff over the past three years and will soon be celebrating the hiring of the company's 100^th employee. The new plant will enable Xcelience to double its headcount again over the next three years.

AROUND THE WORLD

Symbiosis Opens New Plant

Symbiosis has opened a new sterile manufacturing facility in Scotland for production of both pharma and biopharma products.

The plant, in Stirling, will produce small scale injectable sterile liquids, lyophilized, cytotoxic and biological drugs for Phase I and II for clinical trial drug supply. It will also handle related services such as fill & finish, packaging and storage.

Small molecule drugs make up a large proportion of planned production, however Mackay told us that with a growing focus on bio drugs – for instance peptides, proteins, DNA – it will also handle biologics.

The company says the move – along with its recently granted MHRA (Medicines and Healthcare products Regulatory Agency) license allowing it to work with clients globally – will allow it to target the EU and US markets in particular.

Colin MacKay, founder and CEO, said “Our objective is to actively and aggressively drive down the amount of highly valuable drug development time.”

Of the type of client Symbiosis will aim its new services at, MacKay said any pharma or biopharma looking for a quick turnaround is a target.

He said the plant is “cross-recognized by the US Food and Drug Administration (FDA), combined with a unique operational infrastructure to enable Symbiosis to deliver its manufacturing services to its clients in the shortest timeframe that the industry has seen.”

Though the firm are willing to accept short-term contracts, he added, long-term relationships are the end goal. Current long-term clients include Zealand Pharma and Encap Drug Delivery.

In a statement, the contract manufacturing organization (CMO) boasted a build-time of just months for the facility, “achieving a timeline never seen before in the industry”.

MacKay told us the feat was achieved because of its management team’s experience in the biotech industry, as well as a novel design initiative in which the firm asked potential clients how the facility should be shaped.

“The full detailed design of the facility was completed prior to the completion of the investment needed for the ‘build phase’ to begin which permitted fast progress to be made. Post-investment, the facility was built, qualified and MHRA licensed in less than 12 months,” he said.

When asked if the unusually quick completion of the facility meant Symbiosis had cut corners, MacKay replied: “Of course we are aware of those kinds of comments being made in our industry wherever the traditional approach to building a facility has been employed.

“Our approach meant we did not need to cut corners. We comprehensively designed the facility in a way which included carefully specifying materials and equipment along with agreeing realistically achievable timelines with our carefully chosen contractors in advance.”

BASF to Build Biocatalysis Line in India

BASF will add a catalyst production line at its largest facility in India to cater for growing demand from the country's API manufacturing sector.

The catalyst production line - the German chemicals giant's first catalyst production capacity in the Asia Pacific region - will be installed at a facility in Mangalore and is expected to be operational by the end of June next year.

Hans-Peter Neumann, senior VP of process catalysis at BASF, said: "This expansion will allow us to cost effectively increase our manufacturing footprint and production capacity, leveraging a existing BASF facility to enhance our proximity to customers in the Asia Pacific region."

This was echoed by Prasad Chandran - chairman of BASF in India - who said that: "By introducing a new production line for precious metal-based fine chemical catalysts in India, we will expand our offerings to meet the needs of local pharmaceutical producers."

Once the expansion is complete the Mangalore site will become BASF's third catalyst site behind existing plants in Rome, Italy and Seneca, South Carolina.

While it has operated there for many decades BASF redoubled its efforts to build its presence in Asia Pacific since 2007 when it identified the region as a key opportunity in its 2020 growth plan

At the time BASF's head of operations in Asia - Martin Brudermuller - said: "Local innovation and local production are driving business growth in the region," adding that "we therefore want to develop new applications, products and solutions...adapted for Asian needs and then serve local markets."

In the years since BASF has invested in manufacturing capacity in China, joined new excipients group IPEC India and found a new distributor for drug and food excipients in New Zealand and Australia .

More recently the firm has reiterated its plans to conduct more R&D in Asia in an effort to do at least 50 per cent of its development work in emerging pharmaceutical hubs within a decade.

Novasep to Invest in API Production Plant

Novasep plans to build the ‘world’s largest’ chromatography-based API production plant with backing from the French government, banks and gas firm Total.

The Pompey-based processing and manufacturing tech firm announced the €30m ($23m) investment plan at drug industry CPhI in Madrid, explaining the new facility at its site in Mourenx in the south-west of the country should be operational in the next 18 months.

Novasep said the project – which has received financial and logistic support from local authorities, Total and French innovation group OSEO – was motivated by a ‘sharp increase’ in projected demand for large volume API orders according to CEO Patrick Glaser.

“Demand for Novasep’s advanced purification-based manufacturing capabilities in the life sciences industry continues to increase as drugs in development and reaching the market become more complex and specific.”

Key technologies will include Novasep’s Varicol continuous chromatography systems combined with a solvent collection system that Novasep claims will allow it to produce large batches of active pharmaceutical ingredients (API) with 99.9 per cent recovery efficiency.

Novasep hinted it would invest in API production capacity in March, when it said that €40m ($53m) to spend on expansion projects after completing a €310m refinancing round that involved France’s strategic investment fund – the Fonds Stratégique d'Investissement (FSI) – and investment group Azulis.

Novasep also added a new 2,000m2 production plant at its facility in Shanghai China, again citing demand for APIs – as well production used by the food industry – as important drivers for the investment.

More recently the firm said it would invest €3m to add extra high potency API production capacity specifically focused on the production of antibody-drug conjugates at its facility in Le Mans, France.

Novo Nordisk Invests in Chinese Facility

As the first multinational company to open a research center in China in 1997, Novo Nordisk has reaffirmed its long-term commitment to the country by investing an additional $100 million to expand its state-of-the-art science facilities in Beijing.

The 12,000m2 (129,120 sq. ft.) center will make it possible to increase the number of science employees from the current 130 to 200, with extra space available to accommodate additional future growth. With this expansion, Novo Nordisk also fulfils its key strategic objective to ensure the full range of protein research capabilities in China.

“We see the investment in this new R&D facility as a win-win opportunity for both Novo Nordisk and China. Novo Nordisk recognizes the strong science being performed in China and we want to bring innovation from Chinese scientists into our company to help tackle the growing burden of diabetes and other chronic diseases throughout the world,” says Mads Krogsgaard Thomsen, chief science officer and executive vice president, Novo Nordisk.

The site in Beijing has already contributed significantly to the company’s research and development portfolio in both diabetes and biopharmaceutical target disease areas. The expanded facility will enable even stronger contributions from the science team in China across the range of Novo Nordisk’s protein technology, biology and pharmacology research activities.

U of Dundee Plans Translational Research Center

The University of Dundee in Scotland has received £12 million ($19.2 million) from the UK Research Partnership Investment Fund to complete its Centre for Translational and Interdisciplinary Research.

The new CTIR will add 5,200 square meters (55,952 sq. ft.) of additional space to the University of Dundee's College of Life Sciences. It will double the capacity of the Drug Discovery Unit and create a Centre for Quantitative Proteomics that integrates expertise in cell biology, mass spectrometry, proteomics, and "big data" analytics, the university said.

"The project provides an exciting opportunity to bring different disciplines together, allowing contributions of scientists from a number of different fields, each bringing their expertise to bear on aspects of the larger, systems-level problems relating to biology and drug discovery and drug design," Michael Ferguson, dean of research in the College of Life Sciences, said in a statement.

In addition to the funding from the UKRPIF, the Centre has received funding in excess of £26 million from The Wellcome Trust, GlaxoSmithKline, Medicines for Malaria Venture, TPP Global development Ltd., and Global Alliance for Livestock Veterinary Medicines. The Centre previously brought in £12.5 million in investments from the University of Dundee, The Wellcome-Wolfson Capital Award Programme, The Scottish Funding Council, Scottish Enterprise, the Biological and Biotechnology Research Council and several local charitable trusts.

According to the University of Dundee, the CTIR will add 180 new research jobs once it is fully occupied. Construction on the facility is expected to finish in autumn 2013.

Almac Completes Commercial API Facility

Almac’s expansion of its API manufacturing facility at its European Headquarters in Craigavon, UK has been completed and will be operational by the end of the year. The expansion includes the installation of two 1,000L reactors and pressure filter dryer, which allows production of GMP API to 150kg batch size.

“Almac’s investment has further demonstrated our goal of being the outsourcing partner of choice through all stages of clinical development,” said Denis Geffroy, vice president of business development. “We are delighted to have the scale to share the manufacturing journey with our clients from preclinical phase to full commercialization.”

The expansion allows clients to leverage Almac’s API and drug product offering at the same site, allowing technology transfer of small molecule and peptide projects from lab development to large-scale manufacture.

Sanofi to Acquire Genfar of Colombia

Sanofi is to acquire Genfar, a manufacturer of generics, over the counter and prescription drugs headquartered in Bogota, Colombia, for an undisclosed sum.

The French drugmaker says the transaction will make it a market leader in Colombia and expand its portfolio of affordable pharmaceuticals in Latin America.

‘With the acquisition of Genfar, Sanofi has a unique opportunity to strengthen its presence in Latin America through a large portfolio of affordable pharmaceuticals in a broad range of markets in the Andean countries and Central America,’ said Heraldo Marchezini, senior vice president, Latin America at Sanofi.

The closing of the transaction is subject to certain conditions and is expected in the first quarter of 2013.

Genfar, established in 1967, is now the second largest generic company in sales and leader in units in Colombia and has a commercial presence in Venezuela, Peru, Ecuador and ten other countries in Latin America. In 2011, Genfar’s total sales were US$133m, with 30% of sales generated outside Colombia.

Sanofi says Genfar is ‘an excellent strategic fit’ supporting the firm’s emerging markets strategy. It allows it to accelerate its diversification in the Andean Region and complements its portfolio in the region, including Medley, in Brazil.

The addition of Genfar’s animal health products to Merial’s portfolio will also expand Sanofi’s animal health footprint in the region.

AstraZeneca’s has New Manufacturing Facility, Taizhou, China

AstraZeneca began construction on a new manufacturing facility at Taizhou in Jiangsu province of China in January 2012. The facility will manufacture intravenous and oral solid medicines for the Chinese market. It is expected to be completed by the end of 2013.

The new plant is located at China Medical City (CMC) in Taizhou city. CMC is the national-level hi-tech development zone, which is sanctioned and sponsored by the State Food and Drug Administration (SFDA), Ministry of Science and Technology, Ministry of Health, Jiangsu Provincial Government and State Administration of Traditional Chinese Medicine. It focuses on the biomedical field.

The project, which was announced in October 2011, is the single largest investment made by AstraZeneca to date. It involves an estimated investment of $230m and is expected to create about 600 jobs.

"The facility will manufacture intravenous and oral solid medicines for the Chinese market."The plant will enable the company to meet increasing demand for its products in China. It will also expand the availability of its products to about 900 million people in the urban and rural communities, which traditionally had limited access to established medicines.

The company will adopt a multi-channel approach for selling its products in rural areas. It plans to establish an inbound and outbound call centre for reaching out to healthcare professionals.

The new facility will free up some capacity at the company's existing manufacturing facility located in Wuxi, which can be utilized for developing new products in future. It will also enable the company to produce more affordable new medicines for Chinese patients.

The facility will help AstraZeneca to deliver innovative drugs to the Chinese healthcare market. It will produce AstraZeneca's own branded generics as well as the generic brand of drugs of other companies.

The AstraZeneca manufacturing facility at CMC is situated in a 9.2ha site, with a built-up area of about 51,000m² (548,959ft²) and two main production areas. The two key production areas will include a sterile dry powder filling centre for injectable cephalosporin products, and an oral solid-dosage products centre.

The fit-out of the production areas will be completed in two phases.

Cockram was awarded with a contract to provide procurement and construction management services for the plant. The scope of the contract includes offering construction services for two years with a 40-member professional construction crew.

Astra Zeneca is a global biopharmaceutical company headquartered in London. It produces innovative medicines for millions of people across the world with its operations spread over 100 countries.

"The project, which was announced in October 2011, is the single largest investment made by AstraZeneca to date." AstraZeneca established its presence in China in 1993. It currently has more than 5,000 staff working in China and Hong Kong facilities. The main drugs manufactured by the company in China include Losec, Betaloc, Plendil, Nexium, Crestor, Symbicort, and Iressa.

In December 2011, AstraZeneca acquired Guangdong BeiKang Pharmaceutical Company, a Chinese generics manufacturing company, to enter the Chinese market for injectable medicines used to treat infections.

The pharmaceutical market of China grew from $10bn in 2004 to more than $41bn in 2010. It is expected to cross over $100bn by 2015. AstraZeneca's expansion in the country bodes well given the high growth potential of the country for pharmaceuticals business.

Aspen Expanding in Dublin

Generic pharmaceutical company Aspen has announced its decision to make Dublin its centre of excellence for a range of global and EMEA activities and to create an additional 44 high quality jobs bringing its total workforce in Ireland to 58.

The company first established an operation in Ireland in 2010 and this has now become Aspen’s European marketing and supply chain headquarters. In addition, the company is now establishing a global regulatory, pharmacovigilance, quality assurance and supply projects centre of excellence in Citywest.

Aspen is one of the largest generic global pharmaceutical companies and the largest producer of anti-retroviral (HIV) drugs in South Africa.

“Ireland provides for us a workforce with the specialized skills we require and a strong regulatory and business environment,” said Aspen group chief executive, Stephen Saad. “I would like to thank the Irish Government and IDA Ireland for their support and look forward to the future development of Aspen in Ireland."

“Aspen’s decision to locate this operation here adds to Ireland’s cluster of life science companies and will add to our reputation as a leading centre for this sector,” said Barry O’Leary, CEO of IDA Ireland. “A key member of this cluster in Ireland is GlaxoSmithKline which owns a 20pc share of Aspen.

“Ireland offers South Africa’s largest pharmaceutical company a strategic location from which to support its ongoing expansion and grow its sales across Europe.”

“Pharmaceuticals is a major sector of strength for Ireland, with nine out of the top ten global companies located here,” said Minister Bruton. “However a key part of the Government’s plan for jobs and growth is targeting the areas of growth within what is a changing sector – in particular, generics. Today’s announcement that Aspen, one of the world’s leading generic pharmaceutical companies is expanding its operations here is very welcome news.”

UBICHEM Group Acquires New Manufacturing Site

At the beginning this summer UBICHEM Group, based in Budapest, Hungary, acquired a new manufacturing site. UBICHEM Pharma Manufacturing will be producing starting materials, intermediates and other fine chemical products for pharma and non-pharma applications in industrial quantities.

‘Feedback from our customers and partners made it obvious that there is a growing need for high quality and strict deadlines in the market for starting materials and intermediates,’ explained CEO József Répási. ‘We wanted to exploit our competitive advantage in these areas over Chinese and Indian manufacturers.’

The acquisition will support UBICHEM Group in enhancing its portfolio. From now on the company will be able to provide a comprehensive range of services from process R&D through pilot-scale cGMP API manufacture to high-volume manufacturing.

‘On the other hand we can use our resources more effectively, which means faster response times and competitive prices for our customers,’ added Répási. ‘In addition, by applying the rigorous quality control and strict production guidelines we have had in place at UBICHEM Pharma Services since 1996, we are able to ensure the high quality of the intermediates and fine chemical products at our new manufacturing site.’

SMEs are considered to be flexible, adaptive organizations, he believes, and they are able to compete with multinational companies because they provide flexible response to customer needs.

Alphora Research Provides API Technology Development Services

Alphora is pleased to announce the completion of a GMP Kilo Laboratory, for the scale-up high potency, cytoctoxic compounds with occupational exposure limits (OEL’s) of 10μg/m3 or less. This expansion is a continuation of Alphora’s 2011 capital program that included a separate R&D suite with isolator containment, along with other additions to Headcount, R&D, Analytical Services and Warehousing. This investment continues to reinforce Alphora’s experience for developing High Potency API’s and is being driven by growing client demand and a general industry pipeline trends.

The Kilo Laboratory is designed to handle Class 4 high potency active pharmaceutical ingredients (HPAPI’s). It is equipped with glove box technology for operating and isolating reactions to the 50L scale. The facility also employs pressure lock entryways and dedicated HEPA filtered air handling systems suitable for class 100,000 use.

Alphora provides API technology development services to the Pharmaceutical and Biotechnology industry that include process chemistry, analytical development and validation services as well as GMP scale-up capabilities to the Pilot Plant scale. These services cover both early stage projects, where speed and quality are important, and later stage projects, where process economics and commercialization is important. As well, Alphora provides niche commercial manufacturing and has conducted validation efforts in advance of market launch.

Founded in 2003 by Dr. Jan Oudenes, Alphora Research is staffed by 100 employees, operates FDA inspected and approved operations that total 45,000 sq. ft. which include synthetic laboratories, analytical laboratories, GMP Kilo Laboratories, GMP Pilot Plant, GMP stability studies and supporting QC/QA.

Alphora’s services include process/analytical development and validation, cGMP synthesis, stability testing, HPAPI, and a separate facility for cytotoxic work.

Wickham Laboratories Moves

Wickham Laboratories is one of the UK’s leading contract analytical laboratories with an exceptional international reputation, specializing in microbiology and toxicology testing. Significant investment has been made into the company and resources, which saw the successful completion of the relocation and expansion of the business to a new facility in 2012.

Our staff of 90 plus personnel conducts analysis of pharmaceutical and medical device products for batch release into European and international markets. Wickham Laboratories is inspected by MHRA, audited by FDA and all tests are offered to comply with harmonized methods of PhEur, USP and JP.

Our range of microbiology testing services includes routine quality control, method development and validation of products. We also specialize in disinfectant efficacy and log reduction testing, whether for cleaning agents or in novel wound dressing applications (novel drug delivery systems).

Our microbiology team also assists a significant number of pharmaceutical and medical device customers with sterility testing, cytotoxicity and BET. Sterility testing operates within a cleanroom complex finished to the highest standards and boasts accommodation suitable for a number of isolator units complete with ballasted pass-through autoclaves.

Wickham Laboratories also offers toxicology safety testing. Designed to bespoke specifications, this unit carries out safety testing based on small-animal models, which include biological testing for quality control of existing products, new formula registration and new medicines research.

SAFC Expands Capacity in Scotland

SAFC will add powder media manufacturing capabilities at its plant in Irvine in a move supported by the Scottish Government.

The new manufacturing capacity – which is expected to create operational 24 new jobs – will allow SAFC to produce bespoke dry powder culture media for industrial biomanufacturing applications.

SAFC said the additional capabilities will support existing European biopharmaceutical customers by providing an additional back-up source. At present, the US firm only produces powder medias at its plant in Lenexa, Kansas.

The project is being supported by a £1.5m ($2.4m) grant from Government body Enterprise Scotland, which also gave SAFC $260,000 (€201,362) in 2009 to support efforts to upgrade the plant’s liquid media production and handling capabilities.

A Scottish Enterprise spokesman said: "The site is already recognized as a centre of excellence for its liquid manufacturing capabilities and the new dry powdered handling facility at Sigma will allow the company to manufacture cell culture media in dry powder form, making it easier and cheaper for the transportation to customers across Europe."

The decision to invest in biomanufacturing media capacity is in keeping with recent SAFC efforts to win business in the biologics sector.

Archie Cullen, Sales VP, said: “Biological drugs have really come to the fore in the last 15 or 20 years and now we are beginning to see the drugs that reach the market first come off patent…now we are seeing a number of organizations develop biolosimilar versions of these drugs that will challenges and compete with the existing products.”

He added that this demand – coupled with the need for cheaper manufacturing options for biologics – is driving the growth of the biomanufacturing market and SAFC's investment strategy.

This was underlined by the CEO of SAFC’s parent company Sigma Aldrich Rakesh Sachdev in January this year when the firm acquired biologics testing services company BioReliance.

Sachdev said: “As the market continues its focus on biological drug development, our leadership in this area should enable us to build even better more customer-specific solutions.”

Industry expert Jan Ramakers of Jan Ramakers Fine Chemical Consulting Group agreed with the analysis, telling in-Pharmatechnologist.com that: “Expanding the plant will give SAFC better inroads into ‘supporting materials’ for biopharmaceuticals… it looks like they want to have sufficient capacity and capability ahead of the growing biopharma business.”

“In the coming years more biosimilars will appear on the market as the first biopharmaceuticals start going off patent. That will no doubt lead to larger volumes being produced at lower prices so I can imagine the market for sera, buffers, etc getting a boost from that.”

The Irvine expansion plan is also in keeping with SAFC’s growing importance for Sigma Aldrich as a revenue generator.

In July , growth of the fine chemicals unit was cited was one of few positives in Q2 by Sigma, which saw falling demand for its R&D products and services as customers delayed development projects and reduced capital investments.

Johnson & Johnson Expands Puerto Rico Factories

Johnson & Johnson is expanding operations in Puerto Rico. The company and the governor of the U.S. island territory jointly announced an expansion of four existing plants that will add 308 jobs. A Johnson & Johnson spokesman said the company based in New Brunswick, New Jersey would invest up to $225 million to add capacity at two plants in the towns of Gurabo and one each in Manati and San Lorenzo. Spokesman Steve Dnistrian said three plants are part of its Janssen pharmaceutical division. The other is part of the medical device division.

Manufacturing is the largest component of the Puerto Rican economy but has declined in recent years. The island has an unemployment rate of 13.5 percent, higher than any U.S. state.

Alchem Ups Production

Alchem International has expanded its sennosides production facility in India in a bid to meet pharma demand.

The firm – which makes the natural laxative product using its own cultivated senna leaves and pods – will up its production to more than 75 tons per year.

A spokesman at the facility in Neemrana, India, said the move was a result of high demand for sennosides from drugmakers in the U.S. and Europe.

The company said its high good manufacturing practice (GMP) compliance and regular customer audits have driven demand for its production in particular, which creates 60 per cent purity USP (United States Pharmacopoeia) grade sennosides.

“Over the years, as regulatory focus on sennosides has increased globally, a need for high quality, regulatory compliant, drug master file (DMF) supported sennosides has emerged from the United States and Europe. In addition the aging population in these countries has also led to an increase in the volume requirements,” the spokesman said.

As part of the expansion, the firm has made the switch from batch to continuous production, and has installed computer controlled manufacturing equipment.

“For this reason many instrumentation engineers, statistical analysts have been included in our team of engineers, chemists and quality staff,” the spokesman added.

The firm also recently opened a new U.S. liasons office, and has established a local stock of the product, in a bid to help the supply chain and grow business with US customers.

In a statement, president of Alchem Raman Mehta said: "With our long-time North American distributor, Ampak in New York, and our recently opened U.S. liaison office, we're able to better serve our North American customers by offering local inventory of sennosides and technical support.”

NAMSA Opens Office in China

Medical device research organization NAMSA has opened its newest office in Shanghai, China. The company is headquartered in Northwood, Ohio.

The new office is intended to provide NAMSA’s China-based clients with convenient access to its services, as well as increased efficiency. Company officials hope the Shanghai office will allow NAMSA to better support Chinese manufacturers in meeting European and U.S. regulatory requirements. Additionally, the company also is better positioned to assist device manufacturers outside China to meet the necessary standards for marketing products in China.

“This expansion benefits all of NAMSA’s current and potential clients,” said An Liu, general manager of NAMSA China. “Chinese manufacturers can trust in our proven ability to successfully support meeting European and U.S. regulatory requirements, while those manufacturers outside China aiming to distribute products within China can rely on our expertise and proximity for convenient assistance in meeting the country's regulatory demands.”

In his new role, Liu is responsible for establishing and developing NAMSA China business. He previously served as director of biostatistics and data management for NAMSA. Before joining the organization, Liu served as statistics manager for Medtronic Inc.

“NAMSA is pleased to be in a position to expand and better serve our partners with world-class expertise in regulatory, non-clinical and clinical research services,” said Terence Langenderfer, director of global marketing, NAMSA. “It has always been our intention to provide the best strategic guidance and tactical support in the most cost-effective and seamless manner. This expansion in China supports that mission.”

NAMSA is a global contract research organization that provides regulatory, clinical, and compliance services to medical device and healthcare product manufacturers.

Helix Medical Opens Costa Rica Facility

Helix Medical, LLC, a global manufacturer for the medical device and healthcare industries, celebrates the grand opening of its newest medical manufacturing facility located in the Coyol Free Zone and Business Park in Alajuela, Costa Rica, just outside of San José. The Coyol Free Zone is considered the largest and most modern high-tech business park in Central America, located 10 minutes from the international airport and 1½ hours from the port.

Helix Medical supplies contract manufacturing services to medical device OEMs worldwide. This facility is the company’s ninth operation and the first in Latin America. Services offered at the Costa Rica facility include design and development, engineering services, silicone extrusion, silicone and thermoplastic molding, assembly and subassembly, custom packaging, and full validation capabilities.

The company’s inauguration event was hosted by Costa Rica minister of science and technology, Alejandro Cruz; CINDE´s investment director, Irving Soto; president and CEO of Helix Medical, Jorg Schneewind; and the managing partner of Freudenberg & Co., Martin Stark. “We are honored to have Minister Cruz and many other business and community leaders here with us today to celebrate the grand opening of our new facility,” said Schneewind. “The pro-business environment, skilled workforce, and strategic location made Costa Rica a natural choice for our company.”

“We are very pleased that Helix Medical has decided to open a manufacturing facility in our country. This confirms Costa Rica´s high standards of quality and its sophisticated workforce, which allow medical companies to perform complex manufacturing,” said Cruz. Soto added, “We are deeply satisfied with the investment of renowned medical companies such as Helix, which contribute to the growth and consolidation of the Life Sciences sector. This sector has grown from eight companies in 2000 to 41 companies in 2011; multinational ventures have created employment for 13,561 Costa Ricans. This number is six times higher than in 2000, when only 1,500 people worked in the sector.”

Helix Medical, a division of the Freudenberg Group, manufactures in California, Massachusetts, Costa Rica, Germany, Ireland, and China. The company’s operates FDA-registered medical device facilities, certified ISO 13485 with Class 7 and 8 cleanrooms.

Onyx to Expand Capabilities

Chemistry Cro expert Onyx Scientific has announced a collaboration with a purification specialist that will see the company broaden its offering to the global pharmaceutical and biotech industry.

The contract manufacturing organization (CMO) has struck-up a strategic alliance with UK-based Reach Separations, which will allow it to deliver more specialist purification and separation services to bolster its early stage development services.

As part of the deal, Onyx Scientific will be now able to offer custom separation for companies in drug discovery and intermediate environments. This includes chiral, reverse phase and normal phase chromatography using Supercritical Fluid Chromatography (SFC) and High Performance Liquid Chromatography (HPLC).

With MHRA and FDA licensed facilities in the UK and India, Onyx Scientific supports pharmaceutical and biotech companies from medicinal chemistry and preclinical through Phase I-III, scaling-up to large scale commercial API production.

Denise Bowser, commercial director at Onyx Scientific, said: “We were very impressed with the major equipment investment at Reach Separations and the team’s exceptional knowledge in understanding our clients’ challenges in small scale purification.

“Given this is an area that we have limited expertise and one that clients look to outsource, it made perfect sense for us to plug the gap and complement our existing services by working with Reach Separations.

“We expect this strategic partnership will play an important role in giving our clients quicker access to these types of services but with the added benefit of knowing it will be managed by us as part of the overall project,” added Denise.

Reach Separations is located in BioCity in Nottingham, which is one of Europe’s largest bioscience incubators that currently hosts over 70 companies and has a rich heritage in drug discovery.

The company’s technical group is led by purification specialist and Technical Director Phil Abbott. He has worked in the pharmaceutical industry for almost 20 years, including several years at AstraZeneca as a Separation Science Group Leader.

He said: “We are delighted to be working alongside Onyx Scientific given the company’s fine reputation in contract medicinal chemistry, scale-up and manufacturing for the world’s drug development industry.

“We have strong experience in the pharmaceutical outsourcing sector so understand the challenges and issues clients face. Our role will be to bring our expertise to the table and work as part of the Onyx team to ensure clients’ requirements are always met and timelines never exceeded.”

Working as a preferred partner of many of the world’s top pharma firms, Onyx Scientific’s UK labs in North East England deal with complex chemical services and deliver early stage programs involving custom synthesis, lead optimization, chemical process development, solid-state chemistry and GMP synthesis. It is then able to scale-up, internally tech transfer and provide increased efficiency for clients from its commercial manufacturing sites in India.

Hospira to Acquire Facilities

Hospira, Inc., the world's leading provider of injectable drugs and infusion technologies, announced an agreement for Hospira to acquire an active pharmaceutical ingredient (API) manufacturing facility, together with an associated research and development (R&D) facility, from Orchid Chemicals & Pharmaceuticals Ltd., a leading Indian pharmaceuticals company, for approximately $200 million. Acquisition of the modern, U.S. Food and Drug Administration (FDA)-approved facility is expected to reduce Hospira's costs, support continuity of supply of key antibiotic products and pave the way for future API development.

"Our decision to acquire Orchid's world-class API facility demonstrates Hospira's continued dedication to the antibiotics space, enhancing cost-competitiveness and ensuring continuity of supply," said Dr. C. Bhaktavatsala Rao, managing director, Hospira India. "This is a top-of-the-line API manufacturing facility that has been recognized by industry leaders for its high standards. We look forward to welcoming our new colleagues from Orchid and leveraging their expertise to continue to bring high quality, lower-cost products to patients around the world."

The proposed acquisition, which follows Hospira's 2010 purchase of Orchid's generic injectable finished-dosage form pharmaceuticals business, will enable Hospira to vertically integrate into certain critical beta-lactam antibiotic APIs (penems and penicillins), and is also expected to improve Hospira's standard cost position in this therapeutic space. In addition, controlling the source of these beta-lactam APIs will improve the company's security of supply. Orchid will retain its cephalosporin API business and facilities, and will continue to supply Hospira with this associated API.

The Aurangabad, India, facility, staffed by approximately 640 employees including chemists, engineers and technicians, received the International Society of Pharmaceutical Engineering's (ISPE) Facility of the Year Award for Regional Excellence in 2009. Constructed in 2000, the facility includes 50,000 square meters of space. Hospira's purchase also includes an associated Orchid R&D facility based in Chennai that will be primarily directed to beta-lactam and other APIs with approximately 160 scientific personnel and an additional 30 employees supporting the facilities.

Beta-lactam antibiotics represent a class of drugs with a wide spectrum of antibacterial activity. Hospira's imipenem-cilastatin and meropenem injectable beta-lactams have both had successful introductions recently in a number of markets, including Europe and the United States, and today command leading market positions.

The transaction has been unanimously approved by Hospira's and Orchid's boards of directors. It is subject to Orchid's shareholders', regulatory and legal approvals, as well as customary closing conditions. Assuming all necessary approvals are secured, the transaction is expected to be completed in the fourth quarter of 2012. To help facilitate the transition process, the two companies will enter into transitional services agreements of various lengths.

The transaction is expected to be breakeven to slightly accretive to earnings per share (EPS) in the first year post close, excluding the impact of transaction-related expenses, such as purchase accounting charges, integration costs, and the amortization of intangible assets.

Hospira, Inc. is the world's leading provider of injectable drugs and infusion technologies. Through its broad, integrated portfolio, Hospira is uniquely positioned to Advance Wellness™ by improving patient and caregiver safety while reducing healthcare costs. The company is headquartered in Lake Forest, Ill., and has approximately 15,000 employees.

Takeda Plans New Plant

Takeda has opened a new $96m (€75m) pharma facility in Russia as part of its bid to “outgrow” the already thriving local market.

The 79,000 sq. ft. in Yaroslavl will be capable of both solid dose production – from weighing and mixing, to compression, coating, and packaging – as well as liquid sterile production such as solution preparation, sterilization, filling and packaging.

When the plant is up to full production, expected in 2014, the firm says it will produce around 90m sterile ampoules and over two billion tablets per year. Initially, it will produce generics including cardiomagnyl, actovegin and calcium tablets to meet “Russian demand”.

The plant is the Japanese firm’s first new establishment in the area - it has existing operations following its recent Nycomed takeover - however according to CEO Yasuchika Hasegawa it is just early days for Takeda in its bid to dominate the Russian market. The Yaroslavl facility already makes it the seventh largest drug producer in the country, with 2012's revenues projected at €620m.

Tobias Cottmann, senior director of external communications said, "The plant has a solid business case, which is based on the high demand for the company’s biggest products in Russia. It will allow it to better serve the Russian market through local production and demonstrates Takeda’s strategic, long-term commitment to the Middle East and Russia."

As for the firm's next steps, Cottmann told us it is on the lookout for "bolt-on" purchases especially in emerging markets.

"We are open to complementary, bolt-on opportunities that make strategic sense, focusing on emerging markets such as our recent acquisition of Multilab in Brazil," he said, adding that Takeda will not look for any more big "Nycomed" sized deals at this time.

But though all emerging markets - which make up around 13 per cent of total sales, boosted significantly since Nycomed joined the portfolio – are of interest to the company, Cottman maintained that Russia will be the key focus and that the firm plans to beat growth estimates for the pharma production industry in the region.

In a statement, the firm quoted an IMS Health report which marked a $14.7bn Russian pharma market in 2011, and predicted an 11 per cent growth annually up until 2016. The statement said: “Takeda plans to outstrip that with annual growth of 15 per cent over the same period.”

Hasegawa added: "Russia is our largest emerging market in terms of revenues, and is expected to contribute significantly to our growth over the next few years. The Yaroslavl facility will enable us to provide locally produced pharmaceutical products to patients and clinicians, as well as bringing significant benefits to the Yaroslavl and Russian economy."

Takeda is said to be the first major player to set up big operations in Russia. Governor of the Yaroslavl Region Sergey Yastrebov said: "Takeda is one of the flagship companies in Yaroslavl's pharmaceutical cluster and is the first major international pharmaceutical company to invest in a new world class manufacturing facility in the region."

However with former Russian PM Vladimir Putin’s 2010 plans to invest RUB120bn ($3.9bn) to boost the local drug production industry – along with his warning that firms could face “restrictions” if they didn’t set up operations – Takeda is not the first Big Pharma to ponder the market.

GSK, Teva and AstraZeneca , for instance, all announced intentions to work in Russia.

Yastrebov added that the new plant could set an example to other firms looking to house production there. He said: "This project is an excellent example of the benefits that international investment can bring to the Russian economy. Takeda is working closely with Russian companies to build the plant, and will create hundreds of high quality jobs for Russian people in the future."

Sartorius Opens New Plant

Sartorius has opened a new bioreactor production facility to boost capacity for single-use technologies.

The new €18m ($23m) plant in Guxhagen, Germany is located just a few kilometres away from Sartorius’ previous bioreactor facility in Melsungen, which had been operating at maximum capacity for some time.

Sartorius will employ 180 people in Guxhagen at the 10,000 sq.ft. unit, which it rents under a long-term lease from owner Robos GmbH.

Spokesman Dominic Grone took a few minutes out during a busy inauguration ceremony to tell in-Pharmatechnologist.com that Sartorius has relocated all bioreactor production to the new site and that the Melsungen plant is no longer operational.

CEO Joachim Kreuzburg said: “The new plant enables us to substantially enhance our manufacturing processes and creates additional capacity for us in view of the rising demand for biopharmaceutical production equipment. As a result, we are optimally prepared for further expansion, especially for single use bioreactors.”

The move – particularly the decision to increase single-use technology capacity – is in keeping with the growth dynamics of Sartorius business in recent quarters.

According to Sartorius’ financial results for the six months to June 30, 2012 the firm’s bioprocess solutions business – a large part of which is its range of single-use bioreactors – saw revenues increase 21 per cent to €237.4m and order intake increase 12 per cent to €243m. EBITDA increased 21 per cent to €47.6 m.

At the time the firm said that: “This significant growth was primarily driven by the strong demand for single- use products, especially filters and bags.”

Compare this with Sartorius’ lab products and industrial weigh businesses – which contributed revenue of €139m and €51m, respectively, and the importance of adding single-use bioreactor capacity is clear.

Merck Millipore Announces Opening in France

Merck Millipore has announced the opening of its advanced GMP bioproduction facility in Martillac, France, offering a full, single-use process train to speed a molecule's journey to the clinic.

The site will serve users of Merck Millipore's Provantage^™ Biodevelopment and Clinical Supply Solutions, an innovative, "open source" manufacturing option that incorporates the latest technologies for upstream and downstream processes.

The open source approach provides customers with greater control over production.

With a traditional outsourcing model, the customer's process must fit the facility and the contract manufacturer controls the process.

With ProVantage^™ Solutions, Merck Millipore develops the process for further use by the customer.

At the new facility, Merck Millipore provides access to proven technologies, process development expertise and validation services, offering a robust template that makes it possible to go from clone selection to GMP product in only 12 months.

The facility offers GMP production of mammalian proteins for pre-clinical to phase II production at the 50 L to 1,250 L scale.

For phase III and commercial production, customers can transfer manufacturing to any location, at any scale.

This freedom brings enhanced flexibility to the molecule development and the manufacturing process.

"Merck Millipore leverages more than 25 years of biomanufacturing experience with 150 molecules in our new facility in France," said Christophe Couturier, Vice President of Services and Solutions, Merck Millipore.

Couturier continued, "As the basis for Provantage^™ Solutions, our experts complement customers' internal capabilities in a way that combines the best of in-house production and conventional outsourcing. The end result is increased productivity and an accelerated time to market."

Thermo Scientific Opens Molecular Biology Center of Excellence in Lithuania

Thermo Fisher Scientific Inc. has announced the official opening of its Molecular Biology Center of Excellence in Vilnius, Lithuania. The new facility expands R&D and manufacturing capabilities in Eastern Europe for molecular, protein and cellular biology products.

The new facility will provide molecular, protein and cellular biology products to better serve growing demand from life sciences customers throughout Eastern Europe, and create new opportunities globally.

Since acquiring Vilnius-based Fermentas International Inc. in 2010, Thermo Fisher has continued to invest in the region to capitalize on its base of world-class educational institutions and scientific research talent.

The Vilnius site will showcase world-class capabilities for developing and manufacturing products used in a range of life sciences applications.

For example, it provides innovative technologies for PCR-based (polymerase chain reaction) testing, nucleic acid sample preparation protein purification and antibodies for ELISA (enzyme-linked immunosorbent assay) testing.

“Our expanded R&D and manufacturing presence in Vilnius strengthens our ability to serve the growing biotechnology community in Eastern Europe, particularly our research customers who rely on innovations in molecular biology to accelerate developments in diagnosing and treating disease,” said Marc N. Casper, president and chief executive officer of Thermo Fisher Scientific.

Casper continued, “We now have a solid foundation from which we can continue to increase our depth of capabilities for high-growth life sciences markets in the region, from PCR-based products to our broader biosciences portfolio.”

The 156,000-square-foot Molecular Biology Center of Excellence is currently home to more than 400 research, laboratory and manufacturing personnel, with room for expansion.

In addition to its geographically central location, Lithuania is known for its well-established commitment to innovation, highly skilled life sciences workforce and favorable economic environment.

As part of Thermo Fisher’s investment in developing the scientific workforce in Lithuania, the company has collaborated with the University of Vilnius to construct a mobile biology laboratory for high school students that provides hands-on experience with molecular biology and DNA experimentation.

Thermo Fisher also supports science education in Lithuania through a series of initiatives, including internships and scholarships that provide students with practical experience and financial support.

Recipharm gets OK in France

Swedish CDMO Recipharm has been cleared by French regulators to fill biotech drug products at its site in Tours.

The contract development and manufacturing organization announced it has been approved by the Agence Nationale de securite du medicament (ANSM) to fill drug products into glass vials at the facility earlier this week, adding that it can expand and diversify its combined offering.

The Tours site employs 200 personnel and houses three filling lines, two large capacity lines for glass vials for injectable products and a third aseptic line that fills cartridges.

Michel Saudemon, General Manager at Recipharm Monts, commented: “We are delighted to have the opportunity to expand our sterile product manufacturing services with the authorized capability to fill biotech products.”

He added: “This regulatory approval, coming at a time when we have already set in place a program of strategic expansion at the Monts site with the installation of a new service line, will serve to increase the range of sterile product manufacturing services that we can offer to the markets.”

The news follows just a few months after Recipharm announced plans to install a new vials line at the site.

In June the firm said it will spend €600,000 in new filling capacity, including a ‘state of the art’ integrated Dara cartridge filling machine for injectable drugs at its facility, which it claimed can fill and close as many as 7200 units per hour without causing particulate release.

At the time Saudemon, general manager of the plant, said: “Whilst we have for many years filled cartridges in Monts, this new machine allows us to offer a wider client base access to this capability. This should not only reduce lead times but also increase reliability and flexibility."

Luxembourg Provides $1.3M to WaferGen for European Expansion

WaferGen Biosystems has received a €1 million ($1.3 million) matching grant from the Luxembourg government to expand its European operations, the company.

The first tranche of €350,000 is expected in the first quarter, the Fremont, Calif.-based company said, and will be used to offset startup and personnel costs. WaferGen is recruiting sales, support, and technical personnel and eventually will establish research and diagnostic capabilities in Luxembourg, where its European operation is headquartered.

In a statement, Ivan Trifunovich, president and CEO of WaferGen, said, "This grant will help us expand our European sales activities and enable us to provide regional support and service capabilities."

WaferGen first announced its plans to establish its European operations in Luxembourg in early 2010. Later that year, the company announced a collaboration with the Integrated BioBank of Luxembourg to co-develop molecular signatures for diagnostic research and commercial applications.

UCB has Opened a New Plant in Belgium

The 5,100 sq. m. (54,876 sq. ft.) facility - which cost more than €65 million to set up - will produce cell culture-based therapeutic proteins and will support UCB's biologics development activities in the research and clinical trial phases.

The four bioreactors at the pilot facility have a total capacity of 3,200 liters and the unit is currently being validated alongside regulatory authorities. It is expected to become fully operational during 2013, when it will employ around 100 workers, and has been supported by the regional Walloon government.

UCB described the opening of the plant as an ‘important milestone’ that reinforces the firm's commitment to biotechnology, with chief executive Roch Doliveux noting that biologics account for around half of the company's current R&D pipeline.

"With this bio pilot plant, we will more rapidly initiate clinical studies of new antibody-based therapeutics that are addressing serious unmet medical needs", he said.

UCB's biggest biologic drug at the moment is rheumatoid arthritis and Crohn's disease treatment Cimzia (certolizumab pegol) which achieved sales of €209 million in the first half of this year and is tipped to become a €1.5 billion brand at peak by the company.

UCB recently initiated a revamp of its manufacturing network, selling off three production facilities in Germany and Italy to UK-based contract manufacturer Aesica last year. Meanwhile, in 2010 it started construction of a microbial manufacturing facility in Bulle, Switzerland to help meet anticipated future demand for Cimzia. The Bulle facility is due to come online in 2015.

Pharma R&D Centre Opens in Abu Dhabi

The UAE's first pharmaceutical research and development institute, the Dr B.R. Shetty Research Centre, has officially opened in Abu Dhabi.

The R&D facility, a project of Neopharma, Abu Dhabi's generic pharmaceutical firm, was opened by Bank of Baroda chairman and managing director M.D. Mallya.

Dr Shetty, who set up Abu Dhabi's first pharmaceutical manufacturing facility, described the research centre as "the cornerstone of innovation in pharmaceutical formulations, new drug delivery systems, nanotechnology and biological products for chronic or life threatening diseases."

He said the centre would be a hub for the development of novel drug delivery systems aimed at the treatment of diabetes mellitus and cancer. In this attempt, Neopharma has introduced modified antibiotics and tablets to cure diabetes, he said.

The research centre has collaborated with Arkansas University for the development of microfibre nanotechnology for glucose sensors and nanotechnology-based microchips for neurodegenerative disorders. "In our collaboration with biotech leader Biocon, we have introduced novel nanotech product for the treatment of breast cancer," Dr Shetty said.

Mallya praised the contribution of Dr Shetty in setting up a pharmaceutical production facility, which many thought was not viable then. Bank of Baroda had provided financial assistance to the project. He showed his confidence in the company, and its future growth prospects as it has offers for contract production for multinationals drug makers at its facilities.

Neopharma, a pharmaceutical manufacturing company started its operations in 2003. The company, which manufacturers 96 pharmaceuticals, has plans to expand it to 125 products by next year.

Four Haupt Pharma Sites Pass Inspections

Haupt Pharma, one of the leading European companies for pharmaceutical contract development and manufacturing, has successfully passed inspections by the U.S. Food and Drug Administration (FDA) at four sites in Germany during the first half of 2012.

Now six facilities of the Haupt Pharma Group have received permission to manufacture drugs for the U.S. market. The FDA audits examined whether manufacturing and quality control meets US regulations, which diverge from those in Europe.

"These successful audits help the Group to come much closer to its strategic goal of further expanding its presence in the U.S. market," explains Haupt Pharma COO, Dr Karl Heinz Brücher. "This result is an extremely positive signal to our customers and the market, as it reflects both the exceptional performance and the high level of quality of our sites."

The United States is the largest pharmaceutical market worldwide. Further growth is also expected due to the passage of U.S. healthcare reform. Furthermore, a large number of patents will expire worldwide over the next few years. As a result, brand-name products will increasingly be replaced by generics.

These developments are positive for contract manufacturers, such as Haupt Pharma, because - unlike companies specializing in originator medicinal products - generics companies increasingly outsource their production to contract manufacturers.

Wickham Laboratories Expands

Wickham Laboratories Limited is a contract analytical laboratory specializing in microbiology testing for quality control, research and product development.

Wickham Laboratory facilities are GMP and GLP compliant and inspected by MHRA, FDA and other overseas regulatory authorities. Harmonized methods compliant to Ph. Eur, USP, JP.

Dedicated clean room facilities with two flexible film isolators.
Sterility testing for regulatory compliance using Ph Eur, USP, FDA or BS EN ISO 11737-2.
Validation of the test system to demonstrate recovery of low levels of micro organisms.
Sterility testing by fluid pathway or direct inoculation method.

Other services offered include environmental monitoring services for cleanrooms, bioburden, cytotoxicity and bacterial endotoxin testing.

Wickham Laboratories is currently relocating and expanding into a purpose built facility. Sterility testing will become a flagship department providing a 50% increase on existing testing capacity.

In May 2011, Wickham Laboratories announced the expansion of the company with the purchase of a new facility. This complex, now known as Hoeford Point, is a former GMP-compliant small-scale pharmaceutical manufacturing facility and has seen extensive refurbishment since purchase in Spring 2011. Hoeford Point represents a 50% increase in floor space over our existing location. Together with a general refurbishment of existing laboratories, we have created a new media preparation department and purchased additional equipment to complement the facilities including new laminar flow cabinets, incubators and isolators.

Sterility testing is seen as our flagship microbiology department with a cleanroom complex finished to the highest standards that is especially well equipped for Sterility and Cytotoxicity testing. The facility was originally designed for aseptic packing and boasts accommodation suitable for a number of isolator units and comes complete with ballasted pass-through autoclaves. Additional isolator units have been sourced to supplement our existing flexible film isolators, allowing increased testing capacity for an ever increasingly busy department.

Microbiology Expertise & Services include:

Pharmaceutical Microbiology
Pharmacopoeial, client and bespoke methodology
Method development and validation
On-site consultancy and environmental monitoring
Sterility testing and LAL
Preservative efficacy, bioburden and TAMC testing
Medical Device testing
Pharmaceutical testing

Toxicology Expertise and services include:

Quality control of existing products
Registration of new formulations
Research into new medicines and medical devices for the human and veterinary pharmaceutical and medical device industries.

Abbott Expands Potent Manufacturing Capabilities

Abbott continues to expand contract manufacturing capabilities of its multi-product potent facility through the recent installment of a new roller compactor. This new granulation equipment addresses the growing needs of solid dose potent formulations. This new capability will provide customers with the proper flexibility and efficiency needed to advance their drug product needs.

Abbott's potent API and drug product contract manufacturing facility is located in Sligo, Ireland. The facility also offers wet granulation, compression, coating and tableting processes for potent compounds, in addition to the new granulation capabilities.

INC Opens Facility in Korea

INC Research has opened a new clinical operations facility in South Korea in a bid to grab a slice of what it says is a “promising” research market.

The facility – in Gangnam-gu, Seoul – provides a local base for clients looking to conduct Phase I to IV trials in a number of therapeutic areas, including central nervous system (CNS) disorders, oncology, infectious diseases, cardiovascular and endocrinology.

Work will be carried out through partnerships with Korean Food and Drug Administration (KFDA) accredited sites and clinical trial centre support programs from the South Korea National Enterprise for Clinical Trials (KoNECT).

President of EMEA and Asia/Pacific region Kelvin Logan said INC has been working in the region for some time, but with a growing demand for work the firm recognized the need for an official hub there.

“The sites are excellent and the investigators and our clinical research staff are all highly trained in the country,” he said.

Logan told us the growing number of “key” biopharmaceutical companies with operations in the area has also contributed to the decision.

He added: “South Korean companies, for example, have a significant position in the development of biosimilars.”

He admitted South Korea is not the cheapest of the bunch, but that a host of other benefits – such as better regulatory and operational aspects compared with neighboring countries – puts working in the country high on INC’s list of priorities, as well as a number of other outsourcing firms .

“While it is not the cheapest country in Asia in which to operate it is a significant pharmaceutical market in its own right,” he said.

Logan also said a wide acceptance of data collected in the country makes South Korea very attractive for clinical trials. “Importantly the patient data from the country is relevant for marketing submissions in other key Asian countries like China and Japan and is well accepted as part of international new drug applications,” he said.

“We work with a number of dedicated early phase units, in Asia, Australia and New Zealand particularly, but we do not plan to own or manage our own medical or pharmacology facilities in the region.”

MedImmune, WuXi AppTec Form Biologic JV

MedImmune, the global biologics arm of AstraZeneca, and WuXi AppTec, have formed a joint venture to develop and commercialize MEDI5117, a novel biologic for autoimmune and inflammatory diseases, in China. MedImmune will provide technical and development expertise and WuXi AppTec will provide local regulatory, manufacturing and clinical trial support, as the government requires local manufacture of drugs not approved in other markets.

The joint venture will control the development of MEDI5117 in China and will have equal ownership. MedImmune will have the option to acquire the full rights to commercialize MEDI5117. WuXi AppTec will earn revenue for services provided to the joint venture. MedImmune will receive milestone payments as the program progresses.

"We are pleased to partner with WuXi AppTec, a company with strong leadership in the Chinese pharmaceutical R&D sector, to help us address the healthcare needs of Chinese patients through the co-development of MEDI5117," said Bahija Jallal, executive vice president, R&D, MedImmune. "This strategic partnership will enable us to establish a leadership presence in developing novel biologics in China, complementing AstraZeneca's investment in this important emerging market."

"WuXi is delighted to work with MedImmune, an innovative biologics company, to develop and manufacture a novel product for first use in China," said Dr. Ge Li, chairman and chief executive officer of WuXi AppTec. "WuXi is working to build long-term drug development partnerships with leading biopharmaceutical companies like MedImmune to help accelerate the development of novel medicines for the large and rapidly growing Chinese pharmaceutical market."

Sartorius Opens Guxhagen Bioreactor Facility

Sartorius has opened a new production facility for bioreactors in Guxhagen, Germany. The plant manufactures bioreactors and further production equipment for biopharmaceutical customers. The 10,000-sq.-ft. building complex provides space for a high-tech manufacturing hall and offices for 240 employees. Sartorius has moved its former bioreactor production facility in Melsungen, where it had reached maximum capacity limits, to the Guxhagen site.

"The new plant enables us to substantially enhance our manufacturing processes and creates additional capacity for us in view of the rising demand for biopharmaceutical production equipment. As a result, we are optimally prepared for further expansion, especially for single-use bioreactors," said Joachim Kreuzburg, the chief executive officer and executive board chairman of Sartorius AG.

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