PHARMACEUTICAL & BIOTECHNOLOGY
INDUSTRY UPDATE
October 2011
McIlvaine Company
TABLE OF CONTENTS
Althea Technologies Biologics Manufacturing Facility Expands
Consigli Construction Breaks Ground for Bigelow Laboratory Center for Ocean Health
HWI Global Contract for Cleanroom Pharmacy at Mount Sinai Medical Center in New York
Thermo Fisher Scientific Opens New Biomarker Translational Center
Waters Teams with FDA, U. of Maryland on International Food Safety Lab
Czech Republic Launches Life Sciences and Materials Research Center
Solvias and RohnerChem Team on API Development and Manufacturing
The International Vaccine Centre, University of Saskatchewan
Foster Wheeler Awarded Contract at New Biotechnology Park in Malaysia
Catalent Announces Expansion of Its Advanced Dose Form Facility in Italy
PharmIdea - Contract Manufacturing of Sterile Drugs in Vials and Product Development
Portland, Ore., will house a life sciences research and education center that will be a collaborative venture between Oregon Health & Science University, Portland State University, and Oregon State University.
The three schools held a ground-breaking ceremony for the $295 million OSU/OHSU Collaborative Life Sciences Building (CLSB), which will be located at the OHSU Schnitzer Campus on Portland's South Waterfront.
When the 480,000 square-foot building is completely open in 2014 it will have a number of labs and educational facilities. It will include PSU's biology and chemistry lectures and labs (totaling 85,000 square-feet of lab space), OHSU's Center for Spatial Systems Biomedicine, and shared instrumentation labs with tools for electron microscopy, nuclear magnetic resonance imaging, and other technologies.
The CLSB project is funded with $110 million in state bonds through the Oregon University System, $83 million in OHSU philanthropy funds, $92 million in OHSU institutional funds, and $10 million in TriMet funds.
The facility also will increase OHSU's medical and physician assistant class sizes, increase biology and physics classes, and expand OHSU's simulation education capabilities.
Althea Technologies has launched a commercial-scale GMP manufacturing facility in Sorrento Valley area, a major biotechnology hub in San Diego, California. Althea Technologies is involved in contract development and manufacturing.
It offers services in the field of plasmid DNA, recombinant proteins and sterile products.
The new $15m facility was launched in April 2009 in response to the rising demand for outsourced manufacturing capacity, especially by San Diego-based drug and biotechnology companies that put a greater focus on R&D than production.
The facility has been designed to support the company's rising demand in its drug product and biologics manufacturing business units.
"Althea Technologies is involved in contract development and manufacturing."The facility complies with the US and European manufacturing regulations. It received FDA approval to start commercial manufacturing in June 2011, following a pre-approval inspection in April 2011.
The facility is the third on Althea's San Diego campus, bringing the total area occupied by the company on the site to 80,000ft2. The site has five GMP production suites, designed for the development of plasmid DNA, proteins and carrying out lyophilisation as well as vial and syringe filling for pre-clinical and clinical products.
The state-of-the-art facility spans 30,000ft2 and has been designed with flexible capacity. It accommodates laboratories for good laboratory practices (GLP) testing and separate suites for fully compliant GMP plasmid DNA and protein manufacturing and aseptic vial and syringe filling.
The laboratories have been designed for a host of gene quantification and expression services. Separate laboratories have been made available for biodistribution studies, adventitious virus testing and integration studies.
The facility also houses warehousing and materials management facilities. A custom design has been used to facilitate the movement of material and people and reduce the risk of cross-contamination.
Several airhandling systems and a water-for-injection water purification system have been installed. All production processes and unit operations can be scaled-up to commercially viable levels to support any future expansion.
The space dedicated for GMP production and fill / finish operations totals approximately 12,000ft2 (1,100m2). It houses a cellbanking production suite and four fermentation and purification suites equipped with microbial fermentors ranging in capacities from 30l, 100l to 1,000l.
There are six fill and finish suites, equipped with fully automated and semi-automated vial and syringe filling, inspection and labeling equipment and a formulation suite. The syringes vary in size between 0.5ml, 1ml long, 1ml and 20ml. The vial sizes range between 0.5ml and 100ml.
"The new $15m facility was launched in April 2009."A new NOVA H3-5 high speed syringe filling line was installed within the facility in October 2010. The line operates under a restricted access barrier system (RABS) which enables handling of viscous products that require minimal head space.
The line accommodates nested syringes from different suppliers and is capable of generating batch sizes of more than 100,000 units. It began production of GMP batches in the first quarter of 2011. The syringes can be filled under vacuum.
The facility is equipped to undertake production from the pre-clinical development stage through to Phase III and commercial stage. It can develop recombinant proteins, plasmid DNA therapeutics and vaccines. It has been licensed to produce and package a commercial parenteral product for the U.S. market.
The construction has been funded through multiple credit facilities. The company received $12m worth of credit facility from City National Bank, a wholly owned subsidiary of City National Corporation. The credit facility was used to finance the equipment for the facility.
Althea Technologies also partnered with San Francisco based private equity company, Telegraph Hill Partners, for a $23m funding deal.
Alphora has completed a cytotoxics R&D lab, as part of an on-going $4 million capital program for 2011. The program also includes additions to R&D, GMP operations, analytical services and staffing.
The R&D lab is designed to handle high potency active pharmaceutical ingredients (HPAPIs) and class four compounds. It’s equipped with three hard enclosure isolator units, pressure lock entryways and dedicated class HEPA filtered air handling systems.
Alphora’s R&D has been expanded by 50% with the installation of additional fume hoods for process chemistry development and a GC/MS instrument for further API characterization and control of Genotoxic Impurities (GTIs), and increasing the overall company headcount to 95 employees. Other expansion plans include constructing a fourth cGMP Kilo Lab, adding a 10,000-sq.-ft. GMP warehouse, and installing a new Enterprise Resource Planning (ERP) system, which are expected to be complete in 4Q11.
BASi (Bioanalytical Systems Inc.) is expanding its drug discovery and development services capabilities. The company has renovated space at its preclinical toxicology site in Evansville, IN and will relocate some research services to West Lafayette, IN, creating several new positions. BASi also has added research instrumentation at its bioanalytical labs at three sites.
The company is using proceeds from a $5.5 million public offering to make the improvements and purchase lab equipment. The building renovations in Evansville will provide scientists with more space for multiple studies.
BASi is relocating its in vivo discovery services in 2012 to its facility in the Purdue Research Park of West Lafayette, which will create several new positions. These studies will provide information clients need to evaluate new compounds in the earliest stages of development.
General manager John Devine Jr., BS, DABT, has been promoted to vice president of non-clinical services to oversee expansion of the in vivo discovery services business.
Several new triple quad mass spectrometry systems have been purchased and several AB SCIEX Triple Quad LC/MS/MS have been installed at the company’s labs in West Lafayette, McMinnville, OR and Warwickshire, UK.
Sequenom will build a molecular diagnostics clinical laboratory in North Carolina, creating 242 jobs, the office of North Carolina Gov. Bev Perdue announced.
Sequenom also plans to make a capital investment of $18.7 million into the NC Biotechnology Center, which participated in convincing Sequenom to build the laboratory in North Carolina.
Sequenom will launch its MaterniT21 test for trisomy 21 in North Carolina, though the company said as recently as last month at the UBS Global Life Sciences Conference that the test will be introduced as a laboratory-developed test in the coming months through its Michigan-based subsidiary Sequenom Center for Molecular Medicine.
A Sequenom spokeswoman declined to comment on details about the new facility, saying the terms of a lease agreement were still being finalized. She said, however, that like the Michigan facility, the North Carolina lab will serve as a "back up" and add testing capacity to Sequenom's primary laboratory in San Diego, where the firm is headquartered.
In a statement, Paul Maier, president of Sequenom CMM, said, "Sequenom is rapidly advancing innovative technologies and has been looking at the right venue to expand its capacity, so we're extremely pleased to have reached an agreement with North Carolina. The North Carolina region shows great promise for us, as an ideal location on the East Coast with a robust like-minded community and commitment to advancing our technologies through education and jobs creation."
In connection with the announcement, North Carolina's Economic Investment Committee voted to award Sequenom a Job Development Investment Grant, under which the company could receive a grant equal to 60 percent of the state personal income withholding taxes resulting from the creation of new jobs if Sequenom satisfies annual performance targets for the nine years.
The grant could result in as much as $2.3 million in benefits to Sequenom.
The laboratory will be based in Wake County, and Purdue's office said that the average salary for the new jobs will be $53,721, compared to the average county wage of $44,980.
Consigli Construction Co. Inc. announces that its Portland, Maine office has broken ground in East Boothbay, Maine on the third building at the new 64-acre Ocean Science and Education campus they are constructing for Bigelow Laboratory for Ocean Sciences.
Due to be completed in November of 2012, the $11.4 million Bigelow Center for Ocean Health (COH) will be one of three complementary and interconnected research centers on the campus built by Consigli Construction and designed by WBRC Architects · Engineers in association with Perkins + Will. Bigelow Laboratory received major funding for the COH from a federal construction grant awarded through the National Institute for Standards and Technology in September 2010.
The COH joins the Bigelow Center for Blue Biotechnology, which will be occupied this December, and the Center for Ocean Biogeochemistry and Climate Change, slated for completion in spring 2012. The newest facility will house a 16,600 square-foot main building, augmented by a 1,200 square-foot shore facility, with seawater pumping facilities and pier and dock space for research vessels to support field research and SCUBA operations.
“The COH will bring scientists together in a unified facility, where we can develop a multi-disciplinary, multi-scale approach to ocean health that will provide improved management tools to support healthy, productive and resilient ocean ecosystems,” said Laboratory Executive Director, Dr. Graham Shimmield.
When fully completed, the Ocean Science and Education campus will provide over 60,000-sf of laboratory, education and administrative space; replacing the Laboratory’s leased facilities in West Boothbay Harbor. BD+C
Chiltern has opened a new office in Bannockburn, Chicago.
The contract research organization (CRO) says the move will help to establish a recruitment base in the area as well as building client relationships in the area.
Barry Simms, Chiltern’s country manager, North America, said: “Chiltern continues to look for opportunities to increase our strategic footprint and we are very excited about our expansion to the greater Chicago area.
“Our new office is well situated to support our efforts to recruit top-notch staff and be strategically near our clients.”
The new comes just two months after the company established a similar enterprise in Israel.
Vetter, a contract development and manufacturing organization that specializes in aseptic filling, today announced that its first U.S. facility is now fully operational. Located at the Illinois Science + Technology Park in suburban Chicago, the 24,000-square-foot site includes microbiology and chemical analysis labs, material preparation and compounding functions, three cleanrooms for aseptic filling, and visual inspection. The first to use Bosch’s new MHI 2020 B fully automated vial filler, Vetter’s Chicago facility offers state-of-the-art technology and processes to support preclinical through Phase II compounds.
Designed specifically for early clinical-stage, high-value biopharmaceuticals, Vetter’s new automated vial filler can run up to 10,000 liquid or 6,000 lyophilized vials per batch.
Minimum tubing lengths help reduce API loss and increase product yield.
The system’s use of Restricted Access Barrier System (RABS) and its high degree of automation – including both filling and capping – mitigate risk of contamination by minimizing human intervention.
The unit is capable of running a range of fill volumes, from 0.1 to 23 ml, providing ample flexibility.
Intended for liquid fills, a second cleanroom houses a flexible semi-automated filler. The system can fill a variety of packaging materials – syringes, cartridges and vials – with a capacity of up to 500 units per batch.
Both automated and semi-automated units provide a 100 percent in-line check-weigh system, which helps ensure accurate fill volume – critical in small, early-stage fills. Because no sampling is required to verify fill volume, the system increases API yield.
The facility uses exclusively disposable components in material preparation, compounding and filtration areas, which eliminates the need for cleaning validation – and thus saves valuable time and cost.
A third cleanroom will expand current operations and provide filling of pre-sterilized syringes.
Said Vetter Managing Director Peter Soelkner, “Our Chicago facility provides customers with a top-of-the-line clinical manufacturing site located in the heart of the United States. Because Vetter consistently strives to stay at the forefront of innovation, securing Bosch’s new fully automated vial filler was a natural for us. Here in Chicago, our state-of-the-art systems and infrastructure, coupled with our professional expertise, offer customers the quality they expect from Vetter.“ Vetter’s Chicago facility is an expansion of Vetter Development Service, which employs more than 100 personnel in Europe and the United States. Strategic to Vetter’s plan for worldwide growth, the launch of Chicago operations highlights Vetter’s dedication to serving the North American market, where nearly half of Vetter’s client base resides.
Further demonstrating Vetter’s U.S. commitment is the company’s preferred partnership agreement with Midwest-based Sentry BioPharma Services, signed last year. From its site in Indianapolis, Indiana, Sentry is able to label, package and ship clinical supplies filled by Vetter, upon customer request. The collaboration will help streamline the path of study drugs from filling suite to clinic while safeguarding product integrity.
As with all Vetter facilities, the Chicago site and its processes meet stringent FDA and EMA quality requirements. Adjunct services include regulatory counsel and product lifecycle management. Experienced project managers steer all product development projects, so that projects can stay on track, quality standards can be maintained, and deliverables can be met on time and on budget. The Chicago facility provides seamless product transfer to Vetter’s large scale manufacturing facilities in Europe for Phase III and commercial manufacturing.
Roche has opened the doors to its new center of excellence supply manufacturing facility in New Jersey, U.S.
The plant will process high potency compounds into medicines preclinical safety studies, as well as for Phase I and II trials.
Dosage forms produced at the 17,000 sq. ft. factory, in Nutley, include tablets, capsules, powders, suspensions and solutions.
“This is a vitally important milestone for the Nutley site as well as Pharmaceutical Research and Early Development at Roche,” Waseem Malick, VP of pharmaceutical & analytical R&D at Roche said.
“It enables continued support of our portfolio, and is another example of Roche’s commitment to Nutley as a major research center for Roche.”
Plans for the facility were approved in May 2010 and construction began in August 2010. The clinical dosage forms produced by the facility include tablets, capsules, powders, suspensions and solutions. Scientists and engineers manufacture clinical supplies of highly active compounds under current Good Manufacturing Practices (cGMP) for Roche trials worldwide. It also contains warehouses for components, excipients (inactive ingredients) and active pharmaceutical ingredients (APIs), mechanical rooms and multipurpose isolation suites for manufacturing.
Pharmaceutical Development (PPD), a global contract research organization (CRO) headquartered in the US, has expanded its laboratory testing services in infectious diseases.
The Wilmington, NC, US-headquartered CRO is now able to offer a full range of microbiology testing services, including bacteriology, mycobacteriology and testing of microbioterrorism pathogens at its central laboratories in the US, Belgium, Singapore and China.
The laboratory also provides virology testing, including real-time polymerase chain reaction, viral load, genotyping and single nucleotide polymorphism analysis. It is able to culture, quantitate, identify and determine antibiotic susceptibility and resistance for aerobic and anaerobic organisms. PPD is already running studies for staphylococcal and yeast infections and for the identification and quantification of microbiota.
‘Strengthening our microbiology capabilities demonstrates PPD’s commitment to deliver a full range of high quality global central laboratory services and builds on our fully integrated clinical research and development expertise across all areas of infectious diseases,’ said Elena Logan, senior vice president of global central labs for PPD.
HWI Global®, the Pittsburgh-based cleanroom design builder, has been awarded the contract to provide specialized design and build construction services for the new Sub-Cellar Level 2 Pharmacy in Mt. Sinai Hospital's Annenberg Building in New York City. Set to begin Q4-2011, this is the second USP 797 upgrade that HWI® has worked at Mt. Sinai; the company was subcontracted by New York-based Clean Room Depot to provide interior fit-up for the 6th Floor Pharmacy in the summer of 2007. Federal mandate USP 797 requires hospital pharmacies to conduct compounded sterile preparations in ISO classified cleanrooms. HWI® currently holds the annual preventative maintenance contract for the 6th Floor Pharmacy cleanroom.
Deric Haddad, CEO, HWI Global®, states, "We expect this to be a state-of-the-art facility, unlike any other pharmacy renovation in New York City today. Working closely with the Architect, and their customer representatives, HWI® confirms that the highest quality and most innovative products will be woven into the interior design specification. Once again, the ideal layout is available for us to employ our Open Architecture Sterile Compounding design technique for the IV Preparation Room. Moreover, we will be providing HWI's complete portfolio of Bio-Gard products from our aseptic wall system to other custom accessories and casework. A full-time particle monitoring and data-logging system will be installed to validate the room's high-level performance. This will truly be a showcase setting HWI® apart when it comes to USP 797 projects in the cleanroom industry. And, there's no better place to do it than at Mount Sinai on the Upper East Side."
HWI® was specified for this project by Mitchell Architectural Group of Southbury, Connecticut. The Company has entered into a specialty subcontract with New York City-based Morgan Construction Enterprises, Inc.
The Jackson Laboratory plans to build a genomic medicine research center in Connecticut and is working with the state's governor and the University of Connecticut to ask the legislature to help fund the building and its operations, the state governor's office said.
Jackson Lab and Gov. Dannel Malloy said in a press conference that the Jackson Laboratory for Genomic Medicine would be located on the UConn Health Center's campus in Farmington, and that it would employ 300 people over the first 10 years and a total of 600 within 20 years.
The Bar Harbor, Maine.-based institute and Malloy have proposed a total capital and research budget of around $1.1 billion over 20 years, including $291 million from the state to build, outfit, and operate the facility. Jackson Lab said it expects to add $809 million for the lab through its own federal research grants, philanthropy, and service income. The state Legislature is expected to review Malloy's proposal in late October.
Jax Genomic Medicine would combine Jax's genetics and genomics expertise with the clinical and biological capabilities of Connecticut's institutions, including UConn and Yale University. Specialty areas for the new lab could include cancer, aging, genetic disorders, metabolic diseases, and others.
The 173,500 square-foot building near the UConn Health Center campus would house 30 principal investigators and resources, staff, and space would be dedicated to the translation of new applications such as diagnostics and computational services into commercial products. The institute also said that the new lab would identify new potential treatments that could then be tested up at its Bar Harbor facility.
Jax also said that it wants to help the UConn center grow its faculty and to advise the state's economic development agencies to identify the best industrial and biotech partners in personalized medicine.
Jax said that it was contacted by Malloy and representatives from the Connecticut Department of Economic and Community Development and UConn officials to gauge Jax's interest in building a new research center in the state. Landing the new Jax lab would mark the next phase in the Bioscience Connecticut initiative, which has harnessed over $850 million in support for its biomedical industry in the state.
The discussions between Malloy's office, the economic development group, and Jackson Lab were likely well underway when Jax announced that it had hired Edison Liu from his post as head of the Genome Institute of Singapore to be its next president and CEO.
"The faster pace of medical discovery [with the new Jax lab] would drive both research funding and laboratory mouse sales, thus creating more jobs here in Maine," Liu said in a statement.
"Developing this new institute in Connecticut would raise the already considerable prestige of The Jackson Laboratory as the world leader in mammalian genetics,” he said. “It would also bring us into the forefront of personalized medicine."
“By investing in a smart, strategic project like Bioscience Connecticut … the state sent a loud and clear message around the world to companies and research institutes like The Jackson Laboratory that we are ready, willing, and able to be a partner in this up-and-coming [personalized medicine] industry,” Malloy said in a statement.
Malloy pitched the new institute and the Bioscience Connecticut initiative in general as engines of job development. His office estimated that the Jax facility will create 6,800 permanent jobs within 20 years. Under his proposal, the $291 million in funding that would be provided by Connecticut includes $192 million in a secured construction loan and $99 million in research partnership participation.
For more than a year-and-a-half Jackson Lab had been trying to put together a deal to build a new lab focused on personalized medicine in Florida, but after agreeing on facilities first in Naples and then in Sarasota, the plans fell through and Jax shut down its efforts in June. Florida's budget was just too constrained for legislators to approve the $100 million that the institute, which already has a lab in Sacramento, Calif., was seeking from the state.
“The state made a compelling case to establish this lab here and because of its ideal location between New York City and Boston, its world-class colleges and universities, and its existing work in the bioscience field, it made perfect sense to come to Connecticut," Liu explained.
UPM Pharmaceuticals, Baltimore, MD, will expand its existing manufacturing capacity with an OEB 4 processing room, a low humidity processing suite, and a dedicated Xcelodose production facility. The overall expansion will add 50% more manufacturing space for current production.
UPM’s president, James Gregory, said, “To meet our client’s growing needs, UPM is making a major capital commitment to enhance client services. In response to an increasing number of requests for production of compounds with more stringent environmental safety requirements, UPM is building a unique suite for handling of manufacturing processes associated with OEB 4 compounds. We are also building a dedicated suite for handling and production of low humidity compounds. Finally, UPM will be developing a unique segregated four-room suite to handle Xcelodose processing and encapsulation activities associated with the 600 and 600S equipment systems. We intend to provide these services under the strictest handling conditions up to and including OEB 4 compounds. This expansion will allow us to keep pace with our clients’ needs and continue our commitment to speed and quality in the services we provide.”
Construction workers are back at the future Biotechnology Research Center in Syracuse. It's the former location for Kennedy Square Apartments. The framework has been up for while, but work was delayed for some time.
Construction continues at the future Biotechnology Research Center. The framework has been up for while, but work was delayed for some time.
Upstate Medical University Assistant Vice President Tom Pelis said, "It's wonderful to see activity down here. This is going to be a beautiful building."
The facility will house the Biotechnology Research Center. It's a collaborative undertaking between SUNY Upstate Medical University and SUNY ESF. Ground was broken on the $22 million project in 2009.
Construction started here last spring but was stalled this time last year because they were waiting for more than $4 million in state funding. But Pelis said all funding is now in place and construction resumed in June.
"A considerable amount of site work has been done with drainage and sanitation, water lines that sort of thing," Pelis said, "In the building some of the plumbing, electrical, mechanical roughing work which is needed to place concrete has been completed."
The construction of the future center is now projected to be completed in early June of 2012.
The Massachusetts General Cancer Center at Massachusetts General Hospital has received a $10 million gift from former Genzyme CEO Henri Termeer to create the Henri and Belinda Termeer Center for Targeted Therapies. The new center will focus on discovering personalized cancer medicines and will be led by Jose Baselga, chief of hematology/oncology and associate director of MGCC.
The Wistar Institute broke ground on a new $100 million research facility that will sit alongside its original lab, now nearly 120 years old, in Philadelphia's University City.
The seven-story, 90,000-square-foot tower will provide five floors specifically for housing new labs, new researchers, new equipment, and collaborative efforts that will continue to pursue Wistar's research into cancer, vaccine development, and studies of other diseases.
The institute expects to bring in 10 more primary investigators, as well as research teams of staff scientists and post-docs that support them, to work in the new building, and has already added a new bioinformatics professor, said Wistar Associate Director of Communications Greg Lester.
"At a time when biomedical research is advancing at a lightning pace, The Wistar Institute finds itself constrained by aging facilities designed for 19th and 20th century science," Wistar President and CEO Russel E. Kaufman said in a statement. "We designed our new building specifically to foster interactions between researchers in the kinds of multidisciplinary collaborations that spark innovation and drive results."
The expansion project, which Wistar expects to complete in 2014, received funding of $18 million from Pennsylvania's Redevelopment Assistance Capital Program. The institute also received $70 million in debt financing from Citizen's Bank.
Wistar also said that it has embarked on a $35 million capital campaign. It has already received $18.6 million in commitments during a "quiet phase," wherein it sought support from previous Wistar donors.
"The most challenging part is yet to come," said Wistar Trustee Richard Fox, who is chair of the capital campaign. "By entering the public phase of this fundraising effort we are asking for support from the community at large, from everyone who appreciates the impact that Wistar science has had on the world and recognizes its future potential in the new building."
Lester said that Wistar does not expect to petition Pennsylvania for more funding to complete the project, and plans to finish the fundraising on its own.
The new building will sit between Wistar's original campus, constructed in 1892 and still in use, and its cancer research building (Wistar was designated a National Cancer Institute Cancer Center in 1972).
Lester said that the expansion will provide a better public interface for the institute by adding a new grand entrance, a 200-seat auditorium for events, lectures, and readings, and more public space for hosting events and visitors.
"The thinking around here is that you publish more with people you are closer to, so we want to get more folks nearer to each other and make real our promises for collaborative research," he said.
Wistar's researchers engage in studies of genes, gene expression, cancer biology, immunology and virology, and translational research. Specific studies may involve functional genomics, proteomics, epigenetics, computational genomics, bioinformatics, and a range of other molecular research approaches.
Lester said that researchers in the new facility are likely to pursue translational research efforts.
Roquette has opened a new multi-million-dollar innovation center in Geneva, Illinois, designed to strengthen relationships with customers.
With the price of its key raw materials continuing to rise, the commercial imperative to extract higher-value ingredients from corn, potatoes, wheat, peas- and now algae - has never been greater, group chief executive Guy Talbourdet told FoodNavigator-USA at the center’s official launch.
“We are happy to sell high fructose corn syrup," he said. "But we are not the leader in that market. Specialty products are where the growth opportunities are.
“We want to help our customers solve issues, whether it’s cutting calories, fat or sugar or adding fiber, reducing the number of ingredients they use or making their ingredients lists more natural.”
Innovation was critical to protect margins and steal a march on rivals, which were also pumping all available cash into extracting more value from the same crops, he added.
However, Roquette has also explored other raw materials, notably algae, and was constantly looking at new acquisition opportunities, joint ventures or investment opportunities in high-growth markets, he said.
Roquette's new state-of-the-art facility on the aptly named Innovation Drive is staffed by around 50 employees, some of which have moved from a rented site nearby where they have been stationed since 2008, and others who have relocated from Keokuk, Iowa, home of Roquette's corn starch plant and its US head office.
The center includes laboratories for Roquette staff and customers to work together on product development, a culinary kitchen for prototype demonstrations, the Roquette University auditorium for educational seminars, a pilot facility for product trials and customer meeting rooms.
Built for LEED (Leadership in Energy and Environmental Design) silver certification, the center has commercial-scale laboratory equipment and instrumentation to meet customer needs and speed up the product development process, added Fernando Arias, vice president, commercial development, Roquette America.
“This is a strategic investment for Roquette. We also own the land around it so we can easily expand if we want to.”
A new pilot facility at the center featuring extrusion kit, a spray drier and a tablet press would come onstream in the first half of 2012, he added.
One of the biggest growth opportunities for Roquette was pea-based ingredients (protein, fibers and starches), which ticked all of the right boxes when it came to sustainability, functionality and nutrition and tapped into a growing demand for non-GMO, grain-free, non-allergenic, natural ingredients extracted without hexane or other organic solvents, claimed Arias.
Should demand for its pea protein, starch and fiber continue to grow in the US, Roquette could either expand capacity at its manufacturing facility in France (where they are currently made) or build a new plant in Canada, close to the yellow pea crop, said Roquette board member Bernard Yon.
Several prototype products containing Roquette's Nutralys pea protein were on display at the new center including a vegetarian meal kit containing a pack of pea protein shoppers could rehydrate and use to make veggie tacos.
Roquette had also worked hard to improve the stability and solubility of Nutralys for use in ready-to-drink beverages, said human nutrition business unit manager Craig Glover.
Nutralys worked well as an extender or emulsifier in meat (pending regulatory approval in the US), or in combination with fibers to make more satiating weight management products, he added. "We're also seeing gluten free as a growth opportunity."
Meanwhile, Roquette's Nutriose soluble fiber (derived from corn or wheat), was also gaining traction thanks to its superior heat and acid stability and the fact it was better tolerated in the gut than some other soluble fibers such as inulin, claimed Glover.
While reduced sugar and fat claims had lost a little momentum as consumers looked for more positive messages, the wider roll out of front-of-pack nutritional labeling schemes could help to refocus manufacturers' minds on reformulation - and in turn boost Roquette's polyols business - said Glover
J. Craig Venter, the La Jolla biologist who cracked the human genome and created the first synthetic microbe, broke ground on a new $35 million home for his genomics research institute.
The 45,000-square-foot facility will be located in the southwestern corner of the University of California San Diego campus where Venter earned a bachelor's degree in biochemistry and a Ph.D. in physiology and pharmacology in the 1970s.
The institute, which focuses on human genetics and ways to create energy from microbes, has been housed in a leased building just north of UCSD since its founding in 2006.
At the new structure, the institute's current 65-member staff will have space to double in size, said Robert Friedman, director of the research center.
Scientists will serve as adjunct professors at the university, which will allow UCSD students to work at the facility, Venter said.
The location also should enhance the institute's collaboration with a new stem cell research center being built nearby by the Sanford Consortium for Regenerative Medicine.
The Venter building was designed to have a minimal impact on the environment through the use of solar energy and efficient heating and cooling systems.
Photovoltaic panels will cover the structure's roof, and heat generated by refrigeration systems will be captured in water and stored underground for later use.
"It's a giant experiment," Venter said of the construction project. "We are trying to build the first zero-carbon research facility maybe in the world. We're putting some of the fundamental beliefs of sustainability into action."
The building should open in 2013, Friedman said.
While the institute has borrowed money to launch the work, its leaders are hoping to pay for some of the project's cost with donations from local philanthropists.
US drug maker Isis Pharmaceuticals has opened a new R&D centre in Carlsbad, California designed to forge closer interdisciplinary bonds.
The firm said the new 176,000 sq.ft. building in Gazelle Court in the Carlsbad Oaks North Business Park in Carlsbad consolidates its R&D operations in a single site that will foster a more collaborative between its discovery and drug development teams.
Isis CEO Stanley Crooke said: "Completed ahead of schedule and below budget by BioMed, our real estate partner since 2005, our new corporate home provides the ideal environment for us to continue to innovate and create the medicines of tomorrow.
A hub for biotechnology and leading-edge translational science at The University of Miami is opening its first building.
The building at the UM Life Science & Technology Park houses wet and dry labs, lab-ready development suites and retail space. Some space is leased to technology and medical device companies, a blood center, a clinical research firm and the University of Miami Tissue Bank.
The dean of the UM Miller School of Medicine says this is a "giant step toward situating South Florida as the international center for health care innovation it deserves to be."
Thermo Fisher Scientific Inc., has announced at the Human Proteome Organization (HUPO) 2011 World Congress the establishment of a new Biomarker Translational Center (BT Center).
The purpose of the BT Center is to accelerate mass spectrometry (MS)-based biomarker discovery research and its translation into the development of routine clinical assays for subsequent commercialization.
Based in Cambridge, Mass., the BT Center combines advanced expertise from across Thermo Fisher including its B•R•A•H•M•S product line and the team at the Biomarkers Research Initiatives in Mass Spectrometry (BRIMS) Center.
“Through the vertical integration with the unique talent in MS-based biomarker discovery and high-throughput quantitative assay development at BRIMS, we aim to expand our pipeline of new protein and peptide biomarkers with potential as clinical assays,” said Bruno Darbouret, director of research and development for B•R•A•H•M•S Biomarkers at Thermo Fisher.
Darbouret continued, “Ultimately, this development effort will speed the commercialization of diagnostic tests that address life threatening diseases.”
Thermo Fisher, already a leading provider of specialty in-vitro diagnostic tests based on its patented Thermo Scientific B•R•A•H•M•S biomarkers, understands clinical market needs and will apply core strengths in diagnostics development, validation and commercialization to define the disease areas of focus for the BT Center.
The company’s well-established relationships with clinical researchers will provide access to clinical partners and patient samples for biomarker discovery and validation studies using B•R•A•H•M•S Biomarkers.
For the disease areas chosen, the BRIMS Center will apply its competencies in quantitative MS biomarker discovery and multiplexed selected reaction monitoring (SRM) assay development to identify putative biomarkers and their clinically relevant isoforms.
Subsequently it will develop robust, reproducible, targeted MS-based assays appropriate for the validation of putative biomarkers and ultimately for the clinical diagnostics market.
Thermo Fisher will own all intellectual property around the biomarkers and assays, and it will commercialize the assays as clinical diagnostic products and services after obtaining all requisite regulatory approvals.
“Efficient translation of MS-based biomarker discovery research into the development of routine clinical diagnostic assays is an important challenge in the field of personalized medicine,” said Bryan Krastins, group leader, BT Center.
Krastins continued, “Bridging this gap requires high-level competence in MS-based biomarker discovery and routine assay development for biomarker verification and validation. Understanding clinician and patient needs and having extensive experience in clinical validation are also essential to the transformation of novel tests into clinical routine assays. The new BT Center integrates all the capabilities needed to speed the clinical assay development pipeline from biomarker discovery to clinical assay development and validation.”
The Thermo Scientific B•R•A•H•M•S product line features a range of diagnostic test procedures to improve the diagnosis and treatment of life-threatening diseases, using patented biomarkers to bring about medically and economically superior diagnostic know-how for patients and users.
Thermo Scientific B•R•A•H•M•S products are used in more than 60 countries around the world.
Located in Cambridge, Mass., the BRIMS Center develops methodologies and applications for protein biomarker identification and verification.
Equipped with a full complement of Thermo Scientific mass spectrometers, and staffed by a team of scientists with expertise in mass spectrometry, protein techniques and informatics, the BRIMS Center also develops leading software tools for proteomic research.
Molecular diagnostics firm OvaGene announced its laboratory has received Clinical Laboratory Improvement Act certification, making it fully licensed to receive patient clinical specimens from gynecological oncologists from most of the US.
Based in Irvine, Calif., OvaGene develops gene-based diagnostics for gynecological cancer.
Frank Kiesner, chairman and CEO of OvaGene, said the certification marked a milestone for the company.
"The clinical laboratory will become the company's primary channel through which we will bring innovation to the bedside of gynecologic cancer patients," he said in a statement. "As our advanced in-house research continues, additional proprietary gene-based tests will migrate into our clinical laboratory, allowing us to introduce a focused and comprehensive collection of assays created specifically for the gynecologic cancer patient."
The company said it plans launch profile assays in the next few months targeting ovarian, endometrial, and cervical cancers. The initial tests include a protein expression assay to predict recurrence in early stage endometrial cancers. It also will launch a gene-based profile panel for gynecologic cancer-targeted therapy evaluation and a gene-based assay for assessing endometrial cancer recurrence/drug response.
These and complementary tests are expected to launch in October.
Florida, US-based Advanced Pharma CR says decision to move to University of Miami Life Science and Technology Park (UMLSTP) was driven by demand.
The organization, an independent clinical research facility founded in 2009, will quadruple capacity through the move.
Highlights of the new facility include a 100-bed Phase I unit, a 16-bed Intensive Procedural Unit (IPU), and an additional 5,000 square feet of dedicated space for Phase II-IV trials.
Advanced Pharma CEO Samantha Amaba told Outsourcing-pharma.com the firm has seen strong demand for all types of trials, particularly for Phase II to IV studies.
“[The UMLSTP site] provides the exact platform and amenities that we have been seeking,” she explained, adding that it would further facilitate the organization’s efforts to network with the University of Miami and, its research faculty, the Jackson Health System.
This was echoed by spokeswoman ABBY Symonds who said that growing demand the organization had seen over the last few years meant that its existing site, also in Miami, had “almost been bursting at the seams.”
The International Food Safety Training Laboratory (IFSTL), a public-private partnership to provide training for food safety detection methods and regulatory standards, has opened, Waters, a partner on the initiative, announced.
The other partners are the US Food and Drug Administration, the University of Maryland, and their Joint Institute for Food Safety and Applied Nutrition.
The IFSTL, Waters said, is the world's only permanent food safety lab that provides hands-on training on food safety detection methods and classroom lessons on regulations, enabling governments and food exporters to "ensure food is safe before it reaches the table."
The laboratory, it added, will support FDA and help foreign food producers meet requirements such as the US Food Safety Modernization Act signed into law earlier this year.
Scientists from FDA and the US Department of Agriculture and university experts will conduct training sessions on how to detect both chemical and microbial contaminants, and prepare and test samples. Trainees will also be able to enroll for courses that tackle specific issues of concern to the US and other geographies.
The IFSTL, which will be operated by the Joint Institute for Food Safety and Applied Nutrition, has the capability of training 200 professional each year, Waters said.
The company has made a multi-year commitment to provide funding for the construction of the IFSTL and to assist the institute and FDA design training programs. It also is equipping the laboratory with UPLC systems, photodiode arrays, fluorescence systems, and mass spectrometers.
The creation of IFSTL was first announced in May 2010, and since then Waters has had discussions with governments in the Asia-Pacific region, Europe, India, and the Americas about creating additional hands-on training capacity, it said.
A paragon of sustainability for hospitals nationwide, the PeaceHealth Peace Island Medical Center planned for construction on San Juan Island, Wash., will purchase green power to achieve carbon neutrality. Only 7% of the 38,000 sq. ft. hospital’s source energy will come from fossil fuels. The facility is expected to cost $13 million to build. Solar heating, natural ventilation, and daylighting will help the building achieve its energy goals, while narrow building depths at clinical areas will drive daylight to main workspaces. Two wetlands on the site will absorb runoff from the parking lot. Pedestrian walkways linked to a bus stop will encourage the use of public transportation. Mahlum (architect) and Howard S. Wright Constructors head the Building Team.
Novartis began production at its new vaccine manufacturing facility in Marburg, Germany, in April 2011. The plant produces rabies and tick-borne encephalitis (TBE) vaccines and associated supplies such as media, washing operation, buffers and adjuvants for national and international markets.
It has the capacity to produce 20 million doses a year of the rabies vaccine or 40 million doses a year of the TBE vaccine or a combination of both.
The plant is part of the company's integrated facility known as the MARburg Site development (MARS) which broke ground in June 2008. The MARS is designed to serve as a Centre of Excellence for modern vaccine production.
Novartis invested about €145 million ($198.4m) in the new facility, which represented one of its single largest investments in Germany. The foundation stone for the vaccine production building was laid in February 2009 with construction completed in a record time of 26 months.
The plant commenced production in April 2011. It is believed to have added 300 jobs (including 60 new positions) to the already existing workforce of 1,200 employees in Marburg.
The facility has won the Equipment Innovation award for its laser egg opening (LEO) machine in the 2011 Facility of the Year competition organized by ISPE, INTERPHEX and the Pharmaceutical Processing Magazine.
Construction of the vaccine production unit at the existing MARS site was necessitated by factors such as on-site know-how, availability of infrastructure and the growing demand for rabies and TBE vaccines.
The original plant design was revised by the FDA, which facilitated installation of two different production lines in the same area. The lines can be used interchangeably for production of the rabies or TBE vaccines or simultaneously manufacture both.
This changeover system allows Novartis to produce vaccines as per the market demand and also reduce the cost of running dedicated lines.
The vaccine production plant has a floor area of 2,700m2 (29,052 sq. ft.). It adopts lean manufacturing techniques based on process and equipment improvement.
The plant manufactures rabies and TBE vaccines in eggs through a state-of-the-art laser egg opening (LEO) machine. The use of automatic egg opener has replaced the manual process of opening eggs which used to increase the risk of cross-contamination due to contact and egg damage.
The LEO machine eliminates cross contamination and increases productivity by ten times when compared to manual operation.
The system automatically opens four eggs simultaneously by using four independent laser beams and has the potential to open 3,000 eggs an hour while maintaining aseptic conditions.
The production of rabies and TBE vaccines involves three steps which include cell suspension, virus propagation and concentration of the inactivated virus. Egg opening is a part of the cell suspension process.
A conveyor system equipped with optical sensors transports the eggs and places them in to the trays inside the machine. The sensors detect the exact position of the tray and the egg, enabling the laser to fall exactly on the eggs present in the tray.
Turner & Townsend were the main contractors for the project. They were involved in the engineering, execution and start-up of the facility.
The integrated site occupies a total area of 8.4ha. It houses a 3,000m2 (32,280 sq. ft.) raw material storage facility, media, buffer production solutions and vaccine boosters area with 3,800m2 (40,888 sq. ft.) of floor area, cleaning operations, monitoring and control room and a power house.
The 115m long passage in the ground floor connects to all the buildings.
"The LEO machine eliminates cross contamination and increases productivity. "The MARS site also houses a new quality control building in addition to the production building. The quality control building was opened in February 2010 after 15 months of breaking ground.
It occupies an area of 8,000m2 (8,608,000 sq. ft.) and serves as a quality control centre of all of the Marburg facilities. It conducts 35,000 to 40,000 analytical tests and monitors more than 100,000 samples annually.
The warehouse occupies an area of 3,000m2 (32,280 sq. ft.) and has 4,000 pallet spaces with a provision for chilled as well as room temperature storage facilities. A long corridor connects it to the production facility.
Ugandan drugs maker Quality Chemical Industries Ltd (QCIL) is ready to manufacture HIV treatment Tenofovir in a bid to dominate the local antiretroviral market.
The plant, licensed by Indian firm CIPLA, has completed the first part of its $50 million (€36.8m) revamp, which allows it to produce 1.8billion of the one a day antiretroviral (ARV) tablets per year.
Phase two of its expansion – which is due to begin this December – will provide the capacity to make 7.2bn tablets per year in a 24 hour shift.
The Chief Commercial Officer, George Baguma said the company hopes its expansions will allow it to become a leading force for ARV production within the entire East African community (EAC). He also said that with very little competition locally, the firm is hopeful of its success.
QCIL is only the 3rd World Health Organization (WHO) pre-qualified plant in Sub-Saharan Africa.
Though the businesses’ capabilities are rare in the local area, it does face stiff competition from firms who import ARVs.
Edwin Kwesiga, QCIL marketing manager, recently appealed to the EAC ministry to consider imposing a tax on imported medicines from countries who subsidize their exports.
He told in-PharmaTechnologist: “The reason for discussion is that many contractors in India and China have generous export subsidiaries from their governments.
“Manufacturers in Africa don’t have the same support from the government. Leveling out the playing fields would allow us to compete against these companies.”
Beguma estimated that QCIL provides around half of all ARV drugs in Uganda.
Through the new capacities, QCIL plan to move into contract manufacturing.
According to Kwesiga, with the new technology, the firm already has the capacity handle outsourcing from big pharma companies looking to produce drugs at a cheap cost.
However he believes this will be further down the line, as the company is focusing not only on ARVs, but also on floating its shares once phase two of the expansion is complete.
Kwesiga added: “We will go public within the next two – three years. It will allow us become bigger players on the market.
“First of all we’ll float locally on the Ugandan market, then in Johannesburg.
“We may move into contract manufacturing at some stage too, for instance with the likes of GSK who would pay us to manufacture drugs at a cheap cost.
“We’re in discussions with some companies, but we aren’t contract manufacturing just yet.”
Akorn is doubling capacity and hiring after drug shortages sent demand for its injectables soaring.
Drug shortages have swept across the US and sent hospitals searching for other sources. Akorn said the “unprecedented and daunting problem” has driven “sudden growth” in demand for its injectables and pushed existing production capacity to the limit.
“[We have revived] products we could not sell in the past due to economic feasibility”, Raj Rai, CEO of Akorn, said in a call with investors. Akorn is expanding its Somerset, New Jersey facility but the $52m (€39m) move into India is the big shift.
All five facilities, three of which are still being built, are based at one site in northern India. When all the plants are operational capacity at Akorn will more than double. Rai said Akorn is investing $15m to complete the projects and expects to have all the facilities running by the end of 2012.
None of the plants have US Food and Drug Administration (FDA) approval but, Rai said, they are modern and follow good manufacturing practices (GMP). Akorn will install its quality systems and expects to have FDA approval by early 2014.
After gaining approval Akorn will use the capacity to meet US demand for injectables. Anti-infectives, oncology and cardiac-related injectables are opportunities, Rai said, and the Indian capacity will help Akorn in all three areas.
Addition of 230,000 sq. ft. of capacity in India is accompanied by expansion in New Jersey and hiring at a plant in Decatur, Illinois. Rai said Akorn can “barely keep up with demand” and is “hiring as fast as [it] can”.
Akorn considered outsourcing production, instead of adding in-house capacity, but was put off by bad experiences in the past. Manufacturing plants in the US were also looked at, Rai said, but Akorn was unable to find a suitable site.
Believing building capacity would cost more Akorn looked overseas for extra capacity. Entering India also provides other advantages, such as the opportunity to increase sales in emerging markets.
“The company has just started to aggressively pursue an international strategy”, Rai said. Akorn will target specific overseas opportunities and could also sell its ophthalmic portfolio globally.
Takeover of a US production site remains a possibility though. Akorn still has some cash available, Rai said, and if an opportunity became available the company would consider making the acquisition.
Apicore LLC has completed its first inspection by the FDA of its subsidiary Apicore Pharmaceuticals Pvt Ltd., in Vadodara, Gujarat, India. The successful inspection allows the company to provide its customers with APIs manufactured in FDA inspected plants located in both the U.S. and India.
To date, customers have obtained approval to market three generic drug products using APIs manufactured by Apicore. An additional 11 ANDAs have been filed referencing Drug Master Files (DMF) for APIs manufactured by the company.
Mr. Ambrose Stafford, vice president, sales and marketing said, "I feel great pride working with customers and the Apicore team to bring generic pharmaceutical products to market. Partnering
with our customers, we're creating access to affordable drugs for patients and a return on investment for our customers and investors. The successful outcome of the FDA's first inspection of our plant in Vadodara, the fifth inspection of our plants in total, is an illustration of our organization's commitment to quality in everything that we do."
Catalent Pharma Solutions has opened a new European Development and Clinical Services Lab in Swindon, UK, expanding its geographic reach for Analytical Development Services. The new lab is located within Catalent’s Swindon campus, joining the development and commercial supply operations for Catalent’s oral fast dissolve Zydis technology.
The lab systems being implemented are designed to meet regulatory requirements in the EU, U.S. and other major markets. The lab services initially offered include: raw material and finished product release testing, qualified person release, method development and validation, compendial testing, microbiology, and stability testing and storage.
“This is part of Catalent’s continuous investment to strengthen our position as the #1 global partner for drug development and formulation services,” said Scott Houlton, president of Catalent’s Development & Clinical Services business. “Our customers have asked for expanded testing services in Europe, and value the expertise and security that come from working with a company with the depth and breadth of Catalent. This expansion will enable us to better meet customer needs in Europe for analytical testing, including clinical and commercial release testing of their products.”
Quintiles says it will provide a “seamless” service to its customers through a new European headquarters in Reading, UK.
The firm – which provides clinical, commercial, consulting and capital solutions worldwide – opened the doors to its new facility a year after it first broke ground on the plans.
It previously operated its head office functions from three buildings in Bracknell, Berkshire.
By putting 500 of its total 2,000 UK staff in one building, the company believes it will achieve the level of collaboration needed to survive in the efficiency-focused market of today.
Laura Wilson, corporate communications manager for the firm said “With employees from across our four pillars being located in the same building, this move provides opportunity for greater collaboration and cooperation, to deliver a seamless service to customers across the spectrum of drug development and commercialization.
“This is particularly important in the New Health Landscape, with payers and regulators making complex decisions about a particular drug based on its safety, efficacy and value.
“Their decision-making processes increasingly rely on assessment of real world patient outcomes in addition to clinical trial data, so our move reflects this convergence in the industry.”
The latest move is part of Quintiles new focus on growing in the European market, particularly in the UK.
The firm also opened a laboratory and office in Edinburgh in 2009, as well as investing in an expansion for its research unit at Guy's Hospital, London the same year.
In the new office’s opening ceremony, Quintiles founder, chairman and CEO Dennis Gillings said: “With such a wealth of scientific, medical and commercial expertise in the UK, the move has encouraged more cross-discipline collaboration to better serve Quintiles’ customers and power them forward in the fast-morphing world of biopharma.”
Wilson put special emphasis on the importance of patient recruitment within Europe.
She said: “In the last decade, Europe contributed nearly 50 per cent of all of the patients we enrolled globally.
“Last year, Europe managed 40 per cent of the actively enrolling investigators, with the UK managing more than 200 of those actively enrolling investigators.”
Maropack AG is building a facility in Switzerland to be dedicated to biological products. The U.S. FDA inspected facility will be the first to place a Bottlepack blow-fill-seal machine from Rommelag into a BSL-2 environment. The first construction phase entails completing the main facility as well as the first BSL-2 filling suite. Three more module filling suites can be added to support additional products.
“The Maropack facility gives biological product manufacturers the option to use blow-fill-seal technology. Manufacturers of vaccines and other biological products are looking for single-dose packages, and blow-fill-seal packages offer convenience and dosing control as well as tamper evidence, minimizing the chance for counterfeiting. BFS containers feature a single contact material and are more robust than glass, minimizing breaking issues, said Tim Kram, General Manager of Rommelag.
Maropack’s installation will feature advanced aseptic filling capacity modified to accommodate products that require low temperatures such as 2-8 degrees C. “We can bring down the product temperature prior to filling to negate any heat added to the product by the blow-fill-seal process. After filling the product can quickly be brought down to refrigerated or frozen condition. ‘The process minimizes product exposure to temperatures above ambient conditions.” Also, the monolayer plastic containers do not experience the adverse thermal expansion conductions that containers made from multiple materials do, such as glass vials with rubber stoppers and aluminum crimped caps.
The new facility will enable customers to perform stability, clinical trial, and registration runs using BFS technology.
Sanofi Pasteur says it will regain lost ground in India through its new state-of-the-art vaccine manufacturing plant.
The company’s venture into Asia – a $784m (€575m) acquisition of Shantha Biotechnics – suffered a blow in April 2010 when the pre-qualification for Shan5 combination vaccine was cancelled by the World Health Organization (WHO) , due to manufacturing defects.
Now through the new facility, said to be Asia’s biggest, Sanofi’s vaccine manufacturing business hopes to capitalize on the need for quality low-cost vaccines in emerging markets.
Pascal Barollier, VP of global scientific communications said “Shantha offers a platform to localize some of the Sanofi Pasteur products which present a public health interest in emerging markets.
“Sanofi is investing within Shanta and developing its production capacities which are ongoing in order to respond to a strong demand of quality vaccines at affordable price in emerging countries.”
Sanofi Pasteur’s foray into India has been fraught with financial setbacks.
The cancellation of the Shantha-produced Shan5 vaccination for diphtheria, pertussis, tetanus, haemophilus influenza B and hepatitis B set Sanofi back hundreds of millions of dollars in sales.
But with the new plant set to begin partial operations in March, Sanofi believes it will finally see a payoff from the $300m it pumped in to expand its vaccine capabilities through Shantha.
It is expected the facility will become fully operational in October. .
“We are quite positive about the relationship with Shantha and will be participating in global tenders once the pre-qualification process is completed for low-cost and high-quality vaccines.”
Viehbacher also said the facility is just part of the company’s plans for expansion in India, which it sees as a cost effective medicine manufacturing opportunity.
“I am excited to have acquired Shantha, as it has a number of vaccines in the pipeline that Sanofi does not.”
Sanofi expects to rake in 40 per cent of its profits from emerging markets by 2015, as opposed to the current 29 per cent.
AstraZeneca has broken ground on a $200 million (€147m) manufacturing facility in China to meet soaring demand in the country.
Set for completion in 2013, the plant in China Medical City (CMC), Taizhou, Jiangsu province, will manufacture the company’s own products as well as branded generics exclusively for the Chinese market.
It will have the capacity to make both intravenous and oral solid medicines.
The investment – AstraZeneca’s largest in a single manufacturing facility – is part of the firm’s strategy to expand in what it says is one of the most rapidly growing markets.
Isabelle Jouin, part of the global media relations team at AstraZeneca, said “There’s a massive demand for medication in the Chinese market, and our recent expansions are a bid to meet that demand.
“It’s a bit early to say exactly which products we will be producing there at the moment.
“However what I can say is that we are establishing the facility in China so that we can better serve the local community. This is an investment in China for Chinese patients.”
The news is the latest in a string of developments in China for the UK-based business.
One of the largest of the new investments came in 2009, when the company broke ground on a $100m headquarters and research and development (R&D) facility at Zhangjiang, near Shanghai.
The plant, set to be completed by the end of next year, will become one of the company’s largest R&D centers outside the UK.
Mark Mallon, president of AstraZeneca, China, said that the company is now in prime position to grow in the country. IMS predicts the market will be worth $100bn by 2015, as the government invests in improving healthcare infrastructure and expanding insurance coverage.
He said of the latest advancement: “AstraZeneca has been putting down deep and broad roots in China for many years, which will be further strengthened by this $200m investment.
“Our new manufacturing facility will complement our efforts to meet the medical needs of Chinese patients with medicines that are locally produced.
“In particular, it will help us to reach out to more of the estimated 900m people in urban and rural communities who have had less access to high quality medicines.”
Since first establishing a presence in China in 1993, AstraZeneca has fast become one of the leading biopharmaceutical companies in the country, with a turnover of more than $1 billion in 2010. The new manufacturing facility at CMC reinforces AstraZeneca’s long term commitment to the country and its contribution to the Chinese economy.
The Chinese pharmaceutical market grew from $10 billion in 2004 to $41 billion in 2010 and, according to IMS, is expected to grow to over $100 billion by 2015, driven by government investment in improving healthcare infrastructure and expanding insurance coverage.
A new European Union-funded interdisciplinary institute that will house a range of life sciences and materials research officially launched its operations this week in Brno, Czech Republic.
The Central European Institute of Technology (CEITEC) is being built on a facility that will total 269,000 square feet. It is funded with €200 million ($267.5 million) from the EU's Research and Development for Innovation program.
CEITEC will be built on Brno's Masaryk University and Pod Plackeho Vrchem campuses, and it will eventually house 600 scientists and almost 1,200 students when it is completed in 2014, as well as companies from the Czech Republic and abroad.
The institute will include core facilities for genomics, proteomics, molecular and functional imaging, and structural analysis, as well as nanotechnology, single-crystal X-ray diffraction, crypto-electron microscopy, and tomography. The research will involve a wide range of studies of human molecular medicine, plant biology, and animal health and diseases.
"Our ambition is to become a European Silicon Valley in the fields of science and research and the CEITEC center surely belongs to significant projects on the journey back towards the world's elite," the Czech Republic's First Deputy and Minister of Education Jakub Hodinár said in a statement.
CEITEC's researchers will pursue a variety of programs, such as using plant systems as renewable sources of materials and compounds, studying the genesis and spread of diseases and developing diagnostics and treatments, using information and communication technologies for biomedicine, and developing advances materials and nanostructures for a range of applications.
Masaryk University's academic partners on CEITEC include the Brno University of Technology, Mendel University, the University of Veterinary and Pharmaceutical Sciences, the Academy of Sciences of the Czech Republic, and the Veterinary Research Institute.
CEITEC's genomics core facility will be stocked with tools for conducting complete experimental workflows, from sample preparation to genome and transcriptome analysis. Those tools will include high-throughput massively parallel sequencers, microarray systems, real-time microfluidic PCR capabilities, a cellular analysis system, and cell sorting technologies.
The proteomics core will cover all the steps of proteomic analysis and will house hybrid, high-resolution, and MALDI-TOF mass spectrometers and bioinformatic data processing systems.
The center also will host a plant genomics and proteomics program that will focus on studies of plant evolution, including research into genome, karyotype, and chromosome evolution, hormone regulation, epigenetic regulation, bacterial metabolomics, and plant development and stress response studies.
The molecular medicine program will use a broad array of genome analysis approaches to map genetic defects in cancer cells, develop new therapeutic approaches, apply high-throughput analyses of the human genome in predictive biology, develop molecular genetic diagnostics tools, and apply DNA sequencing to analyze small and experimental samples.
CEITEC's molecular veterinary medicine program will use genomic, proteomic, and bioinformatic approaches to analyze the causes of infectious diseases in domestic animals and the prevention of pathogens in the food chain, to study host genomics and genetics in infections and reproduction, and to conduct research into animal models of mammalian reproduction.
South Korean drugmaker Dong-A and Japan’s Meiji Seika Pharma will build a biosimilars plant in a bid to target the global Ab-based drug market.
The new 145,200sqm (1,562,352 sq. ft.) facility in Songdo, South Korea and will house R&D units in addition to manufacturing suites.
Dong-A said the facility will focus on the development of three biosimilar drug products, one of which will be a version of the breast cancer treatment Herceptin, tries of which are scheduled to begin later this year.
Dong-A also plans additional investment in Songdo to export biopharmaceutical products such as PEG-G-CSF for neutropenia, interferon beta, and diabetes treatments in Dong-A's current pipeline.
The firms are also seeking to establish a joint-venture entity to oversee operations at the site when construction is completed in 2014, although this is still under discussion.
French pharmaceutical company Sanofi Pasteur, which acquired City-based Shantha Biotechnics for Rs 3,000 crore in 2009, will soon unveil its largest manufacturing asset here.
It said the Rs 500-crore state-of-the-art vaccine manufacturing facility, stated to be Asia’s biggest, was in the final stages of completion. Setting up the facility in India is a part of the company’s plan to realize 40 per cent of its sales from emerging markets by 2015, compared to 29 percent at present. Sanofi is the vaccines division of the Sanofi-Aventis group.
Sanofi chief executive officer Christopher A Viehbacher said India was one of the company’s important strategic destinations, both as a market and an affordable medicine manufacturing opportunity. “I have brought five of the nine executive committee members to India to study the opportunities here,” he said.
The facility is expected to partly commence operations by March and become fully operational by October. Though the company started work on the project as soon as it acquired Shantha, issues related to land allotted by the government took almost a year-and-a-half before the construction began in full steam.
“I am excited to have acquired Shantha, as it has a number of vaccines in the pipeline that Sanofi does not,” he said. Sanofi has spent $300 million on expanding its capacities through Shantha, according to him.
The facility is expected to provide significant leverage for Sanofi, the world’s largest player in the vaccine space in terms of affordable production. Vaccines are among the six growth platforms identified by the company. The other five are diabetes solutions, consumer healthcare, emerging markets, innovative products and animal healthcare.
According to him, Sanofi is keen on affordable medicines, though not out of profitability considerations. He ruled out the possibility of entering into pure generics. On the acquisition front, he said the company was open to such opportunities if a suitable candidate was out there.
On drug innovations, he said big pharma companies were not doing much, compared with relatively smaller firms, as it required an element of disruptive thinking. “Those who proved productive in innovation have spent only half of what big companies have spent,” he said, adding a fundamental change in the thinking of big companies had also taken place in this respect.
He allayed apprehensions about quality issues in wake of the World Health Organization’s reservations over the five-in-one vaccine, Shan-5, produced at Shantha Biotech. He said all facilities of Sanofi were of global standards and there would be no compromise on quality and safety irrespective of their location.
“We have implemented all the corrective measures. And, we are quite positive about the relationship with Shantha and will be participating in global tenders once the pre-qualification process is completed for low-cost and high-quality vaccines,” he said.
Sanofi’s cholera and tetanus vaccines were pre-qualified by WHO last week, according to him. In the next four years, Sanofi expects 30 per cent of its total sales to come from the US, 33 per cent from Europe and the rest from emerging markets.
Eurofins Global Central Laboratory has opened a new Central Lab in Bangalore, India. Eurofins now has three central labs in the Asia-Pacific region, as well as lab facilities in the U.S., Europe, Singapore and China.
René van Erp, managing director Eurofins Global Central Laboratory, said, “Solely dedicated to providing laboratory testing in clinical trials, Eurofins Global Central Laboratory is uniquely positioned since only a few CROs offer a similar global footprint. This expansion of our global footprint allows us to bring more value to our customers, and makes Eurofins Global Central Laboratory a unique worldwide source for laboratory testing in clinical trials.”
The Bangalore facility offers a full package of safety testing, as well as biomarker testing, and is certified with the National Glycohemoglobin Standardization Program (NGSP) Level 1 accreditation. The company expects NABL and CAP accreditations within the first year of operation.
Pfizer Inc. has signed an agreement to open a pharmaceutical manufacturing plant in Saudi Arabia.
The plant will begin production in 2015 and will employ 200 people in King Abdullah Economic City in Rabigh on the Red Sea coast.
New York-based Pfizer signed the agreement with the Saudi Arabian General Investment Authority.
Active pharmaceutical ingredient (API) manufacturer ScinoPharm has gone public in a bid to raise funds for its upcoming expansions.
The contract manufacturing organization (CMO) – which makes 65 per cent of all APIs exported from Taiwan, where it is based – began trading on the Taiwan stock exchange last week.
Now with the upcoming ribbon cutting for its new plant in Jiangsu, China, the company hopes public trading will fetch the capital needed to support its growing reach.
The new factory will include a full scale R&D center, as well as capabilities for large scale production of key intermediates and two medium GMP API lines.
ScinoPharm president, CEO and co-founder Jo Shen said: “We would like to raise fund from the market for future expansion.
“ScinoPharm Taiwan, recently expanded its facility in Taiwan including adding a peptide plant. In addition, two large production lines are currently under construction.
“Meanwhile the first phase of a brand new world-class facility in Changshu, Jiangsu, China will be completed in the fourth quarter of 2011.”
Shen also said that some of the cash injection would be used towards developing new strategic alliances as well as implementing vertical integration plans.
She added: “Going for an IPO will increase our brand awareness and credibility, leveraging future sales or business to create extra value for the company.”
With founding shareholders taking up more than 80 per cent of ScinoPharm shares – Uni-President with 50 per cent, the National Development Fund with 18 per cent, and the Taiwan Sugar Corporation who hold 18 per cent – the business is on the lookout for investors to take the rest of the stock.
Of future prospects, Wu added: “We are looking for a long term, stable institutional and strategic investors.”
Solvias and RohnerChem have set up a research and manufacturing services partnership designed to accelerate the production, scale-up and commercialization of APIs.
The idea is to combine Solvias’ chemistry, analytical services and solid-state development offering with RohnerChem’s scale up and commercial manufacturing capabilities for the development and production of active pharmaceutical ingredients (API) for drug industry clients.
The new non-exclusive accord builds on a ‘long history’ of collaboration between the firms according to Solvias CEO Hansjorg Walther who told in-Pharmatechnologist.com that customers stand to benefit from a single point of contact for project management.
He highlighted “use of high throughput screening (HTS) in route screening, optimized interfaces within project work, no loss of know-how and information in a tech-transfer, process development focused on a suitable process for an industrial scale” as some of the advantages.
Walther went on to explain that: “Joint project quotes will be based on the focused project management and the optimized up-scaling process which will result in cost savings for the customer.”
He also forecast that the partnership with fellow Switzerland-based firm RohnerChem would generate additional business for Solvias, suggesting that: “As a first step we should see an increase of at least 10 per cent.”
Much of the analytical chemistry and API development work generated by the partnership will be conducted at the laboratory facility Solvias opened in January with RohnerChem carrying out scale-up and production at its plant in Pratteln, near Basel.
Solvias has no plans to increase its workforce to service the collaboration according to Walther, who said: “We streamlined our capacity and focused our expertise, so that we are ready to grow by increasing our productivity with the existing workforce.”
Telstar Group, based in Terrassa, Spain, has delivered two integrated systems for lyophilisation of aseptic pharmaceutical product in vials to the Russian firm R-Pharm and the Italian company Zambon.
For the Moscow-based pharmaceutical firm R-Pharm, Telstar has developed a high technology system consisting of a pass-through lyophiliser with a fully automated loading and unloading system. The loading side operates in a RAB (Restricted Access Barrier) environment while the unloading side is enclosed within an aseptic isolator and could contain toxic products.
For Bresso-based Zambon, Telstar has delivered two lyophilisers, each with ‘push-in/push-out’ automatic vial loading and unloading systems integrated within a RAB system. During the low-temperature loading phase the RAB must maintain precise control over temperature and humidity.
Telstar is a developer of high-technology solutions for the pharmaceutical and biotechnology industries. The firm provides integrated systems based on its own sterilization, lyophilisation, containment and clean air technologies.
A major biotechnology company has put Renfrewshire on the shortlist for a large new factory.
Life Technologies, based in California, says its workforce and track record puts it in a strong position to beat off competition in the U.S. and Asia.
The firm already employs 500 people at Inchinnan, near Glasgow Airport, many in the manufacture of cell culture that goes on to be used for making medicine.
With total sales of £2bn per year, it also dominates the DNA testing market.
The company is now moving into development of personalized medicines based on genetic analysis.
Chief executive Greg Lucier visited the Renfrewshire plant to tell managers they are competing with an American factory and a new site in China for an investment in high-tech manufacturing.
He said the scale is in the tens of millions of dollars, and it is understood that could mean as much as
£20 million.
He said China is making a major commitment to developing its life science sector, which could outstrip that of the US by 2020.
And while Europeans have invested in life sciences, sluggish growth and cuts in government spending could harm the Inchinnan plant's chances of winning the investment.
Mr. Lucier agreed with concerns raised by US Treasury Secretary Timothy Geithner in recent days that Chinese companies have been "aggressively stealing" American intellectual property.
"They want to see more home-grown companies, and there is a worry that our technologies could find their way to those home-grown companies," he said.
"We haven't had that problem yet, but it's something we're keeping our eyes on".
The biotech boss said of his Scottish workforce: "We have a skilled workforce that has been very committed and loyal through the years.
"We have customers who believe in this facility and its quality, as one that delivers on time.
"We're considering substantial investments in the type of things we do here. But it is competitive, and we could do it in other sites we have".
Asked about the advantages of Chinese labor costs over Scotland, he replied: "The labor costs wouldn't be as much of a consideration for us.
"What would be more important would be our ability to quickly get the permitting, to make it work with our existing infrastructure, what potentially would be the demand for us in the European theatre."
A feature on Life Technologies and an interview with Greg Lucier was on Business Scotland on BBC Radio Scotland on Sunday and is available on BBC iPlayer and on as a free download.
Smoking cessation drugmaker Sopharma has opened its new manufacturing plant in the Serbian capital Belgrade.
The €8m ($10m) facility, which was built in collaboration with Serbian partner Ivancic i Sinovi, will produce pharmaceutical tablets and solid dosage forms for local and regional markets. Sopharma said the new site will employ around 120 people.
Sopharma started work on the plant last year as part of a wider manufacturing capacity expansion that also saw it begin building a second oral solid dose production site in Sophia, Bulgaria.
The Sophia plant will employ around 420 manufacturing staff and be the drugmaker’s fourteenth production facility when fully operational in late 2012.
Sopharma’s investment in manufacturing capacity is unlikely to have escaped the attention of Big Pharma firms given that one of its key products, Tabex (cytisine), is a potential threat to established smoking cessation treatments.
UK drug giant GSK is also likely to be keeping an eye on developments at Sopharma given that its two smoking cessation products, Zyban and NiQuitin, are key revenue generators.
Cambridge Major Laboratories Europe (CMLE) is set to start commercial API manufacturing at its facility in the Netherlands after approval by Dutch regulators.
The Weert plant passed a pre-approval inspection by the Inspectie voor de Gezondheidszorg (IGZ) in August and, according CMLE business development director Roger, will begin low-volume production of an active pharmaceutical ingredient (API), details of which are being kept confidential.
CMLE had worked to expand the 12,500m2 (134,500 sq. ft.) manufacturing plant’s capabilities since acquiring it in 2007 when it bought Dutch chemistry services firm Chemshop.
“The site used to focus on the production of developmental APIs for Phase I and II,” he said, adding that the expansion into commercial manufacturing was borne out of CML’s desire “to stay with projects if the drugs in question made it to market.”
He went on to explain that after “some disappointments on projects for drug candidates that didn’t reach the market,” the current clients’ product looks set to gain regulatory approval and there secure CMLE long term manufacturing work.
The Weert facility will continue to produce APIs for trials and provide chemistry services, with the most recent publically announced contract being a synthesis contract with Summit Corp for a preclinical-stage antibiotic drug candidate for the treatment for Clostridium difficile infection.
The approval follows just a few months after CMLE’s U.S. parent, Cambridge Major Labs, gained US Food and Drug Administration (FDA) clearance to start large-scale API manufacturing at its facility in Germantown, Wisconsin.
The US clearance was also intended to support a manufacturing contract for a commercial drug product, although again details of the drug in question are being kept confidential.
Bosch Packaging Technology (BPT) is expanding its operations in China and enlarging its site in Hangzhou, Zhejiang province. The company will enlarge its office building by adding a third floor. The additional 1,400 square meters (15,064 sq. ft.) will provide space for about 120 new associates. The construction started in May this year and the offices will be ready for use in October. In 2010, the company doubled its production capacity, extending the shop floor area to 9,000 square meters (96,840 sq. ft.).
“We have invested $1.5 million in the new office area, making it a total investment of about $14 million since we established the site,” said Friedbert Klefenz, president of BPT.
The site's footprint has not been maxed out. In 2012, an additional 5,000 square meters will be added to the shop floor, and further expansions are planned. From its Hangzhou base, the company delivers mainly to the Chinese market.
The new office floor will be inaugurated on October 21, concurrent with celebrations of the 10th anniversary of the Hangzhou site and the 125th anniversary of the Bosch Group. In 10 years, the site has grown from 14 employees to 390, with demand for pharmaceutical systems leading the growth.
UK-based SCM Pharma is to begin offering formulation development services as part of a collaborative deal with the University of Sunderland.
The move follows a two-year project with UK-based Mitovie Pharma involving specialty drug formulation support for one of its four lead candidates. The, as yet, unannounced drug is being designed in a single use formula for the treatment of accidental overdose.
SCM said it would initially focus on providing developmental services for liquid formulations, such as emulsions and suspensions for parenteral, oral and topical administration.
It will also offer stability and analytical testing support services, along with the capacity to provide good manufacturing practice (GMP) formulation if required.
Dianne Sharp, managing director of SCM said, “The work we have carried out with Mitovie has provided us with an ideal grounding of what to expect when introducing, managing and progressing such projects.
“The main advantage of this service offering is that through our extensive experience in clinical manufacturing, we are capable of designing formulations with downstream processing in mind.
“Formulations will therefore be developed which are capable of realistic and scalable processing. We will design with the end in mind,” she said.
SCM's preclinical capability will be housed in state-of-the-art formulation and analytical laboratories at the University of Sunderland's new £8.5m ($13m) science complex, situated near to the CDMO's existing MHRA-licensed facility.
A specialist department staffed by SCM's formulation scientists has also been created to support clients needing to formulate or reformulate novel, difficult or complex formulations, including those that are potent.
According to Sharp, introducing the new service offerings represents a natural progression for the company.
“Switching contractors costs clients time and therefore money, loses the advantages of process and product familiarity, and adds risks for clients in the knowledge transfer process,” she said.
“As the industry increasingly shifts to an outsourcing model, clients are looking for contractors with whom they can develop long-term partnerships.”
The company intends to showcase its latest in-house service offerings at ICSE at the CPhI trade show in Frankfurt, Germany, and at AAPS in Washington DC in October.
Northumberland-based SCM is not the only CDMO to seize the opportunity to expand its core operations into lucrative formulation development services.
Earlier this month Patheon announced it will be “investing in the pharmaceutical development services (PDS) and expanding its presence in early drug development services.”
Anti-cancer clinical trial specialist, South Texas Accelerated Therapeutics (START), has collaborated with China's largest cancer hospital to open a new Phase I cancer research center.
Located at the Fudan University Shanghai Cancer Center, the facility is the first in China to meet the standards of all three of the major national regulatory agencies: the US Food and Drug Administration (FDA), European Product Evaluation Agency (EMEA) and China's own State Food and Drug Administration (SFDA).
Anthony Tolcher, president of US-based START, said the announcement was "just the beginning", with further developments planned for the near future.
"We plan to transform the way cancer clinical trials are done, because our patients, all around the world, need more effective medicines," he said.
START claims the facility, which was first announced in February, will help meet China's vast anti-tumor drug clinical research needs and help contribute towards the company's goal of delivering round-the-clock cancer research.
China's burgeoning economy and population of over 1.3bn people has seen the country rapidly emerge as the world's third largest pharmaceutical market. The company says cancer is "a global problem that can only be solved by a global integrated research strategy."
Jin Li of Fudan University's department of medical oncology said the center would strive for excellence from the outset.
"The Fudan-START Phase I center aims to become the most respected Phase I cancer centre in China," he said.
Carol Zhu, who will serve as CEO of START Shanghai, was similarly effusive in her assessment of the research hub and its plans for the future.
"Fudan-START Shanghai Phase I clinical research center is committed to continuing the building of START's overall international standard of clinical research platforms," she said.
"Our work here will give China the early clinical research data to compete in global drug development, to help make available China's home-grown new anti-cancer drugs abroad, and give Chinese cancer patients access to the newest anti-cancer drugs."
START Shanghai will occupy roughly 7,000 sq. ft. of dedicated space on the fourth floor of Fudan Cancer Hospital.
The center will have eight beds, eight treatments chairs with the option to expand to 12, plus a facility for pharmacokinetic (PK) study.
It is the second expansion of its kind for the San Antonio-based company in recent years, having already opened a similar Phase I test center in Madrid, Spain, in 2010.
Lonza may build a stem cell production facility dedicated to manufacturing Mesoblast products after inking an alliance.
Mesoblast has exclusive access, with certain exceptions, to Lonza facilities in Singapore for manufacture of allogenic cell therapy products. Lonza will meet Mesoblast's clinical and commercial needs for mesenchymal precursor cell (MPC) products and could construct a manufacturing facility dedicated to this task.
“The cell therapy market is anticipated to become a major growth industry with the potential to mirror the growth we have seen in monoclonal antibodies over the past 20 years,” Stefan Borgas, CEO of Lonza, said.
Lonza has committed to using its intellectual property to cut manufacturing costs for Mesoblast. Capabilities possessed by the contract manufacturing organization (CMO) will also be used to support development of second generation products.
Australia-based Mesoblast, which in December partnered with Cephalon, has the option to trigger a clause that requires Lonza to build a facility. The purpose-built plant would be dedicated to manufacturing Mesoblast products and in return the stem cell developer would buy agreed quantities from the site.
Mesoblast may also buy the facility. The option to buy the facility at a pre-agreed price is valid for two years after the plant receives regulatory approval. Details such as the size and location of the proposed plant have yet to be discussed publicly.
The deal structure is reminiscent of the agreement Lonza struck with Genentech in 2006. At the time Lonza was building an 80,000 liter plant in Singapore which Genentech gained the exclusive option to buy as part of a supply agreement.
In 2009 Roche which had recently bought Genentech, acquired the plant for $290 million (€213m) and milestone payments of $70 million.
Irish diagnostics shop Biotrin has officially opened its research and development facility in Dublin.
The facility was created as part of the company's project announced last year to develop its automated molecular diagnostics platform technology and assay reagents targeting DNA and RNA in infectious diseases.
The technology is based on loop-mediated isothermal amplification.
On deadline, Biotrin's parent company DiaSorin did not respond to inquiries, but its CEO Carlo Rosa told various publications in Ireland that "The investment is highly significant for the Biotrin Group in that it establishes the Biotrin site in Dublin as DiaSorin's corporate headquarters for molecular diagnostics research, development, and manufacturing."
Nestlé’s scheme to expand operations at its Product Technology Centre in York cleared the final hurdle at a planning meeting of City of York Council.
“Confectionery is an exciting business which moves at a rapid pace,” said Stefan Palzer, director of the technology centre. “This expansion will allow us to accelerate and intensify confectionery product development, using sustainable and high quality raw materials, innovative manufacturing processes and reliable and efficient equipment.”
Councillor James Alexander, Labour Leader of the council, said “This was a vote of confidence for a good planning scheme from an important York employer and, of course, an opportunity not to be missed for economic growth and increasing jobs.”
The York centre is part of Nestlé’s global network of specialist facilities that each focus on a different area of interest. The development work at York targets confectionery, including new chocolate products, fruit and wafer-based confectionery, coatings and chocolate ingredients for ice cream products.
The planning decision paves the way for an extension of the site’s pilot plant, where technologists test new technologies and processes at a smaller scale before moving full-scale production operations. The site’s sensory testing facility will also benefit from an extension.
Nestlé said that the planned extension has been designed to minimize waste while maximizing output.
The company added that the design will be built according to the principles of lean construction, which is a global standard for designing and constructing more efficient and environmentally sustainable production systems.
Since Nestlé’s acquisition of York-based Rowntree Macktinosh in 1988, the city has played a role in developing confectionery products for Nestlé’s global operations, as well as manufacturing household names for the UK market, including Kit Kat, Aero, and Milky Bar.
Nestlé cut around 600 jobs from its workforce in the city five years ago, prompting fears that it might withdraw altogether. However, the firm pledged to continue investing in York and currently employs around 1800 people.
“York has a long and rich heritage in the world of chocolate and confectionery,” added Palzer. “The city’s early confectionery companies pioneered the ideas and technology to produce quality products on a mass scale, a tradition which Nestlé continues today.”
In a separate development, the council granted permission earlier this year for Nestlé to redevelop land at its main factory site in York with a scheme including affordable housing, offices, retail units and community facilities. The move is expected to create nearly 600 jobs.
On September 16, 2011, Prime Minister Stephen Harper participated in the official opening of the International Vaccine Centre (InterVac), one of the largest Containment Level 3 (CL3) vaccine research and development facilities in North America.
InterVac is a highly secure facility designed to safely study and handle CL3 infectious pathogens and agents affecting humans and animals. CL3 diseases include SARS, HIV/AIDS, pandemic influenza, West Nile virus, tuberculosis, and mad-cow disease (bovine spongiform encephalopathy). InterVac features airtight rooms with interlocking bio-seal doors, specialized waste disposal facilities, and other fail-safe security measures to ensure the safety of all individuals involved in infectious disease research and vaccine development.
The facility will develop and expand Canadian scientific expertise and national capacity related to the research, development and production of vaccines. These vaccines can be marketed globally to prevent health challenges, such as world-wide pandemics, providing substantial economic benefits to Canadians.
InterVac – which is expected to become fully operational in 2012 – will be operated by the University of Saskatchewan’s Vaccine and Infectious Disease Organization (VIDO). VIDO is already recognized as a world leader in the research and development of vaccines for humans and animals. It holds over 80 patents for its innovative discoveries and has successfully developed several animal vaccines that are commercially distributed.
Support for the $140 million project was provided by the Government of Canada, the Canada Foundation for Innovation, the Government of Saskatchewan, the University of Saskatchewan and the City of Saskatoon.
Foster Wheeler AG announced that a subsidiary of its Global Engineering and Construction Group has been awarded a project management consultancy contract for the central utility facilities associated with a new biotechnology park in Nusajaya, Wilayah Iskandar, Malaysia. The contract was awarded by Malaysian Bio-XCell Sdn Bhd (“Bio-XCell”), a joint venture company between Malaysian Biotechnology Corporation Sdn Bhd (BiotechCorp) and UEM Land Holdings Bhd., which company owns and is developing the new park.
The Foster Wheeler contract value for this project was not disclosed and was included in the company’s second-quarter 2011 bookings.
The new 150-acre park is being created as part of an initiative by the Malaysian Government to develop its healthcare and industrial biotechnology facilities. The park features green initiatives such as natural lighting, passive cooling, solar energy and rainwater harvesting and will include a central hub consisting of offices, laboratories, canteen, 22 standard building shells, and larger land plots for custom-built facilities. All facilities will be supplied with chilled water and steam from a central utility facility (CUF) which will also treat all wastewater. Planned to be built in phases, the initial CUF design includes a 30-ton package boiler and a 40-ton biomass boiler which will use palm waste as its fuel. The chilled water will be produced by three 3,750 KW chillers. The CUF is being designed to accommodate two more 40 ton biomass boilers and four more 3,750 KW chillers in the future.
In addition to assisting with contractor selection for the detailed design and construction of the CUF, Foster Wheeler will review and monitor the design, construction and commissioning of the CUF, which is scheduled for completion during the second quarter of 2012.
“This award reflects value we are able to add in helping our clients to develop a robust design basis upon which to obtain engineering, procurement and construction bids, and also demonstrates Bio-XCell’s confidence in our technical and project management capabilities,” said Umberto della Sala, Interim Chief Executive Officer, Foster Wheeler AG. “Malaysia is a strategically important market for us, in which we are extending our client base and expanding our local operation to provide comprehensive, high-quality services to Malaysian and international clients.”
Foster Wheeler AG is a global engineering and construction contractor and power equipment supplier delivering technically advanced, reliable facilities and equipment. The company employs approximately 12,000 talented professionals with specialized expertise dedicated to serving its clients through one of its two primary business groups. The company’s Global Engineering and Construction Group designs and constructs leading-edge processing facilities for the upstream oil and gas, LNG and gas-to-liquids, refining, chemicals and petrochemicals, power, mining and metals, environmental, pharmaceuticals, biotechnology and healthcare industries. The company’s Global Power Group is a world leader in combustion and steam generation technology that designs, manufactures and erects steam generating and auxiliary equipment for power stations and industrial facilities and also provides a wide range of aftermarket services. The company is based in Zug, Switzerland, and its operational headquarters office is in Geneva, Switzerland.
PerkinElmer has opened a centralized newborn screening lab in Cairo, Egypt, with the support of the Egyptian Ministry of Health and Population. The firm said newborn screening will be offered free of charge to all Egyptian families.
Chemviron Carbon Cloth Division is pleased to announce the next phase in its multi-million pound investment program to expand the Durham facility.
Following the installation of a state-of-the-art-dryer in June 2008, the next phase will involve the creation of a mezzanine floor in the main factory to accommodate a new cleanroom. This area is dedicated to the production of the company’s medical device products such as wound dressings.
The new cleanroom will ensure the company maintains compliance with the ISO 13485 standard, which is awarded for the manufacture of medical products.
The final cleanroom size will measure 170 m2, (1,829 sq. ft.) almost twice the size of the company’s current cleanroom. The new facility will be a multi-faceted area containing a specific room for operator gowning then separate rooms for laminating, cutting and dedusting Zorflex products. The final facility will be constructed to ensure compliance with the Class 7 1SO14644-4 standard for cleanrooms. The contractor used for the cleanroom was WH Partnership Ltd of Gateshead, Tyne & Wear.
The position of the new cleanroom within the factory is designed to create more space on the shop floor. This will allow for the installation of additional furnaces in order to increase the company’s production capacity to meet future demand.
Global healthcare company B Braun Medical has linked up with Granton Medical to become one of the first users of the Cleanpack service for the healthcare and medical market.
Cleanpack allows users to choose from four service levels, which in addition to medical device packaging in a cleanroom environment, include ultrasonic cleaning and passivation, thermal washing and disinfection, and device assembly and sterilization services.
The service can be tailored according to customer variables such as batch size, timescale, traceability, sterilization method, shipping and overall budget.
Granton Medical operates from a 3,700m2 (39,812 sq. ft.) facility in Sheffield that includes an ISO Class 7 (10,000) level cleanroom, laminar flow booths and separate zones for different types of work or product. It is accredited to both ISO 13485:2003 and ISO 9001:2008 and a registered US FDA establishment.
B. Braun Medical, also based in Sheffield, initially approached Granton looking for a sub-contractor to undertake packing and sterilization of a range of medical devices.
Granton handled batch quantities ranging from single items to many thousands of products for the company.
Cleanpack caters for various materials, from metals and plastics to dressings and soft products, as well as different product sizes from screws and burrs to implants and instruments.
Granton Medical’s packaging solutions include peel pouches, paper/film packs, paper/paper packs, blister packs, semi-rigid blister packs, four-side seal packs and thermoformed packs. The company also claims to be the UK’s largest manufacturer of self-seal sterilization pouches.
Services include medical device packaging in a cleanroom environment, ultrasonic cleaning and passivation, thermal washing and disinfection, and device assembly and sterilization services
Preclinical CRO Porsolt has opened a new research centre and laboratory space citing industry demand for large scale studies as the key driver for the investment.
The new 5,500sqm (59,180 sq. ft.) facility, which is in Le Genest-Saint-Isle, northern France, triples the firm’s animal housing capacity for rodents, dogs and mini-pigs. It also provides more than 230 rooms for surgical experimentation.
Martine Lemaire, Porsolt's senior director of commercial and business development, set out the motivation for building the new facility, saying that: “Our clients expressed the need for long-term partnerships with service providers offering an extended range of services.
“We recognized the need to offer to our clients the possibility to continue to collaborate with us on a larger scale. We also considered this [new facility as an] important investment and a way to access new markets and clientele.”
The contract research organization (CRO) began work on the new facility in 2008 at the very height of the global economic downturn – which has to be considered a bold move at a time when pharma clients were cancelling or delaying preclinical development investment.
But, while Lemaire admitted it had been a challenging time to choose to expand capacity, she said that Porsolt was always confident of the success of the project.
“The situation was not easy for such an ambitious project, but I never doubted that it would be completed,” she said, commending the energy and ‘fight’ the Porsolt team had devoted to establishing the new facility.
Lemaire also spoke about pharmaceutical industry demand for preclinical services and was generally upbeat about the state of the market.
“After a couple of difficult years and low demand, the activity in the last few months is encouraging. Demand is certainly coming back, although time for decision-talking is still relatively slow.
And, the facility seems to be having an impact according to Lemaire, who said: “The feedback and new contracts we have received from clients that have visited our new research centre confirm that it answers their expectations,” she said, adding that “we are looking forward to a continuing increase in our work load in 2012. "
Biocon has begun work on the Malaysian biopharm plant that will serve its deal with Pfizer, and is now providing Lipitor ingredients.
When the RM 500 million ($162m) plant opens in 2014 Biocon will use it to produce biosimilar insulin for its October 2010 agreement with Pfizer. Biocon will produce biosimilars and insulin analogs for Pfizer to market.
Biocon is building the plant in the Bio-XCell biotechnology park. Last year Frost & Sullivan said Malaysia is “an ideal location to manufacture generics”. Biocon plans to expand production at the plant beyond insulin by adding capacity for other biopharmaceuticals later.
Progress setting up insulin capacity could benefit Biocon financially. “Biocon [is] eligible for additional $100m milestone payment which will accrue in phases to Biocon depending on the progress on setting up a new $160m insulin facility in Malaysia”, Motilal Oswal Securities said.
Biocon is also collaborating with Mylan on biosimilars. “We view this [partnering strategy] as a long-term positive since it allows Biocon to participate in the biogeneric opportunity without significantly depressing its profitability”, Motilal Oswal Securities said.
Biocon has also begun manufacturing ingredients for Pfizer’s Lipitor (atorvastatin calcium), Bloomberg reports . In recent years Biocon has inked deals for supply of atorvastatin to generic companies and is an established producer of the simvastatin API.
Commenting on the statins market Motilal Oswal Securities said: “Biocon has tied up with a few generic companies for the supply of atorvastatin API. We expect intense competition among generic players in this market as the product is not fermentation based and hence has low entry barriers.”
Catalent Pharma Solutions’ Consumer Health business, a market leading supplier of advanced delivery solutions including vitamins, minerals and supplements, announces the completion of the first phase of a multi-million dollar expansion of its facility in Aprilia, Italy.
Catalent is a specialist in overcoming solubility, stability and bioavailability issues for a wide-range of liquid and semi-solid formulations. Innovative products manufactured at the Aprilia site include Vegicaps® capsules, easy-to-swallow plant-derived capsules that are free from animal derivatives and gluten. “We needed to expand capacity for both traditional gelatin and Vegicaps capsules to ensure reliable supply of strong customer demand” said Gerry Purnell, European Commercial Director for Catalent’s Consumer Health business. “Customers are increasingly considering Vegicaps capsules because the technology accommodates a wide range of formulations and provides access to markets that require products free from animal derived gelatin.”
Over the last 12 months, Catalent’s Aprilia site has been expanded to include a new dedicated gelatine production area. New encapsulation machinery has been added for the production of traditional gelatin and Vegicaps capsules, increasing output by almost one third. Catalent has also added key processing equipment, such as a new turbo emulsifier to replace open roll-milling equipment. Capacity within inspection and drying areas has been increased and workflows and environments have been reviewed and enhanced to maintain high standards of safety and current Good Manufacturing Practice (cGMP).
Pfizer is planning to invest around €145 million ($200m) at its biomanufacturing facility in Co Dublin, Ireland, according to the country's Prime Minister Enda Kenny.
The investment at the Grange Castle site in Clondalkin will be used to introduce two new processing suites to the site and expand current production and product testing capabilities.
Up to 400 construction jobs will be created during the building phase, but there has as yet been no word on whether the investment will add to the tally of 1,100 workers currently employed by Pfizer at the facility.
Earlier this year Pfizer announced it was seeking voluntary redundancies at the former Wyeth facility, which is used to manufacture the pneumococcal disease vaccine Prevnar and arthritis and psoriasis therapy Enbrel (etanercept). At the time it said it was planning a refit of the facility in the coming couple of years.
"Pfizer has a long record of successfully manufacturing some of our top medicines in Ireland", said Paul Duffy, vice president external Supply, at Pfizer. "This investment will allow us help meet the needs of patients throughout the world by introducing new technologies and capabilities at Grange Castle, where we produce highly complex vaccines and biologic products for patients around the world."
Kenny said Pfizer makes "a tremendous contribution to Ireland’s life sciences industry since it first established here in 1969 and this investment is a further demonstration of the company's continuous commitment".
Pfizer has already invested more than $7 billion in its Irish operations, according to IDA Ireland. In March the company sold off a biologics fill-and-finish facility in Dun Laoghaire to biotechnology giant Amgen, saving 280 jobs, following that up by off-loading a bulk biologics manufacturing plant in Shanbally, Cork, to BioMarin.
A third Irish facility in Loughbeg manufacturing solid dose pharmaceuticals is still on the block.
Pfizer says investment in Irish manufacturing facility will boost vaccine conjugation and pegylation capacity and establish a new QC testing hub.
The US drug giant has committed $200m (€145m) to expand vaccine conjugate manufacturing capacity at the plant in Grange Castle, near Clondalkin, Co Dublin, which it hopes will be fully operational next autumn.
Spokeswoman Geraldine O’Connor said the move “will allow Grange Castle to become the primary site of manufacture for Prevenar 13,” a pneumococcal 13-valent conjugate vaccine that it gained when it bought Wyeth.
A core focus of the investment, which has created 400 construction jobs, will be the expansion of the site’s syringe fill/finish suite The U.S. drug giant will also build a new production and processing unit for pegylated products, including Macugen and Somavert.
The investment will also see the plant assume a greater role in Pfizer’s manufacturing quality infrastructure according to O’Connor.
“Grange Castle will expand its role as a centre for quality control analytical testing. Release testing for multiple new and existing products will be consolidated within Grange Castle throughout 2011 and 2012.
“New equipment will be introduced into Grange Castle laboratories. Finally, Grange Castle will become the centre for Cell Bank storage within the Pfizer Biotech network. This will involve the construction of a dedicated cell bank storage facility, which will become operational in Q1 2012.”
News of the investment follows just months after Pfizer said it would be moving the production of small batches of biologic drug candidates to Grange Castle from the facility in Shanbally, Cork that it sold to BioMarin.
The Grange Castle site's increased role in QC is also in keeping with the 'aggressive' plan to make greater use of process analytical technologies (PAT) and quality by design (QbD) that Pfizer outlined last month.
At the time the firm said the idea is to employ PAT and QbD in its manufacturing operations to move closer to real time release (RTR), enabling it to bring products to market more rapidly.
Nestlé will start a multi-million pound investment in its global confectionery research centre in York if, as expected, it receives planning approval at a city council meeting.
The Kit Kat manufacturer plans to develop its Product Technology Centre at its Haxby Road site in a move expected to create dozens of new jobs in the city.
The centre, which opened in 1991, currently employs about 150 engineers, technologists, confectioners, technicians and nutritionists. The facility is responsible for creating all new and reformulated Nestlé confectionery products, and develops equipment and technology.
A Nestlé spokesman said “We’re delighted that expansion plans for Nestlé’s global R&D centre for confectionery have been recommended for approval. Once completed, it will further emphasize York’s role as a global centre of excellence for confectionery.” The expanded research and development facility will undertake new product development and test new manufacturing equipment, he said.
The firm cut about 600 jobs from in its workforce in the city five years ago but has pledged to continue investment in the city. It currently employs about 1,800 people in York.
Meanwhile, construction has started on a £2 million chocolate-themed visitor attraction in York.
The Sweet History of York will showcase the city’s long links with the confectionery industry featuring its trading and manufacturing past.
The project is lead by visitor attraction company Continuum, which also helped to create the Jorvik Viking Centre.
Juliana Delaney, the firm’s chief executive said: “We hope to add value to the fantastic visitor experience the city already offers and give visitors a reason to come back. We hope to add over 30 new jobs to the economy and add to the early evening economy too.”
Alkermes plc has announced the establishment of its corporate operations in Ireland, with new headquarters located in Dublin. The company, including its headquarters and operations in Athlone, County Westmeath, has more than 450 employees based in Ireland and more than 1,200 employees worldwide.
Alkermes plc was created following the merger of Alkermes, Inc. with Elan Drug Technologies (EDT), the profitable, world-class drug formulation and manufacturing business unit that was formerly a part of Elan Corporation. Marking its first day of operations in Ireland, Alkermes has announced a multiyear, multimillion dollar manufacturing agreement with one of the world's top ten pharmaceutical companies.
Under the terms of the agreement, Alkermes will manufacture the company's finished pharmaceutical product, which will be produced at Alkermes' Athlone, Ireland facility. Alkermes expects this agreement to generate $15m to $20m in annual manufacturing revenues by 2016. The Athlone facility is one of three major manufacturing plants owned by Alkermes plc at which the company produces proprietary, partnered and contract-manufactured drug products.
"We are a strong, global company with a diversified product portfolio, and we look forward to accelerating our growth to create value in our business and for the patients we serve," said Richard Pops, chief executive officer of Alkermes. "Alkermes is excited to have our operations based in Ireland, which we view as a gateway to the European Union and global pharmaceutical market."
Frontage Laboratories and Spaulding Clinical Research have teamed up to target China’s rapidly expanding contract research sector.
Under the collaboration, terms of which were not provided, Spaulding will perform the electrocardiographic studies required by Frontage’s clients at its facility in West Bend, Wisconsin.
Frontage spokesman Matt Harrington said that demand for centralized cardiac studies was the key driver for the partnership, citing a 2010 study by the Tufts Center for the Study of Drug Development (CSDD) as evidence.
“[According to the study] nearly 100 per cent of industry respondents believe central cardiac labs are accurate and efficient, yet only 33 per cent of all ECGs are collected centrally using a Core Lab, resulting in higher hidden costs.”
“Clearly, there is need right now for increased adoption of Centralized Cardiac Safety. While Frontage had considered developing its own capabilities to meet the need, it chose to partner with Spaulding Clinical to provide this service more rapidly and with the highest possible quality.”
Harrington added that increasing US Food and Drug Administration (FDA) requirements for data on QT prolongation are also driving pharmaceutical industry demand for this type of service.
In return, Pennsylvania-based Frontage will provide bioanalytical method development, sample processing, formulation and trial supply services for Spaulding.
Additionally, one of Frontage’s two sites in China, located in Zhengzhou and Changchun, will be available to will be available to Spaulding’s customers.
The partnership with Frontage fits with the expansion strategy Spaulding has employed in recent months. In late August the US firm teamed up with Biocon’s India-based unit Clinigene International in a deal focused on the latter firm’s BA/BE testing, lab and bioanalytical services offering.
A few weeks earlier Spaulding used a similar approach to boost its presence in Europe, forming a partnership with French contract research organization Eurofins Optimed Clinical Research.
Sanofi Pasteur, the vaccine division of Sanofi, opened a new vaccine research and development centre in Toronto, Ontario, Canada, in July 2011. The R&D facility is located at Sanofi Pasteur's Connaught Campus and will focus mainly on the development of vaccines for cancer and pediatric ailments. It was established with an investment of $101m.
Sanofi Pasteur produces nearly one billion doses of vaccines per annum for about 20 infectious diseases. It is also developing vaccines targeting chlamydia, tuberculosis and pneumococcal.
Global demand for existing and new vaccines is forecast to double by 2016, necessitating the R&D facility development.
Sanofi Pasteur's Connaught Campus in Toronto is the company's headquarters for Canadian vaccine activities. The 54-acre campus accommodates about 40 buildings and a working space of one million square feet.
The site employs about 1,100 people, of which 700 are involved in advanced manufacturing and 300 in R&D.
Sanofi Pasteur produces tetanus, polio, diphtheria, pertussis and BCG vaccines from the Connaught Campus. It accounts for about 20 percent of the company's global vaccine sales and is the only producer of five-component acellular pertussis combination vaccines in the world. It includes facilities to reserve pediatric vaccines for domestic markets.
"The R&D facility is located at Sanofi Pasteur's Connaught Campus."The Connaught Campus also provides filling and packaging of influenza vaccines. About 95% of its production is exported to more than 90 countries, including major U.S. and European markets. Sanofi has invested about $600m in the campus since 2000.
Construction of the new R&D facility has established the campus as Sanofi Pasteur's North American Centre of Excellence for analytical and bio-processing research and development.
The proximity of the R&D centre to the manufacturing site locations will also aid commercial production of newly developed vaccines.
The new 145,000ft² facility is also called Building 95. Three floors of the four-floor building are occupied by research laboratories and offices.
The facility consolidates the research activities of Sanofi Pasteur under one roof. It brought together state-of-the-art technologies and 300 researchers, scientists and skilled technicians.
The facility is designed to enhance the security and comfort of the employees working in the labs.
The R&D laboratories at the facility are available for tissue culture, microbiology clinical cell culture and vet culture. Elisa and radioisotope labs are also part of the facility.
The mechanical rooms are located in the basement and penthouse. The labs are supported by special piping systems for clean steam, carbon dioxide, vacuum, compressed air and RO water.
The facility will serve R&D of bio-processing to develop and test viral, culturing bacterial and cell line products; optimize purification processes; and improve product stability. It will also provide batches for development and clinical trials.
The analytical R&D facilities will support development and validation of testing methods. It will also enable development and testing of vaccine batches produced for clinical trials.
Data collected on the efficacy and safety of vaccines from stability and release tests will be included in the regulatory filings. The results will support licensing and marketing of the final vaccines.
Building 95 incorporates several environmentally friendly features to reduce consumption of power and water.
"It was established with an investment of $101m."They include energy efficient building façade, installation of occupancy sensors, efficient water fixtures and lighting systems, a heat reclamation system and rainwater recycling for irrigation. These features are expected to provide power savings of 743MWh/y, mechanical savings of 3290MWh/y and about 857,000kg/y reduction in CO2 emissions.
The project is aiming at the Leadership in Energy and Environmental Design (LEED) Green Building Rating System certification.
Construction work on the R&D facility started in April 2008 and was completed in 2010. The facility was designed by G&G Partnership Architects.
Vanbots Construction Corporation was the general contractor and was responsible for project management. Banerjee & Associates was the structural engineer. Crossey Engineering was the mechanical and electrical consultant engineer.
The Ontario province provided $13.9m towards the development of the facility. The funds were contributed as part of the Next Generation of Jobs Fund, a Biopharmaceutical Investment Program (BIP). The project will enable future jobs to be secured in Ontario.
GSK Montrose is a 45 acre site located on the coast in Angus, Scotland. The site performs primary manufacture of active pharmaceutical ingredients and specializes in respiratory, steroid and anti viral products that are shipped to customers worldwide.
In the summer of 2009, GSK had an immediate and urgent requirement to rapidly increase its production of the anti-flu drug Relenza in response to a potential global health crisis, a flu pandemic.
In order to facilitate this requirement, the refurbishment and upgrade of an existing installation was agreed for the GSK Montrose plant. The Dec Group's technology, the Powder Transfer System (PTS), was already well established on the site and used in many production areas for the safe charging of potent powders to reaction vessels. So it came as no surprise that the PTS would be used on this project. There was also now, however, a specific and urgent challenge for GSK Montrose to rapidly increase the production of Relenza, namely to charge up to 20 10kg bags in less than 20 minutes whilst protecting the operator. So something new was required.
Stewart Doyle, engineering director at GSK Montrose, says: "The site had successfully used Dec systems for charging powders to reaction vessels in a safe manner for a number of years. The Dec systems are easy to use and provide both process safety and eliminate occupational hygiene risks for the process operator. The Dec team had always provided good technical support and responded to manufacture systems in a short lead time, so it was automatic that we turned to Dec to meet our requirements."
During 2008 some development had already been completed on Dec's new bag discharge station, the Dec Isocharge, between Dec UK staff and another GSK site. In the latter development stages independent powder trials were conducted and containment levels of <1microg/m³ (8hrTWA) were achieved with an open system. It was this open system that was so vital to GSK Montrose because of the limited amount of time available to charge the full load of powder to the vessels.
The Dec Isocharge is best described as a hybrid design, crossing laminar flow technology with a glove box isolator. This means that the operator has the protection that a gloved visor provides and also the flexibility of an open laminar flow booth. The 'bullet' shape of the main chamber is designed so that a minimum air velocity of 0.7m/s is achieved over the open bag entrance at all times but as the air moves through the chamber it slows to less than half this speed.
In conjunction with the operator's controlled pouring of powders in to the suction cone, there is little dust generation within the chamber.
The operator can load the chamber through the open end and then use the gloves to open the bags and pour the contents into the discharge hopper located in the base of the chamber. The powder is then discharged from the hopper by means of the PTS (attached to a nozzle on the receiving vessel) whose controls are linked to the Isocharge control panel. This also has the added advantage that only one Isocharge is needed for a number of reactors. In this case two stations were supplied to feed three reactors with different powders. A door is provided on the Dec Isocharge, but is only used to prevent splashes during cleaning with the inclusive wash gun (an optional Dec spray ball was not deemed necessary). The washing fluids from the station are then removed either by sucking with the PTS or via a drain.
Chris Broadbent of Dec UK says, "GSK were delighted with the performance of the Dec products in helping the site to meet the challenge to produce Relenza on such a huge scale and tight timescale with the safety of their operators maintained."
Stewart Doyle says, "The Dec systems were delivered on time and have performed to our exact specification. Using the Dec systems, more specifically the Dec Isocharge, Montrose was able to start up the expanded process on time and provide Relenza for customers across the globe. The systems have operated safely and provided occupational hygiene protection for process operators who can work without the need for protective air suits.
"GSK Montrose has continued to use Dec products since this plant expansion, and is eliminating air suit operations across the site by using Dec systems for both powder and liquids charging to reactors."
PharmIdea is an independent pharmaceutical company located in Latvia (EU). We offer contract manufacturing as well as contract development of pharmaceutical products with the main focus on sterile products (solution or freeze-dried formulation) in vials. PharmIdea's manufacturing site is GMP certified to also produce cytotoxic products.
PharmIdea's services include incoming materials control, small batch size manufacturing under GMP conditions including manufacturing of investigational medicinal products, in process control as well as final product release. Altogether three different manufacturing processes can be employed in the sterile manufacturing facility:
aseptic filtration with terminal sterilization
aseptic filtration and processing of solutions
freeze drying.
The average batch size is 1,500 vials for freeze-dried products and 3,500 vials for solutions. The volumes of vials available are 1ml–100ml. PharmIdea applies class A (ISO 4/5) isolator to ensure vials processing under aseptic conditions. Modern manufacturing and analytical equipment and a GMP approach guarantee an efficient and reliable service.
PharmIdea's clinical trial material (CTM) manufacturing services include:
product formulation development
investigational medicinal products GMP manufacturing for Phase I - III studies
clinical trial material labeling, release, dispatching and shipping
final dosage forms (FDF) development services.
PharmIdea formulation services include:
pre-formulation and formulation of sterile solutions, freeze-dried forms as well as solid oral dosage forms (tablets and capsules)
lab-scale batches manufacturing
scale-up and validation batches manufacturing under GMP conditions
stability studies according ICH guidelines
container closure integrity tests
CTD format dossier development for product registration in the EU
active pharmaceutical ingredients (API) development.
Gerresheimer Regensburg GmbH has announced plans to increase production of its medical injection moulders four-fold in its China facility over the next 18 months.
The German packaging supplier will increase its capacity from eight injection moulding machines – used to produce drug delivery systems like inhalers – to 30, and from 100 employees to 350, at its Dongguan facility by the end of 2012.
Stephane Pianigiani, managing director of Gerresheimer Medical Plastics Systems Dongguan, said that the expansions in China are all part of the company’s plans to reduce production costs by working in an up-and-coming area.
He said: “There’s always been reluctance from customers in the medical device industry to come to China, but that is changing,”
And according to Pianigiani, the company also plans to open another manufacturing site or medically-oriented injection moulding facility in the country.
Of their growth strategy, he added: “In the medium to long-term we will not be a leader in China with only one plant in Dongguan.
“By January 2013, we will have another plant running.”
In November last year, the company opened a representative office in Mumbai, India, and said it was part of its plans to capitalize in the emerging market.
The office provided the firm with a new legal entity, giving the company the opportunity to operate within India in the future.
Jens Kürten director of corporate communication & marketing said: “We see a lot of opportunities, not only in India, but in South America, China, Russia, and other countries.”
Future plans for Gerresheimer also include providing more drugs for the areas local to their facilities.
Pianigiani added that over 95 percent of the products made in Dongguan are exported to North America and Europe, and now the business plans to change that.
“We definitely see opportunity with the size of the population and the portion of the population that can afford that product,” he said.
Contract manufacturer CMC Biologics has ramped-up bioreactor capacity to meet demand for biologic drugs for Phase III clinical trials and beyond.
The Danish contract manufacturing and development organization (CDMO) has installed a 2,000 liter Thermo Scientific HyClone single-use bioreactor (SUB) at its manufacturing facility in Copenhagen, which it aims to have up and running by December.
Gustavo Mahler, COO of CMC Biologics, said: "The expansion of the facility to include the 2,000L SUB will allow us to meet increasing demand for producing biologicals for Phase III and into market supply.”
Mahler added: "We have worked closely with Thermo Fisher Scientific to bring this project in on time and on budget."
The investment comes just over a year after CMC boosted bioreactor capacity at its manufacturing facility in Seattle, Washington in a move that also involved close collaboration with Thermo Fisher.
It also follows hot on the heels of CMC’s deal with Oxford BioTherapeutics (OBT), which saw the Danish CDMO grant the UK developer access to its CHEF1 cell line-based expression system for drug research and development applications.
At the time OBT said it would use the expression technology to further the development of candidate anticancer antibodies in its OGAP proteome database.
Jon Terrett, OBT's Chief Scientific Officer, said: “By licensing industry-leading technologies, such as the CHEF1 system, OBT further increases its research and development capabilities in line with our strategy to advance our pipeline of therapeutic antibodies toward clinical development.”
Covidien, a leading global provider of healthcare products, announced the creation of its flagship research and development (R&D) center for China, which will be based in Shanghai. The center, which will be fully functional by July 2012, will house two of Covidien's emerging market R&D organizations:
Tailored Products – will identify and develop products that are customized to meet the needs of China and other countries in the emerging markets
Breakthrough Platforms – will utilize the unique skill sets and expertise of employees in Asia to create and develop new medical device technologies.
"The establishment of this R&D facility is a first for Covidien in China," said Dr. Dong Wu, Vice President, China R&D, Covidien. "We will be undertaking a range of cutting-edge activities that will create innovative products to help physicians improve the health of the people of China and of other markets worldwide."
The 25-member R&D staff that Covidien currently employs in Shanghai will increase to more than 300 once the new 100,000-square-foot facility is completed. "At the core of our R&D facility will be our Laboratory and Operating Theatre Simulation Suites that will enable healthcare professionals to visit the center and be involved in the actual design and development process of future medical devices," Dr. Wu added. "This collaborative approach will help us create products that are best suited to the needs of doctors in China and in other countries in Asia and, therefore, will be more likely to produce better patient outcomes."
To mark the establishment of the R&D facility, a memorandum of understanding was signed between Covidien and the Shanghai Caohejing Hi-Tech Park. "We are very pleased Covidien has chosen Shanghai and CHJ to be the base of the Company's inaugural R&D Center in China," said Mr. Enliang Gui, Vice President of Caohejing Hi-Tech Park and Chairman of Pujiang company. "We are very proud of our long-standing partnership with Covidien, which has also chosen our park as the location for both its regional training center for healthcare professionals and its commercial operations."
Mr. Alex Gu, Vice President and General Manager, Covidien China, said, "This R&D Center is the latest in a series of China-focused initiatives that clearly demonstrates our commitment to this very important market for Covidien. We look forward to a very successful future here."
DaVita Clinical Research has opened a biorepository to help drug discovery teams develop personal medicines by understanding patient populations.
Samples are fed into the biorepository from patients visiting 1,700 sites across the US to give data on treatments, prescriptions and hospitalization, as well as standard information on age, gender and morbidities.
“It is the characterization of our data and the annotation of this data to our sample sets that distinguish our biorepository services from the majority of the industry”, Mahesh Krishnan, vice president of clinical research at DaVita, said.
Kidney-focused CRO (contract research organization) DaVita can give clients sample sets targeted to specific patient populations across a range of therapeutic areas. Samples are ready for proteomic, genomic or metabolomic research.
Accessing this can help support development of personalized medicines and biomarker discovery and validation. DaVita also expects clients to use the biorepository to improve drug safety and clinical trial design.
Supporting research in these areas could also feed into other areas of DaVita’s business, such as biomarker analysis, health economics and outcomes research, and clinical development.
Samples are collected from consenting patients using IRB- (institutional review board) approved protocols and shipped to the biorepository. At the facility DaVita inventories the samples into its laboratory information management system (LIMS) before storing them in -80°C freezers.
All samples are de-identified to support confidentiality and compliance with regulations.
Addition of the biorepository follows the expansion of central laboratory capacity over the summer. Investments at the Florida site focused on analytical methodology, information technology and instrumentation.
“We are confident that, over time, our continued investments in both physical assets and an expanded assay list will position us to be a prominent player in the clinical trials support business”, Kevin Goudreau, vice president of commercial development, said.
CRO Pharmaron is housing Merck Serono’s Chinese laboratory at its 600,000 sq. ft. Beijing campus as part of a partnership.
Merck Serono will use the facility for clinical bioanalysis and biomarker characterization to find gene mutations among the Chinese population and ultimately develop personalized medicines. Being at the Pharmaron campus will give Merck Serono contract research organization (CRO) support.
“Through this unique partnership, we are providing Merck Serono with a favorable environment as well as qualified staff to lead their drug development programs for local and regional clinical trials against local diseases and unmet medical needs”, Boliang Lou, chair and CEO of Pharmaron, said.
SCM Pharma will launch formulation development services following the acquisition of new facilities through a collaboration with the University of Sunderland. SCM Pharma’s preclinical capability will be housed in the formulation and analytical labs at the University of Sunderland’s new science complex. The launch follows a two-year development project with Mitovie Pharma, under which SCM provides formulation support for one of its four lead candidates.
Michael Hawthorne, chief executive officer at Mitovie Pharma, said, “Like SCM Pharma, we generally deal with more complex and challenging products. This is why we have been working closely with their team to help fast-track the development of one of our key products. The knowledge acquired by SCM Pharma during this formulation process will be vital in helping us quickly tech transfer our product into clinical trials manufacturing within their cGMP production facility.”
Initially, SCM will provide developmental services for liquid formulations, including emulsions and suspensions for parenteral, oral and topical administration using either proprietary or customers’ novel delivery systems. Stability and analytical testing support services will also be provided along with GMP formulation.
Dianne Sharp, managing director at SCM Pharma, said, “This is a huge milestone for our business and what better stages than ICSE and AAPS to simultaneously launch this core new service to the European and North American markets. With our track record of consistently supplying products for clinical trials and niche commercial markets, we can now support clients from start to finish, which means lower tech transfer costs, quicker time to market and our personable service throughout the process.”
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