PHARMACEUTICAL/BIOTECHNOLOGY
INDUSTRY UPDATE
November 2010
McIlvaine Company
TABLE OF CONTENTS
Construction Underway at University of Rhode Island
Cancer Genome Institute at Fox Chase
University of Louisville Dedicates New Biosafety Lab
Vaccine and Gene Therapy Institute Begins Construction
Ben Venue has Completed Expansion
BioSolution’s New Facility in Maryland, USA
CMC Biologics Seattle Expansion
Protea Expands Bioanalytical Laboratory
CoreRx Boosts OSD Capabilities
UTSA Wins $12 Million Minority Research Lab Grant
Penn Genome Frontiers Institute to Launch Centers
UCSD Gets New Network Biology Center
Brentwood Nears Completion of Cleanroom
IntegraGen Opens US Subsidiary
Teva Pharmaceuticals Gets New Philadelphia Facility
La Jolla Institute to Develop Genomics Research
CU OK Fifth Wing of Biotech Building
Univ. of Maryland Gets Gift to Support Research
Novartis Plans Investment in U.S.
BioTime Expands Corporate Headquarters
WVU Gains $5.5 Million for Neuroscience Center
GATC Biotech Opening Laboratory
Reinnervate Moves into New Facility
Aesica Building High-Potency Facility
PharmaZell Continues API Expansion in India
New Labs for Replacement Human Tissue
Regeneration at a Dublin Stem Cell Facility
New Hospital Uses Modular Construction
Arrow Medical Expands Cleanroom Space
IBM to Build Lab at University of Melbourne
Aesica Gets New High Containment Facility
Texas Children’s Hospital Expands
Genentech's Facility Named Facility of the Year Overall Winner
Maccine Opens Primate MRI Centre
Jacobs Constructs Porton’s Plant in China
Eli Lilly to Open Diabetes Research Center in China
Sanofi-aventis to Acquire BMP Sunstone in China
ATMI LifeSciences, Austar Complete Beijing Facility
Partners Break Ground on Australia's Translational Research Institute
Smith & Nephew completed a $25 million global distribution center south of the Memphis International Airport in October 2008, then followed through with another $42 million investment to convert an office complex on Goodlett Farms Road into a centralized hub for research, marketing and medical education.
But the biggest symbol of economic renewal has been the new $340 million Le Bonheur Children’s Hospital.
“A lot of people felt warmhearted that something so wonderful was coming out of the ground,” said Donna Abney, vice president of strategic planning for Methodist Le Bonheur Health Care. “Maybe it was just against the backdrop of such a tough time economically that it would be more noticeable. There was just sheer pride that Memphis could do it. It was a sign of innovation and forward movement, vision and bravery and not fear – all those good attributes that we want to be associated with.”
When Abney says “we,” she is speaking of the greater Memphis community. Local residents and organizations contributed $100 million toward the cost of the hospital.
While giving to health care institutions plunged 11 percent nationally during 2009, it remained strong in Memphis.
The gifts to Le Bonheur Children’s Hospital have given back. Its construction was a $726 million boon to the city’s economy, while the hospital itself has a $544 million annual impact, according to a study by Cyril F. Chang, a professor with the University of Memphis who also serves as director of health care economics for the Methodist hospital system.
The children’s hospital is not the only big investment in the Memphis Medical Center. Completed or current construction projects in this Downtown district exceed $1.3 billion. They include investments by the VA Hospital, St. Jude Children’s Research Hospital, University of Tennessee Health Science Center and the Memphis Bioworks Foundation.
The most ambitious of those projects is Bioworks’ $450 million UT/Baptist Research Park, which is a six-building complex targeted for completion by 2015.
“The stakeholders in the Medical Center see the big picture and they work together,” said Beth Flanagan, director of the Memphis Medical Center. “You have to remember they are competitors all sitting together and working together to make it a better place. It helps when we go to our federal delegation. It’s all of us as one group saying this is important instead of just one institution.”
The growth of the Memphis-based health care industry has also brought benefits to the greater Mid-South. Baptist Memorial Health Care invested $165.1 million from 2007 to 2010 to upgrade facilities in three states. Its biggest project is a new hospital in Jonesboro, Ark., a town of almost 70,000 about an hour from Memphis.
“When all is said and done in Jonesboro, we will spend approximately $400 million there,” said Don Pounds, chief financial officer for the Baptist system. “We have already invested in the purchase of the acute care hospital, and there’s a surgical hospital that we bought in 2009. Then in 2010, we bought the NEA Clinic. We’ve invested $100 million thus far with another $300 million approximately to go.”
Bids for the project were scheduled to go out this month, and a general contractor for the project could be selected in early January. Methodist is also building a new hospital in the Mid-South. Abney said she expects construction on a $137 million hospital for Olive Branch in DeSoto County to begin in early to mid 2011.
Besides the new hospitals, expansions are also occurring. Dallas-based Tenet Healthcare Corp. is spending $34 million for an addition to Saint Francis Hospital-Bartlett that will add 96 beds and bring another 155 employees to its payroll by the first quarter of 2012. Early next year, the hospital is scheduled to complete its new outpatient diagnostic imaging center, a $5 million investment that will create 10 jobs.
In addition to building a new children’s hospital, Methodist Le Bonheur Healthcare is also spending $121 million to expand its Germantown hospital. It has completed the $51 million Women’s and Children’s Pavilion, which accounts for 108,000 square feet of the 218,000-square-foot expansion.
Despite all the local infrastructure investment, executives with the hospitals said it’s a misconception to think that health care is recession proof.
“As we saw the economic deterioration of a couple of years ago, our board of governors and our senior management sort of looked at what we had on our plate over the next five years,” Abney said. “We made a decision to move into a very fiscally lean mode to survive the couple of years through what we saw coming that we have definitely experienced.”
As people lost jobs during the recession, they also lost their health insurance. The payer mix changed, making it more difficult for hospitals to determine revenue streams. The Regional Medical Center at Memphis, which already had a low percentage of patients with health insurance, was floundering because of cutbacks in state subsidies to the safety net hospital.
Now on more solid financial footing, The MED can make investments. This month, it will complete a $200,000 project to convert 112 semi-private rooms into single-bed units. The hospital’s board just approved a budget with $20 million in capital outlays, including money for an electronic health record system.
Going forward, economic leaders are looking for the health care industry to continue or even hasten growth. Orthopedic companies stand to benefit from an economic recovery because more people are likely to undergo elective surgery, such as hip and knee replacements, if they feel secure about taking time off from work.
St. Jude over the past two years has acquired more property adjacent to its campus for future expansions, but the hospital’s most ambitious work continues to be research.
The infrastructure is now in place for Memphis to grow in other life science fields. The city is connected to high-speed research networks through the Memphis Coalition for Advanced Networking.
The Memphis Bioworks Foundation added incubator space during the recession by expanding into two more floors and adding lab space. Another research facility, the $25 million Regional Biocontainment Laboratory was completed last year. During the recession, Bioworks has doubled the number of startup ventures that it is assisting.
“Today, we’re looking at about 23 or 24 new companies that we’re working with – new organizations that are either here in our building or they are located in the community,” said Brandon Wellford, chief financial officer of Bioworks. “We’ve seen a tremendous number of new ideas, new companies that have started up over that time.”
The final steel beam of the new pharmacy building’s exterior was lifted into place at the University of Rhode Island, marking a milestone for the construction.
The building will be five stories tall and will have a 148,000 square foot area. Students can also look forward to having new labs and classrooms as well as an auditorium that seats 160 people, according to a press release.
"Our next steps will be to cover the roof and walls, and put up temporary plastic so that we can proceed with the interior fit out," Paul Depace, director of Capital Projects, which oversees construction projects on campus, said.
The project of putting up the new pharmacy building has been an easy process so far other than one small setback when the design plan changed, Depace said. The new design now includes a manufacturing practice facility that was previously not part of the building's proposed design.
"The process has been going very smoothly," Depace said. "We have a great project manager that is overseeing the project from the university. We also have a good architect from Boston and well-known contractors from Suffolk Construction Co. Inc. in Boston. For a project of this size, the team has been doing a good job of moving toward completion and we expect the new building [to be] ready for use in the in 2012."
The $75 million project is now becoming a reality for students at URI. According to a URI press release, the $65 million is being paid for in general obligation bonds which were approved by voters in 2006. The university is searching for $10 million in donations to finance the rest of the building.
The new pharmacy building, being built on the north section of campus, will replace the Fogarty Health and Sciences building and will be home to many courses in the pharmacy and biotechnology fields. The building will be one of the most advanced on campus in terms of smart technology and energy efficiency, along with becoming the most "green" building at URI.
The new College of Pharmacy building will be the university's largest academic building and is expected to be completed by the spring semester of 2012.
Fox Chase Cancer Center plans to raise $30 million over the next six years to establish and equip the new Cancer Genome Institute it is forming with human geneticist Dietrich Stephan, with the goal of creating the nation's largest center devoted to cancer genome sequencing, said Jeff Boyd, Fox Chase's vice president of molecular medicine.
The new institute will combine new equipment, namely 100 next-generation genome sequencers, with the cancer center's resources, and the molecular biology know-how and connections of Stephan and his Institute for Individualized Health — the word "Ignite" has been dropped from his institute's name — with the intent of someday treating all of Fox Chase's cancer patients through personalized medicine, Boyd said in an interview.
Among Fox Chase's resources, he said, are available space; the cancer center's presence in a major Northeast metropolitan area close to academic institutions and pharmaceutical giants; the presence of an NCI-designated Comprehensive Cancer Center since 1974, the first year the distinction was awarded; top-tier doctors and researchers; a biospecimen repository; and a Phase 1 clinical trial program.
Stephan, said Boyd, brings to the new institute contacts with potential partners, including some with expertise in information technology, computational technology, and computational biology.
CGI expects to generate revenue through government grants as well as through contracts with industry and academic partners.
"We'd be looking at RFAs from the government that only a very large sequencing center would be in a position to handle," Boyd said. "But it's impossible to say at this point until we see what's out there, what's available, what the government decides to do in terms of requests for applications, to really say exactly what projects we'd be handling, except those involving human cancer and high-throughput sequencing."
While large numbers of sequencers exist in a small number of research centers — including the Broad Institute, Washington University's Genome Sequencing Center, and Baylor College of Medicine's Human Genome Sequencing Center — CGI says it will maintain the distinction of being the largest center exclusively devoted to cancer genome sequencing.
Boyd is also executive director of Fox Chase's Institute for Personalized Medicine, which consists of a single Illumina genome sequencer and five staffers. IPM will be integrated into the new Cancer Genome Institute, which he said expects to take delivery on the first "15 to 25 instruments" of its 100 planned sequencers, as well as hire "25 to 30" staffers, during the next six months.
That's approximately how soon Fox Chase hopes to raise the "major" gift Boyd said would be needed to launch CGI. "Ideally we'd be looking for a major transformational gift from a donor which would clearly represent a naming opportunity … but of course, we're certainly open to smaller gifts that would get us to the same sum."
While IPM has had more of a translational focus, the new Cancer Genome Institute will start out primarily as a research center and evolve over time into a full-service center for cancer genomic research and clinical services.
"We're not quite there in terms of being a clinical service yet. Patients walking through the door are not having full genome sequences yet," Boyd said. "In our six-year plan, we expect to start transitioning from research and development into the clinical space within two to three years."
Over the next five years, the Cancer Genome Institute will grow to 75 staffers and the full 100 sequencers occupying a full floor within Fox Chase's Robert C. Young, MD, Pavilion, where work on a $70.5 million, 120,000-square-foot addition to what was previously called the Cancer Prevention Pavilion was completed last spring.
The 75 staffers will include "probably in the neighborhood of a dozen, 10 to 12" principal investigators who will be devoted exclusively to CGI research, and will not be considered part of Fox Chase's faculty of about 100, Boyd said. Additional staffers will include biostatisticians, genetic counselors, and ancillary positions.
Still to be decided, Boyd said, are decisions on what areas of cancer the new institute will study, and on what type of genome sequencers CGI will use. "We're leaning toward Life Technologies and the ABI platform based on everything I know about the direction they're headed and the quality of their product," said Boyd.
Stephan's old Ignite Institute joined with ABI last January to announce that the institute would purchase 100 SOLiD 4 machines. That transaction is "history," Boyd said, while ABI has announced that many of its SOLiD 4 customers who bought such machines in recent months would be upgraded to the company's new SOLiD 5500 series machines.
Other operations would be outsourced. CGI will use cloud computing for its computer and information technology needs rather than maintain a room full of servers, while academic partners to be lined up by Stephan will handle the institute's computational biology.
University of Louisville officials dedicated a $44 million biosafety lab on the school’s Shelby Campus that will focus on developing vaccines, treatments and cures for some of today’s infectious diseases.
“Not only will it create more high-tech jobs and help us attract more federal research dollars, but new drugs, tests and vaccines will create licensing opportunities and spur creation of new, locally-based technology companies,” said U of L President James Ramsey, during the lab’s dedication ceremony.
The 50,000-square-foot Center for Predictive Medicine, off Hurstbourne Parkway near Shelbyville Road, is designed to allow scientists to study emerging infectious diseases and develop vaccines, treatments and cures, said Colleen Jonsson, the center’s director.
The lab is scheduled to begin operating by the end of the year.
The center is among 14 regional labs that the National Institute of Allergy and Infectious Diseases has funded since the terrorist attacks in 2001.
The institute awarded U of L a $22 million grant for the lab in 2005, with the university providing the additional $12.6 million to design and build the lab. Earlier this year, the university received an additional $9.8 million through the American Recovery and Reinvestment Act to expand the study of viruses at the lab, university officials said.
The center will house 18 researchers, and will allow scientists from Kentucky and surrounding states to study diseases, such as flu and plague in a secure environment. Reseachers, officials said, will study Level 3 biological agents, which include various bacteria, parasites and viruses that can cause severe to fatal disease in human, but for which vaccines and other treatments exist, such as West Nile Virus.
No Level 4 agents, those that can cause incurable diseases like the Ebola virus, will be handled at the U of L lab, officials stressed.
When it was first announced the lab would be build, some residents in the surrounding neighborhoods expressed concern about its safety.
U of L officials, who held 11 forums with the neighbors between 2004 and 2008 to answer questions about the lab as well as the development of the Shelby campus, said the lab is equipped with numerous safety features, including alarms, cameras, a crash-resistant gate and 24-hour security personnel. Infectious material is kept in special cabinets; any such material to be discarded would be destroyed by heat before leaving the lab. It also has a 25,000-gallon underground fuel oil supply to ensure it continues to operate should the power go down.
“This facility was designed and built according to the strictest safety standards,” said Ramsey, who added that U of L “appreciates the support from everyone in our neighborhoods.”
The center is the university’s newest research building, and also is the first building to be added to its Shelby Campus, which is in the process of being redeveloped into the ShelbyHurst Research and Office Park. While the university has sustained significant state budget cuts over the past decade, Ramsey said during the dedication, the school is committed to meeting its state mandate to become a premier metropolitan research university.
The Vaccine and Gene Therapy Institute of Florida has begun construction on its 100,000-square-foot biomedical research facility at the Tradition Center for Innovation in Port St. Lucie.
The biotech firm's new three-story campus, which is slated to be finished in 2012, will house scientists working on such infectious disease threats as AIDS and Dengue fever, and will focus more on human clinical trials than its parent campus at Oregon Health & Science University. The design, building, permitting and equipment costs for the facility come to $48.8 million, a spokesman said.
VGTI Florida, as it's known, has about 50 employees in a temporary facility on the third floor of the adjacent Torrey Pines Institute for Molecular Sciences building. It plans to have about 200 employees by 2018 with an average wage of $60,000 per year.
"This is the opportunity to lay the foundation for what will become one of the leading scientific facilities in the world," Daniel Dorsa, chairman and board of directors of VGTI Florida, said during a ceremony commemorating the pouring of the foundation for the new facility. "Within two years, we're going to have a building here. You're potentially close to the site of what might be the discovery of the treatment or cure of HIV."
Persuading VGTI to open a campus in Port St. Lucie was a coup for the city and state. The institute was lured in 2008 with $60 million in incentives from the state's Innovation Incentive Fund and a $53 million investment from the city of Port St. Lucie; the agreement to open the campus more than doubled the city's biotech industry.
Gov. Charlie Crist's office, which signed off on the $60 million in incentives, has estimated that the institute and related startup companies will create more than 1,460 positions - directly and indirectly - plus $2 billion in payroll and $4.2 billion in gross state product in its first 20 years in Florida.
Torrey Pines, the city's first biotech institute, was also instrumental in bringing VGTI to Port St. Lucie.
"Torrey Pines is the reason we're here," said Jay Nelson, executive director and vice president of VGTI Florida. He added that he sees this area becoming a nucleus of institutes and biotech firms. "We look at them being here as important for bringing other scientists to this area."
VGTI Florida is the home of prominent HIV-vaccine researcher Rafick-Pierre Sekaly, who moved his team from Montreal to Port St. Lucie. His presence is expected to help recruit other scientists.
VGTI Florida Statistics:
$48.8 million: Cost of the research facility, including permitting fees, design and equipment.
$60 million: How much VGTI received from the Florida Governor's Office of Tourism, Trade & Economic Development to create VGTI Florida.
$53 million: How much the city of Port St. Lucie gave VGTI in incentives.
200: Number of employees VGTI Florida is expected to have by 2018; it currently has more than 50.
100,000: Approximate square footage of the new facility.
Syringe maker Unilife attributed increased first-quarter losses to higher expenditure, costs associated with relocation to the US and the construction of its new global headquarters and production facility in York, Pennsylvania.
The firm’s deficit for the three months ended September 31 was $7.2m (€5.3), or 14 cents per share, compared with a loss of $2.1m (€1.5m), or 6 cents per share, during the same period a year ago. Revenue for the period increased to $3.5m (€2.6m) from $3.1m (€2.3m).
Richard Wieland, Unilife’s Chief Financial Officer also cited higher share-based compensation costs and increased R&D expenditure associated with the Unifill syringe as a factor in Unilife’s quarterly shortfall.
However, despite the continuing losses, company CEO Alan Shortall was upbeat about Unilife’s performance in the quarter.
“During the first fiscal quarter of 2011, our focus has to be directed towards building our operational capabilities to meet projected demand from pharmaceutical and healthcare companies for our proprietary products,” said Shortall.
“We have made progress this quarter towards the completion of our new facility and remain on schedule to move into the new facility next month,” he said.
Unilife also expected staff to begin the relocation process during mid-December 2010, with commercial production of the Unifill syringe scheduled to commence during the third fiscal quarter of 2011.
Unilife also took the opportunity to announce the sale of its Unitract range of 1mL safety syringes in the U.S as part of a preferred, non-exclusive marketing agreement with Independent Medical Co-Op.
Unilife's line of retractable syringes is so far the only syringe that allows operators to control the speed of automatic needle retraction directly from the patient's body into the barrel of the syringe where it is locked in place.
The products, which include insulin and tuberculin variants with a five-year shelf life, are well positioned to help prevent the transmission of blood-borne diseases such as HIV and hepatitis C via needlestick injuries, aerosol dispersal and syringe reuse.
Installation of factory-qualified Mikron assembly line is expected to be completed sometime during the first quarter of 2011 with commercial production commencing during the second quarter of 2011.
Work on the 165,000 square foot facility began in December last year as part of Unilife’s efforts to boost production capacity, particularly for its Unifill ready-to-fill safety syringe range. Wieland revealed the expected total projected cost of the facility was approximately $31m (€22.8m).
Only last month, Unilife were given a vote of confidence by the US Department of Agriculture (USDA), who acted as guarantor for its new Pennsylvania manufacturing facility and global headquarters.
Under terms of the agreement, the US government was committed to financing just under half of the construction costs. Unilife had previously secured $5.4m (€3.9m) in grants and loans from the Commonwealth of Pennsylvania.
Unlike Almac and Vetter, Cook Pharmica is keeping everything at home. The company spent north of $80 million adding parenteral manufacturing capabilities to its Bloomington, IN base. The expansion was planned pre-recession, but Cory Lewis, director of Business Development at Cook Pharmica, said that the company never wavered from its commitment to complete the 118,000-sq.-ft. expansion. “Being privately held,” he said, “it was an easy decision for us.” He pointed out that the original concept was to build a “one source” location, meshing biologics manufacturing with process development and parenteral dosage forms. The expansion concluded in late 2009 and was qualified in August of this year.
On a 10-times-larger scale, Belfast-based Almac Group recently finished a massive North American HQ in Souderton, PA. The $120 million, 243,000-sq.-ft. site will absorb most of the company’s offices in Audubon and Yardley, PA, and give the company’s Clinical Technologies and Clinical Services businesses a large footprint on this continent. Almac will also use the new site to mark the North American launch of its analytical services business.”
Ben Venue has completed a 225,000 sq.ft. expansion in Bedford, OH dedicated to sterile finished dosage forms of cytotoxic/genotoxic products. Expected to be online by the middle of next year, the new site will be able to accommodate clinical and commercial scales, and is equipped to handle some difficult formulation tasks, including flammable solvent and co-solvent formulations. All told, it’s one of the largest facilities of its kind in the world.
That expansion doesn’t qualify as a “post-recession” decision, since it’s part of a decade-long renovation and expansion plan by Ben Venue, which is owned by Boehringer-Ingelheim. BV added an 8,000-sq.-ft. pilot plant in 2009 and a 90,000 sq.ft. quality and development center in 2008, but this new facility is the clearest sign of the company’s faith in the growth prospects for sterile high potency products.
Agendia, a genomics cancer diagnostics company, opened a new clinical genomics laboratory on August 5, 2010. Located in Irvine California, the new laboratory was inaugurated in the presence of politicians in California and other high profile people including Sukhee Kang, the Mayor of Irvine, clinicians and representatives of patient advocacy organizations.
The new laboratory is designed with larger capacity, suited to facilitate Agendia's commercial expansion in the US. Agendia earlier had its offices and genomics laboratory housed in a facility located in Huntington Beach, California, that was opened in May 2009. The 8,000 sq. ft. facility was licensed and registered by the Clinical Laboratory Improvements Amendments (CLIA).
The new facility accommodates corporate offices and a state-of-the-art genomics laboratory that spreads over 15,000ft². The facility was formerly a building with three laboratories and two clean rooms. It was upgraded to include the different laboratory requirements of Agendia and the necessary electrical, plumbing, casework and mechanical works. New electrical labeling was installed while many electrical branch circuits were reworked. Additional equipment included new laboratory sinks, and a new emergency shower and eyewash combination.
The new laboratory will provide increased capacity to meet the rising demand for MammaPrint, a breast cancer recurrence test launched by Agendia in 2004. MammaPrint is the first and only such test that has been approved by the US FDA. The test helps in identifying early metastasis risk among patients and provides a clear rationale to evaluate the benefits of chemotherapy besides other clinical information and pathology tests.
"MammaPrint is the first and only such test that has been approved by the US FDA."The MammaPrint is currently playing a key role in the I-SPY 2 trial, a breast cancer trial launched by Biomakers consortium in March 2010. The consortium includes the FDA, the National Institutes of Health and other big pharmaceutical companies led by the Foundation for the National Institutes of Health. Designed to use Agendia's MammaPrint to measure the biomarkers, the trial is being taken by patients at 20 leading cancer research centers in the US.
The new laboratory will conduct MammaPrint using microarray analysis technology. The technology uses DNA microarrays, a group of several thousands of genes that are printed over a glass slide. A unique DNA fragment with a specific sequence is found on each spot on the slide. The technology allows scientists to view several genes simultaneously.
The MammaPrint is conducted on a tumor sample after it is surgically removed. Customized microarrays developed by Agilent that comprise a number of carefully selected normalization genes are used for this test.
Each microarray has three identical sets of the 70-gene profile of the tumor sample that needs to be tested. To assess the activity of the 70 specific genes, the messenger RNA (mRNA) from the sample is removed and labeled with a fluorescent dye. The labeled mRNA is hybridized to the DNA microarray along with a labeled mRNA from a suggested sample.
"The contract for the facility construction was awarded to LCS Constructors."Scanners are used to detect the fluorescence and establish a digital image that reflects spots on the microarrays, showing where the sampled DNAs have merged. In order to compare gene expression profiles from several patients, the individual chip intensities are normalized to a common standard.
At the end of the microarray process, a score stratifies patients into two groups - patients that are at a lower risk of getting cancer spread to the other parts of the body and others that are at a higher risk.
The score is produced after all the key molecular pathways involved in the metastatic cascade of breast cancer are examined during the MammaPrint test.
The contract for the facility construction was awarded to LCS Constructors. They remodeled the building and provided a range of services including electrical, plumbing, and mechanical work.
Emergent BioSolutions launched a new biotechnology manufacturing facility on 16 July 2010. Formerly known as the MdBio Bio Processing Centre, the facility is located in Baltimore, Maryland and was acquired from MdBio Foundation in November 2009 for $8.2m.
It was constructed in 1996 and has operated under several ownerships. Until 2000, the facility was owned by Bio Science Contract Production (BSCP) Corp, a New York-based contract manufacturing organization.
In 2000, the facility was acquired by generics manufacturer Cambrex that operated the facility until Lonza bought it in 2007. Lonza operated the facility briefly until Mdbio took it over following Lonza's decision to prune its capacity.
The facility will begin production by early 2012. During this course of time, Emergent BioSolutions plans to renovate and re-outfit the plant at an approximate cost of $30m."The renovation will enable Emergent BioSolutions to expand beyond the bio-defense sector."
Approximately $15m is expected to be spent on the renovation by the end of 2010.
The renovation will enable Emergent BioSolutions to expand beyond the bio-defense sector.
It will also allow the company to pursue more government work besides penetrating deeper into the commercial sector.
The new facility will create up to 125 jobs within a span of three to five years.
The new facility includes 56,000 sq.ft. of manufacturing and administration space. Nearly 11,000ft² of space has been dedicated towards manufacturing activities. There are five separate manufacturing suites that have been designed specifically to support clinical and commercial production of Emergent BioSolution's product pipeline which includes rPA, anthrax monoclonal and tuberculosis drugs.
The facility additionally accommodates five laboratories, sterile hallways and white walled workrooms. It is equipped with stainless steel bioreactors and can support concurrent manufacturing.
The company's remodeling plans will combine and convert the five laboratories in the facility into two. This will allow Emergent to develop viral and non-viral vaccines. To expand the footprint of the site, a plot lying adjacent might also be acquired by the company.
The facility will be used to produce Biothrax, a sterile, pure-white suspension that is the only anthrax vaccine approved by the FDA. Emergent has obtained several large government contracts to manufacture and stockpile Biothrax.
In addition, the facility will test potential viral and non-viral vaccines for other common diseases including tuberculosis and typhoid. The development pipeline of Emergent BioSolutions also includes drugs targeting botulism, hepatitis B and chlamyidia.
The facility will begin production by early 2012. During this course of time, Emergent BioSolutions plans to renovate and re-outfit the plant at an approximate cost of $30m."The renovation will enable Emergent BioSolutions to expand beyond the bio-defense sector."
Approximately $15m is expected to be spent on the renovation by the end of 2010.
The renovation will enable Emergent BioSolutions to expand beyond the bio-defense sector.
It will also allow the company to pursue more government work besides penetrating deeper into the commercial sector.
The new facility will create up to 125 jobs within a span of three to five years.
The new facility includes 56,000 sq.ft. of manufacturing and administration space. Nearly 11,000ft² of space has been dedicated towards manufacturing activities. There are five separate manufacturing suites that have been designed specifically to support clinical and commercial production of Emergent BioSolution's product pipeline which includes rPA, anthrax monoclonal and tuberculosis drugs.
The facility additionally accommodates five laboratories, sterile hallways and white walled workrooms. It is equipped with stainless steel bioreactors and can support concurrent manufacturing.
The company's remodeling plans will combine and convert the five laboratories in the facility into two. This will allow Emergent to develop viral and non-viral vaccines. To expand the footprint of the site, a plot lying adjacent might also be acquired by the company.
The facility will be used to produce Biothrax, a sterile, pure-white suspension that is the only anthrax vaccine approved by the FDA. Emergent has obtained several large government contracts to manufacture and stockpile Biothrax.
In August 2010 CMC Biologics completed the first stage of expansion at its site in Bothell near Seattle, Washington, US. CMC is an integrated contract manufacturing organization (CMO) providing biopharmaceuticals development and manufacturing services. The company has two facilities in Seattle and Copenhagen, Denmark.
The company develops bio-processes and manufactures biological therapeutics for global clients in Australia, Japan, North America and Europe. CMC works in collaboration with the European Medicines Agency (EMEA) and the US Food and Drug Administration (FDA).
The company contract manufactures biopharmaceuticals and does not have any in-house products.
With the recent expansion, the company has added a single-use facility to the existing Seattle facility, increasing the workforce by about 30 percent.
CMC Biopharmaceuticals acquired the Seattle facility from Eli Lilly in January 2007.
"CMC is an integrated contract manufacturing organization."
Production of recombinant biotherapeutic proteins at the ICOS Biologics Seattle facility began in 1993. In March 2008, the company changed its name to CMC Biologics following the acquisition. Before Eli Lilly the ICOS Biologics facility was owned by ICOS Corporation.
The facility has been following cGMP (good manufacturing practices) since 2001.
It has four separate buildings with a total space of 16,000m². There is ample space for future expansions. The site has development and analytical laboratories, other suites, manufacturing clean rooms, warehouses and rooms for support services.
Various mammalian manufacturing services are offered by the facility at different scales. The plant has cGMP cell banking, a 100l cell culture pilot plant and cell culture development laboratories with up to 15l bioprocess development and technology transfer capacity.
The capacities include 250l, 600l, 1,350l and 2,500l, all at cGMP standards. The plant can perform fed-batch and continuous operations (perfusion) and generate up to 2,000l of cGMP culture per day.
It also has BioSep and ATF technology. The cGMP facility complies with the stringent regulations of the FDA.
The company announced its plans to expand the Seattle facility in September 2008 in stages. The first stage of expansion was to double the number of employees to about 250. In December 2008, however, the plans were delayed due to global recession.
Construction of the disposable manufacturing facility, which relies on disposable equipment, was completed in August 2010. The expansion was undertaken to increase the cGMP biopharmaceuticals manufacturing capacity and meet the growing demand for commercial production.
CMC in partnership with Hyclone has installed new processing equipment at the facility. The project also included installation of disposable mixers, and two 500l and one 100l single-use bioreactors (SUBs). These help in avoiding the risk of cross-contamination and the necessity to clean the facility, which is mandatory in stainless steel tanks.
"CMC in partnership with Hyclone has installed new processing equipment at the facility."
The new multi-purpose facility is used to conduct early-phase clinical manufacturing of biopharmaceuticals. They include early-phase clinical manufacturing of mammalian cell culture-based recombinant proteins and a range of monoclonal antibodies (mAbs).
The disposable technology also has advantages such as flexibility and efficiency. The facility will also gain cost efficiency through decreased marketing time for several biologics.
The stainless steel tank facilities are expected to decline with single-use technology.
The process yields would also be increased with the modernization of cell culture, protein expression and purification technologies for certain products.
The facility will offer stainless-steel clinical and commercial cGMP manufacturing services if the disposables technology is not feasible.
Protea Biosciences, Inc., a leading developer of technology for biomolecular analysis, announced that the company has completed an expansion of its GLP Bioanalytical Laboratory, including the introduction of quantitative proteomics mass spectrometry services. The announcement was made at the Annual Meeting of the American Association of Pharmaceutical Scientists (AAPS).
"By employing new mass spectrometry methods, we can realize the same specificity for protein and peptide therapeutics as we have for small molecules," stated Jason Breaux, Director of Protea's Bioanalytical Laboratory. "Our laboratory can achieve the same quantitative sensitivity that is achieved with current ELISA techniques, but can eliminate the need for antibodies and the attendant false positives and false negatives that are inherent with the ELISA method, thereby providing better data," he added.
Protea's Bioanalytical Laboratory offers method development, validation, and sample analysis services for both small and large molecules in a GLP environment. The company's laboratory expansion included the acquisition of new Watson LIMS and TrackWise software, and several mass spectrometers, including a second AB Sciex 5500QTRAP, two AB Sciex 4000's, and a Waters Synapt G2 HDMS QTOF.
CoreRx has expanded its oral solid dosage form development and manufacturing capabilities. The company is increasing its capabilities for oral controlled release, and multi-layer dosage forms with the addition of new capsule-fillers, a new high-speed tablet press, and two new V-shell blenders (15 cu. ft., and 30 cu. ft.). This expansion will enable CoreRx to increase its offerings in development and manufacturing services in its new Largo, FL facility and complements the company’s existing oral dosage form development and manufacturing capabilities.
The addition of scale-up and commercial manufacturing equipment will allow products to move through the development stages on to commercialization within the same site, reducing the need for additional technology transfers and facilitating a faster time to market, according to a CoreRx statement. The expansion also builds upon the company's existing controlled release, and multi-layer development capabilities.
“This latest investment in our manufacturing group continues our long established commitment in this field and offers our customers a more comprehensive service at our Florida facility,” said Todd R. Daviau, president of CoreRx’s business.
The new facility is expected to be open for business in early 2011.
The University of Texas at San Antonio has won a five-year, $12 million National Institutes of Health grant under the Research Centers in Minority Institutions (RCMI) program that will support new and existing labs that conduct systems biology, proteomics, and other research approaches at the school.
The RCMI grant will fund faculty research programs, the purchase of advanced scientific tools, and four staffed labs to house the equipment, UTSA said.
The facilities UTSA plans to fund include the Protein Biomarkers Laboratory, the Computational Systems Biology Laboratory, the Biophotonics Laboratory, and the Nanotechnology and Human Health Laboratory.
"This funding will give us the ability to add new laboratories and acquire the latest scientific equipment so we can continue to advance our ability to improve lives with better health," UTSA President Ricardo Romo said in a statement.
"Through the generous support of the National Center for Research Resources at the NIH, we are investing in infrastructure that will serve our researchers well many years into the future," UTSA's RCMI program director Andrew Tsin said.
"It is our hope that these tools will help us understand the mystery of why some diseases like diabetes and obesity affect certain populations more than others," Tsin added.
The Proteomics Core uses liquid chromatography and tandem mass spectrometry to identify, characterize, and quantify proteins, and it provides services including consulting, data collection, and analysis. At the Protein Biomarkers Lab, scientists will identify and study protein biomarkers for disease diagnosis and targeted therapies that use biomarkers specific to minority populations.
The Bioinformatics and Computational Biology Initiative Core provides software for genome analysis, microarray analysis, visualization, and general computation, and the hardware includes high-performance computers, servers, data storage, and workstations. The core also provides training and programming support to researchers with minimal experience with computers.
In UTSA's Computational Systems Biology Laboratory, scientists will simulate biological systems, live-cell imaging, and protein biomarker research.
Studies in the Nanotechnology and Human Health Lab will focus on making nanomaterials for use in diagnostics, drugs, gene delivery, tissue engineering, and electron microscopy.
Researchers in the Biophotonics Lab will study biological processes at the molecular level in live cells, UTSA said.
The University of Pennsylvania's Penn Genome Frontiers Institute plans to invest $5 million in establishing two internal centers for large-scale projects focused on translational and personalized genomics as well as funding five pilot projects.
Over the next three years, PGFI said it will spend $2 million on next-generation sequencing equipment, and $3 million on projects focusing on applications of next-gen sequencing to health and disease. As part of the effort, the Institute has established two internal centers: the Center for Translational and Personalized Genomics of NSAIDs, whose principal investigator is Garret FitzGerald, and the Center for Translational and Personalized Genomics of Inherited Retinal Degenerations, whose PI is Eric Pierce.
The centers are needed "to facilitate and participate in" processing the torrents of data being generated through next-gen sequencing, PGFI said in a statement.
The Institute added that the two centers were selected by an external peer review process from an open proposal solicitation to the Penn community. The solicitation also revealed a "great need" for access to next-gen sequencing technology. As a result, PGFI said that it will provide a total of $200,000 in pilot funding over three years for projects targeting atherosclerotic cardiovascular disease; African integrative genomics; ocular cancers, autism spectrum disorders; and cancer genomics
Health Diagnostic Laboratory will spend $4.2 million in a "matching grant" from local government agencies to expand its Richmond, Va.-based lab and hire 213 new employees, the company said.
It wasn't immediately clear if the company will use any of its own money in the investment.
HDL, located in the Virginia BioTechnology Research Park, said it will use the cash to expand its clinical lab, diagnostics and clinical trial services, and its physician- and patient-consulting services.
A new center created to apply the torrent of data from the operations of biological networks to the development of new treatments and therapies is being funded through a five-year, $6.5 million grant from the NIH's National Center for Research Resources.
The National Resource for Network Biology — to be based at the University of California, San Diego School of Medicine — is designed to allow researchers access to more and better tools for conducting advanced studies of biological systems, resulting in more sophisticated models of how human systems function. According to UCSD, NRNB's research will identify disease biomarkers and molecular targets for potential drugs, define genetic risk factors and decipher how individual or group lifestyles, such as social networks, affect the development and transmission of disease.
NRNB's principal investigator will be Trey Ideker, associate professor of bioengineering in UCSD's Jacobs School of Engineering, and chief of the Division of Genetics at UCSD's School of Medicine.
UCSD said the center is designed to apply knowledge gleaned from all the molecular interactions within cells – such as those described and visualized through Cytoscape, an online open-source platform developed by Ideker.
Alexander Pico, bioinformatic group leader at The Gladstone Institutes at UC San Francisco, will serve as executive director of the NRNB.
Other researchers set to collaborate within the new center include James Fowler, a UCSD professor in the School of Medicine and Division of Social Sciences who specializes in social networks; Bruce Conklin of The Gladstone Institute of Cardiovascular Disease; Chris Sander of Memorial Sloan-Kettering Cancer Center in New York; Gary Bader of the University of Toronto; and Benno Schwikowski of France's Institut Pasteur.
NRNB is the only center of its type to be funded this year by NIH, and the fourth NCRR-funded biomedical technology center to be based at UCSD. The other three are the National Center for Microscopy and Imaging Research, the National Biomedical Computation Resource, and the Center for Computational Mass Spectrometry.
Brentwood Industries is in the final phase of expanding their ISO Class 8 cleanroom to their original cleanroom, from 8,500 sq. ft. The expansion, which began in May and is expected to be completed at the end of October 2010, will insure future capacity to serve growing medical clients and their needs. Concurrent with the expansion of the facility, additional state of the art equipment will be added.
Brentwood’s new cleanroom is a 26,000 sq. ft. facility comprised of 21,000 sq. ft. of controlled environment. The entire system contains over 200 filters to minimize particulate levels required for ISO class 8 environments and is controlled by a state-of-the-art monitoring system that collects and records the cleanroom’s temperature, pressure differentials and humidity values. All finished products transfer into a 3,600 sq. ft. quality inspection area that is integrated with the 12,600 sq. ft. of manufacturing space comprised of four Class 8 compartments capable of housing a total of eleven in-line thermoforming machines.
Brentwood’s reputation for precision in manufacturing rests on the mission that advanced quality planning occurs with all our customer’s products, so materials from carefully selected suppliers are used to complete a product that meets the customer’s requirements. Raw materials are segregated from the manufacturing area and pass through a static elimination and vacuum process to properly clean the film prior to entering the machine. In addition, all entrances and outlets utilize an automatic interlock system to prevent loss of pressurization and contamination from outside the controlled environment.
Novartis said that it will invest more than $600 million over the next five years to expand its global research campus in Cambridge, Mass. The Cambridge site houses the Novartis Institutes for Biomedical Research, Novartis Molecular Diagnostics, Novartis Vaccines and Diagnostics, and the US office of Novartis Venture Funds.
The company expects the investment will include adding 300 jobs, however a company spokesperson declined to provide further details.
French molecular diagnostics developer IntegraGen said that it will open a US subsidiary based in Cambridge, Mass, on Nov. 1. The new US base will support the firm's clinical research initiatives focused on identifying children at risk of autism. IntegraGen also conducts gene discovery research and provides genotyping services to the research community.
Teva Pharmaceuticals USA said that $4.7 million in state aid helped persuade the pharmaceutical giant to put its new distribution facility in Philadelphia's Bustleton neighborhood, where the company hopes to employ 500 people in the next five years.
Teva, a fast-growing maker of generic drugs, expects to employ 250 people initially at the proposed $295 million facility.
The 1.2-million-square-foot distribution buildings will sit on 136 acres at 1 Red Lion Rd., formerly home to Budd Co.'s railcar division, which closed in the 1980s.
William Marth, chief executive officer of the Israeli company's American operations, said government officials from many places had tried to lure the facility.
Teva's U.S. headquarters are in North Wales. The new distribution center will not affect those operations, Teva officials said. The company also had considered Willow Grove and Warrington for the new facility.
The Island Green Country Club now at the Red Lion Road site will close, said Greg Rogerson, principal of J.G. Petrucci Co., which is working with Teva on the new facility.
In April, Teva announced that it was eliminating some jobs at its Sellersville manufacturing plant, but the company has not said how many employees were affected.
At Red Lion Road, the company will construct three buildings for distribution, warehouse, and office space. Marth said he expected it to open in 2013.
Mayor Nutter said the construction phase should employ 400 to 600 workers.
Gov. Rendell, who also attended Thursday's news conference announcing the deal, said he believed Teva would employ as many as 1,000 people there in 10 years.
For now, however, Teva says total employment at the Red Lion Road site will reach 500 in the next few years.
Rendell's projections were based on Teva's strong growth. It is the world's largest maker of generic drugs, which are expected to continue to gain market share as patents expire on brand-name products.
Teva Pharmaceutical Industries Ltd. specializes in developing and selling generic and proprietary drugs. It had 2009 revenue of $13.9 billion and net income of $2 billion. Marth said he expected revenue to hit about $16 billion in 2010.
Acquisitions have fueled much of that growth. In 2008, Teva acquired Barr Pharmaceuticals Inc., a maker of generic birth-control pills, for about $7.5 billion.
Generics are federally approved medications that contain the same amount of the active ingredient as brand-name drugs. They are significantly less expensive, making them a popular choice as consumers and businesses seek ways to lower health-care costs.
La Jolla Institute to Develop Genomics Research
The La Jolla Institute for Allergy & Immunology will develop San Diego's first Center for RNAi screening - a breakthrough genomics technology that will provide the local biomedical community ready access to the Nobel-Prize winning technology.
The National Institutes of Health awarded the La Jolla Institute $12.6 million to develop the Center.
"RNAi (RNA interference) allows scientists to explore new ways of disrupting disease processes based on altering gene function," said Mitchell Kronenberg, Ph.D., La Jolla Institute president and chief scientific officer. "It is a powerful technology with the potential to transform human health and we are pleased that the NIH has entrusted us with bringing the first publically funded RNAi facility to San Diego."
Dr. Kronenberg said one of the NIH's long-term goals in funding such a Center is to boost genetic research because of its strong potential for improving human health. Center set up will begin immediately.
RNAi has been heralded as a revolutionary technology because it opens the door to developing new therapies for cancer and other diseases based on silencing specific genes. Its discoverers were awarded the 2006 Nobel Prize for Physiology or Medicine.
Duane Roth, CEO of CONNECT, an industry group supporting the San Diego life sciences and technology sectors, said a dedicated RNAi Center will be an important addition for San Diego. "San Diego has one of the densest concentrations of biomedical research talent in the world which makes this cutting-edge Center an absolute necessity for our region," he said. "I think it's a testament to the La Jolla Institute's excellence that the NIH has entrusted them with this leadership role in establishing an RNAi Center. This funding insures that the San Diego research community will remain a vanguard in technology-based biomedical research."
Dr. Kronenberg said the Center's creation as a publically funded facility makes it unique and important for the San Diego region, the state and the nation. "There are only a handful of RNAi Centers around the country," he said. "Ours, unlike a number of the Centers, is designed to be openly shared with other research institutes," he said. "While San Diego and immunology will be our Center's primary focus, the La Jolla Institute will certainly attract researchers from institutions in other parts of the nation."
Dr. Kronenberg added that in addition to propelling immunology research at the La Jolla Institute, "a resource such as this will undoubtedly catalyze a broad base of basic and clinical investigations beyond our walls. This will undoubtedly invigorate other genetics-based research in our region and elsewhere around the country and create a self-sustaining and highly collaborative resource that will significantly advance efforts to target diseases at the genetic level."
The RNAi Center grant award originated from the Office of the Director of the NIH, Dr. Francis Collins, who was the leader of the publicly funded project to sequence the human genome. It is funded by the American Recovery & Reinvestment Act of 2009 ("Stimulus Package") and targeted to support research in one or more five thematic areas. In succeeding in this highly competitive grant process, which included thousands of applications encompassing all biomedical research disciplines, the La Jolla Institute proposal addressed several of these thematic areas, by applying "high throughput technologies" in genomics for "reinvigorating the biomedical research community."
An internationally recognized immunologist, Dr. Kronenberg is co-lead investigator on the Center grant along with La Jolla Institute scientist Anjana Rao, Ph.D., a world leader in cell biology and genomics research and a member of the U.S. National Academy of Sciences.
The Center will be launched with four major immunology-focused research projects funded by the NIH as part of the RNAi grant.
Dr. Kronenberg said these initial projects will investigate some of the most fundamental – and critical – questions of how genes affect immune system function. "We recognize the power and groundbreaking capabilities of this technology and will use it to advance scientific knowledge toward new and more effective vaccines as well as potential new therapies for autoimmune diseases ranging from type 1 diabetes to rheumatoid arthritis."
Three of the projects will be led by Dr. Kronenberg and Dr. Rao, along with scientists Sonia Sharma, Ph.D., and Matthew Pipkin, Ph.D., who work with Dr. Rao. Dr. Rao was recruited from Harvard Medical School last year to lead the La Jolla Institute's new Division of Signaling and Gene Expression, which will house the Center.
A fourth project will be led by David Nemazee, Ph.D., and Changchun Xiao, Ph.D., from the Scripps Research Institute. These investigators will analyze how microRNAs regulate B lymphocytes, white blood cells involved in producing antibodies, to either become tolerant of our bodies or make critical missteps leading to diseases like lupus and rheumatoid arthritis. "Dr. Nemazee and Dr. Xiao are outstanding scientists and we are pleased that they will be working with us in initiating the Center," said Dr. Kronenberg.
A panel of University of Colorado regents gave the initial go-ahead for the Boulder campus to add a fifth wing to its biotechnology building if funding becomes available.
Construction plans for the biotechnology complex -- which is being built on CU's east campus and depends on a mix of donations, state money and research funds -- have been in flux because of the economy. But the economic downturn has also led to a favorable bidding climate, campus leaders say.
The addition, which would house classrooms and lecture halls, would cost $31.8 million, ratcheting up CU's total spending authority for the building to $194.9 million. It will only be built if the money comes through from the state --or other funding areas, which could include money saved and stretched over from the original project's budget, federal funds or research grants.
With unanimous approval from the regents on the capital construction subcommittee, the amendment to the construction plan now needs to be approved by the entire Board of Regents, which meets next month.
Frank Bruno, vice chancellor for administration on the Boulder campus, told the subcommittee members that the building is one-third complete.
The university, which makes requests for capital construction funds from the state, has listed the biotechnology building as its top priority, and is asking for the money to be spread out over a period of two fiscal years.
CU officials say that the 57,000-sqaure-foot fifth wing could house teaching laboratories and classrooms for the growing number of students interested in studying biotechnology and related fields.
The first phase of the construction project, which is expected to be completed in November 2011, consists of a 266,000-square-foot building with three wings. Because of economic uncertainty, the original building was split into two projects, with a fourth wing scheduled to open in 2012.
A construction time frame for the fifth wing isn't concrete because it's contingent on funding.
In April, CU received a $15 million grant through the American Recovery and Reinvestment Act to be used toward the building's construction. The grant will allow CU to fill out what would have been shelled space.
The biotechnology hub will bring together more than 60 faculty members and 500 graduate students, researchers and support staff members who will work on complex human health issues -- including cancer, cardiovascular disease, inherited diseases, vaccine development and regenerative medicine.
Now, researchers are spread out in different departments scattered across campus.
Colorado boasts particular potential in the biosciences, with existing businesses generating more than $400 million in state taxes and supporting 36,000 workers.
At CU, biotechnology research has led to more than a dozen start-up companies and attracts tens of millions of dollars annually in sponsored research grants.
Faculty from the University of Maryland Institute for Genome Sciences will work closely with a new research "enterprise" the university is establishing for the study of autoimmune and inflammatory diseases, funded through a $45 million gift from an Indiana businessman and his wife — the largest private donation ever received by the University System of Maryland.
The new enterprise will consist of two divisions, each of them existing research centers set to be expanded — the university's Mucosal Biology Research Center and Center for Celiac Research — as well as a new third division focused on the interaction between the human body and the microbes that inhabit it. The third division will draw upon IGS' expertise in the genomics of microbes on and within the human body, and how interaction with the human genome affects human health, the university said.
Alessio Fasano, a celiac disease researcher and professor of pediatrics, medicine and physiology at the university's School of Medicine, will direct the new research enterprise. Fasano now directs the Mucosal Biology Research Center and the Center for Celiac Research.
"Our goal is personalized medicine. We hope to identify biomarkers to develop diagnostics for autoimmunity that can assist us to develop preventive strategies in the pre-clinical phase as well as to customize treatment for individuals based on their genetics and their microbiome," Fasano said in a statement.
Of the Cafferty donation, $40 million will come from a private foundation in which the Caffertys are key stakeholders. The remaining $5 million will come to the School of Medicine directly from the Caffertys, for the purpose of funding an endowed distinguished professorship that supports a director position in perpetuity for the research enterprise.
Fasano will be the first recipient of that endowed professorship and the director position. He will oversee a research enterprise employing both basic and clinical scientists that will use celiac disease as a model for research into other autoimmune disorders, such as multiple sclerosis, chronic obstructive pulmonary disease, asthma, and Type 1 diabetes, the university said.
"The enterprise will initially include 13 faculty members, with more to be recruited in the future. Dr. Fasano envisions it employing as many as 200 people once it is up and running," the university said in its statement.
Novartis will invest $600m to expand its US R&D campus over the next five years to strengthen its position in US development hotspot.
The plan, which will add 400,000 sq. ft. of extra discovery laboratory space and create 300 new research jobs at the Swiss drugmaker’s facility in Cambridge, Massachusetts, is scheduled to begin next year.
The new facility will be built on the four-acre site that Novartis leasing from the nearby Massachusetts Institute of Technology (2009) in 2009 MIT.
Novartis’ spokesman Mark Fishman, said: "Our scientists and physicians here already have discovered a host of new medicines, and established fruitful collaborations with academic, clinical, and biotech institutions. The constellation of talent and environment are unmatched.”
The region’s standing as a hotbed of drug research and R&D base for drug industry luminaries like GSK, Pfizer and Sanofi was also highlighted by Harry Glorikian, general manager of life sciences consulting group Scientia Advisors.
He told the Boston Globe that: “It’s the talent, it’s the concentration of all the parties who are working on new technologies and new capabilities. The big pharma companies are always doing partnerships and deals. By coming here, it makes it a whole lot easier for them to be part of the conversation.”
BioTime Inc. announced it is expanding its corporate headquarters and laboratory facility in Alameda, California and has signed a new Lease Agreement effective December 1, 2010 for an
initial five-year term, with an option to renew the lease for an additional five years. The new lease extends BioTime’s existing space by 6,000 square feet to 17,000 square feet, enabling BioTime to provide both office and laboratory space for itself and its subsidiary companies. BioTime will also have a right of first refusal on approximately 10,000 square feet of adjacent space.
The facility is good manufacturing process (GMP) capable and has previously been certified as Class 1000 and Class 10,000 laboratory space. The space includes cell culture and manufacturing equipment previously validated for use in GMP manufacture of cell-based products. BioTime expects this space will be used by its family of domestic subsidiary companies for the purpose of developing therapeutic products for human degenerative diseases and disorders based on stem cell technology, and research products for sale to companies, universities, and other institutions engaged in drug discovery and other stem cell research activities. Currently, BioTimes U.S. subsidiaries are developing cell-based therapies for orthopedic disease and cancer.
BioTimes laboratory facilities may also be used to provide therapeutic and research products to its foreign subsidiaries for further development or sale in overseas markets.
This is the optimum time for us to take advantage of commercial lease prices and ensure our subsidiaries have the necessary facilities to develop leading cell-based therapeutics and research products, said BioTimes CEO Dr. Michael D. West. Our location in Alameda within San
Francisco’s biotechnology corridor will also provide access to the talent necessary to advance our wide array of scalable and purified human cell types toward the clinic.
BioTime, headquartered in Alameda, California, is a biotechnology company focused on regenerative medicine and blood plasma volume expanders. Its broad platform of stem cell technologies is developed through subsidiaries focused on specific fields of applications. BioTime develops and markets research products in the field of stem cells and
regenerative medicine through its wholly owned subsidiary Embryome Sciences, Inc.
BioTimes therapeutic product development strategy is pursued through subsidiaries that focus on specific organ systems and related diseases for which there is a high unmet medical need. BioTime’s majority owned subsidiary Cell Cure Neurosciences, Ltd. is developing therapeutic products derived from stem cells for the treatment of retinal and neural degenerative diseases. BioTime's subsidiary OrthoCyte Corporation is developing therapeutic applications of stem cells to treat orthopedic diseases and injuries. Another subsidiary, OncoCyte Corporation, focuses on the therapeutic applications of stem cell technology in cancer. BioTime’s Singapore subsidiary, ES Cell International Pte Ltd, has been at the forefront of advances in human embryonic stem (hES) cell technology, having been one of the earliest distributors of hES cell lines to the research community. ESI has produced clinical-grade human embryonic stem cell lines that were derived following principles of good manufacturing practice and currently offers them for potential use in therapeutic product development.
In addition to its stem cell products, BioTime develops blood plasma volume expanders, blood replacement solutions for hypothermic (low temperature) surgery, and technology for use in surgery, emergency trauma treatment and other applications. BioTime’s lead product, Hextend®, is a blood plasma volume expander manufactured and distributed in the U.S. by Hospira, Inc. and in South Korea by CJ CheilJedang Corp. under exclusive licensing agreements.
West Virginia University has won a $5.5 million grant from the National Institutes of Health to develop new core research facilities at its Center for Neuroscience, including facilities to support biomedical science such as genomics and imaging studies.
The Centers of Biomedical Research Excellence (COBRE) grant from the National Center for Research Resources will fund collaborative multidisciplinary pilot projects in neuroscience and new facilities and technologies that can be shared by researchers in other departments across the university.
Specifically, the COBRE award will be spent developing five Core Research Facilities including facilities for genomics, tissue processing, advanced imaging, non-linear microscopy, and transgenic research.
"This award will enable the University to establish and sustain core facilities that provide advanced technologies for neuroscience research, and provide training opportunities for a new generation of biomedical researchers," NCRR Director Barbara Alving said in a statement.
The center is used to support collaborations between researchers in behavioral neuroscience, stroke and other neural injuries, and cognitive neuroscience.
Genewiz said that it has expanded its DNA sequencing capabilities with the opening of a new lab in Cambridge, Mass. The South Plainfield, NJ-based firm said that the new lab will offer a variety of sequencing services, as well as gene synthesis, molecular biology, and other genomic services.
Gateway Analytical, a new quality-focused analytical testing and consulting services company, opened its doors for business in Gibsonia, Pa., a Pittsburgh suburb. Despite a weak economy, testing companies like Gateway Analytical are thriving, with an expected annual growth rate of 5.7% in the next five years according to a March 2010 report on U.S. laboratory testing services.
“Gateway Analytical fills a necessary niche out there—providing regulatory expertise in the face of increased government regulations on consumer, pharmaceutical and food products,” said David Exline, Senior Vice President of Gateway Analytical. “We’ve invested substantial funds to bring this expertise to the Pittsburgh area.”
Offering a blend of conventional and innovative testing methods, the company’s 3,000-square foot facility serves businesses in the materials science, pharmaceutical and forensics industries. With a focus on quality, Gateway Analytical scientists have expertise in a number of regulatory processes and procedures, including ISO, current good manufacturing practices (cGMP), Quality by Design (QbD) and American Society of Crime Laboratory Directors Laboratory Accreditation Board (ASCLD/LAB).
In addition to regulatory knowledge, the company’s experts draw from their diverse backgrounds to get to the core of each issue before planning a remediation strategy, offering creative solutions to complex scientific problems.
Highlighted testing and consulting services include:
Pharmaceutical
Coating thickness measurement
Content uniformity
Foreign particulate identification
Particle sizing
Polymorph analysis
Regulatory and intellectual property support
The new TriPath facility at Becton, Dickinson, and Co. in Mebane, NC, recently received LEED Silver Certification. Headquartered in New Jersey, BD develops, manufactures, and markets medical devices, instrument systems, and reagents.
Jacobs/Wyper Architects LLP (Philadelphia) designed the facility in a fast-track collaboration with engineers, contractors, and the owner in 7 months.
The facility uses a previously constructed 100,500 sq. ft. shell, of which 64,500 sq. ft. has been outfitted with office, conference, manufacturing, lab, and support spaces. The remainder of shell space will be utilized for future expansion. While the majority of the existing structure was preserved, windows and sunshades were added to provide natural lighting and reduce cooling loads. The envelope of the entire structure was enhanced with additional insulating value to reduce cooling and heating.
Jacobs/Wyper Architects is an award winning architectural, planning, and design firm specializing in high-end technological, institutional, corporate, and academic projects.
GATC Biotech will open in early January a new sequencing laboratory in the Life Science Center Dusseldorf in Germany. The new lab will serve scientists in Northern Germany and adjacent countries and provide them with access to the firm's overnight gene sequencing service.
Reinnervate, an innovative life sciences company driving the adoption of routine 3D cell culture, announced its expansion into a new purpose-built research and production facility at NETPark near Sedgefield, UK. The move to the circa 10,000 square foot facility has enabled reinnervate to begin commercial production of its alvetex 3D cell culture technology in readiness for its planned 4Q 2010 launch.
The Company is also looking to recruit up to 30 new employees over the next 12 months in research, development production, sales and marketing in order to establish the use of alvetex for routine 3D cell culture in academic and industry laboratories around the world.
Reinnervate, a Durham University spin-out, has spent nearly eight years developing its alvetex technology based on pioneering research carried out by its founding scientist, Professor Stefan Przyborski. Alvetex is a unique and proprietary scaffold that enables routine 3D cell culture in the lab, i.e. more akin to the way cells grow in tissues in the human body than conventional 2D cell culture technologies, where cells grow in flat sheets.
The use of alvetex-derived 3D cell cultures is therefore expected to provide greater insight into how cells behave in the body in response to external factors (such as drug candidates) than is currently possible with existing 2D technologies.
In July 2010, reinnervate announced a further £1.8 million of equity investment from Newcastle-based NorthStar Equity Investment Limited and private investors to support the ongoing development and commercialization of its alvetex platform. Commercialization is now at an advanced stage and reinnervate has begun discussions with major distributors of cell culture products in the UK and overseas to sell alvetex in a range of formats for multiple, potential applications in academia and in the pharmaceutical and related sectors.
The Company’s move into NETPark has been made possible by County Durham Development Company (CDDC), which develops, manages and promotes the North East Technology Park near Sedgefield on behalf of Durham County Council. CDDC project managed the development of reinnervate’s specialist production facility and associated laboratories.
Ashley Cooper, CEO of reinnervate, commented: “We are delighted and proud to be moving to this larger, purpose-built facility at NETPark and we are hugely grateful to CDDC and its staff for their support and assistance in this program. The capabilities we can now access will allow the Company to advance to the next stage in its development as we prepare for the official commercial launch of alvetex later this year. Over the next 12 months, we will be looking to recruit up to 30 new employees to rapidly expand our production and sales operations and our new facility gives us the necessary space to meet our ambitious growth targets.”
Stewart Watkins, Managing Director of CDDC added: “This is a really good example of how the public and private sectors can collaborate to exploit new business opportunities and create much needed employment in the area. Reinnervate is a hugely important company to NETPark and County Durham – it has fantastic technology, a highly experienced management team and a great market proposition. It exemplifies the kind of company we want to attract and support, and is a very welcome addition to the NETPark community.”
Aesica, a supplier of active pharmaceutical ingredients, broke ground on a new high-potency facility at its Queenborough site on 17 August 2010. The new facility will allow Aesica to expand its formulation offering in the growing market for contract manufacturing of high-potency drugs.
The facility will increase the company's formulation and packaging capacity of liquid and solid dosage forms. It is scheduled to begin operations by May 2011. Aesica is investing €3m ($4.6m) towards the construction of the facility, which is expected to be completed in November 2010.
Located in Isle of Sheppey, Kent, England, the Queenborough facility was acquired by Aescia from Abbott Laboratories in September 2007. The deal, which included a five-year supply agreement with Abott Laboratories, tripled the workforce of the company, boosted capacity and took Aesica into secondary manufacturing.
The new high-potency facility will house multiple suites for granulation, tabletting and blister packing. All the suites will be equipped with appropriate heating, ventilating, and air conditioning (HVAC) and cleaning facilities. To avoid any occurrence of cross-contamination, the facility will be a segregated unit constructed at a distance from the remaining facilities of the company.
"The multi-purpose Queenborough facility is designed in compliance with ISO14001 standards."
The company says that the design and construction of the purpose-built facility will be in conformance with environmental requirements. The new facility will be equipped with security systems that will ensure the production of Schedule II controlled drugs including opiates.
The multi-purpose Queenborough facility is designed in compliance with ISO14001 standards. It is equipped with a range of capabilities including production of solid dosage forms, anaesthetics, and controlled medicines and packaging facilities that accommodate blister packs, sachets and bottles.
The Queenborough facility is equipped with a range of technologies including high shear granulation, low shear granulation, fluid bed drying, tray drying, blending, compression, bi-layer compression, tabletting with B&D tooling, film coating, liquid manufacturing, blister packaging, solid bottle filling, liquid bottle filling, sachet filling and capsule filling. Other technologies include those for control release, alcohol-based liquids and device assembly.
The new high potency facility will allow Aesica to develop Schedule II controlled substances, potent active pharmaceutical ingredients (API) and intermediates that are classified as Category 3 by Safebridge Consultants, Liverpool UK. The new facility will boost Aesica's the production capacity of Schedule II compounds. Aesica began production of Schedule II compounds in 2009 after the approval of its Cramlington, Northumberland facility.
"The new facility will boost Aesica's the production capacity of Schedule II compounds."
Compounds categorized as high potent are effective in treating a range of diseases at low doses.
The compounds, however, have to be produced in an environment equipped with appropriate safety measures.
The Queenborough facility specializes in the production of drugs containing APIs that require special handling needs including high potent medicines or controlled substances.
It currently manufactures a range of formulated products including anti-infectives, cardiovasculars, anti-virals, anaesthetics, anti-inflammatories, haematinics and hormones. The products are manufactured in solid dosage forms, liquid dosage forms, anaesthetics and potent drugs. The facility can additionally perform packaging in bottles, blister packs and sachets.
The facility can operate at an annual wet granulation capacity of more than 500t, including low shear, high shear and fluid bed drying. Annual tablet production capacity including single, bilayer and film coating is more than 2bn. The facility can additionally manufacture 1.5m liters of liquid at non-critical temperatures and up to 300,000l of liquid at critical temperatures every year. Blister packaging capacity of the facility is 90m packs per annum.
The facility can also pack 15m bottles of solids including tablets and granules and 14m bottle packs of liquids every year.
PharmaZell GmbH has expanded its manufacturing capabilities in India. The company has completed construction of a cGMP kilo-lab at its R&D center in Vizag, India. This follows two other recent expansions in India. In 2007, PharmaZell built a commercial production plant in Vizag, India to produce the API, Mesalamine. In 2008, PharmaZell continued expanding in Vizag by building an R&D facility that now employs approximately 35 chemists focused on chemical route and process development, analytical R&D and small scale synthesis.
The company also expanded its European base in 2007 by acquiring a fully integrated development and commercial production site from Sandoz in Copenhagen. The site in Denmark has a focus on controlled substances, and its scientists have expertise in lab development, pilot plant and commercial manufacturing under cGMP.
“In the past three years PharmaZell has had three expansions in India while growing by acquisition in Europe. We have continued to grow our manufacturing capacity and expand our services to the pharmaceutical and biotechnology industries. We believe that our strong revenue growth and diverse customer base is positioning our company as a significant API manufacturer and service provider,” said Wolfgang Burger, Ph.D., managing partner of PharmaZell.
The worldwide need for the development of replacement human tissue, via regenerative medicine and stem cell applications, recently resulted in the commissioning of a state-of-the-art research facility at the University of Loughborough, in the UK. The now completed 770m² (8,285 sq. ft.) multi-disciplinary Centre for Biological Engineering combines cleanrooms and labs that will enable this important human cell and tissue research to be carried out.
The University aims to achieve the realization of regenerative medicine, cell technologies and plasma medicine by combining the human cell and tissue research programs of three of its departments: Chemical Engineering, the Wolfson School of Mechanical & Manufacturing Engineering and Electronics & Electrical Engineering.
Flexibility and transparency in the design were key to the success of combining the three different fields into one multi-disciplinary research centre. The team at Clean Modules used their previous experience in designing and constructing cell and tissue cleanroom facilities and their novel System I modular cleanroom construction method to ensure that the facility is highly versatile and space-efficient, yet compliant with all the regulatory requirements.
The facility for Biological Engineering Research is a key area within the new Centre. Its range of labs for microbial, animal and human cell culture research will enable the staff to compete with biological engineers on a global scale.
To ensure the risk of exposure to biological agents is minimized, the laboratory research area has been built to Microbiology Containment Level II, in accordance with the 1995 EC Biological Agents Directive. An isolated air system, special room pressure regimes and strict staff operating policies ensure the safety of both the Centre’s staff and surroundings.
Also, within the new Centre, the Wolfson School of Mechanical & Manufacturing Engineering has a dedicated cGMP cleanroom suite that focuses on automated human cell culture, cell culture optimization and mechanical stimulation of growing tissue. Designed to run to an EU GMP Classification Grade B standard, the facility includes cryogenic storage facilities as well as manual and automated cell culture areas, designed to run in an EU GMP Classification Grade A environment.
The facility will aseptically culture, expand, differentiate and harvest adherent cells to be used in the cGMP manufacture of clinical trial phases I to III and licensed product batches of somatic cell therapeutic medicinal products.
Approval from the UK Medicines and Healthcare Agency (MHRA) is essential for frontline medicine and healthcare product research; however, no MHRA reference guidelines were available for this type of research. Extensive discussions between the University, Clean Modules and the MHRA mapped out this new territory and ensured the cGMP facility was MHRA compliant.
The Centre also houses a bioelectrical engineering facility that integrates an advanced atmospheric gas plasma laboratory with a Class II cell laboratory so that engineers, physicists and life scientists can work together under the same roof. The facility represents the world-first integrated laboratory in plasma medicine with co-located plasma and cell labs.
Finally, the three departments will share a common autoclave, storage and office area that will support the research.
The Centre of Biological Engineering brings together three fields of study: biology, engineering and medicine. Each department contributes to the common goal; the realization of regenerative medicine, cell technologies and plasma medicine for regeneration of human cell and tissue. The partnership between Clean Modules and the University of Loughborough has resulted in an exciting innovative new cleanroom and laboratory facility with immense potential for world-breaking developments in human cell and tissue regeneration.
The Haematopoietic Stem Cell Transplantation facility in Dublin, Ireland, represents a major step forward for stem cell transplantation.
The new Haematopoietic Stem Cell Transplantation facility in Dublin, Ireland represents a major step forward for stem cell transplantation. Ronan Quinn, MD of the contractor ardmac, describes the building.
Our Lady's Children's Hospital, Crumlin, Dublin (OLCHC) is an acute paediatric teaching hospital and the National Centre for Oncology and Haematology where approximately 150 newly diagnosed patients are treated each year. Most of these have malignant disease, with a small number of patients having immuno-deficiency or inborn errors of metabolism.
The construction of a new cleanroom laboratory at the Haematopoietic Stem Cell Transplantation (HSCT) facility at OLCHC is a major enhancement to Ireland’s largest paediatric hospital and a major step forward in haematopoietic stem cell transplantation treatment.
HSCT, also known as bone marrow transplantation, is a therapeutic treatment for cancer. It is a special form of therapy that involves taking cells that are normally found in the bone marrow (stem cells) from the donor or from cord blood and giving them, by intravenous infusion, to the recipient, either the same person or to another person. The stem cells extracted from the child may be preserved for their entire lifetime, as future treatment may be required.
A stem cell could be regarded as one of the basic building blocks of the human body and has great significance as it has the capacity to become different cell types.
The HSCT facility at the hospital in Crumlin is designed to be compliant with EU Directive 2004/23/EC, which sets standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. The facility forms part of the Tissue Establishment at OLCHC, which is licensed by the Irish Medicines Board (IMB).
The transplantation of human tissues and cells is a strongly expanding field of medicine offering potential opportunities for the treatment of as yet incurable diseases. To minimize the infection risk involved in transplant operations, it is essential to ensure the quality and safety of the substances concerned. The directive aims to establish high standards of quality and safety for tissues and cells of human origin for human therapeutic uses.
The construction of the new cleanroom laboratory presented many challenges from both a technical and construction perspective. OLCHC is a city centre hospital, in a congested city, which led to restricted access to the site. Working in such a sensitive ‘live’ environment it was important to reduce noise and vibration and to minimize any interference with the patients, their parents and all staff.
Limited access and restricted space provided challenges for the build, which had to be based on pre-fabricated modules that could be craned into place
From a technical perspective, the challenges were manifold and the build included: the design of the HVAC; the ergonomics and layout of the cleanroom suite; the implementation of building services, cleanroom control and life safety systems in small spaces; materials transfer and product flows; separation of raw materials from finished product; as well as personnel access and the provision of administrative and record-keeping areas.
The 120m2 (1,291 sq. ft.) cleanroom laboratory is a free-standing, self-contained structure fully integrated into the hospital building and infrastructure. The new laboratory contains a compact suite of classified areas to international ISO 14644-1 with the highest Grade A processing area in a microbiological safety cabinet. Following the traditional concept of black-grey-white cleanzones, there is a Grade D preparation room, two processing rooms – one upgradeable from C – and a Grade B processing room, with separate changing rooms.
HEPA filtered air, positive air pressure cascades and separation of products from people act as contamination control barriers. Personnel wear contamination control suits with facemasks and sterile gloves to maintain cleanliness and protect the sensitive stem cells.
With space at a premium and with the need to separate incoming and finished products from ancillary components, ardmac designed a unique, vertical twin-tiered pass-through hatch.
The two-tiered pass through hatch helps to separate the flow of sensitive materials
All surfaces are carefully integrated to give flush finishes for ease of cleaning.
Much consideration was given to the design and construction of the cleanroom relative to the administrative aspects of the processing procedure. The management and recording of information during stem cell processing, is a critical QC requirement of the EU Directive. However, given the nature of the work, this recording is a cumbersome activity while personnel are fully gowned with a mask and sterile gloves. It is also a potential contamination risk. Integrated wall-mounted communications devices facilitate recording of relevant information in the unclassified write-up room to facilitate the recording of relevant information in the unclassified write-up room by a second scientist who can also provide visual support. Another feature is a CCTV system with pan, tilt and zoom capability, which can read record labels.
The use of liquid nitrogen for storage required additional safety features.
With a strong pedigree in cleanroom construction, ardmac was well equipped to compete for the contract under the EU OJEC open tender process, a process that included detailed pre-qualification and post tender adjudication.
Ardmac has previously carried out several projects in the healthcare sector, including a laboratory for the Centre of Research for Infectious Diseases at University College Dublin, a CL3 lab at University College Cork, Grade B rooms and preparation suite at St Vincent’s Hospital Dublin, and a CL3 lab at the Royal Victoria Hospital in Belfast.
The HSCT was a challenging project, considering the technical requirements and needs of both the client and end user. Due to space and access considerations, Ardmac had to manage the construction process in a fairly contained area while ensuring staff and patients could continue their daily business as normal.
In view of the restricted space, the only viable technical solution was to specify a prefabricated modular approach. This meant a prefabricated modular building with skid-mounted plant and utilities and “plug and play” equipment and components. It also meant that the individual room-by-room design had to match the construction module design.
This took some very careful planning and co-ordination with the user group and client design team. The finished cleanroom laboratory consists of a series of graded airborne and microbiological quality cleanrooms, including gown rooms, separated by interlocking doors with support areas of admin and liquid nitrogen facilities for storage and preservation.
Restricted space caused additional difficulties in managing the “drop in” of the prefabricated modules and required a special traffic plan and temporary permitting.
From the discussions with the User Group, it was clear that the hospital needed to continue its work routine, and it was imperative that contractors work around its schedule. The management of safety risks and interruptions became a significant and ongoing task.
Ardmac liaised with staff to schedule any unavoidable works and specific protocols were developed and agreed to mitigate risks and disruption to ongoing hospital operations, including redirected access and fire escape routes, staff parking, ambulance movements and deliveries.
The HSCT facility would have to run at maximum capacity 24/7 to maintain regulatory compliance, but throughput and capacity would be exclusively driven by the treatment needs of the children. The needs of the end user had a direct impact on the construction process, and the User Group provided ardmac with an understanding of the need for flexibility and the ability to change strategy requirements.
Ardmac has in-depth experience in cleanroom construction and working in live environments. The hospital had carried out a highly detailed User Requirement Specification, dealing with continuity of work during construction, future proofing, redundant capacity and energy efficiency.
Concise planning, good communications and acting as single point of responsibility for all aspects of the construction meant that ardmac was able to focus entirely on the project and deliver this challenging project to a successful conclusion.
Facility features include:
Ceiling “swirl” diffusers for high level clean air supply without drafts
Low level return with a “grille-less” swept design in stainless steel
Sophisticated control of stem cells preservation in LN2 integrated with flow control back-up
and alarms up
Advanced life safety system in LN2 room with low level oxygen sensors and fast acting extract
system at ground level
Zone control and HVAC redundant capacity
Remote BMS diagnostics access
Multiple set back modes for energy savings when facility not in use
A consultative approach.
John Fitzgerald, project manager, EU Tissue Directive, was the Scientific Liaison between the Hospital Capital Projects Team and the User Group in Oncology and Haematology. A critical link between the construction team and the users, he had to interpret, guide and deliver on their requirements
“The relationship with the end user was crucial but it was important that everyone involved in the project was fully engaged in and committed to the process and able to respond quickly and efficiently to any design changes.
“At an early stage in planning we visited a number of other cleanroom labs and asked each user what they liked and disliked and, more importantly, we asked what they would change if they had to do it again. The common feedback was insufficient User Group input during planning and construction so they felt that they ended up being “given” the facility as opposed to growing and living with the facility during planning, design and execution. It was my responsibility to make sure that not only were my “child patients” protected, but also the staff were operating in a safe and effective working environment. We were not going to get any second chances if we got it only “nearly right”. If the layout and ergonomics were not right then staff would not be able to work at their best and patient quality could suffer.
“The use of liquid nitrogen posed a particular safety risk as it is heavier than air and displaces oxygen. It is an insidious gas and if you fall faint to the floor you end up in pure nitrogen with no oxygen at all. We have very sophisticated control and safety systems with interlinked preservation vessels, flow control and low-level nitrogen and oxygen alarms and fast acting extract systems.
“One of the key performance measurements was the contractor’s ability to accommodate ongoing hospital operations and not interfere with critical hospital utilities while executing the project within a built-up local area inside a capital city. The construction team had a clear plan and the systems and procedures for managing both the design and construction process.”
User features include:
See-through design from write-up room through processing rooms
Hands-free communications with CCTV buddy support
Unique vertical twin tier pass-through hatch for separation of flows
Ergonomic and compact layout
Room classification grade flexibility for capacity changes and interoperability
One touch lighting operation control
Card access tracking and security
Flush finishes for ease of cleaning
Generous in process and consumables storage
Matching needs and demands of the facility staff and patients.
Paul Lynam, chief medical scientist at the HSCT, has been working with the centre for nearly 10 years and his daily workload and priorities come exclusively from children’s treatment needs. He highlights some of the objectives.
“As the main person responsible for working with Stem Cells, my biggest concern was that the new cleanroom laboratory would enhance what I had already been doing, safely and effectively, for years. I am very happy that the EU Directive provides for increased quality assurance and a common understanding in what we do in the EU and internationally.
“We took the opportunity to look at our existing processes from first principles and reviewed these against the requirements of the EU Directive. We then worked out how we could simplify and improve our processes. In many instances we went beyond the directive to meet our needs. I wanted this facility to be as flexible as possible and give us the ability to be nimble in how we operated.
“Getting the opportunity to talk with the project management and construction team was extremely beneficial and also reassuring for me. It was important that we got a facility that met the needs and demands of our work – some of the features make our work so much easier.
“I love the way we have visibility aligned all the way through the suite; it saves us so much time. The wall mounted hands-free communication between myself and the write-up staff frees me up from an otherwise cumbersome activity. It is that attention to detail that can make the big differences during our work.”
The new cleanroom completed for the multinational company Ferrosan is a truly modular facility – constructed in the UK, installed in Denmark and designed to allow for future relocation. Jelle Hanse, export executive, Clean Modules, explains
The cleanroom facility for Ferrosan was completed within a tight time schedule of just 14 weeks. The 325m2 (3,497 sq. ft.) facility was pre-manufactured as a whole in the UK, shipped to Denmark and positioned on site, with final hook-up, finishing module connections and services, commissioning and validation being completed on site in Denmark.
Ferrosan is an international company selling consumer health products and medical devices in more than 60 countries worldwide. The company is continuously looking to offer more innovative and diverse products to its customers. Faced with a tight time line, Ferrosan was forced to consider innovative construction methods to accommodate its latest product line.
Choosing the right location and construction method for a new cleanroom facility can make a huge difference to the program, budget and end result of a project. Ferrosan conducted extensive research into what construction method would best suit the company’s budget, time restraints and user requirements.
The tight time constraints would not allow for the construction of a new building in the conventional way, and renting existing facilities at an alternative site would add to the running costs of the facility. As a result, Ferrosan opted to construct its new cleanroom facility using alternative methods.
After further research, Ferrosan paired up with Clean Modules, a UK cleanroom company that specializes in the design and construction of cleanrooms, especially using pre-built and modular systems for use worldwide. The modular cleanroom solution is a quick and cost-efficient construction method for cleanroom projects without an existing shell building.
This construction method is based on factory manufacture of the cleanrooms in sections, which are then shipped to site, installed and commissioned.
Clean Modules’ modular cleanrooms are constructed with its System I cleanroom panels — composite panels and concrete board within a robust hot-rolled steel frame. On site pad foundations need to be installed and services brought to the cleanroom perimeter. The facility does not contain any timber and unlike cleanrooms constructed within converted timber cabins, these modular cleanrooms feel and behave like a rigid traditional building and have a similar durability.
To ensure Ferrosan’s competitive position within the pharmaceutical and healthcare markets, time was of the essence. A key benefit of the modular cleanroom construction method is that the facility is constructed as a whole away from site. In the UK, Clean Modules constructed the 325m2 (3,497 sq. ft.) modular cleanroom facility, while in Denmark another site team from the construction company prepared the foundations and converted an existing 90m2 in-situ laboratory into an EU GMP Grade D preparation area. The two areas would later be linked together during installation of the modules.
Along with the modular cleanroom facility, a plant skid module housing the air handling unit (AHU) and associated plant was prepared in the UK. The AHU only had to be connected to the modular cleanroom facility on site. All the AHU equipment was installed and pre-commissioned away from the site; other services were also installed off-site with a plug-and-play system and were plugged in, re-tested and commissioned on site.
Traditionally built cleanrooms require the shell building to be completed first, but as the modular cleanroom facility and the air handling plant were prepared off-site, while the foundation and in-situ cleanroom area were being completed in parallel, construction time was optimized and considerable time was saved.
Time on site costs money, especially when the construction site is in another country and crews have to be sent abroad. Consequently, the ability to construct the facility at Clean Modules’ premises, with all the design and construction facilities nearby, resulted in more efficient use of time and reduced labor and specialist trades’ costs.
Ferrosan operates in a competitive market and being able to respond quickly to market demands is essential to the company’s success. Designed with the future in mind, the new facility is flexible, versatile and transportable. To ensure manufacture of the new product can develop in line with Ferrosan’s demands, the facility will allow for future extensions and/or relocation of the facility altogether.
Although it is not planned at this stage to relocate the modular cleanroom facility, it can easily be moved to another Ferrosan site in Denmark or another country. As the facility is designed and constructed to be shipped by road, the services would need only to be unplugged, the modules separated for transport and installed at the new site.
Ferrosan’s modular cleanroom facility is designed and constructed in five modular adjoining hot-rolled frames, each at 10.3m long by 4.9m wide and 4m high. Due to the size of the modules, Clean Modules worked with specialist transport companies, such as Abnormal Loads Services, for the transport of the modules from Clean Modules’ premises to site.
The Ferrosan modules were delivered in Denmark by a combination of 3-, 4- and 5-axle wafer deck low loaders with private escort cars. The modules were loaded and off-loaded by a 250 tonne mobile crane with a combination of 4 x spreader beams to ensure an evenly distributed 6-point lift.
The hot-rolled frames ensure easy transport, provide the backbone to the facility and make modular cleanrooms feel like traditional rigid buildings. The steel frames also allow for a more flexible layout, enabling longer ceiling spans and the creation of rooms that are larger than the individual modules.
The modular cleanroom facility for Ferrosan houses a 160m2 EU GMP Grade C production hall that spreads through all five modules. The production hall has a dedicated filling area with uni-directional air flow, for filling the product into its primary packaging. Additionally, the production hall houses a secondary packaging area with two interconnected packaging systems totaling 17m in length.
An EU GMP Grade C product weighing and mixing room with dedicated extract system and an EU GMP Grade C washroom are also housed within the new facility. The facility is linked to an existing building that accommodates an EU GMP Grade D preparation and final packaging area. A pressure plenum ceiling system with fan filter units runs through the five-unit modular cleanroom facility and distributes the air into the cleanroom areas in the module and the existing building.
A plant skid is mounted externally on the roof, on top of the modules, housing the air handling unit and associated plant and is connected to the plenum system. The plant skid also houses the cooling, vacuum, extract and control systems for the modules and production equipment.
The new cleanroom facility is fully compliant with EU GMP cleanroom standards and Danish and European building standards. Initial product trials have been completed successfully. Ferrosan will be conducting further product trials over the next months and plans to launch its new product within a year.
This project has been a fine example of Clean Modules’ modular cleanroom solution and will serve as a flagship for other modular cleanroom installations throughout Europe. This facility proves that modular cleanrooms can be factory built away from site, transported and installed and commissioned anywhere in the world in less time and at lower costs than traditionally built cleanrooms.
The Emersons Green NHS Treatment Centre is believed to be the largest complete hospital to be built using off-site construction. David Johnson, director and general manager of off-site specialist Yorkon, looks at the challenges involved in the construction of this new surgical hospital.
The Emersons Green NHS Treatment Centre is operated by independent healthcare provider UK Specialist Hospitals (UKSH), and provides a range of elective surgical services to NHS patients, including inpatient treatment.
The £15m hospital was built and commissioned in just 12 months, completed both on time and on budget. Feedback from staff and patients has been extremely positive since it opened, particularly relating to the warm and welcoming clinical environment.
The 4,842m2 (52,100 sq. ft.) facility spans three stores and has four operating theatres with recovery bays, a central sterilization unit, minor operations room, endoscopy suite, diagnostics and x-ray facilities, 33 inpatient beds, procedure and consulting rooms, reception and waiting area, café, pharmacy, physiotherapy suite and admin centre.
The key driver for the client’s choice of off-site construction was the program. Delivery on time was critical as UKSH had set a service start date. By taking a more innovative approach, on-site working could be minimized, reducing the build time to just eight months. This allowed patients to benefit from increased choice and reduced waiting times at an earlier stage.
An important challenge for the client was that the building had to be installed and watertight by the end of the year. Yorkon started on site at the end of August, when the project reached financial close, and within just four weeks of the contract award, had completed the infrastructure works ready to receive the modules, which were delivered and installed by Christmas.
The 114 steel modules were craned into position in just three weeks.
The building consists of 114 steel modules up to 14m long, which Yorkon craned into position in just three weeks. The new centre was delivered on time, despite winter working and adverse weather conditions, which would have had a major impact on traditional site-based construction methods.
Some areas of the building were actually handed over at an earlier stage to give the client beneficial occupation, and the fitting out program was revised to accommodate this requirement.
Many construction clients are not aware that the speed of off-site construction requires faster decision-making. A good relationship and close communications between Yorkon and UKSH were therefore essential to the project’s success.
Designed by concept architects TP Bennett, the building demonstrates the design flexibility and architectural quality that is possible with off-site construction. The centre is clad in horizontal cedar with areas of terracotta, render and aluminum rain screen cladding to contrast with a highly glazed atrium.
The traditionally constructed atrium to the front elevation accommodates the reception, waiting area and café, and illustrates how modular construction can be successfully integrated with conventional building methods.
From the initial concept stage, the whole project was focused on the needs of the end user, creating a high quality therapeutic environment for patients and staff. The client wanted a finished building that would provide a sense of quality and permanence, and that would achieve measurable improvements in thermal performance and sustainability.
The new hospital was designed to meet NHS guidelines for infection control, specifically Health Facility Note (HFN) 30. The design, accessibility and space of the ward accommodation all contribute to ease of cleaning and maintenance. The bed centers at Emersons Green were designed to be at least 3.6m apart in the two and four-bed bays, although the majority of inpatient beds are in single rooms so patients known to be at risk of spreading infection do not have to be accommodated in open wards. The spacing of patient beds took into account access to equipment around the bed, and hand washing.
En-suite sanitary facilities and showers were provided to every single room and ward to ensure patients have easy access, convenience and independence where possible. Clinical hand wash basins are located in each single room and for each four-bed bay, with wall-mounted antibacterial soap dispensers for each sink, no plugs or overflows, and waterproof splash-backs. Taps are either elbow-operated or non-touch mixer taps.
Different specifications of vinyl sheet flooring were used across the building, with sealed joints and coved skirting. Curtain materials were specified to withstand washing at disinfectant temperatures. All surfaces, fittings and furnishings were selected for ease of cleaning, low dust retention, and without ledges. For example, the wall cabinets have sloping tops. Vinyl sheet flooring with sealed joints and coved skirting makes floor cleaning easy. In terms of storage, inpatients are provided with lockers for personal possessions; domestic cleaning equipment is stored in separate areas, and there are storage spaces for large items of clinical equipment when not in use.
The building has separate storage areas for clean and used laundry, and separate staff changing, shower and sanitary facilities were provided for male and female staff at second floor level in line with best practice requirements.
The building is specifically designed for effective patient flows and for clinical efficiency, with extensive use of color for walls and floors to assist in way finding. Patients enter the building via a highly glazed atrium at the front of the building, where there is a waiting area. Consulting rooms are located to the right, and behind is the x-ray department. Patients access the wards and theatres using the lift or stairs.
The first floor accommodates the main wards. Also on this floor are staff support and utility rooms, and an overnight bedroom for doctors. There is a patient lounge and exercise areas in the centre. Visitors access the wards from the atrium on the ground floor, through a sub-waiting area, before entering the wards.
On the second floor, patients arrive at a pre-operative area and are then taken into theatre through an anesthetic area to the right. After their operations, patients are moved to the recovery beds, followed by a pre-discharge lounge. The sterilization unit is also located on this floor.
Clean goods enter the building on the ground floor at the far left entrance into a goods lift. This building also provides a centralized sterilization unit for a number of treatment facilities. ‘Dirty’ operating equipment from other locations enters via the rear doors into a disposal holding area and then into a lift up to the sterilizing unit above. The lift also stops at the first floor where there is a small disposal hold for dirty equipment from the first floor rooms.
The goods arrive at a ‘dirty’ reception where a quick wash is carried out before being processed to a decontamination area for a full wash and scrub. The equipment is then loaded into washers and passes through to a cleanroom for re-packing, followed by sterilization booths. After unloading and cooling, the equipment is put onto trolleys for distribution either to theatres, other floors in the building or to other locations.
The theatres are all finished in light grey with high specification vinyl sheet flooring specially designed for theatre use. The pre-operative and recovery areas, finished in blue, and the sterilization unit use very cleanable vinyl sheet flooring. The flooring in the utility and changing areas is non-slip vinyl sheet safety flooring, with a higher grade anti-slip vinyl floor for showers.
Three types of wall finish were used throughout the hospital in a range of colors:
Antibacterial paint for x-ray, pharmacy, kitchens, utility rooms, theatres and recovery areas,
waterproof whiterock sheeting for showers, acrylic paint for all other areas, including consulting rooms, reception, circulation areas, wards and pre-operative areas.
The project has achieved a BREEAM ‘very good’ rating. BREEAM innovation credits were awarded for the site waste management plan – waste was reported monthly on the site and an average recycling rate of 92% was achieved, diverting waste materials such as timber and plasterboard from landfill.
Thermal modeling was carried out in the design of the building’s complex plant and services to maximize energy efficiency.
Time was also invested in developing ways of integrating low and zero carbon technology into the modular system, which in itself is designed to be highly sustainable. The finished building features services monitoring, water conservation devices, a high level of natural light, solar reflective glass, leak detection system for the kitchen, and cycle storage. A sustainable green roof was used for the adjacent service building.
Badger setts were identified in an initial site ecology report. Yorkon erected a barrier during construction, which has remained on the site, to give these animals a designated foraging area.
The off-site approach is also highly sustainable. It reduces vehicle movements to site by around 90%, reduces material waste by up to 90% and improves the thermal efficiency of the building for lower running costs.
Lastly, the adaptable nature of the building design will allow it to be reconfigured and re-used for other purposes in the longer term.
Commenting on the project, Fiona Calnan, chief executive of UKSH, said, “Yorkon was our preferred contractor for our new treatment centre; following its successful delivery of our Shepton Mallet Hospital. The facility at Emersons Green is a complex building and we wanted the security and reassurance of working with a healthcare construction specialist that had already delivered.
“The site was well managed at every stage and the treatment centre is finished to a high standard throughout. We are pleased with the end result and look forward to welcoming patients at the new facility for many years to come.”
Construction of the Emersons Green centre demanded high levels of innovation, creativity and commitment from the design and construction team. Yorkon’s site management team was also recognized with Considerate Constructors ‘Performance Beyond Compliance’ certification. This independent assessment of site operations looked at areas such as environment, site cleanliness, safety, responsibility, respect and accountability.
Following two visits to site, Yorkon achieved a score of 84%, which exceeded UK industry averages of 75%. The site team was commended for its ‘positive and proactive attitude’, its communications with adjacent properties, energy and water consumption monitoring and conservation initiatives, waste segregation for recycling, site welfare facilities and its good neighbor policy.
More importantly, it has succeeded in meeting the client’s stringent standards for delivering the highest quality of care, helping to provide NHS patients in the South West with increased choice and reduced waiting times.
Contract medical device manufacturer Arrow Medical has commissioned a single-use production unit, with UV curing and assembly lines, which brings the firm’s total cleanroom assembly facilities to 344m2 (3,701 sq. ft.) at its plant in Kington, Herefordshire.
The FDA GMP- and ISO 13485-accredited lines are housed within a new 56m2 soft wall, ISO 14644 Class 7 (US Class 10,000) cleanroom built by Connect 2 Cleanrooms, based in Kirby Lonsdale, Cumbria.
Arrow Medical will be producing a variety of single-use devices used in the anesthetic, emergency surgery and cardiac sectors and building complex inflatable systems from components using materials such as flexible and rigid PVC.
The soft wall cleanroom includes an illuminated transparent ceiling to ensure light levels of 1000 lux and provide suitable conditions for the assembly of small and complex devices.
Complete air handling and air conditioning systems are also included, with HEPA filters, maintaining more than 100 air changes per hour. Programmable day/night controls are also installed to achieve high levels of energy efficiency.
The new facility provides complete product assembly for products built from complex components using UV curing technologies, with complete traceability throughout the product’s life allied to 100% testing inside the cleanroom.
The production lines include a pad printer for adding product details onto complex curved products, multiple adhesive dispensing units and assembly workstations, supported by Dymax UV curing lamps with light guides and Intertronics UV 300 conveyorised UV curing units. Products are sealed into pouches using a Riverside Shaw seal unit. Lot and expiry date details are printed onto the pouch using a Domino G100 inkjet printer.
“Staff training has been a critical and substantial part of investment in this project,” said Rita Didcock, managing director of Arrow Medical.
“High quality standards and demanding production rates for the next generation of single-use devices require a consistent production culture to meet the triple challenges of clinical performance, high yield and traceability, while complying with our customers' stringent delivery performance and quality requirements.”
Arrow Medical's Kington facility now includes three cleanrooms, using solvent and UV curing adhesive assembly, manual and semi-automated lines for RF (radio frequency welding), and multilayer fabric assembly, including cutting and sewing. Support units cover silicone molding and overmolding and complete sterile product assembly.
Australian Prime Minister Julia Gillard, Victorian Premier John Brumby and IBM announced plans to build IBM's first global research and development laboratory at the University of Melbourne in the state of Victoria, Australia. In a world first for IBM, the new global lab will combine research and development in a single organization focused on accelerating progress toward a smarter planet. With this announcement, IBM will expand its presence in Victoria, the technology hub of the Asia-Pacific region.
"IBM has been drawn to Australia by the availability of world-class talent, the innovation environment, continent-scale opportunities and Australia's robust economy," said Glen Boreham, managing director for IBM Australia and New Zealand.
With the support of the Victorian government, IBM and the University of Melbourne will combine resources to help create a national innovation center to solve the significant forward-looking problems in Australia and to share that knowledge and expertise with the world. The world-class facility will employ 150 highly-skilled researchers tasked with finding solutions to natural disaster management, water efficiency, natural resource management, disease prevention, energy efficiency, boosting agricultural yields and harnessing the power of biotechnology.
"We believe there is bright future for ICT in Australia," said Prime Minister Gillard. "A big part of that future is encouraging companies such as IBM to conduct research and development in Australia on the significant problems facing Australia and to share their knowledge and expertise."
As the Information and Communications Technology (ICT) capital of Australia, the state of Victoria is home to more than 8,400 ICT companies, including the Asia Pacific operations of industry giants such as Alcatel Lucent, Cisco, Hewlett-Packard, Oracle and Microsoft. Victoria is also home to the development efforts for the Australian National Broadband Network (NBN) and boasts significant access to quality R&D, a highly skilled workforce and the infrastructure to facilitate cutting-edge technology research via research centers such as the University of Melbourne, the Institute for a Broadband Enabled Society and the Victorian Life Sciences Computation Initiative, home to one of the world's largest life sciences supercomputers.
"Victoria is the perfect place to base globally important ICT research facility like this," said Premier Brumby. "We are home to the hub of the NBN, have the best ICT workforce in the country, a strong base of ICT research institutions and companies, a growing economy and a very supportive government. IBM's new research center keeps Victoria at the forefront of high-end global ICT research and development."
IBM's investment in Victoria is consistent with the annual Australian Bureau of Statistics survey of business expenditure on research and development. The study, released in September, indicates that foreign investors spent $5.8 billion on R&D activity in Australia in 2008 and 2009, with Victoria accounting for the largest share. .
Leading pharmaceutical manufacturer, Aesica, is investing £3 million in a new high containment facility, significantly extending the company’s current capabilities in the formulation and packaging of liquid and solid dosage forms.
As the market for the contract manufacture of potent drugs continues to grow, Aesica believes that the investment in the new containment facility will enable it to significantly extend its formulation offering in this particular market.
It is estimated that the facility will be completed by May 2011 and once operational will enable Aesica to manufacture potent drugs typically classed as Safebridge category 3. The new facility will also include security measures that will ensure it can manufacture Schedule II controlled drugs such as opiates.
Housed in a purpose built facility at Aesica’s Queenborough site, the new high containment unit will include suites for granulation, tabletting and blister packing along with the appropriate HVAC and cleaning facilities and will be completely separate from the rest of the company’s facilities to prevent any potential cross-contamination.
Adam Sims, Commercial Director, Aesica says: “As we continue to consolidate and broaden our service proposition, the addition of the high containment facility has enabled us to add yet another dimension to our offer. The evolution of drug development and the use of more potent compounds has made high containment drug manufacturing a key focus for customers outsourcing their products”.
“With our proven expertise in the production of Formulated Products and APIs, it was a natural progression for us to broaden our reach into this marketplace. Our service offering and capability is the most advanced in the UK and the addition of the new facility will be of huge benefit to our current clients and indeed all pharmaceutical companies who require potent drug product production.”
Aesica supplies contract development and contract manufacturing services for Active Pharmaceutical Ingredients and Formulated Products to a host of the world’s leading pharmaceutical companies and emerging biotechnology organizations.
Its unique proposition lies in its flexible and bespoke approach to service delivery, coupled with its ability to develop products from the initial clinical stage through to final commercial supply. Furthermore, the long established and proven expertise within the company enables it to provide primary and secondary contract manufacturing services to the highest possible standards. It is this all-encompassing offer and its dedication to exceptional standards of service that truly sets Aesica apart from its counterparts.
Aesica was founded in 2004 and has since more than trebled in size, from having a single API site in the North East of England to being a significant global player with four API and Formulation development and manufacturing sites in the UK, global offices in New York, San Diego and Shanghai and an international customer base.
The company also recently announced (29 June 2010) that it successfully acquired leading research and development company R5. R5 is Aesica’s third UK acquisition since 2006 and will complement its existing formulations capability and enable it to significantly consolidate and enhance its portfolio of pharmaceutical and biotechnology clients.
Volunteer organization, the Blue Bird Circle will provide grants of $1m to Texas Children’s Hospital in the US for the establishment of a new clinical research centre.
The centre will support clinical trials into potential treatments for paediatric neurological ailments and diseases, including the degenerative disease, Batten disease, and common neurological conditions, such as epilepsy, autism, Fragile X and Angelman syndrome.
Using the Jan and Dan Duncan Neurological Research Institute at Texas Children’s Hospital as a resource for research and breakthrough scientific discoveries in neurology, the Blue Bird Circle Clinical Research Centre will “advance care to the next level,” by developing treatments for a variety of childhood neurological disorders.
In addition to identifying potential therapeutics for paediatric neurological disorders by studying the effects of various therapies at the clinical research centre, it will also serve as an off-site clinical research centre for other trials being conducted around the country, which Texas Children’s Hospital believes will “allow the maximum benefits to be drawn from each trial.”
Speaking about the grant from the Blue Bird Circle, which will be paid out within a five to ten year period, Dr. Gary Clark, chief of paediatric neurology at Texas Children’s Hospital, said the money will enable Texas Children’s “to put the foundational infrastructure [for the centre] in place, as well as hire the critical personnel needed for the new clinical research centre,”
Describing this type of clinic as “past due,” Clark asserted however, that the research centre is “very forward looking, as not many exist in the U.S.”
Meanwhile, Pat Lucas, president of the Blue Bird Circle, said the organization has “always been involved in research,” and “helping this new clinical research centre come to fruition is a perfect fit” for the Blue Bird Circle, which operates through volunteerism in the Blue Bird Circle Clinic at Texas Children’s Hospital and The Blue Bird charity shop.
“This is a logical progression and in line with our mission,” she said, which is to take “what we see daily in the Blue Bird Clinic at Texas Children’s to the next step in helping patients and families affected by neurological ailments.”
In a review conducted by the National Institutes of Neurological Disorders and Stroke, it was found that 6 out of every 1000 children in the US have autism and 2 out of every 1000 children have cerebral palsy.
ISPE, has announced during the Keynote Session at its 2010 Annual Meeting in Orlando, Florida, USA, that Genentech’s ECP-1 Bacterial Manufacturing Facility is the overall winner of the 2010 Facility of the Year Awards (FOYA) program.
Sponsored by ISPE, INTERPHEX, and Pharmaceutical Processing magazine, the Facility of the Year Awards (FOYA) program recognizes state-of-the-art pharmaceutical manufacturing projects that utilize new and innovative technologies to enhance the delivery of a quality project, as well as reduce the cost of producing high-quality medicines. Now in its sixth year, the awards program effectively spotlights the accomplishments, shared commitment, and dedication of individuals in companies worldwide to innovate and advance pharmaceutical manufacturing technology for the benefit of all global consumers.
Located in Tuas, Singapore, Genentech’s ECP-1 Bacterial Manufacturing Facility was named the 2010 Overall Winner due to its innovative project execution, which outpaced an ambitious schedule. The facility, which was built to increase the production capacity of Lucentis®, a drug used to treat wet age-related macular degeneration, was placed on an ultra-fast track schedule, and was slated to go from engineering kick-off through initiation of GMP qualification batches in just 24 months.
The business requirements of the ECP-1 project presented significant schedule, cost, and execution challenges. The project team took a highly collaborative approach, led by Genentech’s effective decision making. By embracing a modular approach from the beginning, along with an early focus on site issues, outstanding project planning, execution techniques, and team development, the project team beat the aggressive schedule by two weeks. Additionally, the project came in 10.5% under a US$217 million budget. The 2010 FOYA Judging Panel was impressed by the way Genentech’s project brought together three geographic regions to work together and overcome severe logistical challenges.
Genentech’s ECP-1 Bacterial Manufacturing Facility was selected as the overall winner of the 2010 Facility of the Year Awards by a judging panel consisting of eight prominent pharmaceutical industry professionals with global experience. In addition to Genentech, five other companies were Category Winners in 2010. They were:
Biogen Idec, headquartered in Weston, MA, USA, winner of the Facility of the Year Award for Operational Excellence
MannKind Corporation, headquartered in Valencia, CA, USA, winner of the Facility of the Year Awards for both Equipment Innovation and Process Innovation
Pfizer Biotechnology Ireland, located in Cork, Ireland, winner of the Facility of the Year Award for Sustainability
Pfizer Ireland Pharmaceuticals located in Dublin, Ireland, winner of the Facility of the Year Award for Facility Integration.
More information about each of the winning projects, as well as the Facility of the Year Awards program in general, can be found at www.FacilityoftheYear.org.
Maccine has opened a dedicated non-human primate (NHP) MRI centre to strengthen its position in translational imaging research services.
Addition of NHP magnetic resonance imaging (MRI) is part of wider efforts by Maccine to perform preclinical research that more accurately predicts efficacy in Phase II. Producing more relevant data helps make better decisions about which molecules to advance, saving time and money.
Installation of a Siemens 3T TIM Trio instrument at the NHP MRI centre is part of the translational research strategy. The Siemens 3T TIM Trio is widely used in clinical research and secondary care, helping to make information gained in preclinical applicable to later phases.
Mark Wong, associate director of business development at Maccine, said the Singapore-based preclinical contract research organization (CRO) is trying to occupy the translational niche. In doing so Maccine aims to help clients reduce Phase II and III failures.
Implementation of this translational strategy has seen Maccine adopt cross-species biomarkers; naturalistic disease phenotypes, such as diabetic or aged monkeys; and clinical technology platforms, such as MRI, CT (computed tomography) and PET (positron emission tomography).
The new MRI centre will primarily be used for neuroscience discovery. Using the equipment in longitudinal studies Maccine can monitor a treatment’s ability to reverse an induced disease state, such as schizophrenia. The equipment can also be used to measure fat content.
The imaging team will also benefit from a functional MRI cynomolgus macaque colony formed by Maccine. Formation of the colony occurred after a major pharma expressed an interest in investigating the effect of a treatment on a conscious, unsedated animal, said Wong.
Adding this capability puts Maccine at the forefront of preclinical imaging of large mammals. Leading academic establishments have imaged conscious unsedated animals but Wong believes it is a first in the contract research sector.
Imaging is emerging as a possible technique to improve toxicology and safety testing. Wong said performing longitudinal imaging studies on individuals has the potential to reduce animal use and advance a sector that seen relatively little technological development.
Physiological parameters used in imaging to quantify drug efficacy can also be applied to toxicology. This has the potential to support earlier and more informed decisions about whether to advance a candidate into clinical trials.
Interest in using imaging in toxicology has been driven by the US Food and Drug Administration (FDA) Critical Path Initiative (CPI) and desire to reduce Phase II and III attrition. CPI is an FDA project to advance the development, evaluation and production of medical products.
Jacobs Engineering Group is providing engineering services to support construction of a multi-purpose GMP production facility in Chongqing, China.
Porton Fine Chemicals is building the facility to bolster its custom and contract manufacturing capabilities. Jacobs has already performed basic engineering services for the project and will now deliver more detailed support for the good manufacturing practice (GMP) plant.
"This is Jacobs' first major entry into China's pharmaceutical sector. We are delighted that Porton has entrusted us with this facility, and we are fully committed to delivering a plant that proficiently meets their needs”, said Christopher Nagel, a vice president at Jacobs.
Eli Lilly and Company announced plans to open a research center focused on diabetes in China, where the incidence of the disease has reached epidemic proportions.
The center, to open in Shanghai in the second half of 2011, will focus on discovering new medicines to treat diabetes, and reflects both Lilly's longstanding leadership in this disease area and the priority Lilly places on improving the health of the Chinese people.
"We are establishing this research center, first and foremost, to meet the growing unmet medical needs of those living in China with diabetes," said Jan Lundberg, Ph.D., executive vice president, science and technology, and president, Lilly Research Laboratories. "This center will complement our existing network of collaborations in China and also will enable us to further gain the insights of China's talented scientists inside and outside of Lilly as we further explore a disease state in need of new and innovative therapies."
According to a recent article in The New England Journal of Medicine, an estimated 92 million people in China - almost 10 percent of the adult population - have diabetes(1), a number that is expected to increase in the coming decade due in large part to longer life expectancy, dietary changes and lack of exercise. Left untreated or undertreated, diabetes can lead to debilitating or potentially fatal complications, including heart disease, stroke, nerve damage, lower limb amputation, vision loss and kidney disease.
"Our strategy in China, and throughout the world, is to bring innovation to patients," said Jacques Tapiero, senior vice president and president of Lilly's emerging markets business area. "By establishing a diabetes research center in China, Lilly will be better able to discover medicines that are well suited to the particular needs of patients with diabetes in China."
In another timely example of Lilly's commitment to diabetes research, the company said that it is working with the China Diabetes Society (CDS) and the European Foundation for the Study of Diabetes (EFSD) to support collaborative diabetes programs between Chinese and European academic centers. Lilly has committed a total of 1.8 million Euros over three years (approximately $2.5 million or $16.6 million renminbi) to this effort.
Heading up the center will be Bei Betty Zhang, Ph.D., a native of Shanghai and an internationally-recognized diabetes expert who also serves as vice president of research for Lilly Research Laboratories in China.
The center will initially employ approximately 100 scientists and support staff, the majority of whom will be hired from within China.
The center will focus on seeking to discover compounds with novel mechanisms of action leading to breakthrough therapies for diabetes. Its work will be complementary to Lilly's global diabetes R&D efforts.
Scientists at the research center hope to discover medicines that better control blood glucose levels without hypoglycemia (low blood sugar), along with diabetes therapies that address co-morbid conditions such as cardiovascular disease and obesity.
"What we are saying in announcing the establishment of this center is that we are committed to innovation, we are committed to diabetes, and we are committed to improving outcomes for individual patients with diabetes," said David Moller, M.D., vice president of endocrine and cardiovascular research and clinical investigation at Lilly. "Given key differences in the molecular basis of diabetes in Chinese and other Asian populations, a major focus at this center will be on discovering therapies that target critical aspects of the disease."
The Fraunhofer-Gesellschaft, Europe's largest applied research organization, is setting up its first research center in South America. On October 22, 2010, the Fraunhofer-Gesellschaft and the Chilean Ministry of Economic Affairs sign a bilateral agreement giving the go-ahead for an extensive cooperation.
Professor Alfred Gossner, the CFO of the Fraunhofer-Gesellschaft, announced "The new Fraunhofer Center for Systems Biotechnology in Chile will create links and bring forth innovations for new markets: links between Germany and Chile, between scientific disciplines, between pure research and the demands of private enterprises." Dr. Gossner signed the bilateral agreement with Juan Andrés Fontaine, the Chilean minister for commercial affairs, in the presence of the Chilean President Dr. Sebastián Piñera and Chancellor Dr. Angela Merkel in Berlin. The agreement acknowledges the extensive preparation work on both sides, and clears the way for the new research center to be established in Santiago de Chile.
The Fraunhofer Center for Systems Biotechnology is funded by INNOVAChile, which was created by the governmental economic promotional society CORFO to attract world-class international research institutes to Chile for joint research and development partnerships. Several organizations have been evaluated, but Fraunhofer-Gesellschaft is the first and so far the only one to receive a funding commitment from the Chilean Government. Partners on the Chilean side are: the two iconic universities Pontificia Universidad Católica de Valparaíso (PUCV) and Universidad de Talca, and the private non-profit organization Fundación Chile. The German partner is the Fraunhofer Institute for Molecular Biology and Applied Ecology IME, headed by Professor Rainer Fischer. The foundation of the Center was actively supported by the German-Chilean Chamber of Industry and Commerce.
The Fraunhofer Center for Systems Biotechnology is the first research center to be launched by the Fraunhofer Chile Research Foundation established on October 4, 2010, and it will work closely with Chilean research organizations and private enterprises. The research carried out at the new Center will benefit from and make a long-lasting contribution to Chile's pioneering spirit and economic strength, reflecting the country's faith in a traditional economy based upon raw materials, agriculture, aquaculture and the sustainable use of natural resources. Systems biotechnology is an emerging field in life sciences that aims to develop an understanding of the complex and dynamic processes in cells, organisms and even ecosystems at the systems level. This is achieved by creating computer models and mathematical simulations, which are then applied to problems in biotechnology using a combination of large-scale laboratory experiments and computational biology.
German and Chilean researchers will combine their strengths to develop and optimize a wide range of technologies that will be used to develop rapid tests for fish diseases and more effective fish vaccines (partnership with Fundación Chile), to develop new nanotechnology solutions to remove pesticide residues from beverages and purify waste water (partnership with Universidad de Talca) and to improve the performance of enzymes and increase the efficiency of biomass utilization in the energy industry (partnership with PUCV).
Sanofi-aventis and BMP Sunstone Corporation announced that they have entered into a definitive agreement under which Sanofi-aventis is to acquire all outstanding shares of BMP Sunstone for cash consideration of USD 10 per share, or a total of approximately USD 520.6 million on a fully diluted basis. The acquisition is to be structured as a merger of BMP Sunstone and a wholly-owned subsidiary of sanofi-aventis.
BMP Sunstone achieved sales of approximately $147 million in 2009. Almost 60% of these sales were realized in the consumer healthcare segment, where BMP Sunstone has access to retailers, county hospitals and community clinics in Tier III and Tier IV markets. In this segment, BMP Sunstone has established two of China's most recognized brands: "Hao Wa Wa" (GoodBaby), recently recognized as the number one paediatric Cough & Cold brand in China, and "Kang Fu Te" (Confort) a hygiene brand for women's healthcare.
Following the recent establishment of the Hangzhou Sanofi Minsheng Consumer Healthcare joint venture, the acquisition of BMP Sunstone will make sanofi-aventis a leading consumer healthcare company in China, with a strong position in both Vitamins & Minerals Supplements and Cough & Cold, the two largest categories of this market.
"The acquisition of BMP Sunstone will not only leverage our consumer healthcare business in China, but will also bring us unique access to new expanding distribution channels which are expected to account for a third of the pharmaceutical market in the coming years," said Christopher A. Viehbacher, Chief Executive Officer of sanofi-aventis. "This transaction represents another strategic move for sanofi-aventis to reinforce its leadership position in China."
"This transaction offers immediate and significant value for BMP Sunstone stockholders and important benefits to our employees and customers," said Mr. David (Xiao Ying) Gao, Chief Executive Officer of BMP Sunstone. "I am excited to work with the sanofi-aventis team to capture the significant growth opportunities this new combination will create in the consumer healthcare market in China."
Under the terms of the merger agreement, completion of the transaction is subject to the approval of the merger by BMP Sunstone stockholder's meeting, as well as the receipt of certain regulatory approvals in and other customary conditions. Stockholders controlling 23% of BMP Sunstone's shares on a fully diluted basis have committed to vote in favor of the transaction.
Consumer Healthcare is one of the core growth platforms identified in sanofi-aventis' strategy for achieving sustainable growth. Sanofi-aventis is currently the 5th largest consumer healthcare company worldwide, and continues to expand its presence in this area through organic and external growth. The Consumer Healthcare market in China is the second largest in the world after the US, with an estimated size of EUR 12 bn in 2010. It has grown at a CAGR of approximately 11% since 2005, and this trend is expected to continue over the coming years driven by continued urbanization and improvement of patients' affordability, increasing trend of self-medication and the development of pharmacy chains and expanded retail offerings of consumer healthcare products.
About Sanofi-aventis in China: Sanofi-aventis was the first foreign pharmaceutical company to open offices in China. It is today one of the fastest growing healthcare companies in China, with 5,000 people in more than 200 cities across China. From prevention to treatment, sanofi-aventis is uniquely positioned to address public health needs in China. Sanofi Pasteur, the vaccines division of Sanofi-aventis, is a leading vaccines company in China. In Oct. 2010, sanofi-aventis entered the consumer healthcare market in China, with the establishment of Hangzhou Sanofi Minsheng Consumer Healthcare Co., Ltd. Sanofi-aventis currently has three manufacturing facilities in Beijing, Hangzhou, and Shenzhen. In addition, the company is building three new facilities, all scheduled to begin commercial production in 2012, in order to meet the increasing demand of the Chinese market. Sanofi-aventis is engaged in integrated R&D in China from drug target identification to late stage clinical studies. Its China R&D Center and Asia Pacific R&D Center are based in Shanghai.
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in (EURONEXT: SAN) and in (NYSE: SNY).
BMP Sunstone Corporation is a specialty pharmaceutical company that is building a proprietary portfolio of branded pharmaceutical and healthcare products in China. Through Sunstone the Company manufactures leading pediatric and women's health products sold in pharmacies throughout the country. The Company also markets a portfolio of products under exclusive multi-year licenses into China, primarily focused on women's health and pediatrics, as well as provides pharmaceutical distribution services through subsidiaries in Beijing and Shanghai. BMP Sunstone's main office is in Beijing, with a U.S. office in Plymouth Meeting, PA.
ATMI, Inc. has opened a new biopharma manufacturing facility in Beijing, China as part of a joint venture with Austar, a Hong Kong-based pharmaceutical service provider.
The joint venture, ATMI Austar LifeSciences Ltd., is aimed at producing and marketing high-end, ultra-clean sterile materials packaging for APIs and sterile pharmaceutical components to the biopharma industry in the Asia-Pacific region. ATMI Austar LifeSciences will produce certain ATMI LifeSciences products, including Cleansteam products, with local blow-film extrusion and packaging converting lines using a copy-exact strategy. The new facility also has potential expansion opportunities for ATMI’s Integrity line of bioprocess vessels (BPVs) manufacturing.
“This joint venture not only provides ATMI LifeSciences with access to the API and biopharmaceutical markets in Asia but also access to Austar’s existing ISO Class V GMP-certified, cleanroom-based infrastructure that we can begin to leverage immediately,” commented Mario Philips, general manager and senior vice president of ATMI LifeSciences. “Together, under the ATMI Austar LifeSciences banner, we are working to create a new standard for advanced materials packaging for pharmaceutical manufacturing throughout the region.”
“We believe that the flexibility and value that we offer will result in the pharmaceutical manufacturers converting to the film-based, single-use packaging products that ATMI Austar LifeSciences will be able to provide locally,” said Mars Ho, chief executive officer of Austar. “The pharmaceutical market in Asia is expanding rapidly as more multinational firms look to extend their manufacturing capabilities into this vital region. Local supply and support is an important competitive differentiator.”
The Beijing facility, operated with Hong Kong-based Austar LifeSciences, will employ blow-film extrusion technology to produce sterile packaging materials for active pharmaceutical ingredients (APIs) and medical device components.
ATMI said the new plant and Austar partnership improve access to the region’s pharmaceutical packaging market, citing the addition of local ISO Class V GMP-certified, cleanroom-based infrastructure as a particular advantage.
The importance of manufacturing capacity in Asia was stressed by Austar CEO Mars Ho, who suggested it is an “important competitive differentiator” for multinational firms looking to grow their businesses in the region.
The Beijing plant also provides a platform for expansion of ATMIs bioprocessing business which, the firm said, “could be rolled out directly as the Asian biotech market continues to emerge.”
This part of ATMIs business has seen much expansion in recent times, beginning in April when it launched the Integrity disposable bioreactor and continuing this summer with the roll out of a new range of 2 and 3D bioprocess vessels (BPVs).
These launches were accompanied, in July by the completion of a two-year $45.5 million (€3.4m) project that saw ATMI increase BPV manufacturing capacity at its in Bloomington, Minnesota, US.
This extra capability, when added to capacity at its plant in Hoegaarden, Belgium, means ATMI will finish 2010 with double the manufacturing space it had at the start of the year, which is a sure indication the firm expects its bioprocess to grow.
This idea is somewhat supported by ATMI’ s latest set of financials that saw revenue from the life sciences sector increase 31 percent to $6.9 million, continuing the trend seen over the first nine months of 2010 during which sales increased 36 percent to $23 million.
Four Australian institutions have begun construction on a A$354 million ($347 million) Translational Research Institute in Brisbane that will allow researchers to carry out basic research, develop and test treatments, then manufacture them in one facility for the first time in Australia.
Up to 900 researchers and support staffers are expected to work at the new facility, for which ground was recently broken — including the 650 researchers set to work in the wet labs planned as part of TRI. The five-story, 32,000-square-meter (344,448-square-foot) institute will rise at Princess Alexandra Hospital, and is set to be completed in May 2012.
The TRI is a partnership of the hospital as well as three other institutions scattered across Brisbane: Mater Medical Research Institute, Queensland University of Technology, and the University of Queensland. UQ's Diamantina Institute, established in 2007, seeks to discover the cellular and molecular basis of diseases to better understand and prevent disease formation.
"The TRI will enable these stakeholders to concentrate their efforts in the one location, signaling strength, focus, and direction in translational research in Australia," a UQ spokeswoman, Fiona Cameron, said. "It consequently enables the coordination of research efforts on a hospital campus, facilitating research synergies and research critical mass as well as reducing the need for duplicated infrastructure, thereby enabling capacity to invest in state-of-the-art technologies.
Those technologies include TRI's core research facilities, which according to Cameron will include high-end technology platforms such as human genome mapping, high throughput gene expression and function screening, mass spectrometry flow, and facilities for cytometry, microscopy, and histology.
Among facilities set to combine into a single core at TRI, Cameron added, will be the independent flow cytometry and microscopy facilities now operated separately at UQDI and MMRI, as well as the mass spectrometry facilities operated by UQDI and UQ's School Of Medicine.
According to Cameron, a new Genome Mapping Centre with state-of-the-art, high throughput DNA sequencers will complement the existing Australian Cancer Research Foundation Comprehensive Cancer Genomics Centre that recently opened at the UQDI.
"Additional shared facilities include bioinformatics, cell therapy clean rooms and clinical research areas as well as teaching space for both medical and nursing students, together with a demonstration lab for secondary school student science education," Cameron said.
Partner organizations plan to relocate a combined 430 existing staffers to TRI. To fill the remaining positions, Cameron said the institute will undertake a "strategic recruitment campaign upon relocation of stakeholders into the building."
The prospect of being able to research, test, and manufacture drugs all within Australia helped TRI attract funding from several government sources as well as private sources including A$140 million, plus another A$10 million for biopharmaceutical manufacturing, from Australia's federal government; A$107 million from the Queensland state government; A$50 million from The Atlantic Philanthropies; A$25 million from QUT; and A$10 million from UQ.
The remaining A$12 million will come from interest that has been earned on invested funds, Cameron said.
TRI is designed to address what many academic, corporate, government, and institutional leaders have long cited as a gap in Australia's life sciences effort — the dearth of domestic drug manufacturing sites, forcing researchers to sign away rights to global pharmaceutical and biotech giants.
Sanyo Biomedical is launching a cost-effective, space-saving stand-alone cell processing work station (CPWS) for GMP production.
CPWS reduces the investment and space needed to perform good manufacturing practice (GMP) compliant processing and manufacture of regenerative stem cells and cell therapies, according to Sanyo. This lowers the barriers to entry for biopharm, the public sector and academia.
Sanyo is marketing CPWS as a more compact, less expensive alternative to a traditional cleanroom. The stand-alone, self-contained unit features a four-port glove box and, when installed in a Class 100,000 cleanroom, a Class 100 environment within the workstation.
CPWS is 115” wide, 41” from front to back and 87.8” high. The smaller dimensions of CPWS, compared to a conventional cleanroom, increases flexibility when locating and orientating the unit, as well as contributing to easy acquisition and set up.
An integrated cell monitoring system helps reduce GMP floor space requirements. The unit includes a 19” LCD monitor to display real time images taken by a charge coupled device (CCD) camera with objective lens and phase difference filter.
CPWS is currently available in North America and Japan. A European launch is being planned, Deepak Mistry, strategic marketing manager at Sanyo told in-PharmaTechnologist.
Operation of the self-contained workstation is underpinned by in situ decontamination. A H2O2 process is used to decontaminate CPWS without heat. This prepares CPWS for the next protocol within two hours, compared to days or weeks to decontaminate a traditional cleanroom.
Shortening decontamination time increases throughput, which contributes to lower operating costs. In a breakdown of potential operating costs Sanyo says CPWS has a nominal annual budget of $60,100 (€42,800), compared to $91,600 for a conventional GMP cleanroom.
Reduced expenditure on power consumption, validation of the cleanroom and report, and sterilized, non-shedding gowns contribute to lowering CPWS operating costs.
The United States Pharmacopeial Convention (USP) and six government drug control laboratories in the Middle East and Northern Africa (MENA) join to launch a drug quality improvement Network.
Once implemented, the MENA Regional Laboratory Network will encourage communication among participating countries; review guidelines for drugs approval across the region; and take steps towards eliminating substandard and counterfeit drugs, anticipates USP.
Mat Heyman, USP vice president for external affairs and strategic integration, said that by regimenting manufacturing procedures across MENA drug control laboratories, the Network can help harmonize global pharmaceutical quality systems, bringing more medicines that meet global regulatory requirements.
The Network was created by senior officials of government laboratories from Abu Dhabi, Egypt, Jordan, Morocco, Saudi Arabia, and Tunisia, following a meeting with USP officials earlier this month.
Heyman said, “The participating MENA governments recognize that the pharmaceutical sector is growing in the MENA region in response to a demand for more access to medicines for a fast growing population.”
He went on to say, “Like any other region of the world, the increase in volume of pharmaceutical goods is paralleled by an increased risk of introduction of counterfeit or substandard drugs, hence the focus of high quality medicines.”
Under the initiative, the standards-setting organization will provide program management, funding for technical staff, reference standards, and samples. Part of wider plans also includes the implementation of an inter-laboratory testing activity, whereby based on samples submitted by the six labs, each will be given a detailed report containing feedback and recommendations.
“This activity allows USP, the organization that develops the standards, to provide technical assistance to the end-users of the USP-NF monograph standard, thus helping to ensure the quality of medicines in this region of the world,” Heyman said.
‘Strength in numbers’ to set quality medicines standards
The issues the Network sets out to address were again raised by USP CEO, Roger Williams at the forth Joint International Symposium in Hangzhou, China. He said patients and consumers across the world depend on medicine standards-setting bodies to develop robust standards, and “these pharmacopeial organizations must work together more closely than ever before.”
“All of the world’s pharmacopeias face a variety of technical issues as they try to develop and adopt the kinds of standards that drug regulators, manufacturers, patients, and consumers depend upon to assure quality and safety,” Williams said.
He believes “There is a strength in numbers if we work more closely,” reiterating, “We have an obligation to do that if we are going to meet these urgent public health needs around the globe.”
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