PHARMACEUTICAL & BIOTECHNOLOGY INDUSTRY
UPDATE
July 2012
McIlvaine Company
TABLE OF CONTENTS
Albemarle Expands API Capacity
Oliver-Tolas Expands Michigan Facility
9 Planned or Proposed Projects at University of Michigan
Encap Expands CMO Capabilities
ILS Acquires Beckman Coulter Genomics Facility, Creates ILS Genomics
SOM Plans Upgrades at Cincinnati’s The Christ Hospital
Daiichi Sankyo Receives FDA Approval at New Facility
Proposed Vermont Bio-Tech Plant Could Create 500 Jobs
Albemarle Expands South Haven API Production Site
Rensselaer Opens Stem Cell Center
HHS Investing to Speed Pandemic Vaccine Production
Roche Diagnostics to Invest in Headquarters in Indianapolis
Healthpoint Biotherapeutics to Create Manufacturing Facility
Cook Pharmica Gains Commercial Manufacturing Approval
Mozambique Re-establishes National Drug Quality Lab
GSK Opens Anti-doping Lab for London 2012 Olympic Games
Stork Veco Opens New Cleanroom Facility
Encap Drug Delivery Growing CMO Activities
Sartorius Opens New Filter and Aseptic Bag Production Facility in Puerto Rico
Kemwell Announces Expansion of New Pharmaceutical Development Labs
Merck Animal Health Site in Cologne Certified
Ardmac Awarded Contract for Eli Lilly Biopharmaceutical Facility in Cork
TÜV SÜD Canada Expands to Gormley, Ontario
Merck Serono and Compugen Establish Neviah Genomics JV
ScinoPharm to Build Cytotoxic Injectable Plant
Probing Antarctica’s Pristine Lake
GE Healthcare and Intel to Establish Laboratory in Israel
Fujifilm Diosynth Biotechnologies Expands CGMP Capabilities
CRI Lifetree opened an early-stage research facility in Marlton, N.J. The site raises the company’s total bed count to 250 and adds capacity to conduct complex clinical trials.
The additional bed space and added capabilities for conducting complex neurology, pediatrics and normal healthy patient studies comes at a time of considerable need for the industry. Other facility features include six beds dedicated to first-in-human studies. This space has an observation area to allow clinicians and sponsors the access needed. The new center also has separate areas for elderly and pediatric populations. The 21,000-square-foot building adds to CRI Lifetree’s two other facilities in Philadelphia and Salt Lake City.
CRI Lifetree, formerly CRI Worldwide and Lifetree Clinical Research, is a leader in specialized, multitherapeutic inpatient and outpatient early-stage research.
CRI Plans to conduct trials in neurology, pediatrics and normal healthy patients at the site, which also houses six beds dedicated to first-in-human studies.
Gentris Corp., the pharmacogenomic testing and biorepository firm, has expanded its genomic biomarker services by adding multiple technology platforms to its lab in RTP, North Carolina.
Albemarle has increased production capacity at its plant in Michigan, citing demand for custom and generic APIs as the driver.
The Baton Rouge, Louisiana-based fine chemicals manufacturer said it expanded its plant in South Haven through an investment that “matches the solids handling equipment with the reactor capacity.”
Albemarle claims the number of custom API projects conducted at the site has doubled over the past two years and that the expansion “will enable the company to advance its growing portfolio of custom API products, several of which have progressed to late stage clinical development and pre-registration status.”
This was echoed by spokeswoman Jennifer Vaccaro who said the manufacturing investment will allow Albemarle “to produce more of both our current line of generic APIs as well as give capacity for new custom products.”
She also stressed that the expansion is ‘unrelated’ to the series of price increases Albemarle has enacted over the last few months – the most recent of which took place in May – when asked if it had been - in part - motivated by a desire to make more of the now more costly generic APIs.
Albemarle’s comments about demand from the pharmaceutical sector fit with those it made earlier this year when it reported that its fine chemicals business – which includes its API portfolio – saw revenue increase 7 per cent to $712m.
Speaking in April CEO John Steitz said that “positive trends within our pharmaceutical portfolio” were making Albemarle’s fine chemistry business more profitable.
He attributed this to “The impact of evolving our portfolio towards complex, higher margin, longer duration opportunities was evident during the quarter as operating margins rose impressively” which also fit with the firm’s claims about the growth of it custom API business.
Albemarle is due to report its second quarter financials on July 17.
Oliver-Tolas Healthcare Packaging announced a $1.3 million investment in its Grand Rapids, Michigan facility. The investment includes a manufacturing area expansion, additional cleanroom installations, and the modernization and expansion of its Packaging Development and Technology Center.
The manufacturing area expansion adds 40,000 sq. ft. to the existing 140,000 sq. ft. of production space. The new manufacturing space allows Oliver-Tolas to enhance its work flow, expand its cleanroom, and meet growing demand for Xhale hot melt adhesive coated packaging, the company said.
Oliver-Tolas’ Grand Rapids facility first installed cleanroom capability in 2005, producing Osurance zone coated lids and several specialty medical packaging products in a ISO 7 (FED STD Class 10,000) cleanroom. With the 2012 expansion, the balance of Oliver-Tolas’ Xhale lids will be produced in an ISO 8 (Class 100,000) cleanroom.
There are also plans to install cleanroom capabilities for pouch production at Grand Rapids and its sister facility in Feasterville, Pennsylvania. Oliver-Tolas’ Venray, The Netherlands facility already produces lids and pouches in an ISO 8 (Class 100,000) cleanroom.
"For many years, we have been serving a specialized customer base who values sterile-grade materials produced in a cleanroom,” said Jeff Murak, VP of Sales and Marketing. “Now that customer base is growing to include a broad base of medical device manufacturers and we are excited to be expanding our cleanroom capabilities to meet the growing demand."
Coinciding with the expansion of the Grand Rapids production space, Oliver-Tolas also completed the modernization of its Packaging Development and Technology Center, which includes a 2000 square foot state-of-the-art technical laboratory and conference center. In addition to the extensive analytic and testing capability, the Center also houses 8 scientists, packaging engineers, and other technical experts, providing the medical device industry with a wide range of world-class technical capabilities and consultancy services to assist MDMs with packaging ideation and development, optimization, validation, usability studies and other technical service needs.
“The modernization and expansion of our Packaging Development and Technology Center provides an environment more conducive to innovation and problem solving. Containing state of the art analytical tools, our new technology center helps to further distinguish Oliver-Tolas as the industry’s ‘go to’ medical packaging experts” said Dr. Jane Severin, Vice President of Technology at Oliver-Tolas.
“Our objective is to provide our customers advanced industry information, systems solutions, and enhanced analytical services to help them achieve their business goals,” she added.
The building boom at the University of Michigan shows no sign of abating, with the tab for current and upcoming construction at the Ann Arbor campus edging past $1 billion.
The school is undertaking $460 million in current construction projects — including the $163 million retrofitting of the old C.S. Mott Children's Hospital and Von Voigtlander Women's Hospital facility and the $116 million renovation of the 800-plus-bed East Quadrangle dormitory. It has another half-billion worth on the horizon.
U-M is in the early stages of planning a $250 million investment in non-revenue sports facilities, $150 million in large dormitory renovations over a two-year period and $140 million in classroom and lab building upgrades. The university is also contemplating building a $180 million to $250 million pathology building, or a portion of that building.
Continued construction costs add to a surge of new buildings and infrastructure upgrades on the Ann Arbor campus.
U-M recently finished the new $754 million Mott children's hospital, a five-year project and the most expensive in the school's history. Additionally, the new $145 million Stephen M. Ross School of Business opened in 2009, new classroom and dormitory building North Quad opened in 2011 after $175 million in construction, and a renovated and expanded U-M Museum of Art opened in 2009 after $42 million in construction.
The Law School is also experiencing new construction. A new academic Building and Commons addition were completed in 2011 and a $39 million renovation of the Lawyers Club is currently underway.
After four years and $226 million in renovations, an upgraded Michigan Stadium opened in 2010. New hockey, football and basketball scoreboards were purchased in 2011 for a combined $20 million. Construction on Al Glick Field House, a $26.1 million indoor football practice facility, was completed in 2009.
Below is a rundown of nine major current or proposed projects on the horizon at U-M:
New School of Nursing Building
Many of U-M's projects on the horizon include retrofits and renovations, as space on the Ann Arbor campus is limited and new construction is costly. The planned nursing school addition, however, is the only confirmed construction project that includes an entirely new building.
The Board of Regents agreed in March to build a new $50 million facility on a 125-space parking lot near the medical campus, easing a space crunch for the school but further complicating a pressing parking shortage. The nursing school will inhabit the new building and stay in its current building, allowing it more space to grow. The school's student body has grown 26 percent over 10 years and U-M plans to add 40 additional nursing faculty in coming years.
West and South Quadrangle Renovations
Although it's yet to be publicly announced, West and South quads are the next dormitories in line for major renovations.
"Housing will continue to spend money doing upgrades of their facilities," Schulte said, adding that the South Quad renovation may start during summer 2013 and cost roughly $50 million. West Quad will likely start during summer 2014 and cost in the $100 million range, Schulte said.
Starting this summer, East Quadrangle is receiving the largest dormitory renovation in U-M history. The $116 million renovation to 860-bed dorm on Central Campus will take a year and follows $285 million in completed dormitory renovations since 2008.
The dormitory upgrades are part of the Residential Life Initiative started by U-M President Mary Sue Coleman. The first RLI project completed in 2008; by the time Coleman's presidential term expires in 2014 the university will have undertaken nearly $600 million in large-scale dorm renovations and tens of millions in small-scale upgrades.
School of Music, Theatre and Dance Addition
AnnArbor.com reported earlier this year that the U-M School of Music, Theatre and Dance is pinched for space, causing students to wait in long lines to practice or disturb lessons by practicing in classrooms without soundproofing.
There are 50 practice rooms available to the nearly 1,200 students enrolled in the school, and complaints have begun to trickle down to high-level administrators.
"We have students that are hanging out the windows," U-M vocal professor George Shirley told AnnArbor.com. "The practice facilities are inadequate to service the students. They have to wait in line to use the facilities, the rooms are small and they're not up to par with facilities that are being constructed now."
Schulte said the university is seriously considering a renovation — and possibly an addition — to the school starting in 2013. He said the project is "somewhere in the $20 million range" but explained that it remains an uncertainty.
"I don't know that we have all the funding in place," Schulte said.
New Pathology Building
For at least five years the U-M Health System has contemplated building a new 180,000 sq. ft. clinical and research pathology facility between the medical campus and medical school. However, increasing costs have caused the school to pause the project in recent weeks.
"This is a massive project," said Mary Krasny, associate director for U-M hospital design and construction. Krasny said the project would cost between $180 and $250 million. "The problem is it is far more than the hospital thought it wanted to spend on a pathology building."
She continued: "Right now we have done nothing the last six weeks on this while we are waiting for the hospital to determine whether they want to go forward with a portion of it, whether they want to go forward with any of it."
Water Polo, Lacrosse Facilities
Water polo, added as a varsity sport in 2005, and men's lacrosse, added this year, both lack adequate facilities, U-M Athletic Director David Brandon said earlier this month. Brandon said the university plans to invest $250 million in non-revenue sports facilities in the next decade and specifically highlighted the need for better lacrosse and water polo facilities.
"We added water polo and never added any more deck space, any more locker rooms, or any more pool capacity, and so we’re constrained," he said. "We need another pool. We need more capacity. We need more locker room space."
The school has spent $500 million to upgrade football, hockey and basketball facilities in recent years. Crisler Center is currently undergoing a $52 million renovation and the player development center was recently built for $23.2 million. Renovations are also taking place at Yost Ice Arena at a cost of $16.2 million, and Schembechler Hall, at $9 million.
Institute for Social Research
Regents approved a $23 million renovation for the school's Institute for Social Research in 2010 and construction is set to begin this summer. Aside from UMHS and the College of Engineering, ISR brings the greatest amount of federal research dollars to U-M each year.
The four-level addition will add 44,700 square feet to the existing ISR building on William Street, including research and meeting rooms and data and biospecimen storage. Funding is coming in part from a federal grant from the American Recovery and Reinvestment Act of 2009.
GG Brown Memorial Laboratory
This engineering lab building was built in 1958 and, according to Schulte, "doesn't look any different than it did in the early 1980s."
U-M originally thought the state would contribute $30 million to the $56 million project through the appropriations process, but Schulte said that since former Gov. Jennifer Granholm left office and Rick Snyder assumed reins of the state budget, the project has not moved forward as planned.
"Prior to our new governor we were told these were a go," Schulte said about GG Brown and two construction projects planned for U-M's Flint and Dearborn campuses. "I think they got handed to the governor with no funding source."
Schulte said Snyder is still deciding whether GG Brown will get state dollars and, if so, how much.
Old Mott Hospital Backfill
The old children's and women's hospital will turn into a University of Michigan neuroscience building.
Regents in March approved a $163 million retrofitting of the old C.S. Mott Children's Hospital and Von Voigtlander Women's Hospital facility, which was vacated when the hospitals moved into the new $754 million facility in December.
"It's a pretty big space that's being backfilled," Krasny said. U-M plans on using the space almost entirely for neurosurgery, adding 95 general beds, 25 urgent care beds and eight operating rooms. During a presentation, Krasny referred to it as the health system's future "neurosurgery hospital."
U-M Health System officials have said the retrofit will create hundreds of new hospital jobs, with the project following a $17.7 emergency room upgrade completed in late 2011.
"There is continuing demand for our hospital facilities: Mostly for extremely complicated acute care patients," U-M Health System CEO Ora Pescovitz said a recent Board of Regents meeting.
Thomas Peterson, UMHS associate director of operations, said that U-M is in the very early stages of planning a new facility for University Hospital. Design and construction on that project won't begin for at least another decade, he said.
Encap Drug Delivery has invested $2 million to expand capabilities at its Oakbank Park Way facility with additional high volume manufacturing equipment to support CMO services. The company has purchased product mixing and capsule filling equipment, including a highly flexible Esco Labor (EL200) mixer and a high speed Bosch filling machine (GKF2500L) and weight checker (KKE2500). Installation of the new equipment will be completed by February 2013.
Encap’s chief executive officer, Dr. Stephen Brown, said, “Encap has seen tremendous growth in its PDS business in the last two years with the initiation of more than 30 new client projects. We are seeing a growing interest in our commercial manufacturing capabilities and we have discussions progressing with a number of companies on their late stage Phase III products. Encap is investing to make sure that we have the best facilities and the most advanced manufacturing technology available to meet the needs of these new customers over the coming months and years. With the addition of this new equipment we are now capable of outputting over six million capsules per day.”
ILS announced it has acquired the Morrisville, NC site of Beckman Coulter Genomics and formed ILS Genomics.
ILS Genomics provides services in genotyping and gene expression, as well as biologics product safety testing. Sam Tetlow, chief business officer for ILS, was named general manager of ILS Genomics.
The company said that it has capabilities in key platforms for gene expression profiling, including Affymetrix, Illumina, Agilent, Sequenom, and Life Technologies business Applied Biosystems.
The purchase is comprised of the building at the site and some assets, but not Beckman Coulter Genomics. She declined to disclose the terms of the deal. Tetlow added that ILS Genomics has about 20 employees currently.
Technologies used by the company include microarrays and Sanger sequencing, he said.
ILS is based in Research Triangle Park, N.C., and provides research support to federal and commercial clients. Its core capabilities include investigative toxicology, genetic toxicology, molecular biology, histopathology, and environmental and information science services.
The 332,000 sq. ft. design draws on the predominantly red brick character of The Christ Hospital’s existing buildings, interpreting it in a fresh and contemporary manner that fits well within the historic Mt. Auburn neighborhood while reflecting the institution’s dedication to experience, efficiency, flexibility, innovation and brand.
The design incorporates numerous sustainable initiatives and is striving for LEED certification. A recent groundbreaking ceremony inaugurated the first phase of a 1.4-million-sf master plan by Skidmore Owings & Merrill LLP (SOM) for The Christ Hospital in Cincinnati. Demolition will commence on a parking garage at the south end of the hospital’s complex—clearing the way for the new SOM-designed Orthopedic and Spine Center (OSC).
The 332,000 sq. ft. design draws on the predominantly red brick character of The Christ Hospital’s existing buildings, interpreting it in a fresh and contemporary manner that fits well within the historic Mt. Auburn neighborhood while reflecting the institution’s dedication to experience, efficiency, flexibility, innovation and brand.
Completion of the new OSC Building will be in mid-2015, with other master plan improvements, including street reconfiguration, a new entrance, parking garage and central utility plant improvements scheduled to be in operation during the building’s construction.
The structure will provide a new public face for the south side of the hospital, facing downtown Cincinnati. Its asymmetrical façade highlights The Christ Hospital’s iconic cupola while providing new patient rooms on the upper floors with stunning views of downtown Cincinnati and beyond from its hilltop locale. Lower floors house orthopedic, spine and sports medicine facilities that are distinct yet fully connected with the hospital’s existing surgery and imaging infrastructure to increase long term efficiencies.
The seven-story building (plus one below-grade level) includes facilities for imaging and surgery (with 10 new operating rooms and space to add two additional operating rooms) on the lower floors. The third floor (dubbed Level 1) includes public facilities and is part of a new interior circulation path that connects all the hospital’s buildings on a single level. A roof garden is incorporated into the OSC building on this level to provide a private outdoor respite for the building’s users. Non-public mechanical spaces are located on Level 2 while Level 3 provides raw space for future expansion of patient beds. The upper floors—Levels 4 and 5—have a total of 60 new private patient rooms and their attendant services. Another roof garden is accessible atop the structure.
Alabama officials announced an $11 million expansion at Montgomery medical equipment manufacturer Steris Corp. that will soon mean 80 to 100 new jobs for the area. Besides adding new jobs, the expansion will save the 270 current jobs at the site.
Construction will start by Aug. 1 at the 300,000-square-foot facility, with the expansion scheduled to be in operation by the end of next year, according to project agreement documents.
AIDT will handle the recruitment and training of new employees, with at least 40 new hires scheduled to be on board by June 30, 2013, and at least 80 new workers employed by June 30, 2014, according to the project agreement the Montgomery County Commission unanimously approved earlier.
The Montgomery facility currently employs 270 full-time workers at an average of $21.86 per hour.
The agreement calls for a total of $900,000 in incentive money to help with the expansion if the company hits its minimum funding and employment goals by the required dates. The state will pay $600,000 in three installments; the city will pay $180,000 in two installments; and the county will pay $120,000 in two installments.
The deal also calls for the company to give "good-faith consideration" to state contractors and vendors throughout the process.
American Stabilizer Co. opened the local facility in 1976 with 23 employees. Twenty years later, ASC became a subsidiary of Steris, which shifted part of its work force to the city.
In 2010, the Business Council of Alabama selected Steris as the state's Medium Manufacturer of the Year.
"There has been a transformation in the last five years that has been unbelievable," Steris director of operations Mac McBride said at the time.
In January, a national Steris representative told The Associated Press that the company had added 250 employees in the past 18 months and was still hiring. It has more than 5,000 employees globally, about half of them in the United States.
Steris spokesman Steve Norton said the company has benefited from being part of a regional cluster of biomedical firms and research facilities in the Ohio area. Some manufacturers in the region that once focused on auto parts are now also making components for medical devices, he said.
Roche announced on June 26, 2012, that it will be closing its R&D site in Nutley, New Jersey, eliminating approximately 1000 positions. The action is being taken to streamline research activities and to reallocate resources to support programs in early clinical development. According to the company press release, the reorganization will enable Roche to keep R&D costs stable despite a strong increase in the number of clinical development projects in the last 18 months. The company plans to complete the transfer of business operations in Nutley by the end of 2013. Roche’s Genentech division, based in South San Francisco, California, will not be affected by the reorganization.
The site closure will be partially offset by the establishment of a Pharmaceuticals Translational Clinical Research Center on the east coast of the US, which is expected to employ approximately 240 people. The center will support US-based clinical trials and early development programs, support and maintain Roche interactions with FDA, and enhance Roche’s collaborations with US-based partners, such as academic institutions and biotech companies. R&D activities at the Nutley site will be transferred to sites in Switzerland and Germany, which are expected to gain 80 positions.
Daiichi Sankyo, Inc. received U.S. Food and Drug Administration (FDA) approval to package product at its first United States-based packaging facility located in Bethlehem, PA. With this approval, the company expands its global supply chain capability, helping to ensure the supply of medicine to U.S. physicians and their patients.
At this time, the 140,000 square foot facility will package some of the company’s portfolio of marketed products for cardiovascular and metabolic therapies including treatments for hypertension and heart disease, diabetes and hyperlipidemia. Looking ahead, the facility could assume additional responsibilities related to clinical trial materials and perform formulation and analytical testing for select products.
“From facility and process design to quality control and personnel flow, we incorporated leading-edge technology in the design and development of the Bethlehem facility,” said Jeff Lane, Vice President, Operations, Daiichi Sankyo, Inc. “The commissioning of this facility is a major milestone for our U.S. organization and augments our ability to manufacture and distribute quality medicines.”
The plant currently employs approximately 39 full-time employees and will continue to add employees until realizing its full operational goals. Responsibilities range from Line Operators and Material Handlers to Project Engineers and Quality Specialists. Daiichi Sankyo worked with a number of regional and local business leaders and organizations, including the Governor's Action Team, Lehigh Valley Economic Development Corporation, Northampton County and City of Bethlehem to make this milestone possible.
Lane added that by expanding the company’s business operations to include manufacturing in the U.S., the company is helping to minimize risks associated with product supply, and is able to gain greater control over the life cycle of its products, from research and development through packaging and distribution.
The Vermont developer working with a South Korean bio-technology company to bring 250 jobs to the Newport area says another 250 jobs could come to the area by leasing clean rooms to businesses from around the world.
Developer Bill Stenger told members of the Newport City Renaissance Corp. that he and his partners are working with economists and attorneys to prepare for permitting and construction.
AnC Bio is a South Korean company that develops and manufactures artificial organs. It's planning to build a $50 million plant and create about 250 jobs.
The cleanroom jobs would be in addition to the direct AnC Bio jobs.
Albemarle Corporation, a global developer, manufacturer and marketer of highly engineered specialty chemicals, has expanded and upgraded its FDA-registered multi-product cGMP active pharmaceutical ingredient (API) manufacturing facility in South Haven, Michigan. Production using the new expanded capacity commenced on 1 June 2012.
This expansion is the latest in a series of projects at the South Haven site to increase capabilities and production throughput, meeting the increasing demand for both generic API products and custom manufacturing service portfolios.
In the past two years, the number of custom API projects has more than doubled at the South Haven site. The investment matches the solids handling equipment with the reactor capacity and will enable the company to advance its growing portfolio of custom API products, several of which have progressed to late stage clinical development and pre-registration status.
Albemarle Fine Chemistry Services specializes in enabling its customers to go to market in an efficient and fully compliant manner by providing comprehensive process development and validation capabilities followed by seamless transition into commercial-scale production. Albemarle uses the Quality by Design (QbD) approach to establish manufacturing processes and then speed validated commercial products to market.
B. Braun's U.S. facility in Irvine, California is currently installing a new, highly automated production line with Werum's PAS-X as a core component. The line, designed to produce a variety of IV Solution bags for hospitals and clinics, will manufacture the empty bags, fill them, sterilize them and package them, all under full automation. To achieve such a sophisticated approach, B. Braun has defined a multi-level IT architecture that links ERP to PAS-X to the equipment controllers.
‘PAS-X plays a key role for us,’ explains Imran Rauf, the engineering manager for the project. ‘The MES is our main link to the overall order and inventory data controlled by the ERP, triggers the correct recipe execution at the equipment level, and consolidates all of the key production data into our final electronic Batch Record.’
The most notable feature of this project was the high level of integration between PAS-X and a large number of equipment types, resulting in PAS-X supporting 25 different message types.
The expected benefits of this architecture to B. Braun are streamlined batch production execution, final batch review and product release. Additionally, the captured process data will be used for ongoing process improvement. This highly integrated approach has already been proven in the LIFE and LIFE Nutrition sites at B. Braun in Melsungen, Germany.
The first researchers at the Rensselaer Center for Stem Cell Research won’t be working in the lab until August, said Glenn Monastersky, operations director of the Center for Biotechnology and Interdisciplinary Studies (CBIS) and the principal investigator under the $2.45 million grant.
“The lab is fully equipped. Everything is open. We just hired a director but we’re not going to be open for research until August. We have a lot of work to do,” he said.
Monastersky declined to name the new director and identified her only as a woman from New York City.
He said the dozen machines in the lab need to be calibrated and researchers need to learn how to operate them.
“There’s only a handful of these on the whole East Coast,” Monastersky said. “None of us ever used one.”
Three Rensselaer researchers who will move from their current labs to the stem-cell lab in August will focus on spinal cord injury, and bone and muscle repair. Rensselaer will own the intellectual property.
Researchers will be working on existing embryonic stem-cell lines from other research facilities. Some researchers will also be working on adult stem cells that can mimic embryonic behavior.
“If you have a heart attack, in the future we hope we can take a cell from you and then create an embryonic cell line out of that and then make embryonic cell cardiac muscle,” he said. “If it works, you’ll have a perfectly new heart."
The hope is that similar cells could be used for spinal cord regeneration or to help people with Parkinson’s Disease and diabetes.
“At the center, we will work at the frontiers of this promising discipline in collaboration with New York state and investigators from across the region,” said Rensselaer Polytechnic Institute President Shirley Ann Jackson. “The focus of our research here in this center will be the basic science critical to the development of stem-cell based therapies for human diseases.”
The Rensselaer Center for Stem Cell Research was created to lower the cost for researchers across the state. Once the center is open, researchers will be able to conduct work there for free for the first six months. After that, organizations using the lab will be charged $2,000 a year per researcher.
Monastersky said Rensselaer has received letters of interest from as many as 20 research groups.
The center will leverage its research and research at partner institutions, including Albany Medical College.
Dr. Nirav Shah, state commissioner of health, said New York has invested about $200 million in stem-cell research during the last few years and anticipates another $100 million in investments will be announced this year.
“Those are research awards that can only be used in facilities such as this,” he said, noting the center’s interdisciplinary focus. Work at the center will help draw even more federal research dollars to New York as well, Shah said.
Shah said New York receives 24 percent of the federal funds allocated for stem-cell research.
With a common goal of making health care better, safer, more cost effective and more equal, nearly 400 health researchers and partner organizations have formed one of the nation's largest research entities of its kind. The Institute for Healthcare Policy and Innovation, which opened its new home just days ago, unites members of an already strong health care research community in a new way--making U-M a true powerhouse in the field known as health services research.
From cancer, heart disease and diabetes to children's health, surgery and mental health, IHPI's members study topics in health care delivery, coverage and policy. Working together through IHPI, the researchers expect they can accelerate their studies on how health care is delivered today, and their tests of innovations that could improve health care, health insurance and health policy tomorrow.
The opening of a new home for IHPI -- in a dedicated building at U-M's North Campus Research Complex -- arrives on the third anniversary of U-M's purchase of that site. The first 80 IHPI researchers and staff moved in to the newly-renovated building, and more than 400 more will move there in coming months, creating a hub of activity and cooperation that will be one of the nation's largest concentrations of healthcare policy and services researchers.
In all, IHPI includes nearly 400 faculty researchers plus hundreds of professional staff and trainees. "We truly expect IHPI to become the largest university-based collection of health services and healthcare policy researchers in the country, and to pursue research that will enhance the health and well-being of people locally, nationally and globally," says Rodney Hayward, M.D., chair of the interim leadership team that has guided IHPI's formation over the past year. He is a professor of internal medicine at the U-M Medical School, a researcher at the VA Ann Arbor Healthcare System and a faculty member in the U-M School of Public Health.
Just over half the members of IHPI are faculty in the U-M Medical School, where IHPI is based, and nearly a quarter are from the U-M School of Public Health. The rest come from U-M's colleges of Engineering, Pharmacy, and Literature, Science & the Arts, its schools of Business, Dentistry, Law, Nursing, Public Policy and Social Work, and its Institute for Social Research.
A full 12 percent of IHPI members hold full or joint appointments at one of IHPI's partners: the VA Ann Arbor Healthcare System and its Center for Clinical Management Research, the Arbor Research Collaborative for Health, the Center for Healthcare Research and Transformation (a joint venture between U-M and Blue Cross Blue Shield of ), or other partners.
"This cross-disciplinary and public-private nature of IHPI fits perfectly with the overall goal of making the North Campus Research Complex a haven for such research," says David Canter, executive director of NCRC. He notes that IHPI's faculty and staff who have moved or will move to NCRC are joining more than 1,300 researchers and staff from U-M and 20 private companies at the site.
"As the first research group to move into the IHPI building, we have been struck by the renovation of what had been a very traditional office building into a state-of-the-art research Institute designed to enhance collaboration across disciplines and across campus," says Laurence McMahon, M.D., chief of the General Medicine division in the Medical School's Department of Internal Medicine, a member of IHPI's interim leadership team and the School of Public Health faculty. "We look forward to the realization of the interdisciplinary focus of IHPI. We believe the investment in both architectural design to enhance collaboration as well as the investment in the virtual collaborative infrastructure will serve as a model for research groups across the country."
IHPI members' work is mainly computer-based, but a renovation of a former office building has created space that encourages collaboration and spontaneous meetings. IHPI will also offer computing support and facilities. By analyzing large amounts of data from hospitals, government agencies, medical societies, insurance companies and other sources, the IHPI researchers hope to spot problems and trends, evaluate how well new treatments and technologies work, and identify ways to improve quality, safety, equity and cost-effectiveness.
The formation of IHPI will give them access to new tools, partnerships and data sources-- and allow them to share ideas more readily. Even though not all IHPI members will move to NCRC, the ability for all members to come together virtually should spark collaboration and allow them to seek even more public and private partners also interested in health care delivery. The search for a director for IHPI is now under way.
"Our faculty and their teams have for decades made sizable contributions to the improvement of health services and health policy realms," says Martin Philbert, Ph.D., dean of the U-M School of Public Health. "This new institute will deepen and amplify that impact, and will open new avenues for collaboration within and beyond our institution."
"Co-location of health services researchers from across U-M will enable interactions and insights that push the boundaries of our scholarly work and further its impact on health care practice and policy," says James O. Woolliscroft, M.D., dean of the U-M Medical School. "Already the work of IHPI members is making an impact across the country and around the world, and this dedicated new headquarters for the Institute will enable continued success in this growing field."
Lonza, a global leader in the field of biologics manufacturing, announced the successful completion of its new GMP cleanroom within its Houston, Texas operations. The cleanroom supports multiple types of viral vector and viral vaccine projects, with working volumes up to 2,000 liters.
“Since Lonza made the strategic decision to enter the viral manufacturing space less than two years ago, we have seen tremendous business growth,” said David Enloe, Lonza’s Head of Viral-based Therapeutics. “Many of our clients’ projects require higher working volumes than the gene therapy space has historically seen. This facility, along with the additions we’ve made to our process development and GMP manufacturing teams and the numerous other improvements made to our infrastructure and capabilities, will allow our clients to entrust their therapeutic and viral vaccine projects to Lonza from the early clinical phases up to commercial supply. We believe this represents a tremendous advantage for companies when they evaluate contract manufacturing alternatives.”
Lonza announced the launch of this project in May 2011.
Alexion Pharmaceuticals Inc., a fast-growing drug developer that has seen phenomenal success on Wall Street over the last five years, is returning to New Haven from Cheshire and adding hundreds of jobs, Gov.Dannel P. Malloy announced at the development site.
In exchange for moving more than 350 people now in Cheshire and adding as many as 300 additional people by 2017, Alexion will be eligible for a state package worth up to $51 million in grants and loans.
Alexion will build a new headquarters at a key location in the Elm City, near Yale-New Haven Hospitaland the Yale School of Medicine, on College Street along Route 34 -- a part of the city targeted by Mayor John DeStefano for a pedestrian-friendly redevelopment known as Downtown Crossing.
A 400,000 square-foot building with street-level retail and a parking garage of at least 600 spaces, costing a total of $100 million, would open by 2015 under the agreement. The developer is Winstanley Enterprises, a prominent local firm.
Alexion becomes the fourth company in Malloy's First Five program, designed to give large aid packages to businesses adding at least 200 jobs.
It is also part of Malloy's push to support the biomedical industry, which he is making into a hallmark of his administration.
"One of my first acts as Governor was to launch Bioscience Connecticut, an initiative designed to expand and improve Connecticut's research and development capacity," Malloy said in a written release. "Bioscience is a $284 billion dollar business. With the investments we've made, we will ensure that Connecticut is in a position to compete for every dollar for years to come."
Alexion was founded in New Haven's Science Park development in 1992 by Dr. Leonard Bell, a Yale medical professor who is still the company's CEO. The company went public in 1997, and moved to Cheshire in 2000.
In 2007, Alexion received approval for Soliris, the first and only treatment for two rare disorders, including a genetic disease and a life-threatening blood disorder "characterized by the excessive destruction of red blood cells," the company said.
Alexion is part of a wave in which smaller drug developers are emerging as major players in the high-risk, ultra-high-cost business of drug development. Over the last five years, Alexion shares have increased by 723 percent -- more than eight-fold -- as the Standard & Poor's 500 list of major U.S. companies is down by 10.6 percent.
As a result, Alexion, with a market value of more than $18 billion, has been able to make a series of acquisitions, most recently Enobia Pharma Corp. of Montreal and Cambridge, Mass., in February.
"The acquisition was intended to further our objective to develop and deliver therapies for patients with ultra-rare, severe, and life-threatening disorders," Alexion said in its annual report.
Alexion has operations around the world and about 1,000 employees, including a manufacturing facility in Rhode Island. The company is keeping headquarters, research and development, marketing and other functions in Connecticut, but will not move manufacturing here, under the agreement announced.
The deal with the state Department of Economic and Community Development gives Alexion a $20 million, forgivable loan at 1 percent interest; a $6 million grant; and urban enterprise zone tax credits up to $25 million.
The hope behind the agreement, and behind Alexion's move, is that the company completes the transition from its roots as a boutique drug designer into the ranks of international pharmaceutical firms with a pipeline of therapies. Alexion's annual report described several drugs now in development.
Other First Five companies are Cigna, in Bloomfield; ESPN in Bristol; and NBC Sports in Stamford. TicketNetwork of South Windsor was announced last summer as a First Five company, and has already added at least 150 jobs, ahead of its promised schedule, but the company pulled out of the program after Don Vaccaro, its CEO and controlling shareholder, was arrested in February and charged with intimidation and a racial hate crime.
Vaccaro stepped aside as CEO and last month was accepted into the state's accelerated rehabilitation, a special form of probation designed for people with no prior convictions. He said he was treated for alcohol abuse but denied making any racial slurs.
HHS is investing $400 million (€318m) to create centers to speed development and production of medical countermeasures.
Plans to bolster capabilities come two years after reports into the H1N1 outbreak identified speed of vaccine manufacturing as a weakness. In response the U.S. Department of Health and Human Services (HHS) began discussions around the creation of innovation hubs and has now inked three contracts.
“Establishing these centers represents a dramatic step forward in ensuring that the United States can produce life-saving countermeasures quickly and nimbly,” Kathleen Sebelius, HHS secretary, said. The facilities will use cell- and recombinant-based vaccine technologies to cut pandemic response times.
When the centers are working in 2015 HHS expects to have capacity for producing one-quarter of the US need for an influenza vaccine within four months of a pandemic outbreak beginning. In one of the H1N1 reports a halving of vaccine production times within three years was viewed as realistic.
To meet its 2015 goal HHS has inked three deals worth $400m. In the first deal, worth $163m over eight years, Emergent BioSolutions will work with academia to add capacity and get intellectual property rights for process development and manufacture of a pandemic influenza vaccine.
HHS has also turned to industry for the second deal. The $60 million, four-year deal with Novartis builds on the 2009 public-private partnership that created a cell-culture flu vaccine facility in North Carolina.
An academic institute is leading the third project. HHS will give Texas A&M University $176m over five years to lead a project, with support from GlaxoSmithKline and Lonza, to create a vaccine development and manufacturing centre.
Industry spending will add to the investment in the centers. In return, the companies have the chance to secure lucrative long-term deals with the U.S. Government. HHS can renew each deal for up to 25 years.
The Purdue Board of Trustees' Executive Committee approved construction contracts for a drug discovery facility, health and human sciences research facility and a parking garage, all to be located in the university's Life and Health Sciences Park.
The committee also authorized a $3.7 million budget increase for the now $28.7 million drug discovery facility that will provide state-of-the-art space for synergistic, innovative research and training in the discovery, design and development of new drugs.
"Students and faculty across campus are engaged in research that is leading to the development of therapies to treat disease," says Jeff Roberts, Dean of the College of Science. "With this new facility, we are poised to make much greater advances."
The facility will ease crowding in laboratories at Purdue, including in the Wetherill Laboratory of Chemistry, from which researchers like Philip Low have developed powerful drugs that target cancer and inflammatory diseases. Low's research group currently has several drugs in clinical trials through Endocyte, which is based at Purdue Research Park.
F.A. Wilhelm Construction Co. of Indianapolis was awarded the $23.6 million construction contract.
The budget was increased to accommodate higher-than-expected bids and to finish the second-floor interior space sooner than originally scheduled. Bond proceeds will pay for the project's first $20 million, and the remainder will come from gifts or administrative funds.
The committee also approved construction of the $38 million Lyles-Porter Hall that will house the speech, the Indiana Univ. School of Medicine Lafayette, language and hearing sciences department, clinical facilities.
"The building will provide an atmosphere that supports the education and research goals of the participating entities," says Christine Ladisch, dean of Purdue's College of Health and Human Sciences. "It will preserve their individual cultures while expanding opportunities for cross-disciplinary learning and engagement."
F.A. Wilhelm Construction Co. received the $30.5 million construction contract. The project will be paid for with $22 million in bond proceeds, with the remainder coming from gifts.
The committee also approved a $13.5 million construction contract with F.A. Wilhelm Construction Co. to build the Harrison Street Parking Garage, which will be connected to the Health and Human Sciences Research Facility. The $16 million project will create approximately 850 parking spots.
BASF has expanded its R&D center in Tarrytown, New York as part of its strategy to provide a global network of technical and application support.
The company, which also has nutrition ingredient technical centers in Germany, Denmark, China, Malaysia, and Brazil, said that the newly expanded Food Technology & Applications Center would showcase its ‘Think Newtrition’ initiative, designed to help customers create new products and improve existing ones. The food research facility is part of BASF’s 160,000 square foot R&D center in Tarrytown.
Technical sales and applications manager for BASF in North America Charles Barber said: “This is the birthplace for concepts and ideas that meet consumers’ demands for healthy, appealing, and convenient products. Consider it a culinary crossroads where science, technical and application support, and market research all come together.”
‘Think Newtrition’ originally was based on Cognis’ marketing approach: ‘Newtrition – Eat. Feel Live’. After BASF acquired Cognis for €3bn in December 2010, it modified the idea to integrate both companies’ approaches, describing it as a response to rising demand for nutrition solutions that are healthy yet convenient and flavorsome, as more consumers expect products to be nutritious and enjoyable.
Its newly expanded center encompasses R&D developments in food, beverage and dietary supplements. Barber called the center a “one-stop kitchen” for companies with diverse requirements, whether they are looking to create better texture and taste in nutrition bars, to add colors to beverages, or to improve baked goods.
“We realize that identifying the right ingredient for a product is just one part of the process,” Barber said. “In our center, we can eliminate the guesswork and perfect the formulation to help our customers efficiently market products that resonate with consumers.”
The company said it would also offer workshops and demonstrations of how to best use its ingredients in formulations. In the dietary supplements space, BASF said its Tarrytown team is especially focused on finding new supplement delivery forms.
Governor Mitch Daniels joined executives from Roche Diagnostics Corporation to announce the company's plans to invest in its operations, creating up to 100 jobs by 2017.
The company, a leader in in-vitro diagnostics, will invest $300 million over the next 10 years at its North American headquarters on the northeast side of Indianapolis. The capital investments, which will include the refurbishing of existing buildings, purchasing of manufacturing equipment for new diabetes care test strips and upgrading of information technology equipment, will support the company's growing diagnostics and diabetes care businesses.
Roche Diagnostics will begin its campus transformation this fall with the construction of a new commercial education center where approximately 1,500 customers from across the nation will be trained annually.
Roche Diagnostics has been part of the Indianapolis landscape since 1964 when it was founded as Bio-Dynamics and later acquired by Boehringer Mannheim Corporation in 1974. Roche acquired Boehringer Mannheim in 1998 and within three years became a world leader in diagnostics. Today, the company employs nearly 3,000 Hoosiers and more than 4,200 associates nationwide.
"As the leader in the in-vitro diagnostics industry, we're proud to be a part of the growing life sciences movement in central Indiana," said Jack Phillips, president and chief executive officer of Roche Diagnostics. "We appreciate the partnership from the city and state as we look to increase jobs and enhance our Indianapolis campus facilities. The bottom line is we're here to stay and committed to being the best place to work in Indiana."
As the North American headquarters for Roche Diagnostics and Roche Diabetes Care, the 160-acre Indianapolis campus is home to research and development, manufacturing, distribution, information technology, shared services and administrative operations. About two-thirds of the workforce supports sales and marketing efforts. The campus also is a major production site of test strips for ACCU-CHEK(TM) products, manufacturing about 2 billion strips annually.
The Indiana Economic Development Corporation offered Roche Diagnostics Operations, Inc. up to $2,000,000 in conditional tax credits and up to $300,000 in training grants based on the company's job creation plans. These tax credits are performance-based, meaning until Hoosiers are hired, the company is not eligible to claim incentives.
The city of Indianapolis will consider additional property tax abatement at the request of Develop Indy. "Indianapolis' stable tax climate and pro-growth economic environment offers businesses of all types opportunities to thrive," said Indianapolis Mayor Greg Ballard. "We are thrilled with this investment by Roche and are proud to have corporate partners who share our commitment to building a community that is open for business, providing quality jobs for our talented workforce."
Roche Diagnostics' continued growth in Indianapolis builds on the Hoosier State's $44 billion global life sciences sector. Last year, The Wall Street Journal cited Indianapolis as "one of the hottest spots for starting a new business" and a national hub for the life sciences industry. Indiana has added more than 8,800 jobs in the life sciences industry in recent years and today some 854 medical-device companies, drug manufacturers and research labs call the Hoosier State home.
Healthpoint Biotherapeutics announced the company is planning a significant upgrade to its 80,000 square foot research and manufacturing facility in Ft. Worth. The new, state-of-the-art facilities will comprise 25,000 square feet of manufacturing infrastructure, labs and clean room space for the production of cell-based therapies.
"We are very pleased to be embarking on this important and innovative initiative at our headquarters here in Fort Worth," noted Travis E. Baugh, President and Chief Operating Officer of Healthpoint Biotherapeutics. "The planned, ultra-modern facility will create an efficient platform to support our lead pipeline candidate, HP802-247, which recently completed a successful phase 2b study in venous leg ulcers. Importantly, the facility will also add critical capabilities as we look toward the promise of regenerative medicine."
The facility upgrade comes as the company is engaged in developing a pipeline of next generation wound care therapies based on cell and cell-matrix biology. The advanced nature of the facility will provide efficient and scalable manufacturing capabilities to support both development and future commercialization, as well as create a unique environment for novel collaboration and identification of new technologies.
Healthpoint Biotherapeutics is planning to invest approximately $60 million to build out and staff the research and manufacturing facility over the next few years. The company plans to add a total of 51 new employees in research and development (R&D), quality assurance and quality control, operations and information technology (IT), with 31 of these hires planned for 2012.
The project will be built out in two phases to coincide with current pipeline requirements. The first phase will include advanced tissue processing capabilities, master cell banking, production of clinical supplies for phase III trials and process development to support future manufacturing scale-up. Important features of the second, commercialization phase include automated closed system cell culturing, automated vial filling and the use of radio frequency identification (RFID) technology allowing efficient, robotic packaging in -80 degrees C freezers and product traceability in sealed dry ice shippers.
Construction of the new facilities is slated to begin in the second quarter, with the first phase anticipated to be operational by the end of 2012. Full validation and commissioning of the facility to release product for clinical trials is expected in 2013. Completion of the second phase will be timed to meet the requirements for the manufacture and ultimate commercialization of the investigational product HP802-247, following regulatory approvals.
Healthpoint Biotherapeutics already operates advanced, biologic manufacturing facilities worldwide, including its facility in Lausanne, Switzerland--which has received manufacturing authorization from the Swiss Regulatory Agency, Swissmedic, for the production of cell-based therapies--as well as a biologic manufacturing plant in Curacao.
Cook Pharmica has received approval from the FDA for the manufacture of commercial product. The approval follows an inspection by the FDA’s Center for Biologics Evaluation and Research covering the company’s new filling line, lyophilization capabilities, and quality systems.
“This FDA decision marks a very important milestone for our company,” said Tedd Green, president of Cook Pharmica. “This first commercial manufacturing approval opens Cook Pharmica’s doors to access the vibrant biopharmaceutical industry as it generates breakthroughs for patients in the U.S. and worldwide.”
The company’s parenteral manufacturing business unit contains both vial and prefilled syringe manufacturing lines under barrier isolation, as well as secondary packaging to ready products for distribution. The company is capable of filling 15 million vials and 70 million prefilled syringes annually.
Life Technologies said that it will collaborate with Boston Children's Hospital to develop next-generation sequencing workflows in a CLIA and CAP certified laboratory.
As part of the collaboration, the hospital plans to purchase Life Tech's Ion Proton, a benchtop, semiconductor sequencing machine.
David Margulies, director of the Gene Partnership Program at Boston Children's Hospital, said in statement that the deal is an "important first step toward providing informed, personalized care for patients whose conditions are difficult to treat."
The deal is Life Tech's second announced to develop sequencing protocols for the Ion Proton in collaboration with a children's hospital. Earlier they said they would work with the Hospital for Sick Children in Toronto, which has launched a new Centre for Genetic Medicine and plans to install four Proton machines.
Paul Billings, Life Tech's chief medical officer, commented in a statement that these kinds of partnerships are "essential to our medical sciences strategy as we seek to assist researchers in discovering improved diagnostics and treatments for genetic conditions."
In a separate announcement, Life Tech said that it is collaborating with the University of North Texas Health Science Center's Institute of Applied Genetics to use the firm's Ion Personal Genome Machine system to further the center's forensic DNA research. Life Tech said that it will collaborate with the center to train forensic analysts in applying next-gen sequencing to their research.
Efforts by the Texas A&M University System and local government officials to turn Aggieland into a major hub in the biomedical industry received a huge boost when it was announced that Bryan-College Station would be home to one of three new federally funded centers designed to prepare the nation for a biological attack or pandemic.
Other centers include:
Emergent Bio Solutions - Based in Rockville, MD it is a global biopharmaceutical company that “pursues the development of innovative products that direct the immune system to prevent or treat infectious diseases, cancers, and autoimmune disorders." The company employs more than 800 people at ten sites nationwide. It has an eight-year contract valued at approximately $220 million (cost shared with government), and is expected to provide a surge capacity of influenza vaccine in an emergency and develop chemical, biological, radiological and nuclear counterforce measures. It has acquired a license to manufacture pandemic influenza vaccines and will build new facilities to support vaccine production.
Novartis Vaccines and Diagnostics Inc. - Based in Cambridge, MA the company researches health care products that target unmet medical needs. It employees more than 120,000 people at 34 sites worldwide. The Holly Springs, NC facility will support the development of new bio-defense agents and rapid manufacturing response in the event of a public health emergency. The have contracts valued at $60 million over four years.
A&M’s center will be built with a $285.6 million contract awarded by the U.S. Department of Health and Human Services. Most of that money, $176.6 million, will come from the federal government. The rest will come from the state and academic or commercial partners.
The effect on Brazos County could be astronomical. A&M University System Chancellor John Sharp compared it to when NASA came to Houston. Another local official said it will be the biggest thing for the local economy since the establishment of Texas A&M.
“Just in the beginning three years, there will be $1.3 billion of economic activity in the state of Texas,” Sharp said.
The university estimated that 1,000 jobs will be created in the area in the next 5½ years.
A&M is the only university to be chosen to host one of the three Centers for Innovation in Advanced Development and Manufacturing. Pharmaceutical giant Novartis will house one in North Carolina and Emergent BioSolutions will develop the other in Maryland.
The A&M facility will be on the so-called Research Valley One Health Plus BioCorridor, a tract of land along Bryan and College Station’s shared border near the Texas A&M College of Veterinary Medicine.
Local government officials have been working with A&M to develop the corridor in recent years. The hope is that this project will encourage other biotechnology companies and startups to locate in Bryan-College Station.
“It is economic development for the 21st century,” College Station Mayor Nancy Berry said. “For the next 20 or 30 years, the corridor will build out in ways we can’t even imagine today.”
A&M officials didn’t have any detailed renderings of the new center, but described two major construction projects associated with the funding. The first part will be retrofitting the National Center for Therapeutic Manufacturing, a $50 million facility built in 2010 with a grant from Gov. Rick Perry’s Emerging Technology Fund. A new pandemic influenza facility will be constructed nearby, officials said.
The university hopes to have the center operational by December 2015.
Defense experts have expressed increasing concern about the country’s readiness for a biological attack. The A&M facility will be equipped to prepare for both. The goal, A&M officials said, will be to build a facility capable of manufacturing 50 million vaccines within four months.
“These centers are a big step forward to our preparedness and response goals and to building a safer America,” said U.S. Health and Human Services Secretary Kathleen Sebelius.
The idea for the centers was first recommended in 2010 by the Health and Human Services Department’s 2010 Public Health Emergency Countermeasure Review. A request for proposals from private companies and academic institutions wanting to host the facilities was released in March 2011.
The Texas A&M System, led by Vice Chancellor for Strategic Initiatives Brett Giroir, announced that it would submit a bid in May 2011. Giroir compiled a proposal team of 25 public and private partners, including GlaxoSmithKline Vaccines, Blinn College, the University of Florida and Vaughn Construction.
Local government officials were also enlisted in the recruitment effort. The cities of Bryan and College Station negotiated an inter-local agreement to share the infrastructure costs and property tax revenues on the site. U.S. Rep. Bill Flores, R-Bryan, convened a group of 29 congressmen from Texas to lobby the federal government for the project.
The College Station center received the largest portion of the $400 million awarded by the federal government. The Emergent facility in Baltimore will receive $163 million over the next eight years. Novartis’ center will receive $60 million over the next four years. A&M’s $176 million from the federal government will be for the first five years of the contract. Each contract can be extended up to 25 years.
Drug quality in Mozambique looks set to improve following the creation of a national QA/QC testing laboratory.
The Laboratório Nacional de Controlo da Qualidade de Medicamentos (LNCQM), the quality control (QC) arm of the Ministry of Health’s (MoH) Pharmaceutical Department, was formally inaugurated last month at its permanent HQ in Mozambique's capital Maputo.
The lab - which replaces the old national testing facility that closed in 2008 – was developed by the MoH with the support of the US Agency for International Development (USAID) and the United States Pharmacopeial Convention (USP) under their joint ‘Promoting the Quality of Medicines’ (PQM) program.
Patrick Lukulay, PQM director and vice president of global health impact programs at the USP said that: “The main day-to-day activities of the LNCQM are the testing of medicines for registration and post-marketing surveillance. Currently, the lab has 4 staff and more will be hired."
He added that the PQM will continue to work with the Mozambique Pharmaceutical Department to build the QC capacity at the LNCQM and help the lab meet international quality standards.
The current level of oversight of drug quality in Mozambique is hard to assess.
While a 2005 assessment of the national health plan - of the Plano Estratégico do Sector de Saúde - indicated the "availability of high quality medicines in all provinces," the World Health Organisation's (WHO) cites the lack of a "distinct national regulatory authority” as one of the key challenges facing the country's healthcare services.
The PQM has worked with the MoH since the closure of the original lab to both support on-going drug QA/QC assessments – which were carried out at several regional testing sites in the interim period – and to guide development of a replacement national facility.
In 2011 – after conducting a pilot study in Mozambique’s Gaza and Maputo provinces - PQM concluded that additional testing equipment and staff training was needed to help the country develop an effective monitoring system, prompting the creation of the new LNCQM.
Mozambique is not the only African country to have been supported by the USP. In February last year, the organization extended its technical assistance program (TAP) - part of the PQM project – to include Ethiopia, Ghana, Kenya, Senegal and Sierra Leone.
In December the Maryland, US-headquartered organization supported the Ethiopian Government’s s efforts to gain ISO accreditation for its national drug quality control and testing laboratory.
More recently the USP announced it would spend $1.5m to set up a lab in Ghana, West Africa, to provide QC services and offer training.
GlaxoSmithKline has opened the official London 2012 anti-doping laboratory to keep the Olympic and Paralympic Games drug-free.
The UK-based pharmaceutical company said the lab would be open 24 hours a day, seven days a week, and claims it will run the biggest anti-doping operation in the history of the Olympic Games.
Opening of the laboratory will take place on 16 July, which is the same day as the launch of GSK's first UK advertising campaign to celebrate the role that anti-doping science will play at the Olympic Games.
"Our advertising campaign aims to showcase the hard work, determination and natural ability that is central to each athlete's performance."The campaign will feature British Olympians and Paralympians and appear on television and outdoor advertising space across the UK, including GSK's headquarters in Brentford, West London.
GSK senior vice president for global communications said: "Our contribution to the London 2012 Games, through our partnership with London Organizing Committee for the Olympic and Paralympic Games and King's College London, is to help ensure that every medal winner can celebrate their athletic achievement in the knowledge they have won through a fair competition.
"Our advertising campaign aims to showcase the hard work, determination and natural ability that is central to each athlete's performance."
Head of anti-doping at the Organizing Committee Jonathan Harris added: "The fight against doping within sport continues. GSK have been instrumental in providing services to help us deliver the anti-doping program for the games and with their help we have a state-of-the-art laboratory with the ability to process a record number of tests during the Olympic and Paralympic Games.
UK-based Synexus has been expanding, adding a new in-patient facility in Pretoria, South Africa.
The Nyeleti facility – Synexus’ fourth in the country – will focus on Phase II and III studies that involve 24 hour serial spirometry, mixed meal tolerance testing, PK visits requiring an overnight stay or when infusion is required.
This unit includes an in-patient ward, a secure, temperature controlled dispensing unit designed to manage supplies according to ICH GCP and national guidelines. It also houses emergency and other resuscitative equipment, a transit laboratory and food preparation area and has ambulance support.
Stork Veco's manufacturing facility in Eerbeek, the Netherlands, completed the construction of new Class 1,000 and 10,000 cleanrooms for the production of precision electroformed metal parts.
Stork Veco fabricates close tolerance, burr-free parts with micron and submicron features and sharp edge definition.
The Stork Veco Cleanroom facility is 17,000 sq.ft. and is a multi-million dollar investment.
According to David Haines, president, Stork Veco USA, "The demand for higher accuracy parts with tighter tolerances requires a well-controlled total manufacturing process in a clean room. By reducing micron level contamination we will continue to improve our quality and increase our customers' assembly yields."
Drug maker Bristol-Myers Squibb Co. says it will invest $165 million to expand a manufacturing facility in Puerto Rico.
The company says the expansion at the plant in the town of Humacao will allow additional production of medicines to treat type 2 diabetes and new cardiovascular medicines. A statement from the company said the expansion will create about 100 full-time jobs.
Construction at the nearly 49-acre site is scheduled to start this year and be completed in 2016.
The U.S. island territory has long been a major center of pharmaceutical manufacturing, though the industry has cut back in recent years. Bristol-Myers Squibb completed a $200 million expansion of a facility in the Puerto Rican town of Manati in 2009.
Following the earlier expansion in 2008 when the company completed a $3 million investment involving an expansion of the Oakbank Park Way, Livingston, United Kingdom, facility to provide two additional cleanroom suites including a High Potency facility and further expansion of its development laboratories, Encap is now providing new investment for additional high volume manufacturing equipment.
During the last 24 months Encap has experienced a 20% increase in sales of its Pharmaceutical Development Services (PDS) and commercial manufacturing (CMO) activities and is forecasting a similar rate of growth in 2012/14.
To compliment the growth plans Encap has committed a further $2 million of capital expenditure, buying the latest product mixing and capsule filling equipment, including a highly flexible Esco Labor (EL200) mixer and a high speed Bosch filling machine (GKF2500L) and weight checker (KKE2500).
Delivery of the new equipment will start August and will be completed by February 2013.
Encap's Chief Executive Officer, Dr. Stephen Brown said "Encap has seen tremendous growth in its PDS business in the last 2 years with the initiation of more than 30 new Pharma client projects. We have also recently completed the launch of three new commercial pharmaceutical products in EU and North America for which we have signed commercial manufacturing contracts. Encap's liquid fill and banding (sealing) technology is increasingly accepted as the sealing technology of choice for pharmaceutical products. We are seeing a growing interest in our commercial manufacturing capabilities and we have discussions progressing with a number of companies on their late stage Phase III products. Encap is investing to make sure that we have the best facilities and the most advanced manufacturing technology available to meet the needs of these new customers over the coming months and years. With the addition of this new equipment we are now capable of outputting over 6 million capsules per day".
On 27 June 2012, the technology group Sartorius officially opened a new building for the manufacture of filters and single-use bags for biopharmaceutical applications at its Yauco, Puerto Rico site. After approximately one year of construction, the new building was officially dedicated in the presence of the governor of Puerto Rico, Luis Fortuño, the Secretary of the Economic Development and Commerce Department, José Pérez-Riera, as well as numerous guests from the local political and business community.
The global pharma supplier and provider of laboratory equipment invested around €16m into the expansion of its production capacity in Puerto Rico. Covering an area 5,000m2 (53,800 sq. ft.), the new eco-friendly building complex provides space for two new cleanrooms for filter and bag manufacture, labs and offices. By the end of 2012, bag manufacturing operations will be moved from their present site in Concord, California, to Yauco, Puerto Rico. There, Sartorius added about 120 new employees and thus nearly doubled its workforce. The Concord site is due to close by the end of 2012.
By extending its plant, Sartorius is responding to the biopharma industry's growing demand for single-use products. Filters are used in this industry to sterile-filter biopharmaceuticals or to obtain active pharmaceutical ingredients from liquids. Single-use bags are employed as flexible containers for preparing nutrients, installed in single-use bioreactors, or utilized for transporting and storing biological active ingredients. Filters and bags are increasingly being requested as combined, sterile-packaged and ready-to-connect single-use assemblies.
Kemwell Biopharma Pvt. Ltd., an India-based formulations contract manufacturer, has expanded its state-of-the-art pharmaceutical development labs in Bangalore, including a 7,500 sq. ft. cGMP pilot facility to support pharmaceutical projects from pre-formulation to finished products.
"We are seeing an increasing demand for contract development services in the global market. Kemwell has invested in a world-class facility with experienced scientists to meet the growing needs of its customers. With the new labs, Kemwell continues to build upon its ongoing commitment to be a high-quality one-stop shop service provider for its customers," said Anurag Bagaria, managing director.
The 15,000 sq. ft. facility has capabilities to handle solids, injectables (large and small molecules), liquids and semi-solids dosage forms. Currently, the labs have 80 scientists with the ability to scale up to 150 scientists. Our scientists have extensive expertise in developing formulations for conventional and specialized dosage forms, including sustained release (SR) and modified release (MR) solids, liquids, and injectables.
Kemwell has the capability to offer customers pharmaceutical services that include pre-formulation, formulation development, analytical method development and validation, process optimization and scale-up, packaging development, pivotal batch manufacturing, stability batch manufacturing, stability studies, clinical batch manufacturing, labeling for blinded studies, preparation of placebo batches, tech transfer as well as commercial manufacturing. This enhanced facility coupled with our commercial manufacturing network on the same site, enables Kemwell to offer a wider scale of services for the development, testing and commercialization of large and small molecules. In Sweden, Kemwell also provides services for QP release. Says Anurag Bagaria: "Kemwell's sites in India and Sweden can work in harmony to provide the customer with the best solution from both worlds".
GE is investing US$7.5m in Australia-based Nanosonics, a developer of innovative technology for infection control, to progress the development and distribution of the Trophon EPR ultrasound transducer disinfecting system.
The investment is being made through the GE healthymagination Fund, which makes investments in healthcare technology companies.
GE Healthcare worked with Nanosonics in 2006 to support the validation of the Trophon EPR, which received US FDA approval in 2011. Trophon is now installed at more than 800 sites globally.
The advantages of the Trophon EPR system are:
It takes 7 minutes to disinfect between patients, which Nanosonics says is about half the time of traditional disinfection techniques
It can be placed in the same room as the ultrasound machine; other methods require a separate disinfection room due to the powerful chemicals that are used.
The system breaks down residual disinfectants into water and oxygen, which is safer for the environment, patient and sonographer.
Michael Ackland, president and CEO of GE Healthcare Australia and New Zealand, said: “Nanosonics has built an attractive business with an extraordinary product.
“We believe the continued collaboration with Nanosonics will help serve our healthcare customers better, complementing GE’s suite of ultrasound technologies, software and services. By expanding our sales footprint in Japan as well as in the existing locations such as the US, Canada and Europe, GE will help customers improve their overall quality in ultrasound processes.”
The Merck Animal Health FMD research and vaccine manufacturing facility in Cologne is certified to CWA 15793:2008
The Merck Animal Health (known as MSD Animal Health outside the US and Canada) foot-and-mouth disease (FMD) research and vaccine manufacturing site in Cologne, Germany has been certified according to the new CWA 15793:2008 standard on Laboratory Biorisk Management.
This standard sets requirements for the control of risks associated with working with biological agents and toxins in laboratories and facilities.
The German Social Accident Insurance Institution for the Raw Materials and Chemical Industry (BG RCI), an industrial institution for statutory accident insurance and prevention, audited the facility in March.
The official documentation was presented on June 21, 2012 to Klaus Kriebitzsch, site director of the Cologne facility.
“We are extremely proud that our FMD facility here in Cologne is among the first in the world certified according to this biosafety standard that is likely to become a new norm in the international biosafety community,” said Tobias Schlapp, head of Regional Animal Health Bio-Manufacturing at Merck Animal Health.
CWA 15793:2008 has been developed by the European Committee on Standardization (CEN) following discussions with biosafety and biosecurity experts worldwide, including representatives of the European and American Biological Safety Associations (EBSA and ABSA, respectively), the Asia-Pacific Biological Safety Association, the World Health Organization (WHO) and Det Norske Veritas (DNV).
The Cologne FMD site researches, develops and produces vaccines against FMD. The facilities for antigen production, research and quality control are located in an area that is isolated from the environment (high containment, BSL3).
The site also hosts antigen banks for several countries, which can guarantee the emergency supply of FMD vaccines.
Interior design contractor Ardmac has been awarded the construction of the new cleanroom facility at Eli Lilly, Cork, a project which sees the two companies extend their working relationship.
This investment of €330 million by Eli Lilly comes as positive news to the Irish economy, which continues to position itself as a leading location for pharmaceutical and biopharmaceutical companies.
The new plant is estimated to provide employment for up to 200 highly skilled employees in addition to 300 construction jobs on site during building works.
Although construction is not due to start until May 2013, going through to May 2014, Ardmac has already started working with Jacobs Engineering on completing the design phase, with a team having departed to Jacobs Engineering’s office in Cincinnati to close out the cleanroom design.
“This is a great win for Ardmac and fully underlines our credentials as one of the market leaders in cleanroom construction," said Ronan Quinn, director at Ardmac. "It is also great to continue working with Eli Lilly, Jacobs Engineering and Edward Cotter Partnership QS’s".
Founded in 1876, Lilly is now the 10th largest pharmaceutical company in the world, employing 28,000 people.
TÜV SÜD Canada, a global testing, inspection, and certification services firm will relocate to a new and larger facility effective June 30, 2012. The move meets the rapid growth and demand for core and expanded services.
The new office is located at 11 Gordon Collins Drive, PO Box 581, Gormley, ON L0H 1G0.
TÜV SÜD Canada offers a full suite of management system services, including ISO 9001, ISO 14001, ISO/TS 16949, AS9100, ISO 13485, ESD S20.20, OHSAS 18001, Food Services, and ISO/IEC 27001 auditing services.
TÜV SÜD Canada provides technical services in the following market segments: Industry, Products, and Transportation. Its service portfolio includes consultancy, verification, tests, expert opinions, certification, and training, addressing the issues of technical reliability, safety, quality, environmental protection, training, and effectiveness.
TÜV SÜD America, a subsidiary of TÜV SÜD AG, Munich, Germany, is a leading globally recognized testing and certification organization that provides electromagnetic compatibility (EMC), environmental testing and product safety services, CE Marking assistance, NRTL and SCC certification, and performs European Union Notified Body services for a variety of EU directives. Additionally, TÜV SÜD offers a full suite of globally recognized Management System certification services including ISO 9001 and ISO 14001.
Merck Serono, the biopharmaceuticals division of Merck KGaA, and Compugen have established a joint venture, Neviah Genomics, for the discovery and development of novel biomarkers for the prediction of drug-induced toxicity.
Neviah Genomics will be operating at the Merck Serono Israel Bioincubator in Yavne.
Merck Serono Ventures will provide the initial funding and Compugen will provide certain proprietary predictive discovery technologies. Compugen will have a stake in Neviah Genomics and the right to royalties from potential future sales.
No further financial details were released.
Neviah Genomics is Merck Serono Israel Bioincubator’s first investment. It will be housed in the state-of-the-art facilities inaugurated last month at Merck Serono’s Israeli R&D centre, Inter-Lab, which offers 600m2 (6,456 sq. ft.) of infrastructure and a range of incubation services for the program’s new start-ups.
Merck Serono and Compugen have already successfully collaborated on the discovery of biomarkers for drug induced toxicity.
The firms say that by combining their capabilities Neviah Genomics could satisfy the growing market need for products to predict toxicity profiles of leading drug candidates at an early stage of development, thereby minimizing attrition and mitigating against the risk of late-stage drug failure.
Anat Cohen-Dayag, president and CEO of Compugen, said: ‘The formation of Neviah Genomics on a ’discovery on demand’ basis enables Compugen to continue its focus on therapeutic monoclonal antibodies and therapeutic proteins in the fields of immunology and oncology, and provides potential future benefits for shareholders.’
Merck Serono’s executive VP of global business development and strategy, Susan Herbert, added: ‘Neviah Genomics is a perfect illustration of our goals behind the establishment of the Israel Biotech Incubator: to leverage Israeli science and know-how and get access to novel products and technologies for the benefit of Merck Serono's core therapeutic areas.’
Merck Serono initiated the €10m Merck Serono Israel Bioincubator Fund in 2011. It offers both seed funding and access to the dedicated laboratory facilities within Inter-Lab.
ScinoPharm Taiwan, a global provider of process R&D and API manufacturing services, will invest NT$1.13bn (US$37.6m) in a high potency cytotoxic injectable plant for the production of cancer drugs at its plant on the Tainan Science Park in Taiwan.
The firm plans to build a facility that will include space for R&D, quality control, washing, sterilization, manufacturing, filling, lyophilisation, packaging, and storage.
There will be one line for the oncological production, capable for producing liquid and lyophilized vials. In a separate, isolated area, there will also be equipment for prefilled syringes dedicated for non-cytotoxic products.
The entire injectable plant will meet international cGMP standards. For the cytotoxic area, where high potency oncological products will be produced, containment equipment will be installed with proper safety protection.
Design and construction of the plant is expected to begin in the second half of this year, with completion in 2014.
Jo Shen, president and CEO of ScinoParm, said: ‘By expanding into the field of oncological injectable formulation, ScinoPharm will be able to provide a vertically integrated, one-stop shop service for our API customers.’
A lake in Antarctica that is two miles under an ice sheet is where scientists will be looking for signs of life later this year. UK scientists and engineers aim to drill through overlying ice to sample its waters and recover sediment from the lake bed to investigate the history of the West Antarctic Ice Sheet. It is one of the biggest UK projects of exploration in recent years, involving teams from ten of the UK’s top universities, research institutes and manufacturers.
Lake Ellsworth is one of several hundred under-ice lakes in Antarctica. These sub-glacial lakes are made of ice that is kept liquid by the geothermal warmth of the Antarctic bedrock and the pressure of ice above. The lakes have been in existence for around half a million years. Protecting this ancient environment from contamination, and the samples that come from it, is central to the project
GE Healthcare, the healthcare division of General Electric and Intel Corporation announced the creation of an evaluation lab in Israel in an effort to jointly test new technologies. The lab is located at the GE Healthcare premises in Tirat Carmel, in close proximity to the Intel R&D center in Haifa, with managers and employees from both companies leading the activities in the collaboration. The lab will focus on aligning and optimizing the companies' products, such as Intel's microprocessor technologies and GE Healthcare’s healthcare products, including ultrasound diagnostic imaging systems.
"The long term objective of this collaboration is to scale these activities to other GE product areas and use the lab as a worldwide hub for all Intel technologies and expertise," said Michelle Tinsley, general manager of Intel’s Intelligent Systems Group. "As leaders in our respective industries, Intel and GE Healthcare aim to bring truly innovative technologies to the medical imaging industry."
As part of the collaboration, GE Healthcare and Intel will provide technology and expertise support. In addition, GE Healthcare will provide hosting and operational management for the facility.
"This is an exciting collaboration between two global companies who are industry leaders in technology innovation," said Mike Harsh, GE Vice President and GE Healthcare Chief Technology Officer. "The hope is that this partnership between GE and Intel will lead to the development of affordable and advanced healthcare technologies that ultimately will bring better healthcare to more people around the world."
Intel is a world leader in computing innovation. The company designs and builds the essential technologies that serve as the foundation for the world's computing devices.
Fujifilm Diosynth Biotechnologies has announced it is expanding its services in mammalian cell line development / process development and adding a new multiproduct cGMP facility at its Billingham, UK site, further increasing its contract process development and manufacturing capabilities.
The first phase has seen development of the company's cell line and process / analytical development facilities, including addition of the latest high throughput technologies to enable rapid transition of biologics from discovery to clinic. This is supported by a significant increase of the Mammalian Development Group to create a dedicated expert pool of scientists for both new technology development and delivery of customer programs.
Work has also commenced on a state-of-the-art cGMP Cell Bank and 1000L biologics manufacturing facility on the Billingham site. This facility will be based upon single-use technology for both upstream and downstream operations, offering flexible, integrated solutions and speed to clinic.
Steve Bagshaw, managing director, Fujifilm Diosynth Biotechnologies UK business, said: "This expansion will build upon our leadership position in microbial-based biopharmaceuticals, reinforcing Fujifilm's commitment to lead the global Biologics CMO industry through continuous innovation and implementation of new technologies. This European facility, together with our new cell line development and expanded process development capability, complements our US operation and will provide our customers with a full lifecycle offering, from gene to GMP, for pre-clinical studies, early phase to mid-phase clinical production and beyond".
This latest development is the next step of the company's strategy to grow CMO services in Europe and the US based on both microbial and mammalian cell culture. The company announced the addition of a 1,000L single-use bioreactor at its Research Triangle Park, NC, US, facility in May 2011, supplementing its existing 2,000L stainless steel train at the cGMP manufacturing plant.
The new Cell Bank manufacturing facility in Billingham will be available from Q2 in 2013 and the mammalian cell culture biologics manufacturing facility is expected to be validated and fully operational in the second half of 2013.
Quintiles, a fully integrated biopharmaceutical services company headquartered in Durham, NC, U.S. is investing US$14 million to establish a regional headquarters for China in Shanghai and is also significantly expanding its laboratory testing capabilities in China.
Under a joint agreement with the full-service Shanghai Clinical Research Centre (SCRC), Quintiles will provide lab testing services to local customers.
The new 4,000m2 (43,040 sq. ft.) regional headquarters will serve China and nearby Asian countries. The office in Feng Lin Science Park is expected to accommodate more than 450 people in the next five years.
‘These investments and agreements demonstrate our commitment to the Shanghai Xuhui District People’s Government and to China,’ said Ling Zhen, general manager for Quintiles’ operations in China.
‘Quintiles recognizes the unique needs of our customers in China. By collaborating with SCRC in labs we can help local and international biopharma companies develop new and better medicines to serve China’s enormous unmet medical needs.’
Rongxing Gan, president of SCRC, said: ‘SCRC’s Central Laboratory’s experienced staff and modern technology will be further enhanced through Quintiles’ investments. We are delighted to work closely with Quintiles to further biopharma innovation and improve human health.’
The Quintiles-SCRC collaboration follows last year’s launch of Kun Tuo, Quintiles’ local contract research organization, built to help local and global biopharma companies achieve successful registration of medicines in China.
Quintiles commenced operations in China in 1997 and today has offices in Beijing, Dalian, Hong Kong and Shanghai, with employees and capabilities to serve all major population centers and study sites across China.
Waters Corp. broke ground on its new mass spectrometry headquarters in the UK. Located on the 37-acre Stamford Lodge site, three miles south of Manchester Airport, the new facility is intended to unite Waters' existing MS operations, consisting of more than 500 employees, currently located on four separate sites in South Manchester and Altrincham. Plans for the new facility include customer demonstration laboratories, R&D capabilities, and an expanded manufacturing capacity.
Brian Smith, vice president of MS Business Operations at Waters Corp., said, "I am very excited that we now have the ability to move our high technology business forward and provide a world-class center for innovation in mass spectrometry. The new Waters MS Headquarters will be designed to accelerate the rate of innovation with increased access for the world's scientific thought-leaders. Science is such a major contributor to the history of Manchester and we are honored to be writing a new chapter in its rich heritage with our custom built headquarters in Wilmslow."
Terry Shortt, Waters' vice president of Global Quality Assurance and MSHQ Project Director, added, "We remain committed to the sustainability of the project and protecting the local flora and fauna. The building itself will be constructed to the BREEAM (Building Research Establishment Environmental Assessment Methods) 'very good' standard. We have also recently completed a purpose built home for the local bat population and will refurbish the sunken garden from the original lodge."
Manchester has long legacy of mass spectrometry innovation, beginning with John Dalton's Atomic Theory in the early 1800's, according to a Waters statement.
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