PHARMACEUTICAL & BIOTECHNOLOGY
INDUSTRY UPDATE
March 2011
McIlvaine Company
TABLE OF CONTENTS
Carnegie Mellon Lands $4M for Nucleic Acids Center
Metabolon Lab Gains CLIA Certification
New Children’s Hospital in Michigan
MPS Invests in Label and Carton Plant
HWI Global to Implement C3 SmartRoom at Cleveland Clinic
Automated Packaging Systems Acquires Buildings to Meet Growth Needs
Cytovance Receives $22.5 Million Investment
Synergy to Build Innovation Center
Robotic Pharmacy Aims to Improve Safety
Dendreon to Add Manufacturing Capacity
West to Invest in Kinston Syringe Plant
Celerion Adds USP 797-compliant Cleanroom
Jackson Labs Names Sarasota as Location for New Institute
GE Healthcare Cleanroom Facility
Genesis Plastics Plans Expansion
Almac Starts Controlled Drug Operations
Advion Will Open Bioanalytical Lab
AndersonBrecon Opens Illinois Facility
Duke Realty to Build WakeMed Medical Park
Developer to Break Ground on Houston MOB
New Force in Contract Packaging
Merck Will Revamp Former Schering-Plough Headquarters
Paragon Medical Opens Bioskills Lab
NIH Plans Center to Spur Creation of New Drugs
2011 Facility of the Year Awards (FOYA) Winners Announced
AxFlow Creates Cleanroom for Hygienic Pump
U.S.-Funded Bio Lab Opens in Tbilisi
CRUK, Partners Launch Cancer Center in Oxford, UK
PROLOR Biotech Expands R&D Facility
Tetra Pak Opens Middle Eastern Factory
ShangPharma Pilot Plant Facility, Fengxian, China
Nestlé Boosts Chinese Food Science Activity
WR Grace Opens Indian Service Centre
IPCA Gets OK for India API Plant
Medtronic Inaugurates Facility in Singapore
GSK Invests in Sri Lankan Plant
Bristol-Myers Squibb and WuXi PharmaTech to Collaborate on Facility
Cipla, Ranbaxy and Cadila Expansions in Africa
Sri Biotech to Set up Discovery Centre
Clariant Reorganizes and Plans Innovation Center
Genzyme to Build Plant in Belgium
NSF International Opens Testing Laboratory in China
Thermo Fisher Building Facility in China
Spanish Acquisition to Give Sealed Air Access to Aseptic Market
Samsung in Deal with Quintiles
SOHM Expands Indian Manufacturing Capacity
LG to Build Vaccine Site in S. Korea
AstraZeneca R&D Facility, Alderley Park, Cheshire, UK
The Riverside Technology Center hundreds of times is an unassuming, brown brick building. It sits on the banks of the Charles River in Cambridge, across from Genzyme’s castle-like manufacturing plant.
Every tenant of the five-story building is a biotech company. For these companies, it isn’t unusual to talk about needing $100 million or more to get a new drug within spitting distance of Food and Drug Administration approval, at which point it can be prescribed by doctors.
And while the teams of 20 or 30 employees at each company may devote a decade or more to developing new treatments for conditions like cancer, autism, or sickle cell anemia, they do it knowing that a tiny ripple of bad data received after testing in humans could undercut investors’ confidence, and lead to the company’s swift demise.
Still, behind every glass door at the Riverside Center, the hope is that they might not only be creating a drug that will change lives, but also laying the foundation for the next Genzyme Corp. (recently acquired for $20 billion) or Vertex Pharmaceuticals Inc. (a Cambridge company with a market value of $10 billion).
“The timelines and the gestation period are just different from anything else,’’ says Nick Leschly, a former venture capitalist who is now chief executive of Bluebird Bio Inc., developing gene therapy treatments for rare diseases. “This probably isn’t the quickest way to riches or stardom. There is no Facebook in life sciences.’’
Leschly mentions that he fielded a phone call earlier in the day from a father eager to get his son into one of Bluebird’s clinical trials.
“Part of what motivates us is that what you’re doing is important,’’ he says.
Bluebird is a 30-person company trying to succeed in a field littered with failure: Despite two decades of research at Genzyme, and intense efforts by dozens of start-ups, the FDA has yet to approve a single gene therapy treatment. In Bluebird’s case, gene therapy involves extracting stem cells from a patient’s bone marrow, inserting a normal version of the gene that is causing the disease into the stem cells, letting them replicate in a dish, and then re-injecting the healthy cells into the patient.
Like Genzyme before it, Bluebird is starting small: It published research last year showing how one patient with a blood disorder called beta-thalassemia had been able to forgo his normal monthly blood transfusions and go back to his job as a chef after being treated with Bluebird’s gene therapy.
The company got its start in 1991, and has raised about $75 million, some of it from the investment arm of Genzyme. Still, Leschly says the company will spend the next few years testing its therapy in more patients and collecting data to present to the FDA.
One floor up is Cerulean Pharma Inc. The company is developing what chief executive Oliver Fetzer calls “the ultimate Trojan horse,’’ a nano-particle designed to hold potent drugs, find its way to tumors, and release the drug over time. Fetzer estimates Cerulean’s drug could be as much as 20 times better than current cancer drugs in reaching tumors without being absorbed by healthy tissue along the way (a major cause of drug side effects). But, he acknowledges, science can hold surprises, and Cerulean has already abandoned a more complicated, difficult-to-produce version of its nano-particle.
Epizyme Inc., also focused on cancer drugs, is employing new insights into the way disease-causing genes are turned on and off by mechanisms other than DNA. Its chief executive, Robert Gould, spent more than 20 years at the pharmaceutical giant Merck & Co.
Unlike most of its neighbors, Seaside Therapeutics Inc. hasn’t raised millions in venture capital. Instead, it has relied on grants from the National Institutes of Health, funding from patient advocacy groups, and donations from philanthropists. In developing drugs that could help patients with autism and the related Fragile X syndrome, Seaside hopes to outmaneuver much bigger players like Novartis and Roche.
The building doesn’t feel anything like a biotech frat house. But there’s a good deal of interaction among the tenants. One of the Seaside founders, Kazumi Shiosaki, was also a founder and temporary chief executive of Epizyme. When one of the building’s tenants planned layoffs, the company passed resumes along to another firm, Aileron Therapeutics, which hired one of the scientists. (Aileron moved out of the Riverside Center in October.) Aileron chief executive Joseph Yanchik also recalls some high-quality networking with an executive from a major pharmaceutical company during a fire drill at the building.
The building’s owner, Abbey Group of Boston, purchased it in the late 1980s. During the recession, occupancy dropped to about 50 percent, says Abbey Group managing partner Bob Epstein. But in 2011, he says, “we’re probably 70 or 75 percent rented.’’
One hazard of renting to biotechs is they sometimes get acquired by large pharmaceutical companies that move their operations elsewhere. (The bigger companies are hungry for new products as patents expire on their older drugs.)
That’s exactly what is happening with Alnara Pharmaceuticals, a company developing enzyme replacement therapy to help people suffering from chronic pancreatitis and cystic fibrosis. Last summer, Alnara was acquired by Indianapolis-based Eli Lilly & Co for $180 million, with the possibility of another $200 million should the drug win approval and do well in the marketplace.
In January, however, an FDA advisory panel rejected the drug, contending the company hadn’t proved it works well enough. That may force Lilly to conduct more trials and collect more data.
Only a few of Alnara’s 25 full-time employees will stay with Lily and move to Indianapolis when Alnara vacates the center at the end of the month, said Robert Gallotto, Alnara’s chief business officer. “Many of the folks here are local, Cambridge-based folks,’’ he says, “and they’re used to more of a small company environment.’’
Could some of them end up finding jobs elsewhere in the building? “Sure,’’ Gallotto says. “I could definitely see that happening.’’
The Center for Nucleic Acids Science and Technology (CNAST) at Carnegie Mellon University has received a $3.9 million donation from the DSF Charitable Foundation, which it plans to use to develop new tools for manipulating and monitoring gene expression.
The university said that CNAST plans to use the funding to support interdisciplinary research, including studies using peptide nucleic acids (PNAs) — synthetic analogs of DNA and RNA — and other tools to understand the genetic and molecular basis of diseases, and to develop treatments.
In addition to funding research projects at the center, the grant also will support the creation of a facility for producing PNAs and to support graduate students and postdoctoral researchers.
"CNAST's innovation is emblematic of the high-risk, high-return science we do, and for which federal funding is notoriously difficult to secure," Richard McCullough, the center's VP for research, said in a statement. He added that the donation "will help us to jump-start some amazing projects so that we can successfully vie for these additional funds."
"In our labs we've been looking at PNA as a sophisticated way to regulate expression," CNAST Co-Director and Professor of Chemistry Bruce Armitage said. "We don't need to totally turn off a gene in order to prevent disease. If we reduce the amount of gene expression by as little as 20 percent, it could have a profound effect."
Metabolomics and biochemical analysis developer Metabolon has received Clinical Laboratory Improvement Amendment (CLIA) certification for its new facility in Research Triangle Park, NC.
The company said that the CLIA certification from the Centers for Medicare and Medicaid Services will enable it to perform high-complexity tests on patient samples.
Metabolon said that later this year it plans to launch tests for insulin resistance and urological cancers based on biochemical markers.
The firm said its profiling technology identifies and measures all of the biochemicals in a biological sample in order to provide information about disease etiology, drug action, and other personalized medicine-related data.
“Olympus Silver” and “Alpolic Blue” coated metal panels cascade across the dramatic exterior of the new children’s hospital located on Michigan Street’s “Medical Mile” in Grand Rapids, Mich.
The Helen DeVos Children’s Hospital, owned by Spectrum Health, was opened Jan. 11, and spans some 440,000 square feet. The new 206-bed, 14-story pediatric hospital nearly quadruples the size of its predecessor, which opened in 1993, to serve more than one million children throughout Michigan.
Designed to meet the U.S. Green Building Council’s LEED Rating System criteria, the $286 million healing environment highlights natural elements such as land, sky, sun and water. The architects for this project were Jonathan Bailey Design LLC (Dallas), Rockwell Group (New York), and URS Corporation (New York).
Architectural Metals Inc. (Portland, Mich.) manufactured the custom-fabricated aluminum panel system and Linetec finished the material in large, continuous sections at its factory in Wausau, Wis.
The panels were finished using high-performance fluoropolymer coatings, 70% PDVF-PPG Duranar® in “Olympus Silver” and “Alpolic Blue.”
Olympus Silver is a three-coat metallic paint system, which includes PPG's primer, Duranar® color coat containing metallic flakes, and clear Duranar XL top coat, which is mandatory for all metallics to provide chemical resistance against acids and alkaline materials. The XL top coat also offers additional protection against abrasion and atmospheric contaminants, Linetec says.
Alpolic Blue is a four-coat system, which includes PPG primer, Duranar barrier coat, Duranar color coat, and a clear Duranar XL top-coat. A barrier coat is required on certain paints to protect the primer when the topcoat has poor UV opacity. UV opacity refers to a paints ability to protect the primer from the sunlight.
The finishing facility safely and efficiently captures and destroys the VOCs present in liquid solvent-based paints, the company said.
“VOCs can be of special concern to projects pursuing sustainable, green design goals and to health care facilities with sensitive medical equipment and patients with compromised immune systems,” said Schroeder. “We use specialized equipment to safely capture 100% of the VOCs released in the painting process, and to destroy these captured VOCs with 98.5% efficiency at the factory - before the materials' arrival to the building site.”
After applying the finishes, the company shipped the aluminum panels in scheduled phases to Architectural Glass and Metals Inc. (Byron Center, Mich.).
The field team installed approximately 50,000 square feet of finished panels and integrated aluminum louvers as part of the hospital's overall, high-performance, unitized, aluminum curtainwall system, Linetec said.
Wolverine Building Group (Grand Rapids, Mich.) served as the project's construction manager. Wolverine's vice president Bruce Burgess said, “It is a huge success. The Helen DeVos Children's Hospital is a beautiful facility and the quality and pride taken by all of the trades is exceptional.”
The general contractor was Turner Construction Company (Detroit).
Linetec said some of the hospital's services, features and accomplishments include:
· A dedicated, pediatric emergency department caring for more than 100 children each day.
· Six operating rooms, a heart catheterization laboratory and a pediatric radiology department.
· One of the largest children's cancer and blood disorders programs in the U.S., with more than 700 patient visits monthly, and West Michigan's only blood and bone marrow transplantation program.
· The only pediatric radiology department in West Michigan, with nearly 75,000 visits a year.
· The only extracorporeal membrane oxygenation machine in West Michigan for life-saving treatment of babies with acute lung disease.
· The nation's 10th largest neonatal center, with more than 1,200 babies admitted each year.
· Spacious, 330 square foot, private patient rooms with floor-to-ceiling windows and accommodations for parents to stay overnight.
· Quiet spaces throughout the building and a chapel for all faiths.
· Special amenities for families such as laundry and kitchenette facilities, overnight rooms for those in crisis situations, a computer lab and a resource library.
US contractor Multi Packaging Solutions plans to expand its label and carton manufacturing facility in Holland, Michigan to cater for growing demand from the pharmaceutical industry.
According to a report in The Holland Sentinel the expansion is part of a $5.3m project that will also see the firm add capacity at its digital imaging facility in nearby Allegan. MPS plans to hire around 180 new staff when the expansion is completed in 2014.
Company president Dennis Kaltman told the Michigan Business Review that: “We’ve invested significant capital in these facilities over the last five years to upgrade and enhance our capabilities in response to customer needs.”
“Our expansion in Allegan and Holland reaffirms our commitment to expand in the state of Michigan to support our next phase of growth.”
HWI Global, Inc., recently merged with IVT Software, Inc., announces a contract with the Cleveland Clinic in Cleveland, OH. HWI Global, the Pittsburgh-based design-build cleanroom firm, is further expanding its relationship with the renowned healthcare institution implementing its new patent-pending C3 SmartRoom Information Management Solution. HWI Global's contract is to retro-fit the C3 system in the sterile compounding pharmacy of the Taussig Cancer Institute, which provides world-class care for cancer patients and is at the forefront of new and emerging clinical, translational and basic cancer research. HWI provided a USP 797 compliant cleanroom at Taussig in 2009.
Deric A. Haddad, CEO, HWI Global states, "A working relationship with the Cleveland Clinic is one of our top priorities. For years, they have been at the forefront making USP 797 compliance an absolute standard in their production of compounded sterile preparations. And thus, it's safe to say that the Cleveland Clinic's commitment to adhering to these regulations inspired HWI Global to develop our C3 product. The introduction of the C3 SmartRoom will give the Cleveland Clinic automated compliance control by effortlessly ensuring and validating that they remain in compliance, eliminating the risk of undocumented legal exposure caused by unexpected faults in their facility systems."
Automated Packaging Systems Inc. is expanding its operations in Streetsboro, Ohio, by acquiring two commercial buildings. The larger building is 173,000 square feet of combined manufacturing, office and warehouse space located on 32 acres at 600 Mondial Parkway, just three miles from the company’s corporate headquarters on Philipp Parkway. This building was originally constructed in 1995 and will be used to support future expansion plans for multiple product lines, including manufacturing of bag packaging systems and bag materials.
The other recent acquisition is a 33,000 square foot building located at 10320 Philipp Parkway, right down the road from Automated Packaging’s corporate headquarters. This facility will become the company’s Customer Support Center for operations that include customer service, technical support, parts sales, factory repair and technical training. This building, which is just six years old, offers flexible workspace with a functional mix of office, manufacturing and warehouse space in a contemporary style similar to corporate headquarters.
“These two building acquisitions provide us with the flexibility we need to meet the growth we are experiencing in our global businesses,” says Cliff Brehm, president and chief operating officer, Automated Packaging Systems. “Our current manufacturing facilities are at maximum capacity and we plan to begin phasing into these two new buildings over the next several months. The city of Streetsboro, the Portage County Department of Development, and the State of Ohio have been extremely supportive in helping us to expand our business in this community and we plan to be here for a long time.”
Automated Packaging Systems obtained a 45% Job Creation Tax Credit from the State of Ohio for seven years with a commitment to operate the new acquisition on Mondial Parkway for at least 10 years. The company has committed to creating 85 new jobs in the first three years and plans to have 200 to 250 new jobs there in 10 years. Automated Packaging now has three manufacturing and office buildings in Streetsboro, and a total of nine manufacturing plants worldwide.
The investment from Great Point Partners in Greenwich, Conn., will fund facility, service and personnel expansion.
Convincing a large, professional private equity group to invest in a biotech company in Oklahoma City was the biggest challenge in moving Cytovance Biologics to the next level, said Chief Executive Darren Head.
Cytovance, an OKC biotech company, receives $22.5 million investment Capital tends to be given to companies in biotech hubs such as Boston, San Diego and New Jersey — not the Heartland.
But with its state-of-the-art facility at the Presbyterian Health Foundation's Research Park and a talented team of scientists, Cytovance was able to secure a $22.5 million investment to expand its operation here.
The company announced the investment by Great Point Partners in Greenwich, Conn., which will fund facility, service and personnel expansion. Cytovance will move from 840 Research Parkway to more space at 800 Research Parkway to occupy the former Genzyme laboratory.
The company also purchased analytical and bioprocess equipment formerly belonging to Genzyme to equip its facility.
Cytovance provides science and manufacturing for supplies used in clinical trials, Head said. Scientists there produce small quantities of new pharmaceuticals that will undergo clinical testing for the treatment of cancer, gout, Crohn's disease, sickle cell anemia and other ailments.
Sales in 2010 were about $7 million and are expected to top $18 million by the end of 2011, Head said. Cytovance has customers from around the globe including Taiwan, China and Europe.
Its staff of 68 is expected to grow to more than 90 by the end of the year.
The $22.5 million investment is staged, with $10 million up front and additional payments after financial targets are met.
Flavors and yeast extract company, Synergy is setting up a new flavor innovation and manufacturing facility near its current site at Wauconda, Illinois, north of Chicago.
The site, which will be fully operational by the end of next year, will feature an Innovation Center which will include flavor and applications development labs, a demonstration kitchen, sensory testing labs, and analytical and pilot plant facilities.
Occupying a 15-acre site, the new campus will incorporate an existing building that will be modified and expanded into a 125,000-square-foot facility. The campus will be designed in parallel with LEED Certification Standards governed by the Green Building Institute to align with Synergy's Sustainability Platform.
The expanded facility will include new automation to improve liquid processing and packaging efficiencies. The company also plans to add further capabilities in dry production such as expanding its spray drying facility.
The company’s CEO, Roderick Sowders said in a statement: “This facility represents the next phase in our development and we are proud to remain a part of the Wauconda community. We are also proud to be making huge strides in the area of corporate social responsibility and this facility will be a significant part of that.
"We have simply outgrown our current facility, and although we have added staffing and expanded shifts to increase production, we are coming to a time where we won't be able to accommodate our growth plans in our existing facility.”
Greg Bach, the company’s VP, Business Development, added: "Our growth has come from expanding our reach in key markets such as bakery, confection, dairy, ready-to-drink beverages, dry drinks, nutritional and savory products."
Acquisition had also contributed to growth over the past five years, he said. The company acquired vanilla production company Vanlab in 2006.
In 2007, AFF Aromas do Brazil was brought on to establish a technical and manufacturing base in South America.
Applications for Synergy Flavors ingredients include: Bakery spanning bread, biscuits, cakes, muffins, crackers, cereals, waffles and doughnuts, Beverages, including berry fruit, citrus and tropical fruit flavors among others.
Meanwhile, Synergy's Chicago facility received organic certification last May. The certification will allow the company to increase the provision of organic flavors, and respond to sustained demand for ‘clean label’ products, it said.
Synergy Flavors, Inc. is a subsidiary of Carbery, an international nutritional ingredients and cheese manufacturer.
Although it won't be obvious to UCSF Medical Center patients, behind the scenes a family of giant robots now counts and processes their medications. With a new automated hospital pharmacy, believed to be the nation's most comprehensive, UCSF is using robotic technology and electronics to prepare and track medications with the goal of improving patient safety.
Not a single error has occurred in the 350,000 doses of medication prepared during the system's recent phase in.
The robots tower over humans, both in size and ability to deliver medications accurately. Housed in a tightly secured, sterile environment, the automated system prepares oral and injectable medicines, including toxic chemotherapy drugs. In addition to providing a safer environment for pharmacy employees, the automation also frees UCSF pharmacists and nurses to focus more of their expertise on direct patient care.
The new pharmacy is the hub of UCSF's integrated medication management system which combines state-of the-art technology with personalized care.
"The automated pharmacy streamlines medication delivery from prescription to patient," says Lynn Paulsen, director of pharmaceutical services at UCSF Medical Center. "It was important to develop a system that is integrated from end to end. Each step in safe, effective medication therapy – from determining the most appropriate drug for an individual patient to administering it – is contingent on the other."
The new pharmacy currently serves UCSF hospitals at Parnassus and Mount Zion and has the capacity to dispense medications for the new UCSF Medical Center at Mission Bay, scheduled to open in 2014. As the phase-in continues, additional steps in the process will be eliminated as doctors begin inputting prescriptions directly into computers in 2012.
"We are intent on finding new ways to improve the quality and safety of our care, while increasing patient satisfaction," says Mark Laret, CEO, UCSF Medical Center and UCSF Benioff Children's Hospital. "The automated pharmacy helps us achieve that and at the same time, advance our mission as a leading teaching hospital and research institution."
Studies have shown that technology, including barcoding and computerized physician entry, as well as changes in hospital processes for medication management, can help reduce errors. The pharmacy also will enable UCSF to study new ways of medication delivery with the goal of sharing that knowledge with other hospitals across the country.
Once computers at the new pharmacy electronically receive medication orders from UCSF physicians and pharmacists, the robotics pick, package, and dispense individual doses of pills. Machines assemble doses onto a thin plastic ring that contains all the medications for a patient for a 12-hour period, which is bar-coded. This fall, nurses at UCSF Medical Center will begin to use barcode readers to scan the medication at patients' bedsides, verifying it is the correct dosage for the patient.
The automated system also compounds sterile preparations of chemotherapy and non-chemotherapy doses and fills IV syringes or bags with the medications. An automated inventory management system keeps track of all the products, and one refrigerated and two non-refrigerated automated pharmacy warehouses provide storage and retrieval of medications and supplies.
By using robots instead of people for previous manual tasks, pharmacists and nurses will have more time to work with physicians to determine the best drug therapy for a patient, and to monitor patients for clinical response and adverse drug reactions.
In addition, the new pharmacy offers a rich training ground for pharmacy students in the medication distribution systems of the future.
"UCSF led the way in training clinical pharmacists, who focus on the patient rather than the drug product," says Mary Anne Koda-Kimble, PharmD, dean of the UCSF School of Pharmacy. "Automated medication dispensing frees pharmacists from the mechanical aspects of the practice. This technology, with others, will allow pharmacists to use their pharmaceutical care expertise to assure that patients are treated with medicines tailored to their individual needs."
The facility, located at Mission Bay south of downtown San Francisco, has been awarded LEED-CI Gold certification for its sustainable building practices.
Dendreon is set to increase production of Provenge, a prostate cancer medicine, after the company gained FDA clearance to add 36 workstations to its New Jersey plant, adding to the 12 production stations already in operation. The company also sought approval to begin making Provenge at a facility in Los Angeles and expects to finish building another manufacturing site in Atlanta by midyear.
Dendreon expects the FDA to approve 36 workstations at its plant in Los Angeles in June and also hopes to have an Atlanta plant approved sometime later this year.
It forecast about 500 infusion centers around the country will be treating patients by the end of the year.
Provenge, which costs about $93,000 per patient for a course of three infusions, last year became the first approved cancer vaccine to treat rather than prevent the disease. It works by stimulating a patient's own immune system to attack the cancer and in late stage trials extended survival by an average of 4 months.
The company plans to seek Provenge approval in Europe late this year or early next year and is also testing the drug against bladder, kidney, breast, ovarian and colorectal cancers.
Dendreon, which is often mentioned as a takeover target, holds full worldwide rights to the drug -- a rarity for small biotechnology companies -- and has no plans to seek a partner to help market Provenge, Gold said.
West Pharmaceutical Services will invest $29m to expand its syringe and injection device facility in Kinston, North Carolina, in the US.
According to reports in the local media, West will spend the money on improving production processes and add new washing and inspection technologies.
The firm told the Triangle Business Journal that the investment will include a $1.5m contribution from the state as well as a $2m tax credit. The firm did not say whether it will be adding to the facility’s 325-strong workforce.
However, according to a report in the Newsobserver, West plans to hire in the fields of microbiology and engineering as part of the new expansion program.
West has operated in the town since the mid 1970s, however its original facility was destroyed in an explosion that killed six of its manufacturing employees in 2003.
Since then the firm has rebuilt the site through a number of investment, the most recent of which was in 2007 when the firm spent $20m on upgrading capacity and hiring 100 new staff.
The Kinston news marks something of a change of direction for West which has been restructuring its manufacturing operations in recent months.
In December , for example, the firm announced plans to close a plant in Pennsylvania and sell part of a factory Cornwall in the UK to reorganize production operations ahead of impending contract expiries.
These restructuring efforts were reflected in the financial results the firm posted last month , which revealed that year on year operating income had fallen 73 per cent.
At the time CEO Donald Morel said the cuts allow West to “keep our production capabilities and cost structure in balance with the expected changes in demand.”
HudsonAlpha Institute for Biotechnology is among elite research facilities worldwide on the cutting edge of providing information that can be used to improve life through advancements in health prognostics, diagnostics and therapeutics.
The institute is located on a 150-acre biotech campus in Cummings Research Park. Founded by Jim Hudson, HudsonAlpha strives to encourage breakthroughs in the laboratory and then move them into the marketplace and classroom.
Its mission is three-fold involving genomic research, economic development and educational outreach. Scientists place data and information obtained during specific genomic research projects into public databases for use. The collaborative effort helps speed up the process of finding causes and cures for diseases and training young scientists for the future.
Genomics is the study of genes, gene sequences and their functions. It is focused on human health research and much of HudsonAlpha research is funded through grants from the National Institute of Health and philanthropic organizations.
"It's the big picture," Sollid-Penton said. "Genomics looks at component parts. We try to figure out what correlates to what sickness. In a way we are looking for risk factors for certain diseases."
Some researchers at the institute are studying brain, lung and ovarian cancer, "trying to determine commonalities," according to Sollid-Penton. "These become red flags or bio-markers."
The study is ongoing at Clearview Cancer Center in Huntsville and has moved into its second phase at M.D. Anderson Cancer Centers.
The institute is involved in economic development. The state of Alabama invested $50 million in the center under the leadership of former Gov. Bob Riley with the idea being that once research is completed it can be handed off to somebody who can take it to the market place.
The 270,000 square foot institute was built with a $130 million endowment and $80 million from other private sources. One side of the facility houses nine researchers employing from 2-40 staff members while the institute acts as a landlord to 14 for profit companies doing similar work in the other half of the facility. A second building on campus, the Jackson Center, is used for meetings and convention space. A third facility will soon begin construction as the campus expands to a growing cluster of researchers and entrepreneurs.
The state's investment is to be used to help in the development of the remainder of the 150-acre campus by companies that become involved in ongoing research projects at the institute. The goal is to become strong in basic and clinical research and to provide a support system and environment that encourages entrepreneurial investment on site.
Through its environmental health remediation project Hudson Alpha is "trying to reduce America's dependence on foreign oil," Sollid-Penton said. "We are studying the development of alternative fuels from sorghum, soybeans, corn and sugar cane."
HudsonAlpha is also promoting education in Alabama by training teachers involved in the state's Alabama Math Science and Technology Initiative. The institute provides intensive classroom instruction for teachers and a "lab in a box" where teachers can take what they've learned back to the classroom for use by students in a hands-on setting.
"Huntsville is known for engineers and rocket scientists," Sollid-Penton said. "We want to develop the bio-tech reputation and have found it easy to sell Huntsville to some of the top experts in the field."
The addition of the USP cleanroom to Celerion’s Phase I core capabilities enables sterile extemporaneous compounding in-house for microtracer studies, giving clients access to quality data earlier in drug development process.
Celerion, a provider of innovative early stage drug development solutions, announces the completion of a cleanroom and pharmacist certification to comply with USP <797> guidelines. This enables in-house preparation for microtracer studies providing an alternative to the requirement for GMP manufacturing of the IV solution. The sterile preparation and administration allows clients a one-stop option thereby saving time and money.
A large number of bioavailability and First-in-Human (FIH) studies require sterile compounding. The USP <797> cleanroom allows for all types of complex extemporaneous compounding for low, medium and high risk investigational compounds. This allows Celerion to take a client’s API, develop customized dosing and compounding that enable very selective dose levels to be administered. This solution combined with our experience in delivering early stage adaptive trial designed studies will allow clients to reach clinical proof-of-concept (PoC) faster.
“The addition of the USP <797> cleanroom continues to demonstrate Celerion’s commitment to implement innovative solutions to generate critical data to enable decisions in drug development to be made earlier” said Phil Bach, Vice President of Clinical Research at Celerion. “The cleanroom when combined with our Lincoln, Nebraska, facility’s radiolabel license, allows Celerion to offer execution of Phase 0, microtracer and microdosing studies producing data typically not available until later in drug development.”
The cleanroom includes three separate areas, one ante-room that serves two individual clean rooms. One cleanroom is a dedicated microtracer area which contains a Class A2 Biological Safety Cabinet for radio labeled microtracer compounding. An additional cleanroom contains a laminar flow hood for traditional IV compounding. Both cleanrooms are ISO 7, attached to an ISO 8 ante-room and are used for sterile compounding.
The certification, covered by United States Pharmacopoeia (USP) guideline 797 on sterile preparations, allows the firm to offer compounding for medium and high risk candidates, whereas previously it was only able to handle low risk compounds.
Celerion employs two full time pharmacists at the Lincoln facility, both of whom also received training in USP <797> requirements for compounding procedures and sterilization methods from BAXA and PCCA.
The microdosing expansion is one of a number of additions early-phase trials specialist Celerion has made to its business since its launch following the breakup of MDS Pharma Services in 2010.
In June the firm added hybrid ECG core laboratory capabilities to streamline the process of heart monitoring in early phase clinical trials.
More recently it partnered with BryanLGH Health System to add extra capacity for first in human trials at the Lincoln site, citing growing industry and regulatory demand for “in hospital” Phase I studies.
The Jackson Laboratory will open a new personalized medicine institute in Florida that will work in partnership with the University of South Florida (USF), Sarasota County, and the Gulf Coast Community Foundation (GCCF), Jackson Labs said.
The Jackson Laboratory-Florida will reside in a 120,000 square-foot facility and will include labs and offices in the USF Health complex located in Tampa. The institute will focus on developing genetics-based treatments for heart disease, Alzheimer's, and diabetes.
The GCCF and other groups in the community will work to create a "major biomedical village, including research, clinical medicine, education, and residential and retail activity that will grow up around the new Jackson facility," the lab said in a press release.
Jackson Lab and USF had been holding discussions about locating the Florida institute in a site near Naples in Collier County and in Hillsborough County, but those eventually lost out to Sarasota after a long and sometimes controversial discussion over $130 million in state funding and matching county funds that the lab sought to support the project.
Jackson's flagship facility is located in Bar Harbor, Me., where it recently opened a new $4.7 million, 22,500 square-foot research building, and it runs another facility in Sacramento.
"Our facility in Sarasota County, coupled with operations on the USF Health campus, will build the collaborations essential to breakthrough discoveries, clinical medicine, and educational outreach," Charles Hewett, Jackson Lab's executive VP and COO, said in a statement.
Hewett said that Jackson Lab will work with government and private partners to approach Florida Governor Rick Scott "for guidance," and possibly for financial support.
Jackson Lab said that Sarasota officials will seek voter approval for county funding through a referendum that could be held as early as July. If that funding gets the green light, Jackson Lab said, it could start construction within 12 months after the vote, and it would start operating in temporary facilities in the area soon after the funding is secured.
"Our partnership with The Jackson Laboratory and USF Health will bring the most advanced medical thinking in the world to our patients in Sarasota and this region," Sarasota Memorial Health Care System CEO Gwen MacKenzie said. "Together, we will provide personalized health care tailored to each individual's genetic makeup."
GE Healthcare has opened a $165 million production cleanroom facility in the Rensselaer Technology Park in Troy, New York. The facility is 230,000 square foot, including a cleanroom of 60,000 square foot. The plant will make breast cancer digital x-ray screening devices.
The plant is expected to create 100 new jobs for the area, with 50 more employees transfer to Troy from GE’s research center. The new facility will help to meet a growing demand for mammography for breast screening devices, which is expected to grow at 5% in the next few years.
Fortville-based Genesis Plastics Welding plans to invest over $3.3 million to expand its existing production facility east of Indianapolis, adding the capacity for as many as 54 new employees by 2014.
Genesis, which serves equipment manufacturers in the medical, military, automotive and consumer products industries, plans to add 16,000 square feet of space to its 26,000-square-foot building, including a certified medical “cleanroom.”
The expansion, which is in progress, will double clean manufacturing production space to accommodate Genesis’ fast-growing medical contract manufacturing business. Construction is scheduled to be completed by December 2011.
Founded in 1987, the company now employs 65 workers who make products including helmet padding, blood pressure cuffs, inflatable fluid bladders, hot and cold therapy packs, compression therapy sleeves, medical instrument covers, disposable heating blankets and drainage bags.
Genesis is accepting applications for production workers and plant supervisors.
Indiana Economic Development Corp. offered the firm up to $340,000 in performance-based tax credits based on the job-creation plans. The town of Fortville will consider additional property tax abatement at the request of the Hancock Economic Development Council.
Genesis Plastics Welding, a US contract manufacturer, is investing US$500,000 to expand its Class 7 cleanroom to increase production capacity of radio frequency (RF) plastics welding of medical devices, supplies and equipment.
The Indianapolis-based company is doubling the size of its current medical cleanroom, a controlled environment that meets the medical device cleanroom requirements of an ISO Class 7 Standard 14644 clean zone for particle count testing.
The cleanroom features a number of heat-sealing processes including impulse welding, sonic welding and RF welding of polar and non-polar materials. Thermoplastics heat-sealing of non-polar materials is achieved using the company’s ecoGenesis proprietary technology. There is also a gown room that meets the requirements of an ISO Class 8 cleanroom.
“The expansion of our medical cleanroom is an important milestone in our growth initiatives,” said Tom Ryder, president and chief executive of Genesis Plastics Welding.
“The medical industry is a key vertical market where Genesis can bring significant value. Our heat-sealing services paired with an ISO Standard 14644 medical cleanroom enable us to provide high quality, FDA-compliant contract manufacturing services to medical device, supply and equipment companies around the globe.”
Controlled substance supply operations are up and running at Almac’s facility in Souderton, Pennsylvania after the CMO completes the latest stage of relocation to new North American HQ.
The unit includes 3,980 sq. ft. of high security storage space, as well as packaging and distribution areas for compounds covered by the US Drug Enforcement Administration’s (DEA) schedule I – V regulations.
Spokesman Jonathon Calderwood said that pharmaceutical industry demand and the evolution of the drug sector were the key drivers for Almac’s investment.
“Controlled drugs in terms of clinical supply are increasing in prominence as Pharma looks to shift beyond the blockbuster development models and move into targeted, niche therapies.”
He went on to explain that the firm has provided storage and packaging of controlled drugs for some time “but now [with the new unit] we have aimed to provide extensive capacity for these product types.
“Also,” Calderwood continued “global distribution and supply chain management of controlled substance clinical supplies is a growing service area, so we are also progressing the supply chain management aspect via our global distribution depot network.”
The Northern Ireland-headquartered firm has been moving into the Souderton facility in a phased transition program that began last September with the installation of its analytical testing and clinical supplies units.
Since then Almac has opened a clinical technologies unit, which runs the firms trial monitoring and reporting technology business, and a pharmacy and distribution warehouse.
And, just last month, the contract research organization (CRO) announced that the Souderton, Pennsylvania facility’s contract analytical laboratories had been made operational.
Packaging, storage and distribution of schedule I – V controlled substance is now a fully functional capability of Almac’s new North American Headquarters facility in Souderton PA. As the phased transition nears its end, the portfolio of services and capacity offered to customers continues to grow as a result of the $120 million investment.
Storage for controlled materials is located in a highly secured temperature monitored cage and vault. Both locations meet DEA requirements in addition to providing substantially greater capacity. The total 3,980 square feet of storage space comes as a response to demand expressed by both the industry and existing clients. This, as well as expansive growth in areas of storage for ambient, refrigerated and frozen products, is part of Almac’s ongoing mission to ensure drugs get to market faster.
The Almac Group provides a range of services from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply and IXRS technology (IVRS/IWRS), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors.
The company employs more 3000 individuals and is headquartered in Craigavon, Northern Ireland. U.S. operations are based in Pennsylvania, North Carolina and California. Almac has now moved into its new $120m North American Headquarters located in Souderton, PA.
Advion BioServices plans to open a 22,000-sq.-ft. drug discovery bioanalytical lab in the Purdue Research Park in Indianapolis. The lab is expected to be fully operational by the end of May 2011.
Advion’s primary focus is to provide high-quality, later stage bioanalytical drug development services as required by global regulatory agencies, including the FDA. The new Indianapolis facility will focus on the earlier stage, drug discovery bioanalytical services, evaluating how a potential drug is absorbed and metabolized in experimental models. Many of these services are data-generation activities required for clinical testing preparation.
Advion has also entered into a new, multi-year contract with Lilly to provide a variety of these services to be conducted at the new facility. As part of the agreement, Lilly will transition its drug discovery bioanalytical capability to Advion. All Lilly employees impacted will have the opportunity to join Advion. Financial terms were not disclosed.
“Drug discovery bioanalytical services in Indianapolis are a strategic complement to the regulated drug development bioanalytical services in our Ithaca, NY and Manassas, VA laboratories. Advion has always upheld the highest standards of scientific rigor and looks forward to establishing a center-of-excellence for discovery bioanalytical services in Indianapolis,” said Tom Kurz, president of Advion BioServices, Inc.
Locating its new laboratory in Indianapolis, near to the Lilly headquarters, will help forge a closer relationship with the big pharma. Hiring former Lilly employees could also strengthen ties.
Expansion into the state was supported by the Indiana Economic Development Corporation (IEDC) which streamlined many steps in setting up the laboratory. BioCrossroads, an Indiana investment initiative, also provided assistance.
Opening the laboratory expands the portfolio of early-stage services offered by Advion. Adding drug absorption and metabolism services will support clients looking to generate data to progress molecules into clinical trials.
After a molecule progresses into clinical trials Advion can support development from its site in Ithaca, New York. The Ithaca site provides late-stage bioanalytical services to support regulatory filings.
AndersonBrecon Clinical Services, the clinical packaging, storage and distribution services business of AmerisourceBergen Packaging Group, has opened a new clinical services facility with packaging operations at Rockford, Illinois.
The facility will serve North and South America and complements AmerisourceBergen’s UK subsidiary Brecon Pharmaceuticals.
The new clinical services facility, which will employ about 20 people, will provide on-site packaging, storage and distribution for investigational products. Lab services include analytical development and testing, and stability studies. The new site will also offer on-site label printing, including randomization generation and multi-language booklets.
The new site includes dedicated primary and secondary packaging areas. Primary packaging suites feature class 100M/ISO 8 level cleanrooms, which will carry out over-encapsulation of study and comparator drug product, placebo capsule manufacturing and packaging of solid oral doses and powders in pouches, bottles, and blisters.
The secondary packaging suites can be interconnected for scalable and multi-stage operations. Capabilities include child resistant blister carding, secondary labeling including parenterals and injectibles, as well as kit assembly of varying delivery forms.
‘The new clinical services site in Rockford is well positioned, allowing us to provide our domestic and global customers support services and scalable packaging operations for each stage of the drug development process in both the Americas and Europe,’ said Bob Misher, general manager and senior vice president, AndersonBrecon Clinical Services.
‘We have capabilities for small scale Phase I studies all the way through to large scale Phase III and post-marketing Phase IV studies. Our global teams collaborate for successful study execution, filing, approval and product launch, with a seamless transition to ongoing supply. Our goal is provide our customers full support for the development and commercialization of their product.’
Duke Realty is teaming up with WakeMed Health & Hospitals to develop the 90,000-square-foot first phase of an ambulatory surgery center and Class A medical office building on the health system’s flagship campus in Raleigh, NC.
Plans are still being finalized for the WakeMed Medical Park on the health system’s flagship campus located on New Bern Avenue near downtown Raleigh, but it is anticipated that the first phase will provide nearly 90,000 square feet of outpatient space on three levels. Duke will finance, develop, own, lease and manage the building, which will be built on a 7.84-acre site leased from WakeMed.
Raleigh-based WakeMed Health & Hospitals is Wake County’s largest healthcare provider. Indianapolis-based Duke is the largest single owner of office and industrial space in the Triangle market., Duke Realty’s healthcare division, formerly known as BremnerDuke, was created by Duke's February 2007 acquisition of Bremner Healthcare.
The medical park will be anchored by a 30,000-square foot ambulatory surgery center with eight operating rooms and three procedure rooms, an imaging center, a laboratory and a pre-admission testing suite. It will also include the only Class A medical office space on WakeMed’s Raleigh Campus.
Construction is scheduled to begin this month, targeting a May 2012 completion. The architect is the Raleigh office of Chicago-based Perkins+Will Inc. and the general contractor is the Raleigh office of Birmingham, Ala.-based Brasfield & Gorrie LLC.
Tom Pisula Development will break ground in April on the new St. Luke’s Medical Arts Center III (MACIII) medical office building on the campus of St. Luke’s The Woodlands Hospital in Houston. The building is targeted for Leadership In Energy and Environmental Design (LEED) Silver certification.
Leasing has already begun for the four-story, 100,000-square-foot building to be constructed at the southern part of St. Luke's campus along St. Luke’s Way. The building was designed by Browne McGregor Architects.
Tom Pisula Development built The Woodlands’ first LEED-certified medical office building in 2009 at 1111 Medical Plaza Drive as well as several other office buildings in the Greater Northwest/North Houston and Tomball areas.
Four contract packaging and repackaging companies in the pharmaceutical industry have joined forces to create a new, single-source service provider, Aphena Pharma Solutions.
Aphena is a new corporation based on a strategic alliance among Celeste Contract Packaging, PrePak Systems, TestPak, and Integrated Pharmaceutical Packaging.
“We are excited to announce our new parent company, Aphena Pharma Solutions,” says Renard Jackson, president and CEO of Aphena Pharma Solutions. “Through each company’s individual efforts, we’ve offered our clients the best services and products. Now we are poised to offer more products and even better service with an extreme level of single-source efficiency.”
Celeste Contract Packaging (Easton, MD) will become the new liquid and topical division of Aphena Pharma Solutions. It specializes in manufacturing and contract packaging of liquid and topical products in flexible packets, bottles, blisters, and tubes.
PrePak Systems (Cookeville, TN), TestPak (Whippany, NJ), and Integrated Pharmaceutical Packaging will make up the solid dose division of Aphena Pharma Solutions, offering turnkey contract packaging and repackaging for the pharmaceutical, OTC, nutraceutical, animal health, and consumer product markets. Four locations offer low- and high-volume bottle filling, blister packaging (cold and thermoforming), custom pouching, compliance packaging, unit dosing and unit-of-use packaging, kitting, and secondary packaging for solid-dose products.
“Aphena Pharma Solutions will be completely focused on client expectations and success,” Jackson adds. “This is a new and exciting opportunity that is perfectly timed for the changes occurring in the marketplace.”
VaxInnate Corporation announced that it has been awarded a contract by the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services (HHS), worth up to $196 million to fund the development of recombinant seasonal and pandemic flu vaccines. VaxInnate is a biotechnology firm pioneering breakthrough technology for use in developing novel vaccines.
The contract initially provides funding of $118 million for a base period of 36 months, with an option to extend for 24 months. The contract is effective on February 24, 2011.
"We're pleased and gratified to receive this award and look forward to working with BARDA to develop the next generation of vaccines for the prevention of seasonal and pandemic flu," said Thomas Hofstaetter, PhD, President and CEO of VaxInnate. "The contract is an endorsement of VaxInnate's proprietary technology, which makes it possible to produce hundreds of millions of doses of safe, effective flu vaccine rapidly and at low cost. It also demonstrates the potential of our technology to meet other critical and emerging public health threats in the future." Initial clinical trials will evaluate the components and combinations of what will ultimately be several different pandemic flu vaccines and a seasonal quadravalent flu vaccine, produced using VaxInnate's proprietary technology. The technology involves genetically fusing vaccine antigens to the bacterial protein flagellin, a potent stimulator of the innate immune system.
VaxInnate has already completed a series of Phase I/II trials using VAX 125 and VAX128, prototype vaccines for both seasonal and pandemic Type A1 flu vaccines. The most recent trial assessed the safety and immunogenicity of three different forms of the VAX128 vaccine in several hundred healthy adults aged 18-49 and more than 100 community-living adults 65 years of age in the United States. VAX128 was demonstrated to be highly immunogenic at low doses (1-2.5 ‥g) and well tolerated up to 20-‥g doses.
Further, the trial confirmed the safety and efficacy of the vaccine forms in elderly subjects, who are less responsive to flu vaccines due to the effects of aging on the immune system. People aged 65 and older, a population segment that is growing rapidly as baby-boomers age, suffer disproportionately from seasonal flu and its complications.
Ending two years of speculation about the fate of the former Schering-Plough headquarters in Kenilworth, N.J., Merck & Co. has announced plans to convert the site to a biologics research hub as part of a $120 million project.
Merck, which acquired Schering-Plough in 2009, says the shift will begin this year. It will involve the transfer of approximately 350 employees focused on bioprocess and bioanalytic research from Merck's other New Jersey laboratories in Summit, Union, and Rahway to Kenilworth.
Meanwhile, existing pharmaceutical chemical manufacturing and drug and healthcare packaging operations in Kenilworth will be transferred to other Merck locations over the next 12 to 18 months, leading to the elimination of approximately 580 manufacturing positions at the site.
The decision to convert the Kenilworth facility to a biologics R&D hub was based on the range of research already taking place in Kenilworth in discovery and preclinical development, according to Merck spokesman David Caouette. Kenilworth will operate separately from the company's generic biologics division, which has facilities in Palo Alto, Calif., and Boulder, Colo. Merck plans to add about 100,000 sq. ft. of research and office space to the Kenilworth site.
Packaging operations for pharmaceuticals and consumer goods will be moved to company facilities in Wilson, N.C.; Cleveland, Tenn.; Montreal; and Singapore. Merck will also relocate some small-molecule drug manufacturing to other New Jersey sites, though Kenilworth will maintain pilot-scale small-molecule production.
Approximately 900 office jobs in Kenilworth will be relocated, primarily to the company's Whitehouse Station, N.J., headquarters, Merck says. With the changes, Merck will maintain a workforce of 12,000 employees in the state.
Paragon Medical announced the official opening of its new Bioskills Lab at its headquarters in Pierceton, Indiana. Company management and employees were joined at a ribbon cutting on January 19, 2011 by the Warsaw / Kosciusko Chamber of Commerce and other local officials to commemorate this important event for the company and the community.
In December 2009, Paragon announced that through its Orthopaedic Instrument Global Design Center (OIGDC), it would accelerate the construction of this new lab in direct support of OrthoWorx, a Warsaw-based industry, community and education initiative established to advance and support growth and innovation within the region’s globally significant orthopaedics device sector.
The fully staffed facility is ready for client scheduling and includes capacity for up to four cadaveric evaluation stations and targets the comfort of lab attendees through ergonomic tables, laminar airflow, separate temperature zones, and a private conference room with a viewing window into the lab. A multitude of other services are available upon request including specimen procurement and preparation, instrument cleanup in a state of the art instrument disinfection system, C-Arm and Arthroscopy Tower rentals, audio-visual connectivity, and full catering capabilities.
According to Van Flamion, Director of the Bioskills Lab and Paragon’s OIGDC, "The lab was designed and constructed for the sole purpose of providing our customers a convenient, cost effective, full service facility where orthopedic and other medical device companies can perform cadaveric studies on their products and / or train their surgeons or field representatives on surgical techniques pertaining to their products".
Mr. Flamion also commented that a soft launch phase was conducted with a limited and controlled number of labs during the fourth quarter of 2010. The Bioskills Lab exercised its logistics as a full service facility while gathering critical customer feedback to ensure optimization prior to going to its now full-launch status.
DDL, a provider of package and product testing services, is expanding its testing facility in Edison, NJ. The company has recently increased its testing capabilities for thermal performance testing and conditioning for thermal testing.
Chamber space at DDL East now includes:
1200-cu-ft walk-in chamber, capable of up to 6 pallets, with a temperature of 5°C.
1200 cu-ft walk-in chamber, capable of up to 6 pallets, with a temperature range of 30 to 50°C for development projects.
Two 400 cu-ft chambers with temperature ranges of -40 to 60°C.
"With the addition of four new temperature chambers at the facility, we will be able to better serve the needs of all our current and new customers for testing projects across the industry," says Peter Johnson, packaging engineer at DDL East. "We also added two Kaye KL 32 Channel Validators calibrated to 0.25°C and 40 remote data loggers calibrated to 0.25°C, which will provide accurate results, with a high degree of sensitivity, when evaluating thermal/temperature-controlled packaging."
DDL has also begun the process of becoming an ISTA 7E certified lab. The new standard for thermal transport testing includes new protocols and standardized processes.
"We have continued to see a need for services in the thermal testing industry and our expansion efforts are allowing us to continually provide the expertise that our clients are looking for," Johnson adds.
Gov. Mark Dayton and U.S. Sen. Al Franken are praising a biotechnology company that plans to expand in Coon Rapids, Minn., with state and city help.
Biovest plans to start manufacturing a cancer vaccine for non-Hodgkin's lymphoma, adding 14 skilled jobs in Minnesota within two years. Company President Samuel Duffey says the expansion eventually could lead to hundreds of new jobs here.
The Tampa-based company is getting a $250,000 loan from the state Department of Employment and Economic Development and a $100,000 loan from the Coon Rapids Housing and Redevelopment Authority, plus privately financed improvements to the building it leases.
The nation's premier research agency plans to open a new center this fall to spur creation of medications because of concern that exciting discoveries aren't being turned into treatments fast enough.
The plan is on track despite the increasingly likely prospect of budget cuts for the venerable National Institutes of Health, agency chief Dr. Francis Collins said.
The idea: Do more of the risky early-stage research into promising compounds that drug companies are increasingly reluctant to invest in. It's a period called "the valley of death" because so many of those early experiments fail.
"The valley of death needs to become a valley that leads to life," Collins told reporters. "The time is right even in a difficult budget environment, maybe especially in a difficult budget environment."
That kind of drug-related research isn't new for the NIH. The cancer drug taxol and AIDS drug AZT, for example, originated from NIH work, Collins noted, and agency researchers have 550 projects under way devoted to various medications, vaccines or medical devices. He cited recent research that found 20 percent of innovative new medications that hit the market in recent years originated from NIH-funded research — as the drug industry's own research productivity has declined.
The National Center for Advancing Translational Sciences would bring much of NIH's current drug development research — about $700 million worth, from a $30 billion budget — under one roof so scientists could better collaborate, Collins said. It also will explore new techniques to predict, for instance, which experimental medications will be safe enough to test in people faster than is done today.
"This is not an effort to turn NIH into a drug-development company," Collins stressed. "The idea is to ... move projects just far enough along for them to be attractive to commercial investment."
The plan has drawn some objections by researchers and others concerned about the dismantling of another NIH center at the same time, projects that Collins said will be taken over by other parts of the agency.
But some high-profile patient advocacy groups are praising the change. Fewer than 200 of 7,000 rare diseases have an available therapy, said James O'Leary of the Genetic Alliance.
"That's just too slow," he said. "This translational medicine focus is critical to the mission of NIH."
The Bethesda, Md.-based NIH plans to open the center Oct. 1.
NSF International’s acquisition of Connecticut-based contract laboratory Pharmalytica Services will allow the company to deliver of a wider range of health science services to the dietary supplements, biotech, pharmaceutical and medical device industries, it claims.
The acquisition will help deliver of a wider range of health science services for dietary supplements
Incorporated into the parent company’s Health Sciences Division, NSF Pharmalytica will operate mainly as a contract laboratory focusing on Good Laboratory Practice (GLP) and Good Manufacturing Practices (GMP).
Lori Bestervelt, the company’s senior vice president and chief scientific officer said: “NSF Pharamlytica will provide GMP/GLP analytical testing, specializing in extractables and leachables testing, method development and validation, and bioanalysis.”
Other services will include training and research and development. “NSF Pharmalytica offers expert consulting and training in many areas, such as, GLP/GMP compliance, meeting CMC regulatory submission requirements, equipment qualification, process safety and facility audits,” said a company statement.
Bestervelt said: “Combining Pharmalytica’s knowledge in pharmaceutical analytical testing and R&D with NSF International’s existing portfolio of dietary supplement and pharma solutions will help pharmaceutical companies worldwide make informed decisions when developing new products and strategies.”
As the global dietary supplement and pharmaceutical markets continue to grow, demand for such services will also rise, he added.
The company has developed the only American National Standard for Dietary Supplements (NSF/ANSI Standard 173) and certifies dietary supplements to this standard to verify label claims. It also conducts tests to ensure that a product is free of undeclared substances and unacceptable levels of contaminants.
NSF Pharmalytica laboratories are GMP and GLP compliant, are Food and Drug Administration (FDA) registered and inspected and Drug Enforcement Agency (DEA) licensed to handle, store and test Controlled Substances (Schedule I thru V).
Meanwhile, last month NSF International helped create a new voluntary Stability Testing Guideline for supplement manufacturers to ensure they have the necessary data to support expiration dating on product labels.
Current federal regulations and dietary supplement GMPs do not require expiration dating for nutritional supplements. But nearly all dietary supplement products voluntarily use an expiration date on their labels.
Glatt Pharmaceutical Services has added new commercial scale cGMP contract manufacturing capacity at its 86,000-sq.-ft. facility in NJ for tablet and capsule production. Added production capabilities include: high shear wet and fluid bed granulating/drying, tablet compression and pan coating, Wurster HS pelletizing and coating, CPS technology direct pelletizing, oven tray drying/curing, blending, milling, sieving and QC. Additional capabilities include organic solvent or aqueous and DEA controlled substance (CII – CV).
“We've made this investment in commercial scale operations in order to provide our clients the speed-to-market and high quality standards demanded in today’s competitive market,” said Oliver Mueller, executive vice president business development, Glatt Pharmaceutical Services.
Six pharmaceutical manufacturing facilities constructed in Germany, Switzerland, Sweden, and the U.S. have been selected as Category Winners in the seventh annual Facility of the Year Awards (FOYA) program sponsored by ISPE, INTERPHEX, and Pharmaceutical Processing magazine. A seventh facility was selected to receive an Honorable Mention. The winning companies and respective award categories are:
F. Hoffman – La Roche Ltd, winner of the Facility of the Year Award for Process Innovation for its “MyDose” Clinical Supply facility in Kaiseraugst, Switzerland.
MedImmune, LLC, winner of the Facility of the Year Award for Project Execution for its Frederick Manufacturing Center (FMC) Expansion facility in Frederick, Maryland, USA.
Merck and Company, Inc., winner of the Facility of the Year Award for Facility Integration for its Global Clinical Supplies Manufacturing, Packaging and Warehouse expansion project in Summit, New Jersey, USA.
Novartis Vaccines and Diagnostics GmbH, winner of the Facility of the Year Award for Equipment Innovation for its “MARS Project” (Marburg Site) facility in Marburg, Germany .
Pfizer Health AB, winner of the Facility of the Year Award for Operational Excellence for its Project Pegasus – Bio 7 Manufacturing facility in Strängnäs, Sweden.
Pfizer Manufacturing Deutschland GmbH, winner of the Facility of the Year Award for Sustainability for its SPRING & E-MAP (Strategic Plant Restructuring & Energy Master Plan) project in Freiburg, Germany.
Shire HGT, Facility of the Year Award Honorable Mention for its Project Atlas, Building 400 facility in Lexington, Massachusetts, USA.
The Facility of the Year Awards program recognizes state-of-the-art pharmaceutical manufacturing projects that utilize new and innovative technologies to enhance the delivery of a quality project, as well as reduce the cost of producing high-quality medicines. Now in its seventh year, the awards program effectively spotlights the accomplishments, shared commitment, and dedication of individuals in companies worldwide to innovate and advance pharmaceutical manufacturing technology for the benefit of all global consumers.
The Facility of the Year Awards program is truly global, as submissions over the past seven years have been received from more than 25 different countries and territories. Each of the submissions was reviewed by an independent, blue-ribbon judging panel consisting of global senior-level executives from all aspects of the industry.
AxFlow UK has created a cleanroom facility at its Huddersfield-based maintenance facility for the service and repair of pumps for hygienic applications. The cleanroom has been designed and equipped under the guidance of process engineers from one of Europe’s leading chocolate and confectionery producers and is fully compliant with EHEDG requirements.
The introduction of the clean room is the latest addition to the range of services available from AxFlow’s pump maintenance facility in Huddersfield. According to AxFlow’s Service Base Manager Tom Cooper, every effort has been made to ensure that the requirements of its customers in the food processing industry have been addressed. The room is fitted with a clean air supply with Grade I air filter for static pressure testing and a specialist lifting rig.
“Having a clean room facility for undertaking the cleaning of pumps and their final build has been on the agenda for some time,” says Tom Cooper. “It is a facility that several prospective customers had requested, so in order to capitalize on this business opportunity we requested the assistance of process engineers from one of Europe’s leading confectionery manufacturers to advise us on the design and fitting out of the room. Their hands-on support throughout the whole project was greatly appreciated and as a result, we have secured aspects of their pump maintenance work.
In the food and beverage industries it is a basic requirement pumps must be compliant with EHEDG, FDA and 3A regulations. When taken out of service for general maintenance, replacement of worn components and repair, the same regulations apply to the work undertaken and the testing prior to service re-entry. For those food processing companies that do not have a pump maintenance resource in house, or are unable to go back to the original equipment supplier when maintenance and repairs are needed, the facilities of a company such as those now available from AxFlow are of great significance.
A $100M biological research facility was designed to promote public and animal health through infectious disease detection and epidemiological surveillance.
Andrew Weber, the U.S. assistant secretary of defense for nuclear, chemical, and biological defense programs, Georgian PM Nika Gilauri and U.S. Ambassador to Georgia, John Bass, were among the officials present at the inauguration of Central Public Health Reference Laboratory (CPHRL) close to the Tbilisi airport.
“What we are trying to do is to fill in some of the gaps around the world to give us a better global picture of the trends and ways in which diseases crop up and threaten,” Ambassador Bass says.
“Many did not believe that this project would have been accomplished… There have been lots of debates, including at government sessions, but eventually we have this amazing laboratory. This is more than just $100 million investment; this is a genuine expression of strategic partnership [between Georgia and the U.S.]. The United States selected Georgia for construction of such strategic laboratory,” Georgian PM Gilauri says.
CPHRL, located on 8,000 sq. meters (86,000 sq. ft.) with about 2,500 sq. meters (26,900 sq. ft.) of laboratory space, is staffed by the Georgian and U.S. personnel. Anna Zhvania is the CPHRL director. She held various senior positions in the Georgian government in the past and was chief of intelligence service for sixteen months till February, 2008.
According to the U.S. embassy the state-of-the art joint U.S.-Georgian laboratory will complement existing health research facilities in Bangkok, Thailand and Nairobi, Kenya, which serve to improving public health in their respective regions and the CPHRL in Georgia will perform a similar mission for the Caucasus region.
A board of governors with representatives from Georgian government and the U.S., as well as from international organizations will be in charge of the laboratory’s research agenda, according to CPHRL.
Officials say the lab will not be used to conduct any biological weapons research.
A new cancer research center that will emphasize science that delves into the molecular and genetic underpinnings of the disease was launched in Oxford, Cancer Research UK (CRUK) said.
The Oxford Cancer Research Centre, a partnership between CRUK, the University of Oxford, and the Oxford Radcliffe Hospitals NHS Trust, will receive £2.8 million ($4.5 million) in funding from CRUK in its first year.
The center will conduct research into the molecular basis of cancer, lead studies on the genetic and lifestyle factors that increase the risk of cancer, will discover biomarkers for predicting drug responses, and seek to improve cancer diagnostic technologies.
"The center will help bring together the extensive community of outstanding cancer researchers in Oxford, acting as a nucleus for researchers, doctors, and patients to engage with each other," University of Oxford's Alastair Buchan, head of the school's medical science division, said in a statement. "It will ensure optimal translation of fundamental research into patient benefit, and will train the next generation of world-leaders in cancer detection, treatment, and prevention."
The Oxford center is the sixteenth cancer center funded by CRUK, the non-profit organization said.
"Funding these centers of excellence is one of the charity's priorities and will enable us to work towards the goals we have set to improve the treatment and survival of cancer patients across all types of cancer," CRUK CEO Harpal Kumar said.
PROLOR Biotech, Inc. is relocating its corporate office and R&D facility to a new, larger building located near its current site in the Weizmann Science Park in Nes Ziona, Israel.
The new headquarters and upgraded R&D facility comprise approximately 10,000 sq. ft. of leased space, allowing for growth in all areas, including new drug research and clinical development. The expanded R&D facility includes cleanrooms for GMP-grade production of therapeutic drug candidates for the production of a variety of therapeutic proteins for R&D applications.
“We are excited that this move gives us the opportunity to upgrade our R&D facility, allowing for the planned expansion in R&D headcount and activity needed to accomplish the ambitious goals we have set for our clinical development and research programs in 2011 and 2012,” said Shai Novik, president of PROLOR. “This new facility makes it possible for us to strengthen our capabilities across the board, and we intend to leverage it fully to help accomplish our stated milestones.”
Tetra Pak has opened a new €92m packaging factory in Pakistan to serve the booming juice and dairy market in the country.
The carton packaging specialist is describing the new Lahore plant as its biggest factory in the Middle East.
It announced the opening just a month after investing €100m in a new factory in neighboring India. The expanding middle class in both countries is the target for Tetra Pak and its customers.
Although the Pakistani economy has begun to falter since the global financial crisis, it has delivered consistently strong growth over the decade from 2000, swelling the number of middle income households.
“More urban and young consumers as well as an emerging middle class are transforming the food and beverage industry in Pakistan, demanding new, safer and more convenient products,” said Azhar Ali Syed, managing director of Tetra Pak Pakistan.
In concrete terms, this has prompted healthy double digit growth in the market for packaged milk and soft drinks. According to Tetra Pak, demand for dairy beverages over the past six years grew at a 15 per cent compound annual growth rate (CAGR) and juice, nectars and still drinks grew 16 per cent.
The new factory in Lahore is spread over 150,000 meters and has an initial production capacity to produce eight billion packages.
Tetra Pak has built the site in anticipation of the need to expand production to meet future demand; production capacity can potentially be doubled to 16 billion packages.
The factory will focus on the domestic Pakistani market but it will also export to neighboring countries in the Middle East. Initially Tetra Brik Aseptic, Tetra Fino Aseptic and Tetra Classic Aseptic will be produced there but Tetra Pak said the factory has the facilities to produce “many new products”.
China-based contract research organization ShangPharma Corporation launched phase one of a new pharmaceutical development and cGMP manufacturing facility on 14 January 2011.
Located in the Fengxian Industrial Park within the suburbs of Shanghai, the new facility is named China Gateway Pharmaceutical Development Co. It will operate as a wholly owned subsidiary of ShangPharma.
The facility is being built in two phases in a site located in the Zhagjiang Hi-Tech Park, immediately next to the company's subsidiary Shanghai ChemPartner. Construction of phase one required an investment of over $15m. Construction of Phase II is expected to be completed by late 2011 or by early 2012.
The new facility will enable ShangPharma to expand its service portfolio to include process research and development, large scale synthesis, formulation research and development, analytical method development and validation, and cGMP manufacturing of intermediates and APIs for preclinical testing and clinical trials.
ShangPharma plans to construct additional manufacturing facilities extending up to 43,000m² (462,680 sq. ft.) depending on the rise in demand for FDA or EMEA-approved drugs.
The multi-functional facility will comprise a total area of 460,000ft². It has added substantial capacity to the current chemical development and API manufacturing capabilities of the company.
It will have facilities for testing raw materials, intermediates and final products. A separate quality assurance department will ensure that the output quality meets established cGMP standards and manufacturing is carried out following the standard operating procedures.
Additional space is available for further expansions to support any increase in commercial manufacturing activities.
Phase I of the Fengxian facility is spread over 200,000ft². It accommodates two Class 100,000 clean room suites dedicated for isolation and 10 kilo-lab suites meant for non-cGMP as well as cGMP manufacturing.
It also houses a pilot plant with six independent bays. Each bay is equipped with reactor capacities ranging from 200l to 3,000l. Special bays within the facility are installed with reactors ranging from 50l to 2,000l. The reactors will be used for high temperature, cryogenics, highly toxic and pressurized reactions, including hydrogenation.
Other sections include independent buildings for utilities, materials management, warehouse storage and waste water treatment. A dedicated area is available for analytical support. A large research and development laboratory is provided for analytical, formulation and process development operations.
Phase II, covering approximately 260,000ft², will house a cGMP-compliant API plant and a formulation pilot plant.
ShangPharma has so far only handled projects that required provision of materials from early discovery phases to GLP toxicology and Phase I clinical studies. The new state-of-the-art facility will enable it to undertake commercial manufacturing of intermediates and APIs to support projects up to Phase II and Phase III development.
The infrastructure in Phase I will be used to undertake production of APIs and advanced intermediates, supporting projects in the preclinical testing and early-phase clinical trials. The infrastructure in Phase II will be used primarily for the production of APIs for late-phase clinical trials and drugs that will potentially be FDA-approved.
Phase I was financed through internal funds and proceeds from unused bank credit facilities of ShangPharma. The funds include $15m raised through an $87m IPO, announced in 2010, on the New York Stock Exchange. Phase II will utilize the company's proceeds from IPO offering, cash flow from operations and bank loans.
Headquartered in Shanghai, ShangPharma now manages four facilities in the region, including two in the Zhangjiang Hi-Tech Park, a 36,000ft² R&D facility in Chengdu and a 28,000ft² manufacturing plant in Nanhui.
A 150,000ft² laboratory services facility is also under construction in Fengxian, Shanghai. Scheduled for completion in 2011, it will be used primarily for pharmaceutical development services.
Food giant Nestlé has opened a new food science lab in mainland China as it extends the activity of its Beijing-based Nestlé Research Center (NRC).
The new facility is a partnership with Xi’an Jiaotong University’s School of Life Science and Technology which is based in the city of Xi’an and is the latest of a series of university tie-ins Nestlé has established since it opened its first Chinese research and development centre in Shanghai in 2001.
“The new laboratory partnership with Xi’an Jiaotong University strengthens Nestlé’s scientific commitment to China, which already includes a number of research collaborations with 14 different Chinese scientific institutions,” the company said.
It will focus on researching links between nutrition and traditional Chinese ingredients and “metabolic health” issues such as obesity and diabetes.
“This new endeavor will enable our scientists to work alongside academic scientists and students from the university to help develop nutritional solutions for metabolic health issues such as diabetes,” said Peter van Bladeren, Nestlé science and research director.
"It will allow us to continue working with the scientific community to share expertise and to really understand consumers’ needs.”
Nestlé sells seven million products per day in China, of which 90 per cent are manufactured locally.
Its Chinese R&D operations are part of its global research network whose headquarters is the Nestlé Research Centre at its Lausanne, Switzerland, base.
In its recent annual meeting the company’s management stated its goal to expand into developing markets and it is throwing a lot of capital at Africa with projects planned in Kenya, Mozambique, Democratic Republic of Congo, Angola and Zimbabwe this year.
WR Grace and Co has set up a new services centre in India’s “Genome Valley” near Hyderabad to cater for the country’s rapidly expanding pharmaceutical and biotech industries.
The unit, Grace Davison Discovery Sciences, will house capabilities for separations, bulk purification and excipient and pharmaceutical intermediate production and is intended to serve both local customers and those in the wider Asia Pacific region.
The centre is one of a number of new facilities Grace has opened in the last year, including its facilities in Chongqing, China and Hai Duong, Vietnam. In addition, at the end of 2010 the firm expanded operations in Sorocaba, Brazil and Kuantan, Malaysia.
The firm also bought US group Synthetech in September last year to bolster its capabilities in the area of chiral chemistry.
API maker IPCA Laboratories has received UK MHRA approval for its formulations and production unit in Indore, India.
Production operations at the facility, which are focused on active pharmaceutical ingredients (APIs), were deemed to meet good manufacturing practice (GMP) standard following an inspection by the Medicines and Healthcare Products Regulatory Agency's (MHRA).
IPCA told the Hindu Business line that the Indore site, which is in one of the country’s special economic zones (SEZ), “It is the fourth manufacturing unit of the company to have received such approval from UK MHRA.”
Medtronic, Inc., the global medical technology leader, announced the official opening of its new manufacturing facility, Medtronic Singapore Operations (MSO). The facility will enhance the company's manufacturing capabilities to meet the future expected growth of cardiac devices in Asia.
The Cardiac Rhythm Disease Management business at Medtronic accounted for US$5.2 billion of the company’s revenue in the 2010 Financial Year. By the end of 2011, Medtronic will have invested over US$56 million to the development of its MSO to meet the rising demand in Asia. As of November 2011, Singapore will also serve as the distribution hub for the Asia-Pacific region.
As an innovative industry leader that uses technology to transform the way debilitating, chronic diseases are treated, Medtronic opened last year in Singapore the Bakken Education Center, to help employees and customers gain hands-on experience with the latest technologies. In addition to the manufacturing facility, MSO will also serve as the Asia headquarters, International headquarters and ASEAN headquarters as well as the center for Singapore sales operations. The Singapore-based office will also house the heads of departments leading the Manufacturing team, International Leadership team, ASEAN Leadership team and Emerging Countries Business Development team.
The Medtronic Singapore Operations is added on to Medtronic's stable of more than 250 manufacturing facilities, sales offices, research centers, education centers and administration facilities which serve customers and patients in 120 countries.
GSK has invested in a new manufacturing plant in Sri Lanka for the production of its over-the-counter (OTC) painkiller Panadol.
The INR200m ($4m) facility in south western city of Moratuwa will house both laboratory space and production lines and, when operational early next year, will manufacture almost 2bn tablets a year.
UK-based drug major GlaxoSmithKline (GSK), which sells around 70m packs of Panadol in Sri Lanka every year, said that the investment would roughly double production capacity.
The investment fits with the general trend that has seen GSK and its Pharma rivals AstraZeneca, Bayer, Abbott and Novartis boost manufacturing capacity in emerging markets as a means of sustaining revenues ahead of patent expiry in mature markets.
More specifically, the new Moratuwa plant is in keeping with GSK’s expansion in Sri Lanka in the last few years, beginning with its acquisition of skin care specialist Steifel Laboratories in 2009 .
This acquisition provided GSK with a 23 per centre share of Sri Lanka’s skin care market according to analysis by Trading Markets.com
More recently, GSK acquired rights to sell a number of Bristol-Myers Squibb prescription drug products in the country.
Stuart Chapman, MD of GSK Pharmaceuticals in Sri Lanka told the paper that: “The partnership between GalxoSmithKline and Bristol Myers Squibb, two leading and innovative pharmaceuticals companies committed to excellence, will generate many new opportunities."
Bristol-Myers Squibb Company and WuXi PharmaTech announced that they have entered a strategic partnership to conduct stability studies of small-molecule new chemical entities to support global marketing applications.
Under the agreement, WuXi will build, equip and operate a dedicated, fully cGMP-compliant 25,000-square-foot analytical testing facility in Shanghai to store and test stability samples and to perform other services for Bristol-Myers Squibb. WuXi will also employ a dedicated staff for stability testing, sample management, analytical testing, pharmaceutical science, quality assurance, metrology, and other services, including stability data reporting in support of all global dossier submissions by Bristol-Myers Squibb.
"This new agreement expands our already productive relationship with Bristol-Myers Squibb, a valued customer for many years,” said Ge Li, Ph.D., chairman and chief executive officer of WuXi PharmaTech. “We will continue to help them to improve their R&D productivity with our innovation-driven, cost-effective and fully integrated R&D service platform.”
A one-stop solution for all medical and health needs - from doctors, hospitals, ayurveda centers, pharmacies and even insurance referral units - will open in a 10-storied mall in this Kerala city. The BCG group, a 500 crore business conglomerate, is building the country`s first multidisciplinary health mall here and it will be open by August, a company official said.
Spread over 110,000 square feet, the mall will include retail stores dealing with pharmacy, optical ware, skin care products, cosmetics, ayurvedic, herbal, organic, health foods, health and medical equipment, said Rekha C. Babu, CEO of BCG Group.
A separate floor will be for allied services where medical colleges, hospitals, ayurvedic centers and insurance companies can set up their referral centers. `Medical colleges that want to inform students about its facilities or a hospital which wants to educate people on latest treatment procedures can also use this space,` she said.
The fourth and fifth floors will have wellness clinics and rejuvenation centers. "Six more multiple malls under the brand name BCG Health Square will come up across the state in the next five years. Such health malls are found in Singapore, Malaysia, the US and Europe," she added.
The BCG Health Square will have 44 rooms in the sixth and seventh floors and private clinics on the eighth, ninth and 10th floors. These spaces can accommodate doctors who want to set up their own independent practices with the option of utilizing centralized services like patient management desk, secretarial assistance and call monitoring managed by the company, she said.
There will also be adequate parking space. The BCG Group was founded by Babu C. George in 1980 and forayed into real estate business in 2003. The company has developed more than 8.5 million square feet of commercial and residential projects across Kerala, a company statement said. The group has also diversified into education and healthcare sectors, it said.
CSM GlobalPharma has announced plans to invest $65m in a manufacturing facility in Kigali, Rwanda in collaboration with the Rwandan Development Board (RDB).
The firm, which is owned by India’s Cadila Pharmaceutical and the US based Holtzman group, said it will invest $64m (€46m) in the plant, which will produce a range of dosage forms for the local market when fully operational in 2015.
The plant will also make active pharmaceutical ingredients (APIs) and, in time, biologic drugs, injectables and vaccines to cater for the region’s rapidly expanding market.
According to the RDB the new plant will “help Rwanda achieve independence from most pharmaceutical imports by manufacturing high quality products in-country for sale at competitive prices.”
Cadila already has a number of manufacturing interests in Africa including the joint-venture Cadila Pharmaceuticals Ethiopia (CDEL) that it set up in partnership with local manufacturing firm Almeta Impex.
The Ethiopia plant, which produces 390 million tablets, 165 million capsules and 1.44 million liters of liquid pharmaceuticals each year, contributed about INR200m ($4.4m) to Cadila’s revenue in 2010.
The Indian drugmaker, which makes its own products and provides contract manufacturing for APIs and intermediates, also owns South Africa firm Simayla Pharmaceuticals through its subsidiary Zydus Cadila.
Cadila’s efforts to build manufacturing capacity and presence in markets in Africa fits with the trend that has seen a number of other Indian drugmakers invest in the continent.
Most recently Cipla, India’s biggest generic drugmaker, announced that Uganda’s Quality Chemicals Industries would invest $80m in to expand capacity at its manufacturing facility in Kampala.
In September last year for example generics firm Ranbaxy opened its third facility in South Africa, subsequently signing a two-year anti retroviral supply and distribution deal .
Beyond this Strides Acrolab, which makes a wide range of finished pharmaceutical products, has a manufacturing facility in Nigeria and links with South African producer Aspen Pharmacare.
Sri Biotech Laboratories India Limited, a Hyderabad-based multidisciplinary agri biotechnology company, is in the process of setting up an integrated discovery centre at Genome Valley on the outskirts of the city with an investment of Rs 30 crore.
“We will be commencing construction work on the centre soon and expect it to be completed in one-and-a-half years from now,” said Sri Biotech chairman and managing director KRK Reddy.
The project will be funded through the $10-million private equity (PE) money that was infused into the company by Rabo Equity Advisors through its $100-million India Agri Business Fund in 2009. Sri Bio raised the PE fund to focus on seed research and development of new molecules for crop protection besides putting up infrastructure for the same.
Speaking to Business Standard on the sidelines of the Indian Seed Congress here recently, Reddy said the company was developing products since 2003 and had so far got four patents.
“The new discovery centre will focus on agriculture, health and environment. On the agriculture front, we are interested in developing transgenics … in the area of disease and pest-resistance crops, while the thrust will be on developing molecules, enzymes and proteins for the pharmaceutical sector, besides bioremediation studies like waste management,” Reddy said.
Stating that the objective behind proposing to set up the integrated centre was to exclusively dedicate it to intensify its discovery activities in the area of transgenics, Reddy said it would take four to five years for the company to get final results out of its discoveries, after which it would develop products based on them.
Clariant is now organized into 10 market-focused business units—previously it had four large businesses—and it has consolidated corporate operations in Pratteln, Switzerland. Additionally, the firm bundled its research activities into five technology-focused groups that support all of its businesses.
After a period of downsizing, the company took a significant step with its renewed focus on research. Now, it’s taking a second big step with a $75 million investment in the Clariant Innovation Center, a new technical center that will become its global R&D headquarters. The specialty chemical
company has high expectations that scientists working in the custom-designed building will be inspired to collaborate and create innovative new products.
“R&D will be the basis for future profitable growth at Clariant,” Chief Technology Officer Martin Vollmer asserts as he discusses plans for the innovation center. “After hard and deep restructuring, we now have a new organization in place, and we will reshape our R&D portfolio.” Most of Vollmer’s technology services group will be housed in the innovation center when it is completed at the end of 2012. The company expects to break ground this summer at a former Hoechst industrial park in Frankfurt.
Clariant has roots in the former chemical giant, having acquired its specialty chemical business
in 1997. In addition to the five global R&D centers—colorants, surfactants, specialty polymers,
effect chemicals and intermediates, and formulation technology—the new site will consolidate other
Clariant activities in the Frankfurt area will shift some from Swiss locations.
Employees from the application development departments of four business units, the intellectual property group, and the analytical department will relocate to the building.
In total, about 500 employees will occupy the new site, one-third of whom will be focused
on basic research. The center was designed by the architectural firm Hentrich-Petschnigg &
Partner, which emerged with the winning structure after a competition with 10 other firms. HPP Partner Werner Sübai says he focused on Clariant’s expressed need for interaction, designing a work environment “that is driven by spacious quality, by transparency, by bold space, and by mutual communication areas.”
The center will include three interconnected structures, each arranged around a large, open atrium, with offices and laboratories along the outer walls. “The center of each building should be a melting point functionally and visually,” Sübai continues, likening the central space to a kind of living room for scientists. “These open spaces will support communication and interaction throughout the building.”
The three structures will be linked by multilevel walkways that provide a flow that unifies the 29,500-m 2 (317,420 sq. ft.) building. Additionally, the multilayer façade will be constructed with novel materials and coatings so it appears white from the outside but is transparent from the inside. The glass layers of the façade will have sun-shading and a high insulation value for temperature control, thus integrating the green building requirements for German construction.
The use of natural light will continue with elliptical skylights in each atrium and clear walls throughout most of the structure. “We made the walls of the laboratories and offices transparent so we have visual contact between the office and laboratories, and communication through the whole building will be generated,” Sübai notes. Vollmer is quick to point out that this transparency also will be reflected in a new openness with customers and academic and industrial partners.
It is the interaction with customers that is particularly important for Clariant in renewing its product portfolio. The building will have a display lab in the main entrance to demonstrate new products and technologies, and Vollmer anticipates that scientists from customer companies will spend time at the innovation center working alongside Clariant employees. “This interaction along the value chain is key,” he stresses.
Pfizer will shed thousands more R&D jobs as it yet again shakes up how it does research. The company said it will close a research hub in Sandwich, England, and move some activities out of its Groton, Conn., R&D headquarters as part of a winnowing of the therapeutic areas it is working on.
Like every big pharma company, Pfizer is struggling to bring new medicines to market. But the pressure to find new drugs is particularly acute for Pfizer; later this year, it will lose U.S. patent protection for Lipitor, its biggest-selling product.
“The most fundamental question that Pfizer has to fix is our innovative core,” Pfizer’s CEO, Ian C. Read, said in a conference call with analysts. “This is the start of fixing that in a way that will give us consistent productivity in our innovation.” The goal, he says, is to stop pushing resources into high-risk areas that provide a low return on investment or where Pfizer lacks the expertise to compete.
The layoffs come on top of the 15% of its 128,000 employees Pfizer has shed over the past two years after its acquisition of Wyeth. In late 2009, the company said it was closing six of its 20 research sites as it reduced its overall R&D footprint by 35%.
Two research sites previously considered untouchable are the most heavily impacted by this latest round of cuts. Pfizer is closing its Sandwich labs, which had long been viewed as the company’s powerhouse in small-molecule drug discovery. Drugs invented there include the erectile dysfunction treatment Viagra, the blood pressure medicine Norvasc, and the antifungal Diflucan. Pfizer will also shift a number of programs, including neuroscience, cardiovascular, and metabolic research, from Groton to a facility in Cambridge, Mass.
The Sandwich closure will affect roughly 2,400 people. As the site is shut down over the next two years, Pfizer’s goal is to transfer several hundred positions to other locations or to external partners. The jobs of about 25% of the 4,400 employees at Pfizer’s Groton and New London campuses in Connecticut are being cut or transferred. The company notes that Groton “will remain our largest R&D site with a critical go-forward role for Pfizer R&D.”
Pfizer will focus research on several core areas: neuroscience, cardiovascular health, metabolic and endocrine diseases, inflammation and immunology, oncology, and vaccines. The company is creating specialized units in pain and sensory disorders, biosimilars, and Asia R&D.
The firm is exiting research in allergy and respiratory medicine, located in Sandwich; internal medicine, which includes some research in lung, kidney, and urinary diseases, also in Sandwich; oligonucleotides and tissue repair, in Cambridge, Mass.; and antibacterials, in Groton. The company is also abandoning regenerative medicine research in Cambridge, Mass., but will fold similar R&D conducted in Cambridge, England, into the new pain and sensory disorder research unit.
Genzyme plans to build an additional €250m biotechnology facility in Belgium to increase production of alglucosidase alfa, the active ingredient of its enzyme replacement therapy for Pompe disease.
The US-based firm said the extension of its Geel plant was part of its aim to increase overall manufacturing capacity four-fold for all of its enzyme replacement therapies.
About 150 new jobs will be created, bringing the total workforce at Geel to nearly 600.
The new 22,000m2 (236,720 sq. ft.) building also provides room for future capacity expansions, the firm said. It will contain two additional 4,000-litre bioreactors for the production of alglucosidase alfa, as well as a complete purification installation.
This will bring to five the number of bioreactors dedicated to the production of the therapy, as two are already providing global commercial supply for the treatment, and a third is expected to receive its first commercial approvals by the end of this year.
Commercial approvals for the new site are targeted to start towards the end of 2014.
Genzyme’s presence in Belgium has grown substantially since the opening of the Geel manufacturing site in 2005. The site has also recently received approval for commercial activities from health authorities in Europe, US and Canada, Asia and Latin America and plays a strategic role in Genzyme’s global supply chain.
‘The expansion of our Geel facility is a critical element of our manufacturing strategy and is fundamental to our mission,’ said Scott Canute, president, Global Manufacturing and Corporate Operations at Genzyme. ‘We are committed to delivering a reliable supply of high quality medicines to our patients.’
The new facility in Geel will function as a completely independent plant, with the aim of securing sufficient future supply of alglucosidase alfa, marketed as Lumizyme in the US and as Myozyme in the rest of the world.
Genzyme started work on a therapy for Pompe disease, a neuromuscular disease, ten years ago, and has invested nearly US$1bn to support the development program.
SCM Pharma has expanded its potent capacity following an $810,000 investment at its UK-based facility. The expansion includes an additional dedicated suite to handle and fill highly potent products such as cytotoxics to cGMP, as well as a new 500-sq.-ft cleanroom dedicated to making potent products. Additionally, the company has developed a production technique to handle continuous throughput via isolators to boost its aseptic processing capacity.
Along with potent products, the company also provides sterile fill finish of C14 radio-labeled compounds to GMP standards, primarily to assist customers carrying out absorption, distribution, metabolism and excretion (ADME) studies at the pre-clinical or clinical trials stage.
Neal Wesley, technical director at SCM Pharma, said, “As the business has developed and grown over the past few years, we have always tried to adapt to our clients’ changing and increasing potent product manufacturing requirements. We have therefore invested heavily into modifying the facility to ensure we can efficiently deal with a range of different potent projects including small pilot scale, clinical trial progression and the market supply of niche licensed products.”
Canadian technology development company Alphora Research has outlined a C$4m (€3m) capital expenditure program for 2011 that will provide further expansion of its facilities and capabilities for API technology development.
Investments will be made across all areas, with a focus on R&D, cGMP operations and analytical services, while the workforce is planned to increase to more than 90 people.
Alphora recently secured new research facilities, allowing a 50% increase in its process chemistry R&D capacity. Isolation technology is also being added, including the installation of three separate isolators, to support growing efforts with high potency compounds.
A key addition to the company’s analytical equipment will be a GC/MS system, emphasizing Alphora’s capabilities in API characterization and control of genotoxic impurities (GTIs).
cGMP operations will also be expanded with the construction of a fourth cGMP kilo lab, equipped with a 60L Buchi glass-lined cryogenic vessel and supporting equipment. The kilo lab will have a dedicated HEPA filtered heating and ventilation system and pressure locks suitable for Class 100,000 (ISO Class 8) use.
Significant additions are also being made to Alphora’s warehousing capacity. A 10,000ft2 expansion is planned for 2011, providing new storage facilities for APIs, intermediates, raw materials and solvents. This expansion is in advance of a second pilot plant, which is planned for 2012.
Alphora is also installing a new Enterprise Resource Planning (ERP) system to provide greater control and flexibility to its plant operations.
NSF International Shanghai chemistry laboratory will perform testing on a variety of products, including filling materials (excipients) used to manufacture pharmaceutical pills and tablets, dietary supplements and ingredients.
NSF International, an independent public health and safety organization headquartered in Ann Arbor, Michigan, US, has opened a new NSF Shanghai Testing Laboratory in China, expanding its services in Asia to include testing in food equipment, dietary supplements and ingredients, excipients and consumer products.
Additionally, the facility will provide on-site training in HACCP and GMP, GLP, quality and regulatory compliance for these sectors.
The 11,000m2 (118,360 sq. ft.) laboratory complements NSF’s existing certification services in China and provides a means to source safer products, raw materials and ingredients from Asia through independent, third party testing and certification.
Headed by laboratory manager Dongjing Liu, the lab will work with NSF Shanghai Co, a joint venture between NSF International and the Shanghai Audit Centre of Quality System (SAC) set up in 2005 and approved by the Certification and Accreditation Administration of the People's Republic of China (CNCA), to support product certification for companies in China making food equipment, dietary supplements and other consumer products and streamline the import/export process.
The NSF Shanghai Co joint venture also offers management systems certifications (e.g. ISO 9001, ISO/TS 16949) and global food safety certification.
‘NSF International is pleased to bring its testing and technology services to China and Asia. The combination of Asia’s growing export market and the need to ensure the safety and quality of raw materials, ingredients, consumer products and food creates a greater demand for third-party testing and certification services from a reputable organization like NSF International,’ said Lori Bestervelt, NSF International senior V.P. and chief technical officer.
The opening of the NSF Shanghai Testing Laboratory will help companies in Asia ensure the quality of their materials, demonstrate compliance with international public health standards, and conserve.
Thermo Fisher Scientific announced it will be building a new manufacturing facility in China as part of its goal to expand its presence in Asia-Pacific.
The facility will be housed within the Suzhou Science and Technology Town and is scheduled to be completed in early 2012. There, laboratory instruments, equipment, and consumables will be developed and manufactured for China's growing life sciences markets.
The new facility comes on the heels of other initiatives by Thermo Fisher in China as part of its efforts to grow its footprint in that market. During the past 12 months, the company has opened a second demonstration laboratory in Beijing and its new China Technology Center in Shanghai, it said.
The company now employs more than 1,400 in China. Revenues in China grew more than 14 percent year over year in 2010, and is now Thermo Fisher's third-largest country in terms of revenue, the company added.
"China is undergoing tremendous changes that impact its population, from healthcare to the environment to food safety, creating new opportunities for investment and growth," said Marc Casper, president and CEO of Thermo Fisher, in a statement. "By bringing Suzhou online to complement our existing facilities, we continue to increase our depth of capabilities and strengthen our competitive advantage in the region."
The acquisition of aseptic packaging company ProAseptic Technologies will give Sealed Air Corporation (SAC) quick access to the aseptic packaging market, according to the firm.
Bertrand Gaillard, global systems director, Cryovac Food Solutions said that the deal would widen the packaging company’s product range.
ProAseptic will allow SAC to expand its range of pouch sizes from 18ml to 1000ml, “products that were missing in our product range,” he said.
Barcelona-based ProAseptic Technologies produces aseptic and “ultra clean” stand up pouches with fitment in various formats, adapted particularly to the retail format from 100 ml up to 1 liter.
Financial terms of the deal were not disclosed.
The combination of SAC’s expertise in flexible packaging and ProAsepticTechnologies’ knowledge of aseptic packaging will allow the joint business to deliver a “complete range” of products for both refrigerated and shelf stable applications, said SAC
Fluid packaging supplier SAC recently took its first steps into the area through the launch of aseptic flexible packaging for high and low acid fluids.
Jean-Marie Demeautis, president of Sealed Air Food Solutions said ProAseptic Technologies’ aseptic pouch systems would complement the firm’s “growing Food Solutions portfolio”, such as its existing vertical form fill seal and bag-in-box products.
According to SAC benefits of aseptic packaging includes extending the shelf life for food, beverages and pharmaceuticals without refrigeration, while maintaining nutritional value and flavor.
“The technology is particularly beneficial for the dairy, vegetable and fruit products industries that can leverage both the improved microbial food safety assurances with appearance and convenience features of pouches, such as being reclosable and lighter weight,” said SAC.
Operating in 51 countries, SAC generated revenue of $4.2bn in 2009.
South Korea's Samsung Group has announced plans to form a 'strategic partnership' with US contract research organization (CRO), Quintiles, as it gears up to enter the biopharma market.
The deal represents the first phase of an expected $1.9tn (€1.4tn) investment in the healthcare sector by the giant Japanese conglomerate, which has provided initial capital of $264.4m in the joint venture with Quintiles.
Under the terms of the agreement, Quintiles will produce biosimilar versions of a number of best-selling cancer and immunological drugs for Samsung, as well as part-funding the construction of a new manufacturing plant in the Incheon Free Economic Zone, just outside Seoul, South Korea.
“South Korea is an important part of our growth strategy,” said Anand Tharmaratnam, senior VP and head of Asia markets of Quintiles, “This strategic partnership illustrates how Quintiles can use its resources and expertise across the clinical, commercial, consulting and capital spectrum. We're also very pleased to drive innovation and advance the role of south Korea in the global pharmaceutical industry.”
Paul Casey, vice president and head of Asia corporate development for Quintiles, said the deal “shows we are committed to developing non-traditional alliances” and suggested it demonstrated Quintiles's willingness to “seize opportunities in the complex industry landscape.”
The US firm claimed the new site, scheduled for completion in 2013, would be “fully equipped with cutting-edge technologies.” Construction is set to begin later this year.
Samsung recently bought a stake in US medical equipment manufacturer, Medison, and has already intimated its desire to begin the development and manufacture of its own drugs once it gains more manufacturing experience.
Generic drugmaker SOHM has expanded its manufacturing capacity for “lifestyle” diseases to meet growing Indian demand.
The non-branded manufacturer has ramped up its capabilities for the production of treatments for hypertension, cardiac disease and cholesterol reduction at its plant in Ahmadabad.
CEO Shailesh Shah said that: "India has the second largest population in the world. As the population continues to grow and with the rapid movement towards a more western lifestyle SOHM has decided this is the right time to enter the lifestyle segment of the pharmaceutical market.”
Shah used the cardiac disease market, explaining that sale of such drugs in India generates INR50bn ($1.1bn) and is growing at a rate of around 21 per cent a year driven by a number of key drugs.
“Products like Atenolol, Amlodipin, Losartan Potassium, Ramipril and Olmesartan are the fastest growing products and cholesterol reducing agent Atorvastatin is another big growth engine within this segment.”
He also predicted that: “this area of generic pharmaceutical sales will only get larger in the future and we are preparing now to be a major distributor of lifestyle drugs in India."
News of the expansion follows just days after SOHM received an order for 10 generic medications from a distributor based in neighboring Sri Lanka.
The deal, which will see SOHM supply some two million tablets and capsules, covers treatments for a wide range of ailments include a number of “Western lifestyle” related disorders.
At the time Shah said: “Sri Lanka is considered a gateway to Southeast Asia and one of the fastest growing pharmaceutical markets in the world. We are positioning SOHM to be a major distributor of generic pharmaceuticals in this region.”
LG Life Sciences is to build an influenza vaccine production facility in South Korea after licensing technology from Novavax.
Construction of a 30m dose a year production facility in Osong, South Korea strengthens LGLS’ vaccine capabilities and continues the spread of Novavax technology. Licensing the virus-like-particle (VLP) technology to LGLS follows the Indian joint venture with Cadila Pharmaceuticals.
“LGLS will help us advance our technology in Korea and other countries, consistent with our commercial strategy of developing regional partnerships and in-country manufacturing solutions with leading pharmaceutical companies around the world", said Rahul Singhvi, CEO of Novavax.
VLP technology transfer and manufacturing support will be provided by Novavax to help LGLS set up the vaccine plant. With a capacity of 30m doses the site should be able to serve South Korea, a 15m dose market according to LGLS, and other countries covered by the license.
“We anticipate that Novavax and LGLS together will make significant achievements in the field of influenza vaccines with our technology, expertise and combined resources", said Iljae Jung, CEO and President of LGLS.
For granting LGLS an exclusive license to use the VLP technology in South Korea, and on a non-exclusive basis in certain emerging markets, Novavax will receive upfront and milestone payments. Novavax will also receive double-digit royalty rate payments from commercial sales.
Shortly before news of the LGLS deal the US Department of Health and Human Services (HHS) released details of a vaccine technology contract with Novavax. The contract, worth $97m (€70m) over the first three years, will see Novavax develop insect cell vaccine production technology.
Extension of the contract by two years could see its total value rise to $179.1m. Development of the technology will further plans, detailed in recent documents, to equip the US with seasonal and pandemic flu vaccine production capacity. Novavax shares rose by 38 per cent after hours.
The HHS also awarded a contract, worth $196.6m if extended, to VaxInnate for development of a recombinant vaccine technology based on combining influenza and bacteria proteins. Combining the proteins is intended to stimulate a strong immune response.
VaxInnate and Novavax will conduct clinical safety testing and efficacy studies of their respective technologies. Manufacturing process optimization and validation will also be performed in anticipation of obtaining licenses from the US Food and Drug Administration (FDA).
Molecular Profiles announces the expansion of its service offering to include new manufacturing capabilities, enabling the company to handle larger projects for pharmaceutical clients from preformulation through to Phase IIa. This new manufacturing capability will initially focus on the company’s expert area of difficult-to-formulate molecules and enable it to offer a greater range of services to its customers. This decreases the need to perform a technical transfer of work to other companies and therefore lessens the risk to the customer’s research.
Nikin Patel, PhD MRPharmS, CEO of Molecular Profiles, commented “What makes Molecular Profiles unique is that we have an innovative problem-to-solution approach, which has resolved some of the toughest drug substance and formulation issues. We have a large number of highly experienced PhDs with a track record including over 1000 projects and many blockbuster products.
This, coupled with our dedication to providing the best service for our customers, means we provide a consummate and cost-effective project delivery. “
Founded in 1997 by a group of pharmaceutical scientists specializing in advanced characterization of pharmaceutical materials, Molecular Profiles has gone on to achieve a unique global position in drug analysis. The company has developed a wide portfolio of clients from smaller drug delivery firms to multinational pharmaceutical companies. Molecular Profiles’ contribution to the industry was acknowledged in 2007 by the receipt of the Queens Award for Enterprise in the innovation category, the most prestigious business honor achievable in the UK.
AstraZeneca's Alderley Park site is the company's largest R&D facility. Located in the middle of Cheshire in the north-west of England, the site has been engaged in the discovery and development of a number of anti-cancer drugs for more than 50 years. It operates with 4,000 people including approximately 2,800 employed in R&D for a host of disciplines including chemistry, bioscience, pharmacology, genetics, clinical research and regulation.
The history of the site dates back to 1950 when Imperial Chemical Industries (ICI) purchased the land to create a research facility with leading scientists. R&D laboratories were officially launched at the site in 1957 following two years of construction. In 1993 ICI formed the Zeneca Group after de-merging its pharmaceuticals, agrochemicals and specialties businesses. Astra AB and Zeneca Group merged in 1999 to form AstraZeneca.
Over the seven years that followed, AstraZeneca spent more than £150m on expanding the site. A £70m expansion including new laboratories and administration areas was completed in 2001.
In 2003 a £27m safety assessment laboratory for drug safety testing was constructed. In 2006, with AstraZeneca's largest investment at the site, a £60.9m cancer research building known as the global advanced lead discovery centre was completed.
A new four storey R&D facility is currently under construction at the site. The £45m project will replace the existing facilities that will be demolished.
The Alderley Park site spans 400 acres. Nearly 80% of the space consists of woodland, water and farmland. The complex accommodates the cancer research area building equipped with state-of-the-art facilities for compound management and high throughput screening to help in the drug discovery process. The building has provision for 20,000m² (215,200 sq. ft.) of multi-purpose laboratories with a capacity to house 260 cancer research scientists.
The laboratories are spread across two five storey laboratory blocks. The top floor of the laboratory wings is dedicated for the chemical laboratories.
The new R&D facility will house multiple research departments including a pre-clinical imaging facility.
The Alderly Park site is AstraZeneca's global R&D headquarters for cancer research. It also serves as a vital centre for the company's operations, global sales, marketing, product strategy, licensing and other vital international departments.
The design contract for a new R&D facility was awarded in 2009 to Mott MacDonald, a global engineering, management and development consultancy.
As part of the contract, Mott MacDonald will offer structural, civil and architectural design services.
It will also provide complete design coordination and project construction support as part of an alliance framework which includes AstraZeneca's preferred design and installation contractors.
The alliance contractors will assist in identifying project risks during the design process before approval and provide a basis for future commercial project management.
The design of the new R&D facility will be modeled using three-dimensional design software that will be used along with clash detection, a tool that identifies areas of possible clashes between various elements of the project. The software will also have a walk-through capability that will allow detailed visualizations of the entire building that will facilitate design co-ordination between equipment vendors and the other design consultants.
Demolished material will be used for the construction. The material will be crushed on site and recycled for the new building.
CSK Food Enrichment is investing in a new dairy cultures plant in the Netherlands that will double existing production capacity.
The planned expansion at its Leeuwarden site is being pursued in anticipation of high growth rates in the cultures market.
CSK managing director Paul Visschedijk told this publication: “The total culture market is growing worldwide and especially in Central Eastern Europe and Asia a strong growth is observed in fermented dairy products.”
Value added cultured dairy products are expected to be another major source of future sales growth.
At its expanding Leeuwarden plant, Visschedijk said CSK therefore expects to be producing new cultures for flavor differentiation, bio preservation and texture improvement in semi hard and hard cheeses as well as fresh fermented products.
The managing director said such cultures can help manufacturers respond to the food trends of indulgence, clean labeling and health.
The new facility at Leeuwarden is expected to become fully operational at the end of 2014. CSK said the company is determined to build an efficient, aseptic and energy-efficient production location.
Visschedijk said: “In the new plant the latest technologies for culture fermentation will be implemented, including Ehedg standards, energy savings and heat recycling protocols. An important objective is to achieve a high level of sustainability.”
CSK has two manufacturing facilities in the Netherlands. The production of coagulants, cheese coating, colorings, culture media and other processing agents takes place in Leeuwarden. And In Ede CSK manufactures cultures, lactic acid permeate and distillate.
AstraZeneca has become the latest drug firm to invest in Russian manufacturing capacity with the announcement of plans for a $150m facility in the country’s Kaluga region.
The facility, located at the Vorsino industrial park, will undertake everything from formulation to packaging and, according to the Anglo-Swedish drugmaker, will produce 16 million packs a year for the local drug market.
AstraZeneca joins Big Pharma peer GlaxoSmithKline (GSK) and generic drugmaker Teva Pharmaceutical industries as the third major manufacturer to unveil a Russian investment in as many months.
The wave of investment follows hot on the heels of the Russian government’s call for drugmakers to expand production capacity in the country or risk facing what Prime Minister Vladimir Putin described as “restrictions.”
This was clearly a factor in AstraZeneca’s plans, at least that’s, if comments by the drugmaker’s boss in the country, Nenad Pavletic, are any indication.
In a translated statement, Pavletic said: “We want to be in Russia for Russia. We are also going to invest in R&D to support Russian innovative developments in fundamental science.
“Our investment decisions are supportive of Russian policy to modernize and develop the Russian pharmaceutical industry to make it innovative. Our main goal is to make high-quality medicines that will make a meaningful difference in the health and quality of life of Russian patients.”
The Kaluga plant’s focus on the Russian market was also stressed by regional governor Anatoliy Artamonov, who predicted “the new manufacturing facility will develop steadily to produce variety of affordable innovative GMP medicines for Russian patients.
Artamonov added that: “For our part, Kaluga government will strive to provide AstraZeneca with conditions for efficient operating in our region”.
The facility, work on which is scheduled to begin next month, will produce drugs for cancer, cardiovascular disease, neurological disorders, respiratory conditions and infections and will employ a staff of 145 people when fully operations in Spring 2013.
US contract research and manufacturing services firm, Viropro, has signed a $21m (€15.3m) deal for the acquisition of Malaysia-based Alpha Biologics.
Under the all-share deal, Viropro acquires Alpha's state-of-the-art 5,000sq. meter (53,800 sq. ft.) advanced good manufacturing practice (GMP) mammalian cell production facility located at its headquarters at the Penang Science Park, Malaysia.
Viropro also gains access to Alpha's new Cambridge, UK process development lab. Completed in November 2010 and designed to complement its Penang counterpart, the lab produces supplies of mammalian cell proteins, such as monoclonal antibodies and recombinant proteins.
Both the Cambridge and Penang sites were recently the subject of multi-million dollar upgrades designed to ease the path of clinical trials and the commercialization process for Alpha's international clients.
Rajiv Datar, president and CEO of Viropro, said: “With this acquisition, Viropro has taken the first step towards creating a global biotech contract research services business, and towards achieving our goal of offering an integrated contract development and GMP manufacturing services platform to our clients in the biopharmaceutical industry.”
Viropro said it expects Alpha Biologics' UK plant to receive certification this year under the Pharmaceutical Inspection Cooperation Scheme (PICs), which harmonizes GMP guidelines in 39 member countries and agencies, including the US Food and Drug Administration (FDA). The company hopes European Medicines Agency (EMEA) accreditation will follow shortly afterwards.
Datar revealed that Viropro intends to make further acquisitions as it seeks new partnerships for its biosimilar cell lines and manufacturing processes. The company already enjoys a strong position in pharmerging markets such as South America, Asia and Eastern Europe.
Commenting on the deal, Kim Tan, chairman of Alpha Biologics, said, “This transaction allows us to participate in the entire biotech contract development and manufacturing services offering, and thus provides increased leverage to our Penang facility.
“We look forward to working closely with Viropro and its other subsidiaries towards the realization of a common mission,” said Tan, “which is to make biotech drugs for clients, efficiently and economically.”
McIlvaine Company
Northfield, IL 60093-2743
Tel: 847-784-0012; Fax: 847-784-0061
E-mail: editor@mcilvainecompany.com
Web site: www.mcilvainecompany.com