PHARMACEUTICAL & BIOTECHNOLOGY
INDUSTRY UPDATE
April 2011
McIlvaine Company
TABLE OF CONTENTS
Sensient Pharma Expands Production Facility
Organogenesis Breaks Ground on Facility
PharmStar Pharmaceuticals Has a New Facility
Vince & Associates Clinical Research Facility Opens
UMass Opens New Food Science Center
Almac Open CLIA Lab for Biomarker Clinical Trials
No Hands-free at New Johns Hopkins Facilities
Kettering Hospital’s Infection Control
West Adds Manufacturing Capacity
Perrigo Facility Cleared By FDA
QualTex Labs to Open in Georgia
ThermoSafe Brands Moves to Louisville Facility
Imperial Acquires D. Anderson & Company; Expands Clinical Trial Services
March of Dimes, Stanford Launch Premature Birth Center
AAIPharma Relocates, Expands Compendial Testing
Yale and Gilead Sciences Announce Cancer Research Collaboration
Althea Expands Service Offering Through Agreement with Sherpa Clinical Packaging
Research Facility Added to Texas Medical Center
Almac Opens Analytical Labs in New U.S. HQ
HWI Global Gets New UPMC Hospital Contract
Boehringer Ingelheim Finalizes Acquisition of Amgen's Fremont Facility
DYMAX Expands European Operation
A. Schulman Adds Manufacturing Line in Brazilian Facility
Agilent Technologies Chosen by University of Toronto
Clearstone Expands in Asia through Mitsubishi Partnership
Glycotope Biotechnology Expands
Dr Reddy’s Opens Technology Centre in UK
The National Institute for Bioprocessing Research and Training (NIBRT) Opens
SIRO Clinpharm Expands into Malaysia
Glycotope Biotechnology Begins Expansion
Bayer CropScience Opens New Singapore Lab
Icon Opens Shanghai Office and Plans Expansions
Chiltern Expands European Operations
Schott Pharmaceutical Packaging Adds More Facilities
Almac Opens CLIA-Registered Lab
Singapore Expansion for Marken
Hungary’s Karsai Plastic Grows
Agilent Expands Indian Facility
Quintiles Ph I Facility Open at Guy’s Hospital
Sealed Air Takes Stake in SteriPack
MTC to Build Cleanroom for Wasdell
Telstar and Indra to Build Containment Lab
Pharmatek Laboratories has been approved by the U.S. Drug Enforcement Agency (DEA) for the analysis of Schedules I through V controlled substances, adding to its existing license to develop and manufacture drug products containing Schedules IV and V controlled substances.
“Receipt of this additional registration from the DEA demonstrates that we meet the Agency’s stringent requirements, and further validates our facility design, security systems, and procedures for analysis, handling, storage and disposal of controlled substances,” said Jeffrey Bibbs, Ph.D., chief executive officer and chief scientific officer at Pharmatek. ”This registration allows us to perform analytical and stability testing for all controlled-substance drug products within both our non-potent and highly-potent GMP facilities.”
Sensient Pharmaceutical Coating Systems has completed the expansion of its pharmaceutical coating production facility, more than doubling manufacturing capacity and equipment dedicated to the pharmaceutical and nutraceutical industries.
Steve Strickland, general manager of Sensient, said, “This expansion signals our commitment to the pharmaceutical coating market and increases our ability to effectively compete for new business. Our clients have responded favorably to our latest pharmaceutical coating innovations and we now have the production capacity to meet their increasing demand.”
DaVita Clinical Research (DCR), a provider of clinical research services focused on kidney research as well as a multitude of specialty therapeutic populations, announces the completion of its Phase 1-2a Cleanroom to comply with USP 797 high risk regulations. In establishing this distinction, DCR has demonstrated its Cleanroom abides by the requirements set in place for the USP 797 high risk compliance and ensures its ability to handle compounds in a safe and efficient manner.
With more than 20 years of experience in early clinical studies in renal research, DCR performs a vast number of clinical trials each year. Operating under USP 797, DCR emphasizes the importance of meeting quality standards to maintain, components and environments for sterile compounding preparations. In addition to its hospital co-located facility; on-site, state-licensed pharmacy; 8,000 patient database; and complex study focus, DCR now adds its USP 797 compliant clean room to its list of tools that distinguish the company as a renal industry leader.
“The purpose of the cleanroom and the USP 797 guidelines is to reduce infection risks to patients where compound sterile preparations are prepared, as well as to protect pharmacy staff,” stated DCR Vice President of Clinical Services Amy Young. “Many clinical facilities are struggling to fully comply with this regulation. We are dedicated to delivering superior clinical results. The achievement of the USP 797 standard demonstrates this dedication and DCR’s commitment to our patients.”
US-based tissue regeneration specialist, Organogensis, has broken ground on the construction of the world’s largest automated living cell manufacturing plant in Canton, Massachusetts.
Organogenesis is beginning construction of a 95,000-square-foot manufacturing plant, on Dan Road, scheduled for completion in 2013.
The company, which makes regenerative medicine therapies to speed healing, has grown steadily in recent years, adding to its office campus with financial help from the state. The campus will ultimately include four buildings with 330,000 square feet of office and manufacturing space.
Organogenesis Inc. also bought another office building to accelerate the expansion of its Canton headquarters. The firm said it acquired a 78,000-square-foot building at 65 Dan Road, which it will use for warehouse space and future growth.
The company will use advanced robotic and modular manufacturing technologies at the new facility, which it claims will allow it to “leverage its leadership in the regenerative medicine field to attract substantial resources and jobs to Massachusetts over the next ten years.”
Organogenesis, which is in the midst of a major, multi-year expansion of its global headquarters, R&D and manufacturing facilities, attracted a host of local luminaries to the opening ceremony.
“Today we’re honored to have so many state and local officials join us to commemorate the start of construction of this state-of-the-art facility,” said Organogenesis president and CEO, Geoff Mackay.
“This is a huge milestone for Organogenesis, as well as for the Commonwealth and for the regenerative medicine industry as a whole. We’re growing in Massachusetts in size, in revenue and capacity, and in order to keep pace with our rapid growth we’re hiring across all departments.”
Organogensis is the latest company to benefit from the Massachusetts Life Sciences Initiative, which provides support for life sciences companies across the state through funding, planning advice and perhaps most importantly, sizeable tax breaks.
Susan Windham-Bannister, CEO of the Massachusetts Life Sciences Center, said: “This is a great example of the Life Sciences Initiative at work. The regenerative medicine industry was born here, in our state’s universities and labs, and we’re thrilled to watch this burgeoning industry thriving and creating jobs.”
State governor, Deval Patrick, said the new development was further proof that the Life Sciences Initiative was helping create jobs.
PharmStar Pharmaceuticals, Inc., a U.S. drug developer, manufacturer and marketer of the FDA-approved, Over-the-Counter (OTC) liquid pain reliever AQUAPRIN, announced that it has entered into negotiations to purchase an over three-acre site and 24,000 square foot building for production and research activities in Wilson, NC.
According to PharmStar CEO Howard Phykitt, moving PharmStar's production and R&D to a stand-alone facility can provide greater economic benefits as well as accelerate the commercialization process to bring AQUAPRIN to market.
The property is strategically located in a professional industrial park near a third-party pharmaceutical testing facility. In addition, it is close to many pharmaceutical companies such as Merck; Sandoz, a division of Novartis; Perdue Fredrick; Natures Bounty; and GlaxoSmithKline. Talented pharmaceutical production and research personnel are readily available for hire.
"To better meet FDA CGMP guidelines, it is prudent for AQUAPRIN be manufactured in a facility that has only one tenant," said Mr. Phykitt. "While our current location meets these FDA guidelines, it also would require that we continuously monitor and have knowledge of all materials that are located our building, even those unrelated to PharmStar. After carefully evaluating the economics of these FDA guidelines, it made more sense to move PharmStar into its own building, where we can have complete control and move quickly, while ensuring that the highest standards of the FDA are consistently met."
The company has received an offer to purchase the building, and is currently assessing the offer. Mr. Phykitt concluded, "I made a commitment to shareholders when we restructured the capitalization table that the company has no need to dilute its common stock for at least the next six months. This decision will not affect that commitment."
PharmStar Pharmaceuticals, Inc. is a U.S.-based drug development, manufacturing and marketing company and the innovator of AQUAPRIN, an FDA-approved Over-the-Counter (OTC) liquid pain reliever. In development since 1993 with over $3 million invested to-date, AQUAPRIN is a liquid derivative of aspirin based on a patent-pending formula. The product is designed to dissolve nearly instantly in just 1.5 ounces of water, which can be absorbed into the bloodstream up to 10 times faster than traditional OTC pain relievers, and with little to no stomach upset. PharmStar's headquarters are located in Rocky Mount, NC.
Vince & Associates Clinical Research, Overland Park, Kan., has opened a 90-bed Clinical Pharmacology Research Unit designed as a boutique hotel experience for the study volunteers and a first class scientific research setting for the biopharmaceutical industry, according to a company statement.
Amenities include bedside 20-inch touch screen entertainment systems, in-house theater room, and individually themed luxury suites. Subject safety and security measures are coupled with a Physician Research Model where principal investigators lead and are involved in all aspects of ongoing clinical studies.
"The unit is purpose-built for the complex trials our clients require to make earlier drug development decisions and advance their drugs to market more aggressively than ever before. For example, we provide the full technical resources and medical expertise required for Phase I/IIa Proof of Concept (POC) studies which incorporate a single ascending dose (SAD), multiple ascending dose (MAD) and a patient proof of concept study into a single protocol," says Dr. Brad Vince, president and medical director of Vince & Associates Clinical Research.
The facilities include a USP 797-compliant bio-safety cabinet and full time pharmacy staff, which allows for sterile preparation. The client’s API can be compounded on site or drugs can be prepared extemporaneously. The facility includes laboratory areas for the processing of biomarkers and blood samples and for specialized testing.
Becton, Dickinson and Company (BD) announced plans for a 48,000-square-foot expansion at its Columbus West, Nebraska, production facility that is expected to create 40-48 new jobs in the next two years.
The $48 million project at the BD Medical plant, 2153 12th Ave., will increase manufacturing capacity for the company's medical surgical systems business unit, specifically, production of PosiFlush Syringes.
The groundbreaking marks the fourth expansion at the Columbus West facility since its construction in 1949.
"I'm amazed how far we've come," said Brian Broderick, worldwide program director for BD Medical Surgical Systems, "but after working here awhile, I'm probably more amazed with how far we can go."
Broderick credited the company's growth to the partnership it holds with the community and local economic development efforts.
"Without companies like BD, Columbus and Platte County would not have grown to be what they are today," said Tom Martens, chairman of Platte County Board of Supervisors.
The proposed expansion will increase the Columbus West facility's footprint to 570,000 square feet. Presently, the production site has 875 full-time employees.
More than 1,500 people are employed at BD's two Columbus facilities.
"This new expansion is the result of our positive experience with the skilled work force in Columbus," Plant Manager Todd Zeller said. "BD is pleased to be growing in Nebraska, and we appreciate the support we have received from the local community for this investment."
In total, BD has more than 2,500 employees in Nebraska, at locations in Columbus, Holdrege and Broken Bow.
Gov. Dave Heineman, in attendance at Thursday's groundbreaking ceremony, credited companies like BD with helping keeping the state's unemployment rate low -- presently 4.3 percent -- and proving Nebraska industries can compete globally. "Regardless of the economy, BD just keeps moving," he said.
Headquartered in Franklin Lakes, N.J., BD is a leading global medical technology company that develops, manufactures and sells medical devices, instrument systems and reagents, employing approximately 29,000 people in more than 50 countries.
The University of Massachusetts Amherst has opened a new $5.6m food technology center to provide state of the art facilities for food science students, after enrollments in its undergraduate program more than tripled in the past five years.
The new Clydesdale Center for Foods for Health & Wellness adds 7,800 sq. ft. of new and renovated chemistry, microbiology and biology laboratory space, incorporating six laboratories - three of which are named for food science industry partners Kraft, ConAgra and PepsiCo, and three for alumni and other major donors.
Head of the UMass food science department Eric Decker said: "Establishing the Clydesdale Center is a terrific example of a research and development partnership between the university, the food science department, its alumni and the food industry to make foods part of our preventive health care strategy."
He said that the number of undergraduate students enrolling in the university's food science program has more than tripled over the past five years, from 25 to 80, which he suggests is a reflection of changing public attitudes toward food.
"People are starting to move beyond the artistic and more toward an appreciation of the science of food," Decker said. "The number one priority of food companies now is to improve health and wellness. They are our partners in developing ways to make the food supply healthier and safer, with a lower incidence of pathogen outbreaks, a high and stable nutritional value, great flavor, texture and convenience."
The sharp rise in the number of food science students has been experienced across the country. The Institute of Food Technologists (IFT) said last month that overall, the number of students graduating with B.S. degrees in IFT-approved food science programs has nearly doubled since 2004, from 319 to 591 in 2010. It said that increased interest in food in general is behind the trend, boosted by the rise of celebrity chefs, diet-related health issues and greater awareness of contemporary food movements, such as local, organic and sustainable food systems.
Almac’s Diagnostics business unit has announced the opening of its CLIA registered laboratory.
The opening of the Almac CLIA Laboratory supports the company’s ongoing Biomarker Discovery and Development Strategy by enabling the use of novel tests to stratify and enrich prospective clinical trials.
This ability is of key importance as Almac begins to transition the novel biomarkers that they have developed into clinical use, with the resulting potential to inform the drug development process and target therapies to responsive patients.
In addition to standard molecular tests, Almac have a pipeline of both internal clinical tests and companion diagnostic tests with Pharma partners in development that will be delivered from the Almac CLIA Laboratory.
Professor Paul Harkin, President and Managing Director of Almac’s Diagnostics business said: “We are very happy to announce the launch of our CLIA lab, which has been opened to meet both our needs and the needs for our Pharma partners. We have come to a point where the biomarkers we have discovered and assays that we have developed are being used to stratify patients, enrich clinical trials and impact patient treatment decisions. As such, CLIA is a key necessity for the processing of these samples.”
Almac’s genomics laboratories have been supporting biomarker discovery projects for 8 years and already operate under ISO17025 accreditation and work to the principles of GLP.
A study of newly installed, hands-free taps at the Johns Hopkins Hospital, in Baltimore, MD, US, which are equipped with electronic-eye sensors automatically to detect hands and dispense preset amounts of water, has found that they were more likely to be contaminated with one of the most common and hazardous bacteria in hospitals than old-style fixtures with separate handles for hot and cold water.
“Newer is not necessarily better when it comes to infection control in hospitals, especially when it comes to warding off potential hazards from water-borne bacteria, such as Legionella species,” said Lisa Maragakis, senior study investigator and director of hospital epidemiology and infection control at Hopkins Hospital.
Although the high-tech taps cut daily water consumption by well over 50%, Johns Hopkins researchers identified Legionella growing in 50% of cultured water samples from 20 electronic-eye taps in or near patient rooms on three different in-patient units, but in only 15% of water cultures from 20 traditional taps in the same areas. Weekly water culture results also showed half the amount of bacterial growth of any kind in the manual taps compared with the electronic models.
While the precise reasons for the higher bacterial growth in the electronic taps still need clarification, the researchers say it appears that standard hospital water disinfection methods, which complement treatments by public utilities, did not work well on the complex valve components of the newer taps. They suspect that the valves simply offer additional surfaces for bacteria to become trapped and grow.
Infection control experts behind the study say the electronic devices were widely introduced in patient care and public areas of hospitals across the US, including in The Johns Hopkins Hospital, more than a decade ago. The aim was to prevent bacterial spread from people touching the taps with dirty hands.
As a result of the study, conducted over a seven-week period from December 2008 to January 2009, Johns Hopkins facilities engineers removed all 20 newer faucets from patient care areas and replaced them with manual types.
In addition, 100 similar electronic taps are being replaced throughout the hospital, and the hospital has decided to use traditional fixtures – some 1,080 of them – in all patient care areas in the new clinical buildings currently under construction at Johns Hopkins’ East Baltimore campus. The new buildings are set to open in 2012.
Cable management specialist Marshall-Tufflex has equipped the upgraded pathology laboratories at Kettering General Hospital, Northants, UK, with an Odyssey Bio antimicrobial cable containment system to improve infection control.
The project, part of a £1.1m refurbishment, has involved fitting more than 400 linear meters of Odyssey Bio (with red colored back boxes to provide Part M compliance at a competitive cost) in a phased 18-month program of works while the department remained operational.
Marshall-Tufflex says Odyssey Bio is different from many other antibacterial cable containment systems because its unique curved profile avoids the collection of dust. It also features bacteria-fighting, silver-based active ingredients, which are added to the PVC-U during manufacture rather than applied as a surface coating.
Consulting engineers for the refurbishment, Building Services Design, of Corby, Northants, chose Odyssey Bio for these qualities.
“I like the fact that the antimicrobial formula is integral to the plastic so that, despite what happens to it, it will continue to do its job,” said project consultant Jens Haugaard. “Additionally its curvature is easy to wipe clean.”
Once scratched or damaged, cable management systems that have antimicrobial agents applied as a surface coating can become contaminated by germs penetrating the surface.
Odyssey Bio benefits from having the antimicrobial additives distributed evenly through the product, which continue to neutralize bacteria such as MRSA, E-Coli and Salmonella, rendering them harmless even if the trunking becomes damaged, the company says.
“The client is happy, it is a good product and it is looking good on site. We have had no problems and are very pleased,” said Haugaard.
Odyssey Bio, supplied by Edmundson Electrical and fitted by Mann Electrical Services, both of Northampton, has been used on the benchtop upstands and against walls in the pathology laboratories. Where there are no upstands to benches, Marshall-Tufflex supplied triangular bench trunking units to special order. The containment systems carry essential power to analytical equipment used by the department.
Odyssey Bio has been tested to the quantitative standard ISO 22196:2007. Results show the survival rate of tested bacteria to be less than 0.1 percent.
Cat 6-approved Odyssey Bio is also registered with the Environmental Protection Agency (EPA) and compliant with the European Biocidal Products Directive (BPD).
With biopharmaceutical companies seeking safe packaging and delivery solutions for high-value drug products, West Pharmaceutical Services, Inc. is preparing to increase its capacity for manufacturing the Daikyo Crystal Zenith 1mL syringe system. Ideally suited for biopharmaceutical drug packaging and delivery, the Crystal Zenith syringe system overcomes problems inherent in glass-based systems, such as breakage and glass delamination. By creating additional cleanroom manufacturing environments within its Scottsdale, Ariz., facility, West will have room for production cells capable of producing up to 20 million units annually. The facility will also handle the warehousing and release of other ready-to-use Crystal Zenith systems such as vials and bulk drug containers.
"We found a high level of interest in the Crystal Zenith insert needle syringe system during its formal launch at a customer open house in Scottsdale last October," said Donald E. Morel, Jr., Ph.D., Chairman and CEO. The renovation project will give us the space for additional sophisticated injection molding technologies required for manufacturing Crystal Zenith syringes. These will be needed to support numerous customer stability trials and anticipated scale-up as customers realize the significant benefits of this system."
West is converting 32,000 square feet of existing space to include ISO 7 (Class 10,000)
cleanrooms for automated manufacturing, microbiological and functional testing laboratories, and additional climate controlled and monitored warehouse space. Completion is scheduled for the fourth quarter of 2011.
"In the past few months, several drug products have been recalled because of glass delamination, which creates glass flakes in drug solutions stored over time," said Dr. Morel. Recalls are expensive, cause serious interruptions to the drug supply chain and are potentially harmful to patients. Crystal Zenith containment solutions can overcome these and other problems inherent with glass."
Daikyo Crystal Zenith, a cyclic olefin polymer developed by West's Japanese partner Daikyo Seiko, Ltd., provides a proven solution to glass syringe problems. West's innovative system, device and component solutions help improve the safety and administration of injectable drugs.
A year after receiving a warning from regulators, over-the-counter drug maker Perrigo Co. said that a manufacturing facility in Michigan now meets regulatory standards.
Perrigo said any export or generic drug applications from the facility are now eligible for review by the Food and Drug Administration. The FDA sent Perrigo a warning letter about the facility in April 2010, saying the company had been receiving complaints for years about tablet contamination, that its quality control unit did not follow written procedures, and that Perrigo was not taking steps to prevent the problems.
QualTex Laboratories has fulfilled a promise made early last year to open a new blood-testing facility in a suburb of Atlanta.
In a statement, the San Antonio-based blood-testing lab said it will hire "more than 100" clinical-lab scientists, lab techs, quality specialists, materials management personnel, and general-management staff to run the facility.
QualTex, whose menu includes some genetic tests, added today it "plans to invest $12 million" over five years in the lab, based in Norcross in northwest Georgia.
Founded in 2007 as an independent affiliate of the South Texas Blood & Tissue Center, QualTex provides infectious-disease testing services to blood banks and plasma centers worldwide and claims to be the largest independent testing lab in the US for blood and plasma products.
In February, it also said the Norcross lab will screen "more than 8 million" whole-blood and plasma donations annually, which is double QualTex's current throughput.
The Georgia Department of Economic Development provided the company with undisclosed incentives and other help to open the Norcross lab.
ThermoSafe Brands announced the relocation and expansion of its Louisville, KY, facility. The new facility enables ThermoSafe to expand its product lineup from this location, including ThermoSafe Brands’ new Off-the-Shelf Certis Qualified Shippers, and Phase Change Materials (PCMs). This plant will also continue to produce polyurethane insulated shippers.
“This new facility is truly state of the art in our marketplace, and has been built to incorporate the latest in technology and the best manufacturing practices in the industry,” said Stefan Polywka, VP of Operations for ThermoSafe Brands, in a press release. "Although we are relocating to a more modern facility, it was important to us to remain in the Louisville area so that we could continue to deliver exceptional value to our customers, while also retaining and developing our existing, highly talented workforce.”
“The expansion of our capabilities in Louisville delivers on ThermoSafe Brands commitment to growth, both for our customers and our employees. This new facility gives us the opportunity to service our customers from a unique, state-of-the-art, cold-chain facility that is centrally located in the Midwestern United States,” added Prakash Mahesh, VP of Marketing and Business Development, ThermoSafe Brands, in the release.
Nolato, a Sweden-based manufacturer of medical plastic products, says 2010 was the ‘best year’ in terms of income as sales rose 30% to SEK3.4bn (€385m). Operating income increased 58% to SEK262m (€29.7m). “The recovery following the financial crisis was much quicker than expected, and all our operations showed an improvement,” Hans Porat, president and CEO of Nolato, said in a statement. Nolato Medical’s sales rose by 17% to SEK808m (€91.5m), with operating income rising to SEK100m (€11.3m).
The company is in the process of adding liquid silicone injection molding capacity in the US at its Nolato Contour facility, by building a third cleanroom for the machines at its facility in Baldwin, Wisconsin.
Nolato created Nolato Contour last year after acquiring medical molder Contour Plastics for €17m.
Nolato Contour is currently adding its third cleanroom, a Class 7 cleanroom that will accommodate the new liquid silicone injection molding machines. Completion for the building and equipment expansion is scheduled for the spring of 2011.
The new liquid silicone injection molding service is built on transfer of technology and knowhow from Nolato Medical in Sweden. Nolato boasts more than 30 years of liquid silicone and thermoplastic injection molding experience for complex implantable and non-implantable medical products.
GigaCyte, LLC., a leading provider of human stem cell-based products and preclinical contract research services, headquartered in Branford, Connecticut USA, announced that they have completed construction and validation of their new Class 10,000 cleanroom facility for mass cell culture media production. This department, led by Richard Malavarca (former founder of Specialty Media Inc., now part of Millipore Inc.) has developed the next generation formulations of complete media products for the growth and differentiation into neuronal and hepatic cells and for the maintenance of the mature cell types. These complete media products are expected to fuel the continued growth of GigaCyte’s cellular products and CRO businesses.
“Rich’s extraordinary expertise with specialized media formulations coupled with his vast experience in scaling its production are the key ingredients to our company’s continued growth. The value of stem-cell models to researchers is highly limited without GigaCyte’s culture media that are truly optimized for the specific cell types and unique lineage stages of each line. Combining Rich’s world-class media team with our expertise in stem-cell and primary cells research has proven most effective in making these highly sought after model systems practical for industry,” said Shiloh Barfield, EVP/General Manager of GigaCyte, LLC.
“I am tremendously excited about our new media production laboratory. Its capacity has allowed us to increase accessibility of our formulations. Having a state of the art facility allows us to scale even further our ability to optimize the drug discovery efforts of our clients. I am very proud of the laboratory and the effects it is having to further enable this field of research.” said Richard Malavarca EVP of Media Production on GigaCyte’s new facility.
Michigan, US-based clinical research organization (CRO), Imperial, has completed the acquisition of clinical trial specialists, D. Anderson & Company for an undisclosed fee.
The deal represents the first corporate acquisition of a patient recruitment organization by Imperial which, according to the company, helps “increase Imperial’s global presence within the clinical trial industry.”
Matthew Bissell, president and CEO of Imperial said the deal marked an important day for the company and its clients.
“Independently, each company is a global leader respected for quality, integrity and ingenuity,” he said. “Together, we are a global force, with the capacity to serve clinical trial sponsors regardless of need, size, location or disease sector.”
Imperial is perhaps best known for its iWorx platform: a flexible suite of clinical trials services the company claims can be tailored to suit a client’s needs.
Dallas, US-based D. Anderson & Company specializes in developing patient recruitment and retention campaigns for clinical trials across five continents and 40 disease indications.
Stanford University in a partnership with the March of Dimes Foundation launched a new center that will use an interdisciplinary approach that includes genomics research to identify the causes of premature birth.
The research center at the March of Dimes Prematurity Research Center at Stanford University School of Medicine will use a $2 million contribution from the foundation to bring together specialists in a range of areas, such as genetics, neonatology, computer science, and artificial intelligence, to study this problem.
Premature birth is the number one cause of death in newborns in the US, but nearly half of the time there is no identifiable cause for the prematurity, Stanford said.
The research initially will focus on four areas, including: studies of maternal genetic biomarkers that that identify maternal genes and proteins that could indicate premature birth; studies of the effects of placental genetics on premature birth; research into how infection and inflammation and immune response could contribute to prematurity; and analysis of databases to identify premature birth patterns in relation to seasonal, weather, geographical, regional health risks using artificial intelligence theory.
The March of Dimes will continue supporting the center until 2020, Stanford said.
AAIPharma Services Corp. has relocated its compendial raw materials testing group to a new purpose-built laboratory space located within the company's Wilmington, NC headquarters. The move follows a series of recent reinvestments into the company's core analytical testing business.
The new lab will tie together the compendial raw material testing lab and its supporting business group under one roof. The new location will increase turnaround times for high-quality raw materials testing. The company states that a standard 10-day turnaround will be offered for most compendial raw materials.
Features of the new GMP laboratory space include state-of-the-art engineering controls, updated IT infrastructure utilizing Waters Empower-2 Chromatography Network data acquisition software, updated gas generation systems to support the dedicated Agilent 6890 gas chromatographs, HPLC systems for improved sample through-put and "completely updated support systems down to the new Milli-Q water systems and Lancer Laboratory Glassware Washer." In addition, the move integrates AAIPharma Services' physical chemistry and raw materials Laboratories to provide full service compendial testing and API characterization in-house.
Group manager Ryan Taro remarked, "This investment is one more sign of the commitment AAIPharma Services has to its customers in providing top-notch, cGMP testing services to support pharmaceutical and biotech industries." Future planned improvements include implementation of an online quotation and sample submission system that will facilitate how clients request quotes and submit samples for testing.
The recent lab move is a physical relocation of current lab operations, not a "laboratory site change" associated with the transfer of lab operations from one company to another.
Gilead Sciences, Inc. and Yale School of Medicine announced the formation of a multi-year research collaboration focused on the discovery of novel cancer therapies. The research effort will initially span four years with an option to renew for up to ten years. Gilead will provide $40 million in research support and basic science infrastructure development during the initial four-year period, and will provide a total of up to $100 million over ten years should the collaboration be extended through that timeframe. Gilead will have the first option to license Yale inventions that result from the collaboration.
Yale and Gilead will develop a multi-disciplinary research program to search for the genetic basis and underlying molecular mechanisms of many forms of cancer. Scientists from both organizations will work together to identify new molecular targets that provide better understanding of the basis of disease and enable development of novel targeted therapies, including new therapies that overcome drug resistance that develops in some cancer patients treated with current targeted therapies.
The collaboration brings together one of the world’s top research universities and a biopharmaceutical company dedicated to addressing unmet medical needs with the goal of finding new treatments for cancer, Yale President Richard C. Levin said. This truly is transformative support that leverages the Yale Cancer Center’s top scientists, our West Campus technology investments and the resources of the new Smilow Cancer Hospital. I can’t think of a better partner to have in this collaboration than Gilead.
Following Gilead’s recent acquisitions of cancer development programs, this partnership serves to strengthen our discovery capabilities in the area of oncology, said Norbert W. Bischofberger, Ph.D., Gilead’s Executive Vice President, Research and Development and Chief Scientific Officer. Based on the strong track-record of the Yale cancer research team, I am confident this collaboration will lead to important advances in the understanding of the genetic basis of cancer as we collectively seek to develop novel targeted therapies for patients in areas of unmet medical need.
Research projects will be chosen by a joint steering committee to be chaired by Joseph Schlessinger, Ph.D., and chair of Yale's Department of Pharmacology and director of the Cancer Biology Institute at West Campus.
When we find cancer targets that are new, we will work with Gilead on designing drugs, which they can then test in the clinic, Schlessinger said. This is a tremendous opportunity for Yale and Gilead.
The Yale science team will also include Dr. Thomas Lynch, Director, Yale Cancer Center, Physician-in-Chief, Smilow Cancer Hospital at Yale-New Haven Hospital and renowned for his work in personalized treatments for cancer patients.
The Yale Center for Genome Analysis at West Campus, headed by Richard Lifton, M.D., Ph.D., chair of the Department of Genetics, will analyze the DNA of a variety of tumor types to look for genetic mutations associated with cancers. Schlesinger’s team will use the data to understand effects of the gene mutations on cancer and to identify ways to intervene in the disease process, such as indentifying small molecules that will serve as the basis of new cancer therapies.
Yale’s faculty in this partnership possess critical and complementary skills that comprise an optimal team for cancer drug development, according to Robert Alpern, M.D., Dean of the Yale School of Medicine. Tom Lynch brings experience in clinical cancer trials, Rick Lifton has been a leading innovator in genetics and genomics, and Yossi Schlessinger has unparalleled success in cancer drug development.
For more than fifty years, Yale School of Medicine has been at the forefront of the continuously evolving field of cancer research. The Yale Cancer Center is one of a select network of 41 comprehensive cancer centers in the nation designated by the National Cancer Institute and
the only comprehensive center in southern New England, whose mission encompasses basic and clinical research, cancer prevention and control, patient care, community outreach and education.
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Asia Pacific.
Althea Technologies Inc. announced that it has extended its service offering to include labeling, packaging, storage, and distribution of drug and biological products through its co-marketing partner, Sherpa Clinical Packaging. Sherpa, founded in 2011, is located adjacent to Althea's clinical and commercial-scale biologics and drug product manufacturing facilities. The proximity of the facilities to one another simplifies supply chain logistics for clients of each organization. Additionally, the co-marketing agreement will provide Althea's clients developing complex biologics products the option of producing, labeling, and packaging of drug and biological products during a single campaign.
"Contract packaging services offered through our co-marketing partner, Sherpa, will allow our clients to meet aggressive manufacturing timelines. We are very excited to present these capabilities to our existing and potential clients," stated Valerie McDonnell, Vice President, Sales and Marketing, Althea Technologies.
"Sherpa is pleased to be partnering with Althea to offer clients an expanded array of manufacturing and supply services that will improve time to delivery and reduce supply chain risks for our customers," said Mark Paiz, President of Sherpa Clinical Packaging.
Situated on the Texas Medical Center’s North Campus in Houston, the new Methodist Hospital Research Institute is a 12-story, 440,000-sf facility dedicated to translational research. Designed by New York City-based Kohn Pedersen Fox, with healthcare, science, and technology firm WHR Architects, Houston, the building has open, flexible labs, offices, and amenities for use by 90 principal investigators and 800 post-doc trainees and staff. A comprehensive imaging suite connects to the existing hospital, while a new two-story lobby has second-floor pre-function, conference, and auditorium spaces. A 12th-floor terrace overlooks the medical center campus.
Almac has opened analytical laboratories at its new 240,000-sq.-ft. North American Headquarters in Souderton, PA. The move is part of the Almac Group’s integrated services solutions strategy.
The site's analytical labs complement existing facilities in the UK. The lab provides support for clinical packaging operations as well as stand-alone analytical services. The labs are equipped with the latest equipment, including HPLC, UPLC, GC, UV, IR, DSC, KF and others. The new group will also offer Polymorph and Salt Screening and Solid Form Development, according to an Almac statement.
Almac has installed the latest bathless dissolution apparatus for rapid and efficient comparative dissolution studies. Installation of the newest Waters H-Class HPLC/UPLC systems provides maximum flexibility for developing, validating and running assay, dissolution and stability methods. Large capacity stability chambers provide required ICH stability conditions in the new labs.
The new analytical facility complements Almac’s specialty capabilities, including biocatalysis, radiolabeling, and peptide and protein synthesis. These services are all part of Almac’s comprehensive Drug Development Services, including API and drug product development and GMP manufacture.
South Side-based HWI Global Inc. has been awarded a contract to provide consultation and interior fit and finish clean room services at the 156-bed University of Pittsburgh Medical Center hospital that’s under construction in Monroeville, the company announced. The value of the contract was not disclosed.
For the UPMC East project, HWI will be a subcontractor to North Side-based P.J. Dick Contracting Inc. and Barton-Malow Co., which is based in Southfield, Mich. The new hospital is being built on a 15-acre site and is scheduled for completion next year.
HWI Global, which recently merged with IVT Software Inc., specializes in clean room design, engineering and construction in the hospital, nanotechnology, microelectronics and aerospace industries.
Today Boehringer Ingelheim formally acquired Amgen's biopharmaceutical development and manufacturing facility in Fremont, California. This acquisition involves leasing buildings, acquiring physical equipment and assuming manufacturing processes done at the Fremont site. The state-of-the-art facility currently employs more than 300 employees and consists of more than 200,000 square feet for laboratories, manufacturing and process development suitable for clinical and market supplies. The purchase agreement was signed in January 2011. The companies agreed not to disclose details of the purchase price.
"Presence in Fremont, CA aligns with our growth strategy in several ways," said Simon Sturge, Corporate Senior Vice President Biopharmaceuticals, Boehringer Ingelheim GmbH. "The strategic decision to have a state–of-the-art contract manufacturing facility in the U.S. Bay Area biotechnology cluster will give Boehringer Ingelheim a greater opportunity to serve current and future customers. In addition the technological expertise present at Fremont will complement our goal to further increase Boehringer Ingelheim's world leading position in the process development and manufacture of Biopharmaceuticals."
As a fully integrated manufacturing site, the Fremont site complements the existing capabilities and technology found across the existing Boehringer Ingelheim biopharma network located in Biberach/Germany and Vienna/Austria.
Boehringer Ingelheim has been a contract manufacturer for Amgen for ten years and will continue to support Amgen's delivery of safe and effective medicines to patients around the world. "We look forward to our continued contract manufacturing partnership with Amgen," said Simon Sturge.
The Boehringer Ingelheim contract manufacturing portfolio includes sixteen licensed biopharmaceuticals manufactured in globally licensed multi-product facilities, a growing pipeline of New Biological Entities (NBEs), and a growth strategy in the Contract Manufacturing Business (CMB). Boehringer Ingelheim's objective is to remain a leader in Contract Manufacturing as an industry benchmark for operational excellence including technical expertise and state-of-the-art technology.
Pharma Tech Industries (Royston, GA; PTI) recently completed the construction of a cleanroom dedicated to pouch filling of powder-based products. The room was built specifically to house the new high-speed Oystar Jones Adjustable Pouch King. The machine will fill pouches for multiple powder-based products including a cholesterol medication and laxative granular powder.
“As leaders in the pharmaceutical space, our customers require the highest-standards of quality and compliance,” said Tee Noland, Director of Business Development for PTI, in a press release. “Both the completion of this room, as well as the installation of this new machine, allow us to provide our customers with fast, precise production of their product, without compromising safety or quality.”
Features of the Oystar Jones Pouch King include:
Quick and repeatable pouch size changes.
Speeds up to 500 pouches per minute.
Flexible production capabilities and easy reconfiguration process.
A remote filling module, which provides flexibility and sanitation benefits.
All new machine configuration, offering ergonomic benefits and easier machine threading.
Highly consistent temperature profile to ensure a high-quality side seal.
As a pharmaceutical contract manufacturer and packager of powder products, PTI has been serving the needs of global pharmaceutical and personal care companies with product development, manufacturing and packaging services for more than 35 years. PTI currently serves its clients in two facilities located in Royston, GA, and Union, MO, and produces more than 300 SKUs of powders, effervescent and solid dose products, as well as cotton swabs and injection molded components.
DYMAX Corporation, an ISO 9001 certified, world-leading manufacturer of advanced light-curable adhesives, coatings, sealants, and dispensing and light-curing equipment, has relocated its European office to a new facility in Wiesbaden, Germany by the end of March. DYMAX, headquartered in Torrington, CT, also has locations in China, Hong Kong, and Korea. The company, founded in 1980 by Andrew and Clai Bachmann, continues to be a family-owned firm.
Greg Bachmann, President, says that the new facility, which is four times as large as the previous location, serves as the home base for the company’s business in Europe, the Middle East, and Africa. It will house additional production equipment and an expanded work force which will support the growth that DYMAX continues to experience. Along with its fourth straight year of inclusion on the Inc. 5000 list of most rapidly growing private companies, DYMAX was recently recognized by the U.S. Department of Commerce for its innovation and export activity. Today, DYMAX has over 200 employees globally and holds more than 25 patents.
A. Schulman, Inc. announced that it will add one manufacturing line in its Sao Paulo, Brazil plant to accommodate increased demand for the company's masterbatch and engineered plastics products. The company expects the line to be installed and operational by November 2011. A. Schulman acquired the plant as part of its October 18, 2010 purchase of Mash Compostos Plasticos, a masterbatch additive producer and engineered plastics compounder. "As a result of the robust Brazilian market, which is being driven by packaging (food, medical, pharmaceutical), consumer goods and transportation, we are adding a fourth line to this facility to better serve customer demand," said Gustavo Perez, General Manager and Chief Operating Officer of the Americas. "We are pleased with the success of the Mash acquisition, and we plan to continue to grow our presence in South America, which offers outstanding strategic growth opportunities for A. Schulman as we expand our global footprint." The type of line being installed at this facility can provide up to 8 million to 10 million pounds of annual capacity. Including this line, the plant will have a total annual capacity of approximately 22 million to 24 million pounds.
Technologies Inc. announced a $4.3-million contract with the University of Toronto’s department of chemistry to equip its new 4,000-square-foot laboratory with multiple nuclear magnetic resonance (NMR) spectrometers. These include 500-, 600- and 700-MHz NMR systems equipped with multiple probes and automated sample changers.
“These new NMR systems will provide a vital boost to our new Centre for Spectroscopic Investigation of Complex Organic Molecules and Polymers, increasing the range and scope of research in key areas,” said Professor Robert H. Morris, chair of the university’s chemistry department.
The new facility is scheduled to open later this year, the International Year of Chemistry. More than 45 scientists as well as 300 graduate students and postdoctoral fellows will be able to use the facility to investigate powerful solutions for inorganic, organic, materials and bio-organic research, including broader investigations into the fate of fluorinated compounds in the environment.
The new facility is supported by the Canada Foundation for Innovation and the Ontario Ministry of Research and Innovation.
“We are excited that the University of Toronto’s new facility has chosen Agilent as its primary NMR equipment provider,” said Kevin Meldrum, director, research products marketing for Agilent. “Agilent is dedicated to helping scientists meet all of their spectroscopy research needs and this agreement further illustrates that commitment.”
Agilent’s portfolio of NMR instrumentation and technology includes:
The VNMRS systems suite: Ideal for advanced research applications, it allows for analysis of bio-liquids, bio-solids, small molecules, polymers and materials, and microimaging experiments.
The 400-MR: A compact and easy-to-use system, it can be fully automated to save time.
The DirectDrive RF architecture and the DirectDigital receiver system: Standard components on all Agilent NMR instrumentation, they remove inconsistencies in measurement and prevent delays in data acquisition.
VnmrJ 3 software: This workflow-based program focuses on organizing samples and related data to help scientists easily monitor, track and manage results.
Contract research organization (CRO) Clearstone Central Laboratories has unveiled a ‘preferred provider’ partnership with Mitsubishi Chemical Medience (MCM), continuing its efforts to expand in Asia.
The deal grants Canada-headquartered Clearstone access to MCM’s 21-strong network of contract clinical and diagnostic laboratory facilities that extends across Japan.
In return, MCM and its customers will be able to use the Canadian CRO’s global laboratory facilities, including its recently expanded lab in Beijing, China and its unit in Singapore.
Spokesman Bernie Clark said that: “Clearstone has been working with Mitsubishi over the last year in a similar fashion and we are now at a point where we can publicly announce the partnership,” adding that the deal stands to benefit both parties.
He went on to explain that while Clearstone does not have any lab facilities in Japan, it does service a large number of trial sites in the country and added that access to MCM’s labs will provide customers with more options.
The MCM deal is also similar to an agreement Clearstone formed with Lab Corp’s Esoterix Clinical Trial Services unit late last year, which granted the latter firm access to the Beijing laboratory.
More broadly the new partnership, financial terms of which have not been disclosed, is in keeping with the global expansion strategy Clearstone set out for 2011.
In February the Canada-headquartered CRO said that its plan was to build its presence in the Asia-Pacific region through the formation of strategic partnerships with local players.
Heidelberg-based Glycotope Biotechnology, a full subsidiary of Germany company Glycotope GmbH, has initiated the setup of further cleanroom facilities as a first step in the expansion of its GMP-production capacities.
By mid 2011, the company will be able to produce 4kg of recombinant antibodies per year and up to 11 kg upon completion of works towards the end of 2011. In total an additional 1400m2 of facility and office space will be created.
“In particular the expansion of our DSP (downstream processing) capacities now places us among the top providers of GMP-production for recombinant proteins and in particular antibodies in Germany,” said Dr Steffen Goletz, founder and CEO of Glycotope GmbH.
Dr Reddy’s Laboratories has moved its UK subsidiary, Chirotech, to a new purpose built lab facility at the Cambridge Science Park.
The new 33,000 sq. ft. facility will provide a range of small molecule manufacturing services for both Dr Reddy’s and to third-party pharmaceutical companies as part of the firm’s contracting business.
Chirotech site head David Chaplin said that the additional capacity was called for by the firm’s expansion plans.
He said that: “Apart from growing the existing chemocatalysis and biocatalysis business, the new site will have capabilities in fast growing segments like activated mPEGs and peptides.”
Chaplin added that Dr Reddy’s also plans to expand the facility’s 40-strong workforce, explaining that: “The new facility has provisions for an initial doubling of scientific staff while providing for further capacity additions in future.”
He explained that: “The majority of our scientists are synthetic organic chemists, many with expertise in Chirotech's focus areas of chiral technologies, particularly chemocatalysis and biocatalysis.
“Alongside the chemists we have analytical scientists and biologists. We would expect further expansion to cover these activities as well as specialists in particular new areas of interest.”
This is in keeping with comments by Dr Reddy’s CEO GV Prasad, who said the decision to invest in the UK was due to the access, the science and the talent available in the country.
“The UK is an expensive location, but it has talent we could not attract to India. The UK is more appealing because of its 'ecosystem' of links to universities and biotech companies."
The new Cambridge facility also fits with Dr Reddy’s plans to grow its custom pharma services business (CPS), which now has a network of three R&D centers and eight API manufacturing plants in India, Mexico and the UK.
Europe is a particular growth target according to Chaplin who said that: the “region contributes about 35 per cent to the overall PSAI [Pharmaceutical Services and Active Ingredients] business revenues.
“Our CPS business aims to be the preferred partner for innovators world-wide by offering a comprehensive basket of services with competitive pricing, speed and additional IP.”
Cherwell Laboratories, a supplier of microbiology media and instruments for the pharmaceutical industry, based in Bicester, UK, is to expand its facilities by more than 60%, increasing manufacturing and warehousing capacity.
The opening of the new facility will mark Cherwell’s 40th anniversary and follows seven years of sustained growth, including a 20% increase in export sales within the past financial year.
The company says this expansion will support future company growth and ensure that product stock is always rapidly available, whatever the quantity required by customers.
The expanded Cherwell plant will total more than 36,000ft2 and house new cleanroom manufacturing for its Redipor microbiological media products, in addition to expanded warehousing facilities for its Redipor products, DataTrace wireless dataloggers and SAS microbial air sampling systems. Cherwell’s fully automated aseptic plate filling machinery is capable of processing more than 5,000 plates per batch, but can also produce small batches of just 50 plates for selective or investigational media.
‘We pride ourselves in delivering excellent customer service and support, and it is for this reason that we are investing in the future by expanding our facilities to ensure that we can always rapidly respond to our customers’ demands,’ said Andy Whittard, managing director at Cherwell.
The first phase of Cherwell Laboratories’ new facilities will open in autumn.
The Wall Street Journal reports, Huntsman Corp. plans to expand and acquire companies in India to keep up with customer demand. The company expects to double revenue from India in the next four to five years, chief executive Peter R. Huntsman said in an interview. The company will invest $10 million to develop a full-fledged office with research and development facilities and hire around 400-500 people in the next two to three years in India. Huntsman completed the acquisition of Gujarat-based chemicals manufacturer Laffans Petrochemicals Ltd, its fourth Indian acquisition, extending a technical collaboration with the Indian chemicals maker. Huntsman is expanding capacity to meet demand from clients that have set up factories in India. The company's clients include Procter and Gamble Co. and competitors include BASF SE, Bayer AG and Dow Chemical Co.
U.S. drugmaker Amgen has acquired Brazilian manufacturer Bergamo in a bid to improve its access to ‘one of the fastest growing pharmaceutical markets in the world.”
Bergamo, which is headquartered in Sao Paulo, owns a number of manufacturing facilities at which it produces drugs for hospitals and clinics across the country. The takeover values the firm at $215m.
The firm generated revenue of some $80m in 2010 and, according to Amgen, has been growing at a rate of around 19 per cent a year since 2007.
Amgen said that, in addition to Bergamo’s manufacturing capacity and market share, another key motivation for the deal was regaining Brazilian rights to the cancer drug Vectibix and the hyperparathyroidism medication Mimpara.
In a separate deal with Brazilian supplier Hypermarcas Amgen also bought rights to several other key products it had previously licensed.
The drugs in question, Vectibix and Mimpara, were previously sold in Brazil under license by recent Hypermarcas’ recent $1.47bn acquisition, Sao Paulo-based firm Mantecorp
Amgen has also regained rights to Nplate, its treatment for the blood disorder idiopathic thrombocytopenic purpura which is approved in the US and currently under review by authorities in Brazil.
Kevin Sharer, Amgen's CEO, said that: "Acquiring Bergamo, a profitable company with an established local infrastructure, and regaining the rights to our products in Brazil, provides us an attractive entry into the Brazilian market."
Amgen said that the acquisitions are part of its plan to grow in emerging markets and establish itself as a top five pharmaceutical firm by the year 2015.
The National Institute for Bioprocessing Research and Training (NIBRT) opened its doors in Dublin on February 21 to provide research, training and education for all aspects of bioprocessing. According to its new director, Professor Ian Marison, the 6,500 m2,
(69,940 sq. ft.) purpose-built building will provide infrastructure ranging from small-scale pilot suites to a factory-scale production environment, and will focus on biologics and small molecules.
The government-funded NIBRT will be run as a collaborative effort by four Irish universities. The aim is to support local companies and to attract new industrial partners both at home and abroad. Marison says that what makes NIBRT special is that its activities will be solely driven by industry need. Once a biomanufacturing need is identified, the NIBRT will put together diverse expertise to solve it in collaboration with industry. If a problem is deemed especially important, the NIBRT may recruit a basic research laboratory to work on it long term. The ethos is flexibility.
The institute might engage in contract research for companies or can collaborate as equal partners. The NIBRT can also host visiting industrial scientists, and vice versa. This flexibility will also be reflected in new intellectual property, which can be generated and owned by the universities, by the industrial stakeholders or as a partnership.
Eisai Inc. and its parent company Eisai Co., Ltd. announce the establishment of a subsidiary company in Brazil, which will be named Eisai Participações Ltda. (Eisai Brazil). As a direct subsidiary of Eisai Inc., Eisai Brazil will be based in Sao Paulo, the country's largest city.
"The establishment of Eisai Brazil marks our entry into Latin America," said Hajime Shimizu, President, New Markets and ASEAN, Eisai Co., Ltd "In keeping with Eisai's mission to satisfy unmet medical needs and contribute to the health and well-being of people worldwide, this expansion will enable us to introduce many of Eisai's first-in-class products to people living in Brazil."
Eisai Brazil's immediate focus will be on establishing an initial infrastructure to support its operations debut into the Brazilian market. The company's areas of commercial focus will include neurology, oncology and critical care.
Eisai Inc. was established in 1995 and is ranked among the top-20 U.S. pharmaceutical companies (based on retail sales). The company began marketing its first product in the United States in 1997 and has rapidly grown to become a fully integrated pharmaceutical business. Eisai's areas of commercial focus include neurology, gastrointestinal disorders and oncology/critical care. The company serves as the U.S. pharmaceutical operation of Eisai Co., Ltd., a research-based company that discovers, develops and markets products throughout the world. Eisai has a global product creation organization that includes U.S.-based R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania as well as manufacturing facilities in Maryland and North Carolina.
The company's areas of R&D focus include neuroscience; oncology; vascular, inflammatory and immunological reaction; and antibody-based programs.
SIRO Clinpharm, the Mumbai, India-based contract research organization (CRO) has expanded its operations into Malaysia.
The company already maintains a strong presence across the region after forming strategic alliances with Taiwanese CRO, Virginia Contract Research, and South Korea-based clinical trials specialist, DreamCIS, in 2010.
Anjit Nair, SIRO’s vice president of clinical operations in Asia, explained the reasons behind the move.
“Besides advantages common to other Asian countries, what attracted us to Malaysia was a robust regulatory framework with complaint timelines strong government commitment towards clinical research and modern medical facilities.”
Rajenedra Talele, vice president of clinical operations in Asia, said SIRO had big plans to make the most of rapid growth in the region.
“Malaysia is a highly developed and fast growing clinical trials destination and we are extremely proud to be one of the first India headquartered CROs to announce its operations.”
He went on to reveal that the company’s first phase of service offerings will include clinical monitoring and project management activities.
Commenting on the announcement, Chetan Tamhankar, SIRO’s CEO, said the company had plans to expand into other Asian countries, and were already sizing up potential destinations.
“This expansion in Asia gives us an opportunity to immediately offer and additional geography to conduct clinical trials to our existing as well as potential clients,” he said.
“From a futuristic expansion perspective, we are in the process of evaluating the Philippines and Thailand amongst other Asian countries.”
Early in 2010 SIRO Clinpharm entered into talks with Indian healthcare company, Biocon over a potential partnership centered on Biocon’s Clingene contract research services business. However, Biocon backed out of talks later that year before an agreement could be reached.
SIRO Clinpharm has since expanded its operations across Europe, forming partnerships with UK regulatory affairs specialist, CambReg, and French early-stage contract drug development group, Mediscis Medical Science Services.
Germany-based Glycotope Biotechnology has stated adding new cleanrooms at its antibody production facility in Heidelberg.
The addition of cleanrooms is the first stage of an expansion program that will eventually see the Glycotope increase its annual antibody production capacity at the plant from its current level of 4kg to 11kg by the end of the year.
In total the firm, which is a subsidiary of Berlin-based Glycotope, will add 1,400 sq.meters
(15,064 sq. ft.) of manufacturing, downstream processing and office space at the facility.
Steffen Goletz, founder and CEO of Glycotope, predicted that the expansion will position the firm “among the top providers of GMP-production for recombinant proteins and in particular antibodies in Germany”.
Bayer CropScience today announced the opening of an expanded seed research laboratory in Singapore to support development of new high-yielding and high quality seed varieties and hybrids.
The center represents a €20 million ($28.4 million) investment over the next five years, and research will employ cutting-edge technologies such as DNA biomarker analysis and molecular-assisted breeding.
The original rice seed analytics laboratory has been relocated and expanded to support a broader range of seed breeding and development work across Asia/Pacific, Bayer said.
Researchers at the new facility will screen and integrate innovative agronomic and quality traits in canola, corn, cotton, wheat, soybean, and rice. Additional work will be directed at plant pathology for better control of disease. Agronomic traits of interest include new modes of enhanced resistance to disease, pests, and environmental stress.
Quality traits of interest include better storability, easier processing, improved grain quality and nutritional profile, better cooking features, and in cotton, enhanced fiber quality.
Currently 15 scientists and technicians are employed in the new facility, which has a capacity for more than 30 researchers. Bayer said that it anticipates demand from its customers in Asia/Pacific for high quality sees to grow and plans to further invest in R&D as well as infrastructure to expand its seed business.
Icon has opened an office in Shanghai, China and plans continue expanding by increasing its presence in Beijing and Guangdong.
Expansion in China follows continued sponsor interest in the country and wider Asia Pacific region. To establish the scale sponsors want Icon has opened a small Shanghai office, which will employ up to 15 people, and is looking to expand into new regions.
“The next location will be Guangdong”, said Alan Morgan, president, global clinical research services at Icon. Icon is particularly interested in Guangdong because of the concentration of Chinese State Food and Drug Administration (SFDA) approved trial sites in the area.
Expansion in Beijing is also planned. Icon already has a presence in Beijing but is looking to relocate to a larger site. In-house operations are supported by Icon's China-based partner Tigermed, which has its headquarters in Shanghai. Having Tigermed nearby allows Icon to, for now, operate a relatively small office in Shanghai.
Although Icon and others are investing in China the country is yet to realize its potential. “China is important but regulatory lead times mean that it's limited in its role in global clinical trials”, said Morgan. Consequently, “there's an artificial market in China at this time”, with CROs investing in anticipation of it truly taking off.
The market in other countries in Asia Pacific is more mature. South Korea is now a “very, very strong” market for Icon, driven, in part, by changes to Japanese regulations that free up companies to recruit patients from overseas.
In response to the change Japanese companies want to outsource trials to China, Taiwan and South Korea and Icon has benefited. Gains made by Icon come at the expense of local Japan-focused CROs and the market for these companies is now under threat, said Morgan.
To support expansion of operations in the region Icon has appointed Malcom Burgess as executive vice president (EVP), Asia Pacific. Burgess has moved to China to take the position but it is rare for Icon to relocate its Western staff to Asia Pacific.
Employees at the Shanghai and Beijing offices mainly come from China and Taiwan. However, hiring experienced, senior-level staff in China is a challenge and as such Icon chose to relocate Burgess. Recruiting experienced staff in South East Asian countries, such as Vietnam, is another challenging area.
In India retaining staff is difficult. As in all countries, competitive salaries, career development opportunities and special measures help retain staff. Also, retention is easier in areas where fewer competitors have operations.
Chiltern International, a global contract research organization (CRO) has expanded its European operations with the opening of a new office in the Netherlands.
The Berkshire, UK-based company claims the office, located in Leiden, will help it capitalize on an increasingly favorable market in the Low Countries- an area including Belgium, the Netherlands and Luxembourg.
Commenting on the announcement, Maurizio Passanisi, Chiltern’s director in the region said: “The Netherlands continues to be an excellent place for clinical research with experienced investigators as well as highly regarded international key opinion leaders, all adhering to the highest of medical standards."
Newly appointed Netherlands country manager, Angela Pasma, said Chiltern hoped to build on existing ties with other Benelux companies and clients.
“Having already cultivated positive relationships with clients and colleagues in the region, we look forward to expanding our operations here to further serve our clients’ needs,” she said, “The Leiden office is well situated geographically to support this effort.”
“In leading the growth of the Chiltern office in Leiden, Ms Pasma brings a wealth of knowledge and experience to support Chiltern’s growing full-service clinical and flexible staffing services in the region,” he said.
Armand Czaplinski, executive director of global country management for Chiltern, said the opening of the Leiden office made perfect sense as the company looks to increase its presence across Europe.
Situated in the south of the Netherlands, Leiden is home to Leiden University: one of Europe’s foremost research institutes, with departments specializing in translational drug discovery and development, biopharmaceuticals and drug delivery technology.
Schott Pharmaceutical Packaging detailed its expanded worldwide production capacities in Argentina, Japan, and Russia.
A new production facility for ampules and vials in Argentina augments existing facilities in Brazil and Colombia. This move was the result of two prior acquisitions. In summer 2009, Schott acquired parts of two Argentinean pharmaceutical packaging manufacturers, Medical Glass S.A. and DIESCA S.A., and incorporated their business activities into a new subsidiary, Schott Envases Argentina S.A. The new plant to the north of Buenos Aires efficiently consolidates production previously spread over two locations.
“The combination of the company’s local market experience, access to customers, and technological know-how makes SCHOTT a strong partner for the Argentinean pharmaceutical industry,” said Jurgen Buhr, Director of Schott Pharmaceutical Packaging in South America. “At the same time, this will open up opportunities for us in other South American markets as well.”
Earlier this year, Schott and Japanese company Naigai Glass Industry Co. Ltd. founded a joint venture for pharmaceutical packaging activities in Japan. The new company, Schott Naigai K.K., is based in Osaka, Japan, where Naigai has been operating a production site for many years. The two companies have had a long-standing buyer/supplier relationship in which Schott supplied pharmaceutical glass tubing to Naigai for primary pharmaceutical packaging products. Naigai has shifted its existing vial manufacturing activities over to the new company, which will make use of Schott's automatic inspection system (AIS).
“As a result of this collaboration, customers will benefit from the high quality and technology standards, as well as supply safety along the entire supply chain,” says Dr. Juergen Sackhoff, Executive Vice President of Schott Pharmaceutical Systems.
In May 2011, Schott Pharmaceutical Packaging will open its latest manufacturing facility for premium quality ampoules and vials in Zavolzhe, near the Russian city of Nizhny Novgorod. Adjacent to another Schott facility in Nizh-ny Novgorod, it will produce several hundred million ampoules and glass vials made of Schott Fiolax glass tubing annually. Schott is the first international manufacturer of glass primary pharmaceutical packaging to open a production facility in Russia.
“The new plant in Russia represents yet another important step in our global growth strategy in the area of pharmaceutical systems,” said Prof. Dr. Ing. Udo Ungeheuer, Chairman of the Board of Management of Schott AG. “This will allow us to further extend our leading position in the area of high-quality pharmaceutical packaging in Russia and we will be able to satisfy local demand even better in the future.”
Almac Diagnostics, a branch of UK-based contract research organization (CRO), Almac, has opened a Clinical Laboratory Improvement Amendments (CLIA) registered lab at its headquarters in Craigavon, Northern Ireland.
The company said the new facility will help support its on-going biomarker discovery and development strategy by allowing it to develop novel biomarkers for clinical use.
Commenting on the news, Paul Harkin, president and managing director of Almac‘s diagnostics business unit, said the lab had been opened to meet both Almac’s needs, and also those of its pharma partners.
“We have come to a point where the biomarkers we have discovered and assays that we have developed are being used to stratify patients, enrich clinical trials and impact patient treatment decisions,” he said.
“As such, CLIA is a key necessity for the processing of these samples.”
Almac said that in addition to standard molecular tests, it is also developing a pipeline of both internal clinical tests and companion diagnostic tests with its pharma partners. The company said the CLIA laboratory would play a large part in the testing process.
The firm’s genomics laboratories have been involved in biomarker discovery projects for the past eight years, with its diagnostics unit already operating under ISO17025 accreditation and working to Good Laboratory Practice (GLP) principles.
The company recently transferred its US staff to a new, custom-built $120m (€85m) facility just south of Philadelphia, US.
Introduced in 1988, the Clinical Laboratory Improvement Amendments are US regulatory standards designed to improve the quality of testing in laboratories that examine human specimens.
During their two-year registration period, Almac can conduct ‘moderate or high complexity tests’ on the premises, after which full CLIA accreditation must be approved by Medicare and Medicaid - the US government administered health programs.
But since their introduction in 1988, CLIA regulations have been described as a thorn in the side of doctors, researchers and biotech companies, with critics claiming the approval process is lengthy, cumbersome and unnecessarily bureaucratic.
Marken plans to expand internationally by building clinical trial supply depots, similar to its new Singapore site, around the world.
Future clinical trial supply depots will follow the wholly owned, purpose-built model Marken used for the Singapore site. Marken took this approach to meet demand for one-stop-shop clinical trial logistics services and, with the Singapore depot completed, is planning further expansions.
Construction of similar depots in India, China, Japan, and beyond Asia Pacific is being considered, said Lee-Peng Goh, global CTS (clinical trial services) director at Marken.
Opening depots over the next five years will give Marken a network of supply sites based on the Singapore-model. Like the 14,500 sq. ft. Singapore supply depot, each of the new sites will provide a range of clinical trial logistics services.
From the Singapore site Marken can provide: storage and distribution; returns and destruction; kit building; and short- to long-term storage of biological specimens in ultra low freezers. A range of storage temperatures from ambient down to -80ºC are possible at the Singapore site.
Marken will provide these services to clients from around the world who need to distribute Phase I to IV clinical trial materials in Asia-Pacific. Singapore is very convenient logistically, says Marken, and materials can be moved quickly and easily in and out of the clinical trial supply depot.
The Singapore site was audited in February and, within a week of the visit, received regulatory clearance. Now, Marken is working to secure Asia-Pacific logistics and distribution contracts for the site.
Discussions with one client are at an advanced stage and Marken expects the depot to begin operations in April. Potential clients and other interested parties were shown round the site this week in an opening in conjunction with BioPharma Asia Convention 2011.
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.”
Hungarian plastics processor Karsai Plastic Holding is forecasting its profits will more than double this year, reflecting its strong recovery following the global recession of 2008 and 2009.
Karsai group companies are upgrading and expanding their operations this year to meet growing demand for molded plastics products, including automotive components, packaging and specialist containers.
The group plans to make investments worth €4.5m during 2011. Projects include an injection of €2.2m to upgrade the Kunsplast-Karsai auto parts plant in Kiskunfélegyháza, Hungary. That will enable it to provide components to the new Daimler group Mercedes car assembly plant in nearby Kecskemét. A new Mercedes compact model is due roll off the line there in 2012 when construction of the €800m plant is complete.
Kunsplast-Karsai injection moulds polyolefin, polystyrene and technical plastics vehicle parts for manufacturers such as Suzuki and General Motors. Components include interior parts, wire-chase and exterior and interior lighting covers.
It also produces auto components molded in ‘duroplast’ thermoset composite and fibreglass strengthened SMC materials as well as injection molded bakelite.
Meanwhile, another group subsidiary, Karsai Alba is expanding. It is spending nearly €1.5m to build a 1,800m2 (19,368 sq. ft.) production hall at its plant in Székesfehérvár which is due for completion this spring. It is set to create 50 new jobs.
Alba concentrates on the production of packaging containers and caps for the pharmaceutical, cosmetics and food industries. It injection moulds and blow moulds products including phials, flasks, tablet dispensers, spray containers and PET bottles.
The 10,000m2 (107,600 sq. ft.) plant has a cleanroom and storage space for 4,500 pallets as well as a mold making shop.
Agilent Technologies announced the expansion of its Life Sciences and Chemical Analysis Center of Excellence in Bangalore as well as the opening of a Life Science development laboratory in an adjacent facility.
Together, the center and lab cover more than 8,000 square feet, making it the largest Agilent research facility in the world.
The Center of Excellence was originally founded in 2006 to serve Agilent's customers throughout India. The facility is now outfitted with the company's newest instruments, including the 6490 triple quadrupole and 6540 Q-TOF mass spectrometers, the 1290 and 1260 liquid chromatographs, 7700 Series ICP-MS, and 7000B GC triple quadrupole MS.
Agilent's core instruments, such as gas chromatographs, liquid chromatographs, mass spectrometers, electrophoresis, and genomics products also are available for evaluation.
"This is the first Agilent lab facility where development of application solutions, customer interactions, and training will happen in parallel," Parmeet Ahuja, country general manager for Agilent Technologies, India, said in a statement.
Contract research organization (CRO) Quintiles gained new ‘first-in-human’ (FIH) trial capacity with the opening of an ‘experimental medicine hub’ at Guy’s Hospital in London, UK.
The new suite also houses a pharmacy for trial materials, labs for stem cell and genetic research and a study information centre and is designed to encourage patient participation and foster closer links between scientists and health professionals.
Quintiles, which collaborated on the project with Guy’s and St Thomas’ NHS Foundation Trust and King’s College London, will operate the 30-bed Phase I unit for FIH and proof-of-concept drug research.
CEO Dennis Gillings, told attendees at the opening ceremony that: “The biopharma world is changing rapidly…it requires a new, highly collaborative approach that follows the “think global, act local” concept to ensure that scientific advances are translated into patient benefits.
“Our involvement in the Experimental Medicine Hub has increased our capacity to conduct proof of concept programs. These facilities bring Quintiles physically and professionally closer to academic and medical colleagues.”
The opening of the Phase I centre follows just a few months after Quintiles partnered with another organization in the English capital, genomics and proteomics specialist London Genetics (LG).
The accord, which was formed in November, also focused on building the CRO’s presence in the rapidly developing experimental and personalized medical research sectors by leveraging LG’s capabilities in pharmacogenetics.
The Guy’s Hospital Phase I unit is now one of six Quintiles operates and is the second to be opened this year behind the facility it unveiled in Hyderabad, India in January.
Like the London site, Quintiles established the Hyderabad 86-bed, INR400m (€6m) centre through a collaboration, partnering with the Apollo Hospitals Group which retains a 40 per cent holding in the facility.
The opening in London follows just 24 hours after the US CRO confirmed that it is still continuing to assess various partnering, acquisition and investment opportunities to drive growth.
Kerry Logistics has opened two distribution centers in China to serve pharmaceuticals, fine chemicals and other industries.
Having opened offices and logistics centers in major Chinese cities Kerry is now expanding into emerging, second tier regions. As part of this plan Kerry has opened logistics hubs in Chongqing and Kunshan.
“The new facilities in Chongqing and Kunshan add to our existing China network of 130 offices and logistics centers and continue our strategy of expanding our presence in emerging and second tier cities across the country”, said Edwardo Erni, managing director, mainland China.
Opening a 20,500 sq. m. (220,580 sq. ft.) logistics centre in Chongqing, in inland China, links Kerry via rail, air and the Yangtze River to the rest of the country. Transport links are helping Chongqing overcome its relatively remote, inland location and grow its business district.
Kerry aims to distribute pharmaceuticals, as well as electronics, fashion and other products. Companies can outsource labeling, packaging and distribution to regions throughout Southwest China, such as Sichuan Province, Guizhou and Yunnan Provinces, to the Kerry site.
The second logistics centre is in Kunshan City, 45km from Shanghai on the east coast of China. From the 18,800 sq. m. (202,288 sq. ft.) site Kerry will offer similar services to the Chongqing hub and distribute products to Shanghai, Nanjing, Hefei Province and other locations throughout east China.
Fine chemicals and pharmaceuticals are among the sectors Kerry expects to serve from the Kunshan site. Other target industries include electronics, precision machinery and semiconductors.
Sealed Air has taken a minority stake in SteriPack, a global supplier of medical packaging, with facilities in Ireland, Poland and Malaysia, for an undisclosed amount.
Sealed Air's NeliPak division, which has plants in Ireland, the UK and The Netherlands, specializes in thermoformed films and trays for the medical and pharmaceutical markets. The company will use the investment as a way to build on its presence in these sectors.
“We are thrilled about the long-term implications of this alliance,” said SteriPack’s group sales director Barry Moore.
“We are combining the strengths of both companies to deliver innovative product solutions in the area of medical device packaging. This alliance will enable both companies to extend their customer bases and provide profitable growth.”
A spokesman from Sealed Air added: “We have a growing business in aseptic packaging. This gives us another technology platform that complements our existing technology and also provides opportunity for further expansion.”
SteriPack houses its manufacturing capabilities in a Class 100,000 cleanroom and has been servicing the medical device industry worldwide for more than 16 years.
MTC Insulation Solutions has been awarded the second phase of a £2m project after its initial factory design enabled contract packaging company Wasdell Packaging to cut its production times.
The Solihull, West Midlands-based design and build specialist constructed a 5,574m2 (59,976 sq. ft.) factory for Wasdell last August. The A+, BRE Green Guide-rated factory exceeds Good Manufacturing Practice (GMP) and has been such a success that the company has now moved into 24/7 working and requires a new cleanroom.
Geoff Daren, commercial director at MTC Insulation Solutions, says he is delighted to have been awarded the second phase of the project for Wasdell Packaging
In the second phase, MTC will build an 800m2 (8,608 sq. ft.) cleanroom, including seven production lines, insulated walls, ceilings, a mezzanine extension and ventilation work to prevent over-cooling within the plant.
The £500,000 project is expected to be completed in May and will increase Wasdell Packaging’s capacity by a further 75 percent.
Geoff Daren, commercial director at MTC Insulation Solutions, said: “We are delighted to have been awarded the second phase of this project. The plant was specifically designed to allow future expansion and we’re pleased Wasdell Packaging has grown so quickly and is now working 24 hours a day, 5 days a week with plans to introduce weekend shifts.”
Containment laboratory supplier Telstar Group has been working with another Spanish firm, Indra Sistemas, to develop a mobile laboratory equipped to carry out the analytical identification of Nuclear, Radiological, Biological and Chemical (NRBC) threats for the Turkish Ministry of Defense.
The containment laboratory will detect the presence of high-hazard NRBC contaminants. It is integrated in a module that is easy to transfer to an operations zone and provides users with a clean working space that does not endanger their health, where collected samples can be studied and the results transmitted once they have been obtained. The 20ft module has been standardized to make it easy to transport to the required zone by helicopter or military aircraft.
Indra Sistemas has developed the laboratory, with Telstar Group involved in the design, integration and testing phase.
Telstar says the project acknowledges its technological capacity and knowledge of engineering in the design and development of critical and non-critical integrated facilities for the containment and life sciences field. The firm allocates 3% of its turnover to research, development and innovation in technology.
Future cooperation between the two firms is expected on similar projects at both domestic and international level, and in projects that require mobile, fixed or semi-fixed solutions.
This is not the first time that the Telstar Group has developed this type of modular laboratory for use in high biological risk areas. The firm also designed and manufactured laboratories for the Thai Health Ministry in 2007 to allow it to conduct field tests for the prevention and control of avian flu. The Group has also worked previously with the Spanish Army on the development and supply of a complete system for the treatment of biocontaminated waste.
Interior contracting firm ardmac has completed fitting out two new ultraclean operating theatres for the Cardiac Renal Centre at Cork University Hospital in Ireland. The completion of the two theatres is said to be a major step in advancing the delivery of high quality cardiac care throughout the south-west of Ireland.
Ardmac had full responsibility for the HTM-03 environment, which required the integration and coordination of specialist equipment such as: UCV canopies; surgeons’ panel; surgeons’ lights; pendants and gases and an audio-visual system.
As part of the design process and in order to reduce the occurrence of micro-organisms in the operating rooms and, more specifically, in the wound site, ardmac selected an ultra clean ventilation canopy, from supply chain partner Howorth, as the best solution for the operating theatres.
“This facility is all about increasing the levels of patient care within the region, and we are delighted to have been involved in the project,” said Dermot McKenna, group technical manager for ardmac.
Ardmac, which has offices in Dublin in the Irish Republic and Craigavon in Northern Ireland, and in Manchester, UK, provides controlled environments for high performance hospital applications including CL3 biosafety labs, operating theatres, sterile pharmacy suites, IVF labs, stem cell labs and isolation wards.
Engineers at the pharmaceutical plant calculated that their CIP costs would be reduced by 40%
Converting a manual CIP process to automatic across 80 reaction vessels, using pressure transmitters, condition sensors and flow meters, has enabled Burkert Fluid Control Systems to achieve savings of £120,000 per annum for a major UK pharmaceutical manufacturer.
Prior to the installation of the Burkert system, the reaction tanks were each cleaned for six hours, constantly flushed to drain with hot water at 70°C. This was a purely manual process based upon operator experience, rather than positive signals from the process that the cleaning procedure was complete.
The weekly costs for the manual cleaning procedure were substantial: energy costs were running at around £4000, with water at approximately £1,000 and effluent costs approaching the same figure. In total, the combined weekly figure across all activities included in the cleaning was £5,900, or a considerable £295,000 per annum.
The company suggested a solution for each reaction vessel based upon a Type 8311 pressure transmitter, a Type 8222 condition sensor and a Type 8041 flow sensor.
Keen to reduce these costs, engineers at the pharmaceutical manufacturer contacted Burkert and the company suggested a solution for each reaction vessel based upon a Type 8311 pressure transmitter, a Type 8222 condition sensor and a Type 8041 flow sensor. These products were installed on a test group of the vessels and linked the plant SCADA system.
The CIP process was then undertaken in an automatic mode, with the 8222 condition monitor providing effective feedback of when the water in the vessel was clean – and hence the vessel itself – to the SCADA system, which terminated the process.
On the basis of the initial tests, engineers at the pharmaceutical plant calculated that their CIP costs would be reduced by 40%, or £120,000 per year using the Burkert equipment.
‘This application highlights the savings that can be achieved on even the simplest of processes, as a result of consulting our specialist engineers,’ said Burkert UK sales manager, Neil Saunders. ‘All business sectors today are incredibly competitive, so all opportunities to exploit so-called ‘low hanging fruit’ have to be taken and optimized. The results speak for themselves, as evidenced by this application.’
McIlvaine Company
Northfield, IL 60093-2743
Tel: 847-784-0012; Fax: 847-784-0061
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