PHARMACEUTICAL & BIOTECHNOLOGY
INDUSTRY FORECAST
UPDATE
December 2012
McIlvaine Company
TABLE OF CONTENTS
Regenerative Medicine Campus Planned
UConn Establishes Genomics Institute, Partner for Jackson Lab
Capsugel Unveils Quality Control Laboratory
LGC Genomics has Opened a New Lab
Biogen Idec Opens New RTP Facility
Durata Therapeutics Moving Global Headquarters to Chicago
Genesis to Double Size of Cleanroom
DPT Laboratories Expands in Lakewood, NJ
BioLife Solutions Completes Expansion
PerkinElmer Working on New Personalized Health Innovation Center of Excellence
Tekni-Plex Expands Manufacturing Facility
Isis Pharmaceuticals Offers New R&D Facility
Sanofi Pasteur R&D Centre, Canada
Lewis Integrative Science Building, University of Oregon
Neurosciences Research Building, Indiana University, Indianapolis
Ahlstrom Announces Virus Testing Capability for Disruptor Water Filter Media
H3 Biomedicine Expands Cambridge Facilities
Intertek Pharmaceutical Services Pass Inspection
Medical Murray Opens New Design and Development Facility
Human Metabolome Technologies Open Facility
Merck Named Overall Winner in 2012 Facility of the Year Awards
Suzhou Pharma Services Receives Certification
AMRI to Close Bothell Site and Shift Work to Singapore
Covance Gets Chinese Preclinical Lab
TTY Biopharm Opens Drug Factory in China
Schott to Expand Pharmaceutical Packaging in Russia
MDxHealth, Ghent University Form Epigenomics Center
The National Institute for Bioprocessing Research and Training (NIBRT), Ireland
Pii to Double Sterile GMP Manufacturing Capacity
BioPure has ISO Class 7 Cleanrooms
Phillips-Medisize Completes Czech Republic Facility Expansion
ACM Global Relocates to Expanded Facilities
QPS Opens Expanded Phase I Unit in the Netherlands
Shionogi Pharmaceutical Research Facility, Osaka, Japan
PAREXEL and National Taiwan University Hospital Expand
Merck Millipore to Open New Bioavailability Lab
AstraZeneca, Pfizer to Develop Research Centre in Québec
Promega Opens New Facility in Shanghai
German Hospital Installs Copper Touch Surfaces
Aesica Ramps up HPAPI Capacity
California BioMed Realty Trust is planning to build a regenerative medicine campus in San Diego. The project entails building 150,000 sq. ft. of office, laboratory, warehouse and manufacturing space, which it has leased to Advanced BioHealing Inc., a regenerative medicine company that develops, manufactures and commercializes living, cell-based therapies. DPR Construction Inc. will serve as the construction manager. The project has been valued at between $25 million and $50 million.
Nashua, N.H.-based Resonetics, a supplier of polymer micromachining services for life-sciences, has opened a facility the company has dubbed “Lightspeed ADL,” an 8,000-square-foot center focused exclusively on micromachining process development, prototyping and pilot production. The lab will offer laser technologies including excimer, DPSS, CO2, femtosecond and picosecond workstations, and will be staffed with engineers, technicians, and skilled operators on two shifts, according to the company.
“With this investment, Resonetics has created a world-class capability to service the needs of the life-sciences industry,” said Tom Burns, CEO of Resonetics. “Speed to market is critical for our customers when launching new products, as is reliable, well-designed and validated manufacturing processes. Laser micromachining is an enabling process for some of the industry’s most cutting-edge technologies; Resonetics intends to maintain its leadership by dedicating significant resources to the product development process.”
Resonetics also has received its fifth patent granted by the U.S. Patent Office. The new patent is for apparatus for minimizing a heat-affected zone (HAZ) during laser micro-machining. The patent addresses a common problem in laser micromachining: In the application of lasers to micro-fabrication there is always a degree of undesired side effects due to the spread of laser energy to adjacent material. These include loss of geometrical fidelity of the cut, irreversible modification of the adjacent material properties and changes in its surface characteristics. These effects are often more pronounced in polymers.
According to Sergey Broude, Ph.D., vice president of technology at Resonetics, the company’s invention “manages the delivery of laser energy to the target so that the HAZ is minimized or effectively eliminated while the ablation throughput is kept as high as possible for a given laser. This efficient management is achieved by optimizing the configuration of the illumination field and the target scanning pattern.”
“The new patent is another example of how Resonetics continues to be at the forefront of innovation in laser micromachining,” added Burns. “It shows that we’re dedicated to providing our customers with products and services that offer the highest levels of quality and value.”
The University of Connecticut has established a new Institute for Systems Genomics that will seek to capitalize on the university's partnership with The Jackson Laboratory, which is building a $1.1 billion genomic medicine center at the UConn Health Center campus in Farmington.
UConn said on Monday that the new interdisciplinary institute will bring faculty from the university together with researchers from Jackson Lab, as well as representatives from nine of the university's schools, including its medicine, nursing, engineering, and agriculture, and pharmaceutical programs, among others.
Mun Choi, UConn's interim provost and executive vice president for academic affairs, said in a statement that the institute will undertake research involving human, animal, and environmental genomics, and over the next year the school will support the institute by hiring new faculty and appointing a professorship in genomics and personalized medicine.
The university wants the institute to be a research and training program focused on genomics and personalized medicine, to partner with academic and corporate partners, and to encourage students to tackle genomics-related science as a career.
"The Institute for Systems Genomics is the vehicle to foster collaboration between UConn and The Jackson Laboratory in genomics research and education," Marc Lalande, professor and chairman of Genetics and Developmental Biology at the UConn Health Center, and the new institute's director, said in a statement.
Jackson Lab President and CEO Edison Liu, who will serve on the institute's senior advisory council, said in a statement that it will "provide the intellectual critical mass needed to propel The Jackson Laboratory for Genomic Medicine to the front of the pack."
Capsugel has doubled its laboratory capacity with the opening of a new US$3m Quality Control Laboratory in Greenwood, SC.
The laboratory will add a global resource to its network of manufacturing sites and R&D laboratories in Boston, US and Strasbourg and Colmar in France.
The US-headquartered dosage forms specialist says the new facility will be a global centre of excellence for quality control and testing of all raw materials and finished products for Capsugel sites worldwide.
Guido Driesen, president and CEO of Capsugel, said: ‘Our new Quality Control Laboratory positions Capsugel for future growth in an increasingly complex regulatory marketplace.
‘Quality is the hallmark of our business and a core principle at Capsugel that provides added value to our customers. Our thorough testing equates to faster time to market as our products are designed to comply with today’s strict regulations.’
The 9,600 sq. ft. facility will provide a range of analytical and microbial testing services, as well as development of color formulations.
With the new capacity, Capsugel has expanded its Global Stability Program with walk-in stability chambers and photo stability chambers, which are used to support the shelf life of the finished products, to register new products in different countries, and to conduct studies to determine the impact of different temperature and humidity conditions on the quality of the capsules. By the time a product is ready for market it may have gone through up to 23 individual quality tests at the new laboratory, the company says.
LGC Genomics has opened a new lab facility in Hoddesdon, North London. The firm, which provides genomic products and services, is 25,000 square feet and houses offices, lab, and warehouse space. The new facility opening follows the firm's expansion in the US, where it opened a lab facility near Boston.
Biogen Idec has dedicated a new facility in Research Triangle Park (RTP), consolidating its 300-person Patient Services operation with the existing RTP campus. The new 190,000 square foot building is anticipated to achieve LEED-Gold certified status in the coming months and will accommodate increasing levels of manufacturing activity at the site. The official groundbreaking for the building was in April of 2011.
“With the opening of this beautiful facility Biogen Idec has united on one site more than 1,000 people dedicated to meeting the needs of patients with serious diseases,” said George A. Scangos, Ph.D. and chief executive officer, for Biogen Idec. “The expansion of our footprint in RTP underscores our commitment to providing a secure supply of medicines and to helping patients overcome obstacles to receiving them.”
As the “front door” to the Biogen Idec campus in North Carolina, the five-story Building 26 will initially house 500 employees.
“Our RTP site focuses on patient care – from manufacturing high quality therapies to providing patient support and financial assistance. With this new building, our employees are constantly reminded of our purpose through the patient stories that adorn the main areas and workspaces within the building,” said Machelle Sanders, vice president, Manufacturing and general manager, for Biogen Idec RTP.
“North Carolina is a leader in biotech and Biogen Idec is an important part of that success,” said Gov. Bev Perdue. “This new facility will further strengthen the company’s manufacturing and Patient Services operations, in addition to helping ensure its continued success in North Carolina.”
The Morristown, N.J., firm is developing a single drug, dalbavancin, a once-weekly intravenous antibiotic aimed at acute bacterial skin infections and skin structure infections. The product has not been approved commercially to treat patients.
The 3-year-old company, which has no reported revenue, acquired the rights to the drug from Pfizer Inc. in December 2009 and initiated two rounds of late-stage clinical trials. Durata plans to submit the drug for approval to the Food and Drug Administration in the first half of next year.
Durata's move will helped by a package of state incentives that includes tax credits tied to job creation. It will be eligible for up to $2 million in tax credits over a 10-year period, provided it is able to bring dalbavancin to market.
The company, which employs about 35, expects to add about 100 new workers here within three years. It has moved some employees into its new offices at 200 S. Wacker Dr., said Paul Edick, Durata’s chief executive.
Durata said several of its executives have ties to the Chicago area, including its chief executive, Edick, who lived in the city in the 1990s as an executive of G.D. Searle, a Skokie-based drug company acquired in 2000 by a firm that would later become part of Pfizer. John Shannon, Durata's chief commercial officer, also spent time at G.D. Searle before joining Baxter International Inc.
Durata went public in July, raising $73.9 million in its initial public offering. It is using those proceeds to finance its attempt to bring dalbavancin to market. It has spent nearly $100 million in the effort, according to federal securities filings.
The company targeted Chicago, Edick said, in part because "it’s a fertile recruiting ground for us," with a growing biotech industry footprint.
Genesis Plastics Welding, a U.S. contract manufacturer, is investing US$500,000 to expand its Class 7 cleanroom to increase production capacity of radio frequency (RF) plastics welding of medical devices, supplies and equipment.
The Indianapolis-based company is doubling the size of its current medical cleanroom, a controlled environment that meets the medical device cleanroom requirements of an ISO Class 7 Standard 14644 clean zone for particle count testing.
The cleanroom features a number of heat-sealing processes including impulse welding, sonic welding and RF welding of polar and non-polar materials. Thermoplastics heat-sealing of non-polar materials is achieved using the company’s ecoGenesis proprietary technology. There is also a gown room that meets the requirements of an ISO Class 8 cleanroom.
“The expansion of our medical cleanroom is an important milestone in our growth initiatives,” said Tom Ryder, president and chief executive of Genesis Plastics Welding.
“The medical industry is a key vertical market where Genesis can bring significant value. Our heat-sealing services paired with an ISO Standard 14644 medical cleanroom enable us to provide high quality, FDA-compliant contract manufacturing services to medical device, supply and equipment companies around the globe.”
Genesis welds medical products such as surgical instrument covers, medical device inflatable components, oxygen hoods, compression therapy and DVT sleeves, cooling caps, disposable warming blankets, cooling therapy products, fluid bladders and drainage bags.
DPT’s new sterile center will focus on aseptic production of sterile dosage forms to include small-volume parenterals, ophthalmic preparations, preservative-free nasal sprays and sterile ointments.
The firm has invested more than US$30 million to enhance the 175,000 sq. ft. center. Additional features include new water for injection, clean steam and HVAC systems, as well as a microbiology laboratory. This micro lab provides in-house microbiology testing services such as environmental monitoring, sterility testing using isolation technology, and endotoxin testing. The centre is also equipped with pharmaceutical cleanroom assets that include Class A filling suites, Class B and C support suites and Class D component preparation areas.
“Not only did we invest in the facility, but we also hired the right individuals who are experts in this field,” said Gene Ciolfi, DPT’s general manager for sterile and specialist products.
DPT’s Centre of Excellence for Research & Development in San Antonio will work with staff in the new centre to provide pre-formulation and formulation development activities as well as analytical development services and technology transfers. DPT has more than 1,000 employees, including more than 100 scientists and engineers.
“The industry is ready for a service provider who is focused on providing solutions for clinical, small-lot, and large scale sterile manufacturing needs,” said J.J. Feik, director of marketing and corporate development for DPT. “I believe with our combined reputation for expertise, quality, service and regulatory compliance, we are a logical choice for contract sterile manufacturing and development services.”
BioLife Solutions, a US manufacturer of clinical grade hypothermic storage and cryopreservation freeze media for cells and tissues, and a contract manufacturer, has completed the expansion of its corporate office and operations workspace.
The firm says the move will enable it to increase production of its HypoThermosol and CryoStor biopreservation media products as well as store raw materials and finished products manufactured under contract.
BioLife Solutions has also completed the build-out of its second current Good Manufacturing Practice (cGMP) cleanroom suite.
Mike Rice, chief executive of BioLife Solutions, said: ‘We are currently in a hiring and expansion phase, thanks to the growth of our customer base and increased demand for our products.
‘Our second, independent, multi-classed cGMP cleanroom suite is currently in the validation phase and we look forward to bringing this on line early in the fourth quarter of 2012.’
Certified to ISO 13485:2003 since 2009, the company's manufacturing facility and quality systems meet 21 CFR Part 820 – Quality System Regulation for Good Manufacturing Practices (GMP) of medical devices, 21 CFR Parts 210 and 211 covering GMP for Aseptic Production, Volume 4, EU Guidelines, Annex 1 for the Manufacture of Sterile Medicinal Products, ISO 13408 for aseptic processing of healthcare products, and ISO 14644 for Clean Rooms and Associated Controlled Environments.
Rice continued: ‘Our investments in additional manufacturing capacity and new team members will enable us to meet current and future demand for our proprietary products. We’re also actively seeking new contract manufacturing opportunities to leverage our capacity and expertise.’
Once fully validated and staffed, BioLife Solutions’ management forecasts that total annual production capacity will be in excess of 120,000 liters.
JM Coull is renovating a cleanroom for Caliper Life Sciences, now part of PerkinElmer, a global technology company dedicated to improving the health and safety of people and the environment, in Hopkinton, Massachusetts. The cleanroom will accommodate a cell manufacturing process as part of the development of the company’s new Personalized Health Innovation Center of Excellence which will focus on creating new enabling technologies for scientists developing and commercializing new diagnostic and therapeutic products.
The renovations will encompass 7,000 square feet of clean and non-clean space for the production of microfluidic cells. In addition to the construction of the ISO 5 (Class 100) and ISO 6 (Class 1,000) cleanrooms, the project will include an upgraded electrical service, roof membrane replacement and a new power generator. The microfluidic cell cleanroom is scheduled to be completed in four months.
The project is JM Coull’s fifth with Caliper Life Sciences. JMC Coull previously completed renovations and additions to two buildings at the company’s Hopkinton, Mass., facility.
In preparation for the cleanroom project, JM Coull visited PerkinElmer’s location in California to learn about the manufacturing process. The knowledge aided the team in working with project architect Gorman Richardson Lewis Architects, of Hopkinton, Massachusetts, during the planning and design phase.
JM Coull is a construction management and design-build firm specializing in new construction and renovations for the life sciences industry. The firm uses an integrated approach to project management and focuses attention on the early phases of a project, using its proprietary StartSmart® process, to ensure overall success. The company works throughout New England from its offices in Maynard, Mass., and Shelton, Conn.
Tekni-Plex, Inc. is investing more than $9 million to upgrade and expand manufacturing infrastructure at its facility in Flemington, NJ. The investment will add new capabilities and additional capacity to meet customer needs.
The Flemington facility primarily produces multi-layer flexible packaging structures for a range of heatseal and pressure-sensitive closure liners for pharmaceutical, food and beverage, cosmetic, automotive and other applications, as well as lidding foils for pharmaceutical blister packs, medical device packaging and pouch materials. Manufacturing capabilities include extrusion and dry bond lamination, coating, slitting and printing.
“Upgrading our Flemington facility enhances our ability to meet the needs of our expanding customer base with high-quality, competitively-priced products and provides the foundation to introduce new and innovative products,” said David Andrulonis, general manager and vice president of Tekni-Plex’s Flexibles Division. “The project also utilizes the vast experience of our dedicated workforce to deliver a pipeline of new products nearing commercialization.”
Isis Pharmaceuticals inaugurated a new research and development (R&D) facility at Carlsbad in California, USA. The new facility is provided with sophisticated drug discovery and development facilities. It acts as both corporate headquarters and R&D centre for the company. It was built at a cost of $49m.
The facility is located at Carlsbad Oaks North Business Park, which is a 414 acre development in Carlsbad, built for corporate business development. The Carlsbad Oaks North is developed by BioMed Realty Trust. The completion of the new facility increased the total space rented by BioMed to Isis to 204,700ft2.
"The facility acts as both corporate headquarters and R&D centre for the company. It was built at a cost of $49m."The research laboratory at the facility is built over a floor space of 176,000 sq.ft.
It features modern laboratories for the promotion of innovation and to encourage interdisciplinary collaborations. It has ample outdoor space for informal meeting areas and for the exchange of ideas. It is also features laboratories with mobile bench cabinets.
The facility contains administrative offices, a central utility plant, about 550 parking spaces, a warehouse, an outdoor dining area and a sports court. It is accessible by Interstate Highway 5 through Palomar Airport road.
The building is incorporated with modern design features such as maximum use of natural lighting, eco-friendly equipment such as solar panels and drought-resistant native landscaping. It is expected to qualify for Silver LEED certification from the US Green Building Council.
The preconstruction activity included developing a 12 acre greenfield site in the Carlsbad Business Park. The construction was completed three days ahead of the scheduled completion of 13 months.
More than 350 construction crews from 30 trades were employed in the construction of the facility. A total of 280,000 working hours were completed in the construction of the building without any report of an injury. The usage of building information modeling (BIM) in the construction significantly reduced the coordination problems in the field and, as a result, the project was completed within the stipulated time.
The new facility is used for carrying out research, discovery and development of new drugs by using antisense technology to treat various diseases. It is engaged in the development of RNA-based drug discovery.
"The building features maximum use of natural lighting, eco-friendly equipment such as solar panels and drought-resistant native landscaping."Isis also plans to play a lead role in the development of antisense drugs through the new facility. The company has already initiated the research and development of mipomersen (Kynamro), an antisense drug being developed for the reduction of cholesterol, at the Carlsbad facility. A new drug application (NDA) for the same is currently under review by the US FDA. Isis is developing the drug in collaboration with Genzyme.
The research facility was designed by DGA, an architectural firm based in San Diego. The general construction contract was awarded to DPR Construction, which is also based in San Diego. DPR also acted as construction manager and management advisor for the project. The civil engineering services were provided by O'day.
Isis Pharmaceuticals is a US-based biopharmaceutical company engaged in the discovery and development of novel drugs. The company has a product portfolio of 24 drugs including those for the treatment of metabolic, cardiovascular, cancer, and neurodegenerative diseases. It primarily focuses on drug discovery and productivity.
Sanofi Pasteur, the vaccine division of Sanofi, opened a new vaccine research and development centre in Toronto, Ontario, Canada, in July 2011. The R&D facility is located at Sanofi Pasteur's Connaught Campus and will focus mainly on the development of vaccines for cancer and pediatric ailments.
University of Oregon's (UO) new Robert and Beverly Lewis Integrative Science Building (LISB) was opened in November 2012. Named after the university's alumni, Robert and Beverly Lewis, the new facility was built at a cost of $65m.
The facility will carry out cutting-edge, interdisciplinary research activities. It will be home to biologists, psychologists and researchers of various disciplines.
"The facility will carry out cutting-edge, interdisciplinary research activities."Research activities form a core part of UO's functions. In 2011, the university sponsored $120m in research activities which fostered innovations. This in turn generated about $7.9m revenue through licensing for the university. These activities also supported the Oregon economy and generated new jobs.
The LISB will help in further expanding the university's research activities. It will address the need for additional research space required due to increase in enrolment and sponsored research activities.
The facility will enable researchers to focus on individual as well as collaborative research activities. It will bring different groups of researchers together to carry out fundamental research starting from cellular processes to finding cures for major ailments.
LISB is located within the university's Lorry I. Lokey Science Complex. It links all the other science buildings in the complex including Lokey Laboratories, Huestis Hall, Streisinger Hall and Klamath Hall.
LISB is spread over an area of 103,000 sq. ft. and includes five levels. Four levels are above ground and include laboratories, 46 faculty offices, wet and dry labs, ERPS booths, meeting areas and office space. About 30,000 sq. ft. of laboratory space in the facility is dedicated for life and materials sciences. The underground level houses mechanical equipment.
The facility has been designed to encourage collaboration between researchers. The labs have an open layout design with shared laboratory facilities. All the walls and doors of the building are made of glass enabling equipment and facilities to be viewed from outside. The atrium has glass walls and stadium style seating. The walls double up as a whiteboard inviting participation and sharing of ideas.
"The facility has been designed to encourage collaboration between researchers. The labs have an open layout design with shared laboratory facilities. "LISB houses the Support Network for Research and Innovation in Solar Energy (SuNRISE), the Center for Sustainable Materials Chemistry (CSMC), and the Robert and Beverly Lewis Center for NeuroImaging.
SuNRISE is an instrumentation facility which can be used by industrial and academic clients for a fee. The CSMC will carry out green chemistry research.
The NeuroImaging centre will carry out research in cognitive neuroscience and other disciplines. It is equipped with a Siemens MAGNETOM Skyra 3T magnetic resonance imaging (MRI) scanner, which can carry out full body scans. The scanner weighs nearly 12,716lbs and was installed by removing an exterior wall of the facility. It cost about $2.7m and will be used to carry out neuroscience research.
About $30m of the funding for the LISB came in through Article XI-G bonds, which is the biggest G-bond investment made in the university's history. The remaining $35m came in the form of grants and private donations. Donors included Robert and Beverly Lewis ($10m), Lorry I Lokey, William Swindells, the James R Kuse Family Foundation and Rosaria Haugland.
The MRI scanner was partly funded by a federal grant provided by the Telemedicine and Advanced Technology Research Center (TATRC).
LISB has been built according to Leadership in Energy and Environmental Design (LEED) Platinum standards. It makes extensive use of natural daylight and features a green roof. The roof includes a heat recovery unit which recovers heat from exhaust air. The majority of the heat required by the building is provided by the unit. A total of 28 solar panels are also installed on the roof top for preheating water.
The building is fitted with chemical fume hoods featuring automatic sashes. The sashes automatically close when idle and conserve energy by reducing exhaust flow.
Bamboo has been used for majority of the wood finish works in the facility. The energy usage by the building is reduced through use of chilled beams and radiators.
Other sustainable features include building control and daylight sensors, green lights, and reclaimed water usage.
HDR and THA Architects were the architects for the building. The construction manager was Lease Crutcher Lewis.
Construction of a new neurosciences research building at Indiana University (IU) was initiated in August 2012, and is scheduled to be completed by 2014. It is located near 16th Street and Senate Avenue, near the IU Health Methodist Hospital.
Ahlstrom Corporation has internally validated a biological testing laboratory at its Advanced Filtration plant in Mount Holly Springs, PA, to support the global growth of its Disruptor water filtration technology.
With this lab, Ahlstrom is able to test Disruptor for the removal efficiency, or Log Reduction Value (LRV), of virus and bacteria.
“Submicron efficiency validation of Disruptor is critical for our customers who are using Ahlstrom Disruptor in the most demanding drinking water applications. New laboratory techniques were also developed specifically for rapid flat sheet LRV testing of cryptosporidium (cysts) sized particles as well,” says Rod Komlenic, product manager for Disruptor technology.
Ahlstrom Disruptor water filtration technology delivers the filtration efficiency of ultrafiltration or reverse osmosis membranes but at flux rates many times higher than possible with polymeric membranes. The Ahlstrom Disruptor technology is capable of reducing many pathogens, cell debris and a wide range of submicron particulates through electroadsorption and hydrophobic interactions.
Due to its large pore size, it is not possible to test the sub-micron removal efficiency of Ahlstrom Disruptor using test methods typically used for nonwoven macrofiltration media the company says. Currently used tests such as bubble point, pore size, monodispersed beads or test dusts are all virtually not compatible as direct indicators of pathogen reduction or filtration efficiency in the submicron range when dealing with adsorptive media.
“The construction of this lab is the first of its kind within Ahlstrom to have been installed at a plant site for testing of pathogen removal by a nonwovens media,” says Fulvio Capussotti, vice president of Advanced Filtration. “This investment again demonstrates Ahlstrom’s continued commitment to the highest quality standards for all grades of Ahlstrom Disruptor water filtration media.”
Following a productive first year of headcount growth and scientific advancement, H3 Biomedicine Inc. (H3), a biopharmaceutical company specializing in the discovery and development of oncology treatments, announced that it has completed an expansion of its headquarters and laboratory facilities in Cambridge, Massachusetts. The increase more than doubles the company's original space to approximately 48,000 square feet, including new state-of-the-art laboratories, offices and meeting rooms. The expansion will support an anticipated staff of 75 employees by the end of 2013, an increase in H3 Biomedicine's employee base of 29 in 2011.
"While we remain an early-stage, research-focused company, our rapid growth this year marks a significant step toward developing novel oncology drug candidates, and, ultimately, expediting the delivery of new therapies to the patients who need them," said Markus Warmuth, M.D., President and Chief Executive Officer of H3 Biomedicine. "Our unique corporate culture encourages science-driven work and access to shared resources. We are fortunate to attract top talent while operating in the Cambridge area, where the technical expertise and entrepreneurial spirit are a strong fit for our organization." In December 2011, H3 Biomedicine opened its headquarters in Cambridge with 24,000 square feet of working space. Eisai Co. Ltd., a research-based human health care (hhc) company, pledged up to $200 million in research funding to H3 Biomedicine and will provide additional support for the company's clinical development programs, including access to many of Eisai's drug development capabilities.
"Eisai's commitment is based on our recognition that H3 Biomedicine possesses strong fundamentals in their science programs and innovative approach toward cancer treatment development," said Haruo Naito, Eisai Co., Ltd. President and CEO. "We are pleased that in this past year alone, the strong growth of their research-based initiatives has brought us closer to the vision of realizing the potential of personalized medicine."
Intertek Pharmaceutical Services' San Diego, CA, Bioanalytical Immunochemistry facility has successfully completed a seven-day inspection by the United States Food and Drug Administration (FDA).
In September 2012, an investigator from the FDA visited Intertek's San Diego facility for a routine inspection to assess the facility for overall compliance with Good Laboratory Practice (GLP) regulations. The San Diego facility is a leading GLP compliant laboratory providing development and validation of quantitative ligand-binding assays (immunoassays) for use in PK (pharmacokinetic) and TK (toxicokinetic) studies including immunogenicity and biomarker studies for novel biologics and biosimilars.
During the course of the audit, the investigator toured Intertek's facility over several days, focusing on sample management, equipment and equipment records, archival practices (storage, retrieval and tracking of archived data), and QA reporting functions. The FDA investigator also reviewed multiple reports, including several method validations and sample analysis projects.
Upon completion of the inspection, the investigator reported no findings and Form 483 was not issued.
'Intertek Pharmaceutical Services operates under the most stringent of Quality systems, assuring our clients that the quality of data received will always be of the highest standard,' stated Dr Dominique Gouty, Director of Intertek Pharmaceutical Services in San Diego. 'All laboratory personnel who were interviewed gave professional confident responses related to their jobs and responsibilities.'
'We are extremely pleased with this successful inspection, which confirms Intertek’s commitment to meeting the highest quality standards. It was incredibly gratifying to see the San Diego facility complete such an intense audit with no findings,' added Dr Andrew Swift, Executive Vice President of global operations for Intertek Chemicals & Pharmaceuticals.
Lake Zurich, Ill.-based contract manufacturer Medical Murray Inc. has opened a new design and development facility in Charlotte, N.C.
“We are excited to move forward with our plans to open a new Charlotte facility, which will allow us to better service our new and existing customers in the Southeast and Mid-Atlantic,” said Phillip Leopold, president of Medical Murray. “Similar to both of our Chicago-area facilities, our new Charlotte facility will focus on total customer satisfaction by providing intricate medical solutions at all phases of the design, development, and regulatory process.”
The facility, which is located close to the Charlotte Douglas International Airport to facilitate easy access and transportation of products, will be fully functional by March.
Heading the new 4,000-square-foot operation will be Regional Vice President Tanner Hargens, who will supervise sales, design, and development activities. Hargens’ expertise includes implants, biomaterials, and minimally invasive procedures. Having spent eight years working in medical device engineering, he is also well versed in the commercialization of medical products, patent protection, and regulatory strategizing.
“Our mission is to increase our support of the medical community and the need for highly complex device requirements from concept to production,” said Hargens. “This operation will allow us to further embrace new and existing customers in the southeast and mid-atlantic, and continue to advance the betterment of patient care.”
Medical Murray specializes in the design and contract manufacturing of catheter systems, permanent implants and bioabsorbable technology for less invasive vascular, urologic and surgical applications.
Japanese firm Human Metabolome Technologies has opened its first US office in Cambridge, Mass. The firm expects to employ up to 20 people at the new office and lab by 2015. The company offers metabolome analysis services, called Carcinoscope, which was specifically designed for cancer research, and another service called Basic Scan for more global, general-purpose metabolomics research, including biomarker discovery and companion diagnostics, it said.
Merck’s vaccine bulk manufacturing facility (VBF) series of projects has been named as the Overall Winner of the 2012 Facility of the Year Awards (FOYA).
The project also won the Facility Integration category.
Sponsored by the U.S.-based International Society for Pharmaceutical Engineering (ISPE), Interphex and Pharmaceutical Processing magazine, the FOYA program acknowledges state-of-the-art pharmaceutical manufacturing projects that use new and innovative technologies to enhance the delivery of a project, as well as reduce the cost of producing high-quality medicines.
Faced with a projected production shortfall for the Varicella product franchise, Merck responded by delivering the vaccine bulk manufacturing facility (VBF) program of projects in Durham, North Carolina, US. The 214,000 sq. ft. facility was built in record time and doubled the output of the vaccine used for chicken pox and shingles.
The Merck team used an innovative hybrid modular construction strategy that maximized off-site fabrication and equipment testing. The integrated construction execution strategy decoupled the design and construction of the building envelope and shell from interior process components, enabling parallel processes. As soon as the building shell was dried in and elevated slab poured, modules were installed simultaneously above the slab. This allowed Merck to establish two independent work zones (above and below the slab) and saved five months on the schedule.
The team was organized as single group, with all members co-located in an integrated partnership. Lean six sigma principles were used throughout the project and resulted in an accelerated transfer of systems to operations. Integrating more than 200 lessons learned from the existing facility and process, the facility was delivered 40% faster than industry benchmarks. For this, Merck received the accolade 2012 Facility of the Year Awards Overall Winner.
The other winners were:
Category winner for Sustainability:
Chiesi Farmaceutici’s research and development centre in Parma, Italy
Category winner for Project
Execution: Eisai Pharmatechnology & Manufacturing’s Eisai Knowledge Centre in
Visakhapatnam, Andhra Pradesh, India. In just 17 months, the Eisai team
delivered a contemporary, Japanese-style, highly automated API research and
production and oral solid dose manufacturing complex with necessary support
functions.
Category winner for Equipment
Innovation: Rentschler Biotechnologie for its REX III project in Laupheim,
Germany, to host multiple products and achieve maximum flexibility. The
9,800ft2 facility has an annual capacity of 10 manufacturing projects with up
to 24 batches at 1,000 L scale.
Category winner for Operational
Excellence: Roche Diagnostics, for its TP Expand project at its biotechnology
site in Penzberg, Germany. The project was the result of an innovative and
well engineered master plan featuring six independent projects and a GMP IT
system known as DAMAS.
Special Recognition for Novel Collaboration: the National Institute for Bioprocessing Research and Training’s (NIBRT) new greenfield facility built at University College Dublin, Ireland. The plant is a medium scale bioprocessing facility for providing manufacturing research and training solutions to industry.
Suzhou Pharma Services, a contract development and manufacturing organization has received the latest 2010 cGMP certification from the Chinese SFDA for their development and manufacturing facility located in the Suzhou Industrial Park, Suzhou, China. Situated 100km west of Shanghai, Suzhou Pharma Services is one of China's only US FDA-approved and inspected facilities for solid oral dose manufacturing and now joins an elite group that can offer both operating quality standards.
"Suzhou Pharma is well positioned to offer our formulation and manufacturing services backed by our western experienced management team to companies in China and the Asia Pacific region looking for outsourcing partners operating under the latest GMP and quality standards" said Marc Finn, Director of Business Development. "It allows us to better support our local client's growing needs in outsourced drug development, clinical trial material and formulation services for the Chinese and Global markets".
Suzhou Pharma's recently upgraded and newly outfitted facility includes capabilities to support development of oral solid dose products with expertise in extended, sustained and modified release tablets and capsules.
Chr. Hansen has been present in Russia since 1998, but the addition of an application lab will allow it to work directly with local customers, using local ingredients. This is expected to be particularly useful for its recently introduced FreshQ starter culture for extending the shelf life of the popular Russian fresh cheese product, Tvorog.
Area country manager for Northern Europe Kristian Elsborg said that it was very important to use local milk supplies when testing new products and ingredients for any market, because of differences in milk quality as well as equipment.
“FreshQ is part of our bio-protection program,” he said. “…The mode of action is not fully understood yet, but what we can see is that we can extend shelf life by weeks.”
He added: “Before we had and application lab, if we had an application question from a local customer, it would have been a challenge. Now we can test it with Russian milk. …Our response time is so much faster.”
About 60 percent of Chr. Hansen’s dairy customers in Russia are multinationals and about 40 percent are local companies, he said.
Chr. Hansen said the move will also tap into desire for natural colors in Russia, as the country has opted to implement warning labels similar to those required in the European Union for the so-called ‘Southampton Six’ artificial colors from June next year. It expects a surge in interest for its natural colors as a result.
The new application centre will enable to company to run stability trials with natural colors in foods and beverages.
Chr. Hansen’s color customers are roughly evenly split between local companies and multinationals, said Elsborg.
“The Russian customer base is changing,” he said. “The international customers are consolidating and getting bigger, and with that the demand on products and services is increasing. This leaves us with great business potential.”
AMRI says the decision to close its second discovery services facility in a year and shift work to Asia reflects changing market demand.
The contract services firm announced the move, explaining that it will transfer discovery operations from its leased facility in Bothell, Washington to its site in Singapore and move structural analysis work to its laboratory in Albany, New York.
News of the closure - which will be completed by the end of March next year - comes just weeks after AMRI reported that revenue from its discovery services business fell five per cent in Q3 and eight months after it closed its discovery laboratory in Hungary .
Company VP Bruce Sargent said the move was prompted by “shifting market preferences related to the preferred co-localization of integrated drug-discovery activities and a shift to lower cost jurisdictions have created an opportunity for AMRI to improve the alignment of our integrated service offerings.
“Many of our customers around the world have expressed that the services offered at Bothell would fit better with their strategies if the services were co-located in Singapore, where they may already be doing related work or other projects with us,” he said.
Sargent cited AMRI’s customers in Japan as an example, which he said would benefit from being able to access biology and chemistry services in a location much closer to their central operations.
He also predicted that the Bothell closure would not be a negative for US and European customers for which AMRI conducts research at the site.
“We have already proactively reached out to customers with on-going projects in Bothell and the overwhelming response has been positive. We are committed to continuing some projects that need to run until the spring of this year, and have put in place transition strategies with our customers to start new projects in Singapore, or Albany, moving forward.”
When AMRI was asked how the Bothell closure will affect the 24 staff the firm currently employs at the facility.
Sargent responded that: “The transition will open a number of opportunities at AMRI’s Singapore and Albany locations, which would be suitable for some employees interested in a transfer.”
And for those analytical services employees unwilling to make the 13,000km move to Singapore, there may be other jobs in the U.S. according to Sargent who said that shifting work to Albany will create “opportunities for staff interested in transferring from Bothell or possibly for external hires.”
GE Healthcare says new cell science lab in Wales will save drugmakers time and money and create more accurate alternatives to animal-based drug toxicity testing models.
The new £3 million (€3.6m) complex – at GE Healthcare’s Maynard Centre in the Welsh capital Cardiff – houses bioprocessing, imaging technologies and manufacturing capacity and will employ a staff of 43 scientists.
Activities will focus on the development of novel technologies for cell therapies and on cellular based tools to help pharmaceutical companies develop better and safer medicines at lower cost according to GE spokeswoman Val Jones who talked about the new lab.
“The technologies that we are working on include technologies for multiplying cells. An example of this is our WAVE technology for growing cells and others used to process umbilical cord blood for cord blood banking.
“The Cardiff lab is also working in collaboration with a number of partners to help make cell therapy a reality,” Jones continued, adding that “Pharmaceutical companies are already expressing interest in the cell therapy arena. GE’s role is to develop the technologies that will help make cell therapy a reality on a wider scale.”
GE also plans to use the cell development capabilities available at the facility to create new based methods of determining the toxicity of candidate drug products, which the firm believes it can market to the pharmaceutical industry.
Jones said: “GE Healthcare’s Cytiva cardiomyocytes offer enormous potential as a more reliable model for studying cardiac toxicity than current animal models.
“This is clearly of great interest to pharma. Our aim here is to provide tools and technologies that will help pharmaceutical companies develop safer and more effective drugs at lower cost.”
Covance says SFDA GLP certification for Shanghai early-phase facility will save sponsors time and money in China and elsewhere.
The contract research organization (CRO) received good laboratory practices (GLP) accreditation earlier this week for the facility it opened in 2010 as a China hub for non-clinical safety assessment, in vivo pharmacology and bioanalytical and DMPK services.
Covance said: “The SFDA GLP certification is significant because unlike in the United States, where a facility can claim compliance to GLP without prior inspection, a facility must have been in operation under GLP for at least 12 months and have completed validation studies prior to applying for SFDA inspection and obtaining a certification.
“Without SFDA certification, data generated from the facility will not be accepted by SFDA for regulatory approvals.”
The firm also said that the award – which adds to the accreditation it received from the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) Belgian GLP Monitoring Authority in 2011 – will give it an edge over other global CROs operating in China.
"Covance is the only global CRO with SFDA GLP certification in China. With our SFDA GLP certification, our clients can now file an IND in China and other global regulatory authorities based on the one set of GLP studies - a significant advance that will offer time, as well as cost, savings for clients in their drug development projects.”
Competition in China’s preclinical research services is increasing with Covance being only the latest global CRO to be positioning for growth in the country.
Early last month fellow US-based contractor Charles River Laboratories (CRL) bought a controlling stake in Beijing-based Vital River citing an uptick in demand for its research models business from academia, government and biopharmaceutical companies.
Local players are also upping their game. In October Sino-US CRO Pharmaron bagged a discovery services contract with AstraZeneca .
A month prior to that China-based Wuxi PharmaTech partnered with US transgenic animals firm Open Monoclonal Technology (OMT) to boost its antibody discover capabilities.
Recipharm has made a strategic investment to expand capacity for analytical services and stability studies at its facility in Solna, Sweden. The facility, which is equipped with advanced labs for pharmaceutical formulation and a GMP suite for development and manufacture of sterile and non-sterile clinical trial materials, will be reconstructed to facilitate the expansion of analytical development.
Analytical services will include: development and validation of stability indicating analytical methods, supply and execution of method transfer protocols, establishment of new product assay and degradation methods, graduated validation plans, cleaning validation, report writing and stability studies according to ICH. The company anticipates that the analytical lab in Solna will be ready and compliant with ICH, EU and FDA GMP in May 2013.
“This is a very important step for us as increasing this capacity will enable the company to enhance the high quality services to our customers,” said Maria Lundberg, general manager at Recipharm Pharmaceutical Development. “Our analytical development service is already an integrated and vital part of the pharmaceutical development work, and this investment will enable our business to continue to grow, creating more flexibility and a better service offering. We are convinced that it is vital to small and large pharma companies that competent service partners can supply high quality pharmaceutical development services including high quality analytical development.”
Kemwell signs an agreement with Mercury Pharma Group for contract manufacture of pharmaceuticals in the new state-of-the-art production facility in Uppsala. "This agreement shows that we are indeed competitive in Sweden in production. Our new modern facility gives great opportunities for pharmaceutical manufacture in collaboration with both new and existing customers," says the company's CEO Agneta Bergvall.
Kemwell is a Swedish-Indian contract manufacturer with production facilities in both India and Sweden. Kemwell established themselves on the European market six years ago when they acquired a facility from Pfizer. Here the company manufactures tablets, suppositories and capsules. Strong business development has allowed Kemwell to double their production space in Sweden through expansion in new facilities.
Mercury Pharma Group Ltd is an international pharmaceutical company specializing in the sale of prescription drugs. The company's products are marketed worldwide with a focus on the European market. Kemwell's agreement with Mercury Pharma Group Ltd covers
manufacture of tablets and release and distribution of products to Great Britain and Ireland.
"It is always exciting to start a new collaboration with a client," says Bergvall.
"We aim to serve our customers with the highest levels in quality and service, ensuring that the customer gets the right product at the right time. At Kemwell we strive daily to live up to our ambition of being a contract manufacturer of merit and to help our clients become more competitive. We focus on being a continually developing company with a reputation for trustworthiness and dedication" says Bergvall.
Taiwan-based pharmaceutical maker TTY Biopharm has opened a new drug factory in Suzhou, Jiangsu, China.
The $100m facility, which will be operated by the company's subsidiary TOT Biopharm, will produce anti-cancer drug injections.
In addition, the company's other new facility producing anti-cancer injections, which is ready for pilot run, is expected to begin volume shipments by the end of the year after passing related certifications.
TTY Biopharm chairman RJ Lin said, "The company's pilot-run factory in Chungli, northern Taiwan plans annual capacity of 800,000 injections, and as many as one million by 2013."
The US Food and Drug Administration (FDA) is expected to carry out the new plant's inspection by the end of this year, as soon as the new factory will start mass production.
The third-stage factory construction of the Suzhou factory is scheduled to be completed in the next four years.
In addition to the production of taxol anti-cancer drug, the company is now stepping into the liposomes anti-drug field, which extends the treatment period and decrease side-effects.
Schott Pharmaceutical Packaging plans to increase production capacities at its plant in Zavolzhye, Russia by more than 50 percent to meet growth in demand.
The German manufacturer of glass tubing and primary packaging for the pharmaceutical sector will install new production lines for vials and ampoules at the plant.
‘Expanding our presence in Russia represents an important strategic step for the benefit of our customers,’ said Jürgen Sackhoff, who heads the German glass tubing and primary packaging manufacturer’s pharmaceutical systems division.
‘We are seeing continued growth in demand for locally manufactured primary packaging that also meets all of the international standards for quality. This will result in shorter delivery routes and better export opportunities for our customers.’
The Russian pharmaceutical industry has experienced double-digit growth in recent years. Initiatives such the government’s Pharma 2020 strategy that seeks to encourage local manufacturing of high-quality medications that meet GMP standards has continued this development.
Schott says it was the first international manufacturer in Russia to open a new GMP-compliant pharmaceutical packaging plant in 2011. A growth in orders has made it necessary to expand capacities earlier than expected.
‘GMP will be required by law for all companies that manufacture in Russia starting in 2014 and Schott has the necessary know-how in helping its customers to establish GMP-certified manufacturing thanks to its 125 years of experience and global manufacturing network,’ added Sackhoff.
MDxHealth and Ghent University announced that they have formed a new epigenetics research center to accelerate innovations in personalized medicine.
The partners have established NXTGNT, a Center in Pharmaco (Epi)genomics, at Ghent University within its laboratory of pharmaceutical biotechnology. The Center, which will be fully operational as of Dec. 1, will bring together disease-centered basic researchers, clinical validation teams, and bioinformaticians to apply epigenomics technology to personalized medicine.
The facility also will house researchers from MDxHealth, which is based in Irvine, Calif., and has its European headquarters in Liege, Belgium, who will develop epigenetic-based tests.
"There is a history of successful collaboration between MDxHealth and the University of Ghent, where much of the early epigenetics sequencing work on our biomarkers was conducted," MDxHealth CEO Jan Groen said in a statement. "We believe our experience in successfully developing personalized cancer epigenetic tests combined with the sequencing, bioinformatics, and methylome analysis expertise contained in the new Center will prove extremely attractive to the pharmaceutical industry."
The National Institute for Bioprocessing Research and Training (NIBRT) is a state-of-the-art, multi-functional building specifically built to serve the needs of the Irish bioprocessing industry by providing a world-class platform for research and training. It is located at Belfield Innovation Park, in the University College Dublin (UCD) campus in Dublin, the capital city of Ireland.
A groundbreaking ceremony to mark the commencement of construction of the purpose-built facility was performed in November 2009. The institute was officially inaugurated in June 2011 by Seán Sherlock, the Minister for Research & Innovation, Government of Ireland. It was built with an investment of €57m (approximately $73.24m).
In January 2012, the institute won ISPE Facility of the Year Award (FOYA) in "Special Recognition for Novel Collaboration" category. The NIBRT also won the Bioprocess International Award in "Manufacturing Collaboration of the Decade" category in October 2012.
The success of NIBRT is the result of a forward-looking collaboration between the four leading institutes for higher education in Ireland. These institutes include the University College Dublin, which is the country's largest university, Trinity College Dublin, Institute of Technology, Sligo (ITS) and Dublin City University (DCU).
The majority of the project cost was financed by IDA Ireland, the government agency responsible for industrial development in Ireland.
Endress+Hauser, an industrial automation equipment supplier based in Switzerland, commissioned a custom-built training facility for biotechnology at NIBRT through a collaborative deed.
"The success of NIBRT is the result of a forward-looking collaboration between the four leading institutes for higher education in Ireland.”NIBRT is a two-floor greenfield facility designed as a medium-scale bioprocessing plant. The entire facility is built over an area of 6,500m2 (69,965ft2). It includes seven research laboratories, a bioprocessing pilot plant and training and office facilities.
The bioprocess-simulated GMP pilot plant, located on the upper level, is the main attraction of the facility. It is provided with a range of upstream, downstream, fill and finish and associated analytical facilities. Both the downstream and upstream pilot plants are operated under GMP conditions.
The downstream plant houses integrity testing stations and an instrumentation rig. This pilot plant is also provided with two UF/DF skids, two chromatography skids, a column packing skid and pH viral inactivation tubes.
The upstream pilot plant facility includes an inoculum preparation laboratory, shake flasks and two wave reactor trains, four bioreactors with support vessels, vessels for batch and fed-batch fermentations, utilities for single-use bioreactors up to 1,000l and microfiltration and centrifuge system for cell harvesting and culture clarification to remove cell residues.
The fill-finish suite is also located on the upper floor. It is equipped with a Watson-Marlow Flexicon pilot-scale filling machine with restricted-access barrier systems (RABS). On the same level there are two dedicated training rooms (one on the ground floor), with a combined seating capacity of up to 100 people. It is equipped with a data projector and drop-down screen. A power amplifier is made available for larger assemblages.
Ground floor facilities in the National Institute for Bioprocessing Research and Training
The ground floor houses downstream processing labs, a molecular biology lab, utilities room, glycobiology research laboratory, training rooms, a cafe and a shared services area that is the heart of the ground floor. A space of 450m2 (4,843ft2) has been reserved for future labs, which can be developed and installed as per client requirements.
"NIBRT is a two-floor greenfield facility designed as a medium-scale bioprocessing plant. "The downstream laboratory is built over an area of 170m2 (1,830ft2) and includes a 20m2 (215ft2) walk-in cold room, featuring double refrigeration units and alarms. The molecular biology laboratory is built over 165m2 (1,776ft2). It is divided into three rooms, where two rooms are fully equipped for cell culture operation and the third room is used as a general laboratory.
All the essential utilities such as the steam boiler, compressed air and bio-waste deactivation services are put up in the utilities plant room.
The atrium, which joins the administrative room / classroom with laboratory / process area, is furnished with polished natural concrete floor and covered with a glass roof.
Contractors involved with the construction of NIBRT Dublin facility
DPS Engineering provided design and construction management on behalf of NIBRT. Integrated design services for the project were rendered by Jacobs Engineering. PM Group provided the bioprocess design and John Sisk and Son was the construction contractor.
Pharmaceutics International, Inc (Pii), a U.S.-headquartered contract development and manufacturing organization, specializing in difficult to formulate compounds, will more than double its sterile GMP manufacturing capacity with a new 24,000 sq. ft. cGMP aseptic fill/finish manufacturing plant currently under construction in Hunt Valley, Maryland.
Pii says the expansion is focused on meeting current projects with near-term commercial manufacturing needs and on meeting demand for larger batch sizes
Targeted for completion in the fourth quarter, fill/finish suites will include automated vial and syringe filling, inspection and labeling equipment capable of producing batch sizes of more than 100,000 units.
The facility expansion closely follows the company's recent US FDA pre-approval inspection (PAI) as a result of which Pii has been approved to manufacture commercially an aseptic vial in its existing Hunt Valley aseptic facility.
Steve King, senior vice president of Pii, said the additional facilities would enable the firm to support its clients from pre-clinical to commercial-scale production and meet growing demand for fill/finish services for potent compounds and oncology drugs.
BioPure Technology is now manufacturing, assembling and finishing its full range of BioBarbs, Bio Y’s, Bio End Caps, BioValves and BioClamps in ISO Class 7 (Class 10,000) cleanrooms at its new facility in Horndean, Waterlooville, UK.
All of the products are packaged in Tyvek pouches, which the company says delivers a balance of bacteria penetration resistance, tear strength, puncture resistance, clean peel and compatibility with existing and emerging sterilization methods.
The pouches are then bagged with polythene. Both packaging materials are manufactured in ISO Class 8 cleanrooms.
Phillips-Medisize, a US-headquartered provider of design and manufacturing services to the medical device, diagnostics, drug delivery and commercial markets, has completed a 1,000m2 (10760 sq. ft.) expansion of its plant in the Czech Republic to enable it to fulfill new contracts. The expansion provides more cleanroom production space while expanding its capabilities, which include plastic and liquid injection molding, catheter extrusion and assembly capabilities in Class 7 and 8 cleanrooms.
The facility is FDA registered and ISO 13485 certified and uses the global Phillips-Medisize quality system.
“Our Czech facility is an important part of our strategy of providing state-of-the-art medical facilities, equipped with the latest technologies, to our customers in regions around the world,” said Matt Jennings, president and CEO of Phillips-Medisize.
There are now 138 employees at the plant, an increase of more than 60% as a result of new business.
Phillips-Medisize is headquartered in Hudson, WI, and employs more than 2,100 people in 19 locations throughout the US, Europe and China. The company also has design centers in Wisconsin, California, and the Netherlands.
Annual sales are at nearly US$500 million, with 75 percent of the total revenue coming from drug delivery, medical device and diagnostic products such as disposable insulin pens, glucose meters, specialist inhalation drug delivery devices, single-use surgical devices and consumable diagnostic components.
Innovent Biologics Expands
Innovent Biologics, Inc., a company dedicated to the development and manufacturing of monoclonal antibodies to be marketed in the rapidly growing China market and elsewhere around the world, has raised $25 Million in a Series B financing to put toward the continued expansion of its pipeline and manufacturing capabilities. The money comes from Lilly Asia Ventures, part of the innovative global pharmaceutical company Eli Lilly, and from Fidelity Biosciences and Fidelity Growth Partners Asia, a division of Fidelity, one of the world's leading financial services companies. Fidelity is a follow-on investor from the Series A.
"We are fortunate to have world's premier investors believing in our team and business. Biologics are going to be a huge category in China just as they are worldwide, which presents a unique, once in a lifetime opportunity. Innovent has positioned itself to be a leading biologics company in China", Said Michael Yu, Ph.D., Co-founder, President and CEO of Innovent Biologics.
The team at Innovent brings extensive experience in the discovery, development and manufacture of biologics in the US, Europe and worldwide and were involved in the launch of such products as Bexxar, Conbercept, Humira, Natrecor, Oncorine, Orencia, and others.
Innovent has a GMP-compliant pilot plant for the production of clinical trial material and is building a new campus located in Suzhou near Shanghai China. In addition to laboratories and offices, the campus will house a commercial manufacturing plant with multiple 12,000 L bioreactors and a pilot plant, with two 1000L bioreactors, for production of clinical materials. The 90,000m2 (968,400 sq. ft.) biopharmaceutical facility will be the largest biologics production facility in China designed to comply with international requirements for cGMP as defined by the European EMA and the US FDA, as well as meet China SFDA cGMP regulations.
Companies who want to leverage the Innovent commitment to bring quality manufacturing and development to the expanding China biologics market have helped Innovent begin building a pipeline of biologics. The pipeline currently includes a CD20 antibody for Non-Hodgkins Lymphoma (NHL) and other B cell mediated diseases, a bispecific antibody for cancer and an antibody for oncology. Innovent continues to actively seek product candidates for in-licensing and co-development.
ACM Global Central Lab has relocated its facilities to York, England. The larger facility offers 14,500 sq. ft. of lab and office space and accommodates ACM’s expanding lab operations, and growing staff of data analysts, project managers and quality assurance specialists.
“Our new facility enables us to continue our growth in the European market and to expand the menu of clinical trials testing services we offer our clients,” said Jerry Boxall, managing director, Europe at ACM Global Central Laboratory. “We are excited with the prospects offered by our new facility, which has been purpose-built to optimize our laboratory processes. The additional space enhances our ability to continue to meet the needs of our clients with high-quality laboratory services, while positioning us to take advantage of new opportunities in the market.”
“Expansion of our European laboratory hub represents a significant investment by our company, driven by our growth over the last several years,” said Angela J. Panzarella, president of ACM Medical Laboratory, Inc., the parent company of ACM Global Central Lab. “We have enjoyed robust growth in our European and global business, and the new facility represents our commitment to the region and to continuous improvement of the services we offer our clients.”
CRO QPS has added another 24 beds to its Phase I site in the Netherlands, citing increasing demand for complex, early-phase research.
The expanded unit at the University Medical Center in Groningen – which now houses 58 beds – will cater for a wide range of Phase I studies according to QPS, including ascending dose, PH/PD modeling, 14C trials and BA/BE analysis.
Divisional director Wim Tamminga said the investment was prompted by drug industry demand, explaining that: “For tight schedules, the Netherlands CTA approval timelines of 14 days are very attractive.
“Furthermore, our clinics are staffed with very experienced medical professionals who are accustomed to managing higher risk compounds and more complex clinical protocols for investigational medicinal products.”
QPS bought the Groningen unit in 2010 when it acquired contract research organization (CRO) Xendo Drug Development (XDD) in a move that was also promoted by the countries rapid start-up times.
At the time the firm said time savings are possible because of the Netherlands’ favorable regulatory environment and streamlined protocol approval process adding that costs for managing trials are also lower in the Netherlands.
The opening of the expanded Netherlands unit follows just a few months after QPS further built its presence in Europe through the acquisitions of Austria’s largest home grown, early phase focused CRO, JSW Life Sciences.
At the time QPS CEO Ben Chien said: “Clients all over the world will now have access to an even wider range of the exceptional services they have come to expect from QPS, along with an expanding global footprint.”
Further evidence of QPS’ expansion efforts came just last month with the firms QPS Qualitx unit set up an office in Beijing, China.
Shionogi & Co's new pharmaceutical research facility is located in Toyonaka City in Osaka, Japan. The new facility was opened in August 2011. It is equipped with drug discovery research laboratories and laboratory equipment, as well as information technology capabilities.
The new facility was built with an investment of about ¥18.9bn ($247m). It will serve as the main research facility for Shionogi. With the construction of the facility, Shionogi has integrated drug discovery research operations into the Shionogi Pharmaceutical Research Centre (SPRC). These operations were earlier dispersed between four other sites in Osaka and Shiga Prefectures. The SPRC will now include the new facility and the existing three sites in Osaka.
The aim of establishing the SPRC is to achieve leading research productivity in drug discovery. The SPRC integrates different drug research functions of the company, such as basic to exploratory research, synthetic and early-stage formulation research, into a single location.
“With the construction of the facility, Shionogi has integrated drug discovery research operations into the Shionogi Pharmaceutical Research Centre. "The research facility covers an area of 34,627.97m² (372,597 sq. ft.) spread over five stories. The built-up area of the research centre is about 9,800m² (105,448 sq. ft.) and it has a total floor space of about 43,000m² (32,680 sq. ft.). Operations at the new facility began in mid-August 2011.
Each floor of the facility provides space for about 160 researchers. The state-of-the-art drug discovery laboratories of the facility are equipped with sophisticated laboratory equipment.
The design of the new facility specifically stimulates creativity and supports innovation by increasing communication and mutual collaboration among the researchers. A wellhole space located in the building conveys a feeling of unity among the researchers. The facility also includes several meeting areas and relaxation corners.
The new facility provides support for maximum creativity and high productivity for drug discovery research functions.
The research facility features modern and sophisticated drug discovery equipment. It includes a 25l mini plant reactor system, which enables the researchers to perform medium-scale synthesis of candidate compounds. It also has a high-content screening system that provides high-throughput screening of compounds against novel drug targets.
The safety aspect was given top priority during the designing of the biochemistry laboratories, which are arranged functionally with respect to the measuring instruments.
The facility is located in the same premises as Shionogi's developmental research laboratories. Ground breaking for the facility took place in September 2008. Construction was completed in July 2011. It was constructed using quake-absorbing materials, steel and reinforced concrete.
"The facility is located in the same premises as Shionogi's developmental research laboratories."The facility was built according to environmentally friendly standards. The environment-friendly triple skin structure of the facility reduces about 40% of the heat load from outside. The facility was adopted as a model project of housing and buildings for promoting carbon emission reduction by Ministry of Land, Infrastructure, Transport and Tourism in 2009.
Takenaka Corporation was responsible for design and construction of the facility.
Osaka-based Shionogi & Co is a leading pharmaceutical research company. It has over 5,277 employees and its core areas of activity involve research and development, production, and marketing activities, with a focus on prescription drugs, OTC drug and diagnostics. The company's operations are spread over Europe and North America.
Shionogi built the new drug research facility to upgrade its research capabilities and improve its global competitiveness. Through the facility, Shionogi will focus on tapping unmet medical needs by deploying various technologies such as small molecule drug discovery. It will continuously supply innovative pharmaceuticals to the patients in Japan and the world.
The new facility will also serve as the foundation for Shionogi's growth over the next 10 to 20 years. Shionogi's research is targeted on three main areas, which include metabolic syndrome, pain, and infectious diseases. The research facility will provide the company with top-class global research capabilities to focus on these areas.
PAREXEL International Corporation a global biopharmaceutical services provider, and the National Taiwan University Hospital (NTUH) announced that they have established an alliance. Under the agreement, PAREXEL and NTUH will collaborate to provide drug development services in Taiwan.
"Partnering with National Taiwan University Hospital further enhances our ability to meet the increasing demand from our clients to provide a full scope of Phase I-IV clinical trials in a rapidly growing market," said Joe Avellone, M.D., Corporate Senior Vice President, Clinical Research Services, PAREXEL International. "The National Taiwan University Hospital is well-known and highly respected in Taiwan. We are pleased to have the opportunity to work together to advance our biopharmaceutical clients' programs in the region and help them to compete more effectively in the global marketplace."
"We are delighted to collaborate with PAREXEL, a world-leading biopharmaceutical services provider" said Ming-Fong Chen, M.D., Ph.D., Superintendent at National Taiwan University Hospital. "PAREXEL has a wealth of experience in both local and global clinical development programs. This partnership will bring opportunities for both PAREXEL and NTUH to leverage our combined expertise in order to accelerate clinical development programs in Taiwan and meet patients' need for more effective treatments."
The alliance will drive greater efficiency for biopharmaceutical sponsors worldwide. As a center of excellence for clinical trials in Taiwan and the Asia-Pacific region, the National Taiwan University Hospital is ideally positioned to support PAREXEL in delivering a superior clinical development service to local and global biopharmaceutical companies. The combined experience and development expertise of the two organizations will help to create innovative solutions for biopharmaceutical companies looking to develop or market their products within this important region.
The bioavailability market lacks a leader that can offer comprehensive solutions according to Merck Millipore, which has set its sights on filling the gap through investments and a new lab.
The firm – formed in 2010 when Germany’s Merck KGaA bought Millipore – has been touting its bioavailability credentials at various trade shows this autumn, explaining that drug industry demand for solubility solutions is on the increase.
Roger Weibel, Head of Bioavailability Enhancement at the firm, said that: “Solubility is a major problem facing the industry. APIs have become hundreds of times less soluble over the past 20 years.
He gave micronization as an example, explaining that while the approach has some merit in terms of bioavailability, it is not always effective. This he said makes salt screening more important and – in turn – increases demand for products like Merck’s couterion Meglumine, which is used to make active pharmaceutical ingredients (APIs) into more soluble salt forms.
Weibel also said that: “Although there are many technologies available on the market today, there are still many challenges regarding bioavailability and formulation of today's APIs. New NCEs and NBEs always present new challenges.
“Today, single technology providers are the only players helping customers address bioavailability enhancement issues. There is a clear market need for a provider of comprehensive products and technologies to support bioavailability enhancement. Merck Millipore aims to meet this need.”
Part of this effort will involve investment according to Weibel, who cited a new application lab in Darmstadt, Germany the firm will open in early 2013 as an example.
“Merck Millipore is and will continue to make considerable investments in innovative technologies and products to overcome these [bioavailability] hurdles,” he said, adding that the firm’s R&D department is also working on inorganic drug carrier solutions that will be available by the end of the year.
Merck’s bioavailability ambitions are not limited to small molecule drugs according to Weibel, who said that both Big and small pharma companies are becoming more and more interested in developing pill forms of their biologic products.
“Many pharmaceutical companies and academia are currently working on bioavailability enhancement solutions for biologics and we are collaborating with them. We expect this to continue in the coming years.
AstraZeneca and Pfizer have formed a partnership with the Québec government to develop a $100m research centre in Montreal.
The Neomed Institute will seek to bring academics, researchers, venture capital funds and Big Pharma under one roof.
The aim is to strengthen the life sciences sector in Québec by promoting early-stage drug collaborations and create more efficient use of resources.
It will also seek to attract investment by showcasing the results of local research to international investors.
The Québec government has contributed $28m toward the project, while AstraZeneca Canada is donating $35m toward the land acquisition, the neuroscience basic research facility and laboratory equipment.
Pfizer Canada is providing a financial contribution of approximately $3.5m towards the project.
Neomed Institute president and CEO Max Fehlmann said; "The cost of discovering new drugs keeps rising and pharmaceutical companies need to adapt.
"The Neomed Institute, acting as a competitive actor in the drug development sector, will allow Québec's scientists to make the bridge between academic innovations and commercial opportunities in a better way."
AstraZeneca Canada President Elaine Campbell said; "Today's announcement is a strong testament to AstraZeneca's commitment to biopharmaceutical research and development in Quebec and Canada."
Promega has opened a new facility in Shanghai for its China operations. The new site for Shanghai Promega Biological Products replaces an existing molecular biology reagent production site and provides additional R&D and cGMP manufacturing capabilities, said Promega.
AKH Hagen has equipped its intensive care ward for children with antimicrobial copper touch surfaces.
As part of its general refurbishment measures, Hagen General Hospital (AKH Hagen) in Germany has equipped its children’s intensive care ward with antimicrobial copper touch surfaces to help lower the risk of healthcare-associated infections. The decision to do this was taken as part of the hospital’s multi-dimensional approach to hygiene.
Reinhard Tennert, director of AKH, said: “It is important for us to get ahead with investing in supplementary hygiene measures, and therefore to be able to offer our youngest patients the best possible protection against infections carried by germs.
“Cases of illness resulting from a lack of hygiene are unethical, extremely expensive due to treatment costs of up to €250,000 per case of treatment, and furthermore have a negative effect on the image of the whole organization.”
In addition to 60 beds in the children’s clinic, AKH has a further eight beds available for intensive acute or long-term medical care of children of all ages. To ensure the best placement of antimicrobial copper surfaces, it was necessary to identify key areas in the environment were contamination was most likely to result in infections.
AKH’s technical manager, Peter Uszkoreit, said: “Since door and window handles are frequently touched by both medical personnel and visitors, these have all been replaced with copper fittings.”
This, however, is just the beginning. Uszkoreit would also like to see other hotspots upgraded to antimicrobial copper, including light switches and bed rails.
The second phase of the refurbishment is planned for early next year, during which key fixtures and fittings in the Perinatal Center at the highest level of perinatal care (Level 1) are to be replaced with antimicrobial copper items.
Bayer Healthcare has partnered with Medsintez in a deal designed to allow the German firm to make and sell drugs in Russia.
The agreement will see the companies build new good manufacturing practices (GMP) standard manufacturing facilities for the production of pharmaceutical products and diagnostic imaging agents for the local market. Further details of the plants have not been disclosed.
Andreas Fibig, president of Bayer HealthCare Pharmaceuticals, said: "The local production of our products will provide additional momentum to our business development in this growth market.”
Partnerships have become increasingly common since the country launched its Russia 2020 plan for the drug industry.
The policy – unveiled by Vladimir Putin during his most recent inter-Presidential stint as Russian Prime Minister – is designed to reduce the country’s dependence on drug imports and encourage local manufacturing.
As the time Putin said international drugmakers wanting to sell products in Russia would face restrictions if they did not establish manufacturing operations in the country.
The drug industry’s reaction has been to invest in manufacturing capacity either alone like AstraZeneca, Novartis and Teva or through partnerships like GlaxoSmithKline (GSK), which teamed with Binnopharm on vaccine production.
The partnering approach has dominated more recent industry efforts in Russia. In September 2011, for example, Aurobindo Pharma partnered with OJSC Diod on the manufacturing of generic and over-the-counter (OTC) pharmaceuticals and set up a plant in Moscow’s Podolsk district.
ViiV – GSK and Pfizer’s HIV joint venture – partnered with Moscow based manufacturer Binnopharma last November.
The technical challenge posed by potent APIs means drug industry demand for R&D-scale contract manufacturing is largely unmet, according to Aesica.
A fear of handling toxic compounds has led to a shortage of HP contractors, according to Aesica
The UK contract manufacturing organization (CMO) spoke to Outsourcing-pharma.com at CPhI, and said the observation was one driver behind its decision to invest in development-scale granulation and coating capacity at its facility in Nottingham.
The other, according to site manager Ian Lafferty, was the number of enquiries Aesica has received about capacity for high potency work at the site since it opened in May.
He said: “We’ve had a number of enquiries about more difficult capabilities, such as granulation and we’ve shown we can build an isolator around this equipment and still operate them.
“For instance, fluid bed coating and fluid bed granulation are dusty processes, and doing that with a HP compound causes even more issues than with capsule filling. Doing it inside the isolators makes those issues go away.”
Lafferty said that a lack of highly potent (HP) contractors for R&D (research and development) stems from an unwillingness to deal with toxic products because of old stigmas associated with workers using suits, rather than the safer isolator technology as found in the Nottingham facility.
He said issues like finding staff willing to work with the molecules, the extra investments associated with handling them, and even hesitance from sponsors who fear working in HP facilities have also led to a shortage of vendors.
However with a growing industry need for innovation, and many HP pipelines left untouched because companies cannot find suitable partners to manufacture products for R&D, Lafferty said the need for providers has never been greater.
“I do think this is a growing trend in the industry, but there are few places that offer the services. HP puts people off - it takes investment, and staff don’t want to work on it because of associated perception of danger,” he said.
He also said that for rare and orphan indications there is an opportunity for firms to work on the product commercially, as they need smaller – but higher value – batch sizes.
Ahlstrom has inaugurated its new production facility in Longkou, Shandong Province, in eastern China. The plant is a joint venture together with Longkou Yulong Paper Co. Ltd, and produces medical papers used for sterilization wraps and masking tape base papers for the building industry in the Asian market.
"This joint venture in Longkou supports Ahlstrom's growth strategy and strengthens our presence in Asia. Crepe paper used in the medical and building industries in Asia provides us interesting opportunities for growth in the area," says Jan Lång, president and CEO.
The new plant in China is the outcome of a €21.9 million investment, of which €13.1 million was contributed by Ahlstrom, and employs approximately 140 people. Located in the Zhu You Guan Industrial Park in Longkou, the plant is conveniently positioned near a large commercial port with access to China and Asia by road and sea, ensuring easy logistics for both incoming raw materials and shipment of products. The investment was initially announced on October 28, 2010.
The plant is a part of Ahlstrom's Food and Medical Business Area. In addition to Longkou, Ahlstrom has three other manufacturing plants and twelve sales offices in Asia, providing service throughout the region.
Merck’s vaccine bulk manufacturing facility (VBF) series of projects has been named as the Overall Winner of the 2012 Facility of the Year Awards (FOYA).
The project also won the Facility Integration category.
Sponsored by the US-based International Society for Pharmaceutical Engineering (ISPE), Interphex and Pharmaceutical Processing magazine, the FOYA program acknowledges state-of-the-art pharmaceutical manufacturing projects that use new and innovative technologies to enhance the delivery of a project, as well as reduce the cost of producing high-quality medicines.
Faced with a projected production shortfall for the Varicella product franchise, Merck responded by delivering the vaccine bulk manufacturing facility (VBF) program of projects in Durham, North Carolina, US. The 214,000ft2 facility was built in record time and doubled the output of the vaccine used for chicken pox and shingles.
The Merck team used an innovative hybrid modular construction strategy that maximized off-site fabrication and equipment testing. The integrated construction execution strategy decoupled the design and construction of the building envelope and shell from interior process components, enabling parallel processes. As soon as the building shell was dried in and elevated slab poured, modules were installed simultaneously above the slab. This allowed Merck to establish two independent work zones (above and below the slab) and saved five months on the schedule.
The team was organized as single group, with all members co-located in an integrated partnership. Lean six sigma principles were used throughout the project and resulted in an accelerated transfer of systems to operations. Integrating more than 200 lessons learned from the existing facility and process, the facility was delivered 40% faster than industry benchmarks. For this, Merck received the accolade 2012 Facility of the Year Awards Overall Winner.
The other winners were:
Category winner for Sustainability: Chiesi Farmaceutici’s research and development centre in Parma, Italy
Category winner for Project Execution: Eisai Pharmatechnology & Manufacturing’s Eisai Knowledge Centre in Visakhapatnam, Andhra Pradesh, India. In just 17 months, the Eisai team delivered a contemporary, Japanese-style, highly automated API research and production and oral solid dose manufacturing complex with necessary support functions.
Category winner for Equipment Innovation: Rentschler Biotechnologie for its REX III project in Laupheim, Germany, to host multiple products and achieve maximum flexibility. The 9,800ft2 facility has an annual capacity of 10 manufacturing projects with up to 24 batches at 1,000 L scale.
Category winner for Operational Excellence: Roche Diagnostics, for its TP Expand project at its biotechnology site in Penzberg, Germany. The project was the result of an innovative and well engineered master plan featuring six independent projects and a GMP IT system known as DAMAS.
Special Recognition for Novel Collaboration: the National Institute for Bioprocessing Research and Training’s (NIBRT) new greenfield facility built at University College Dublin, Ireland. The plant is a medium scale bioprocessing facility for providing manufacturing research and training solutions to industry.
McIlvaine Company
Northfield, IL 60093-2743
Tel: 847-784-0012; Fax: 847-784-0061
E-mail: editor@mcilvainecompany.com