PHARMACEUTICAL/ BIOTECHNOLOGY
INDUSTRY
UPDATE
October 2013
McIlvaine Company
TABLE OF CONTENTS
LECO Supports New West Coast Metabolomics Center
UFP Technologies Expands Illinois Operations
New York Genome Center Launches in Manhattan
Mayo Clinic, Collaborators Establish Arizona Biobank
Sanofi Opens Cancer Research Hub
Cedarburg Hauser Upgrades Plant
PCI Builds Out Cold Chain, Serialization Capacity
MIT-based Center to Advance Brain Understanding
Mylan Completes Facility Expansion
BioReliance Opens New U.S. Clearance Facility
Catalent Plans New Single-Use Biopharmaceutical Manufacturing Facility
Merck Received U.S. FDA Approval for Vaccine Facility
GE Healthcare Life Sciences to Build Factory for JHL Biotech in China
Amgen and ShanghaiTech University Announce Plans for Amgen China R&D Center
Harlan Expands European Footprint
Teva Pharmaceuticals Sterile Manufacturing Facility, Ulm, Germany
Aesica Unveils Facility at Queenborough
Hikma JV to Build Pharma Plant in Ethiopia
Capsugel Rxpands Manufacturing at Three Plants
VistaMed Expands Manufacturing Operation
Phebra Manufacturing Facility, Sydney, Australia
Greatview Aseptic Packaging Opens in Europe
AstraZeneca to Build in Macclesfield, UK
Novartis to Increase Biologics Manufacturing
GSK Seeks Romanian Oral Dose Plant
Dainippon Sumitomo Pharma's Chemistry Research Building, Osaka, Japan
Merck's Pharmaceutical Packaging Facility, Hangzhou, China
LECO Corporation has announced its support of the West Coast Metabolomics Center, a new high-tech consortium of research and service laboratories housed within the University of California, Davis, Genome Center.
As part of an agreement with LECO, the West Coast Metabolomics Center will receive access to the LECO Citius™ LC-HRT (High Resolution TOFMS) for applied research in metabolomics that will help scientists better understand and develop more effective treatments for complex diseases like diabetes, cancer, and atherosclerosis.
Designed for complex sample analysis, LECO’s HRT instrumentation provides acquisition speeds of up to 200 spectra/second, mass resolution up to 100,000 FWHM, and mass accuracy less than 1 ppm.
The new center is under the direction of Dr. Oliver Fiehn, professor of molecular and cellular biology at UC Davis. A worldwide leader in metabolomics, Dr. Fiehn has utilized LECO instruments to analyze more than 50,000 samples for more than 520 projects and 80 different species over the past seven years.
The results have been the basis for many scientific papers, ranging from microbial products to plant and pre-clinical and clinical studies.
“LECO is known for its robust and sensitive instruments, and its great software capability for distinguishing closely eluting compounds,” said Dr. Fiehn. “We believe the Citius may solve urgent bottlenecks in metabolomics, specifically because in our field, we have highly complex mixtures of compounds!”
UFP Technologies, a producer of custom-engineered components, products and specialty packaging, has expanded its Glendale Heights, Illinois manufacturing operations to meet the increased demand by medical device manufacturers. Since attaining ISO 13485:2003 certification in Glendale Heights in 2011, UFP Technologies has made significant investments within this facility to better service its customers in the medical industry.
An ISO Class 8 (Class 100,000) cleanroom was constructed that qualifies the facility to produce up to Class III medical devices. New production machinery was installed within the cleanroom to manufacture custom components, products and packaging from medical-grade foams and thermoplastic polyurethanes (TPU). The new capabilities, which include RF welding, high speed die cutting and heat sealing, increase UFP Technologies’ manufacturing output by multiple-millions of parts per week.
'Investing in our medical manufacturing capabilities was vital to support the growing demands of our customers,' says Michael Zumpano, General Manager of the Glendale Heights facility. 'Our facility is equipped to fabricate the latest medical-grade foams, films and other specialty materials that we have access to from our broad supply base.'
The recent addition of advanced processing capabilities at Glendale Heights builds upon UFP Technologies’ strong presence as a manufacturing partner to medical device OEMs. Seven of its 11 manufacturing facilities are ISO 13485:2003 certified which house multiple ISO Class 8 (Class 100,000) and ISO Class 7 (Class 10,000) cleanroom facilities.
Using foams, plastics, composites, and natural fiber materials, the company designs and manufactures a range of solutions primarily for the medical, automotive, aerospace and defense, and packaging markets.
The New York Genome Center officially launched at its new facility in downtown Manhattan with a ribbon-cutting ceremony that featured statements by NYGC President and Scientific Director Robert Darnell and New York City Mayor Michael Bloomberg.
Nearly two years after the plan for the center was unveiled, NYGC has effectively completed the build-out of its seven-floor, 170,000-square-foot facility, and it is currently working to hire the bioinformatics, genome sequencing, and lab specialists who will fill the space.
The center is actually a consortium of 16 institutional members, mostly academic research institutions and hospitals from the New York region, as well as Jackson Laboratory, and each of the faculty members on its staff will hold joint appointments with both NYGC and their home institution.
The center so far has reeled in $140 million from its members, philanthropic organizations, and funding agencies, including the Simons Foundation, the Alfred P. Sloan Foundation, and Bloomberg Philanthropies, as well as the New York City Economic Development Corporation, the Partnership for New York City, and the Empire State Development Corporation.
The NYGC will have a heavy emphasis on bioinformatics and genome sequencing, and it plans to pursue multidisciplinary projects that harness the facilities and capabilities of its members in research institutions and clinical medicine.
The facility includes one full floor specifically for bioinformatics, which will take up an estimated 30,000 square feet, a sequencing facility, multiple lab spaces with movable benches that could be converted for expanded informatics space, and an administrative floor, said NYGC Deputy Scientific Director of Informatics, Toby Bloom.
Other floors have space for a clinical lab, an auditorium, multiple conference rooms, training space, terraces, freezer rooms, data storage, and a technology testing center. At an offsite facility near the Brooklyn Bridge, NYGC has server space providing up to a petabyte of data storage.
The sequencing space houses 16 Illumina HiSeq machines and a BioNano Genomics Irys DNA mapping instrument already in place, and the center has room apportioned for as many as 80 sequencers total, GWDN sister publication In Sequence reported in July.
Bloom said the center has already launched research programs involving whole-genome and whole-exome sequencing, RNA sequencing, and epigenetics.
She said the NYGC has applied with New York State for certification for its CLIA lab, and explained that the state approval would qualify the center for its CLIA certification.
The center currently has around 16 bioinformaticians, but it is recruiting more and expects to eventually have around 100.
Earlier this week the center received institutional review board approval to undertake the first clinical genomics project that NYGC will lead — a study focused on autoimmunity that will involve several of its members and other partners in academic centers and hospitals. He said the center also is expecting to receive approval in late October to undertake a clinical cancer study.
Mayo Clinic said that it has established a new biobank at its Arizona campus that will support genomic and other research projects in areas that are of particular concern to the Latino population, including obesity, metabolic conditions, and diabetes.
The Sangre por Salud Biobank, a collaboration between Mayo, Mountain Park Health Center, and Arizona State University, will support a wide range of research studies, although there will be an emphasis on projects involving cardiometabolic risk and obesity.
Patients will be able to donate to the biobank only after they have been informed about procedures and consented, and researchers will be able to use the genomic resource without having to seek new samples and consents for each project they pursue, Mayo said.
The bank aims to have 2,000 Mountain Park participants enrolled over the next four years. Mayo noted that 100 participants have already enrolled.
Mayo also said that its main biobank, which launched in 2009 and is located in Rochester, Minn., has expanded participation to the Mayo Clinic Health System, Mayo's group of primary care clinics and hospitals in Wisconsin, Minnesota, and Iowa.
Mayo also launched another biobank at its Florida facility last year, and it expects to have a total of 50,000 participants providing samples and clinical information for use in genomics research by the year 2016.
Sanofi opened a new research and development facility in Cambridge, MA, where 250 investigators and support staffers will focus on research in oncology and other areas.
The new facility expands to about 5,000 employees—including some 1,700 researchers—the combined greater Boston workforce of Sanofi and its Genzyme biotech subsidiary, which is based in Cambridge.
“Our presence at 640 Memorial Drive underscores our belief that together with physicians, scientists, and academics from the Boston area, we can make a real difference in the lives of patients through developing innovative solutions,” Sanofi CEO Christopher A. Viehbacher said in a statement. “It also reinforces our presence in one of the world’s most vibrant life science ecosystems.”
Sanofi is among biopharma companies benefiting from the Massachusetts Life Sciences Center (MLSC), the quasi-public agency that oversees the commonwealth’s $1 billion, 10-year Life Sciences Initiative.
MLSC awarded Sanofi $2.45 million in tax incentives toward 100 jobs in Cambridge, and saw a $500,000 accelerator loan to Pluromed repaid with interest after Sanofi bought the company last year. MLSC also received a total $500,000 from Sanofi when it joined its corporate consortium aimed at supporting the growth to life sciences in the state.
Sanofi is one of several biopharma giants that are expanding in Massachusetts: Novartis, Pfizer, and Vertex Pharmaceuticals are set to open new sites over the next year. The sites are expected to significantly expand a workforce that grew by only 365 jobs during 2012, to 56,462 jobs.
Massachusetts Governor Deval Patrick led dignitaries at a ceremonial ribbon-cutting for the new research facility. During the event, Sanofi also announced a $1 million gift to support workforce training for students at the University of Massachusetts, College of Science and Mathematics.
“The new facility builds on our global leadership in the life sciences and will keep us at the forefront of the innovation economy for generations to come,” Patrick said.
Cedarburg Hauser Pharmaceuticals announces the improvement of its Active Pharmaceutical Ingredient plant in Grafton, WI. These upgrades are a continuation of a long-term capital improvement initiative that results from an increased demand for the contract manufacturing of commercial APIs.
“Our customer’s demand for Cedarburg Hauser commercial APIs continues to grow; upgrading our facilities are a must as we grow with our customers,” says Cedarburg Hauser CEO Tony Laughrey. “We will continue to upgrade and expand our facilities, ensuring supply for our customers.”
The upgraded facilities are expected to facilitate in a 20 to 25% increase in API production. Improvements to the plant include the addition of a 30 ton process chiller, an additional 200 kilowatt backup generator, and an industrial vacuum pump. CHP has also tripled its filtration capacity through the addition of new, large Aurora Filters.
“The upgrades to our manufacturing facility are all about operational efficiency,” says John Flahive, Director of Operations. “With these improvements we are able to increase our functional capacity by approximately 20%, allowing us to produce more material in a shorter amount of time for our clients.”
Cedarburg Hauser Pharmaceuticals is a contract development and manufacturing organization, specializing in small molecule active pharmaceutical ingredients and pharmaceutical intermediates.
Packaging Coordinators, Inc. has expanded cold chain storage capacity and built out serialization services for pharmaceutical companies moving forward with serialization this year and next.
In recent investment activity--three months after the acquisition of AndersonBrecon, Inc. — the contract packager has added packaging lines and new hires supporting business growth.
At Rockford, IL, PCI has expanded 2-8 degree C cold chain storage capacity by 250 pallet spaces bringing cold chain capacity at Rockford to over 1000 pallets, says Justin Schroeder, senior director, marketing and development services, PCI.
“This segment of our business has flourished in North America and Europe with the growth of biotech products and clinical investigational drugs. We anticipate continued cold chain expansion across several sites in the remainder of 2013 and 2014,” Schroeder says.
Philadelphia, PA-based PCI is experiencing its fourth straight year of significant growth in the greater Rockford area where it operates nine facilities. Since January 2012, 160 new associates have been hired in management and hourly positions, the company has reported.
Peter Belden has been named as general manager of the Rockford- based facilities which support pharmaceutical and biotech packaging services for clinical and commercial medicines, as well as medical device and consumer healthcare products. Belden was previously senior vice president of sales and marketing at Rockford, and headed the PCI operations in Hay-on-Wye, Wales in the United Kingdom.
PCI has recently added multiple Uhlmann blistering lines and multiple IMA/Nova bottling lines at the Rockford sites in support of anticipated growth, Schroeder says.
“The growth we have experienced has really been across categories. We have had several opportunities in the OTC space that have warranted capital expansions for blistering lines. Additional growth in ethical products has us investing in additional bottling lines to accommodate that expansion. We are seeing growth at the Philadelphia, Woodstock, and Wales sites as well,” Schroeder says.
PCI has partnered with Xyntek-Antares for serialization integration. “We are expanding our serialization services to support several top-20 pharmaceutical companies that are pushing forward with commercial serialization in 2013/2014. This entails many primary and secondary packaging lines and is quite a substantial investment for PCI across all our sites,” Schroeder says.
Such an awesome challenge requires that scientists and engineers across key fields work together to learn how the brain performs complex computations, from social interactions to visual recognition. The hope is that through building intelligent machines, we can better understand ourselves.
To help encourage progress in this field, the National Science Foundation (NSF) recently awarded $25 million to establish a Center for Brains, Minds and Machines at the Massachusetts Institute of Technology (MIT). The center is one of three new research centers funded this year through NSF's Science and Technology Centers: Integrative Partnerships program.
"NSF is pleased to support a cohort of exceptionally strong center proposals in Fiscal Year 2013 that scientifically 'top the charts' in terms of their timeliness and their potential contribution to U.S. competitiveness," said Wanda Ward, NSF's office head of the Office of International and Integrative Activities, which oversees the program. "These new leading-edge centers will produce the next generation of diverse, globally engaged talent and have the potential to attract more Nobel Prize-caliber researchers."
The MIT center will also play a key role in the new BRAIN Initiative, an effort by federal agencies and private partners to support and coordinate research to understand how the brain works.
Recent advances in areas ranging from artificial intelligence to neurotechnology present new opportunities for an integrated effort to produce major breakthroughs in fundamental knowledge. For example, some digital computers can now rival the raw processing power and memory of the human brain. New tools allow researchers to switch individual brain cells "on" and "off" to affect behavior. Yet, a three-year-old child can identify a door knob better than an intelligent machine can. Significant obstacles clearly remain before the gap between brain and machine can be bridged.
"Understanding the brain is one of the grand scientific challenges at the intersection of the physical, life, behavioral and engineering sciences," said John Wingfield, assistant director of NSF's Biological Sciences Directorate. "Despite major research and technological advances achieved in recent decades, a comprehensive understanding of the brain--how thoughts, memories and intelligent behavior emerge from dynamic brain activity--remains unexplained."
Human intelligence has many aspects--including an ability to understand people and surroundings by using vision and language--so the researchers will take a multi-faceted approach. Recent work in artificial intelligence has focused in part on improvements in modeling human vision and social interaction, producing self-driving cars and the verbally quick Watson, for example.
Work at the new MIT center will cross disciplines to build more human-like machines, with the goal of establishing a theory of intelligence.
The five-year award will enable the center's researchers to benefit from the expertise of neuroscientists, engineers, mathematicians and computational scientists through a global network of academic, industrial and technological partnerships. Tomaso Poggio, the Eugene McDermott Professor at the Department of Brain Sciences at MIT, is the principal investigator for the project.
The award will also help train the next generation of scientists and engineers. A summer school program, technical workshops and online courses are planned to create a new community of interdisciplinary researchers fluent in the study of intelligence.
"Investments such as this in collaborative, fundamental science projects will ultimately lead to discoveries that revolutionize our understanding of the brain, which is the goal of the new BRAIN Initiative," Wingfield said. "Progress in this area holds enormous potential to improve our educational, economic, health and social institutions."
The center's other principal investigators include Haym Hirsh, Dean of the Faculty of Computing and Information Science and Professor of Computer Science and Information Science at Cornell University; Lakshminarayanan Mahadevan, Lola England de Valpine Professor of Applied Mathematics at Harvard University and Matthew Wilson, Sherman Fairchild Professor of Neuroscience and Picower Scholar at MIT.
The Center for Brains, Minds and Machines will partner with the following institutions and organizations.
Academic institutions:
California Institute of Technology
Cornell University
Harvard University
MIT
Rockefeller University
Stanford University
University of California, Los Angeles
Broadening Participation institutions:
Howard University
Hunter College
Universidad Central del Caribe, Puerto Rico
University of Puerto Rico, Río Piedras
Wellesley College
International partnerships:
City University, Hong Kong
Hebrew University of Jerusalem
Italian Institute of Technology
Max Planck Institute for Biological Cybernetics, Tübingen
National Center for Biological Sciences, Bangalore, India
University of Genoa
Weizmann Institute of Science
Pharmaceutical company Mylan Inc. has completed an 85,000 ft2, three-story expansion project at its transdermal patch facility, operated by Mylan Technologies Inc., in St. Albans, Vt. MTI provides transdermal drug delivery systems - patches that deliver medication through the skin - and related technologies.
Through Mylan's investment, including funding for expanded research and development capabilities and additional manufacturing and laboratory space, the company is in the process of adding more than 160 new positions to its St. Albans-based workforce. The 14-month expansion project has increased MTI's total operating space to more than 391,000 ft2.
Mylan is a global pharmaceutical company that offers approximately 1,100 generic pharmaceuticals and several brand medications; as well as a range of antiretroviral therapies, upon which approximately 40% of HIV/AIDS patients in developing countries depend.
BioReliance, the biologics and early-development services business under SAFC, has opened a new Clearance Services facility in Rockville, MD. The facility, commissioned on August 1, 2013, allows BioReliance to offer increased capacity, flexible scheduling, and more than doubles the amount of space to conduct critical downstream bioprocessing studies.
The Rockville facility features four large clearance suites with modular layouts for customized laboratory setups. According to the company, all studies are secure and supported by dedicated scientists and chromatography equipment, such as GE Healthcare’s ÄKTA avant, as well as fully compliant with applicable global guidelines and regulations, including the FDA and EMA.
“Combining our deep knowledge and proven experience with a global investment in modern facilities and equipment enables BioReliance to offer robust validation packages and proprietary CompleteClearance™ services to our clients. It’s all about simplifying the viral clearance process through an unrivaled combination of scientific expertise, client-focused service and decades of experience,” said Archie Cullen, president of BioReliance. “Any time a client comes to work with us, they are assured that their study is expertly designed and performed by personnel that have participated in thousands of successful studies in support of clinical and commercial biopharmaceutical products.”
Extensive adoption of single-use technologies and unidirectional flow reduces cross-contamination risk in the company’s new biomanufacturing facility.
Expected growth in demand for biologic drugs is leading to investment in new production facilities. Part of the decision-making involved in expanding or building biomanufacturing facilities is to what extent to use single-use technologies in the equipment used for biopharmaceutical manufacturing. In April 2013, Catalent Pharma Solutions opened a new biomanufacturing center of excellence in Madison, Wisconsin. The facility was designed to extensively leverage single-use technologies. Michael Jenkins, general manager of Catalent’s new Madison facility, spoke with Cynthia Challener, editor of the Pharmaceutical Sciences, Manufacturing & Marketplace Report, about the drivers of growth in biologics and the application of single-use technologies in biopharmaceutical manufacturing.
Pharmaceutical Sciences, Manufacturing and Marketplace Report: What were the leading market drivers and other reasons that led Catalent to invest in a completely new biologics manufacturing facility rather than expand its existing operations?
Jenkins (Catalent): Because of significant customer interest in our GPEx cell-line engineering technology for the rapid development of stable, high-yielding cell lines and the growing market demand, it became clear we needed a larger facility in view of capacity constraints at our 43,000-ft 2 facility in Middleton, Wisconsin. The new, state-of-the-art cGMP facility at Madison quadruples our clinical-scale biomanufacturing capacity. We wanted to ensure reliable production at our old site while we expanded and did not want to assume any risk to cGMP manufacturing during construction. At the same time, we made a strategic decision to transition from stainless-steel production vessels to single-use technologies, increasing our flexibility at the same time as reducing cross-contamination risk.
Pharmaceutical Sciences, Manufacturing and Marketplace Report: Can you explain the facility design and how the operations are organized at the new facility?
Jenkins (Catalent): Moving to the new, larger facility allowed us to focus on some of the fundamental principles of good manufacturing practice, including unidirectional people and material flows to minimize the risk of cross-contamination and to make an investment in the building infrastructure and services, such as WFI (water for injection) production and a design in which softwalls were not required for production. Additionally, our new facility has full-purpose designed media and buffer kitchens.
We then looked at the efficiency of production and designed the ability to produce three different products in each suite. This approach dramatically increases the number of production runs we can complete each year and maximizes flexibility and scalability. Lastly, we incorporated the ability to move bioreactors so that we can reconfigure the suites to produce a variety of batch sizes and simultaneously maintain efficiencies. Such an arrangement is only possible with single-use reactors.
Our cell-line development area was also redesigned to optimize efficiency. The areas in Middleton were originally designed to work toward the production of transgenic cows, but our GPEx technology for engineering mammalian cells for use in production vessels is a far more evolved process. The Madison cell-line engineering laboratory is approximately 30% smaller than that at the Middleton facility, and yet has a greater capacity. It is also much more user-friendly for the cell-line development technicians.
Pharmaceutical Sciences, Manufacturing and Marketplace Report: With respect to the equipment, can you describe the different types of systems that were selected and why?
Jenkins (Catalent): We are using single-use bioreactors, and the typically associated advantages of avoiding product cross-contamination and fast suite turnover are real and very valuable, particularly at the Phase I/II clinical-trial stages. In addition, avoiding clean- and-place and steam-in-place processes, which are required for stainless reactors, is a big efficiency and safety advantage.
Furthermore, the ability to reconfigure the suites is key to increasing efficiency. Our process dictates that product spends from approximately 112 to 120 days in the terminal reactor, and we can reconfigure our suites to have any reactor size from 10 L up to 1000 L in the area where this production occurs. This ability to use reactors interchangeably fundamentally allows us to be more flexible than a traditional stainless facility.
We also took a single-use approach to mixing vessels and liquid management, including the use of disposable tubing for pumping protein between rooms in the suite and buffers from the clean corridor into the processing rooms. Our tangential flow filtration skids also use disposable flow paths.
In designing the operation, however, we did not assume that single-use systems will always be appropriate. For example, we chose traditional downstream processing skids because we found that they are more versatile, and the cost of the disposable flow paths for downstream skids was quite high. Similarly, in the process-development area, we continue to use traditional glass vessels. These systems are relatively easy to clean and sterilize, and using them avoids the cost of the single-use vessels.
Pharmaceutical Sciences, Manufacturing and Marketplace Report: What types of activities will be pursued at the new facility? Will special manufacturing techniques be implemented?
Jenkins (Catalent): We carry out mammalian-cell-line engineering, process development, analytical development, master cell bank production, manufacturing of the quantities required for toxicology, and Phase I/II manufacturing. We have a platform approach. The techniques employed vary from product to product, but revolve around bioreactor production, clarification, column purification, membrane absorption, and bulk filling of bulk drug substances. The manufacturing activities are also supported by integrated analytical, formulation development, and viral-clearance capabilities, small-scale and large-scale process development laboratories, and separate microbiology and quality-control functions.
With respect to special manufacturing capabilities, Catalent will be employing its proprietary GPEx cell-line engineering technology at the new Madison facility, as well as the SMARTag precision protein-chemical engineering technology from Redwood Bioscience for the development of advanced antibody drug conjugates (ADCs), which we recently licensed. Redwood’s novel, site-specific protein modification and linker technologies enable the generation of homogenous bioconjugates engineered to enhance potency, safety, and stability. The combination of these two advanced technologies and the broad range of analytical and fill-finish services at the Madison facility will enable Catalent to further expand our ability to help customers develop more and better biologic treatments.
Pharmaceutical Sciences, Manufacturing and Marketplace Report: Is there room for further expansion at the new facility? Does Catalent have any additional plans for the site?
Jenkins (Catalent): The ability to expand was, in fact, a major reason for our move to the Madison location; there were no good longer-term expansion options at our old site in Middleton. At the Madison site, we have the room to expand into a space equivalent to one GMP suite and would just need to build out. We also have the possibility of building out into the current parking lot. Short term, our focus is on considering whether we should scale up our current capabilities for commercial production. This decision will depend on client input.
Pharmaceutical Sciences, Manufacturing and Marketplace Report: With respect to the equipment, can you describe the different types of systems that were selected and why?
Jenkins (Catalent): We are using single-use bioreactors, and the typically associated advantages of avoiding product cross-contamination and fast suite turnover are real and very valuable, particularly at the Phase I/II clinical-trial stages. In addition, avoiding clean- and-place and steam-in-place processes, which are required for stainless reactors, is a big efficiency and safety advantage.
Furthermore, the ability to reconfigure the suites is key to increasing efficiency. Our process dictates that product spends from approximately 112 to 120 days in the terminal reactor, and we can reconfigure our suites to have any reactor size from 10 L up to 1000 L in the area where this production occurs. This ability to use reactors interchangeably fundamentally allows us to be more flexible than a traditional stainless facility.
We also took a single-use approach to mixing vessels and liquid management, including the use of disposable tubing for pumping protein between rooms in the suite and buffers from the clean corridor into the processing rooms. Our tangential flow filtration skids also use disposable flow paths.
In designing the operation, however, we did not assume that single-use systems will always be appropriate. For example, we chose traditional downstream processing skids because we found that they are more versatile, and the cost of the disposable flow paths for downstream skids was quite high. Similarly, in the process-development area, we continue to use traditional glass vessels. These systems are relatively easy to clean and sterilize, and using them avoids the cost of the single-use vessels.
Pharmaceutical Sciences, Manufacturing and Marketplace Report: What types of activities will be pursued at the new facility? Will special manufacturing techniques be implemented?
Jenkins (Catalent): We carry out mammalian-cell-line engineering, process development, analytical development, master cell bank production, manufacturing of the quantities required for toxicology, and Phase I/II manufacturing. We have a platform approach. The techniques employed vary from product to product, but revolve around bioreactor production, clarification, column purification, membrane absorption, and bulk filling of bulk drug substances. The manufacturing activities are also supported by integrated analytical, formulation development, and viral-clearance capabilities, small-scale and large-scale process development laboratories, and separate microbiology and quality-control functions.
With respect to special manufacturing capabilities, Catalent will be employing its proprietary GPEx cell-line engineering technology at the new Madison facility, as well as the SMARTag precision protein-chemical engineering technology from Redwood Bioscience for the development of advanced antibody drug conjugates (ADCs), which we recently licensed. Redwood’s novel, site-specific protein modification and linker technologies enable the generation of homogenous bioconjugates engineered to enhance potency, safety, and stability. The combination of these two advanced technologies and the broad range of analytical and fill-finish services at the Madison facility will enable Catalent to further expand our ability to help customers develop more and better biologic treatments.
Pharmaceutical Sciences, Manufacturing and Marketplace Report: Is there room for further expansion at the new facility? Does Catalent have any additional plans for the site?
Jenkins (Catalent): The ability to expand was, in fact, a major reason for our move to the Madison location; there were no good longer-term expansion options at our old site in Middleton. At the Madison site, we have the room to expand into a space equivalent to one GMP suite and would just need to build out. We also have the possibility of building out into the current parking lot. Short term, our focus is on considering whether we should scale up our current capabilities for commercial production. This decision will depend on client input.
Merck has received US FDA approval to manufacture bulk varicella at its site in Durham, NC, for use in chickenpox and shingles vaccines. The approval will enable the site to produce bulk varicella supply for the U.S. and help boost Merck’s overall global supply capabilities.
Prior to this licensure, all global bulk supplies for Merck’s varicella-containing vaccines were produced at a site in West Point, Pennsylvania.
The Durham facility is part of Merck’s more than $1 billion investment in its vaccine manufacturing capabilities over the past nine years. The company has also modernized and expanded vaccine operations at its facilities in West Point, and Elkton, VA, and built a new facility in Carlow, Ireland, which is scheduled to be licensed in 2014.
The company broke ground for the Durham site in 2004 and in 2010 it was approved to produce finished chickenpox vaccines. In the longer term, Merck plans for the site to produce bulk and finished product for other Merck childhood vaccines, and for the shingles vaccines as well.
“The licensure of the Durham varicella bulk facility marks a significant milestone for Merck and adds additional manufacturing capabilities to an already strong Merck vaccine network,” said Willie Deese, president, Merck Manufacturing Division. “The Durham facility will help us meet the increasing global demand for our quality vaccines that enhance health care for millions around the world.”
In 2008, Merck dedicated the facility in the memory of its most distinguished vaccine researcher, the late Maurice R. Hilleman, who developed vaccines for eight of the diseases for which vaccines are routinely recommended for children in the US. The manufacturing center in Durham employs 1,100 people.
Promega Corporation began construction of a support regulated product manufacturing facility at Feynman Centre in the city of Fitchburg, Wisconsin, in August 2011.
The facility will provide service to customers who require molecular biology reagents for In Vitro Diagnostic (IVD) tests. It is expected to be opened in October 2013.
The new facility will have total floor space of about 260,000ft2. It is expected provide employment to an additional 100 people in the next five years. It will manufacture cGMP-compliant products under strict controls to guarantee consistent, high-quality reagents. It will be dedicated to manufacturing with dedicated production lines and flexible manufacturing areas.
The facility will include 50,000ft2 area dedicated for customer experience centre, also known as Crossroads. It provides employees and guests with ample spaces dedicated to offer training, laboratory demonstrations, conferences, an exercise and fitness centre, as well as dining.
It will provide an opportunity to learn more about the science behind molecular tools and technologies through guest speakers, behind-the-scenes facility tours, and refreshments.
The facility will be equipped to produce bulk reagents ranging between 0.5ml and 650l. It will also produce luciferase-based substrates, which can be lyophilised in batches up to 21,500 units.
Technologies used at the facility will include integrated automation and instrumentation, amplification systems, bioluminescent assays, organic chemistry, and enzyme purification. Also included in the technologies will be human genetic identity products, protein analysis, and nucleic acid purification and detection. It will also feature reproducible processes with change control.
The facility will have state-of-the-art bioprocess equipment for producing consistent and high-quality products. It will have flexible manufacturing and dispensing lines. It will feature automated dispensing equipment for avoiding human to product contamination.
It will be equipped with clinical sample DNA and RNA concentrator kits, components for laboratory-developed IVD tests, and amplification reagents and master mixes for molecular diagnostics.
The new support regulated product manufacturing building began construction in August 2011. It is expected to be completed by October 2013. It is being built using environmentally sustainable construction practices.
The design of the new facility was jointly undertaken by three firms, which included Uihlein-Wilson Architects, EwingCole, and Archemy Consulting.
Uihlein-Wilson Architects were the lead designers who provided the overall design of the facility and the public space component. EwingCole provided the design for the cGMP facilities, and Archemy Consulting provided the design for the sustainable building practice.
Kraemer Brothers were awarded with the general construction contract.
The total estimated investment for the construction of the facility is $110m. The city of Fitchburg contributed $4m through development incentives for the facility construction.
The new building will be served by a geothermal heating system. Hot water will be provided throughout the building using a solar system. The facility will also feature four electric-car-charging stations. The building will use dark-sky-compliant lighting system and fixtures, which are designed to provide maximum illumination where it is needed.
Promega Corporation was established in 1978. The company provides innovative solutions and technical support to the life sciences, clinical, pharmaceutical R&D and forensic markets. The headquarters of the company is located at Madison in Wisconsin, US.
The branches of the company are located across 15 countries worldwide. The company also has more than 50 international distributors spread over 100 countries.
It manufactures more than 2,500 products in the fields of cellular analysis, genomics, protein analysis and expression, genetic identity, and drug discovery. It obtained international quality standard certifications such as ISO 13485 and ISO 9001.
Bard plans to acquire Rochester Medical, a medical device company in Stewartville, Minn., for about $262 million, according to a deal announced.
Under terms of the merger agreement, Rochester Medical shareholders will receive $20 in cash for each share they hold at the closing of the merger, according to an announcement from the companies.
The acquisition price represents a 37 percent premium over Rochester Medical's average closing price during the 90 trading days leading up to Sept. 3, the company said.
The acquisition is subject to certain conditions including regulatory approvals and the approval of Rochester Medical shareholders. It is expected to close during the fourth quarter of 2013.
Rochester Medical sells disposable medical catheters and devices used for urological and continence care. The company also sells wound and scar care products.
"Our agreement with Bard represents an attractive valuation for Rochester Medical shareholders and as an all-cash offer provides liquidity for shareholders," said Anthony Conway, chief executive officer at Rochester Medical, in a news release. "We believe the merger represents a great opportunity for the combined companies to create a broad product portfolio."
Last year, Rochester Medical employed 344 full-time workers and had revenue of nearly $62 million for the 12-month period ended September 2012. Its headquarters is just south of Rochester.
In 2012, Bard employed 12,200 and had revenue of nearly $3 billion.
Bard acquired Lutonix Inc., a start-up based in Maple Grove, for $225 million in 2011. At the time, Lutonix was developing an experimental balloon device meant for use in angioplasty procedures on leg arteries.
Myriad Genetics announced that it will build a new laboratory at its Salt Lake City facility within which the company will develop companion diagnostics in line with US Food and Drug Administration's regulations.
The new lab build out, according to Myriad, expands its non-exclusive collaboration with AstraZeneca to study the drug olaparib in Phase III trials using Myriad's BRACAnalysis test to pick out best responders to the treatment. The partners did not disclose the specific terms of the expanded collaboration.
AstraZeneca is developing olaparib as a breast and ovarian cancer treatment for women with BRCA-mutated tumors. In August, the FDA approved Myriad's investigational device exemption for BRACAnalysis, which allows the company to use the test in human trials investigating olaparib.
At the American Society of Clinical Oncology's annual meeting in June, AstraZeneca released data from a pharmacogenomic subgroup analysis of a Phase II study. The data showed that cancer patients with germline or somatic BRCA mutations lived approximately seven more months without their cancer progressing when treated with olaparib compared to placebo. When the study investigators considered all patients with BRCA mutations (germline and somatic), they noted a trend favoring survival in those taking olaparib, although the difference between the olaparib and placebo arms was not significant.
AstraZeneca has previously stated that it plans to launch two Phase III trials involving olaparib in BRCA-mutated ovarian cancer in the third quarter of this year. One study will focus on olaparib as a maintenance therapy in the first-line setting in ovarian cancer patients with BRCA mutations, and a second trial will assess the drug in platinum-sensitive, relapsed ovarian cancer patients who harbor these mutations. According to AstraZeneca's website, the company is also investigating olaparib in breast cancer patients with BRCA mutations.
During its latest earnings call with investors and analysts, Myriad officials said that AstraZeneca is hopeful that it can garner approval for olaparib in the European market in the next 18 months. If the drug passes muster with EU regulators, Myriad could be looking to launch its first commercial companion diagnostic in early 2015.
In addition to its collaboration with AstraZeneca, Myriad has five other companion diagnostic arrangements with drug developers using its tests to pick out best responders to investigational DNA damaging agents.
GE Healthcare Life Sciences, a business unit of GE Healthcare, and JHL Biotech, a provider of biopharmaceutical process development and manufacturing services, announced that a KUBio™ modular biopharmaceutical factory will be built in China for JHL Biotech. The site for the new factory, which will be fully operational beginning early 2015, is the Biolake Science Park in Wuhan, China.
Worldwide demand for biopharmaceuticals, such as antibodies for the treatment of cancer and a new generation of innovative vaccines, is increasing dramatically. KUBio is a new approach to readily establish biopharmaceutical manufacturing capacity by delivering customers a fully functional, ready-to-run bioprocessing facility in 14-18 months, which is significantly shorter than constructing a traditional facility. Pre-designed to meet cGMP requirements, KUBio helps manufacturers, such as JHL Biotech, respond to local healthcare needs and support global customers in bringing life-saving treatments to market more quickly.
GE Healthcare’s innovative turnkey approach will involve the assembly at the JHL Biotech site in Wuhan, China of pre-made modules equipped with GE Healthcare’s world-class technologies for the start-to-finish manufacture of biopharmaceuticals. In addition to GE project-managing the build, members of its experienced Shanghai Fast Trak team will be deployed to validate the equipment and provide training for JHL Biotech staff. After completion, the JHL Biotech KUBio facility will have a floor space of approximately 2,400m 2 and will contain a number of 2,000L single-use bioreactors.
Olivier Loeillot, General Manager of Enterprise Solutions, GE Healthcare Life Sciences, commented, “The decision of JHL Biotech’s highly experienced team to select KUBio as the basis of its commercial cGMP biopharmaceutical manufacturing capabilities in China is a fantastic endorsement of our complete, turnkey approach. We look forward to working with them to bring the facility online to serve the fast-moving biopharmaceutical industry. A diverse range of customers, including governments and pharmaceutical companies, are continuing to recognize the breadth, depth, simplicity and flexibility of what we offer with KUBio.”
Racho Jordanov, Co-founder, President and CEO of JHL Biotech, added, “In realizing our vision of making world-class biopharmaceuticals affordable and accessible to all patients, KUBio was the natural choice. Utilizing manufacturing innovations was always a key part of our strategy and GE Healthcare’s KUBio delivers the technologies we want, with the technical support and training we need.”
KUBio is the latest addition to GE Healthcare’s broad offering of world-class tools, technologies and services for the biopharmaceutical manufacturing industry, allowing customers to benefit from a wide range of solutions that can be tailored to meet specific needs, from pilot to commercial scale. KUBio aligns with GE’s healthymagination initiative which focuses on reducing cost, increasing access and improving quality in healthcare.
Amgen and ShanghaiTech University announced the two organizations have entered into a memorandum of understanding (MOU) to form a strategic partnership for the advancement of biopharmaceutical discovery and translational research in China. This agreement includes plans for Amgen to open a China research and development (R&D) center at ShanghaiTech University.
"Amgen and ShanghaiTech University share mutual goals of scientific excellence and rigor and will benefit from each other's strength and expertise in advancing biopharmaceutical discovery in China," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Expansion into China is a business priority for Amgen and opening this R&D center is another clear and important step forward in Amgen's commitment to the China market." Under the terms of the MOU, Amgen will co-locate its China R&D center with ShanghaiTech University's two life science institutes: the Shanghai Institute for Advanced Immunochemical Studies (SIAIS) and the iHuman Institute.
Harlan Laboratories has expanded its specialty research production facility in Bresso, Italy. The expansion in southern Europe allows the company to provide its portfolio of contract breeding and health monitoring services to customers in both mainland Europe and the U.K.
"Expanding our facility in southern Europe is a significant part of our global growth strategy to provide pharmaceutical and biotech companies throughout Europe with the highest quality services that support their research models," said Joe Meyer, vice president of Global Commercial Operations, Harlan Laboratories. "The expansion of our contract breeding and health monitoring services facility reinforces Harlan Laboratories' commitment to provide researchers around the globe with critical services that ensure the specialized models they use in their research will produce reliable and consistent results."
The expanded operations are designed to mirror Harlan's contract breeding service capabilities already established in the UK These services include rederivation, cryopreservation, revitalization, colony management, contract breeding and quarantine services.
As with all of Harlan Laboratories' facilities, the Bresso site was designed with the utmost consideration for the health and welfare of research models. The enhanced facility includes dedicated areas for quarantine to reduce the transmission of pathogens between animal colonies and also features an expanded and updated health monitoring laboratory. In addition, the company incorporated the Locus Technology's LabTracks software system, which provides a fully integrated animal husbandry network that supports realtime inventory data, records on cryopreserved materials, and information on cage capacity and the health status of animals within the facility.
The facility expansion comes on the heels of Harlan Laboratories' recent announcement that the company has increased its specialty model production capacity in North America by more than 30% with expansions of its facilities in Indianapolis, IN and Livermore, CA
Teva Pharmaceuticals opened a new sterile manufacturing facility at Ulm city in Blaubeuren-Weiler state of Germany in July 2013. The new plant is an expansion of the existing ratiopharm plant. Ratiopharm is the leading brand of Teva in Europe.
Teva occupies third position in the German pharmaceuticals market. The company conceived the construction of the new ratiopharm manufacturing plant in 2011, in order to tap the substantial increase in demand for nasal sprays across Europe.
The expansion has increased the nasal spray production capacity at the existing site from 27 million to 45 million a year. It entailed an investment of €30m ($39.78m).
The new sterile manufacturing facility has one building with a total floor space of
16,000m² (172,160 sq. ft.). It produces ratiopharm nasal spray, which is the best selling over the counter (OTC) medication in Germany.
The plant was officially inaugurated by the German Federal Minister of Health Dr. Sven Dethlefs in July 2013.
The first production line at the facility initially provided employment to 25 highly qualified personnel. The line ensures the production of the high quality sterile medicine using the latest technology.
The construction of the new sterile production facility began in January 2012.
Drees & Sommer was awarded the design and construction services contract for the new facility. The contractor used a fast tracking method for construction. The planning for the building was completed in four months and the actual construction of the facility was completed within 18 months.
The facility produces ratiopharm nasal spray both for adults and children. The spray is indicated for reducing swelling of nasal mucosa in occasional rhinitis and allergic rhinitis.
The plant produces about 30 million units of the spray in a year without using any preservatives. The first filling line, which is now operational at the facility, doubles the nasal spray production capacity.
The sterile production facility was built strictly in conformity with the defined guidelines and requirements which focused on the protection of the product from potential contamination by germs.
The facility uses state-of-the-art technologies for producing preservative-free products. It utilizes an aseptic process to produce nasal sprays. It uses open Restricted Access Barrier System (RABS) for maximum product protection. RABS is a gloveport system that avoids employees from contacting open products in the facility.
The facility was designed to maintain the sterility of the product. It features sterile-filtered air flows and airlock systems for materials and personnel. Sterilisation in the production environment is also maintained with the help of special clothing. The surroundings and premises of the facility also feature hygienic design. Maximum sterility zones are maintained by equipping the plant with contactless switches and door handles.
The process technology at the facility is compliant with Good Manufacturing Practices (GMP) requirements for sterile production.
Teva Pharmaceuticals is a leading global pharmaceuticals company with its headquarters located in Israel.
The company is engaged in the development, production and marketing of medicines, generic and OTC products, active pharmaceutical ingredients (API) and novel new therapeutic entities.
Teva has offices in more than 60 countries across the world with an employee base of about 46,000 people. It has more than 120 product distribution centers and 73 pharmaceutical manufacturing facilities across the world.
Aesica, the global contract development and manufacturing organization (CDMO), has officially opened a new high capacity manufacturing facility following a £30mm investment at its Queenborough, UK site. The 10,000m2 (107,600 sq. ft.) expansion has been constructed for the production of a solid dose medication used in treating Type 2 diabetes in adults.
Commercial production at the facility will commence in November. The facility contains a large amount of highly technical and specialist equipment, including spray granulators, coaters, tablet presses, a delumper, blender and a sieve system.
Her Majesty’s Lord Lieutenant of Kent, Viscount De L’Isle, attended the ceremony to unveil the new facility, in recognition of the contribution that Aesica is making to the regional economy, both in terms of the creation of new jobs and commercial expansion.
Aesica is already a strong, committed, local employer in the Queenborough area and with this latest investment and expansion, the facility will have a dedicated workforce of 55 technicians who will be recruited locally and trained on site. The design of the facility will allow the current capacity to be more than doubled in the future which would require the recruitment of a further 50 staff.
The company is well established as a manufacturer and a major exporter of formulated products, and this latest investment reflects the continued growth in export demand it has experienced. The specific product manufactured at the new facility has global sales and is set for worldwide export.
'The new investment and opening of the high capacity manufacturing facility marks another key milestone for our company and a further step towards achieving our vision to be the world’s number one supplier of APIs and formulated products to the pharmaceutical industry,' said Dr Robert Hardy, CEO of Aesica Pharmaceuticals.
Hikma Pharmaceuticals has signed onto a joint venture with MIDROC Pharmaceuticals to establish a presence in the Ethiopian pharmaceutical market.
The JV will be called HikmaCure and London-based Hikma and MIDROC will invest in equal proportions and have committed to provide up to $22.3 million each in cash.
The combined company over the next five years will establish an Ethiopian operating company, build a local manufacturing facility and begin marketing and distributing pharmaceuticals in Ethiopia. In the short term, MIDROC will work with Hikma and HikmaCure to register, market and distribute Hikma’s products in the Ethiopian market.
“We believe Ethiopia offers strong growth potential in the medium to long term and our investment at this stage will enable us to be well positioned in the market. We will continue to explore opportunities to build our presence in the sub-Saharan region,” Said Darwazah, CEO of Hikma said.
The Ethiopian pharmaceutical market is valued at over $500 million and is growing at a compound annual rate of around 15% and is expected to reach approximately $1bn in 2018. Currently about 75% of the market there is based on pharma imports.
The funds for the JV will be invested to build and fit-out a local manufacturing and distribution facility in Ethiopia and to provide working capital support for the operations of HikmaCure. The facility is expected to begin commercial production in 2017.
Capsugel’s DFS Unit has upgraded three FDF (finished dose form) manufacturing facilities in the US and Europe.
The expansions come in response to growing customer demand for hormonal and high-potent compounds for soft gelatin and liquid-fill hard capsules.
At its Ploermel plant in France, Capsugel increased containment capacity to deal with hormonal and high potent compounds in soft gel manufacturing. The expansion also includes a new dosing system and high-speed capsule printing capability.
The company also added more lab space, equipment and analytical scientists at its facility in Livingston, UK. A CFS 1500 capsule filling and sealing machine was installed at the plant and incorporated into the team’s finished dosage form development process.
Meanwhile, in the US, at the company’s Greenwood, North Carolina-based plant, Capsugel commissioned and validated a new commercial scale liquid-fill encapsulation unit for pharmaceutical applications.
Another installation at the site is for a commercial production capability for the new solid lipid pellet (SLP) technology. SLP technology is currently being used on select customer development projects as a unique lipid-based formulation option for bioenhancement and other formulation issues.
Anthony Macci, SVP of Global Operations, said that the company expects to “add manufacturing, quality assurance and support staff as these new products are introduced.”
“Each of our manufacturing facilities provides unique and complementary solutions and offerings that will significantly impact Capsugel’s DFS business unit,” he added.
The expansions cap a busy summer for Capsugel in terms of acquisitions and expansions. Earlier this month Capsugel bought Bend Research to expand its dosage form solutions.
That acquisition also followed the purchase of Encaps in March. The Livingston, UK plant was acquired as part of that deal. Earlier this summer the company also launched a new encapsulating platform .
The company’s DFS (Dosage Formulation Unit) was established in February and is based in Morristown, New Jersey.
Piramal Healthcare is investing US$11m at its Morpeth, UK facility to triple production capacity for hormonal products, including contraceptive pills and hormone replacement therapies.
The expansion will see the Morpeth site’s production capacity increase by around two billion tablets a year.
Work on the new suite, which will house formulation, packaging coating and tableting equipment, will start at the end of the year, with mechanical completion anticipated within 12 months and full operations expected to begin following a six-month validation period.
Vijay Shah, Piramal Enterprises’ Executive Director and COO, said: 'The production of hormonal products is a highly specialized, niche area. The Morpeth facility is our Centre of Excellence for these products and this expansion will greatly enhance our offer and potential for growth in this space.'
He added that the hormonal sector currently represents an $11bn market globally and is growing at 4–5% annually.
'With major competition limited to a small number of CMOs in Europe, Piramal sees major opportunities for growth in this area given our vast experience in this field, which spans more than 40 years.'
The 1,200m2 (12,912 sq. ft.) Morpeth facility, acquired from Pfizer in 2006, also houses Active Pharmaceutical Ingredient (API) production, general solid formulation production, and a range of clinical trial supply and research facilities. Piramal Healthcare provides late phase API services on an integrated manufacturing model across North America, Europe and Asia.
This latest investment follows Piramal Healthcare’s decision to invest $2.5m at its FDA approved Grangemouth, UK, site to upgrade one of its antibody drug conjugate (ADC) manufacturing suites, from clinical phase to commercial grade. The upgrade will give Piramal two commercial grade ADC suites at the Grangemouth facility, while retaining clinical phase manufacturing capacity in other suites on site.
VistaMed, an extrusion and catheter provider to the medical device industry, is expanding operations in Carrick-on-Shannon, County Leitrim, Ireland, to increase capacity due to the market’s increasing demand for sophisticated catheter systems, the company reports. The 35,000-square-foot expansion of the facility includes 12,000 square feet of cleanroom required to meet the growing need for diverse braided catheter assemblies as well as a new area dedicated to thermoplastic extrusion. VistaMed, a joint venture partner of Helix Medical, also is developing an engineering laboratory that will support the company’s growth in design and development projects and enhance project turn-around time.
“Over the last two years, VistaMed has made a significant investment in state-of-the-art extrusion equipment,” said Patrick Mulholland, managing director of VistaMed Ltd. “These new extrusion lines have allowed us tighter dimensional control together with superior control over tubing mechanical properties. The new equipment also supports our growing balloon catheter business and gives VistaMed increased capability to produce more complex balloons.”
The facility expansion also will increase capacity for VistaMed’s existing high-pressure braided tubing lines and will be the production center for a newly developed range of extra high-pressure braided tubing. VistaMed expects to move into the expanded facility in November.
VistaMed was founded in 1999 and has two medical manufacturing operations in Ireland. Products produced in VistaMed’s clean rooms include PTFE-lined guide catheters, steerable catheters, balloon catheters, endoscopic catheters, urological catheters, micro perfusion pain management catheters, as well as ancillary devices such as dilators and introducers. Working with PEEK, polyurethane, polycarbonate, nylon, and other thermoplastics, VistaMed offers single-lumen, multi-lumen, tri-layer and co-extrusion, micro-extrusion, bump, braided, and wire-reinforced tubing solutions for complex catheter systems.
Phebra officially opened a new pharmaceutical manufacturing facility at Lane Cove West in Sydney, Australia, in March 2013.
The new plant augments the production capacity of sterile and critical medicines for the local Australian, as well as New Zealand and other wider export, markets.
The new facility enhances the research and development programs of Phebra and also helps the company deliver extra production capacity for producing critical medicines for local and export markets.
The new facility develops and produces a variety of emergency injectables, antidotes and other small volume injections, and critical medicines. It produces a range of sterile injections, which are used throughout the Australian hospital system. It will employ more staff to carry out drug development and manufacturing.
The facility is expected to increase pharmaceutical investments in Australia. It will also conduct development programs for Australian scientists and medical researchers for enhancing the skills development and employment.
Phebra obtained the final approval for Development Application (DA) and Building Certificate to carry out construction at the Lane Cove site in June 2011.
Construction of the facility began in second half of 2011 and was completed in 2013. The plant became fully operational in March 2013.
The sterile manufacturing plant was constructed in compliance with good manufacturing practice guidelines (GMP) and ongoing series of product validations. The plant obtained a manufacturing license from the Australian Therapeutic Goods Administration (TGA) in May 2013.
Bosch, a German company, was awarded a $2m contract to assemble and install integrated filling machine in one of the three filling rooms, which is located at the sterile injectables unit of the facility. The installation of the integrated filling machine was completed by a team of eight engineers from Bosch in May 2012. Validation manufacturing at the new plant began in December 2012.
The Bosch filling machine increases the hourly rate of production for the range of sterile injections and critical medicines. It is expected to enhance the production five times more from the current capacity.
Total investment for the construction of the plant was about $25m. The project was sponsored by Phebra, which initially invested about $16m for construction of the plant in February 2011.
The Australian pharmaceuticals industry is a leading high-tech industry in the world. It employs more than 40,000 people, and generates about $4bn in revenues through exports in a year. Australia invests about $1bn per year on pharmaceutical research and development.
The Australian Government announced $1bn jobs plan in February 2013. The government boosts reforms in the arrangements for clinical trials of new medicines and treatments in Australia, as part of the plan.
The plan also supports innovation and investment in the Australian pharmaceutical research industry for developing new medicines and treatments.
Phebra collaborates with major hospitals located in Sydney, Melbourne and Newcastle for clinical trials of new medicines and treatments.
Phebra is a leading Australian specialty pharmaceutical company. The company engages in the development and production and marketing of critical medicines in Australia, New Zealand, Asia, Canada and parts of Europe.
It produces critical medical products covering a range of therapeutic areas, including anti-infectives, antidotes, cardiovascular and respiratory disease, central nervous system, diagnostic dyes and agents and infusion solutions. The therapeutic areas also include intravenous additives and electrolyte replacement solutions, oncology and pain, vitamins and specialty pharmaceuticals.
The Chinese packaging giant Greatview Aseptic Packaging Co. Ltd opened its new manufacturing plant in the German federal state of Saxony-Anhalt. The second largest manufacturer of sterile packaging materials in the world began construction of its production facility in June 2011, investing 50 million euro ($67 million) in the process. Since June 2012, approximately 120 employees have been active producing aseptic packaging.
"At the end of the day, what convinced us were the high degree of professionalism and the depth of commitment shown by the public authorities of Saxony-Anhalt in their efforts to win this project," says Hong Gang, Greatview's Chairman and Executive Director. "They made clear from the beginning that together we could create a win-win situation to the benefit of all parties involved." Commenting on the significance of the new plant, he adds, "Europe is the world's largest regional market when it comes to sterile packages. This commitment will help us to increase our market share, widen our customer structure and take full advantage of the rapid growth in the international market for sterile packaging."
Investors in Saxony-Anhalt benefit from its central location in the heart of Europe, its state-of-the-art infrastructure, the availability of a highly skilled and motivated workforce, an outstanding research landscape and a culture of innovation.
Cheshire East Council approved last week an application registered in June for AstraZeneca to build a 6,668m2 (71,748 sq. ft.) facility in the North England market town, which is home to the Pharma Giant’s second largest global manufacturing site.
In a statement the firm confirmed it had submitted the planning application to the Council in order “to assess whether this is an acceptable location for possible future expansion.
“As our second-largest manufacturing site we regularly review our activity here and this is just one of a number of options we are looking at as part of our general planning,” it said.
According to the planning approval document, the proposed development would provide a replacement for a finished formulation facility currently on the site.
A report in local newspaper The Macclesfield Express suggests that the new plant will replace an existing facility that is “reaching the end of its useful life” and predicts that the two sites would operate in parallel for up to two years.
The paper also reported that 36 jobs would be created following this approval and added that AstraZeneca’s commitment to Macclesfield was a boon for the town.
The site is home to the aseptic production line for Zoladex — an injectable testosterone and estrogen suppressant in the treatment of breast and prostate cancer – as well as making tablet formulations for drugs including Seroquel, Zestril, Accolate and Iressa.
The site, which employs nearly 2,000 people, has had a tumultuous few years with the firm announcing 700 jobs were to go in 2007, with further cuts announced the following year.
Earlier this year, the company’s R&D reorganization suggested some jobs lost at the nearby Alderley Park facility would be absorbed by the Macclesfield Plant.
In March the company received a subpoena from the U.S. Department of Justice’s Attorney’s Office in Boston demanding documents and records relating to quality and GMP from the Macclesfield site. The firm sent the required information and AstraZeneca said at the time it was fully confident in the quality of its manufacturing processes.
The industrial component of the French cell therapy sector was built with the backing of BPI France (the French public investment bank) under France’s “Investing in the Future” program.
The first products will be produced on the plant by the end of 2013. CELLforCURE is inaugurating the first-ever European facility for the large-scale manufacturing of advanced therapy medicinal products.
At the inauguration, a first international partnership agreement with the Canadian organization Héma-Québec will also be signed.
The new manufacturing facility is located in Les Ulis (Essonne), France and is operated under the coordination of CELLforCURE, a specialized subsidiary established in 2010 by the French biopharmaceutical group LFB.
The facility is a key component of the path for the future of the French cell therapy industry.
The new facility will allow autologous and allogeneic cell therapies R&D projects resulting from public research or by small and medium businesses, all the way through to industrial production.
With this pharmaceutical platform, cell therapies will be more accessible to patients and will position French cell therapy industry on the international scene.
Les Ulis plant will have an annual production capacity of 5000 therapeutic batches and will have the capacity to manufacture 8 different products simultaneously. The LFB group has invested 18 million euros in the facility.
Five innovative cell therapy medicinal products, that are currently being developed as part of the C4C project funded by the “Investing in the Future” program and BPI France, will be first manufactured in the CellForCure facility.
C4C is based on the expertise of CELLforCURE and its partners: biotechnology companies (Celogos and Clean Cells), the EFS (French National Blood Bank) through its regional branches in the Aquitaine–Limousin and Pyrénées-Méditerranée regions, Bordeaux University Medical Center, the Lille Regional University Medical Center/University of Lille 2, the Nantes University Medical Center, the Toulouse University Medical Center, and the Tissue and Cell Bank [Banque de Tissus et de Cellules-BTC] and Civil Hospices of Lyon [Hospices Civils de Lyon-HCL].
These products use various types of cells: cord-blood stem cells, lymphocytes, hematopoietic stem cells, immunologically competent cells, and progenitor or adult somatic cells.
In addition to the five cell therapy products of the C4C Project, the new industrial facility will be manufacturing products for other customers in the private and public sectors beginning in 2014.
On the occasion of the inauguration, CELLforCURE will sign its first international partnership agreement, with the Canadian non-profit organization Héma-Québec; Jean de Serres, president and CEO of this organization, will be there for the signing. This agreement will provide CELLforCURE, with a North American production partner approved by the U.S. and Canadian authorities.
It will speed up access to the North American continent for both CELLforCURE’s products and those of its European customers. By the same token, CELLforCURE will be able to offer a European entry point to Héma-Québec customers wishing to expand their products’ markets into Europe.
Although Europe's first marketing authorization for a cell therapeutic was granted in October 2009, the cell therapy market is set to be worth an estimated US$5 billion by 2015 and could double again to reach US$10 billion in 2020.
Cell therapy involves the administration of human cells to prevent, treat or alleviate a disease. In some situations, the administered cells repair and/or rebuild damaged tissue. In others, modified cells are used to provide tissue with compounds that it previously lacked.
Cell therapy is at the heart of tomorrow's personalized medicine and is expected to provide new ways of preventing or treating a wide range of diseases - many of which currently lack effective therapeutic solutions (e.g. certain cancers, neurodegenerative diseases, neuromuscular diseases and degenerative diseases like myocardial infarction, heart failure and rheumatoid arthritis).
In fact, this type of therapy is a "cell transplant" in which cells taken from the patient him/herself ("autologous" grafts) or a donor are selected, modified or treated in vitro before being administered (usually by injection) to the patient.
Hence, this approach often requires the use of completely new production models that are far removed from “traditional” pharmaceutical or biotechnological manufacturing processes.
Novartis half-billion dollar investment in a new biologics production plant in Singapore represents a strategic commitment to its growing biologics portfolio.
The number of biologic drugs is increasing, and as they begin to account for a larger percentage of pharmaceutical companies’ portfolios, investments in new biologics production facilities are taking center stage. Novartis broke ground in February 2013 on its new $500-million biologics facility in Singapore, which underlies the company’s long-term strategy to establish a worldwide manufacturing network of technology centers of excellence. The facility is co-located with Novartis’ pharmaceutical production site in Tuas, Singapore and will focus on drug-substance manufacturing based on cell-culture technology. In addition, the investment represents a strategic commitment to Novartis’ growing biologics portfolio, which represents 25% of the company’s current clinical pharmaceutical research pipeline.
“Singapore’s marked biomedical presence and regional knowledge, well-trained talent, and proximity to Asian growth markets makes it a strategic location for biotechnological research and advancement,” says a Novartis spokesperson, who notes that Singapore is a well-regulated, secure environment in which Novartis can operate. The company recognizes Singapore’s value as a center of technology excellence and has partnered with the Singapore Economic Development Board since its establishment in 2002. Novartis also has several other ongoing operations in the country, including the Novartis Institute for Tropical Diseases, the Novartis Asia-Pacific head offices, two production facilities for its eye-care subsidiary Alcon, and a pharmaceutical manufacturing site. With the completion of the biologics facility, Novartis will have more than 1500 associates based in Singapore. Novartis began construction of this Singapore biologics plant earlier in 2013, and the production facility is expected to be fully operational by the end of 2016.
The facility will focus on drug-substance manufacturing based on cell-culture technology. The plant will be designed with the capability to support clinical and commercial production of potential new products, including monoclonal antibodies for use in the treatment of autoimmune, respiratory, and oncology diseases.
The site will be designed to operate in a flexible manner in order to handle small and large-scale volumes, according to a Novartis spokesperson. Novartis will use a mix of disposable technology and stainless-steel systems placed in modules in an effort to get a high degree of repetition of design and automation. Multiple commercial-scale bioreactors with adjacent seed trains and corresponding purification lines will be designed and installed. In addition, the purification lines will be constructed in a flexible manner so as to be able to combine the purification steps in the order needed for specific therapeutic proteins. “With the equipment we are installing, the plant will produce material for clinical trials of biologics in the Novartis biopharmaceutical pipeline on the same scale as will be expected for commercial production,” the spokesperson notes.
The investment in Singapore comes on the heels of the recent acquisition (late 2012) by Novartis of Dendreon’s FDA-approved Provenge plant in New Jersey, which is designed for the production of clinical and commercial quantities of Novartis’ CTL019 Chimeric antigen receptor and other human autologous cellular immunotherapy products. In December 2011, Novartis also began production of cell-culture based influenza vaccines at a new plant in North Carolina.
GlaxoSmithKline is in talks with a number of companies interested in buying its Romanian manufacturing facility that was recently earmarked for closure.
The facility in Brasov is GSK’s “only manufacturing site in Romania,” said GSK spokesperson Kalpesh Joshi, but the company announced in June it was closing the facility due to an assessment of its oral solid dose manufacturing network.
Joshi said Brasov had been under-utilized as a site, was “not sustainable in the long run” and therefore the company gave a period of six months to search for a buyer.
Three months into this process Joshi told us GSK was in talks with several firms: “I can’t provide specifics but we have had discussions with a mixture of local and international investors.”
According to the company’s website, the factory in Brasov makes 16 brands of drugs for both the local and international markets which, according to Joshi, will be transferred to other sites across GSK’s network.
GSK acquired the facility when it took over local manufacturer Europharm in 1998 and has since invested over $106m (€80m) into the site which employs approximately 240 people.
If no buyer is found, operations are set to wind down with production ceasing by the second half of 2015.
The decision to shutter the site had “nothing to do with the performance of the plant in Brasov,” said Pascal Prigent, Director General GSK Romania, in a translated statement from June . “The decision comes following a wave of expired patents [that] has led to excess capacity on oral solid forms.”
The patent cliff, over-capacity and network reviews are affecting manufacturing for a number of Big Pharma firms. Pfizer, for example, has put its Little Island, Ireland manufacturing site up for sale following the expiration of the drug Lipitor.
Merck & Co. recently announced it was shuttering an API plant - also in Ireland – as part of an “ongoing review of its worldwide manufacturing facilities.”
The facility helps in improving the efficiency of DSP's operations in research and development, ranging from drug target discovery to applications for manufacturing and marketing approval.
DSP invested about ¥6.4bn ($64m) for the construction of the new building.
The new building has eight floors above the ground. It has a total building area of 2,463m² (26,502 sq. ft.) and total floor space of 16,322m² (175,625 sq. ft.). It has laboratories meant for drug discovery, process chemistry and analytical research and development. It will enhance DSP to promote efficient research and development, and facilitate the creation of highly innovative drugs for unmet medical needs.
The facility will carry out drug research on the central nervous system (CNS) as a focus therapeutic area, and cancer and immune-related diseases as challenge therapeutic areas.
The new building will combine the work of the drug discovery division and the technology research and development division. The work in these two divisions is distributed to Osaka research centre in Osaka, and central research laboratories in Suita City.
The research building will optimize chemistry research-related departments assigned to drug discovery research. DSP will be able to focus on improving the efficiency of the series of operations in research and development of drug target discovery and quality management of investigational new drugs through the facility.
The new facility of Dainippon Sumitomo Pharma has meeting spaces located on each floor, which enables active communication for the creative research environment for developing highly originated drugs. It is also equipped with video conference rooms for carrying out communication with other research sites worldwide. It also features a stringent security system for chemical reagent storage.
Ground was broken for the new chemistry research building's construction in January 2012. The construction was completed in June 2013. The operations are scheduled to begin in July 2013.
The 40m tall building was constructed with a seismic isolation structure to withstand damage caused by earthquakes and liquefaction. It was constructed using foundation improvement methods.
The key drug products developed and produced by Dainippon Sumitomo Pharma include ephedrine indicated for the treatment of bronchial asthma, Gasmotin, a gastroprokinetic agent and Lonasen, which is used for the treatment of schizophrenia. The new Osaka research facility will further help boosting pharmaceutical research of DSP.
The building was constructed in compliance with environment-friendly methods. It features airflow fume hoods and is installed with solar panels and energy efficient air conditioning and lighting systems. The building is designed to make the best use of natural light.
Dainippon Sumitomo Pharma is a leading international pharmaceuticals company with its head offices located in Osaka and Tokyo, Japan.
The company is engaged in the production, sales and import and export of pharmaceuticals, food additives, veterinary products, diagnostic agents and research materials.
It has more than 7,218 employees with two distribution centers and four manufacturing plants located in Japan.
Its subsidiaries include Sunovion Pharmaceuticals, Boston Biomedical and Sunovion Pharmaceuticals Europe.
Merck officially inaugurated a new drug packaging facility at Hangzhou in April 2013. The new plant is located in the Hangzhou Economic and Technology Area (HEDA) in Hangzhou, China.
It is one of the largest facilities of the multinational pharmaceutical company in Asia Pacific.
The plant was established by joint venture comprising of MSD China and Huadong Medicine. It was constructed with an investment of $120m.
The plant largely supplies the packed solid and sterile medicines to China and Asia-Pacific countries. The facility has a total floor space of 75,000m² (807,000 sq. ft.). It packages medicines for China as well as the Asia Pacific region. The plant created about 350 new jobs. It is Merck's second facility in Hangzhou and third plant in China. The facility is fully compliant with the rigorous international quality, environmental, safety and compliance standards.
The facility includes 16 high-speed lines for packaging both tablets and sterile products. It has the annual capacity for producing more than 300 million packages.
The plant packages drugs that are especially meant for diabetes and cardiovascular diseases, as well as those for infectious, respiratory and bone diseases. The plant will also package products for clinical studies and medicinal products to be launched in future.
The plant largely supplies the packed solid and sterile medicines to China and Asia-Pacific countries.
The construction of Merck's Hangzhou facility was started in July 2010 and took more than two years to complete. The plant was officially inaugurated in April 2013.
The Hangzhou facility was constructed in compliance with quality measures and standard environmental and safety practices. It received Good Manufacturing Practices (GMP) certification in January 2013. It was constructed using environment-friendly procedures, which included waste, special air and water-management procedures and systems.
Merck entered into the Chinese Pharmaceuticals market in 1992. The company opened its first production facility in Hangzhou in 1994 with the partnership of Hangzhou East China Pharmaceutical Group. It later opened its second facility in China in Shanghai.
The company, including its new Hangzhou facility, currently has three factories in China. The manufacturing plants of the company in China produce and supply products to the highest standards of quality, environment, health and safety for China and the Asia Pacific region.
Merck has offices in ten Chinese cities, with the marketing and sales headquarters located in Shanghai. The company has more than 5,000 employees in China.
The healthcare system in China has been growing rapidly, which prompted Merck to establish the Asia R&D headquarters in Beijing in 2011. The company is committed to invest more than $1.5bn for R&D in China in the next five years. It has introduced more than 40 innovative medicines and vaccines in China during the last two decades. It continues to invest more towards research and innovation in the country.
Merck's sales revenue in China exceeded $1.0bn in 2012, which represented a 25% increase over 2011.
Merck has 72 drug manufacturing facilities and approximately 83,000 employees worldwide with its drugs and vaccines supplied to more than 140 countries. The company produces a range of prescription medicines, vaccines, biologic therapies and animal health and consumer healthcare products. Its sales revenue for 2012 stood at $47.3bn.
Merck's strategy in the recent times has been to reduce the manufacturing operations worldwide where it faces cost challenges, and to expand in emerging Asian markets. The company especially prefers to expand the operations in China, because it desires to leverage from increasing domestic demand coupled with low cost production potential.
Phebra officially opened a new pharmaceutical manufacturing facility at Lane Cove West in Sydney, Australia, in March 2013.
The new plant augments the production capacity of sterile and critical medicines for the local Australian, as well as New Zealand and other wider export, markets.
The new facility enhances the research and development programs of Phebra and also helps the company deliver extra production capacity for producing critical medicines for local and export markets.
The new facility develops and produces a variety of emergency injectables, antidotes and other small volume injections, and critical medicines.
It produces a range of sterile injections, which are used throughout the Australian hospital system. It will employ more staff to carry out drug development and manufacturing.
The facility is expected to increase pharmaceutical investments in Australia. It will also conduct development programs for Australian scientists and medical researchers for enhancing the skills development and employment.
Phebra obtained the final approval for Development Application (DA) and Building Certificate to carry out construction at the Lane Cove site in June 2011.
Construction of the facility began in second half of 2011 and was completed in 2013. The plant became fully operational in March 2013.
The plant was inaugurated by Mr. Greg Combet, Minister for Industry and Innovation, Australia.
The sterile manufacturing plant was constructed in compliance with good manufacturing practice guidelines (GMP) and ongoing series of product validations. The plant obtained a manufacturing license from the Australian Therapeutic Goods Administration (TGA) in May 2013.
Bosch, a German company, was awarded a $2m contract to assemble and install integrated filling machine in one of the three filling rooms, which is located at the sterile injectables unit of the facility. The installation of the integrated filling machine was completed by a team of eight engineers from Bosch in May 2012. Validation manufacturing at the new plant began in December 2012.
The Bosch filling machine increases the hourly rate of production for the range of sterile injections and critical medicines. It is expected to enhance the production five times more from the current capacity.
Total investment for the construction of the plant was about $25m. The project was sponsored by Phebra, which initially invested about $16m for construction of the plant in February 2011.
The Australian pharmaceuticals industry is a leading high-tech industry in the world. It employs more than 40,000 people, and generates about $4bn in revenues through exports in a year. Australia invests about $1bn per year on pharmaceutical research and development.
The Australian Government announced $1bn jobs plan in February 2013. The government boosts reforms in the arrangements for clinical trials of new medicines and treatments in Australia, as part of the plan.
The plan also supports innovation and investment in the Australian pharmaceutical research industry for developing new medicines and treatments.
Phebra collaborates with major hospitals located in Sydney, Melbourne and Newcastle for clinical trials of new medicines and treatments.
Phebra is a leading Australian specialty pharmaceutical company. The company engages in the development and production and marketing of critical medicines in Australia, New Zealand, Asia, Canada and parts of Europe.
It produces critical medical products covering a range of therapeutic areas, including anti-infectives, antidotes, cardiovascular and respiratory disease, central nervous system, diagnostic dyes and agents and infusion solutions. The therapeutic areas also include intravenous additives and electrolyte replacement solutions, oncology and pain, vitamins and specialty pharmaceuticals.
Europlaz Technologies Ltd., a medical device manufacturing company based in Southminster, U.K., has expanded to 50,000 ft2 to keep up with the demand for U.K.-based manufacturing.
Europlaz took control of the freehold of the additional 18,000 ft2 building within its existing industrial estate in August. The extra space will be used to double capacity for quality, technical injection molding, and cleanroom assembly.
Following investment in machinery and cleanrooms over the past two years, Europlaz has seen a surge in new business won as well as the extension of existing contracts. Europlaz will keep its current site and cleanrooms but add extra production, cleanroom, and warehouse capacity. The additional buildings also offer an opportunity for the Europlaz management team to work in closer proximity.
McIlvaine Company
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