PHARMACEUTICAL & BIOTECHNOLOGY
INDUSTRY UPDATE
September 2013
McIlvaine Company
TABLE OF CONTENTS
University in Minnesota Opens Science Building
NSF Funds Kansas State Wheat Genetics Center
U. of Kentucky to Create Metabolomics Cancer Center
Helix Medical Expands in Ireland
Bayer CropScience Expands Cleanroom Site
Mayo Florida Lands $5 Million for New Individualized Medicine Clinic
Silcotech to Open Molding Facility
NanoViricides Constructing Pilot Production Plant
Velesco Expands with Center for Innovation
PTI Expands Production Facility
NIH to Fund Sequencing Core Facility
Amway’s Nutrilite Vitamins Manufacturing Facility
Pillar5 Pharma Expands Operations
JHS Expands Sterile Manufacturing
Greatview Aseptic Packaging Opens Manufacturing Plant
SPS' New HQ Up and Running, Service Expansion Planned
Agilent to Open Analytical Sciences Lab in Singapore
Thermo Fisher Scientific Opens Its First Dry Powder Media Facility
Phillips-Medisize to Buy Manufacturing Facilities in China and Mexico
Nypro Establishes New Facility in Ireland
Piramal Expands ADC Capacity at UK Site
Ranbaxy to Invest $35 Million in Second Malaysian Facility
IDT Opening of Singapore Plant
Pall Opens Indian Tech Support Center
DS Smith Packaging Opens Cleanroom
Merck's Pharmaceutical Packaging Facility, Hangzhou, China
Dainippon Sumitomo Pharma's Chemistry Research Building, Osaka, Japan
Julphar Manufacturing Facility, Addis Ababa, Ethiopia
MedGenome, Eye Hospital to Create Omics Lab in India
Cleanroom Will Give the Gift of Sound
Even as New York's largest biotech company keeps reinvesting at two locations in its native New York, it's also looking abroad to the Emerald Isle. And it's planning to reignite a once-hot Dell manufacturing site in the process.
Last November, New York Gov. Andrew Cuomo announced Regeneron's plans to invest nearly $70 million to expand its manufacturing capacity in Rensselaer, N.Y., and create 300 new jobs in the Capital Region. Then, in April, the company said it would expand its Tarrytown corporate headquarters and laboratories in Westchester County and create more than 400 new high-skilled jobs.
"Our recently approved drugs and our robust development pipeline have transformed Regeneron into one of the largest and fastest-growing biopharmaceutical companies in the United States," said Leonard S. Schleifer , M.D., Ph.D., president and CEO, in April. "Regeneron has been based in New York since we began 25 years ago, and we are grateful to Gov. Cuomo and New York State for financial support that helps us to continue to expand and create jobs in New York."
According to the state, the company had also considered expanding outside New York before the State stepped in with $8.5 million in tax credits through the Excelsior Jobs Program and the Town of Mount Pleasant Industrial Development Agency offered additional incentives. Construction of the new buildings is anticipated to begin in late 2013 and to be completed in late 2015.
The project will add two new buildings with 300,000 sq. ft. of laboratory and office space to the Regeneron complex at the Landmark at Eastview in the Town of Mount Pleasant in Westchester County. Currently, Regeneron occupies approximately 590,000 sq. ft. of space at the site and will occupy another 85,000 sq. ft. of additional space there later this year. The expansion will enable the company to continue to accommodate the rapid growth it has experienced over the last six years - from 682 employees in 2007 to 2,000 today, including more than 1,300 employees in Tarrytown and nearly 600 at its industrial operations and product supply facility in Rensselaer.
The Rensselaer project involves the construction of two facilities at Regeneron's East Greenbush location - a new 65,000-sq.-ft. building at 81 Columbia Turnpike that will add manufacturing capacity for Regeneron products for clinical trials and potential commercial sale, and an expansion of the company's facility at One CSC Way. The new project caps a period of rapid growth for Regeneron in East Greenbush. Empire State Development will assist the company in Rensselaer with $6.7 million in Excelsior Jobs Program tax credits.
With the Rensselaer and Tarrytown expansions, the company is slated to create more than 700 new jobs in New York State and invest approximately $170 million in capital expansion in New York over the next few years.
But when you're the world's No. 1 biopharmaceutical employer (according to Science Magazine in 2012), the world awaits.
Now the company is in final negotiations to bring new life to a former Dell complex in Ireland, and the timing is nearly as good for that region as it is for the company.
Regeneron has grown from 682 employees in 2007 to 2,000 as of earlier this year, including more than 1,300 employees in Tarrytown, N.Y., and nearly 600 at its industrial operations and product supply facility in Rensselaer. Another 700 jobs are on the way over the next few years.
"Regeneron has a preliminary agreement with Dell to acquire a 400,000 sq. ft. manufacturing and distribution facility owned by Dell in Limerick, Ireland," said an official statement from Regeneron emailed to Site Selection, referencing a site in Raheen, County Limerick. "Subject to definitive agreements and permitting, Regeneron intends to renovate the facility and install new equipment for biopharmaceutical production and product supply operations. When operational, Limerick will become a second industrial operations (production) site for Regeneron. The primary industrial operations site will remain in Rensselaer, NY."
"We are also currently expanding our production capacity in Rensselaer by approximately 50 percent by building a new production suite that will house two 10,000-liter bioreactors," the statement continued. "It is premature to estimate which products and product candidates we will produce in Limerick or the number of jobs that Regeneron may create there. We expect a slow build there in personnel."
According to the statement, the company needs more production capacity to support anticipated commercialization of antibody drug candidates now in late-stage clinical trials and to support clinical requirements for the growing number of early-stage molecules in the Regeneron pipeline. "The expansions are not specifically to increase production capacity for EYLEA® (aflibercept) Injection, the drug we market in the U.S. for wet age-related macular degeneration and central retinal vein occlusion," said the statement.
Dell famously closed the Limerick plant in January 2009, letting to some 1,900 employees and moving computer production to Poland. It originally invested in Ireland in the last years of last century, part of massive investments in multiple global locations.
A filing this summer with the US Securities and Exchange Commission says Regeneron anticipates investing between $225 million and $300 million through 2014 on its activities in the two New York locations and the Limerick location, as well as for new equipment.
Two developments in Limerick bode well for the business climate Regeneron will find as it arrives.
In early July, the Limerick Chamber welcomed the announcement of US$40 million in funding to support world-class research at the Synthesis & Solid State Pharmaceutical Centre (SSPC) based at University of Limerick - a unique collaboration between 17 companies & academic institutions that will position the region and Ireland as a global hub for pharmaceutical process innovation and advanced manufacturing.
Speaking at the announcement, Limerick Chamber CEO Maria Kelly said it will "build on existing success and can be the foundation of a strong cluster potential for the Limerick and Mid West area. It aligns with the recent Limerick 2030 draft Economic and Spatial Plan and will allow Ireland to become an even more attractive and competitive international location for the pharmaceutical sector."
The Irish pharmaceutical industry supports over 60,000 Irish jobs and exports over 50 billion annually.
That $250-million plan - 'Limerick 2030 - An Economic and Spatial Plan for Limerick' - is also of recent vintage. The city and county councils say it has the potential to deliver 5,000 new jobs and sets out a number of objectives which will considerably change the infrastructure of the city centre and deliver a whole new vision for Limerick as a leading centre for commercial investment.
Speaking at the launch, Limerick City and County Councils Manager/CEO Conn Murray described Limerick 2030 as "a once-in-a-generation plan to guide the economic, social and physical renaissance of Limerick city center, the wider county and Mid-West region. The plan will allow us to work together to bring much needed investment to Limerick, to revitalize the city center and to project a positive image giving confidence to investors, businesses and the local community. It is by design a flexible, dynamic framework capable of responding to changing circumstances and providing, perhaps for the first time, a holistic perspective on Limerick's future. And it's timely, as we move towards the full merger of Limerick City and County Councils in 2014,"
Merger is nothing new in those parts. In addition to the launch of the Limerick 2030 plan, a Charter of Convergence and Cohesion was also signed this summer by the heads of the principal agencies in the Mid-West region. "This Charter, which in many ways is reminiscent of the original Charter of Limerick signed in 1197, sets out a series of commitments which at the center contains a resolution to working in a collaborative way for the benefit of Limerick," said the announcement.
The economic and spatial plan is part of a wider and more ambitious 750-million Limerick Project to deliver improved economic infrastructure including new third-level (higher) educational facilities, new Port facilities along the Shannon Estuary, and new infrastructure at Shannon International Airport over the next two decades.
Among other investments recently welcomed in the area has been a 142-job expansion by CPL Industries in Foynes, where the solid-fuel supplier announced in June it aims to develop a bio-fuel plant. In March Worldwide Tech Services announced it's establishing its European Headquarters in Limerick City Centre at Riverpoint, with an initial head count of 62 new jobs. And Vistakon Ireland, a Johnson & Johnson company, recently announced the addition of 100 production jobs as it plans to invest over 100 million in the expansion of its manufacturing operations at its site in the National Technology Park, Plassey, Limerick.
Established in Limerick in 1996, Vistakon designs, manufactures and markets the ACUVUE® range of soft disposable contact lenses. It is one of several Johnson & Johnson companies operating in Ireland, employing a total of 1,900 people.
St. Cloud State University in Minnesota has inaugurated its $45 million, four-level, 100,000 ft2 Integrated Science and Engineering Laboratory Facility (ISELF). The building contains a cleanroom, robotics lab, and imaging center consultation space. ISELF is expected to attract area manufacturers who want to bring their processing problems and meet with students and faculty to find solutions. That effort won’t be an academic sidelight but a requirement for graduation.
Former dean of the College of Science and Engineering, David DeGroote, conceptualized a facility in which laboratory space would be temporarily allocated to projects and teams of people, not permanently given to campus entities. He famously said: “They’ll come. They’ll work. They’ll leave.”
Central Minnesota businesses, including more than 50 precision manufacturing companies, can prototype new processes using ISELF space and student-faculty ingenuity, school officials say.
"We have the courage, and are committed to being changed by our partners. That's one of the most special things this learning environment, the ISELF, will do for us," said university president Earl H. Potter III
ISELF goes into service fall semester, completing the three-part Science Initiative that creates St. Cloud State's science campus for the future. The $14.5 million addition to the Wick Science Building was completed in January 2009. The $15 million renovation of Brown Hall was finished in December 2009.
St. Cloud State is the largest of the 31-schools in the Minnesota State Colleges and Universities system.
The National Science Foundation has provided seed funding to launch a genetics research resource at Kansas State University that will work with partners at Colorado State University and the agricultural technology industry to improve production and disease resistance in wheat and other crop plants.
The new center, which NSF will fund with around $100,000 per-year for five years, already houses a collection of germ-plasm and genetic tools that are used in applied breeding programs around the world, Kansas State said.
The new NSF Industry/University Cooperative Research Center for Wheat Genetics will build upon resources that are already in place at Kansas State's Wheat Genetics Resource Center, and it will serve as a training ground for graduate students and young investigators.
The current gene bank, which houses about 14,000 wild wheat species strains and around 10,000 genetic stocks, and its accompanying lab will be moved to the Kansas Wheat Innovation Center in Manhattan, Kan.
This center will work with its partners to develop new ways to use wheat genetic diversity to provide novel traits in elite genotypes that may be used to reduce the market-ready time of wheat crops, and it will develop methods and traits for use in breeding programs and for sustainable and profitable farming.
Along with Colorado State, the Center for Wheat Genetics' partners include Bayer CropScience; Syngenta; Dow AgroSciences; Limagrain; General Mills; the Heartland Plant Innovation Center; the Kansas Wheat Commission and the Kansas Wheat Alliance.
Kansas State said this center is the first NSF-established research center for any crop plants.
The University of Kentucky plans to establish the UK Center for Regulatory and Environmental Analytical Metabolomics (UK-CREAM), and it has hired several metabolomics and cancer researchers from the University of Louisville to launch the program.
The UK Markey Cancer Center will partner with the four new researchers over the next few months to establish UK-CREAM, which will be located at UK's BioPharm Complex, according to the Markey center.
The investigators UK has recruited to establish the UK-CREAM also were the executive committee members at Louisville's CREAM.
According to the Markey center, these investigators will hold the same positions at its center that they held at the Louisville CREAM. They include: Teresa Fan, director; Andrew Lane, associate director of NMR Development; Richard Higashi, associate director of mass spectrometry development; and Hunter Moseley, associate director of informatics.
Fan, Lane, and Higashi have pioneered techniques for using NMR and mass spectrometry to study environmental stress-induced metabolic changes in a variety of indigenous and model organisms, according to the Markey center.
Together, these research partners will bring more than $17 million over five years in federal funding with them to support the center.
The researchers' current projects include a newly funded one from the National Cancer Institute using a systems biology approach to studying non-small cell lung cancer, and another effort to develop an integrated chemoselective and informatics platform for large-scale metabolomics.
Just more than a month ago, the Markey center announced it had become an NCI designated cancer center, the only one in Kentucky. The designation required that the center demonstrate certain capabilities and standards in lab and clinical research, and UK said at the time that it will enable the center to engage in more clinical trials offered only through NCI centers, and will provide more opportunities for federal funding.
Carpinteria, Calif.-based Helix Medical LLC has added capabilities for thin-wall injection molding with PEEK (polyetheretherketone) and silicone materials at its facility in Gloucester, Mass. The company also provides other specialized molding services including implantable thermoplastic and silicone specialty components, biopharmaceutical components, and fully-automated molding of tight-tolerance silicone bellows.
“We have made a significant investment in technology over the last year to continually expand our portfolio of services allowing us to provide our customers with a total manufactureable design solution,” said Edward Callahan, vice president and general manager of Helix Medical in Gloucester. “Our range of capabilities includes product design support, quick turn prototypes, and low volume tight tolerance tooling concepts which are…available for both thermoplastic and silicone.”
For high-volume projects the team employs dedicated automated cells using standardized multi-cavity direct gated systems. Added Callahan, “our approach is to validate each tool using scientific injection molding methodology for both silicone and thermoplastics to ensure the process is repeatable and continually controlled in production.”
Helix Medical is a division of Germany-based Freudenberg Group.
Bayer CropScience plans to consolidate and expand its U.S.-based R&D operations for vegetable seeds and biological crop protection products in a new site in West Sacramento, Calif. The site will encompass 30,000 ft2 of cleanroom space; 40,000 ft2 of research and development space; 30,000 ft2 of office space; and 40,000 ft2 of warehouse space.
The vegetable seeds research, as well as the company’s Biologics business management, both located in Davis, Calif., will move about 10 miles to West Sacramento in Q1/2014. The site will also include a pilot plant, and additionally Bayer CropScience has identified nearby land for greenhouse and test plot purposes in West Sacramento.
“We are focused on better leveraging our full research and development capabilities by both consolidating and expanding our global R&D organization,” says Dr. David Nicholson, Bayer CropScience’s Head of Research & Development. “Our new facilities in West Sacramento will enable us to deliver integrated crop solutions more rapidly by intensifying the research links between our vegetable seeds and Biologics experts and thus strengthening our innovative power.”
The scientists at Bayer CropScience specialize in developing biological crop protection products which provide additional options for farmers.
Monsanto has completed a $31 million expansion at its vegetable seed research headquarters in Woodland, Calif. The expansion included a 90,000-square-foot laboratory and office building and makes the Woodland location the company's primary site for the molecular breeding of vegetable seeds, according to Monsanto's Beyond the Rows blog.
Mark Oppenhuizen, Woodland's strategy and operations lead, said the expansion would allow Monsanto to "maintain a close working relationship with our customers in an area which has become a hub for seed science and which produces more than half of all vegetables grown in the U.S."
The Woodland site employs 250 full-time workers and 150 contract seasonal employees.
Mayo Clinic in Florida said that it has received a $5 million private donation to help fund the launch and operations of a new clinical center in Jacksonville that will use genomic technologies to tailor treatments to individual patients.
The new Individualized Medicine Clinic in Jacksonville will be a component of Mayo Clinic's broader Center for Individualized Medicine, a program that also spans Mayo's operations in Minnesota and Arizona, and harnesses a range of resources, including genome sequencing, proteomics, biobanking, and gene expression facilities, among others.
In the new program, a team at the Jacksonville center that includes genomics scientists, genetic counselors, bioinformatics experts, and bioethicists, will work with physicians to determine whether specific patients are good candidates for treatments guided by genetic testing.
This multidisciplinary group will provide consulting for cancer patients who have seen standard treatments fail and for patients with "diagnostic odyssey" cases, disorders that are complex or difficult to diagnose but which appear to be genetic in origin, Mayo said.
The new funding was provided by the Cecilia and Dan Carmichael family, who in 2008 established the Mayo Clinic Carmichael Family Endowed Fund for Individualized Breast Cancer Medicine and helped to fund the Breast Clinic at Mayo Clinic.
Mayo's Center for Individualized Medicine has translational programs focused on biomarker discovery, clinical genomics, epigenomics, pharmacogenomics, and the microbiome, and infrastructure programs that include a medical genomics facility, biorepositories, bioinformatics resources, as well as bioethics and education and training components.
Silcotech North America Inc., a manufacturer of silicone components, plans to locate its new facility near York, S.C. The $3.5 million investment is expected to generate 50 new jobs. The company will establish an 18,000 ft2 silicone injection molding production facility in East York Industrial Park. The site, which will include a cleanroom, is expected to be completed and operating in July 2014.
“The new facility will have state-of-the-art equipment and technology to serve the most demanding requests in today’s silicone injection molding industry,” says Isolde Boettger, vice president of Silcotech North America Inc.
Silcotech produces specialized silicone components for a number of industries including the medical device, automotive, consumer electronics, and solar industries. With the startup of Silcotech Carolina, the Silcotech Group expands its offerings in molding, two-component molding, and micro molding of liquid silicone rubber.
The Coordinating Council for Economic Development approved a set aside grant of $160,000. readySC, a division of the S.C. Technical College System, will provide pre-employment training.
The renovation of NanoViricides Inc.’s clinical scale cGMP production plant facility in Shelton, Conn., is progressing on schedule. The renovation will include an expanded R&D facility and a cGMP pilot scale production facility, including cleanroom suites suitable for injectables active pharmaceutical ingredient manufacture.
The company reports that its project for enabling clinical scale drug product cGMP capability is now in the construction phase. Design, engineering, and architecture for this facility were completed at the end of June 2013, and subcontractors were retained at the end of June as well. The demolition plan was executed in July with initial construction work began on schedule in August. The construction is on schedule to be completed by the end of December 2013.
NanoViricides has also started sub-kg scale production of its injectable FluCide anti-influenza drug candidate at its current facility. Safety and toxicology studies of the injectable and oral FluCide drugs are estimated to require very large quantities of the drugs, because of strong safety data evidenced from the in vivo (animal) efficacy studies to date. The company will be able to initiate GLP Safety/Toxicology studies of the injectable FluCide drug when the requisite large amount of drug substance is produced. The FluCide drug candidates have already shown strong effectiveness against distinctly different subtypes of influenza viruses, namely H1N1 and H3N2, in highly lethal animal models. In addition, NanoViricides has developed drug candidates against dengue, HIV/AIDS, herpes, and ocular viral diseases that have shown strong effectiveness in relevant animal and/or cell culture models. The US FDA has recently designated DengueCide®, our drug for dengue and dengue hemorrhagic fever as an “orphan drug”.
Velesco Pharma has expanded its drug formulation, analytical development and cGMP clinical trial manufacturing services with the opening of a new business development office in the greater Boston area. Velesco will be the first life sciences tenant of the Quincy Center for Innovation, a 12,500-sq.-ft. facility providing inexpensive and flexible office space and support services to assist start-up companies and aspiring entrepreneurs. The QCI is expected to open fully September 1.
“The growth of Velesco’s early phase CMC services has led to a need to increase our presence in this global hub for pharma and biotech companies. As we enter our sixth year of operations, we are looking forward to having a presence nearer to our existing and prospective clients,” said Gerry Cox, Velesco's co-founder and chief operating officer, who will be leading the new office. Velesco has R&D operations in Plymouth, MI and GMP operations in Kalamazoo, MI.
“In Massachusetts we invest in the life sciences because we are choosing to shape our own future,” said Deval Patrick, Massachusetts' Governor. “We welcome Velesco to Quincy’s new Innovation Center and look forward to them creating jobs and economic opportunities in the region.”
“One of the goals of the QCI is to provide a landing spot for those companies who are not yet located in Massachusetts, but have an interest and need to get acclimated to the region before choosing a permanent location,” said Donna Mavromates, director of the Quincy Center for Innovation.
“We will continue our focus on drug formulation, analytical method development and the supply of cGMP clinical supplies to early phase clinical trials while maintaining an evolving understanding of our clients’ needs. The Quincy Center for Innovation’s emphasis on working with young vibrant companies makes this location an excellent fit for Velesco,” added Mr. Cox.
Pharma Tech Industries (PTI) is expanding its production facility in Union, MO, adding approximately 60,000 sq.-ft. of manufacturing space, bringing its total area to 160,000 sq.-ft. The new manufacturing space will be used primarily for the production of ingestible powders and will include a dedicated ISO 8 clean room. The project is scheduled to be completed in March 2014.
PTI also has a 270,000-sq.-ft. facility in Royston, GA and recently completed an analytical lab to broaden its on-site testing capabilities for both prescription and OTC drugs. The new equipment adds several analytical services including High Pressure Liquid Chromatography (HPLC) for Assay/Impurity profiles of liquids and powders; Quantitative/Qualitative Fourier Transform Infrared (FTIR) Spectroscopy; Particle Size Analysis of powders by Laser Diffraction; and Gas Chromatography (GC) analysis.
“Our latest expansion and upgrade projects reflect not only an increase in the volume of overall business, but in the variety of manufacturing services that Pharma Tech Industries can offer to customers,” said Tee Noland, chairman of PTI. “These projects are in line with our goal of responsible, gradual growth that allows PTI to reach into new areas while continuing to refine and hone existing capabilities.”
The National Institutes of Health plans to provide $5 million in funding over the next few years to create a DNA sequencing core facility that will support its Undiagnosed Diseases Program.
NIH launched the UDP in 2008 with the expectation that new genetics and genomics approaches could make it possible to identify, study the characteristics of, and develop new ways to manage and treat previously undiagnosed diseases. Last year, NIH said that it committed $145 million to fund the program and its network of investigators over a seven-year period.
NIH said that it now plans to provide $800,000 in 2014 and $1.4 million per-year between 2015 and 2017 to fund a DNA sequencing core facility that will provide a range of services to the investigators in the Undiagnosed Diseases Network (UDN) who are tackling these cases, which represent the "most puzzling" problems seen at the NIH Clinical Center.
The core facility will provide a centralized DNA sequencing shop to support the UDN, and it will increase the availability of diagnostic services, provide data and protocols to the broader research community, and foster collaborations between labs and clinical investigators.
This core will provide exome and genome sequencing and CLIA variant validation to support research into the etiology of these undiagnosed diseases, and it will collect and share high-quality sequence data. It also will provide raw sequence results as quickly as possible, within a two-week turnaround time, and expects to sequence and estimated 3,300 exomes and/or genomes over the next four years.
The facility also will participate in collaborative research across multiple sites and core labs with investigators who are seeking to understand the pathophysiology of these new and rare diseases.
NIH added that it plans to establish a network coordinating center several months before it selects new clinical sites and the DNA sequencing core this fall, which will contain all of the clinical and sequencing data.
Amway, a direct-selling company based in the US, started the construction of a new Nutrilite® production facility in May 2013. The new facility is located at Spaulding Avenue, close to Ada in Michigan.
The first phase of construction is scheduled for completion by 2014. The new facility will be engaged in the production of Nutrilite® brand of vitamins and dietary supplements by 2015.
The new facility will create about 200 jobs in the next three years and an additional 50 jobs upon opening of its first phase in 2014.
It will produce more than three billion tablets and more than 1.3 billion softgel capsules in a year.
"It will produce more than three billion tablets and more than 1.3 billion softgel capsules in a year. "The new facility is being constructed adjacent to Amway's headquarters in Ada. It will have a total floor space of 317,000ft². It will include a production facility and a warehouse facility.
It will also feature a 22,000ft² quality assurance laboratory for onsite testing of the products.
The plant will include three lines each for the production of gel capsules and tablets. The gel and tablet production lines will have enough space provision for expansion in future.
Amway will produce Nurtilite Vitamin C plus Extended Release and Nurtilite Cal Mag D tablets, at the new vitamins and dietary supplements facility. It will also produce Nurtilite Natural Carotene, Nurtilite Natural B Complex and Nurtilite Salmon Omega-3 at the facility.
Nurtilite is one of the best-selling brands of vitamins and dietary supplements internationally. It provides a complete range of supplements for a variety of health needs and general nutrition.
The new manufacturing facility will have state-of-the-art equipment to produce high quality Nutrilite® products. It will use organic plant concentrates harvested at Amway's farms.
The plant will be equipped with technology to dehydrate, mill and extract the nutrients. It will also have equipment for testing and measurement of concentrate powder.
It will feature more than 100 major equipments, including bending, coating, compression, inspection and sealing machines.
The facility will be equipped with a fully integrated packaging line.
Pre-construction works began at the site in December 2012. Construction was started in May 2013.
Latest in design technologies, such as building information modeling (BIM) and 3D modeling, are being used for the construction of the facility. The construction will also include measures to comply with Good Manufacturing Practices (GMP).
The design for the new manufacturing facility was provided by FTC&H. The general construction contract for the construction was awarded to Erhardt Construction.
The nutritional supplements production facility is being constructed as part of $375m global manufacturing expansion by Amway across the world. The total investment on the construction of the facility is estimated to be $81 million.
The new plant was funded with $1.6m in financing by the Michigan Economic Development Corporation through its Michigan Strategic Fund. It was also offered tax abatement for 12 years by the Ada Township.
Amway is headquartered at Ada in Michigan. The company has more than three million distributors spread across 100 countries across the world.
It offers consumer products supported by global agribusiness, manufacturing and logistics supply chain. It employs more than 900 scientists, technical professionals and engineers in 75 R&D laboratory locations spanning internationally.
The top selling brands of the company include Nutrilite®, Artistry and eSpring. The sale of nutritional products alone by Amway accounted for about 46 percent of its total sales in 2012.
Providence Sacred Heart Medical Center and Children’s Hospital in Spokane, WA, is constructing a new 28,000-sf emergency department with a new 24-hour entry for pediatric and adult care. Expansions include 24,000 sq. ft. of new construction, totaling $18.6 million, with a red-clad second story that will house a children’s treehouse, or clubhouse, for patients and their families to relax in. Fifteen exam rooms, two treatment rooms, a trauma bay, and a medical mental health room round out the plans for the pediatric department, which has been designed for 27,000 patient visits a year. DCI Engineers (civil engineering), Bouton Construction, and Mahlum Architects form the Building Team.
Skanska USA announced that it has been awarded an $80 million contract to construct a new Children’s Pavilion at Children’s Hospital of Richmond at VCU in Virginia. Skanska’s share of the contract is 100 percent.
The new Children’s Pavilion project will include the construction of a 640,000 sq. ft. building with exam rooms; a surgical area with operating and procedure rooms; areas for diagnostic testing, imaging, and lab services; and faculty offices all dedicated to pediatrics. Included in the facility is an attached 600-space parking garage. The facility will be built behind the existing Children’s Pavilion on the VCU Medical Center campus.
Once completed, the new Children’s Pavilion will be the most advanced outpatient facility dedicated to children’s healthcare in the region. It also will bring the majority of the outpatient pediatric services across the medical campus to one facility, while reinforcing VCU’s commitment to research and its investment in advancing pediatric care.
Construction on the Children’s Pavilion began in mid-September. Seeking LEED Silver certification, the project is slated for completion in August 2015.
PYRAMID Laboratories, Inc. a premier clinical and commercial contract aseptic drug product developer and manufacturer is proud to announce it is celebrating 25 years of providing cGMP services to the Pharmaceutical and Biotech industries during July 2013.
PYRAMID's President & CEO, Medhat Gorgy states "I am very proud of the high quality services we have provided the past 25 years and wish to thank our employees and Clients for making it possible. PYRAMID has grown tremendously since our modest beginnings in 1988 to having over 70,000 square feet of GMP facilities with state of the art equipment today."
PYRAMID also announces that it has expanded its portfolio of services with the addition of a new state-of-the-art Warehouse, Storage and Distribution Facility. The new facility includes cGMP labeling, approximately 27,600 cubic feet of monitored and alarmed validated controlled temperature storage, and distribution service capabilities for parenteral drug products. PYRAMID's Warehouse, Storage and Distribution Center is located adjacent to PYRAMID's clinical and commercial manufacturing sites that include aseptic fill/finish for vials and syringes in addition to lyophilization services. PYRAMID also provides full service formulation and process development as well as analytical support for all phases of drug development and manufacturing.
Yvonne Verburgt, Senior Director of Business Development states, "The addition of these services is in response to our client's request for a West Coast strategic location for warehousing and distribution for their parenteral products. The focus on labeling, controlled temperature storage and distribution fulfills a demand within the industry."
Even as New York's largest biotech company keeps reinvesting at two locations in its native New York, it's also looking abroad to the Emerald Isle. And it's planning to reignite a once-hot Dell manufacturing site in the process.
Last November, New York Gov. Andrew Cuomo announced Regeneron's plans to invest nearly $70 million to expand its manufacturing capacity in Rensselaer, N.Y., and create 300 new jobs in the Capital Region. Then, in April, the company said it would expand its Tarrytown corporate headquarters and laboratories in Westchester County and create more than 400 new high-skilled jobs.
"Our recently approved drugs and our robust development pipeline have transformed Regeneron into one of the largest and fastest-growing biopharmaceutical companies in the United States," said Leonard S. Schleifer, M.D., Ph.D., president and CEO, in April. "Regeneron has been based in New York since we began 25 years ago, and we are grateful to Gov. Cuomo and New York State for financial support that helps us to continue to expand and create jobs in New York."
According to the state, the company had also considered expanding outside New York before the State stepped in with $8.5 million in tax credits through the Excelsior Jobs Program and the Town of Mount Pleasant Industrial Development Agency offered additional incentives. Construction of the new buildings is anticipated to begin in late 2013 and to be completed in late 2015.
The project will add two new buildings with 300,000 sq. ft. of laboratory and office space to the Regeneron complex at the Landmark at Eastview in the Town of Mount Pleasant in Westchester County. Currently, Regeneron occupies approximately 590,000 sq. ft. of space at the site and will occupy another 85,000 sq. ft. of additional space there later this year. The expansion will enable the company to continue to accommodate the rapid growth it has experienced over the last six years - from 682 employees in 2007 to 2,000 today, including more than 1,300 employees in Tarrytown and nearly 600 at its industrial operations and product supply facility in Rensselaer.
The Rensselaer project involves the construction of two facilities at Regeneron's East Greenbush location - a new 65,000-sq.-ft. building at 81 Columbia Turnpike that will add manufacturing capacity for Regeneron products for clinical trials and potential commercial sale, and an expansion of the company's facility at One CSC Way. The new project caps a period of rapid growth for Regeneron in East Greenbush. Empire State Development will assist the company in Rensselaer with $6.7 million in Excelsior Jobs Program tax credits.
With the Rensselaer and Tarrytown expansions, the company is slated to create more than 700 new jobs in New York State and invest approximately $170 million in capital expansion in New York over the next few years.
But when you're the world's No. 1 biopharmaceutical employer (according to Science Magazine in 2012), the world awaits.
Now the company is in final negotiations to bring new life to a former Dell complex in Ireland, and the timing is nearly as good for that region as it is for the company.
Regeneron has grown from 682 employees in 2007 to 2,000 as of earlier this year, including more than 1,300 employees in Tarrytown, N.Y., and nearly 600 at its industrial operations and product supply facility in Rensselaer. Another 700 jobs are on the way over the next few years.
"Regeneron has a preliminary agreement with Dell to acquire a 400,000 sq. ft. manufacturing and distribution facility owned by Dell in Limerick, Ireland," said an official statement from Regeneron emailed to Site Selection this week, referencing a site in Raheen, County Limerick. "Subject to definitive agreements and permitting, Regeneron intends to renovate the facility and install new equipment for biopharmaceutical production and product supply operations. When operational, Limerick will become a second industrial operations (production) site for Regeneron. The primary industrial operations site will remain in Rensselaer, New York."
"We are also currently expanding our production capacity in Rensselaer by approximately 50 percent by building a new production suite that will house two 10,000-liter bioreactors," the statement continued. "It is premature to estimate which products and product candidates we will produce in Limerick or the number of jobs that Regeneron may create there. We expect a slow build there in personnel."
According to the statement, the company needs more production capacity to support anticipated commercialization of antibody drug candidates now in late-stage clinical trials and to support clinical requirements for the growing number of early-stage molecules in the Regeneron pipeline. "The expansions are not specifically to increase production capacity for EYLEA® (aflibercept) Injection, the drug we market in the U.S. for wet age-related macular degeneration and central retinal vein occlusion," said the statement.
Dell famously closed the Limerick plant in January 2009, letting to some 1,900 employees and moving computer production to Poland. It originally invested in Ireland in the last years of last century, part of massive investments in multiple global locations.
A filing this summer with the U.S. Securities and Exchange Commission says Regeneron anticipates investing between $225 million and $300 million through 2014 on its activities in the two New York locations and the Limerick location, as well as for new equipment.
Two developments in Limerick bode well for the business climate Regeneron will find as it arrives.
In early July, the Limerick Chamber welcomed the announcement of 40 million (US$ million) in funding to support world-class research at the Synthesis & Solid State Pharmaceutical Centre (SSPC) based at University of Limerick - a unique collaboration between 17 companies 8 academic institutions that will position the region and Ireland as a global hub for pharmaceutical process innovation and advanced manufacturing.
Speaking at the announcement, Limerick Chamber CEO Maria Kelly said it will "build on existing success and can be the foundation of a strong cluster potential for the Limerick and Mid West area. It aligns with the recent Limerick 2030 draft Economic and Spatial Plan and will allow Ireland to become an even more attractive and competitive international location for the pharmaceutical sector."
The Irish pharmaceutical industry supports over 60,000 Irish jobs and exports over 50 billion annually.
That $250 million plan - 'Limerick 2030 - An Economic and Spatial Plan for Limerick' - is also of recent vintage. The city and county councils say it has the potential to deliver 5,000 new jobs and sets out a number of objectives which will considerably change the infrastructure of the city centre and deliver a whole new vision for Limerick as a leading centre for commercial investment.
Speaking at the launch, Limerick City and County Councils Manager/CEO Conn Murray described Limerick 2030 as "a once-in-a-generation plan to guide the economic, social and physical renaissance of Limerick city center, the wider county and Mid-West region. The plan will allow us to work together to bring much needed investment to Limerick, to revitalize the city center and to project a positive image giving confidence to investors, businesses and the local community. It is by design a flexible, dynamic framework capable of responding to changing circumstances and providing, perhaps for the first time, a holistic perspective on Limerick's future. And it's timely, as we move towards the full merger of Limerick City and County Councils in 2014,"
The economic and spatial plan is part of a wider and more ambitious $750 million Limerick Project to deliver improved economic infrastructure including new third-level (higher) educational facilities, new Port facilities along the Shannon Estuary, and new infrastructure at Shannon International Airport over the next two decades.
Among other investments recently welcomed in the area has been a 142-job expansion by CPL Industries in Foynes, where the solid-fuel supplier announced in June it aims to develop a bio-fuel plant. In March Worldwide Tech Services announced it's establishing its European Headquarters in Limerick City Centre at Riverpoint, with an initial head count of 62 new jobs. And Vistakon Ireland, a Johnson & Johnson company, recently announced the addition of 100 production jobs as it plans to invest over 100 million in the expansion of its manufacturing operations at its site in the National Technology Park, Plassey, Limerick.
Established in Limerick in 1996, Vistakon designs, manufactures and markets the ACUVUE® range of soft disposable contact lenses. It is one of several Johnson & Johnson companies operating in Ireland, employing a total of 1,900 people.
Pillar5 Pharma, Inc. has received $1 million from the Eastern Ontario Development Fund (EODF) to expand production at its Arnprior manufacturing facility, creating 56 new jobs and retaining 94 more in the community.
With support from EODF, Pillar5 will increase its operations by installing two new, advanced production lines for the manufacturing and packaging of eye care products. This expansion will better position the company to pursue new markets, both at home and abroad.
Dr. Eric Hoskins, Minister of Economic Development, Trade and Employment, said, “We are proud to be supporting job creation right here in eastern Ontario. This investment will help Pillar5 become a leader in the production of eye care products while expanding their markets and bringing new jobs and prosperity to the community of Arnprior.”
Kevin Rampton, chief executive officer of Pillar5 Pharma, commented, “We are thankful for the support from the Ontario government. This expansion means we can offer our customers more solutions for their pharmaceutical outsourcing needs. It also gives us greater capacity to increase production and explore new markets.”
Jubilant HollisterStier (JHS) says expansion of its sterile manufacturing capacity at its facility in Kirkland, Canada will be used to fulfill several new contracts.
The contract manufacturing organization (CMO) is increasing its ampoule production capacity at the plant by nearly 200 percent as part of a first phase expansion of its sterile manufacturing services offering.
In a statement the company said a significant part of the expansion would be dedicated for new customer products and JHS’ CEO, Marcelo Morales, added: “We have been fortunate to secure several new contracts that will utilize our expanded capacity starting this year.”
The company is adding a new ampoule filling line utilizing a rigid barrier system which is scheduled to be operational early next month.
In February this year the Kirkland plant was hit by a warning letter from the US Food and Drug Administration (FDA) who cited a number of violations, including failure to confirm to final specifications for the drug product, and failure to establish criteria for sampling and testing.
This came as a result of an inspection in 2012 that noted “water running on the floor of the equipment wash room that was tracked into the dirty equipment staging room and further, into the pharmaceutical corridor leading to the sterile production hallway, the line, and the vial filling area.”
However, a statement from Jubilant Life Science in February said manufacturing at the Kirkland had not been affected by the warning letter and added “JHS is committed to implementing the necessary corrective actions required to address the FDA concerns, and will work closely with the FDA to bring resolution to this matter.”
VistaMed, an extrusion and catheter provider to the medical device industry and a Helix Medical joint venture partner, is expanding their operations in Carrick-on-Shannon, Ireland.
The 35,000 ft2 expansion of the facility includes a 12,000 ft2 cleanroom required to meet the growing need for diverse braided catheter assemblies as well as a new area dedicated to thermoplastic extrusion. VistaMed is also developing an engineering laboratory to support the company’s growth in design and development projects.
“Over the last two years, VistaMed has made a significant investment in state-of-the-art extrusion equipment,” says 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 will also 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 premises in November 2013.
The new UK biomanufacturing hub will help BioPharmas cut costs and let those developing novel biodrugs assess manufacturability according to the Centre for Process Innovation (CPI).
Earlier this month the CPI announced that a site Darlington in the North East of England had been selected as the location for the £38m (€57m) UK National Biologics Manufacturing Centre (NBMC), plans for which were outlined by Chancellor George Osborne in March.
Construction of which will begin in 2014. It is designed to foster the development of new biomanufacturing and analytical technologies and predicted that industry stands to benefit considerably when it is operational in 2015.
“[The NBMC] will dramatically reduce development costs," said spokeswoman Helen Briggs adding that "as many companies, in particular SME’s, will not have the existing facilities to be able to trial these processes and would therefore have to put a significant amount of investment into the development of their own facility."
“Also the manufacturing sector is largely geared up for process development and manufacture of the existing platform technologies,” Briggs said, adding that the “NBMC will help companies with molecules that fall outside of these categories determine manufacturability and undertake early stage process development.”
“We envisage that the major equipment suppliers will also undertake alpha and beta testing of new equipment technologies in the hub.”
Biopharmaceutical companies that use the NBMC will either pay a commercial rate for use or gain access through a public private partnership, such as the Horizon 2020 project.
Briggs explained that in addition to the Darlington ‘hub,’ BioPharmas that use the site will be able to access facilities available at various ‘spoke’ partners at existing centers across the UK.
The approach is similar to the Ireland’s National Institute for Bioprocessing Research and Training, However, as Briggs pointed out, the Darlington centre has a broader scope and will provide manufacturing space as well as training.
“We have generated a lot of interest across the UK Biologics sector and are about to start talking to potential partners about working on early programs using CPIS existing facilities at Wilton with NBMC equipment. All activities will transfer to Darlington once the facility is complete.”
Intertek, a provider of quality and safety services to a wide range of industries around the world, has opened a new apparel and textiles testing laboratory in Hanoi to support the growing textile and garment industry in the northern part of Vietnam.
The new Intertek facility occupies more than 6,000 square feet and is fully equipped with state-of-the-art equipment combined with highly qualified engineers and chemists to provide reliable quality and safety solutions. The new lab performs textile testing for dimensional stability, colorfastness and seam strength, among others. The lab also supports full testing capabilities to U.S. Consumer Product Safety Improvement Act (CPSIA) requirements and restricted substances regulations.
Thanh Nam Nguyen, general manager for Softlines, Hardlines and Toys business lines, says, "The addition of the Hanoi facility aligns with Intertek's continuous effort to provide a local presence for our customers, wherever their business operations are located. This provides a distinct competitive advantage in an industry where getting safe and high-quality products to market is imperative for success."
The Hanoi apparel testing laboratory is the most recent addition to Intertek's global network of 45 textile and footwear laboratories that serve fabric, apparel, fashion accessory, home textile and footwear retailers, brands and manufacturers. In addition to testing, Intertek offers the following services for textile, footwear and apparel customers: chemical management, inspections, certification, auditing, safety and compliance training, outsourcing and advisory, quality assurance and risk management.
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 ($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.
Specialist tablet dissolution-focused preclinical CRO SPS Pharma Services has started operations at its new French HQ and plans to expand its offering.
The new site – which was officially inaugurated in May – is in Orleans and is around ten times the size of SPS’ old headquarters, which were at the School of Pharmacy in nearby Clemont-Ferrand.
In a press statement SPS said that with the extra space it is “now able to fulfill the needs of its clients, many wanting more than method development in line with the relevant agencies’ expectations but also a partner for the implementation of routine analysis.”
The contract research organization (CRO) – which spun out of laboratory equipment and measuring technology specialist Sotax a few years ago – added that quality system have been completely reviewed and reinforced to ensure GMP / GLP compliance.
It explained that: “Processes were redefined according to the new facility and are managed using centralized laboratory software an appropriate technical structure setup, and the laboratory staff is now ready for clients’ audits.”
The effectiveness of oral dosage forms relies on the drug dissolving in the fluids of the gastrointestinal tract - or, for buccal dissolution, the mouth - prior to absorption into the system.
Drug dissolution - the rate of release of a finished drug product and SPS’s focus- is therefore an important aspect in development, particularly with the introduction of controlled-release dosage forms and the increasing use of poorly water-soluble drugs.
However, while drug tablet dissolution testing services are likely to continue to be SPS’ core focus, the opening of the new facility will also see the CRO expand its services offering to the drug industry.
The firm said it “has heavily invested in laboratory equipment and is now able not only to provide dissolution-focused services but also best-in-class analytical services including HPLC / UPLC method development for assay and degradation products, automated sample preparation, and physical testing of solid dosage forms.”
Agilent Technologies has partnered with a polytechnic to open a laboratory and help small and midsize enterprises maintain strict safety and quality standards.
The Lab is expecting 50 percent of its business to come from the food industry.
It will be able to provide methodologies to detect, screen, identify and quantify chemicals in ingredients and products at various stages of the chain – from product innovation to quality control, pesticides, toxins, or adulterants screening and identification to product authentication.
Agilent will offer the bio-analytical technologies and resources from Temasek Polytechnic will help businesses that develop, manufacture or distribute traditional Chinese medicine and food products.
Technologies used in the lab include modern mass spectrometry, chromatography, atomic and molecular spectroscopy and PCR techniques.
The lab is part of the Agilent Partner Labs network in the company’s South Asia-Pacific and Korea region.
Agilent Partner Labs program is designed to bring specialists from laboratories around the world together with their technologies in the chromatography, mass spectrometry and spectroscopy areas.
“When Agilent and Temasek Polytechnic starting collaborating together, it took about a year before this idea of a Partner Lab came to fruition. We marked the collaborating with the official opening of the new Agilent Partner Lab in July.
“We find that Temasek Polytechnic’s School of Applied Science has strong ties with the local business communities," said Tan Mei Mei, regional business manager, South Asia- Pacific region, chemical analysis group, Agilent.
“As such, we believe that SMEs that are in the development or distribution of traditional Chinese medicine (TCM) and food products will want to seek the Lab’s help to conduct tests to for product innovation, quality control, trace substance screening and identification, and product authentication,”.
Temasek Polytechnic will have access to the latest technologies from Agilent, maintain know-how in instrumentation skill-sets, and develop applications that customers need.
“SMEs will benefit from the lab’s expertise in analytical sciences. These SMEs can utilize the facility to conduct their testing and manufacturing of products in a controlled and safe environment,” said Dr Lee Chee Wee, director, School of Applied Science, Temasek Polytechnic.
“This will help SMEs, in particular those that develop, manufacture or distribute food, TCM and health supplement products.
“Quality and safety control and the validation of origin are critical in the production of food and its distribution, and are of primary concern to food suppliers, manufacturers, and regulatory agencies.”
Thermo Fisher Scientific Inc., the world leader in serving science, announced it is expanding its global cell culture and bioprocessing capabilities by opening a new manufacturing plant in Singapore to produce dry powder media (DPM), a crucial cell culture raw material used to manufacture biologics, including vaccines, anti-cancer therapeutics, and others. The facility is the first-ever cell culture DPM production site in Singapore and is designed to address the increased global requirements from biopharmaceutical companies to mitigate critical raw material supply risks.
Located in Tuas, the 30,800 square foot (2,861 square meters) facility will provide critical manufacturing redundancy of DPM to help ensure a secure and uninterrupted supply to biopharmaceutical customers globally. The facility will also serve as an additional logistics hub for DPM distribution to Asia Pacific customers. According to a recent BCC research report, the DPM market in Asia has been estimated to grow to US$220million by 2016, representing a 20 percent compound annual growth rate, the highest in the world for media products.
“Asia continues to be our fastest-growing market and a central contributor to our growth,” said Greg Herrema, president of Biosciences at Thermo Fisher Scientific. “Our new Singapore facility further strengthens our global presence, expands our manufacturing infrastructure and establishes local production capabilities to meet increased demand for biologic drug discovery and development in Asia.”
Featuring state-of-the-art pin milling technology, the new Singapore DPM facility is a cGMP manufacturing plant — mirroring the functionality and quality systems used in Thermo Fisher’s DPM facility in the United States. The facility and equipment used are in compliance with 21 CFR 820 cGMP, ISO 9001:2000, and ISO 13485:200 guidelines.
According to the Singapore Economic Development Board (EDB), Singapore’s biopharmaceutical sector contributed about S$22.8 billion in output in 2011 and more than 6,000 jobs. In particular, Singapore’s eight biologics manufacturing facilities have invested approximately S$2.4 billion, and employ more than 1,700 people.
“Singapore is committed to the development of the supporting industry for biologics manufacturing, through local talent development as well as with specialized infrastructure such as cold chain logistics services,” said Thien Kwee Eng, Assistant Managing Director, Singapore EDB. “We strongly welcome Thermo Fisher’s DPM facility, which would further strengthen Singapore’s supporting ecosystem and position us as the leading biologics hub in Asia.”
“Congratulations to Thermo Fisher on the opening of their dry powder media manufacturing facility in Tuas,” said Dennis Tan, Director, Biomedical and Chemicals Cluster, JTC Corporation. “The establishment of this DPM facility affirms Singapore's attractiveness as a location for the biologics supply and manufacturing value chain, and is at the doorstep of our Tuas Biomedical Park, a world-class biopharmaceutical manufacturing hub.”
Phillips-Medisize Corporation, a contract manufacturing company based in Hudson, Wis., has inked a deal to purchase Adval Tech Holding AG’s assets in Mexico and China. The value of the deal has not been disclosed.
The Suzhou, China medical technology facility (Adval Tech Medical (Suzhou) Co. Ltd.) is both ISO 9001 and 13485 compliant and certified by China’s State Food and Drug Administration to manufacture finished drug delivery systems and related medical devices. The Queretaro, Mexico, facility (Omni Manufacturing Services S.A. de C. V.) also is ISO 9001 and 13485 compliant and U.S. Food and Drug Administration-registered to manufacture components and subassemblies, drug delivery systems and other related medical devices. The Mexico facility also manufactures injection molded components and decorative components for automotive and consumer applications.
Phillips-Medisize plans to retain all approximately 350 employees from both operations, which executives hope will ensure continuity for all existing customers of these operations. This is also hoped to position Phillips-Medisize to begin serving its global customer base from these locations immediately.
“We are very pleased to welcome the China and Mexico employees to the Phillips-Medisize team,” said Matt Jennings, president and CEO of Phillips-Medisize. “This acquisition reflects continued successful execution of our strategic acquisition growth strategy to offer our customers a global manufacturing and designing standard while providing local production and development capabilities. Because these facilities are state-of-the-art manufacturing sites to Switzerland standards, in China and Mexico, we expect these operations will integrate rapidly and seamlessly into Phillips-Medisize and be available immediately to support our global customers.”
Nypro Inc., which was recently purchased by Jabil Circuit Inc., is establishing a $78.8 million facility in Waterford, Ireland. The site will manufacture respiratory and injection devices for healthcare customers, and is expected to begin production in April 2014. The company hopes to create 200 new jobs in the area.
Nypro also has a facility in Bray, Ireland, which supplies final packaging and assembly of drugs into medical devices. This location is set to create 100 new jobs in the next 18 months, expanding its workforce to 460 employees.
“We have a great relationship with the Waterford Institute of Technology, which will support us with technicians and engineers,” said Nypro Vice President Chris Nother. “Foras Áiseanna Saothair the Irish Training Alliance can provide us with general employees.”
Ken McClannon, director of programs and engineering for Nypro Healthcare Europe, said that Nypro would install rainwater harvesting and solar panels in the new facility. The company has worked with Sustainable Energy Ireland in order to develop more energy efficient cleanrooms, resulting in a reported 20 percent savings in energy.
“Jabil is bringing its healthcare divisions in under the Nypro brand and management, creating one the largest healthcare manufacturing and development companies in the world,” added Nother. “Nypro’s healthcare business is worth €308 million and Jabil’s is €769 million.”
Those numbers translate to $404 million and approximately $1 billion, respectively.
Nother also said that the Jabil buy was a bonus to Nypro as it would be able to integrate Jabil’s optics and electronics technology where previously the company had to outsource those operations.
Jabil makes electronic components for devices used in health care, clean technology and other industries, and is headquartered in St. Petersburg, Fla. Nypro makes plastic parts for many of the same products. The two companies have done business for 15 to 17 years, and also competed in some areas. In the 1990s, Jabil sold two plastic molding factories in China to Nypro.
Piramal’s Healthcare unit will invest $2.5 million 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 expansion will provide two commercial grade ADC suites at the facility, while retaining clinical phase manufacturing capacity in other suites on site. Piramal also plans to expand its Proof of Concept (POC) offering at the site for pharma companies looking to demonstrate antibody and/or toxin suitability for use as an ADC.
The batch size offered from the Grangemouth facility ranges from 1-1.5 kg and the company has capacity for further expansion on site if required. As part of the investment, the areas supporting the manufacturing suite will also be upgraded to provide new areas for buffer preparation, equipment preparation and antibody freeze/thaw.
"Piramal was a pioneer when it came to the commercial manufacture of ADCs," said Aidan Walker, president of Formulation Services at Piramal. "Continued growth in the ADC market and customer demand has led to this latest investment. As part of our POC offer we draw on our experience in ADCs to supply model antibodies to demonstrate suitability of client materials for use in ADC conjugation. We have worked on more than 65 ADC candidates and more than 30 different ADC drug linkers to date and also have experience with PEGylation, chelating conjugates for radioimmunotherapy and protein toxin conjugates."
Sales and profit were down in Q2 for Ranbaxy but the firm has signed an agreement with the Malaysian Government to build a new manufacturing facility.
Indian drugmaker Ranbaxy, through its Malaysian subsidiary RMSB, has said in a filing with the Bombay Stock Exchange it will invest INR 2.13bn ($35m) into a new facility to manufacture dosage forms including tablets and capsules in Kedah, Malaysia.
“In addition to serving the local market, the new facility will also export products to the ASEAN markets, Middle East, Europe, Sri Lanka, China and other select nations,” said T. Jeyabalan Thangarajah, Managing Director of RMSB.
The Greenfield site has been allocated to the firm following the signing of a letter-of-offer agreement with Government owned industrial park Kulim Hi Tech Park (KHTP), and will employ over 200 people on a 15 acre area of land.
Malaysia has been focusing on attracting foreign pharma manufacturers – especially from India - in recent year by offering incentives and infrastructure, and this new site will be the second in the country for Ranbaxy.
Ranbaxy's sales in the region grew to INR 2.1 billion ($34 million), up 13 percent for the second quarter 2013.
The results also mentioned the INR 1.46 billion Ranbaxy agreed to pay during the quarter as the first part of an INR 26.5 billion ($500 million) settlement the firm agreed to pay the U.S. Food and Drug Administration (FDA) after pleading guilty in May of manufacturing violations and cover-ups.
The total amount was set aside in 2011 when the firm inked a consent decree in order to resolve an import ban imposed by the FDA on 30 products made at two of its plants in India.
Though the firm has said the implementation of the consent decree, signed in January 2012, progressed as planned for the period, Ranbaxy spokesperson Chuck Caprariello said the firm did not know when it will be resolved and is dependent on further FDA inspections at the sites.
Integrated DNA Technologies (IDT) has opened a facility in Singapore in order to manufacture oligonucleotides for research companies throughout the region.
The SGD 6 million ($4.7 million) facility was completed earlier this year but now officially opened its doors to offer nucleic acid synthesis services to customers in South-East Asia.
Jean Huang, Marketing Manager of IDT Singapore said, “There is an increasing local demand in volume from both industry and academia for custom made oligonucleotides, used in genetic research,” she said. “With this Singapore facility we can turn around customers’ sequences by 12 the next day.”
This cuts the present speed of product delivery to Asia by several days, allowing “IDT to deliver longer pieces of DNA much quicker,” she continued.
Oligonucleotides are single strands of RNA or DNA molecules which can be manufactured for genetic research companies to be used in a number of applications, including microarrays and gene expression profiling.
"Additionally, customers in the Asia Pacific region will benefit from quick access to IDT products for real-time polymerase chain reaction (qPCR) applications, also for which there is an increasing demand."
Singapore was an important choice of location for IDT, said Huang, being home to an increasingly growing pharmaceutical and research industry and serving as a base for South-East Asia.
The 939m2 (10,104 sq. ft.) GMP facility services customers throughout the region and from August will see New Zealand come aboard. In the next 3-6 months the firm expects to be able to offer its services to Australia, Japan and South Korea, conquering much of the Asia-Pacific region, according to Huang.
The new facility was welcomed by the Singapore Economic Development Board. Kevin Lai, Director of Biomedical Sciences, said: “Oligonucleotide manufacturing is knowledge-intensive, and requires a high proportion of skilled degree and diploma holders. This new investment will create excellent job opportunities for Singaporeans.”
In an original article Ms Huang as was quoted as saying the new facility was GMP certified. We have now been informed by the firm the Singapore facility is not GMP certified at this time.
NovaMedica and the Russian Government are to build an $85m (€64m) facility as part of a joint venture encouraging local manufacturing, the company says.
Russia’s Pharma 2020 strategy is implicit in its target of manufacturing at least 50% of its medicines on home soil by the end of the decade and the impending 50,000m2 (538,000 sq. ft.) GMP facility in the Grabtsevo technopark, Kaluga, will support such legislation, producing NovaMedica’s products for the domestic market.
This is a specific example of the Pharma 2020 initiative at work, said NovaMedica spokesperson Elena Pochesneva.
Furthermore, she continued, “last week it was announced that construction of 2 new pharmaceutical plants have been started in different regions of Russia simultaneously” in parallel with NovaMedica’s facility.
Along with aid from RUSNANO - a Russian government-owned investment company – the plant will be built under a joint venture with DRI Holdings Limited, part of US portfolio firm Domain Associates, and will manufacture a range of medicines and medical devices currently “demanded and not present in Russia,” Pochesneva said.
The companies are involved with sourcing pipeline products to build NovaMedica’s portfolio. So far, deals with US-based firms Regado Biosciences, Marinus Pharma, and Lithera, plus New Zealand-headquartered CoDa Therapeutics, have resulted in four products in the pipeline, though more are planned.
“Negotiations are almost rounded off with several [other] companies,” Pochesneva continued, which will add a “number of finished innovative therapeutics area-specific pipeline products that are a complete fit with NovaMedica’s technological concept.”
The international presence in the joint venture, and the sourcing of foreign medicines to be made at Kaluga demonstrate one of the ways non-Russian companies can benefit from Russia’s protectionist policies.
Another way for multinationals to penetrate a market expected to reach $35bn by 2020 is by building facilities on Russian land. This was the response of a number of Big Pharma following the announcement of the Russian strategy, including AstraZeneca who built a $150m facility - also in the Kaluga region - in 2011.
Such tactics are still ongoing, according to Pochesneva, who said “two big international pharmaceutical companies - Novo Nordisk and Berlin-Chemie/Menarini - are in the process of building their production facilities in the same regional cluster.”
Pall India Pvt. Ltd. has inaugurated its expanded Scientific Laboratory Services Technical Support Centre in Bangalore, India, which now has more than 60% enhanced validation and testing capacity. Established in 2006, expansion of this SLS Technical Support Centre further enhances Pall’s dedication to the growing biopharmaceutical industry in India.
“Investment in this SLS Technical Support Centre to establish a premier filter validation facility represents a strong commitment from Pall Corporation towards solving the diverse and complex filtration and separation challenges of our customers in the South Asia region. It caters to both Life Sciences and Industrial businesses providing our customers with advanced scientific support for their application needs. The expanded facility also houses a state-of-the-art training Centre,” says Naresh Narasimhan, Managing Director of Pall India.
The Pall India SLS Technical Support Centre offers customized solutions through Pall products and technologies filtration and validation packages and optimization of customer applications and processes. This expanded facility provides a validated cleanroom for microbiology, a validated lab capable of handling cytotoxic materials, a validated cold room to facilitate low temperature testing, and it also houses new technologies for protein purification and characterization.
The SLS Technical Support Centre is focused on providing customers with wet laboratory training using specialized resources in the fields of filtration biotech and vaccine process development protein purification process characterization and optimization.
Pall Life Sciences provides products and services to meet the needs of customers discovering, developing, and producing biotech drugs vaccines and classic pharmaceuticals. Pall’s membranes and membrane devices optimize detection and sample preparation in the drug research clinical diagnostics genomics and proteomics markets. Pall is a provider of separation systems and single-use filtration and purification technologies to pharmaceutical and biotechnology companies to support faster development of new drugs and vaccines that are safer and require less energy and water to produce. Pall technologies are also used in clinical institutions and the food and beverage industries.
DS Smith Packaging, a UK supplier of corrugated packaging, has opened a purpose-built cleanroom manufacturing facility at its Wellingborough plant in Northamptonshire, UK. The plant, which will enable the packaging of foods, pharmaceuticals and electronics in a sanitized environment, has BRC/IOP High Risk Global Standard food accreditation.
Dominic Drew, Managing Director at DS Smith Packaging Sheet Plants, said the firm was seeing an increasing demand from food, pharmaceutical and electronic manufacturers for their packaging to be produced in this kind of environment.
‘It’s great news for our customers that we were able to secure the significant investment required for this state-of-the-art facility, which will create new jobs in Wellingborough alongside our existing box making plant,’ he added.
The factory is already producing innovative new baking trays manufactured with corrugated sheet from DS Smith Packaging’s sister plant at Kettering.
The specialty papers incorporated into the board allow direct food contact, which means that the trays can be used in a similar way to consumer baking trays – food manufacturers can put a wide range of ingredients into the trays without liners, and then into the oven for cooking.
Roy Waddington, Plant Manager at DS Smith Wellingborough, said: ‘In line with our carbon reduction commitment, the new building uses 192 solar panels which will generate sufficient energy for 50% of our total power consumption, when at full capacity.’
The new structure has achieved an ‘A’ rating for insulation, and boasts a range of features to ensure hygiene integrity and minimize the risks of cross contamination, such as CleanTrax ProfilGate, a tire and footwear cleaning system for removing dirt, dust and moisture from forklift wheels and footwear at factory entrances.
Richard Davison, Regional Sales Director at DS Smith Packaging added: ‘Following numerous food safety issues over the last 12 months, product contamination has become a vital issue in the food supply chain. The events have only served to focus our customers’ minds – not only on the need for hygiene and full traceability, but also the complete chain of custody for their food ingredients and packaging products. The cleanroom at Wellingborough will help us to provide that.’
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 facility is fully compliant with the rigorous international quality, environmental, safety and compliance standards."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.
Dainippon Sumitomo Pharma (DSP) opened a new chemistry research building in Osaka, Japan, in June 2013. The research facility is located within Sumitomo Chemical's plant at Osaka research centre in Japan.
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 research facility is located within Sumitomo Chemical's plant at Osaka research centre in Japan."The new building has eight floors above the ground. It has a total building area of 2,463m² (26,501 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.
UAE-based pharmaceutical firm Gulf Pharmaceutical Industries (Julphar) officially opened a new pharmaceuticals manufacturing facility in February 2013. The new plant is located at Gerji Jakros region in Ethiopian capital city Addis Ababa. It was developed by Julphar in association with Medtech, a local Ethiopian company.
The inauguration ceremony of the new manufacturing plant was attended by Hailemariam Desalegn, the Prime Minister of Ethiopia.
The plant is expected to become fully operational in the second quarter of 2013. The investment for the construction of the plant was about ETB170million ($9.17 million).
The new facility has a total floor space of about 40,000ft2. It will produce solid as well as liquid dosage forms of medicines. It will manufacture about 25 million bottles of suspension and syrup, 500 million tablets, and more than 200 million capsules.
It will provide many employment opportunities and is expected to recruit 50 local staff for various positions such as quality assurance, quality control, production and maintenance, regulatory affairs, and administration services.
The new plant was built in order to produce relevant and much needed medicines for Ethiopian market. The pharmaceutical products produced at the new facility will be exported throughout Africa. Medtech manages the sales and marketing of the products and will become a key supplier in the local as well as other markets in the African continent.
The new manufacturing facility is equipped with advanced technology processes to produce high-quality pharmaceutical products for use in the domestic market and other African countries.
Pharmaceutical products developed by Julphar include antibiotic, biotech, cardiovascular, dermatology, insulin, metabolic, over the counter, pulmonary, women's health, and paramedical solutions.
The facility also has a pharmaceuticals packaging line equipped with labeling, cartoning, shrink wrapping, packing, and blistering machines.
The new plant was designed as well constructed by Julphar's engineering and construction division. It was constructed with cGMP-compliance. Julphar is also working towards obtaining international accreditation for the plant.
The African pharmaceuticals market has been growing at a fast pace. The continent has a population close to a billion. The pharmaceutical market in Africa is set to grow between $8 billion and $10 billion a year, with pharmaceutical spending in Africa expected to increase to about $30 billion by 2016.
Africa's healthcare market is growing at an annual rate of 10.6 percent. Industry growth is attributed to the extensive surge of middle-class spending on diseases, and rapid urbanization. The industry has been growing fast despite the infrastructural shortcomings in many of the African countries.
Narayana Nethralaya and MedGenome announced a joint initiative to create a "multi-omics" diagnostic and basic research service laboratory in Bangalore, India.
The partners are investing $5 million into the effort with the goal of creating a one-stop solution for molecular diagnostic testing. Services provided at the lab will include gene testing, gene panels, exome sequencing, whole-genome sequencing, gene expression microarrays, proteomics, and immunohistochemistry.
A flow cytometry facility already exists for research purposes as well as for the diagnostic assessment of blood biomarkers.
Specialty eye hospital Naryana Nethralaya and genomics and diagnostics firm MedGenome said that most of the tests to be offered at the new lab will leverage DNA sequencing. The lab will also offer companion diagnostic testing to allow clinicians to determine the most appropriate treatments for diseases such as cancer.
The partners added that they are collaborating to create a proteomics facility for the analysis of small molecules, metabolites, amino acids, and proteins, for the diagnosis of metabolic syndromes and whole proteome analysis.
"Our mission is to make [genetic] testing available and affordable to people with cancers or genetic conditions and their families, thereby actively working toward guarding health," Sam Santhosh, chairman of MedGenome, said in a statement. "The market in India is still in the nascent stage while the U.S. market is about $5 billion. The opportunities for growth are tremendous."
MedGenome is a division of SciGenom Labs with offices in Chennai, India and Kochi, India, as well as Pleasanton, Calf.
The announcement follows the news in October 2012 that Piramal had formed an alliance with Fujifilm Diosynth Biotechnologies through which the two companies offer seamless contract development and manufacture of ADCs.
Campbell Newman, Premier of Queensland, with Cochlear Limited CEO, Chris Roberts, at the official opening of the new state-of-the-art microchip processing operation at Cochlear Limited’s Brisbane facility.
A microchip processing operation has opened at Cochlear Limited’s facility in Brisbane, Australia, which will continue to bring the gift of sound to clients worldwide.
This high-tech innovation, housed in a new cleanroom, is a key part of a $3 million upgrade of Cochlear’s facilities in Queensland and plays a major role in growing the company’s manufacturing capabilities. The Cochlear facility, makers of several hearing aids, will use the room to bond wires a fraction of the size of a human hair to microchips.
Cochlear CEO Chris Roberts described the new cleanroom, which is used for the manufacture of electronic components, as an integral part of the company’s local operation.
“These products go into the external components of our cochlear implant systems – essentially the sound processing ‘brains’ of our products,” Roberts explains. “Indeed, they will be going into the world’s most advanced cochlear implant system, the Nucleus 6, which we have recently launched.”
“Government support for both manufacturing and healthcare is critical, both for businesses like ours and for Australia. The Queensland government’s recent increase in funding for cochlear implantation in this state is testament to the support it is providing.
“Our own commitment to Queensland remains strong and our aim is to grow our manufacturing capabilities here, which will support Cochlear’s ongoing global success.”
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