PHARMACEUTICAL & BIOTECHNOLOGY
INDUSTRY UPDATE
September 2012
McIlvaine Company
TABLE OF CONTENTS
Battelle Unveils Simulation Lab
Cambridge Major Laboratories (CML) Expands Facility
UC Davis Receives Grant for Metabolomics Center
Biomedical Expansion for Charles River
Icon Has Added Capacity at Sites in the US and UK
Charles River Laboratories Has Opened a New Facility
Baxter Plans Plasma Treatment Manufacturing Facility
Catalent Biologics Facility in Wisconsin
Start Up of UCSF Robotic Pharmacy, San Francisco
Invisible Sentinel Establishes Pilot Manufacturing Facility
Exact Sciences Expands, Epicentre Relocates
Amway Breaks Ground on Facility
Biotechnology Center Opening Delayed
Aesica, U of Bradford in CT Supply Pact
CMIC Gains Qualification of Three New Sites
Life Tech Wins Contract from U.S. Army
AMRI Begins Pre-filled Syringe Launch
Quality Packaging Specialists to Open
Millstone Medical Expands Capacity
Hospira to Invest in Rocky Mount, NC
The New York Genome Center (NYGC) to Be Established in Manhattan
Philadelphia's University City Science Center will Begin Construction
DaVita Opens Facility for Research
Gerresheimer to Expand Dongguan Plant in China
Telstar Develops Production Lines for Hisun Expansion
Braun Group has Completed Factory in Barcelona, Spain
Takeda Opens New Plant in Russia
Agilent Technologies Opens Center in South Korea
LycoRed has New Facility in China
Alphora Completes GMP Kilo Lab
Hospira to Buy API Manufacturing and R&D Facilities in India
U of Edinburgh Receives $95 Million for Genetics Institutes
Telstar Builds Pharma Facilities for B. Braun Spain
Center for Clinical Research into Cancer Opens in Australia
West Breaks Ground on New Manufacturing Facility in India
WuXi PharmaTech Receives GLP Certificate for Toxicology Facility
Diabetes Academy to Open in Denmark
Bosch Expands Capacity in India
Battelle has unveiled a new lab that allows researchers in human factors and design to observe and evaluate how real-life patients and clinicians use and interact with medical devices. The Battelle User Research Lab (uLab) is located at its Columbus, OH, headquarters, just a few steps from its medical device development building.
The uLab allows researchers to conduct usability studies as they launch new products. Battelle’s Human Centric Design (HCD) team now can observe and evaluate human behaviors and challenges as they use various devices or systems in a real-world setting.
The 4,500 sq. ft. lab features five rooms configured to test everything from hardware and software to full-scale interiors for home healthcare settings. The uLab also has an additional 5,000 sq. ft. that can be transformed into any environment necessary. With multiple high-definition cameras in every room, Battelle can stream live video feeds to its clients across the globe. By allowing both clients and development teams to watch how their devices are used, the uLab streamlines the development process and saves time and money over the course of the R&D timeline.
“The FDA continues to increase its focus on incorporating human factors studies prior to clearing or approving a medical device,” says Reade Harpham, manager of Battelle’s HCD team. “Battelle’s long history and expertise in human factors, combined with the ability to conduct human factors studies under a registered medical device quality system has helped the demand for our service grow significantly. It is critical to get as much feedback from the patient or clinician as you can, as early as you can. This enables teams to evaluate behaviors in a real-world setting and to design safe and effective devices.”
Battelle’s HCD researchers also leverage high-fidelity simulated surgical suites at several hospitals across the country. This allows the team to observe and evaluate how doctors, nurses, and other hospital staff are using certain medical devices in environments such as an emergency room, an intensive care unit and a surgical suite.
Cambridge Major Laboratories (CML) has expanded its active pharmaceutical ingredient (API) facility in Germantown, WI, in what it says is a response to a boom in demand for late phase clinical production services.
Under the plans, the company will add “significant” extra reactor capacity and isolation equipment.
Brian Scanlan, president and CEO said the undisclosed investment is a bid to meet an industry demand for speedy manufacturing in late phases.
“By making these new investments, we show our commitment to support our loyal client base at the most critical point, when quality and timely delivery are imperative,” he said.
The new center will bring together existing UC Davis service facilities in mass spectrometry, nuclear magnetic resonance and imaging.
With a $9.3 million startup grant from the National Institutes of Health, the University of California, Davis, has announced plans to open the West Coast Metabolomics Center, a high-tech consortium of research and service laboratories that will help scientists better understand and develop more effective treatments for complex diseases like diabetes, cancer and atherosclerosis.
The facility, which will be housed within the UC Davis Genome Center, will celebrate its grand opening Oct. 8 with a mini-symposium featuring UC Davis and regional scientists, and corporate supporters.
Metabolomics is a new field that looks at the biochemical changes taking place in living cells during metabolism. The West Coast Metabolomics Center at UC Davis will use more than 30 mass spectrometers — instruments for analyzing chemical structures — to target thousands of different molecules produced in cells, allowing researchers to look at changes taking place at specific times and under specific environmental conditions.
“The NIH recognizes metabolism as a very important part of human physiology and disease processes,” said Oliver Fiehn, professor of molecular and cellular biology and director of the new center. “When you analyze metabolism, you can tell the state of the body at the onset and during the progression of diseases ranging from cardiovascular disease to cancer.”
It will help researchers throughout the western U.S. with small grants for annual pilot and feasibility studies, provide courses, statistics and bioinformatics services, and perform metabolomic analyses on a fee-for-service basis. The center is designed to be self-sustaining within five years.
One researcher who plans to use the new center is UC Davis Professor Bruce German, who studies lipid metabolism, especially in milk production, in the Department of Food Science and Technology.
“This new center shows the effects of the university’s long-term investments into biochemistry and genomics,” German said.
One of the center's first big projects will be as part of a large international study, led by the NIH, to look for environmental causes of childhood diabetes. Juvenile, or Type 1 diabetes is an autoimmune disease that causes the body to destroy pancreatic cells that produce insulin, and people with the disease must inject insulin regularly in order to survive.
Called the TEDDY study — The Environmental Determinants of Type 1 Diabetes in the Young — the project will track nearly 8,000 children over a three-year period to try to identify factors such as infections, diet, stress or other conditions that may trigger the disease.
“We know that children who get Type 1 diabetes all have certain gene signatures, but most children with those same genes don’t get the disease,” Fiehn said. “Researchers now believe there’s an environmental trigger — something that activates those genes and causes the disease. Metabolomics is a way to try to identify those environmental triggers by seeing what’s happening inside the cells over time. In addition, metabolomics is a chemical screening tool that might find further environmental cues, including pollutants.”
The West Coast Metabolomics Center will analyze blood samples taken from children every three months during the study period, providing data to researchers that may help them identify a single factor or series of factors that trigger the disease. The TEDDY consortium will pay more than $1.5 million for the services provided by the new center.
Another promising aspect of metabolomics research is creating individualized treatments for people with certain diseases, or choosing the best available treatment for a patient.
Metabolomics could be used to determine the best dose of treatment for a patient. People with higher metabolisms may need higher doses of drugs than people with lower metabolisms, for example.
"Understanding metabolomics and disease response will help scientists to develop new therapeutic strategies," said Professor Ralph de Vere White, director of the UC Davis Comprehensive Cancer Center. "This metabolomics research center will allow the UC Davis Comprehensive Cancer Center to advance this exciting area in cancer research, more deeply understand underlying mechanisms, and improve treatment options for patients."
The West Coast Metabolomics Center at UC Davis has received instrumentation support from mass spectrometry equipment companies Agilent Inc. and LECO Corporation.
Designed to be self-sustaining within five years, the center will help researchers in the western region of the US who have small grants for annual pilot and feasibility studies, and it will provide courses, statistics, and bioinformatics services, as well as perform metabolomic analysis on a fee-for-service basis, UC Davis added.
ViroPharma Inc. will expand its operations in Exton, Chester County, PA and create 151 new, high-paying jobs.
"ViroPharma is a true success that continues to grow and create jobs in the region," said Governor Tom Corbett. "What started as a small team of entrepreneurs in has now evolved into an international biopharmaceutical company employing hundreds of Pennsylvanians."
ViroPharma will nearly double its current available space by leasing an additional 71,000-square feet of office space to accommodate planned growth. The expansion will enable the company to retain its existing 188 employees and create at least 151 new jobs within three years.
The company received a $583,000 funding offer from the Department of Community and Economic Development, including a $130,000 Pennsylvania First grant and $453,000 in Job Creation Tax Credits.
"For us it is about growth. ViroPharma has been in Exton for many years and we love our home here," said ViroPharma President and CEO Vincent J. Milano. "We're committed to this area for the long-term and look forward to creating opportunities in this community."
The project was coordinated by the Governor's Action Team, or GAT, economic development professionals who work directly with businesses that are considering locating or expanding in Pennsylvania. GAT worked with the Chester County Economic Development Council (CCEDC) to support ViroPharma's expansion.
"Chester County is fortunate to have companies like ViroPharma who continually innovate and reinvent themselves," said CCEDC President and CEO Gary Smith. "Their expansion is the latest evidence that the life science community in is alive and well."
Founded in 1994 by a small team of entrepreneurial scientists in Exton, ViroPharma is focused on developing drugs for rare diseases in which there is an unmet medical need. The organization has grown into an international biopharmaceutical company with significant operations in Europe, in addition to Pennsylvania.
Charles River has opened a new US biomedical diagnostic facility in a bid to boost its drug discovery and pharmacology business.
The plant, a 60,000 sq. ft. factory based in Wilmington, Massachusetts, will provide services in research model health monitoring, clinical chemistry, haematology, biomarker assay development and immunoassay services.
The facility will work with a range of biomaterials, including proteins, genes, metabolites, and cellular and microbial endpoints.
General Manager of research animal diagnostic services Lisa White said that though there are some similar services on the market, it is the facilities “lean” design and broad range of services – from assay design and development to data analysis – which makes it special.
“The facility and operations are designed for lean operations including physical attributes; high-throughput, controlled environments, building monitoring and mechanical systems redundancy to provide an energy and space saving environment,” she said. “This allows us to provide high-throughput, cost effective assay determinations.
“We are a one-stop shop for all types of studies ranging from genetic models to therapeutic profiling.”
White added that the services would be targeted at both biopharmaceutical and academic clients.
In a statement, president and CEO James Foster also indicated the expansion makes room for further growth in research and development (R&D) services.
“Our new facility provides Charles River with additional capacity for growth, as well as the capability to utilize innovative technology platforms to advance the high-quality R&D services we provide our clients,” he said.
White also said that the firm strongly believes molecular markers are key in the drug discovery field as researchers move from the age of “serendipitous” findings to “deterministic profiling.”
She said, “We are at an exciting time in biology and medicine that combines new platforms and informatics technologies to identify, and validate new biomarkers that help us unravel many unmet medical needs. Charles River is dedicated to be a partner in moving these new therapies forward.”
When asked if the expansion was at all tied with Charles River’s recent acquisition of Accugenix – which at the time EU technical service coordinator Guy Mbaya said was a bid to boost the firm’s overall microbial testing services – White said, “No. The deal with Accugenix was a separate agreement, with no ties to the new facility opening.”
The Ireland-based contract research organization (CRO) added space at its facilities in Whitesboro, New York, and Manchester, UK, which will house dedicated immunoassay laboratories.
Brian O’Dwyer, senior VP of Global Bioanalytical Services at Icon said, “We have expanded our bioanalytical facilities to provide the necessary scale to support the ever-broadening range of testing services required by our sponsors.
“In particular, the expansion of our dedicated biomarker testing laboratories allows us to support biomarker development programs across multiple testing platforms globally.”
Charles River Laboratories has opened a new biomedical diagnostic testing facility in Wilmington, Mass., the firm announced. The 60,000-square-foot R&D services facility expands the firm's capabilities for clinical chemistry, hematology, biomarker assay development, and immunoassay services.
Baxter International announced plans to set up a manufacturing centre in the US for plasma-based treatments, in April 2012. It has selected a site for the proposed facility in the city of Covington, Newton County, in the state of Georgia. The company plans to invest more than $1bn on the new facility during the coming five years.
The planned investment will create approximately 1,500 full-time jobs in the state. It will also result in the creation of about 2,000 direct and indirect jobs. The plant will begin commercial production in 2018. It will recruit full time staff from 2014.
A biotech training centre announced by Georgia Quick Start, a customized workforce training program, will provide technically trained workforce to Baxter, as well as other biopharmaceutical companies in the state.
The facility's focus will be on the manufacture of products related to immunoglobulin therapy and albumin, a protein commonly found in animal tissues and liquids.
Immunoglobulin therapy is offered to patients with immune deficiencies. Patients who require critical care or those facing trauma or burns are principally treated with albumin products. Albumin therapy helps to maintain fluid levels in critically ill patients.
The site for the new facility is located in Stanton Springs, a business park spread across four counties, namely Jasper, Morgan, Newton and Walton. Baxter plans to acquire 160 acres for the project, in the business park.
"The facility will help Baxter meet the needs of patients worldwide who are dependent on the company's plasma-based therapies. "The site is strategically located in the I-20 corridor, which provides quick access to road transport. It is also close to a number of plasma collection centers in the U.S.
The new plant will have facilities to support development of plasma-based treatments. The facilities will support plasma fractionation, purification and fill-finish operations for biologic medications of Baxter. There will also be a testing laboratory. The fractionation facility will have up to three million liters capacity per annum.
In addition, there will be separate buildings for warehousing, utilities and administration.
Baxter will commence construction on the new facility in 2012. The company is yet to choose construction partners for building the facility.
Baxter BioPharma Solutions is a contract manufacturer of pre-filled syringes, vials and cartridges for the packaging of vaccines and drugs.
Baxter plans to develop the Covington site in a phased manner. The current development forms part of the initial phase of the project. The gross built-up area in the initial phase will be one million square feet.
The later phases will expand the facility, depending upon the demand for the manufactured products. The facility will be, therefore, designed with flexibility to expand the infrastructure when the global market needs mean an expansion is required.
The construction of Covington facility also calls for the expansion of the existing filling and finishing capacity at Baxter's manufacturing facility in Round Lake, Illinois.
The associated expansion will result in the creation of about 200 more jobs. It will include addition of production capacity for the company's plasma-based albumin treatment known as Flexbumin, which is offered in a flexible container.
The licensed immunoglobulin therapy currently marketed by the company in the US and Canada is the Gammagard Liquid. It is marketed under the name Kiovig outside the US and Canada. It is used to treat patients with primary immunodeficiency.
The U.S. FDA has also approved Gammagard Liquid 10 percent for the treatment of multifocal motor neuropathy making it the first immunoglobulin treatment to be approved for that indication. In addition, the company provides blood protein therapies for alpha-1 antitrypsin-deficient patients.
Headquartered at Deerfield, Illinois, Baxter is a diversified conglomerate which is engaged in the development, manufacturing and marketing of healthcare products.
Catalent Pharma Solutions announced its plans to expand its manufacturing capabilities in December 2011. It currently operates from a 43,000 sq. ft. facility in Middleton, WI. Under the expansion plan, Catalent will relocate its operations to a 100,000 sq. ft. facility in Madison, WI.
Construction of the new facility is expected to be completed by the end of 2012 with full operations commencing in 2013. It will quadruple Catalent's manufacturing capabilities and help generate innovative biologic products.
Catalent is expected to invest $29 million in leasing and equipping the facility. It will receive $1m in job creation and job training tax credits from the state. The company is expected to hire 60 people for the new facility.
"Catalent will relocate its operations to a 100,000ft2 facility in Madison, Wisconsin. "Catalent's Middleton facility is equipped with biopharmaceutical development and mammalian cell line engineering capabilities. It is also capable of carrying out protein production for clinical phase I-II trials.
The facility uses the patented GPEx (Gene Expression) technology used for producing stable mammalian cell lines. The technology enables current Good Manufacturing Practice (cGMP) production of biopharmaceuticals.
The Middleton facility also includes development laboratories and space for research and development and QC. It includes cGMP manufacturing suites featuring stirred tank bioreactors.
The facility was ideal during the initial growth stages of the company in the early 2000s. It is, however, aging and its size placed constraints on Catalent's bioprocess capabilities. Relocation was considered as the best solution to address these issues.
Relocation to Madison is part of several strategic initiatives being undertaken by Catalent to improve its product offerings. Increase in demand for cell-line engineering was one of the main reasons for the decision to relocate.
"The new facility will feature significant upgrades to Catalent's current process and manufacturing capabilities."In 2010, contracts requiring use of the GPEx technology doubled and are growing by nearly 20 percent every year. Competition is also increasing in contract manufacturing of biologics. Companies such as ShangPharma, Lonza and DSM are expanding their offerings in the field.
The increase in demand for Catalent's products and manufacturing capabilities, as well as competition from other companies, resulted in a need for more space and a robust infrastructure. The additional capacity provided by the new facility will help Catalent's customers bring their products to the market faster.
Catalent also recently partnered with Toyobo Biologics to increase its product offering in biologics.
The Madison facility was originally built in 2000 for the production of bone-scanning medical devices. It was later operated by GE Healthcare. Catalent will retrofit the facility to its standards.
The new facility will feature significant upgrades to Catalent's current process and manufacturing capabilities. It will help in optimizing its unidirectional process flow to increase production capacity. The facility will be equipped with three separate cGMP compliant production suites.
The Middleton facility currently uses 200l stainless steel bioreactors. The new facility will shift to the use of single-use bioreactors with capacity ranging from 50 to 100l. This will increase Catalent's production capacity for Phase I and II clinical trials.
Single-use bioreactors will help increase the number of batches produced. They will provide Catalent with greater flexibility in terms of cleaning and change-over. This flexibility will prove essential in an environment where Catalent has to work on different proteins supplied by several customers.
The increased capacity from stainless steel bioreactors will help Catalent to scale up its manufacturing capabilities according to customer requirements.
Catalent has already installed one single-use bioreactor at the Middleton facility. This will enable employees to familiarize themselves with the system.
The new facility will help in increasing the efficiency and output of the GPEx technology. It uses retrovector technology which enables transduction of targeted cells with accuracy. Any kind of complementary DNA can be targeted using the technology to generate a mammalian cell line of customer's choice.
The technology enables generation of stable mammalian cell lines in 4.5 months compared to 18 months using conventional technologies. It is more efficient and reduces expenses by halving development time.
The University of California San Francisco (UCSF) has built an automated hospital pharmacy at its new medical centre at Mission Bay, San Francisco. The system is capable of dispensing medication automatically. It utilizes robotic technology to prepare and track medications.
The under-the-radar pharmacy system was introduced in March 2011 and to-date nearly 350,000 doses of oral and injectable medications were prepared without error.
UCSF believes the system will achieve the goal of improving patient safety and increasing the medical centre's efficiency. It plans to build robotic pharmacies at all of its branches.
The Mission Bay pharmacy currently dispenses medications to UCSF's hospitals at Parnassus Heights and Mount Zion in San Francisco. It will also dispense medications to a new hospital that UCSF plans to open at Mission Bay in 2014.
The Mission Bay facility is the second such state-of-art pharmacy in the world. The first is located at Cedars-Sinai medical centre in Los Angeles.
"The University of California San Francisco has built an automated hospital pharmacy at its new medical centre at Mission Bay, San Francisco. "UCSF initially planned to upgrade and renovate its existing pharmacy with an investment of $24m. It later decided to develop a new robotic pharmacy for $15m, not including the full automation cost.
The automated hospital pharmacy relies on a hub of automated robots to distribute medicine to patients. It enables UCSF to research various ways of dispensing medicine and relieves nurses and pharmacists from regular manual tasks. UCSF is able to train clinical pharmacists to focus on patients rather than drugs.
The pharmacists and nurses also get more time to discuss suitable drugs for a patient with physicians. This enables closer care and monitoring of patients.
Studies indicate that barcoding, computerized physician entry and development in medication-management reduce errors significantly.
The robotic pharmacy uses the pill-pick system to separate batches of pills into individual doses. The collected pills are bagged and stored. Pill-pick is a modular system with connected devices that automatically produce unit dose medicaments. The automated warehouse, where the dose medicaments are stored, is always ready to provide personalized therapy to patients.
"The under-the-radar pharmacy system was introduced in March 2011 and to-date nearly 350,000 doses of oral and injectable medications were prepared without error. "The physicians of UCSF send orders to the system electronically. The robotic system then picks the packages and dispenses the individual doses of pills. The system dispenses more than 10,000 doses per day.
The packed doses of the pills required by a patient are tied together on a plastic ring and barcoded for a 12-hour period. The nurses confirm the right medication for the patients through the bar code readers. The system also keeps record of the medication stock available in the pharmacy.
Three RIVA (Robotic IV Automation) robots fill doses of liquid medication into IV syringes and bags. The robots work in a protected germ-free environment where there is a less chance of the medication getting contaminated. The pharmacists also don't handle the drugs, so there is less risk of the medication being mixed.
Human pharmacists were appointed to check the work of robots. Once the phase-in is fully operational, the human intervention will be eliminated and doctors will start prescribing medicines directly through computers.
Switzerland-based Swisslog has developed the pill-pick robots for UCSF's medical centre.
Intelligent Hospital Systems, a medical device company has prepared the RIVA robots for dispensing doses of liquid medication.
Dome Construction constructed the robotic pharmacy building.
The robotic pharmacy has been awarded with LEED CI Gold certification for its sustainable building practices.
Invisible Sentinel has established a pilot manufacturing facility to supply customers with foodborne pathogen detection systems ahead of product launches later this year.
The program has been established at the University City Science Center in Pennsylvania in preparation for commercialization.
Invisible Sentinel develops rapid diagnostics for the detection of foodborne pathogens and said the site has the potential to be scaled for larger product volumes.
The firm began its laboratory research in 2007 and added manufacturing capabilities in July 2012 with the first device expected to launch late 2012.
The pilot manufacturing facility complements the existing R&D laboratory and off-site animal facility.
"We anticipate receiving regulatory approval this fall and look forward to supplying our customers with some of the fastest and most sensitive tests for the detection of foodborne pathogens," said Invisible Sentinel CEO Benjamin Pascal.
Exact Sciences will expand into 10,000-square-feet of additional space at University Research Park at the University of Wisconsin, Madison, while Epicentre will move its Madison operations into a 27,000-square-foot space at the park, URP announced.
Exact Sciences already occupies about 25,000 square feet at URP and will move into a space that previously was occupied by biotech firm Aldevron and EMD Millipore, a division of Merck KGaA. Aldevron, which specializes in plasmid DNA and protein production and antibody technologies, is moving to new spaces at URP, while EMD Millipore's lease expired.
As Exact Sciences approaches the completion of its DeeP-C clinical trial for its Cologuard colorectal cancer screening test, the firm plans to use the additional space to prepare its manufacturing and other capabilities for the launch of the test, following anticipated approval by the US Food and Drug Administration, company President and CEO Kevin Conroy said in a statement.
Exact Sciences recently raised around $58 million in a public offering of its common stock, with proceeds intended to support commercialization efforts.
Epicentre, which Illumina acquired at the start of 2011, will occupy a floor of URP's Accelerator building, which offers companies a "mix of shared resources, value-added amenities, and the potential for growth through specialized research and development facilities," URP said.
Epicentre, founded in 1987, provides nucleic acid sample preparation reagents and enzymes for sequencing and microarray applications.
Direct selling giant Amway is on schedule for its new 48,000-square-foot extraction and concentration facility in Quincy, WA, as the company breaks ground on its Nutrilite Botanical Concentrate Manufacturing facility.
The new facility, expected to begin operations in 2014, fits Amway’s plans to move processing facilities closer to its growers.
The extraction and concentration facility will process ingredients for nutritional products sold under its Nutrilite brand. The company also has the option for an additional 15 acres at the same industrial park.
The Quincy facility is part of a more ambitious plan to expand US manufacturing, said the company. These include a new $81 million nutrition soft gels and tablet manufacturing operation in Ada, Michigan, a $24 million nutrition powder products plant was unveiled in 2012 in Ada, MI, and a $42 million project in Buena Park, California, which includes a new granulation facility to support tablet manufacturing; new research and development facilities and pilot laboratories.
The first phase of the Biotechnology Research Center will be done soon. But the opening of the facility in Syracuse will not happen for at least a few months. This is not the first time the project has been delayed. Our Iris St. Meran tells us when we can expect it to be occupied.
The first phase of the Biotechnology Research Center will be done soon. But the opening of the facility in Syracuse will not happen for at least a few months. This is not the first time the project has been delayed. Our Iris St. Meran tells us when we can expect it to be occupied.
This time last year, this building was just a foundation of beams. But construction crews have been working on the first phase of the Biotechnology Research Center.
Upstate Medical University Facilities and Planning Vice President Tom Pelis said, "Phase one of the project was to construct the building shell, to finish one-and-a-half floors, which includes seven laboratories, as well as administrative offices."
That is expected to be completed in a few weeks. It's a $22 million undertaking in a partnership between Upstate Medical University and SUNY ESF. After breaking ground in 2009, construction was stalled waiting for state funding.
Work resumed last spring with a projected opening of this past June. The delay is for good reason: Additional funding was received for phase two, which will have eight smaller incubator labs.
"We thought about the time people would start moving in for phase one, we would start construction for phase two,” Pelis added. “That made really no sense so we don't expect occupancy to occur much before the end of the year."
This has been a labor of love and Pelis says he's proud of the progress.
"We have a lot of interest in this facility. It's the only one of its kind in the area," Pelis.
He can't say how many clients are booked for this space, but says there's a committee to vet potential occupants. They will consist of startup companies looking to develop their research.
If you'd like to learn more about the Biotech Center, Upstate Medical University has a website with information on programs, services and much more. Visit www.upstate.edu/biocenter
Aesica has entered a partnership with the Centre for Pharmaceutical Engineering Science at the University of Bradford, enabling the Bradford team to use Aesica’s GMP capabilities and assets, and giving Aesica access to the Centre’s research facilities. The Centre offers several processing technologies, including hot melt extrusion, and will rely on the GMP expertise of the formulation development team at Aesica to manufacture GMP clinical trial supplies.
Paul Titley, managing director of formulation development at Aesica, said, “We provide GMP contract manufacturing services to six other universities, but this partnership is particularly important and unique as it is mutually beneficial. While the team at Bradford has development expertise in several key approaches and as such can evaluate the viability of compounds presented by virtual and small pharma organizations, our GMP expertise is crucial to take the compounds into clinical trials. In addition, the facilities at the Centre for Pharmaceutical Engineering Science will enable us to further enhance our overall formulation development service offering which will add value to our existing clients.”
Dr. Riddhi Shukla, business development manager at the Centre for Pharmaceutical Engineering Science, said, “Aesica is a well established pharmaceutical company with exemplary GMP credentials, which we were keen to tap into for the benefit of our contacts within the multinational pharma community. Our facilities at the Centre are second to none and we believe this coupled with our research expertise will deliver significant benefits to Aesica as the partnership evolves.”
CMIC CMO USA received qualification of three new development suites at their FDA registered site in Cranbury, NJ. Gary Wada, executive vice president and general manager said, “The increased capacity will allow us to initiate development projects quickly and reduce the time for our clients to initiate clinical trials and file for regulatory approval.”
Also, Jeffrey Dopf has been named director of business development. Mr. Dopf served most recently as a business development manager with Glatt Pharmaceutical Services and was previously with Patheon.
The U.S. Army announced that it has awarded Life Technologies a $45 million contract.
The firm-fixed-price contract is for the purchase of reagents and consumable supplies for the Army's DNA Identification Laboratory at the Armed Forces Medical Examiners System in Dover Air Force Base in Delaware. The Army said that work will be done at Life Tech's Carlsbad facility and completed around Aug. 9, 2017.
Life Tech won the bid through a solicitation on the Internet. One bid was received, the Army said.
Analyst David Ferreiro of Oppenheimer said in a research note today that the deal "highlights the resilience of [Life Tech's] CE business. Irrespective of the inevitable decline of CE utilization in the academic setting, we believe the applied CE market will remain stable for the foreseeable future."
He added that the contract also is evidence of Life Tech's efforts to diversify its end markets to rely less on the academic market, which could face deep funding cuts.
Albany Molecular Research, Inc. (AMRI) is manufacturing sterile prefilled syringes at its Burlington, Massachusetts site in support of the U.S. introduction of Cardium Therapeutic’s Excellagen topical gel.
Excellagen is a new, highly refined fibrillar collagen-based gel for treating diabetic foot ulcers, pressure ulcers, and other dermal wounds. It is topically applied through prefilled single-use syringes.
The aseptic fill-finish line for Excellagen at Burlington uses an Inova filling machine with product- dedicated stainless steel rotary piston pumps. “The line has a maximum filling rate of 4,000 syringes per hour,” says Chris Phillips, director, operations, AMRI Burlington.
The line supports efficient , contamination-free filling of pre-sterilized nested syringes , in a RABS (restricted access barrier system) ISO-5 environment. All manipulations within the fill machine enclosure are automated and facilitated via servo motors, Phillips says.
Syringe tubs are fed manually into the enclosure onto an automated syringe tub conveyance system. “The tubs are then transported to the first station where the syringe nest is removed from the syringe tub via a vacuum frame. The syringe nest is placed into an XY Table which is machined to articulate directly with the syringe nest array. The XY Table then indexes to the filling and stoppering station where filling needles, supported by rotary piston pumps, deliver the required dose to the syringe barrels, Phillips says.
“After the syringes are filled with the required amount of Excellagen, the syringes are vacuum stoppered. Once all syringes in the nest are filled and stoppered, the XY table indexes to the exit pick up station where a second vacuum frame picks up the syringe nest from the XY Table and places it back into the syringe tub. The tub is then conveyed out of the filling machine enclosure.”
Excellagen is a unique high molecular weight bovine Type 1 collagen formulation. “Filling challenges associated with Excellagen are due to its physiochemical properties as a viscous biopolymer emulsion,” Phillips says. “The fluid dynamics of the product presented challenges with respect to maintenance of sterility and homogeneity as well as accuracy of fill volume. Solutions were engineered through adjustments in upstream processing as well as optimization of filling parameters and equipment configuration,” he adds.
After filling, the Excellagen syringes are bulk packaged in the syringe tubs and plastic seals are placed on to the tubs. The tubs are then bulk labeled and shipped to a commercial packaging company.
Excellagen lots are 100% visually inspected by operators trained and qualified to inspect final product for all attributes including cosmetic defects and foreign particulate, Phillips says.
“Once the 100% visual inspection is complete, an AQL inspection is performed on a statistically significant number of the accepted units by Quality Assurance. Once the AQL inspection is performed and deemed acceptable, the lot is transferred to shipping for final packaging and shipment from AMRI Burlington.”
AMRI provides integrated drug discovery, development, and manufacturing services as a global contract research and manufacturing organization. AMRI has launched SmartSourcing to provide customers with strategic sourcing options.
“Projects are complex in nature and inherently prone to unforeseen logistical and technical challenges. A real strength of SmartSourcing is the ability to tap into a wealth of collective experience and knowledge that identifies and manages risk in a way that continuously imparts preventive measures to avoid problems from manifesting in the first place, Phillips says.
“When the project scope is initially defined the expectation for project deliverables/timelines and risk is discussed and fully agreed with the customer. SmartSourcing takes advantage of integrated service offerings across the entire life cycle of drug discovery, drug development, and drug substance/product cGMP manufacture. These services and business sectors all operate as one company, under one global quality system and one global procurement and project management team.
“While AMRI Burlington has its own capabilities, if we encounter an issue with procurement of packaging materials or are looking for better solutions than we have come up with, we can tap into the many other procurement channels existing across the AMRI global operations,” he says.
“Finally, SmartSourcing includes working under one quality system that does not change at each juncture of the project that might otherwise involve a third party under a separate quality system. This allows for continuity and cost control to keep projects moving forward as expected.”
Quality Packaging Specialists International, or QPSI, will move its packaging operations facility from New Jersey to Lehigh County, creating more than 280 new jobs.
"We are creating an economic environment in Pennsylvania that encourages business expansion and attracts new growth," Corbett said. "QPSI is the latest example of an out-of-state operation that will now call our state home. As a result, more than 280 jobs are coming to the Lehigh Valley."
QPSI will move its pharmaceutical packaging operations from a 62,000-square-foot facility in Moonachie, New Jersey into an expanded, 157,000-square-foot facility in Lower Macungie Township. The company will enter into a 10-year lease and invest $10 million to install clean rooms, purchase equipment and train employees. The project is expected to create at least 283 full-time jobs within three years.
The company received a financial assistance offer from the Department of Community and Economic Development that included a $500,000 Pennsylvania First grant, $100,000 in job training assistance, $566,000 in Job Creation Tax Credits and a $2.25 million loan from the Machine and Equipment Loan Fund.
"We are excited for the start of an expanded pharmaceutical packaging operation at QPSI," said QPSI founder, President and CEO Mike Ricketts. "The physical assets being deployed to delight pharmaceutical manufacturing customers, coupled with recruitment and highly technical training of local talent, underscore our commitment to investing in Pennsylvania. We are appreciative of DCED and Lehigh Valley Economic Development Corporation for their support for our business."
The project was coordinated by the Governor's Action Team, or GAT, economic development professionals who work directly with businesses considering locating or expanding in Pennsylvania. GAT worked with LVEDC to bring QPSI's packaging operation to Pennsylvania.
"The Lehigh Valley's standing as a business epicenter is one of our region's great strengths," said LVEDC President and CEO Don Cunningham. "Quality Packaging Specialists International is the second pharmaceutical company to move here this year and their investment in our region by creating 283 quality-paying jobs stems from our region's unique location, a diverse customer base and skilled workforce."
QPSI is a contract packager and supply-chain solution provider for Fortune 500 companies, primarily in the pharmaceutical, personal care, confection, consumer packaged goods, and electronics industries. The company employs more than 1,200 people across its network of facilities. QPSI has a plant in Mechanicsburg, Cumberland County that currently employs 139 people.
Millstone Medical Outsourcing will expand its Memphis, TN, operations to a new facility offering 150,000 square feet for mechanical inspection, loaner kit processing, bone/tissue storage, packaging services, and distribution, the company reported in a press release. Memphis staff will move with Millstone Medical to the new facility in Olive Branch, MS, a Memphis suburb. Construction is expected to be complete by the end of the fourth quarter of 2012. Its current facility in Memphis will remain open.
“Millstone Medical is preparing for explosive growth,” said Chris Ramsden, Chief Executive Officer of Millstone Medical Outsourcing, in the press release. “The additional operational space will allow Millstone to expand programs for existing customers and to bring on new customers. In addition, the new facility is strategically located near the distribution hubs of the area’s major carrier and continues to enable Millstone to provide extended service hours and expedited shipping. We are tremendously excited about all the possibilities the new facility will deliver for the company and our customers.”
Millstone Medical Outsourcing is FDA registered and ISO certified by BSI, Inc. to ISO 13485: 2003.
U.S. injectable drugmaker Hospira will invest $85 million and create 200 new jobs at its plant in Rocky Mount, NC.
In a statement Governor Bev Perdue said Hospira plans to make the investment – which could increase to $270 million over the next decade – to improve the facility in a project supported by a $645,000 grant from the One North Carolina fund.
News of the investment comes just a few months after Hospira successfully resolved significant and long running quality problems at the facility that forced it to halt operations, severely impacting its contract manufacturing business.
The New York Genome Center (NYGC), the first major biotech center engaged in genomics research to be established in Manhattan, will occupy 170,000 sq. ft. (15,793 sq. m.) of office and laboratory space at 101 Avenue of the Americas. NYGC is to take occupancy on seven floors of custom built-out space in the LEED Silver-certified building by mid-2013. The $47-million build-out, for which work has already begun, will create sequencing, bioinformatics and research labs, a new technologies center and computing infrastructure.
"The center is expected to grow vigorously, from about 100 employees at the start to more than 500 employees within five years," said Bill Harvey of Newmark Grubb Knight Frank, who represented NYCG in negotiations with landlord Edward J. Minskoff Equities. "The capacity to grow as rapidly as needed, and a location in the vicinity of vibrant Hudson Square that would draw employees to the center, were both critical requirements for this assignment."
NYGC's offsite data requirements will be managed at Sabey Data Center's (SDC) Intergate.Manhattan.
Philadelphia's University City Science Center will begin construction in September on a new 11-story tower at 3737 Market Street in West Philadelphia. The project is a joint venture between the University City Science Center and Wexford Science + Technology. Penn Presbyterian Medical Center will be the anchor tenant. The 272,700-sq.-ft. (25,333-sq.-m.) building will feature outpatient medical facilities, ground-floor retail, and office and lab space for start-up and growing companies.
Penn Presbyterian Medical Center will be the largest tenant with orthopedics and outpatient medical facilities. The building, which has a completion date of June 2014, is being designed with a goal of receiving LEED Silver certification.
Accelr8 has entered into a lease for a 15,096-square-foot facility in Tucson, AZ, as well as an agreement that will provide it with a $1 million grant, the company disclosed in a document filed with the US Securities and Exchange Commission.
Accelr8 announced its plans to relocate to Tucson from Denver and to hire at least 65 workers in the next three years. The company said at the time that its facility will be at the Herbert K. Abrams Public Health Center and that it expects the space to be operational in early 2013 after the build-out of a wet laboratory space.
According to its SEC document filed today, the lease for the facility is for three years. Accelr8 also has an option to lease two additional areas with an aggregate size of 7,920 square feet. The lease stipulates that the company must employ at least 30 individuals with a median salary of at least $70,000 within 18 months after moving into its new space and the start of operations. Accelr8 must maintain the $70,000 median salary throughout the term of the lease, it said.
Also, Accelr8 entered into a grant agreement with the Arizona Commerce Authority, under which the company will receive a grant totaling $1 million. The grant is payable out of an escrow account in four installments upon Accelr8 achieving four milestones.
The first is that Accelr8 relocate to Arizona and create 15 qualified jobs, defined as a job that is permanent, full-time, new to Arizona, and with an average annual wage of at least $63,000. Accler8 must also offer health insurance and pay at least 65 percent of the health insurance premiums.
The second milestone is the creation of 30 qualified jobs, and the third milestone is the creation of 40 qualified jobs. The last milestone calls for the creation of 65 jobs and a capital investment of at least $4.52 million.
Accler8 is in the midst of a turnaround effort. In June it received an investment of $35 million and with it, a new CEO, Lawrence Mehren, a former executive at Roche Tissue Diagnostics, who replaced Tom Geimer.
The firm said that it eventually hopes to employ between 200 and 300 individuals. It currently has five employees.
DaVita Clinical Research has opened a Phase I facility focused on kidney research in a bid to meet a “growing demand” for renal trials.
The centre, a 35,000 sq. ft. 80-bed amenity based in St.Anthony hospital campus in Colorado, US – will help sponsors assess how drugs pass through the kidney or how they interact with the liver.
The move extends DaVita’s total number of beds in North America to 122, and means the clinical research organization (CRO) can for the first time recruit healthy volunteers as well as patient populations.
VP of commercial development Kevin Goudreau said the expansion was a response to a rise in the number of renal trials as a result of increasing regulatory pressures.
“The regulators are putting more focus on understanding exactly how the drug works in vitro and as a result are putting more focus on this area,” he said.
VP of clinical services Amy Young added that 80 per cent or more of studies going through the US Food and Drug Administration (FDA) approval process at present are required to look at toxicity activity in the kidney, and an increasing focus on hepatic trials.
“Basically, there is an increase in pressure to do more early on in clinical trials,” she told us, adding that more than 90 per cent of trials need renal or hepatic data.
Goudreau admitted that the decision to open such a specified facility may seem unusual in the present climate, with the industry leaning towards bigger strategic deals rather than more niche offerings.
However he said it is those strategic deals that provide it with a large chunk of business.
“We don’t only go directly to pharma companies, we build relationships with CROs who have strategic relationships with these companies. When they need this sort of specialized activity, they come to us,” he said.
He added that renal and hepatic expertise is only part of the attraction for those looking to outsource, as patient access is also a big boon.
Young added: “It takes a different level of staff and expertise to manage these kind of trials. Finding the right patient population is exactly what companies are looking for, rather than cost.”
Goudreau however said that cost still does come into the equation, but that supply and demand for patients means that getting a bargain is not necessarily as important as in other service arenas.
“Any of the big partnership models forged between sponsors and CROs have really focused on driving costs down over the past five years, but it’s crucial to have access to patients and often companies are all vying for the same patient,” he said. “Sometimes you have to beat five or more other companies to get access.”
Bend Research Inc., a leading independent drug-formulation development and manufacturing company, announces the addition of a current Good Manufacturing Practice (cGMP) spray-drying facility. The facility expands Bend Research’s capabilities and expertise in the area of development and manufacture of high-potency drug candidates.
The facility is well-suited for the manufacture of a wide range of compound types and safety classifications, ranging from inhalable biotherapeutics to oral solid form high-potency small molecules. The facility is physically separated from the company’s other development and cGMP manufacturing facilities and is designed for high containment operations at the highest safety and quality standards, utilizing the latest best-practice design features, finishes and engineering controls at the equipment level.
“We’re excited to offer our clients expanded cGMP spray-drying capability for high-potency compounds,” said Rod Ray, chief executive officer. “This facility will complement our small-molecule cGMP spray drying capabilities.”
In addition to the high-potency spray-drying facility, the company recently expanded its solid-dosage-form capability and purchased an additional building for future expansion of development and manufacturing capabilities.
Morphotek, Inc., a wholly-owned subsidiary of Eisai Co., Ltd., has opened a new pilot manufacturing plant in Exton, PA for the production of biologic-based therapeutics to support its early-stage clinical trials. The company invested $80 million in the 60,000-sq.-ft. cGMP facility to maximize efficiencies for its product development process.
The facility will begin production operations in late 2012 and GMP manufacturing in 2013. The company has hired 23 new employees and expects additional jobs to be created in the near future.
"With the opening of our state-of-the-art pilot plant we now have the capability to produce our therapeutic antibodies much more efficiently and faster than we were capable of previously when we had to outsource their manufacture," commented Philip M. Sass, Ph.D., Executive Vice President and Chief Operating Officer. "The facility is designed and equipped to produce multiple biologics simultaneously and will enable us to initiate more Phase I studies to test the safety and efficacy of our lead antibodies than we could previously." Morphotek has a number of monoclonal antibodies (mAbs) in clinical development including a Phase III mAb for ovarian cancer; a Phase II mAb for mesothelioma; and another mAb in Phase II clinical trials being developed to treat a broad array of solid tumors.
Gerresheimer Medical Plastic Systems, a leading manufacturer of special products made from glass and plastic for the international pharmaceutical and healthcare industry, is expanding its plant in Dongguan, China, into a centre of competence for injection molding, printing and assembly of medical devices.
The production of price-sensitive products starts at the German plant in Pfreimd, and is then transferred to China by the company’s Production Co-ordination Unit. The production of two lancing devices has already been transferred successfully in this way.
In the market for medical devices product cycles are becoming increasingly short and the price pressure increasingly high. Therefore, product development is based on modular platform concepts, the elements of which can be used for several product generations. This is complicated by the demand for highly efficient solutions for product manufacture and assembly.
‘By combining our European development and industrialization competency with the production potential in China, we are able to offer customized solutions with attractive production costs,’ Manfred Baumann, COO/CTO of Gerresheimer Regensburg, explained. ‘Processes that are only cost-effective in Europe if they are fully automated, can be performed in a manual or partially automated fashion. This means fewer investments in automation technology.’
In the case of the two lancing devices, many of their components are the same, enabling costs to be decreased. The industrialization takes place in the Technical Competence Center of Gerresheimer MPS in Wackersdorf; the production was first set up in Europe and then transferred to China in accordance with preset milestones. Continuous of components was guaranteed by a respective product transfer and logistics concept. An important element of the successful transfer was the training program for the Chinese employees.
The entire transfer was coordinated and supervised by the Production Coordination Unit, including the layout planning for production and assembly, the personnel planning, as well as the capacity planning, machine specification, and qualification. During the transfer phase, the unit also had to address many detailed tasks from packaging to the handling of customs formalities.
In the meantime, the entire process chain for lancing devices has been set up in China. Fifteen injection molding machines, two semi-automatic assembly units including welding installations and six Kent printing machines for the pad printing process are available in China.
Telstar Develops Production Lines for Hisun Expansion
Telstar has developed three integrated production lines incorporating dosing, freeze-drying, unloading and packaging technologies for the manufacture of bulk sterile antibiotics for Hisun, one of the largest Chinese producers of active pharmaceutical ingredients (APIs).
This is said to be the largest integrated project to be carried out in China in which a single company provided all of the technology for the entire primary packaging process.
The integrated freeze-drying system features an automatic loading and unloading system operating under sterile conditions within a production isolator. Specifically designed for the freeze-drying of antibiotics, the system incorporates a sterile isolator, which protects the operator and provides an ISO 5 class manufacturing environment.
The first stage of the process (freeze-drying) is composed of three GMP production freeze-dryers and automatic tray loading and unloading systems installed inside sterile isolators, together with equipment to dispense the liquid product into trays.
After the freeze-drying cycle is complete, vacuum unloading systems move the freeze-dried product into IBC containers.
The project also includes steam autoclaves and various RAB (Restricted Access Barrier) and isolator systems necessary for other applications associated with the production process.
The second stage of the process involves weighing and packing support for each of the freeze-drying systems. An integrated autoclave is used to steam-sterilize aluminum canisters, which are then dosed from the IBC with a weighed quantity of the freeze-dried product. Packing then completes the process.
Telstar has supplied the complete system in triplicate, thereby giving the client greater flexibility in carrying out large-volume production.
The facility includes three continuous processing production lines which operate around the clock, including four 30,000ltr manufacturing tanks, two 15,000ltr tanks and three bottling lines.
It works on lean infusion factory technology (LIFT).
Takeda has opened a new $96m (€75m) pharma facility in Russia as part of its bid to “outgrow” the already thriving local market.
The 79,000 sq. ft. in Yaroslavl will be capable of both solid dose production – from weighing and mixing, to compression, coating, and packaging – as well as liquid sterile production such as solution preparation, sterilization, filling and packaging.
When the plant is up to full production, expected in 2014, the firm says it will produce around 90m sterile ampoules and over two billion tablets per year. Initially, it will produce generics including cardiomagnyl, actovegin and calcium tablets to meet “Russian demand”.
The plant, which is approximately 280 kilometers from Moscow, was constructed on time and on budget to local and international GMP standards and adheres to the latest safety and environmental standards. It will have the initial capacity to manufacture 90 million sterile ampoules and more than two billion tablets per year.
Liquid sterile production includes solution preparation, washing of ampoules, sterilization, filling, inspection, and packaging. Solid production will encompass all stages, from weighing, mixing and granulation through compression, coating, and packaging.
The plant is the Japanese firm’s first new establishment in the area - it has existing operations following its recent Nycomed takeover, however according to CEO Yasuchika Hasegawa it is just early days for Takeda in its bid to dominate the Russian market. The Yaroslavl facility already makes it the seventh largest drug producer in the country, with 2012's revenues projected at €620m.
Tobias Cottmann, senior director of external communications said "The plant has a solid business case, which is based on the high demand for the company’s biggest products in Russia. It will allow it to better serve the Russian market through local production and demonstrates Takeda’s strategic, long-term commitment to the Middle East and Russia."
As for the firm's next steps, Cottmann told us it is on the lookout for "bolt-on" purchases especially in emerging markets.
"We are open to complementary, bolt-on opportunities that make strategic sense, focusing on emerging markets such as our recent acquisition of Multilab in Brazil," he said, adding that Takeda will not look for any more big "Nycomed" sized deals at this time.
But though all emerging markets - which make up around 13 per cent of total sales, boosted significantly since Nycomed joined the portfolio – are of interest to the company, Cottman maintained that Russia will be the key focus and that the firm plans to beat growth estimates for the pharma production industry in the region.
In a statement, the firm quoted an IMS Health report which marked a $14.7bn Russian pharma market in 2011, and predicted an 11 per cent growth annually up until 2016. The statement said: “Takeda plans to outstrip that with annual growth of 15 per cent over the same period.”
Hasegawa added: "Russia is our largest emerging market in terms of revenues, and is expected to contribute significantly to our growth over the next few years. The Yaroslavl facility will enable us to provide locally produced pharmaceutical products to patients and clinicians, as well as bringing significant benefits to the Yaroslavl and Russian economy."
Takeda is said to be the first major player to set up big operations in Russia. Governor of the Yaroslavl Region Sergey Yastrebov said: "Takeda is one of the flagship companies in Yaroslavl's pharmaceutical cluster and is the first major international pharmaceutical company to invest in a new world class manufacturing facility in the region."
However with former Russian PM Vladimir Putin’s 2010 plans to invest RUB120bn ($3.9bn) to boost the local drug production industry – along with his warning that firms could face “restrictions” if they didn’t set up operations – Takeda is not the first Big Pharma to ponder the market.
GSK, Teva and AstraZeneca , for instance, all announced intentions to work in Russia.
Yastrebov added that the new plant could set an example to other firms looking to house production there. He said: "This project is an excellent example of the benefits that international investment can bring to the Russian economy. Takeda is working closely with Russian companies to build the plant, and will create hundreds of high quality jobs for Russian people in the future."
Agilent Technologies opened a new Customer Applications and Training Center in South Korea for its bio-analytical instruments including its mass spectrometry and spectroscopy instruments. The center is aimed at researchers conducting environmental, agricultural, materials science, and semiconductor research.
Growing awareness of nutritional intake among Chinese consumers has opened the door for Israel-based global premix supplier LycoRed.
Three years after the contract was signed to start construction, the Changzhou factory is now open. The company said that its new premix plant in Changzhou, China, has received full approval and will start operations immediately. It will serve processors of infant formula, beverages, baby food and other food products across the Asia-Pacific region.
Milo Shen, regional sales manager for China at LycoRed, said the company will target makers of infant foods, dairy products, and supplements with its dairy business.
“This business is being supported by the growing population in China as well as the growing of awareness about nutritional intake in the country,” said Shen, revealing that the company is already working on projects with customers.
Wim van den Broecke, general manager for the Changzhou site, related the growing concern about food safety is another factor supporting the company’s foray into China.
“This is a key driver for the infant market in China. We have implemented our LycoRed standards to this new site for ensuring the highest and safest production process,” he said of the country's current concerns about safety.
He added that LycoRed opened the plant with the intention of being closer to its existing customer supply base of customers, who are increasingly present in the Chinese and Southeast Asian markets.
“In addition, LycoRed clearly wants to further grow, and the place to be for that is the region which is still enjoying significant growth: China and Southeast Asia,” said Van driveren Broecke.
Project planning for the site began in 2009, construction started June 2010, and installation, qualification and validation were completed by December the following year. LycoRed has invested a total of US$8m in the site.
“The facility is capable to make all dry blends for infant formula, fortification and supplementation. The facility is built according to the highest standards, and has room for further expansion,” he added.
Ilan Ron, LycoRed’s vice-president for sales and marketing, revealed that the company had recently received its Halal MUI certificate for its new vitamins D3, E and K1 formulations.
“These vitamins are made with a proprietary spray-drying process to ensure the completely solubility of vitamins. They can be used in premixes for infant formula and baby food, as well as in dry blends for beverages,” he said.
Alphora has completed a GMP Kilo lab for the scale-up of high potency/cytoctoxic compounds with occupational exposure limits (OELs) of 10μg/m3 or less. The expansion is part of the company’s 2011 capital program, which included a separate R&D suite with isolator containment, along with additions to headcount, R&D, analytical services and warehousing.
The kilo lab is designed to handle Class 4 high potency active pharmaceutical ingredients (HPAPIs) and is equipped with glove-box technology for operating and isolating reactions to the 50L scale. The facility employs pressure lock entryways and dedicated HEPA filtered air-handling systems suitable for Class 100,000 use.
Alphora Research operates FDA inspected and approved operations that total 45,000 sq. ft., and include synthetic laboratories, analytical laboratories, GMP kilo laboratories, GMP pilot plant, GMP stability studies and supporting QC/QA.
Hospira, a U.S. manufacturer of injectable drugs, has agreed to buy a factory and a research and development centre from Indian pharmaceuticals firm Orchid Chemicals & Pharmaceuticals for US$200 million.
The factory, located in Aurangabad in India’s western state of Maharashtra, manufactures active pharmaceutical ingredients. It was built in 2000 and employs around 640 people.
The R&D facility in the southern city of Chennai has about 160 scientific personnel.
Hospira, based in Lake Forest, Illinois, says the acquisition of the FDA-approved manufacturing facility will reduce costs, support continuity of supply of key antibiotic products and pave the way for future API development.
Dr Bhaktavatsala Rao, managing director, Hospira India, said: ‘This is a top-of-the-line API manufacturing facility that has been recognized by industry leaders for its high standards. We look forward to welcoming our new colleagues from Orchid and leveraging their expertise to continue to bring high quality, lower-cost products to patients around the world.’
The acquisition, which follows Hospira's 2010 purchase of Orchid's generic injectable finished-dosage form pharmaceuticals business, will enable the firm to integrate vertically into certain beta-lactam antibiotic APIs (penems and penicillins) with a wide spectrum of antibacterial activity.
Orchid will retain its cephalosporin API business and facilities, and will continue to supply Hospira with this associated ingredient.
The boards of directors of both companies have approved the deal, which should be completed in the fourth quarter.
Hospira expects the deal to break even or slightly increase earnings per share in the first year after completion.
The Aurangabad, India, facility, staffed by approximately 640 employees including chemists, engineers and technicians, received the International Society of Pharmaceutical Engineering's (ISPE) Facility of the Year Award for Regional Excellence in 2009. Constructed in 2000, the facility includes 50,000 square meters of space. Hospira's purchase also includes an associated Orchid R&D facility based in Chennai that will be primarily directed to beta-lactam and other APIs with approximately 160 scientific personnel and an additional 30 employees supporting the facilities.
The University of Edinburgh said that it has won £60million ($94.8 million) in new funding from the Medical Research Council to support its genetics and genomics research programs.
It also has received a £3.5 million award from the Wellcome Trust and Wolfson Foundation to help fund the building of a new systems medicine center.
The MRC funding will be used to fund research at Edinburgh's MRC Human Genetics Unit and the MRC Institute of Genetics and Medicine (IGMM) into a range of conditions, such as schizophrenia, cystic fibrosis, and genetic eye disorders, and to develop and test new therapies. IGMM is a partnership between the MRC, the University of Edinburgh's Centre for Molecular Medicine, and Cancer Research UK.
"The majority of the [MRC funding] will continue to fund ongoing programs in the Human Genetics Unit, IGMM and Human Genetics Unit, said Director Nick Hastie.
"However, a significant proportion – 10 to 20 percent – combined with money from the University of Edinburgh, will allow us to do exciting new science, to recruit [new scientists], to buy new microscopes for imaging of cancer cells, to build a brand new PhD program, and help us integrate with the National Health Service."
The £3.5 million in funding from the Wellcome Trust and the Wolfson Foundation, awarded under the Wellcome-Wolfson Capital Awards program, will support a new systems medicine building that will begin construction at Edinburgh's Western General Hospital in 2013.
The five-story systems medicine building will total 2,700 meters squared (29,052 sq. ft.), and will "create a physical and intellectual bridge between centers that make up the IGMM. In addition to research spaces, the facility will include spaces for computational biology, a seminar room, offices, and an "open design" to encourage research collaborations, according to IGMM.
The remainder of the estimated £10.2 million for the systems medicine facility will be provided by the University of Edinburgh and the MRC.
Telstar has completed the construction of the pharmaceutical manufacturing and process facilities for parenteral solutions in the new 30,000m2 LIFT (Lean Infusion Factory Technology) plant at B. Braun Group's production centre located in Rubí (Barcelona), Spain, which features three production lines.
Telstar handled the project management under an EPC (Engineering, Procurement and Construction) arrangement, which enabled direct client involvement in the project's development, particularly in the selection of vendors for the critical phases of the project.
The firm developed the engineering phases, coordinated all involved vendors, built the pharmaceutical manufacturing and process facilities, supplied the equipment and performed start-up and validation.
The facilities were designed for a continuous production process, which required the installation of four 30,000-litre manufacturing tanks, and two additional 15,000-litre tanks, to feed three bottling lines with 24/7 production capacity.
Telstar carried out the design, installation, start-up and validation of manufacturing tanks with magnetic stirring and interior product recirculation, which ensure a uniform and aseptic production. For the tank loading system, a critical phase of the process, Telstar implemented a custom, bin-to-tank product transfer system, using 'Alpha/Beta‘-type high containment valves.
In addition to the tanks, Telstar installed the transfer lines from the reactors to the bottling equipment, featuring blow-fill-seal technology and terminal filter systems.
For the raw materials preparation stage, Telstar supplied the weighing booths and Special Airlock Systems (SAS) for materials pass-throughs and unloading into bins, as well as a specially configured bin washer.
The pharmaceutical manufacturing and process facilities operate automatically, including management of weighing, in-tank preparation management, traceability of bins in the LIFT manufacturing room, and interconnections to the new plant's other automated systems.
The Kinghorn Cancer Centre in Sydney, which will focus on clinical research for the prevention, diagnosis, and treatment of cancer, has officially opened.
The A$128 million (US$133 million) center is a joint venture between the Garvan Institute of Medical Research and St. Vincent's Hospital and is billed as Sydney's first major cancer research and treatment center. It brings together 250 researchers and clinicians from across St. Vincent's campus into one site "to find personalized solutions to each person's cancer by fundamentally understanding each individual's needs at the molecular level," the center said in a statement.
By using biomarkers, the researchers aim to provide doctors the ability to sub-stratify patients so that targeted therapies can match each patient's genetic profile and treatment efficacy can be improved.
"The Centre’s approach to personalized medicine places the patient at the centre of all decisions, maximizing the rapid translation of research findings to new approaches to cancer diagnosis, treatment, and prevention," Professor Rob Sutherland, director of The Kinghorn Cancer Centre, said. "This will spare individuals from side effects of treatment from which they won’t actually benefit, and more expeditiously get them the therapies that will be specifically effective for them and in the process save the health system money."
Work at Kinghorn will focus on breakthroughs in novel diagnostic, prognostic, and treatment options for several key national health priority cancers, such as breast, prostate, gastrointestinal, and non-Hodgkins lymphoma. The research will not necessarily be directed at high-throughput treatments, it said, but instead will seek to deliver targeted, cost-effective, personalized therapies that can be integrated into larger nationwide cancer treatment services.
Funding for the center comes from the federal government, which provided a A$70 million grant from the Health and Hospital Fund, and from major philanthropic support.
West Pharmaceutical India Packaging Private Ltd, an indirect subsidiary of West Pharmaceutical Services, Inc., Lionville, Pa., USA, hosted a ground breaking ceremony to mark the start of construction of its new compression molding facility located in Sri City, India. The plant will become part of West's global supply chain for its world-class, standard-setting pharmaceutical packaging components.
In June 2012, West signed a 99-year lease on 72,800 square meters (783,328 sq. ft.) of land in the Sri City Special Economic Zone (SEZ). Sri City offers all the advantages of an SEZ with a metropolitan location and was selected primarily on suitability because of land, availability of utilities, labor suitability, logistics, quality of life and SEZ special factors.
"We are experiencing a very exciting period of growth and business expansion in Asia and we are proud to begin construction of our first facility in India," said Donald E. Morel, Jr., West's Chairman and Chief Executive Officer. "The plant in India will help West meet market demand and establishes a West presence near our pharmaceutical customers in India."
"On behalf of West's Board of Directors, I would like to thank the many representatives of the Indian government for their support throughout the planning process. Our future facility in Sri City will provide much needed capacity to satisfy the needs of a dynamic, growing market in both India and the Asia Pacific region."
Construction of Phase 1 will begin in August 2012 on a metal seal assembly and compression molding facility that will produce metal and elastomeric pharmaceutical components used in primary packaging of injectable medicines manufactured by West's pharmaceutical and biopharmaceutical customers in India and the wider Asia Pacific region. The built-up area of Phase 1 will be 15,300 square meters (164,628 sq. ft.), with commercial production of metal components expected to begin in the first quarter of 2014. Production of a range of West's high-quality standard elastomeric components is expected to begin in the first quarter of 2015. The capability to produce ready-to-sterilize components will be available by 2016. The built-up area for the plant and office will eventually reach 37,700 square meters (405,652 sq. ft.) at the completion of Phase 3 in 2023.
"This investment is important to our strategy of partnering with customers in India and the Asia Pacific region to help them provide medicines to patients more efficiently, reliably and safely," said Warwick Bedwell, President, Pharmaceutical Packaging Systems, Asia Pacific Region. "When the facility is completed, we anticipate a reduction in lead times for supply to our customers in India. By leveraging our global sourcing activities and process engineering expertise, we will be able to carefully manage the overall costs of production."
West plans to file Drug Master Files for the plant with the United States Food and Drug Administration and Heath Canada's Bureau of Pharmaceutical Sciences.
WuXi PharmaTech announced that its toxicology facility in Suzhou had received a Certificate of Good Laboratory Practice (GLP) from the State Food and Drug Administration (SFDA) of the People's Republic of China after successfully passing two GLP inspections conducted by the SFDA. Good Laboratory Practice is a quality system concerned with the organizational processes and conditions under which health safety studies are planned, performed, monitored, recorded, archived, and reported. The receipt of this GLP certificate is an important acknowledgement by the SFDA about the capability of the Suzhou facility to carry out non-clinical laboratory studies with respect to the requirements of the Chinese Food and Drug Act and SFDA GLP Regulations.
Award of the certificate resulted from a four-day inspection conducted by a team of five inspectors from the SFDA in March 2012. In addition to an extensive facility assessment, the inspection included an audit of 16 studies in areas that included reproductive toxicology (Segment I and II), carcinogenicity, safety pharmacology, dermal irritation, skin phototoxicity, vascular irritation, and immunology. The facility inspection evaluated key operational sites, including the vivarium rooms, pharmacy, central archive, and laboratories relating to analytical chemistry, bioanalytical services, toxicokinetics, clinical pathology, histopathology, and immunology. This successful inspection now expands WuXi's capability to conduct all non-clinical laboratory studies regulated by SFDA. The facility successfully passed an earlier inspection and received a Certificate of Good Laboratory Practice in 2010.
In May 2012, WuXi announced that it had received a statement of Good Laboratory Practice from Belgium Scientific Institute of Public Health for the Suzhou toxicology facility.
"WuXi's receipt of this certificate is further acknowledgment that we offer our clients non-clinical laboratory studies that meet national and international GLP quality standards," said Edward Hu, Chief Operating Officer and Chief Financial Officer of WuXi PharmaTech. "This award is additional confirmation of WuXi capability in offering our pharmaceutical and biotech clients a comprehensive, fully integrated platform of pharmaceutical R&D services."
A new academy to strengthen the quality of diabetes research and investigate ways to prevent and treat the disease is being launched in Denmark on 1 September.
The Danish Diabetes Academy is being established following donations of more than DKK200m (€26.8m; US$33.2m) from the Novo Nordisk Foundation and DKK40m from the Juvenile Disease Research Foundation. Danish universities are providing more than DKK50m.
The Danish Diabetes Academy aims to create a world-class research and education environment with the best researchers from Denmark and abroad.
Dean Allan Flyvbjerg, Aarhus University’s representative on the board of the Diabetes Academy, said: ‘The academy is open to all diabetes researchers who would like to make use of its offers. The vision is that collaboration cutting across the faculties and national borders will create a synergy effect that strengthens research in Denmark and internationally.’
The academy also aims to ensure diabetes research in the future by offering a number of new research positions and events targeting talented young researchers, and providing them with the best possible opportunities for upskilling their qualifications and pursuing a career in this field.
Over the next five years, the venture will contribute to financing approximately 150 new research positions in the form of 90 PhD positions, 50 postdoctoral fellowships, a number of professorships and some short-term visiting researcher positions for scientists from abroad.
More than 300 researchers from universities and hospitals across the country will be affiliated to the Diabetes Academy.
‘The Danish Diabetes Academy will be a combined virtual unit that provides researchers with an optimal framework for taking up the fight against diabetes. The aim with the academy is to strengthen the growth layer of research, and ensure research of the highest international quality,’ said Ulf Johansson, chairman of Novo Nordisk Foundation.
Professor Henning Beck-Nielsen, Odense University Hospital, who will be director of the Academy, added: ‘Diabetes is a major threat to our health, and the Danish Diabetes Academy provides an opportunity to find new solutions in the fight against type 1 and type 2 diabetes. This will benefit both diabetes research and diabetic patients throughout Denmark.’
Bosch packaging Technology India opened its new manufacturing facility at Verna, Goa. The company invested about $6 million in the new plant to expand capacity and meet increasing demand. The new plant aims to increase localization of new packaging machine production and to make German technology available to the Indian market.
Mr. V K Viswanathan, managing director of Bosch Ltd. and president of Bosch Group in India, said, “Bosch sees India and the South Asia region as a high potential market for packaging technology particularly in the pharmaceuticals and foods segments. This state-of-the-art manufacturing facility in Goa will meet the growing needs of the region through appropriate products and packaging solutions. The new facility will also generate good growth and employment opportunities for the people of Goa.”
Bosch Packaging Technology India employs 130 associates and with the new facility, it is expected to increase to about 160 within the next three years. The current production capacity at the plant is 200 machines per year, which is expected to double in three years.
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