PHARMACEUTICAL & BIOTECHNOLOGY
INDUSTRY UPDATE
December 2010
McIlvaine Company
TABLE OF CONTENTS
ATEK Plastics Builds Cleanrooms
Silicon Biosystems Forms Subsidiary
McCarthy Breaks Ground at Fort Hood
Unilife Moves Operations to New Facility
Medical Center Announces Expansion
Merck Frosst's Kirkland Facility to Close
Halo Pharmaceuticals' Whippany Facility
Alliance Medical Products Expands
Novo Nordisk's Insulin Manufacturing Facility
Bayer Schering Pharmaceutical's New R&D Centre
DPT to Manufacture Sterile Ointment
Medicago to Build Plant in RTP
West to Close U.S. Plant and Downsize UK Site
UW-Madison Opens Public-Private Institute
Harvard's Wyss Institute Inaugurates New Labs
RiconPharma Acquires NJ Manufacturing Facility
Safety of Proposed U.S. Disease Lab
GSK Sells Facility to Dr. Reddy’s
PRA International Opens Bioanalytical Lab
Bayer Plans Biologics Expansion
Inno Biologics Manufacturing Contract
ProJect Pharmaceutics Opens Operations
PRA International Opens in Prague
Lotus to Sell Inner Mongolia Site
O2h Providing Services to Phytopharm
Sopharma to Invest in New Plant
Takeda & Baxter Set Up in Japan
GSK to Acquire Nanjing MeiRui Pharmaceuticals
West Announces Plan to Consolidate Certain Operations
Kemwell and Boehringer to Build in India
GlaxoSmithKline and Kemwell Facility in India
Vindon's State-of-the-Art Premises Open
Lubrizol Opens Indian Coating Applications Lab
GSK to Invest in UK with Tax Incentives
Beike Opens China Stem Cell Storage and Processing Site
New Building for Cardiff U's Institute of Medical Genetics
Almac Adds Late Stage Customization Suite
Aushon Partners with LightArray in China
Ortho Opens Manufacturing Facility in Wales
Brunel University has New Containment Suite
GSK and Binnopharm Plan Manufacturing
Richter-Helm BioLogics Plant Modernizes
Dr. Schleuniger Pharmatron Moves
Arrow Medical Expands Single-Use Device Facility
SGS Boosts Bioanalytical Capacity
Christie Cancer Centre Opens Unit
German Cancer Center Completes Renovation
Kemwell Begins Construction on New Non-Sterile Liquid Facility in Bangalore
INC Research has shifted its headquarters to new and larger offices as part of the firm’s wider plan to ramp up its clinical trials outsourcing operations in Research Triangle, US.
“This move better positions us to accommodate future growth of our clinical trials outsourcing services,” said INC Research CEO, James Ogle.
INC’s Corporate Learning Centre, which focuses on internal training and certification programs in project management and therapeutic clinical research, will be set up within the 120,000sq. ft. space between the firm’s new location at 3201 Beechleaf Court in Raleigh, US, and its existing office at 4800 Falls of Neuse Road.
The CRO’s Project Solutions Lab which provides simulation training for staff will also be housed at the new plot. INC said it has sealed a multi-year deal to occupy the area to accommodate current work being carried out and to allow future growth for the business.
Over the last year, the firm launched its Alliance Partnership division which is responsible for creating and managing clinical delivery collaborations with pharma and biotechnology customers.
With an eye to expanding clinical trial research operations across the globe and to strengthen its presence in emerging markets, INC expanded its global medical management team in September with the addition of three new medical directors in Buenos Aires in Argentina, China’s capital of Beijing and Gurgaon in India.
Furthermore, the company acquired MDS Pharma Services’ later-phase clinical trials business in 2009 in a $50m deal which covers the Phase II, III and IV clinical operations of MDS Pharma.
The acquisition was made as INC had planned to expand its footprint in international markets, including South America, Asia and Africa.
INC now employs over 2000 research staff and conducts clinical trials in more than 40 countries around the world.
ATEK Plastics recently constructed multiple portable Class 100,000 (OSO Class 8) cleanrooms around their existing presses at the Kerrville facility due to new medical growth. The cleanroom units will be used to make surgical components and stem cell therapy devices. More cleanroom units and additional presses are to be added in 2011.
ATEK Plastics started manufacturing medical device components in 2001 and today medical products manufactured at their facility amount to 89% of their business. Molded components manufactured at the facility are predominately for cardiac surgery, stem cell therapy and pre-surgical skin preparation.
Silicon Biosystems, S.p.A., a provider of specialized molecular and cell biology technology, has formed a U.S. subsidiary operation, Silicon Biosystems, Inc., to be headquartered in San Diego, CA. The newly formed business will focus on commercial operations and the development of the North American research and clinical diagnostics markets for the company’s DEPArray technology platform.
"The formation of our own commercial operation in the U.S. represents a significant step forward for our business," stated Giuseppe Giorgini, CEO of Silicon Biosystems, S.p.A. "Our DEPArray platform will allow clinicians and researchers working to advance personalized medicine in areas such as clinical oncology to identify new biomarkers and improve patient treatment based on genetic information they have previously not had access to.”
The company’s DEPArray technology exploits microelectronics and the principles of dielectrophoresis to isolate and manipulate cells in a suspension matrix. The approach, patented by Silicon Biosystems, offers the unique possibility of controlling individual cells and micro-particles inside a disposable cartridge. The DEPArray platform makes it possible to find, sort, select and separate individual cells for further analysis or culturing.
Silicon Biosystems, S.p.A. is based in Bologna, Italy and has developed a set of proprietary solutions called lab-on-a-chip technologies, targeted at miniaturized cell-biology testing.
McCarthy, in joint venture with Balfour Beatty Construction, joined with U.S. Army Corps of Engineers (USACE), Health Facilities Planning Agency (HFPA) and Medical Command (MEDCOM) to celebrate the official groundbreaking for the Carl R. Darnall Army Medical Center Replacement at Fort Hood, Texas. At $534 million, the Medical Center replacement is the largest project to date funded by the American Recovery and Reinvestment Act of 2009.
The Balfour Beatty/McCarthy team is providing design-build services for the 947,000-square-foot project, which will replace the existing 45-year old Carl R. Darnall Army Medical Center and provide a new, state-of-the-art healthcare facility for Service Members and their Families. The team also includes HKS Architects and Wingler & Sharp as design partners and Southland Industries / M.C. Dean for MEP services.
“This is among the first design-build healthcare projects of this magnitude to be awarded by USACE,” said Michael J. McWay, president of McCarthy’s Texas Division and chairman of the Balfour Beatty | McCarthy Management Committee.
“From the start, our goal was to have a fully integrated team approach on this project. We selected our team members based on their healthcare expertise as well as their experience working with us on similar projects. We brought that expertise, team approach and lessons learned to benefit this project. Over the last few months, through partnering, project kick-off sessions and design charrettes, we further solidified the integrated team approach with USACE, HFPA and MEDCOM, and created a strong foundation that will help us ensure the new Medical Center is a world-class facility,” said Billy Bryan, Director of Operations for Balfour Beatty Construction.
The new medical center is being designed to meet USGBC LEED Gold certification requirements. Key sustainable measures include more than 30% reduction in energy use over ASHRAE Standard 90.1, utility use reduction of 55% over the existing hospital, 50% water reduction for irrigation use and 30% decrease in water usage for plumbing systems. In addition, the new facility will utilize a 100% dedicated outside air system, which will improve overall indoor air quality and eliminate recirculation of air within patient care areas.
The formal notice to proceed was authorized on November 8, 2010, and construction is scheduled to complete in May 2014.
Unilife Corporation announced that it has initiated the relocation of its operations into its new, 165,000 square foot state-of-the art manufacturing facility and global headquarters in York, PA.
All essential production equipment, including the automated assembly and packaging systems used to manufacture the Unitract® range of 1mL syringes, has now been transferred from Unilife's original Lewisberry site into designated cleanrooms at the York facility.
Unilife expects to have all of its 170 employees working out of the new facility by December 20th.
The $31 million facility, which has been designed by leading U.S. architects to meet the most stringent international pharmaceutical standards for primary drug containers, has been completed fully on schedule and largely on budget by Unilife in conjunction with its construction partners.
Mr. Alan Shortall, Chief Executive Officer of Unilife, stated, "The combination of this state-of-the-art facility, our best-in-class products and the advanced production systems used to manufacture them are together helping us set a new industry benchmark for safety syringes. We are very proud to be delivering upon our key business milestones with the completion of our York facility just one year after we first commenced the clearing of the site. We look forward to continuing this strong track record of success with the commercial production of our Unifill ready-to-fill syringes and their supply to pharmaceutical customers during the first half of 2011."
Unilife's York facility has been designed to manufacture up to 400 million of Unilife's syringes a year. A second stage of the facility is already pre-approved that would add another 100,000 square feet of production space, and take the total production capacity of the site to around one billion units per year subject to commercial demand.
Production of the Unitract 1mL syringes will recommence in February 2011 following the recertification of the automated assembly line, as required by regulatory agencies. The automated assembly system for the Unifill ready-to-fill syringe is expected to be transferred into the York facility during the first quarter of 2011 when Factory Acceptance Tests at the Denver, Colorado facilities of the Mikron Group are completed. Commercial supply of the Unifill syringe to pharmaceutical customers is expected to occur during the second quarter of 2011.
Some of the amenities at the new Unilife facility in York, PA include:
• Eight Class 8 (100,000) and three Class 7 (10,000) clean rooms where environmental factors such as temperature, humidity, microbial and particulate matter are tightly controlled;
• An advanced Water-for-Injection (WFI) system that will meet established pharmaceutical standards of water purity required for the production of the Unifill ready-to-fill syringe;
• A microbiology lab;
• A product development center;
• Quality physical and analytical inspection labs;
• A 20,000 square foot temperature controlled warehouse for efficient inventory management;
• A 54,000 square foot office wing to serve the Company's global headquarters and support management functions.
Clear Lake Regional Medical Center, an HCA-affiliated hospital in Houston, announced that the 40-year-old facility will begin a nearly $92 million expansion and renovation project, including a new 154,470-square-foot patient tower.
Groundbreaking for the expansion is scheduled for next summer with a projected completion date of summer 2013. The new tower will feature large pre-operating rooms for patients and their families, operating suites and recovery rooms. The tower also will house a new 30-bed adult Intensive Care Unit. Plans will allow for an additional three floors to accommodate growth.
The project also includes renovations to other areas of the facility, which will result in 79,000 square feet of remodeled space, including the women’s and children’s services departments.
Since 2007 the medical center has invested $164 million in projects to expand and renovate its facility, including a $55 million heart and vascular hospital.
Kansas, like the rest of the United States, has felt the effects of the economic recession. But thanks in part to the state’s diversified economy, they are emerging from the recession stronger than ever. While many states rely on one or two major industries for economic growth, Kansas is investing in several promising sectors of our economy, including the biosciences.
A recent study, prepared by the Battelle Technology Partnership Practice for Biotechnology Industry Organization, says, “the biosciences are already shaping up to be a key engine of economic growth in the United States.”
Kansas has been involved in building bioscience infrastructure. Working through the Kansas Bioscience Authority, the state has invested millions of dollars in efforts such as the Animal Health Corridor (from Manhattan to Columbia), the National Bio and Agro-Defense Facility in Manhattan and artificial joint composite research at Wichita State University. These projects are moving forward in bioscience research, development, commercialization, education and workforce preparation.
Another promising project has been the University of Kansas Cancer Center’s quest for National Cancer Institute designation. The designation is considered the gold standard in cancer research and is given to institutions doing the most significant research.
National Cancer Institute designation is much more than a plaque to hang on the wall. The economic and health-related benefits are potentially enormous. They include nearly 10,000 new, permanent jobs and $1.3 billion in annual benefits through construction, licensing revenues and cancer mortality reductions.
In addition, millions of dollars in anticipated increases in federal research grants to the Cancer Center means the highest level of cancer care in the country — right in Kansas. Patients from Kansas and the Midwest can participate in early clinical trials, testing new treatments, close to home.
Much of the funding needed to attract researchers, construct buildings and equip them with the latest technologies for National Cancer Institute designation comes from the National Institutes of Health, and Kansas leads the pack.
Kansas is the number one state in the nation in terms of increased funding from the institutes, jumping 37 percent from 2004 to 2009, at a time when overall federal funding from the institutes declined by 4.7 percent. This is significant momentum.
And while NIH funding has been critical to this effort, the quest for National Cancer Institute designation is a public-private partnership that rivals anything the state has seen.
The University of Kansas, state government, the Johnson County Education and Research Triangle initiative, the Stowers Institute for Medical Research and the Kansas Masonic Foundation has committed tens of millions of dollars toward the effort.
In addition to the KU Cancer Center, the state proudly boasts one of the best schools of pharmacy in the country, at the University of Kansas. Its recent expansion will nearly double the annual number of graduates and further boost our state’s potential to develop life-saving cancer drugs.
Biotechnology company Genzyme Corp. said it completed the $925 million sale of its genetic testing business to Laboratory Corp. of America Holdings. Genzyme announced the sale in September.
LabCorp, based in Burlington, N.C., provides a range of clinical laboratory services, which the addition of the genetic testing unit will enhance. Genzyme’s genetic testing unit had $371 million in revenue in 2009.
The deal includes the sale of testing services, technology, intellectual property rights, and the rights to continue operations at the unit’s nine genetic testing laboratories.
Genzyme Genetics has 1,900 employees. All of its 500 Massachusetts employees are in Westboro.
The sale is part of Genzyme’s broader strategy to shed nonessential units and focus on its core products, which are biotech-based treatments for genetic conditions. Other deals include the $265 million sale of its diagnostic products unit to Sekisui Chemical Co. The Cambridge, Mass., company also plans to divest its pharmaceuticals unit.
Emergent BioSolutions launched a new biotechnology manufacturing facility in 2010. Formerly known as the MdBio Bio Processing Centre, the facility is located in Baltimore, Maryland and was acquired from MdBio Foundation in November 2009 for $8.2m.
It was constructed in 1996 and has operated under several ownerships. Until 2000, the facility was owned by Bio Science Contract Production (BSCP) Corp, a New York-based contract manufacturing organization.
In 2000, the facility was acquired by generics manufacturer Cambrex that operated the facility until Lonza bought it in 2007. Lonza operated the facility briefly until Mdbio took it over following Lonza's decision to prune its capacity.
The facility will begin production by early 2012. During this course of time, Emergent BioSolutions plans to renovate and re-outfit the plant at an approximate cost of $30m.
Approximately $15m is expected to be spent on the renovation by the end of 2010.
The renovation will enable Emergent BioSolutions to expand beyond the bio-defense sector.
It will also allow the company to pursue more government work besides penetrating deeper into the commercial sector.
The new facility will create up to 125 jobs within a span of three to five years.
The new facility includes 56,000 sq.ft. of manufacturing and administration space. Nearly 11,000 sq. ft. of space has been dedicated towards manufacturing activities. There are five separate manufacturing suites that have been designed specifically to support clinical and commercial production of Emergent BioSolution's product pipeline which includes rPA, anthrax monoclonal and tuberculosis drugs.
Skanska was awarded the construction management contract that will create a U.S. Center of Excellence for Johnson & Johnson at its Spring House, Pennsylvania campus. The project is being constructed for J&J's Pharmaceutical Research and Development (PRD) division.
Phase I of this project includes a new 150,000-square-foot Research Center (RC1) Lab and 80,000 square feet of renovated space in their existing research building (ERB).
Market segment - Life Sciences
Contract value – US$128.0 million
Start - 2007
Completion - 2010
City - Spring House
Merck Frosst's Kirkland facility is the oldest and the largest biomedical research facility in Canada. Established in 1969, the facility is located 60km east of Montreal in Kirkland and is known as the Merck Frosst Centre for Therapeutic Research.
The facility has produced some of the company's blockbuster drugs including Singulair and is currently hosting the Canadian head office for Merck.
In July 2010, Merck announced its plans of closing the research facility by the end of 2010. The closure will represent the latest phase of Merck's global merger restructuring program that aims at consolidating its global operations and research activities.
Following Merck's merger with Schering-Plough in 2009, the company decided to focus on fewer, larger discovery sites.
The Kirkland research centre is one of the eight manufacturing facilities and research sites that will be closed.
The closure will affect 180 researchers. A few among them will be relocated to other US-based research facilities of Merck. The company plans to maintain a strong presence in Canada despite the closure. It has planned a C$100m investment over the next five years for R&D collaborations with companies and academic institutions based in Quebec.
"The closure will represent the latest phase of Merck's global restructuring program."
The Kirkland site accommodates a state-of-the-art research centre and administrative offices. Spread over 35-acres, the site has been designed to support every aspect in the process of pharmaceutical product development, from discovery to production.
The research facility is housed in two separate buildings, spread over three floors.
There are specialized laboratories dedicated for medicinal and process chemistry, analytical and bio-analytical chemistry, molecular biology, robotics, NMR (300 and 500 MHz), mass spectroscopy, tissue culture, cold rooms, hydrogenation, radio isotopic-labeling and iodination, and pharmacology and pharmaceutical R&D. The research centre also includes a cafeteria and a daycare centre.
The entire first floor of the building is dedicated to pre-clinical pharmacology and pharmacology laboratories. The second floor houses 15 typical laboratories. There are six biochemistry laboratories, five molecular biology laboratories, three laboratories for organic chemistry and one for analytical chemistry.
The floor also includes a range of other laboratories for support activities.
The research centre has focused on discovering new and better therapeutic agents for the treatment of respiratory, inflammatory and other diseases. A major focus of the facility has been on leukotrienes and prostaglandins research.
"The Kirkland facility was expanded to form the Merck Frosst Centre for Therapeutic Research."Leukotrienes and prostaglandins are chemicals naturally produced within the human body that are basic in the mechanism of several diseases including asthma, psoriasis, inflammatory disorders and gastrointestinal conditions.
Between 1979 and 1993, the centre defined the structure and metabolism of leukotrienes and developed potential new drug therapies from these biological mediators to treat asthma and other respiratory diseases.
Research on leukotrienes within the facility resulted in the development of Singulair, an oral medication for asthma, which can be taken by adults and children to control the symptoms of asthma.
The Kirkland facility was expanded in 1991 to form the Merck Frosst Centre for Therapeutic Research. Construction of the new building involved approximately 218t of metal, 70 miles of pipe, 91 miles of wiring, and 17 acres of floors, ceilings and walls.
The expansion saw the addition of 31,000ft² of chemistry, biology and pharmacology laboratories to the existing research facility. A new 35,000ft² building was constructed to accommodate the quality control laboratories, instrumentation and chemistry laboratories, and the chemical storage area of the manufacturing facility.
An existing 5,000ft² facility was renovated and a 5,000ft² extension to the packaging facilities was also undertaken. The expansion also included construction of a 7,500ft² organic chemistry laboratory and modernization of a 9,000ft² building.
The facility's construction management services were provided by Aecon. The building was designed by La Socidte d'Experts-Conseils Pellemon and Les Architectes Stahl Nicolaidis Fukushima Orton.
Halo Pharmaceuticals' Whippany facility is a cGMP compliant pharmaceutical manufacturing and packaging plant. The facility was established in 1972 and was acquired by Halo Pharmaceuticals in early 2009 from Abott Laboratories.
The plant was originally owned by Knoll Pharmaceutical which sold it off to Abott Laboratories in 2001. Over the years, the facility has undergone multiple expansions and modifications and has been equipped with new capabilities in order to bring it in line with cGMP standards.
The facility is FDA and DEA (Drug Enforcement Administration) approved and operates with 80 members of staff.
The facility occupies 167,000ft² and accommodates a Kilo lab for API synthesis, microbiologic labs for testing and analytical method development, and chemistry laboratories. It also has two primary dispensing suites equipped with safety screening systems and dust control booths for product containment.
Additional solid dosage form manufacturing equipment at the facility includes Lodige 125l and 600l high sheer mixers and a Glatt 760l fluid bed granulator and dryer for wet granulation.
Sterile ointment is manufactured in a sterile Class 100 filling suite that provides through-the-wall sterile filtration to 0.2 microns. IWKA tube fillers of between 5gm and 45gm capacities are used. The suite is additionally equipped with ophthalmic capabilities and has an aseptic transfer vessel. The facility is also installed with Cherry Burrell equipment for liquid compounding and Sarong suppository manufacturing machines.
Primary packaging is carried out within enclosed suites that are separated from the secondary packaging operations by air pressure differential. Primary and secondary packaging equipment within the facility includes three king / slat fillers, a Klockner blister packaging line and National Instrument automatic vial fillers. The packaging lines are installed with bar code readers, vision systems with optical character recognition capabilities and weight-checkers to ensure compliance.
The facility undertakes a range of pharmaceutical development activities including manufacturing of clinical trial materials, conducting manufacturing scale up and registration batch manufacturing.
"The Whippany facility develops, produces and finishes multiple dosage forms."It also offers technology transfer and validation in preparation for commercial manufacturing.
The facility develops, produces and finishes multiple dosage forms including compressed tablets, micro tablets, aqueous film coated tablets, capsules, sustained release beads, powders, liquids, ointments for both biologics and small molecules and suppositories. It is fully licensed to manufacture controlled substances.
It also manufactures key intermediates and high-value active ingredients in small volumes.
The facility additionally undertakes packaging of solid, semi-solid and liquid non-sterile and sterile dosage forms into a range of final packages including plastic and glass bottles, tubes and blister packs with PVC, PVDC, Aclar and other flexible materials.
Technologies and processes available at the facility include dry blending, direct compression of tablets, high shear granulation, fluid bed drying, tablet film coating and tablet compression, wurster column based beads and bead coating, encapsulation and controlled substances handling.
The facility operates at a production capacity of 3bn units of solid dosage forms, 500,000l of liquid dosage forms, 5m units of suppository, 200,000kg of ointment and 1,500kg of bulk powder per annum.
Alliance Medical Products (AMP) operates a state-of-the art cGMP facility in Irvine, California, U.S.
The facility offers contract manufacturing and analytical services to the pharmaceutical and biotechnology industries. It is designed and equipped to support initial stage small batch clinical manufacturing through to commercially marketed products.
The facility was installed with a high volume vial filling line in September 2010. The new line is expected to further expand AMP's capabilities to provide a comprehensive range of developmental, clinical and commercial contract manufacturing services to large and small pharmaceutical and biotechnology customers.
The facility is spread over 53,000ft² and houses Class 100, 1,000, 10,000 and 100,000 clean suites. The configurable aseptic filling suites are installed with five automated filling lines for commercial products and three semi-automated filling lines for clinical manufacturing.
The automated filling lines can operate at a batch capacity of up to 1600l. Filling lines include a Cozzoli inline filler, a Capmatic monoblock dropper filler, a Capmatic 8 head moving beam filler, a Bosch monoblock cartridge filler and an IMA tube filler. The IMA tube filler received commercial approval in October 2010.
"The new line is expected to further expand Alliance's capabilities."
The new vial filling line is a high volume eight head Conquest line with a production capacity of 150,000 vials per batch. The line is equipped with an inline vial washer, depyrogenation tunnel and 12 automatic spindle inline cappers.
Designed to support nitrogen purge or blanket, the new line can fill vials ranging in size between 2ml and 150ml.
The semi-automated Class 100 vertical flow filling suites are designed to provide efficient materials and people flow. They are equipped with stainless steel and disposable container mixing options and sterile filtration.
The facility also accommodates an automated carton and bundling area, automated labeling area, customer work area, three autoclave sterilizers, SCADA integrated formulation rooms and on-site chemical and microbiological laboratories. There are 16 stability chambers that run on power back up. All the stability chambers are equipped with Stability Trac tracking systems and operate on ICH guidelines, and custom temperatures and humidity.
The facility is additionally equipped with water for injection (WFI), vial and bottle depyrogenation, and automated vial and bottle washing capabilities.
The facility specializes in manufacturing difficult-to-produce formulations. It does aseptic filling of solutions, suspensions, emulsions, sterile ointments and gels. It also undertakes powder filling of solid dosage forms. The facility is equipped to develop combination drug delivery products including drug coated implants, drug delivery devices and sustained release delivery systems.
Laboratory services provided by the facility include analytical testing, microbiological testing, USP / EP / BP / JP compliant testing, method qualification / validation and stability study programs meeting all ICH guidelines. Additional services include final formulation, process development, process scale up, clinical trial production, CMC documentation services, sterilization development and validation, and Phase IV marketing trial repackaging.
The plant can operate at batch sizes ranging up to 150,000 units per shift. The Cozzoli inline filler operates at a capacity of between 5,000 and 30,000 vials per shift. The Capmatic eight head moving beam filler fills between 10,000 and 150,000 vials per shift.
The operating capacity of the Capmatic monoblock Filler ranges between 5,000 and 30,000 vials or dropper bottles per shift. The Bosch monoblock cartridge filler is designed to fill between 5,000 and 30,000 cartridges per shift.
Operating at a similar capacity, the IMA tube filler fills between 5,000 and 30,000 gel or ointment tubes per shift.
The facility can fill a broad range of container closures, including 2ml to 100ml vials, 5ml to 500ml screw cap bottles, 3ml to 30ml dropper tip bottles, 1gm to 50gm squeeze tubes, 0.5ml to 10ml cartridges and 50ml to 250ml bags.
The semi-automated filling lines operate at batch sizes up to 5,000 units per shift. Fill volumes range from 0.5ml to 500ml.
Novo Nordisk's insulin manufacturing facility in North Carolina is located south-east of Raleigh near the town of Clayton, nearly 35 miles west of Research Triangle. The facility undertakes formulation, aseptic filling, packaging and distribution of insulin products. It is the only insulin manufacturing facility of the company in the US and the second in North Carolina. The FDA approved facility operates 24/7 with 420 full-time employees.
Opened in 1996, the facility has been expanded over the years to add new capabilities. A $12m expansion in 2004 and a $100m two-phase expansion in 2007 increased the facility's size by 19,000ft² and 181,000ft² besides doubling its insulin filling capabilities. In 2007, the facility began the first domestic production of FlexPen.
A $73m expansion of the facility was announced in October 2010. The expansion will add two new final assembly lines and two new packing lines, and refurbish the building. Scheduled for completion in 2012, the expansion will increase the production capacity for insulin delivery devices (delivered as autodosers) and provide better treatment options for diabetes in the US. It will create 85 new jobs at the facility.
Novo Nordisk is partnering with plastic manufacturer Nypro for the supply of parts for the new insulin delivery device that is awaiting FDA approval. In order to meet the demand, Nypro is also expanding its facility in Buncombe County outside of Asheville by 75,000ft². Novo Nordisk and Nypro are together investing $161m towards the expansion, including $88m for Nypro's plant.
The Clayton site spans 264 acres, and includes offices and laboratory space for raw material quality assurance, in-process testing and finished products in addition to the manufacturing facility.
The manufacturing facility at the Clayton site occupies 328,500ft². The latest expansion will add approximately 21,000ft² to the facility.
The Clayton facility develops six different products for the treatment of diabetes, including Levemir Flexpen, a new disposable, prefilled insulin pen used to dispense insulin detemir from rDNA origin. The facility also undertakes packaging and distribution of diabetic treatment products.
As diabetic patients in the US are shifting from the conventional vial and syringe method to a pen dosage device for administering insulin, the demand for FlexPen has been growing rapidly.
Aseptic manufacturing and bioprocessing is the two core technologies used at the facility. The facility uses recombinant DNA technology to produce insulin. The insulin production process begins with product formulation wherein human insulin crystals are mixed with chemical stabilizers and highly purified water.
The resultant product is filled into glass vials and cartridges under aseptic conditions. Following inspection, the products are packaged for distribution.
The expansion will be funded through incentives. Novo Nordisk has received state incentives amounting to $2.3m for the expansion. The expansion project has also been approved to receive incentive support amounting to $400,000 from the state's One North Carolina Fund and an incentive package from Job Development Investment Grant (JDIG).
Novo Nordisk will be entitled to receive a rebate of 65% of the state withholding taxes on new hires. The company will get up to $840,000 from JDIG if it meets its target for new jobs and retains them for 10 years.
The company will also get $300,000 for infrastructure improvement from the state Department of Transportation grant. The facility will receive an additional incentive package of $3.3m from Johnston County upon approval by the county commissioners.
The Clayton site was chosen for expansion due to the amount of financial support through local and state resources. In addition, Nypro has been awarded a grant worth $200,000 for its contribution towards the expansion.
Bayer Schering Pharma announced its plans to open a new R&D facility in San Francisco, California in May 2010.
The new facility will be located within 455 Mission Bay Blvd, the third building of Alexandria's Center for Science and Technology which is a 13-building life science complex near the University of California's Mission Bay campus.
Bayer considers the new R&D centre as its US innovation centre. The facility will serve as the science hub of the company and allows it to expand its global research network.
The facility is currently in the build out stage and is pursuing LEED Silver Certification.
Scheduled to begin operations by the end of 2010, the facility will operate with 65 scientists who will be shifted from Bayer's Richmond site. The Richmond site will be subsequently closed.
The building was originally to be occupied by Pfizer's Bio-therapeutics and Bio-innovation Center. In July 2009, however, Pfizer opted out after it restructured its entire facility network following its $68bn merger with Wyeth.
Bayer will occupy only half of the 200,000ft² space that Pfizer had agreed to lease. The remaining half will be leased to Nektar Therapeutics, a biotechnology company that will relocate from San Carlos, Sonora, Mexico.
The Mission Bay location will allow Bayer to operate in the heart of an expanding biomedical research community.
The existing biotech cluster within the area includes companies such as Merck, Celgene, and FibroGen and a number of other smaller biotech firms.
Being in Mission Bay will also benefit Bayer in obtaining an enterprise zone designation that would result in tax credits for a few employees for a period of five years.
In addition, Bayer will be entitled to be exempt from San Francisco's 1.5% payroll tax for approximately seven years.
The new centre will occupy 49,000ft² of space within a new 210,000ft² complex that accommodates two five-storey buildings. Each building includes 105,000ft² of space and has a robust building shell design.
Bayer's new centre will occupy the third and fourth floors besides a part of the ground floor. It will accommodate laboratories that can be customized into highly functional wet and dry lab areas. It will also have space for administrative activities. The second floor will be occupied by Nektar Therapeutics which had subleased 102,000ft² of space from Pfizer.
The buildings have been constructed of structural steel and feature a fully unitized skin system. Additional features within the building include generous slab-to-slab heights, 100lb live-load floor rating, robust mechanical, electrical and plumbing design, and an emergency generator for critical operations.
The state-of-the-art R&D centre will be used to conduct research in the fields of oncology, women's healthcare, cardiology and diagnostic imaging. Haematology research programs with an emphasis on coagulation factors and discovery of new biologic drug candidates will also be carried out.
New product development and marketing of new therapies will be carried out at the centre in collaboration with academic research institutes and small biotechnology companies within the Mission Bay campus.
Scientists will move around the campus to partner with a number of innovative thinking life science companies centered within the campus. Partnerships and collaborations will be established in areas ranging from research benches to clinics.
The facility has been developed by Alexandria Real Estate Equities. The labs have been designed by Alexandria in partnership with Bayer Schering Pharmaceutical and Flad architects. Alexandria Real Estate Equities had obtained permits amounting to $10m for tenant enhancements in the building.
The contract for the construction of laboratories was awarded to San Mateo-based BN Builders.
The interior architect for the building is Flad Architects based in Madison, Wisconsin.
France-based Texcell has partnered with Cell Trends, a Maryland-based contract research organization (CRO), to increase its presence in North America.
“The partnership with Cell Trends provides a strong opportunity to develop new business relationships with biotech and pharmaceutical companies on both sides of the Atlantic Ocean", said Bernard Plichon, President and CEO of Texcell.
Housing cGMP labs in the same Pennsylvania, US facility as its vaccine and biologics centre is allowing PPD to offer more integrated services.
The first two projects at the Wayne, Pennsylvania facility were on vaccines, said Magdalena Mejillano, vice president of cGMP (current good manufacturing practice) lab services at PPD.
Consequently, although the site was established to work on a range of therapeutics, PPD benefited immediately from co-locating the laboratory and vaccine centre of excellence.
PPD is also hoping to expand its formulation development and clinical trial material production collaboration with Bend Research. Particle size engineering technology at Bend could benefit inhalation clients, said Mejillano, and consequently PPD is hoping to expand this area of the deal.
PRA International opens state-of-the-art bioanalytical laboratory in Lenexa, Kansas. The laboratory will enhance PRA’s early phase study capabilities in the United States, expand bioanalytical laboratory breadth worldwide and bolster the region’s biosciences community, creating numerous high tech jobs.
PRA’s new North American Bioanalytical Laboratory will deliver quality analysis for local, national and international clinical trials. It will also offer a highly experienced staff possessing the scientific, regulatory, project management and communication skills to support the most complex and demanding studies
PRA International says its new bioanalytical services laboratory in Lenexa, Kansas offers clinical customers streamlined services.
He went on to explain that the unit will increase access to drug industry customers across the US and beyond and it will also provide support for PRA's existing bioanalytical lab in the Netherlands.
The addition of a new bioanalytical lab is something of a departure for the contract research organizations (CRO) expansion program this year.
In April, PRA strengthened its presence in Asia-Pacific with a point of contact in New Zealand and, in February, the firm partnered with Oncopartners and IBPC to boost access to patients in Latin America.
Norwich Pharmaceuticals is expanding its services to now include small scale feasibility and initial product development for prescription and over-the-counter pharmaceuticals. The non-GMP development facility will offer Norwich customers greater flexibility and speed when assessing the feasibility of technical concepts and formulations, and create streamlined progression from clinical into scale-up and through commercial manufacturing.
DPT Laboratories, Ltd., a pharmaceutical contract development and manufacturing organization, announced that it received FDA approval to manufacture commercial supplies of a leading sterile ointment for wound care at its Center of Excellence for Sterile & Specialty Products in Lakewood, NJ. Beginning this month, Healthpoint will ship commercial lots of Collagenase SANTYL® Ointment produced at DPT's Lakewood facility to its North American customers.
"DPT and Healthpoint have had a long and mutually beneficial relationship over the years, with DPT having been our preferred manufacturing partner on a variety of products. The recent FDA approval of DPT's Lakewood facility to produce Collagenase SANTYL® Ointment allows Healthpoint to immediately double its production capacity, thereby helping assure continuous, uninterrupted supply for this important therapeutic agent." Building on its reputation as the industry leader for semi-solids and liquids, DPT's Sterile & Specialty Products center focuses on aseptic production of sterile dosage forms to include small-volume parenterals, ophthalmic preparations, preservative-free nasal sprays and sterile ointments.
The SANTYL® approval is the third commercial approval for the Lakewood facility since launching its full-scale sterile operation in early 2010. The first approval was for a new sterile product that is launching in North America and Europe; the second approval was for manufacturing an existing product used for ophthalmic therapy. The company will begin manufacturing small-volume parenterals and additional ophthalmic preparations in early 2011 and expects to successfully complete several site transfers and new product launches over the next 24 months.
Medicago is to build a 90,000 sq. ft. cGMP vaccine facility in RTP, North Carolina, US using a $21m (€16.1m) grant from the US Department of Defense.
Operation of the current good manufacturing practice (cGMP) facility will allow Medicago to scale up and automate production of its virus-like particle (VLP) vaccines. When fully operational the facility will produce 10m doses of influenza vaccine a day, with potential for future expansions.
This capacity could be used in the event of a pandemic. During the H1N1 outbreak Medicago demonstrated its plant-based VLP technology can develop a vaccine candidate in under a month, making it a potentially useful tool in a pandemic.
Recognizing this potential, the US Department of Defense is partly funding the project. "It is vitally important to our Homeland Security that we have a robust domestic vaccine supply”, said David Price, a North Carolina Congressman.
In addition to helping the US mitigate future threats, the facility will “ultimately bring hundreds of good paying jobs to the region” and be “another significant contribution to local recovery efforts”, said Price.
For Medicago, the facility will help validate its VLP technology and strengthen its position in the market for pandemic and seasonal vaccines. Operating a US plant will also increase the number of grants and funding opportunities that are open to Medicago.
The project is due to cost $42m. This is made up of a $21m grant from the Defense Advanced Research Projects Agency (DARPA), $7.5m from Medicago and $13.5m from Alexandria Real Estate Equities.
West Pharmaceutical Services will close a plant in Pennsylvania, US and sell part of a factory Cornwall in the UK to reorganize production operations ahead of impending contract expires.
The firm said the move, which will cost 320 jobs across the sites and up to $21m (€16m) in charges, will reduce manufacturing capacity devoted to product lines that no longer support sustainable, competitive operations.
The company will close its manufacturing facility in Montgomery, Pa., which has been focusing on molded plastic components for consumer products. The company will also downsize operations at its facility in St. Austell, Cornwall, U.K., which makes components for disposable medical devices, as well as elastomeric and plastic components used in pharmaceutical packaging.
Company vice president Mike Anderson said that: “The current volume of business is not sufficient to cover the costs of maintaining operations at the Montgomery facility.
“Efforts to replace lost business have been unsuccessful during this period of soft economic activity and reduced investment in new products from our customers.”
He went on to explain that a number of factors were involved, citing competitive market conditions as a key.
“The availability of lower-priced products from other regions, including lower-cost sources of supply for customers, and lower- priced competition for their products, is certainly a factor that has impacted the industry at large and West specifically.”
Anderson also discussed West’s plans for its St Austell facility, explaining that the move was in preparation for the expiry of a $10m-a year contract for the production of non-filled single-use syringes that is due to end in 2012.
He added that the UK plant, which will continue to make inhalation device components, is the subject of an “asset purchase and long-term supply agreement with [German contractor] Poschmann Union.”
Under the new supply agreement Poschmann will manufacture injection molded plastic components for West’s internal needs, retaining 46 of the facility’s 200-strong workforce.
West expects the move to have a minor impact on its financials for 2010, predicting that earnings will be at the “lower end of the previously announced range of between $2.13 and $2.20 per share.”
The company said it will cut 170 jobs with the closure of the Pennsylvania facility, beginning in January and continuing into the third quarter. It will eliminate 150 jobs in the U.K. Restructuring costs will range from $18 million to $21 million, but the move will reduce annual operating costs by $12 million, the company said.
Two new institutes aimed at bringing together public and private research efforts in epigenetics, personalized medicine, systems biology, and other areas opened on the campus of the University of Wisconsin-Madison.
The 300,000-square-foot Wisconsin Institutes for Discovery building in Madison houses the UW-Madison Wisconsin Institute for Discovery and the private Morgridge Institute for Research.
The costs of the project, which totaled $150 million and included $60 million for laboratories, equipment and support, was funded by UW-Madison, the State of Wisconsin, private donors John and Tashia Morgridge, and the Wisconsin Alumni Research Foundation.
Researchers at the Wisconsin Institute for Discovery will engage in studies focused on epigenetics, personalized diagnostic and therapeutic technologies, systems biology research, and tissue engineering studies, among others.
The Morgridge Institute for Research will serve as home for studies of virology, development of new medical devices, pharmaceutical informatics, and regenerative biology.
Support services for both institutes, which could employ up to 350 people, will include core computational technologies and education research efforts focused on helping the public learn more about science and biomedical and health management concepts.
"The institutes were created to make the UW-Madison even more competitive than it is," WARF's Managing Director Carl Gulbrandsen said in a statement. "Putting a private research institute next to a public research institute allows the public side to leverage the flexibility and nimbleness of the private side and the private side to take advantage of the impressive infrastructure and human capital available at UW-Madison."
Vindonwestech, a member of the Vindon Healthcare group, opened their brand-new pharmaceutical and biological stability storage facilities in Kennesaw GA, on Veteran's Day, 11 November 2010. The mayor of Kennesaw, Mark Mathews, performed the official opening ceremony, which was attended by invited guests from the pharmaceutical and biopharm industries as well as local dignitaries.
Vindonwestech currently provides environmentally controlled storage products and services to companies in the pharmaceutical, biological, cosmetic and heritage industries throughout the US. This move will dramatically improve the company's storage capabilities.
Patrick Jackson, business development director, said of the new facility: "Vindonwestech is looking to the future. Our new storage suite offers biological storage down to -80°C and ICH and unique stability storage conditions. We're grateful for support we've received in the US along the way. We're keen to progress and we're now well placed for even more growth."
Harvard University's Wyss Institute for Biologically Inspired Engineering has officially inaugurated a combined 60,000 square feet of office and laboratory space — the entire fifth floor of the Center for Life Science Boston building on Harvard's Longwood campus; and the fourth floor of 60 Oxford St. in Cambridge, Mass.
Wyss has nearly 200 researchers and support staffers engaged in projects led by 16 core faculty members and a group of associated faculty drawn from several Harvard schools and affiliated institutions, including Harvard Medical School, the Faculty of Arts and Sciences, the School of Engineering and Applied Sciences, and several affiliated hospitals.
The Wyss Institute focuses on technology development and translation in research disciplines ranging from medicine to bioenergy. The Institute was launched in January 2009 with a $125 million gift from Swiss engineer and businessman Hansjörg Wyss, representing the largest single philanthropic gift in the history of Harvard University.
RiconPharma has acquired a cGMP pharmaceutical manufacturing company in Fairfield, NJ to be called Mirror Pharmaceuticals LLC. The 32,000 sq. ft. facility manufactures solid oral products and is currently manufacturing magnesium oxide tablets, sodium bi-carbonate tablets, sodium chloride tablets, and percogesic tablets (private label).
This acquisition adds seven approved ANDAs and two more pending ANDAs. RiconPharma will manage Mirror, which will file several ANDAs that are being developed by RiconPharma.
The facility is DEA-Licensed to manufacture schedule II-V drug products and features the following capabilities: wet granulation and drying capabilities, dry granulation, direct compression, different size blenders, Fitz mills, tableting machines, coating machine (to be installed and qualified), encapsulation machines, packaging lines, and QC/Analytical Labs.
The newly opened Souderton, PA facility of Almac will boast state-of-the-art analytical labs, complementing existing facilities in the UK. The lab will provide support for clinical packaging operations as well as offer stand-alone analytical services. The labs are equipped with the latest equipment, including HPLC, UPLC, GC, UV, IR, DSC and others.
A company statement read, "Clinical packaging projects often require a range of analytical support. The simplest projects may just require a basic ‘ID test.’ More complex projects might include over-encapsulation of comparators, requiring full method development and validation for assay, dissolution and other critical tests. The comparator products will also often require stability studies. Almac has installed stability chambers and will run all required ICH stability conditions in the new labs. With labs established in-house at Souderton, Almac can offer a ‘one-stop shop’ to our customers."
Dr. Aeri Park, operations director for the new facility, commented, "We are rapidly building a professional team of skilled scientists, each with extensive pharmaceutical industry experience. We look forward to supporting the clinical packaging operations and growing our stand-alone analytical business."
The next phase of growth for the group is the planned launch of a Polymorph/Salt/Solid Form development group.
An expert panel has concluded that the US Homeland Security Department has not adequately gauged the potential risks associated with a multimillion-dollar infectious-disease research laboratory to be built in Kansas.
Congress requested that the US Department of Homeland Security (DHS) produce a site-specific biosafety and biosecurity risk assessment (SSRA) of the proposed National Bio- and Agro-Defense Facility (NBAF) in Manhattan, Kansas.
The NBAF will be a biocontainment facility for the study of foreign animal, emerging and zoonotic (transmitted from animals to humans) diseases that threaten US animal agriculture and public health, such as Foot and Mouth. It will contain 500,000 ft2 of facility space that includes Biosafety Level - 2, 3, and 4 shared research space for the development of vaccines and other countermeasures.
The NBAF will be built on a site on Kansas State University adjacent to the existing Biosecurity Research Institute. However Federal auditors have queried the safety of locating such a facility in the heart of "tornado alley," a region of the country prone to tornadoes.
Based on those concerns, Congress instructed the department to complete a site-specific "biosafety and biosecurity risk assessment" of the proposed laboratory before construction funds would be obligated. Lawmakers also directed the National Research Council to conduct an independent evaluation of that study to determine its adequacy and validity.
Upon review of the DHS assessment, the National Research Council found "several major shortcomings." Based on the DHS risk assessment, there is nearly a 70% chance over the 50-year lifetime of the facility that a release of FMD could result in an infection outside the laboratory, impacting the economy by estimates of $9 bn to $50 bn.
The committee found that the SSRA has many legitimate conclusions, but it was concerned that the assessment does not fully account for how a Biosafety-Level 3 Agriculture and Biosafety-Level 4 Pathogen facility would operate or how pathogens might be accidently released.
The NBAF is being designed by the NBAF Design Partnership (Perkins & Will, FLAD & Associates, Merrick & Co., AEI Engineering Inc., CCRD Partners, and Affiliated Engineers, Inc.).
The estimated five-year project is scheduled to begin construction in 2010, become operational by 2015, and employ up to 300 people.
In a joint statement Ron Trewyn, Kansas State University’s vice president for research, and Tom Thornton, president and CEO of the Kansas Bioscience Authority, said the project was still in its early design stages and while they welcomed the input said it was moving forward with the project.
The statement added: “There is wide agreement that the NBAF mission is too critical to delay. It also should go without saying that redundant, iterative mitigation will be at the core of every aspect of the NBAF, from the physical structure to all operating policies and procedures. This will help ensure safe, modern, and effective disease research at the NBAF in Kansas — just like research taking place every day in places such as Atlanta, Georgia; Ames, Iowa; and Galveston, Texas. The danger is not in modern research but, rather, in the lack of accelerated research to protect the food supply.”
While some sectors of Maryland's economy struggle to shake free of the Great Recession, the biotechnology parks adjacent to Baltimore's two top teaching hospitals stubbornly continue to add laboratories, offices and — most importantly for the city — jobs.
The gains have been both large and small, and not always along the path or at the pace envisioned when the parks were created. But the growth is unmistakable, fueled by the critical mass of expertise, resources and discoveries at both the Johns Hopkins and University of Maryland Baltimore medical campuses.
Among the most recent arrivals is Frank Diehl, chief scientific officer at Inostics, a German company seeking to perfect a new diagnostic tool for cancer patients. He hopes to have a small lab running next year on the city's east side, at the Science + Technology Park at Johns Hopkins.
The technology was invented at Hopkins, and Diehl says it was always in the cards to bring it back to Baltimore as it matured. "You want to interact with the brightest people," Diehl said by phone from Hamburg. "In oncology, the brightest people are in Baltimore."
GlaxoSmithKline and Dr. Reddy’s Laboratories have signed an agreement under which, GSK will transfer ownership of its penicillin manufacturing site in Bristol, TN, and rights for the Augmentin and Amoxil brands in the U.S. to Dr. Reddy’s. GSK will retain the existing rights for these brands outside the U.S. The transaction is expected to close in 1H11. Financial terms were not disclosed.
Abhijit Mukherjee, president of Dr. Reddy's Global Generics Business, said, “We are excited about this acquisition, as it allows us to enter the U.S. penicillin-containing antibacterial market segment and serve the needs of our customers and patients through manufacturing capabilities that did not previously exist within Dr. Reddy’s. This acquisition is in line with our strategy to significantly scale up our generics business in North America while providing an opportunity to explore additional synergy with our other businesses.”
“The sale of this site and divestiture of these products in the U.S. are a positive step forward for this manufacturing facility. The Bristol site has had a long and successful history with GSK. This sale will enable the facility to continue to provide oral penicillin-containing antibacterial products to meet the needs of patients in the U.S., and will allow GSK to focus resources on our newer portfolio of differentiated products,” said Jean-Paul Reynaud, senior vice president of antibiotics and emerging markets supply for GSK.
LabStrong Corporation recently completed construction on a new sales, production, and distribution facility near the Dubuque Industrial Park West. Located in Dubuque, Iowa, the new facility is adjacent to LabStrong’s previous location and opened on November 8, 2010. This new facility tripled the space that LabStrong previous occupied.
The modern facility provides LabStrong with new offices, cutting-edge R&D spaces, a much larger production area, and warehouse storage. Among the many amenities on-site is the state of the art production facility that allows LabStrong to build and test systems more efficiently and continue development of new standard laboratory and OEM products. Additionally, there is ample space for management, engineering, and customer service.
LabStrong Corporation President, Mark Lockwood, is particularly thrilled about the new building. In a statement on the completion of the building he said, “We are excited about this new facility. Not only will it improve the flow and tracking of our product, but it will also increase our production capabilities.” In recent years, LabStrong has experienced exponential sales growth due to their North American distribution agreement with Fi-Streem International and their internal focus of providing new, innovative laboratory equipment while providing customers with high-quality service and convenience. The company serves the scientific, laboratory, and medical marketplace.
PRA International announced the opening a new bioanalytical laboratory in Lenexa, Kan., to support the company’s early-phase study capabilities in the United States. The lab will also enable PRA to expand its bioanalytical laboratory breadth worldwide, while adding bioscience jobs to the region.
The North American Bioanalytical Laboratory will deliver quality analysis for local, national, and international clinical trials. The staff will provide scientific, regulatory, project management, and communication skills to support a variety of studies, according to a company statement.
PRA currently has a Clinical Pharmacology Unit early-phase facility in Lenexa. The addition of the bioanalytical lab will enable PRA to perform adaptive clinical trials.
Bayer HealthCare is investing €35 million ($47m) in a new centre for the biotechnological production of ‘innovative’ pharmaceuticals to be used in clinical trials.
The company said the new cell biology facility centre, in Wuppertal, Germany, will represent “an investment in its long-term success,” with innovation being “the key to success”.
“Biological research and development is one of the pillars of our overall strategic concept. We want to increase the prospects of being able to offer new drugs in the fight against serious diseases,” said a Bayer spokesperson.
“Therefore, we are working on the development of small molecular weight compounds as well as biological active ingredients,” she added.
Bayer said its main focus lies with the manufacture of antibodies, as well as coagulation factors and other therapeutic proteins, and the firm hopes the new centre will increase its chances of being able to offer new drugs in the fight against serious diseases such as cancer.
Operations at the 1000 sq. meter (10,760 sq. ft.) facility are expected to begin at the end of 2012 and the centre will house the equipment necessary for all stages of biotechnological procedure, said the firm.
Bayer revealed that production will take place over two stories of the building in ‘cleanrooms’ kitted out with air lock systems to limit contaminating airborne germs and particles to a minimum.
This cautionary measure may perhaps have been taken after the firm’s biologics manufacturing division experienced a number of cleaning validation problems at its US Clayton, North Carolina facility several years ago.
Technology areas, offices and social rooms will be distributed over a further three stories, while 20 qualified members of staff will be employed to manufacture a range of products.
Dr. Klaus Jelich, location manager at Bayer HealthCare in Wuppertal believes the new facility centre is “well-integrated” for every aspect of biotech production of drugs for clinical trials.
“From research and development to the production of active substances, we cover all important disciplines – namely those related to chemical and biological active ingredients,” he added.
Inno Biologics has delivered the first batch of clinical grade biopharma material made in Malaysia and entered into its first agreement to commercially manufacture biosimilars for Avesthagen Ltd., a life science company based in India.
Dr. Mohd Nazlee Kamal, group managing director of Inno Bio Ventures, said, “This accomplishment is a reflection of the propensity and capacity of the Group to pioneer Malaysia’s foray into the global biotechnology arena. To be chosen to undertake this complex project in a highly competitive business environment, and to deliver the project with quality, value and in a timely manner, is a testament to the capability and expertise of our young team.”
“We chose to collaborate with Inno Bio and our faith and confidence has been repaid with the commitment and professionalism and proof of this is the timely delivery of the batch of clinical grade material,” said Avesthagen’s founder, chairperson and managing director, Dr. Villoo Morawala-Patell. “Avesthagen has a rich pipeline of biosimilars, four of which are already through the RCGM (Indian Regulatory body) for conducting clinical trials. We foresee Inno Bio playing an important role in meeting Avesthagen’s goals in getting our biosimilars quickly to the market.”
Sartorius Stedim Systems GmbH, a subsidiary of Sartorius Stedim Biotech (SSB), is expanding its capacity and optimizing its production operations by combining its work and production areas. A new plant will be built in the industrial zone in Guxhagen, Germany. The new building will be approximately 93,000 sq. ft., providing 50% more office and production space. The cost of the project will be approximately 14 million Euros. Construction is scheduled to begin in the spring of 2011 with a relocation date scheduled for 1Q12.
Managing director Hans-Peter Casel remarked, “We are happy to have found such a capable partner and investor for our building project as Robos. The new building complex in Guxhagen will create entirely new production conditions. It will enable us to significantly optimize our process operations and enhance collaboration among our individual departments and units. Moreover, the new site is also a good solution for our employees, most of who live in the region.”
UK chemicals company, Yule Catto & Co, is to acquire PolymerLatex of Germany from private equity house TowerBrook Capital Partners for €443m (£376m; US$592m), a move that will help the firm expand its business in Europe and Asia-Pacific.
PolymerLatex, based in Marl, Germany, is Europe’s third-largest producer of synthetic latex. It employs around 600 people and has production sites in Germany, Dubai, Finland, Italy and Malaysia. Sales were around €387m in 2009.
The deal, which is subject to regulatory and shareholder approvals, should be completed during Q2, 2011.
Yule Catto, based in Harlow, Essex, UK, already owns the Synthomer polymers business, and says this deal will bring together two companies with a combined turnover of approximately £800m and employing more than 2,000 people.
Synthomer and PolymerLatex are suppliers of emulsion polymers, which are used to manufacture a wide range of everyday products including synthetic latex gloves, floor coverings and paints and coatings.
This transaction will result in a new business with the market expertise, geographic reach, manufacturing capabilities and R&D team to provide customers with a broader range products supported by an extensive manufacturing network, said Yule Catto.
Adrian Whitfield, Yule Catto Group chief executive, said: “The combination of Synthomer's polymer business and PolymerLatex will create a business of great potential to our customers, our people, our shareholders and the communities in which we operate. We look forward to learning from each other and building a business that combines the best of both companies.”
Synergy Health, a provider of sterilization and infection control services to hospitals, has expanded its European business with the acquisition of Gamma- Service- Produktbestrahlung (GSP) for €9.5m (£8m).
The acquisition of GSP, based near Dresden, Germany will enable Synergy to add electron beam processing to its service offering in mainland Europe. GSP's proximity to Poland and the Czech Republic will also provides Synergy with a route to enter other markets in Eastern Europe, the company said.
GSP provides both gamma and e-beam sterilization services to the healthcare and industrial sectors. Sales in 2009 were €5.5m.
Synergy Health, headquartered in Swindon, Wiltshire, says its European sterilization business grew by 7% in the first half of 2010 and is operating at capacity in Germany, where it currently has one facility.
As well as assisting in the company’s efforts to break into the German decontamination market, the acquisition will complement existing plans to expand sterilization capacity in Venlo, Netherlands, as well as building a new gamma facility in Marcoule, France.
Richard Steeves, chief executive of Synergy Health, said: “This acquisition builds on our position in Germany and opens up further opportunities in Eastern Europe. Germany could become a key market for Synergy and we are actively bidding for a number of decontamination contracts there.”
ProJect Pharmaceutics has opened its Munich headquarters and laboratory facilities in Martinsreid, Germany, beginning business operations to transform proteins, peptides and small molecules into novel drugs.
The new pharmaceutical service provider said its aims is to help client’s successfully transfer products from the pilot lab into large scale GMP manufacturing without the risk of defective batches thorough its service offerings.
Based on its ‘Advaceutics’ concept, ProJect Pharmaceutics (PJP) claims it can add value to clients’ bio-therapeutic products using state-of-the-art analytical methods, science-based formulation design and tailor-made drug delivery systems.
“Advaceutics ensures that customers receive tailor-made solutions for their recombinant and synthetic polypeptides,” said managing director and founder Andreas Schütz.
Explaining that the service is targeted towards small and mid-sized biotech companies looking to outsource responsibility for the pharmaceutical and technical aspects of their projects, Schütz said Advaceutics comprises of several services which will be offered out of the new facility.
As part of the package, the firm promises it will design safe and convenient formulations and drug delivery systems as well as identifying packaging systems and delivery devices and developing reliable and cost-effective manufacturing processes.
Furthermore, the firm offers to select and qualify suitable contract manufacturing organizations (CMOs) for the pharmaceutical system, leading to the eventual “smooth transfer” of the technology into large scale GMP manufacturing.
Schütz claimed PJP’s Advaceutics provides “a holistic approach, which integrates the marketing aspect of a safe and convenient drug presentation, science based stabilization technologies for long term stability of therapeutic proteins and economic aspects for the optimized and cost-effective manufacturing of the drug.”
The new facility, located in the biotech cluster in Martinsried, comprises of analytical labs, equipped with analytical instrumentation used to characterize therapeutic proteins and protein drug products, such as chromatography, spectroscopy, and electrophoresis, as well as a pilot lab, equipped with process technologies used in commercial aseptic manufacturing of drug products.
While the PJP started out with six employees, the firm said it expects to “expand significantly” next year as Schütz is “strongly convinced” PJP’s services are growing in demand in the industry.
PRA International, a leading Clinical Research Organization, announces the opening of a new Phase I facility in Prague, Czech Republic that will provide innovative "unit-on-demand" services and further enhance our capabilities for conducting early development trials.
Situated in a new state-of-the art medical building, the unit contains 10 beds and is designed for Phase I patient studies. The new Phase I unit is accredited and reinforces PRA's commitment to provide early phase services in the Czech Republic. This opening also enhances the ability to accommodate increasing client demand for Phase I trials in patient populations.
Like other PRA facilities in Central and Eastern Europe, the Czech unit will use innovative unit-on-demand business model that brings a Phase I center to patients. This model establishes a Phase I study environment in central medical facilities that have access to the target patient population. Practicing physicians in these facilities can recruit high volumes of patients using extensive networks of referring specialists and general practitioners. The studies placed in this model occur both in single-center and in multinational, multi-center settings.
PRA Early Development Services is a diverse, international group helping pharmaceutical and biotechnology customers in their Phase I development programs. In addition to five Central and Eastern Europe locations, PRA also has traditional-model clinical research units in The Netherlands and United States. PRA conducts more than 300 complex and bioanalytical studies every year, and has an active volunteer pool of 30,000 healthy subjects and access to a number of patient populations in specific therapeutic areas.
About PRA International
PRA International conducts clinical trials in more than 85 countries across 6 continents and provides services through all phases of clinical development across all therapeutic areas. In the last five years, PRA has supported over 3000 clinical trials through its 38 global offices.
PRA's therapeutic expertise, global reach and project experience, combined with extensive local knowledge and our differentiating PERSONAL ELEMENT enable our project teams to deliver consistent and on time performance for our clients. This unique PRA philosophy - THE PERSONAL ELEMENT - recognizes that true client service comes only from trained, empowered and dedicated employees who are encouraged to use innovation and their personal commitment to accelerate the development lifecycle.
PPD, Inc. announced it has opened a vaccine clinical research center in Taizhou, China, further strengthening its clinical research and development services in one of the country's major regions for conducting vaccine studies. Through the center, PPD will provide clinical monitoring services to global and local biopharmaceutical companies seeking to develop vaccines in China.
Located at the Taizhou China Medical City, the center will help biopharmaceutical companies address unique requirements for conducting vaccine clinical trials in the country. Vaccine studies in China are conducted by the Chinese Center for Disease Control and Prevention instead of at Phase 1 clinics or by investigators at hospitals, and they require thousands of patients for enrollment, compared to hundreds for studies conducted in other countries. Yet, China has a short recruitment period for vaccine trials.
"The vaccines market is one of the fastest growing segments in the industry, and in China the clinical trial market is growing at about 20 percent each year," said Simon Britton, PPD's vice president of clinical development for Asia Pacific. "Our strong expertise in vaccine clinical research and large presence in China make us well positioned to help our clients ensure adherence to global standards while addressing unique requirements for monitoring vaccine studies."
The China Medical City has become a national hub for international and domestic pharmaceutical, biomedical and biotechnology companies and is part of a long-term plan to advance Taizhou as a global leader in research and development and position it as one of the world's premier biopharmaceutical facilities.
PPD opened its first office in China in 2003 and is now the largest contract research organization in the country with nearly 1,100 employees. Its acquisitions of Excel PharmaStudies, Inc., and BioDuro LLC, last year strengthened the company's drug discovery and development services in the country and advanced its goal of becoming China's number one services provider for the biopharmaceutical industry.
Ocimum Biosolutions has secured $8m (€6m) to complete its 360,000 sq. ft. facility and add trial support services, biomarker discovery and biobanking.
When complete the new campus in Patancheru, Hyderabad, India will cover four acres and house good laboratory practice (GLP) compliant genomic and diagnostic. Ocimum will complete construction using some of the $8m and plans to move in by March 2011.
Some of the remaining funds, which came from a number of sources including founders and existing shareholders, will be used to expand service offering. Ocimum wants to be a one-stop-shop for genomics and to achieve this will expand into other parts of the drug development chain.
Lotus Pharmaceuticals plans to sell 165 acres of land in Inner Mongolia after abandoning plans to build a production and storage facility on the site.
The land was purchased in 2008 with the intention of building a pharmaceutical production and storage facility to serve Inner Mongolia and the five North-Western provinces of China. However, Lotus is now looking to sell the land and focus on completing its facility in Beijing, China.
"We have decided not to move forward with the construction of our planned facility in Inner Mongolia in order to focus our efforts and resources on expanding our core business in Beijing", said Zhongyi Liu, chairman and CEO of Lotus.
O2h is providing chemistry and ADME services to support drug discovery programs at Phytopharm.
UK-based Phytopharm is developing a series of compounds, the Sapogenins, for treating neurodegenerative diseases such as Parkinson’s, motor neurone and glaucoma.
O2h is co-located in Cambridge, UK and Ahmedabad, India. The UK office provides project management support while the Indian operations offer expertise in chemistry, including adsorption, distribution, metabolism, and excretion (ADME).
Bulgarian drugmaker Sopharma will invest BGN70m ($47m) in the construction of a new manufacturing plant in a further bid to drive export growth.
The facility, Sopharma’s thirteenth, will produce up to 100 different types of medication, have capacity to make four billion tablets a year and employ a workforce of 420 people.
Sopharma, which competes in Bulgaria’s BGN1.7bn a year drug market with Actavis, Novartis, Roche and Sanofi Aventis, saw sales climb 22 per cent to BGN138.6m and year-on-year profits grow 31 percent to BGN12.7 in the first six months of 2010.
However, while Sopharma did see a modest increase in market share over the period, the key growth driver was its export business, which increased by nearly a third over the six months to June 31.
Key markets in terms of sales growth were the US, up 23 per cent, Central Asia and the Caucasus, up 9 per cent and Singapore, which generated 5 per cent more revenue than the equivalent period in 2009.
The export and international revenue growth reflects the expansion effort Sopharma has undertaken over the last few years.
This process began a year and half ago Sopharma founded its US unit Extab, in a bid to win regulatory approval to sell its plant-derived smoking cessation aid, Tabex, in the world’s most lucrative drug market.
And, last April, the Bulgarian firm continued its expansion, entering the Austrian drug market with the launch of its neurological disease treatment Nivalin under the Nivaject brand name.
More recently, Sopharma unveiled plans to establish a new subsidiary in Poland and revealed that it is working to register its production operations and products with authorities in Finland and China.
Takeda is collaborating with Baxter to establish a Vero cell-based influenza manufacturing facility in Japan and launch vaccines in the country.
Japan, like other nations, is keen to ensure it can effectively respond in the event of the rapid spread of a virulent influenza strain. Establishing a cell culture-based influenza vaccine production facility is one proposed element of pandemic preparation plans.
"By collaborating with Baxter, a global leader in cell culture-based vaccine technology for influenza, we plan to establish an infrastructure for the production of pandemic vaccines in Japan", said Yasuchika Hasegawa, president and CEO of Takeda.
Under the terms of the development, license and technology transfer agreement Baxter will support Takeda in its pursuit of funding from the Japanese government. Takeda will use the funds to construct a Vero cell-based influenza production facility in Japan.
Technology transfer from Baxter will enable Takeda to produce a H5N1 influenza vaccine at full scale by March 31, 2014, the end of the Japanese company’s 2013 fiscal year. Payments from Takeda to Baxter will be made on completion of certain milestones, such as technology transfer.
To construct the facility and successfully meet all milestones, Takeda and Baxter will apply for the government's public offering under the secondary supplementary budget. Takeda was previously chosen to receive ¥3.6bn ($42.9m) to invest in pandemic vaccines under the primary supplementary budget.
Other aspects of the deal include the exclusive license of Baxter’s Vero cell-based technology for the Japanese market and the joint efforts to develop and license a H5N1 vaccine in Japan.
Baxter claims use of Vero cell-based production technology can, and in the H1N1 outbreak did, shorten the time taken for full-scale production of an influenza vaccine. Time savings are realized by eliminated the need to adapt the virus strain to grow in eggs.
Recognizing this some governments want to boost cell culture-based production infrastructure. A US report into the H1N1 response said in the long-term cell culture should replace “the inherently time-consuming egg-based method” which makes production “a long and unpredictable process”.
GlaxoSmithKline announced that it has entered into an agreement to acquire Nanjing MeiRui Pharma Co., Ltd (MeiRui) for a cash consideration of approximately $70 million. Ninety per cent of the share capital of MeiRui is to be acquired from Pagoda Pharmaceuticals Limited and the remaining ten per cent from Allergon AB in a move to further expand GSK’s presence in China, one of the fastest-growing and most significant of the emerging markets.
MeiRui is a leading Chinese pharmaceutical business with a strong portfolio of urology and allergy products, including Prostat for benign prostatic hyperplasia and Sheniting for overactive bladder syndrome. GSK will gain access to this portfolio of products, as well as MeiRui’s established sales and marketing platform and a manufacturing facility in Nanjing City, Jiangsu Province, China.
Completion of the transaction is expected by the end of 2010, subject to regulatory approval.
Nanjing Merui Pharmaceuticals (MeiRui) is a Chinese pharmaceutical company specializing in manufacturing urology and allergy medicines in China. MeiRui is the China operating entity of Pagoda Pharma Group Inc, a privately owned company registered in the British Virgin Islands.
West Pharmaceutical Services announced its intention to consolidate selected operations in order to improve operating efficiencies. The company expects to close its Montgomery, Pennsylvania, USA manufacturing facility and to downsize operations at its facility in St. Austell, Cornwall, U.K. The Pennsylvania facility has been engaged primarily in contract manufacturing of molded plastic components and assemblies for consumer-product applications. The Cornwall facility produces molded elastomeric components for disposable medical devices, as well as elastomeric and plastic components used in pharmaceutical packaging. Ancillary to the manufacturing changes West is also planning to eliminate a limited number of other operational and administrative roles.
Morel Jr., Ph.D., Chairman and Chief Executive Officer said, "The plans announced will reduce the manufacturing capacity devoted to product lines that no longer support sustainable, competitive operations, and will unfortunately result in the loss of a number of jobs over time. These are difficult decisions that fall most heavily on our employees in these locations, and we will be providing support that should ease the burden placed on them." The costs of the restructuring are expected to be between $18 million and $21 million. When fully implemented, the changes are expected to reduce annual operating costs by approximately $12 million.
Danisco has completed the next phase of its cultures capacity expansion with the opening of modernized and enlarged facilities in Epernon, France, allowing it to reduce response times for DVI cultures.
The company is in the midst of a three-year, €60m plan to expand its cultures capacity in the US and Europe by 2,000 tons by 2012, in order to maintain the high growth momentum of the business.
In full year 2009/10, cultures accounted for 15 per cent of group revenue, coming in a DKK 2.1m – up 7per cent year-on-year with 10 per cent organic growth and a 3 per cent negative currency impact. The company said that the growth was broad-based but starter cultures performed particularly well we the wave of conversion to direct vat inoculation (DVI) continues.
“Global demand for direct vat inoculant (DVI) cultures is growing fast as more manufacturers recognize their more consistent performance and ease of use compared to traditional bulk starters,” said Olivier Le Lièvre, manager of the Epernon plant.
Since the modernization work began Epernon has doubled its cultures capacity. New facilities at the site include a warehouse shipment zone and an ultra cold storage unit (UCS) that ensures a 12 month shelf-life for frozen lactic acid and probiotic cultures produced at the plant for use in probiotic and fresh dairy products.
“The new UCS enables us to consolidate all frozen shipments from our French sites at Epernon and cuts our CO2 emissions due to the reduced use of dry ice and transport,” said Pierre Cans, Operations Vice President, Cultures Division.
Earlier this year Danisco effected a similar expansion at its cultures plant in Niebüll, Germany.
In February it announced the doubling of its freeze-drying capacity at Dangé-Saint-Romain, France, to support growing demand for ripening and protective cultures due to the trend towards natural foods.
The Dangé site, which specializes in freeze-dried cultures but also produces limited amounts of liquid format cultures, became fully operational in December 2009.
The company’s facility in Rochester, Minnesota, is also a recipient of funding for expansion.
DVI systems (also known as direct vat set cultures, or DVS) are designed to combat bacteriophage – an age-old problem in the dairy industry that kills bacteria, thereby slowing the production process – by enabling manufacturers to rotate cultures. Traditional bulk starters are less easy to rotate, so it is said that the risk is higher.
Danisco is not the only supplier to see increased demand for its direct-to-vat cultures. Chr. Hansen has also said that the global recession had boosted demand for its DVS culture systems as its customers looked for ways to raise productivity. It claims that DVS technology reduces wastage and increases yield – important attributes at a time when manufacturers are making cost reduction a top priority.
DVI has not always been an option associated with value, and the current international swing away from bulk starters takes starter methods full circle. Fifty years ago, DVI was the only culture of choice for the dairy industry, but when bulk starters developed about two decades later they were seen as a lower cost alternative.
Kemwell has completed construction of a new biopharmaceutical manufacturing plant in Bangalore, India, a strategic collaboration with Boehringer Ingelheim, Germany.
With this collaboration, Kemwell will complement its early clinical supply services ranging from full-service process development, manufacture, formulation and fill and finish at the cGMP manufacturing facility in Bangalore, India, as a one-stop-shop through access to Boehringer Ingelheim's cell line development with the BI HEX® technology platform, followed by a preferred access to the large-scale commercial production of Boehringer Ingelheim at its facilities in Europe.
"Most importantly, Kemwell and Boehringer Ingelheim will provide the customer with state-of-the-art technology from Europe along with the benefit of low cost manufacturing from India," says Anurag Bagaria, vice president of Kemwell.
Kemwell's new 15,000m² (161,400 sq. ft.) greenfield state-of-the-art facility will be designed for process development, fermentation, purification and formulation of biologics for early-phase preclinical and clinical studies. The facility will consist of a cGMP drug substance manufacturing facility and a sterile fill and finish facility for drug product with a floor for process development laboratories to support production of protein therapeutics from mammalian-cell culture or microbial fermentation.
The Kemwell Biologics factory will be located on the Kemwell site in Bangalore as it will share synergies with the other facilities on the site. Kemwell has facilities dedicated for tablets, semi-solids and liquids manufacturing as well as pharmaceutical development services on the same site and can thus synergize its current competencies by using existing trained personnel in analytical and quality services at the new facility.
Kemwell will also provide in-house experts in toxicology and clinical development and partner with Indian CROs to help customers manage toxicology and clinical studies in India. Thus, the customer can benefit from low costs through the development process.
"Kemwell will continue its commitment to pure-play contract manufacturing and build on its extensive experience in contract manufacturing. We find high opportunities for supplying monoclonal antibodies and are committed to provide these services in a timely and cost-effective manner," says Anurag Bagaria.
"Through the partnership with Kemwell Biologics, Boehringer Ingelheim will strengthen its presence for biologic services in Asia, providing state-of-the-art technologies for economic manufacturing of innovative, high-quality biopharmaceuticals," comments Rolf G Werner, corporate senior vice president of the corporate division biopharmaceuticals, Boehringer Ingelheim, who was present at the groundbreaking ceremony in Bangalore.
Kemwell, India's leading pharmaceutical contract manufacturer has set up a new R&D facility in Bangalore, India, in partnership with the world's leading pharmaceutical company, GlaxoSmithKline (GSK). This R&D centre has been set up to cater to GSK's global oral healthcare development projects.
GSK's sales in oral care amounted to £1,049m in 2007. Its leading oral care products are toothpastes and mouthwashes under the Aquafresh, Sensodyne, Macleans and Odol brand names. GSK Consumer Healthcare (CH) has an aggressive target to significantly grow the business by 2013. To enable this to happen, the R&D arm of the company has committed to doubling the number of projects running through its pipeline. A series of initiatives have been identified within CH R&D to enable this target to be achieved. Specifically, a global resourcing (GR) department has been established to identify and qualify contractors in India to increase the capacity for delivering new products through to the launch phase.
Kemwell has been selected by GR as a preferred partner for the development of oral care products. Kemwell achieved this privileged status through their senior management commitment to diversification / innovation, their ability to deliver a new GMP facility, skilled manpower and their commitment to planning, delivery and quality. GSK and Kemwell share a relationship that spans over 20 years and have collaborated on several pharmaceutical manufacturing projects in the past. They are now extending their relationship to meet the R&D demands of GSK.
The newly established oral care unit (OCU) at Kemwell is a state-of-the-art GMP facility suitable for all requisite development activities prior to technical transfer of product for manufacture into a GSK facility. The facility and staffing have been put in place by Kemwell in little over six months and the unit is now fully operational.
Kemwell is further investing in infrastructure to provide R&D services such as formulation and analytical services, stability studies and clinical trial manufacturing in various dosage forms.
HRH the Duke of Gloucester has paid tribute to the newly redeveloped Kingsway Business Park, marked by an official visit on 13 October 2010 to Rochdale, Greater Manchester.
Recognizing the important regeneration of this area, Vindon Scientific has relocated its headquarters to Kingsway. Vindon operates in several markets, including the healthcare, pharmaceutical, life sciences, food sectors and heritage sector. It is a leading supplier of environmental control products and services for the management of temperature, humidity and light, where controlled environment storage is needed.
The Duke of Gloucester formally opened the new premises. He met Vindon's directors who gave him a tour of the 29,000ft² state-of-the-art facilities that are now fully functional and geared up to support the company's ambitious growth plans for the future. The Duke was shown the specialist products and services that Vindon provides, including their heritage storage facility designed for the safe storage of acetate film and care of collections, stability storage, ultra-low temperature facilities and cryogenic sample storage for stem cells.
Patrick Jackson, business development director at Vindon, concluded: "We were delighted to welcome the Duke of Gloucester to our new home here at Kingsway. To be chosen to represent this area of Rochdale is a great honor. We're pleased to see continued investment in the business park, which will encourage more new ventures to join us."
Lubrizol has opened a new applications centre in India to capture a share of the country’s growing coatings and drug ingredients market.
The new Mumbai unit, which will be operated by Lubrizol’s advanced materials division, will provide drug industry with application and formulation development services, focused around its range of coating technologies.
The facility, which is worth INR50m ($1m) according to a Hindu Business Line report, is one of several the firm operates in the region, which was a point stressed by unit president Eric Schnur.
“We view this market as a great opportunity for Lubrizol Advanced Materials, and our new site represents an important step in what we intend to be a long-term effort focused on growth and investment in this region.”
Lubrizol is also planning to expand its 160-strong workforce in India by hiring 100 new employees over the next five years to cater for industry customers in the country's rapidly expanding drug manufacturing and personal care sectors.
Managing director Timothy Madden said: "We are working closely with various universities for hiring the best of the talent for the overall domestic development of the company. This will help the company to be able to offer solutions to fit local customer needs.
He also said that: "We are in talks with certain companies especially in the field of pharma, personal care and painting and coating. We may need more people in case there are acquisitions or mergers."
GSK has announced plans to invest £500m in its UK R&D and production operations with a particular focus on boosting biomanufacturing capacity.
The investment fits with the deal GSK announced with Lonza earlier this year and, more generally, with the direction in which the UK drug major's business is moving, given that biopharmaceuticals represent about 20 per cent of its clinical pipeline.
GSK also said it will add manufacturing capacity at its existing facility in Ware, Hertfordshire for respiratory disease treatments and solid-dose tablet products.
A new dermatology-focused production centre of excellence in Barnard Castle, County Durham and, in partnership with the University of Nottingham, a “green chemistry” unit are also planned as part of the investment program.
GSK will also establish a £50m venture capital fund that will invest in small specialist firms and academic spin-outs which are “pursuing innovative, breakthrough science.”
Overall, the firm expects to create more than 1,000 new jobs over the next few years.
News of the investment follows just a day after the UK government announced the introduction of its “patent box,” which will reduce the tax rate on income generated by patented products by some 10 per cent.
However, a GSK spokesman said that tax was not the key motivation for the firm's plan, explaining that: “As a global company, GSK is already able to access this kind of tax rate elsewhere in the world.
“[The patent box],” he continued “doesn’t necessarily change GSK's tax rate; it simply means we will be able to do work in Britain rather than having to move it to other countries in the way that we have for the last 20 or 30 years.
"Over the last 20 or 25 years, GSK has not built any new manufacturing capacity in Britain. We have built many new factories but they have been all over the world, in countries such as Ireland, Singapore and Belgium.
"Yesterday's announcement will start to change that approach by putting the UK on a level playing field with some of the more competitive countries with whom we operate around the world. Therefore, the UK will now move to the top of the list when thinking about where to invest.
This echoes comment by CEO Andrew Witty who said: “The introduction of the patent box is a bold and forward-thinking measure which builds on the UK’s strength as a global centre of excellence for science and R&D.”
The Government’s announcement was also welcomed by AstraZeneca CEO David Brennan, who said that it “Will make the UK a far more attractive place to invest in developing new medicines.
"In response to the implementation of a competitive patent box, we plan to increase our U.K. investment in intellectual property in diabetes, cancer and respiratory disease."
The decision follows just days after the drug industry issued a warm response to the Irish Government’s commitment to maintain the country’s 12.5 per cent corporate tax rate.
Beike Biotechnology has opened a stem cell storage and processing facility at the 20,000 sq. m.
(215,200 sq. ft.) regenerative medicine base in China, furthering the nation’s development in the field.
China has identified stem cell research as an area that it can become a global leader in and is willing to invest to make this happen. Beike is a beneficiary of this policy, receiving support from Jiangsu government-backed China Medical City (CMC) to establish the stem cell site.
The 20,000 sq m site, called the Stem Cell Regenerative Medicine Industrial Facility of National Bio-Industry Base (NBPD), forms part of a multi-stage project to give China a central research zone.
Industry partnerships form part of this strategy. The NBPD gives Beike the capacity to process and store 1m stem cell samples, making it the largest facility of its type according to the company. This represents a significant expansion on Beike’s earlier 1,800 sq. m., (19,368 sq. ft.) 100,000 sample site.
Beike broke ground on the new site in April 2009 and now it is operational, ahead of schedule, researchers will begin work. Using the processing, storage and clinical application development capabilities Beike intends to “produce the highest quality stem cell therapies” in the world.
"Stem cells are the crown jewel of medical research", explained Ying Song, the site’s vice president for medical, scientific and regulatory affairs. Song added research at the site will serve as a model for scientists around the world.
To advance stem cell research three main goals have been established for the site. Firstly, the facility will be involved in adult stem cell collection and storage. This will be supported by the establishment of international standards, such as ISO9001 certification.
By forming these working processes and infrastructure Song believes the site can work towards its third main goal – to patent and develop stem cell therapies into clinical practice.
Cardiff University in Wales opened the £5 million ($7.8 million) Cancer Genetics Building, a research facility designed to provide expanded space for the Institute of Medical Genetics.
The new facility, based at the University Hospital of Wales, contains over 1,500 square meters (about 16,146 square feet) of floor space, including two floors of laboratory space designed for research into the detection, diagnosis, and treatment of cancer and inherited disorders. The Cancer Genetics Building will also bring together genetic research that can identify DNA changes associated with cancer, and research into the effects of the genetic changes on proteins within cancer cells, according to the university.
Among the inherited disorders to be studied is Tuberous Sclerosis Complex, in which tumors in the brain, heart, and kidneys have led to epilepsy, autism, and severe learning disabilities.
Also in the new facility, Ray Waters, head of the Cancer Studies Interdisciplinary Research Group at Cardiff School of Medicine, will continue research into DNA damage and repair. That research has used high-resolution microarrays to analyze the entire human genome, with the goal of someday pre-screening people for responses to specific cancer therapies capable of damaging the DNA in cancer cells.
The new building's fixed louvers are color-coded to correspond to the sequence of the TSC2 gene, which was discovered by Cardiff researchers. The louvers also serve a practical purpose, namely keeping the south facing laboratories cool.
"The new facilities will help us to translate the discoveries we make in the lab and shape them into new tests and treatments in patients," said Julian Sampson, head of the institute.
With a growing requirement to support clients with their EU product launches, reduce stock holdings and provide greater flexibility with regional packs, Almac has added an additional dedicated Late Stage Customization Suite to the company’s commercial facilities.
Mark English, Distribution Manager at Almac explains, “Late stage customization involves working with the client, understanding their country launch requirements to develop an EU regional supply strategy. Grouping countries by language allowing for multi-language packs to service multiple markets, with country specific information added at point of dispatch, provides significant cost advantages. Working with products that are manufactured in very low volumes at, often, a very high cost means that solutions to minimize stock holding are of particular benefit.”
Historically the countries grouped together tended to be based on geographical proximity to ensure that distribution to the end user was as short as possible. However with modern shipping methods this is no longer necessarily the case. The main factors now tend to be which countries share a common language (e.g. UK/Ireland and Germany/Austria) and having at least one of the "Big five" (Germany, France, Spain, Italy & the UK) in each regional pack, meaning that smaller markets can be served when required without committing any stock for orders that may never arise.
Regional pack assembly produces a single pack available for as many as five markets, with country-specific information applied to the ‘Blue Box’ area as orders are received direct from pharmacies or hospitals. The addition of the dedicated late stage customization suite gives Almac the flexibility to process these orders immediately.
David Downey, vice president of commercial operations at Almac, said, “With our client partners, we have successfully launched many high-value, orphan drug / niche products into the European market, hitting launch timelines, and maximizing product flexibility to supply multiple markets. Utilizing our integrated pharmaceutical and distribution services we can provide a seamless transfer of product and services to the end-user.”
Aushon BioSystems, Inc., a leading provider of multiplex immunoassay products and services for biomarker discovery, development and analysis announced during the ChinaTrials 2010 Summit in Beijing, China, that it has entered into a partnership with LightArray Biotech Company, Ltd., to provide Aushon’s comprehensive suite of multiplex biomarker products and services to pharmaceutical, biotechnical, and academic research institutions located in mainland China.
LightArray operates a comprehensive drug development services laboratory in Wuxi, China and will now provide researchers with a local, centralized protein biomarker testing laboratory employing Aushon’s protein biomarker technologies including:
A growing menu of 300+ validated assays
Multiplex biomarker sample testing service
Multiplex protein biomarker kits
Custom arrays and assay development
Array imaging and analysis systems
“Our strategic partnership with LightArray enables companies located in China and involved in pre-clinical and clinical research to take advantage of our full range of biomarker products and services, including our flexible sample testing service and growing menu of more than 300 biomarkers in key therapeutic areas such as oncology, inflammation, cardiovascular disease, and diabetes,” said Pete Honkanen, CEO of Aushon. “They can also count on the same exacting level of reliability, performance and support that we deliver to our current customers in the United States, Europe and Southeast Asia.”
“We are extremely excited by the opportunity to assist Aushon in bringing their portfolio of multiplex biomarker services and products into the emerging China market,” said Alan Zhang, President and CEO of LightArray. “The adoption of biomarkers as a critical research tool in pre-clinical and clinical studies is growing rapidly in China, and our ability to provide local, regional access to the proven Aushon multiplex technology platform will be vital. We also look forward to providing the same unrivaled service and support to our customers that Aushon has built its reputation on.”
Ortho Clinical Diagnostics (OCD) announced the opening of a new, state-of-the-art manufacturing facility in Pencoed, Wales.
The new, 110,000 square foot facility will help stimulate the local economy by employing approximately 350 people in manufacturing operations, quality, product technical support, human resources, finance, and information technology. The plant will manufacture immunodiagnostic tests that can help detect diseases early, leading to patient care and treatment that will hopefully help to avoid progression to more serious disease. Immunodiagnostic tests indicate the presence or level of a protein to help diagnose disease in categories such as thyroid function, reproductive endocrinology, cardiology, anemia, metabolism, oncology and infectious diseases.
“OCD has almost 30 years of manufacturing history in Wales and continues to invest in the region with the opening of the Pencoed facility,” said John Gethin, General Manager for Ortho Clinical Diagnostics, UK Operations. “The opening of this new facility enables OCD to provide our customers worldwide with advances in diagnostics to improve patient care.”
Each year, more than 100 million tests are manufactured by OCD in Wales, eight percent of which remain in the United Kingdom (eight million tests). The remaining tests are shipped to company distribution centers for hospital laboratories, public health laboratories and blood banks worldwide.
The Pencoed facility, located in the Pencoed Technology Park, will replace the company’s existing Cardiff plant by the end of next year. Existing Cardiff-based staff will be transitioned to the new Pencoed facility.
About Ortho Clinical Diagnostics
Ortho-Clinical Diagnostics, Inc., a Johnson & Johnson company, delivers high-quality in-vitro diagnostic products that give healthcare professionals around the world the knowledge they need to make better treatment decisions sooner. The company serves the global transfusion medicine community with donor screening and blood typing products to ensure every patient receives blood that's safe, the right type, and the right unit. Ortho Clinical Diagnostics also brings sophisticated information management, testing technologies, and automation and interpretation tools to clinical laboratories worldwide to help them run more efficiently and improve patient care.
SPX Corp launched construction yesterday of a US$40m ‘manufacturing campus’ as part of its strategy to expand in China and the Asia-Pacific region.
The company held a ground-breaking ceremony for the 53-acre site that will be built in the FOHO Economic Development Zone, near Shanghai, over the next three years. The first phase is scheduled for completion next year and the centre is expected to eventually have 1,000 workers.
The campus is designed to support both regional and global expansion for all areas of its business, the company said. The facility will also contain R&D, logistic and customer service functions.
"SPX continues to see significant demand for its products and services in China and the Asia-Pacific region," said SPX Asia-Pacific President Bob Foreman.
ShangPharma expects its cGMP production site, due to open in 2011, and biologics services to drive growth as it builds on a 17 per cent increase in revenues in the third quarter.
To drive further growth, ShangPharma is investing some of the IPO proceeds into a multi-purpose current good manufacturing practice (cGMP) facility in Fengxian, Shanghai, China. Addition of research manufacturing capabilities will join biologics services as an additional revenue stream.
Having added biologics services ShangPharma has initiated projects and expects to see strong demand in coming quarters, said Michael Xin Hui, founder and CEO of the company.
Shanghai ChemPartner, the wholly-owned contract research organization (CRO) subsidiary of ShangPharma, has received an award of excellence from Genzyme. The award is recognition of the achievements of the ChemPartner-Genzyme over the past three years.
“ChemPartner has proven its capabilities and effectiveness during almost three years of working with us and has become our preferred choice for a chemistry CRO", said Jim Burns, senior vice president of drug and biomaterial discovery and development at Genzyme.
Brunel University based in Uxbridge, Middlesex, UK, needed a new pass-through autoclave for their new CAT III containment laboratory suite to be installed within the Heinz Wolf building. This would provide a Centre for Infection, Immunity and Disease Mechanisms, and a School of Health Sciences with a CAT II and CAT III Research Facility.
The company contracted to source the autoclave based on the Brunel brief was Cleanroom Design and Construction Limited (CDC) based in Stourbridge. As CDC have considerable experience in the type of laboratories Brunel University require they were chosen as the specialist contractor to design and build the turnkey, laboratory containment facility from start to finish. This included: the demolition and alteration to the building structure; the selection of the pass-through autoclave and other laboratory capital equipment and furniture; the organization of the full commissioning and validation of all the capital equipment they sourced for the containment suite.
According to Nick Henley, CDC's Contracts Director, Priorclave's already proven track record with Brunel University had secured them as the preferred supplier of the laboratory autoclave in the new containment suite.
Pass-through or double entry autoclaves are used in relatively small numbers and require, often complicated, building work as part of the installation process. For this reason double entry units are considered, to some extent, bespoke and create degrees of flexibility which raises additional points for consideration. Such points for example may include the application - clean room or containment, the direction of workflow, door swing profile, thermocouple entry ports etc.
Prior to quotation is an on-site survey to locate the services after which final manufacture would require the full details of the proposed locations and operation routes. However, while Priorclave met with Dr Anthony Tsolaki of Brunel University to discuss the requirements of the autoclave and the best options to suit, it was impossible to do a full site survey as the would-be laboratory was a building site with no walls. Nevertheless, the Priorclave representative was able to walk the route from entry into the building to the laboratory. The route required the use of a goods lift and passing through single doorways as narrow as 900mm, then through another laboratory whose entrance lay between a sink and a bench. There are many obstacles just waiting to create difficulties and if these can be anticipated at the site survey then corrective measures during manufacture and at the point of delivery can minimize or even eliminate costly and nasty surprises.
Dr Tsolaki explained that the autoclave needed to be electrically heated or have its own separate steam generator as there was no on-site steam available. Due to the nature of the cycles the autoclave would fulfill, it would also need a vacuum facility, a printer and an exhaust filtration system for the containment of any hazardous pathogens. It was also noted that the hardness of the water around Uxbridge would require the installation of a water softener.
At this point Priorclave needed to specify the autoclave by using room drawings. After deciding on a 350L capacity version, Priorclave submitted drawings to CDC with the autoclave in-situ and various changes were made by CDC to accommodate the unit. One of the main problems of pass-through autoclaves is space inside the machine to house the workings. The more options on the autoclave the more space is required beneath the chamber to fit them - on a pass-through autoclave there is a wall taking up valuable space. For this reason as well as cost, Priorclave opted for elements within the chamber rather than supply an autoclave with a separate steam generator. The former uses less power as the autoclave is switched on only when in use while a separate steam generator would be kept on all day, even when the autoclave is not in use.
In the case of Brunel University, their application of this autoclave was for containment purposes. It is used for the de-contamination of material prior to its release from the containment suite which would be hazardous material. Both ends of the autoclave were required to be isolated and were sealed at the point of passing through the wall by means of a bulkhead. The integrity of the containment was improved by an air pressure differential between the rooms in which the autoclave is located. It is an essential requirement of BS2646 that double ended autoclaves have interlocks to prevent both doors being open at the same time as this would obviously breach the integrity of the site. The interlock must also be present to prevent the door at the unloading end from being opened until the sterilization cycle has been successfully completed and the load is safe to pass into the unloading end. It is also a requirement of BS2646 that it is not possible to release the loading door until the unloading door has been opened and subsequently closed and locked. However in this instance Brunel wanted the ability to open either door as long as the autoclave had finished and it was safe to do so. An added benefit, enabled by a programmable key lock facility, was the ability to use the autoclave as a single door autoclave at any end.
As Brunel's autoclave was a containment suite autoclave, most of it was located within the unloading room with just the door section of the autoclave protruding into the containment area. This allowed the majority of the maintenance tasks to be completed without the need for an engineer to enter the containment area or for the area to be decontaminated and temporarily disabled. CDC was instructed to install the drains and services at this end, thus minimizing the number of pipes and wires etc that need to pass through the wall or bulkhead.
A printer is essential to produce a permanent record of each autoclave cycle, whether an integral part of the autoclave system or a separate and independent chart recorder device. It is normally desirable for the operator unloading the autoclave to be able to examine the record before opening the autoclave. For this reason and the fact that it is often not permissible to remove a paper record from a containment area, the printer was put on the non-containment end of the autoclave.
Priorclave designed and built the autoclave to the specifications requested by CDC and the end users at Brunel University and was delivered by a chosen delivery company who specialize in this type of project and who are used to handling equipment such as this and others that Priorclave manufacture.
Engineers were available on-site to take delivery just in case any difficulties were encountered. The engineers installed and commissioned the autoclave over a couple of days and end users were given instructions on using the equipment. When the Brunel personnel were proficient, Priorclave engineers returned to Brunel University to test the autoclave with the actual loads and made adjustments to the autoclave and software to ensure optimum performance. Performance Testing was done to UKAS accreditation and a full report and certification was given to the University on completion.
The autoclave is now serviced on a regular basis as stated in the extended warranty purchased within the purchase order.
UK drugmaker, GlaxoSmithKline and Moscow-based JSC Binnopharm have formed a deal that will see the latter produce GSK’s cervical cancer, rotavirus and pneumococcal vaccines in Russia.
Under the terms of the agreement, GSK will deliver bulk vaccine and supply technology and expertise to Binnopharm, which will carry out the secondary manufacture, including filling and packaging under international current Good Manufacturing Practice (cGMP) standards.
The companies said the deal will enhance sales of the vaccines, which will be sold and branded under Binnopharm's trademark for the Russian market.
“This agreement is an example of the flexible approach we are taking to make innovative vaccines more available in emerging markets through local partnerships,” said Abbas Hussain, president, emerging markets & Asia Pacific at GSK.
“GSK has one of the broadest and fastest growing vaccines businesses in the world,” he added. “This alliance with Binnopharm should ensure that more of these innovative vaccines are made available in Russia to benefit public health.”
The vaccines include: Cervarix, which protects against HPV infections that cause cervical, head and neck cancers; Rotarix that protects against rotaviral gastroenteritis and diarrhoea; and Synflorix, which protects against Streptococcal pneumonia that can lead to illnesses such as pneumonia and meningitis.
The local manufacture of these vaccines should help Russia to modernize its National Immunization Calendar in the future, adding additional vaccination against highly prevalent infections, said the two firms.
The deal comes after the Russian government announced plans to boost local drug production, improve healthcare and modernise the pharmaceutical sector by encouraging international pharma companies to establish manufacturing units in the region.
As part of the strategy the state said it aims to raise local producers’ share of drug sales from 20 per cent to 50 per cent.
Furthermore, the government predicts total investment into the Russian pharma market will top 188bn roubles ($6bn) until 2020, including 120bn roubles in state funding.
Richter-Helm owns a biologics plant at Hanover Medical Park, Germany. The plant has been operational since 1987. It was fully re-modeled in September 2009, to bring it in line with the latest regulatory standards.
The modernized facility bridges the gap between Richter-Helm's research facility in Hamburg and its commercial scale production facility in Bovenau near Kiel in central Germany. The facility is currently undergoing qualification operations.
The Hanover plant was established as Pharma Biotechnologies in 1987. In 1997, it was renamed Strathmann Biotec after being incorporated into the Strathmann Group as a subsidiary of Strathmann GmbH & Co. KG.
In mid-2007 Strathmann Biotec was acquired by the Gedeon Richter and Helm pair of companies and has been operating under the name Richter-Helm BioLogics.
Richter-Helm BioLogics focuses on its core operations such as contract development and contract manufacturing of biopharmaceuticals as well as the areas of business development, marketing and sales, and product development management.
The multipurpose GMP compliant facility occupies 1,000 sq. meters (10,760 sq. ft.). It accommodates cleanroom facilities of the class D category that contain up to class A and class B sterile workbenches.
The facility also houses upstream processing area that undertakes fermentation and primary recovery of microbial cultures.
The cleanroom area for purification and the up-stream processing area were upgraded and made state-of–the-art following a strict GMP room concept during the modernization, which began in 2008.
The modernized facility is equipped with bioreactors of between 15l and 300l fermentation capacity. During the modernization, bioreactors of up to 300l fermentation capacity were installed along with related downstream processing technologies required for the development of proteins, plasmid DNA and vaccines.
The facility is also equipped with quality control laboratories that conduct testing of in-process control samples. Equipped with advanced apparatus, the laboratories are used for analyzing the active ingredients and pharmaceuticals that are developed at the facility.
The facility undertakes a range of services from strain establishment to API production. Process development services offered by the facility include process optimization, development of scalable fermentation process for cGMP production, development and optimization of processes of high cell density fermentation, refolding strategy development for insoluble expressed proteins and scalable downstream process development including cell disruption, re-notarization and chromatographic purification sequences.
Analytical development services provided by the facility include development of bioassay methods, studies to characterize proteins and plasmid DNA, analytical development to establish host cell proteins and host DNA, reference standards characterization, formulation studies, method validation and stability studies conforming to ICH standards.
"Downstream processing at the facility includes common cell separation methods."Aseptic production includes development of recombinant proteins, plasmid DNA and vaccines that are derived from microbial fermentation.
The facility cultivates production strains (including E. coli and a number of yeast strains) that are suitable for producing recombinant proteins and plasmid DNA.
The E. coli and other yeast strains are cultivated using both batch and fed-batch techniques.
Recombinant proteins of several origins are purified from the E. coli and yeast strains using different techniques such as precipitation methods, filtration, ion exchange, affinity, hydrophobic interaction and size-exclusion chromatography. Proteins are secreted in partially active form into the surrounding medium. The microbial production is conducted at biosafety level two.
Downstream processing at the facility includes common cell separation methods, high pressure homogenization, centrifugation, including continuous and discontinuous, several filtration methods, and a number of refolding strategies and chromatography methods including preparative High Performance Liquid Chromatography (HPLC).
Dr. Schleuniger Pharmatron, a global leader in solid dosage form testing and specialist in complete tablet testing solutions for measuring weight, thickness, diameter and hardness, has moved to new business premises in Thun, Switzerland.
Optimized processes paired with modern infrastructure are key factors for further development of the company.
The layout of the new building has been designed for fast processes and streamlined operations. At the same time, the open architecture encourages teamwork and interaction.
The official move from the old location in Solothurn, where Dr Schleuniger Pharmatron was founded in 1972, became effective on 20 September 2010. Since then, all Swiss-based operations of the corporate headquarter are located in Thun.
Genzyme met its first consent decree deadline by transferring all fill/finish of US products from its Allston plant to its site in Ireland and Hospira.
Transferring fill/finish of products for sale in the US away from the plant in Allston, Massachusetts by November 28 was the first in a number of tasks in a consent decree with the US Food and Drug Administration (FDA). Genzyme shares were up $1.06 following release of the news.
Fill/finish of products for sale in the US will now be performed on a contract basis by Hospira and at the Genzyme plant in Waterford, Ireland. Genzyme is now working with regulators to transfer fill/finish of products for sale outside the US must be away from Allston by August 31 2011.
Completion of the first phase of fill/finish transfer lifts restrictions on the marketing and distribution of Thyrogen (thyrotropin alfa for injection) within the US. Also, it represents a positive step in its recovery from manufacturing difficulties and attempt to secure more than $69 a share if acquired.
Cerezyme (imiglucerase for injection), Myozyme (alglucosidase alfa) and Fabrazyme (agalsidase beta) are the other products transferred from Allston by Genzyme.
The Kington, Herefordshire plant now has three cleanrooms. Contract medical device manufacturer Arrow Medical has commissioned a single-use production unit, with UV curing and assembly lines, which brings the firm’s total cleanroom assembly facilities to 344sq. meters (3,701 sq. ft.) at its plant in Kington, Herefordshire.
The FDA GMP- and ISO 13485-accredited lines are housed within a new 56 sq. meters (603 sq. ft.) soft wall, ISO 14644 Class 7 (US Class 10,000) cleanroom built by Connect 2 Cleanrooms, based in Kirby Lonsdale, Cumbria.
Arrow Medical will be producing a variety of single-use devices used in the anesthetic, emergency surgery and cardiac sectors and building complex inflatable systems from components using materials such as flexible and rigid PVC.
The soft wall cleanroom includes an illuminated transparent ceiling to ensure light levels of 1000 lux and provide suitable conditions for the assembly of small and complex devices.
Complete air handling and air conditioning systems are also included, with HEPA filters, maintaining more than 100 air changes per hour. Programmable day/night controls are also installed to achieve high levels of energy efficiency.
The new facility provides complete product assembly for products built from complex components using UV curing technologies, with complete traceability throughout the product’s life allied to 100% testing inside the cleanroom.
The production lines include a pad printer for adding product details onto complex curved products, multiple adhesive dispensing units and assembly workstations, supported by Dymax UV curing lamps with light guides and Intertronics UV 300 conveyorised UV curing units. Products are sealed into pouches using a Riverside Shaw seal unit. Lot and expiry date details are printed onto the pouch using a Domino G100 inkjet printer.
“Staff training has been a critical and substantial part of investment in this project,” said Rita Didcock, managing director of Arrow Medical.
“High quality standards and demanding production rates for the next generation of single-use devices require a consistent production culture to meet the triple challenges of clinical performance, high yield and traceability, while complying with our customers' stringent delivery performance and quality requirements.”
Arrow Medical's Kington facility now includes three cleanrooms, using solvent and UV curing adhesive assembly, manual and semi-automated lines for RF (radio frequency welding), and multilayer fabric assembly, including cutting and sewing. Support units cover silicone molding and overmoulding and complete sterile product assembly.
SGS Life Sciences will expand bioanalytical capacity at its facility in Poitiers, France in the latest stage of its effort to become the biggest biologics testing services firm by 2014.
SGS will invest $2.9m (€2.1m) to add 500 meters (5,380 sq. ft.) of laboratory space and new bioanalytical testing technologies, which will be installed over the next few months according to general manager Alain Renoux.
Renoux said, "We have ordered two of the latest generation of mass spectrometers (MS), one of which is due to be received in December and the other in February 2011.”
He went on to say that in addition to the two new MS units, the twentieth and twenty-first at the site, SGS will install a fourth multiplex biomarker analysis platform to further enhance its capacity for immunoassays.
In a press statement SGS said that: “The investment in the Poitiers laboratory will increase the analytical development capabilities and facilitate extensive GLP services for large molecules.”
The expansion, which will also see the firm hire 50 additional analysis staff over the next three years, is part of a concerted effort to boost capacity for the analysis of biologic drugs.
The process actually began in August last year with the opening and expansion of units in Toronto, Canada and Illinois, US to add more bioanalysis testing capacity.
SGS acquired UK based contract chemical testing company M-Scan, adding four testing facilities in the US, Korea, India and Singapore to its 16-laboratory strong global network.
The Christie cancer centre in Manchester, UK, has opened a £35m (€41m) early phase clinical trial unit to help develop new treatments for a range of cancers.
The new centre houses a Phase I trials unit, the UK’s largest chemotherapy facility as well as a private patients’ suite, all paid for by the Christie, its charitable group and Cancer Research UK, with chemotherapy treatments funded by the national health service (NHS).
Working with pharmaceutical contract research organizations (CROs), the Christie will begin 10 new Phase I and II trials at the unit over the next few months after patients have been recruited for the trials.
Dr Tony Elliott, a doctor at the Christie said: “Clinical trials are vital in taking forward effective new cancer treatments and it is excellent that we undertake more trials with this new centre.”
The 10 new trials will focus on various cancers including gynecology, breast, gastro-intestinal, genito-urinary, lymphoma, haematology, lung, sarcoma, melanoma, and some studies will involve a mix of cancer patients.
Furthermore, up to 40 Phase I and II trials which have already begun in the old Christie trials unit will be transferred to the new centre, while the chemotherapy division of the new patient treatment centre will enable patients to participate in around 30 national and international Phase III trials.
By 2014 the Christie expects that 2,400 patients a year will have access the latest cancer treatments through the clinical trials funded by pharmas such as AstraZeneca, with up to 200 drug trials taking place at any given time.
The Christie claims its early clinical trials centre is the world’s largest and that it has the capacity to treat around 700 chemotherapy and clinical trial patients each week.
Housing 70 beds and 65 treatment chairs, the centre also accommodates 19 consulting rooms and a special pharmacy and research laboratory which is capable of processing 11,000 blood and tissue samples every year.
The early clinical trials centre, says the Christie, will help further the development of personalized oncology medicines as new biomarkers will be identified whilst drug studies are being undertaken. “This information will enable us to target medications to match a patient’s disease indication,” said Angela Ball, research manager at the Christie.
“This new centre will enable us to undertake even more research, ultimately saving lives across the world,” added The Christie’s CEO, Caroline Shaw.
“Through providing the highest quality environment and integrating clinical trials and chemotherapy services we will also be able to significantly improve the patient experience and ensure local patients can access the very best services and treatments,” said Shaw.
The German Cancer Research Center has completed a €77 million ($104.7 million), renovation to its main building in Heidelberg designed to help the institution launch several new molecular biology programs.
"We want to implement new programs in cancer stem cell research, cancer genome sequencing, neuro-oncology and cancer epidemiology," said Nicole Schuster, a spokeswoman for the cancer center, known in German as Deutsches Krebsforschungszentrum (DKFZ).
She said the new programs will enable DKFZ to grow its staff from its current 2,200 members, including 1,000 scientists, to 3,000 staffers. Schuster said that is a result of both the renovation and DKFZ's function as a core center in the German Consortium for Translational Cancer Research.
The new staffers, as with the veterans, will be working from the eight-story main building that DKFZ began using for science purposes more than 30 years ago. Over time, the facility became obsolete, necessitating the repairs, Schuster said.
Those repairs and renovations began with the eastern part of the high-rise building in 2006. Two years later, in July 2008, the first employees were able to move from the old west wing into the newly renovated offices and laboratories of the east wing. Renovation of the west wing also took about two years, and since last month, work in the whole main building has been back to almost normal, according to DKFZ.
"To keep our cancer medicine and cancer research at the highest level we need to attract the best brains from all over the world. For this we have to offer excellent working conditions, modern equipment, laboratories with the best available technology, and appealing premises," Schuster said.
DKFZ receives 90 percent of its funding from the German Federal Ministry of Education and Research, and the remainder from Baden-Württemberg.
The renovation of DKFZ's main building was funded mostly by the German Ministry of Education and Research, which provided about €70 million, with another €7 million coming from the Ministry of Science, Research and the Arts of the German state of Baden-Wuerttemberg.
Kemwell has started constructing a new non-sterile liquid facility in Bangalore to meet the region's increasing demand. Kemwell is one of India's largest liquids manufacturers, having been supplying to customers such as GSK and Pfizer for decades.
Scheduled for completion in May 2011, the plant will double Kemwell's current capacity to produce 250 million bottles per year, with provisions to increase capacity by another 60 million bottles annually. The facility will be highly automated and flexible to service both large and small requirements of Kemwell's current and new customers. It will also be designed the meet the quality requirements of regulated markets.
In India, Kemwell currently operates between two sites. With the new facility, all manufacturing will shift to its site in Neelamangala. The consolidation will reduce costs while maximizing the efficiency of the organization, manufacturing, inventory management and supply chain.
"The move also gives us an opportunity to relook at the entire liquids manufacturing process," said Anurag Bagaria, VP business development. "Working with consultants, the new facility is being designed with a lean manufacturing layout, streamlining the manufacturing methods to maximize value and minimize waste in the process. We are also collaborating with our customers at the design stage itself to ascertain that we meet their needs to the fullest extent possible."
Liquids manufacturing has been one of Kemwell's core competencies and the plant will benefit from the team's 25 years of expertise and knowledge. The new facility will enable Kemwell to supply to its existing customers effectively while positioning the business to meet the regional market's growing demands. Kemwell has also recently forayed into the large molecule space and is building a new biopharmaceutical facility at the same site in Bangalore in collaboration with Boehringer Ingelheim, Germany. It is also expanding its pharmaceutical development labs which are present on this site to meet the contract R&D needs of its existing and new customers.
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