PHARMACEUTICAL & BIOTECHNOLOGY INDUSTRY
UPDATE
January 2013
McIlvaine Company
TABLE OF CONTENTS
AAIPharma Expands Manufacturing
Exela Expands North Carolina Facility
Iroko Pharmaceuticals Global Headquarters, Philadelphia
Novo Nordisk's Type I Diabetes Research Facility, Seattle
NanoViricides Retains AES Clean Technology for Cleanroom Suite
Catalent Expands Inhalation Capabilities
Biomedical Structures Expands Facility
Training Facility Offers Cleanroom
Pluristem Completes New Manufacturing Facility
Lewis Integrative Science Building, University of Oregon
Neurosciences Research Building, Indiana University
Flambeau Medical Adds Cleanrooms
Health Diagnostics Laboratory Expands
Chemsultants International Adds Cleanrooms
Mt. Sinai's Science and Medical Center Opens
Isis Pharmaceuticals New R&D Facility, California
Amgen to Spend $200M on Singapore Drug Facility
Pfenex Partner Expands Production Capacity
Idifarma Gains High Potency Authorization
Almac Doubles Development Capacity
Kemwell Plant Passes U.S. FDA Inspection
Canada Funds Livestock Genomics Center
Norbert Dentressangle Opens Cleanroom
Novartis Pharmaceutical Manufacturing Plant, St Petersburg, Russian Federation
SCHOTT Pharmaceutical Packaging Plant Expansion, Zavolzhe, Russian Federation
Immunovative Upgrades Manufacturing Facility
Avid Completes Bio-Facility Upgrades
Abbott Expands Potent Capability
Aptar Pharma Expands in Germany
Roche Plans for Center in Germany
Fluidigm, Genome Institute of Singapore Establish Single-cell Genomics Center
Shionogi Pharmaceutical Research Facility, Osaka, Japan
Roche to Build Diagnostics Production Facility
Clondalkin Wentus GmbH Enhance Environmental Credentials
Nypro Healthcare Expands in Ireland
Harlan Laboratories Investing in Switzerland
New Sino-Cambodian Food Lab Opens in Phnom Penh
TOT Biopharm Completes Project
Suzhou Pharma Services Receives Latest SFDA GMP Certification
AAIPharma Services Corp., a provider of pharmaceutical product development services, is expanding the capacity and capabilities of its parenteral manufacturing facility in Charleston, S.C.
Facility expansions currently underway at AAIPharma's Charleston location include the installation of compounding and aseptic processing suites to contain a newly acquired Monoblock vial filling machine, expansion of the microbiology laboratory with a new cleanroom, and addition of on-site formulation development capabilities and enhanced analytical instrumentation.
AAIPharma's FDA- and EU-approved facility utilizes disposable product contact components and maintains redundant critical capabilities to minimize potential downtime. The fill and finish capabilities support vial sizes from 2 to 50 mL and can include 100% weight check. Manufactured products include solutions, lyophilized products, emulsions, and suspensions with batch sizes ranging from a few hundred vials to 20,000 or more.
"In addition to the new fill line, integration of our formulation development and technical services capabilities through the build-out of a new pilot suite allows us to seamlessly support the manufacturing process from development through scale-up, further enhancing our compound to clinicTM strategy" says Paul Maffuid, Ph.D., vice president of pharmaceutical operations. "Expansion of the existing laboratories with a new clean room for on-site sterility testing using isolator technology continues our primary objective of providing a world-class parenteral manufacturing facility with all supporting infrastructure under one roof."
AAIPharma Services Corp. is headquartered in Wilmington, NC.
Exela Pharma Sciences will invest $8.5million in its research and manufacturing plant in North Carolina. The venture, to be spread over the next three years, will provide 38 new jobs almost doubling its present workforce.
The 20,000 sq.ft. cGMP site in Lenoir, Caldwell County offers R&D and manufacturing of injectable, ophthalmic and inhalation solutions both in-house and on a contract basis.
The expansion is supported by an $189,000 grant from the One North Carolina Fund. The local economy has been boosted by this fund, backed by State governor Bev Perdue, and the area has cultivated a high-end business climate attracting a plethora of biotech companies.
According to the North Carolina Department of Commerce, state investment of $1.2billion in the last ten years has led to more than 538 bioscience companies having operations in the area, employing over 58,000 people.
The world’s first state-supported biotechnology centre is based there, as are many of the Big Pharma companies, including GlaxoSmithKline, Novartis and Pfizer.
Iroko Pharmaceuticals inaugurated its new global corporate headquarters in December 2012 at the Navy Yard Corporate Centre in Philadelphia, PA, in the U.S. The building was developed by Liberty Property Trust and Synterra Partners. Liberty invested $15.4m in the project.
"The new global headquarters will focus on bringing therapeutic improvements through lower dose submicron non-steroidal anti-inflammatory drugs (NSAIDs)."The Navy Yard Corporate Centre is a business campus spread over in 1,200 acres. More than 120 companies have established their offices and more than 10,000 people have been employed in the research, manufacturing and development sectors. It has been developed and operated by Philadelphia Industrial Development Corporation (PIDC), a real estate group.
The new global headquarters is situated in a four-storey building with a floor space of
56,412 sq. ft. It will focus on bringing therapeutic improvements through lower dose submicron non-steroidal anti-inflammatory drugs (NSAIDs). The company has employed over 60 people in the new building, and plans to accommodate up to 180 employees in the next two years.
The company's product portfolio includes pain relievers such as Indocid (indomethacin) capsules, which are used for rheumatoid arthritis, osteoarthritis, acute bursitis and tendonitis of the shoulder, and Aldomet (methyldopa) tablets, used for the treatment of various forms of hypertension.
These drugs will be produced using SoluMatrix technology developed by iCeutica. The technology reduces the drug particles to finer particles that are at least 10 times smaller than standard NSAID drug particles. It will also improve drug-dissolution properties without altering the chemical structure of the drug.
Iroko broke ground for the construction on the new headquarters building in September 2011. The topping off ceremony was held in March 2012. The final construction was completed and the facility was opened for commercial activity in December 2012.
The design contract for the new headquarters building was awarded to DIGSAU. The building construction contract was awarded to Penn Construction.
The building was designed to obtain LEED-CS Gold certification. It was built in compliance with LEED (Leadership in Energy and Environmental Design) categories as well as sustainable design principles.
The building was mostly built with the locally available materials. It features an energy-efficient building-wide area network (BWAN) system, which can track and manage energy use through a phone, computer, or PDA. The BWAN system was developed by Liberty.
Iroko Pharmaceuticals is a US-based pharmaceuticals company engaged in the development and marketing of innovative therapeutic products. It maximizes the potential of existing marketed products by developing new formulations according to the patient requirement, and introducing new product-life-cycle management activities. Its products are marketed across 48 countries in the world. The company has many products developed on NSAID submicron technology. The company established the first offices at Navy Yard in 2007.
More than 100 million prescriptions in a year in the US are written for NSAIDs. The currently marketed NSAIDs contain higher doses, which result in developing the risk of cardiovascular events, gastrointestinal bleeds, and ulcers in the patients who regularly use them for a longer time. Iroko produces and develops lower dose submicron NSAIDs from the existing commercial drugs that will provide helpful pain relief at a very low dose.
The largest city in the north-western United States, Seattle, has become a hub for pharmaceutical research activity with the world's leading pharmaceutical companies establishing their research and development (R&D) centers there.
Denmark-based Novo Nordisk announced it was to set up a new R&D centre for immunological research in the city in January 2012, more than three years after announcing an inflammation R&D centre in 2008.
The company opened the inflammation research centre in Seattle in September 2009.
The research focus of the new R&D centre, announced in January 2012, is type 1 diabetes.
The company officially opened the facility in June 2012. The research activity at the facility is supported by a team of 20 researchers.
Novo Nordisk established the type 1 diabetes R&D centre with the intention of taking the lead in advancing the scientific research in the area to the next level, given the significant rise in type-1 diabetes patients.
"The type 1 diabetes R&D centre in Seattle is located on the same premises as the inflammation research centre, which was opened in 2009.
The company believes that the collocating of the two research centers brings about synergies in the R&D activities. The existing research centre complements the biopharmaceutical research activities of two of the company's R&D sites in Denmark and China.
Novo Nordisk's corporate offices in the US and Denmark support and oversee the activities of the new diabetes R&D centre.
Matthias von Herrath, who heads the research team at the facility, is a scientist specializing in auto-immune diseases.
The R&D centre combines basic research and early proof-of-concept trials on type 1 diabetes under one roof, which is a unique translational approach.
This approach enables the company to speed up the transition of early-stage discovery projects based on animal models to small clinical exploratory trials.
Novo Nordisk has developed many innovative products for the treatment of diabetes.
"Novo Nordisk specializes in diabetes research and has 88 years of experience in diabetes care."Most researchers and pharmaceutical companies, including Novo Nordisk, have however focused majorly on developing treatments for type 2 diabetes in the last ten years.
Type 1 diabetes, as a result, lacks major scientific progress.
According to the International Diabetes Federation's 2011 estimates, 5% to 10% of diabetics worldwide are suffering from type 1 diabetes. The report also estimates that there are 366 million diabetics worldwide.
Novo Nordisk believes the establishment of a dedicated R&D centre for type 1 diabetes research enables it to transform its medical research expertise in immunology to the successful development of life saving treatments for diabetes patients.
Type 1 diabetes is caused by the body's natural defense system impeding insulin production in an auto-immune reaction. Insulin is a hormone produced by the pancreas.
The hormone controls the glucose level in the blood by causing the body cells to take up the excessive glucose from the blood. This action is essential to regulate the carbohydrate and fat metabolism in the body.
Lack of insulin production in diabetics causes the glucose levels to rise, which causes chronic complications or even death. Diabetics hence need to be injected with insulin to control the blood glucose levels.
The Seattle R&D facility conducts research to discover treatments for type 1 diabetes. It first puts these discoveries to laboratory testing on mice and then conduct human clinical trials.
Novo Nordisk specializes in diabetes research and has 88 years of experience in diabetes care. It produces several diabetes drugs. The company is headquartered in Denmark and has research centers in Måløv (Denmark), Beijing (China) and Seattle (the US).
NanoViricides, Inc. announced that it has retained AES Clean Technology, Inc. ("AES"), for the design, engineering, and construction of the Cleanroom Suite for its laboratory and cGMP pilot production facility project. The Cleanroom Suite comprises the main cGMP manufacturing sections of the pilot plant. This Suite provides for walk-in, process scale, Class 100 laminar hoods; walk-in, process scale chemical fume hoods; Class 1,000 and Class 10,000 work areas; entry airlock and egress systems.
AES is the leader in turnkey design, manufacturing, and construction, of modular cleanroom systems (www.aesclean.com). Modular cleanroom technology delivers more speed, cleanliness, quality, and repeatable performance to the cleanroom project. AES is a leading vendor in cGMP-compliant manufacturing facilities for Pharmaceutical and BioPharma Manufacturing industries. Their pharma client list comprises several industry leaders and can be found at Leading Industry Leaders in Pharma, Biotech, Medical Device, Semicon, Micro | AES (http://www.aesclean.com/aes-portfolio/industry-leaders).
"AES has the industry expertise in designing and building modular, validated, cGMP manufacturing suites for pharmaceutical industries," said Anil R. Diwan, PhD, President, NanoViricides, Inc., adding, "We are very pleased to have such experts working with us to enable this project in a cost effective fashion without compromising on quality or performance."
As previously announced, this facility will be built by renovating an existing 18,000 sq. ft. light manufacturing plant on a 4.2 acre lot in Shelton, CT. AES will be responsible for the critical cGMP manufacturing suites space. In addition, NanoViricides, Inc. has retained ID3A architects as the Principal Architect for the project and integration of the separately constructed Clean Room Suite for cGMP production. Ms. Kathyann Cowles, AIA, of ID3A joins Mr. Phil Mader of MPH Engineering, LLC (MPH) , and Mr. Andrew Hahn, to complete our architecture, design and construction management team. As previously announced, Mr. Hahn continues to provide overall stewardship of the project, while Mr. Mader is responsible for detailed project management, and his firm, MPH, is providing engineering services.
The company has previously reported about the Shelton light industrial building that will house the cGMP pilot production plant, research laboratories, and offices. The cGMP pilot plant is being designed for the production of sufficient quantities of the drug needed for human clinical trials for each of the various nanoviricides® drug candidates as they advance into the clinical pipeline.
The light industrial building at 1 Controls Drive, Shelton CT was purchased by Inno-Haven, LLC. Inno-Haven is a private company that was founded by Dr. Anil R. Diwan, the company's CEO, and financed by himself and certain of his friends and associates, with the specific purpose of enabling clinical cGMP manufacturing capabilities for NanoViricides, Inc. drug substances. Acquisition of this 18,000 sq.ft. building on 4.2 acres of land was previously announced by NanoViricides, Inc. in September, 2011. Renovation of the building is to be performed as per the requirements of NanoViricides, Inc. for the production of the nanoviricides drug candidates for clinical trials under cGMP processes. The drug substance produced in this facility will then be delivered to a third party for final processing and labeling, as required, for human clinical trials when ready. NanoViricides, Inc. expects to lease this facility. No lease has been signed yet and no terms of lease have been finalized as of now.
Catalent Pharma Solutions is expanding its inhalation drug development, delivery and supply capabilities at its Inhalation Center of Excellence in Research Triangle Park (RTP), NC. The $20 million investment will focus on expanding pressurized Metered Dose Inhaler (pMDI) clinical and commercial supply capabilities.
Catalent provides a broad range of inhalation services including API optimization, pre-formulation, formulation, analytical testing and manufacturing across all inhaled dosage forms at the RTP facility.
“Pulmonary and nasal represents the second largest drug delivery market by delivery route. Catalent’s investment in commercial manufacturing at our Inhalation Center of Excellence not only fits with our advanced drug delivery growth strategy, but also positions us as a world leader supporting inhaled products,” said Scott Houlton, president of Catalent’s Development and Clinical Services business.
“In addition to the introduction of scalable processes for micro-dosing inhalation powder formulations, and the recent commissioning of our new nasal filling suite, this $20 million investment will upgrade our pMDI manufacturing capacity and allow us to better support our customers from early development all the way through to commercialization; bringing more products and better treatments to market faster,” Mr. Houlton added.
Catalent provides a range of inhalation services including API optimization, pre-formulation, formulation, analytical testing and manufacturing across all inhaled dosage forms at the North Carolina facility, and at its advanced aseptic development and fill/finish supply solutions facility in Woodstock, Illinois.
Biomedical Structures LLC, a developer of biomedical textiles for medical devices and other advanced clinical applications, has expanded its facilities in Warwick, R.I., for medical textile development and manufacturing. The expansion includes a 10,000 sq. ft. addition, which will support the engineering center for new product development, and an increase in total cleanrooms for biomedical textile development.
Ultrasonic and roll-to-roll triple cleaning capabilities are part of the expanded cleanroom space, which triples BMS' 2011 total. BMS has also increased weaving capacity with equipment to accommodate demand for vascular grafts, synthetic tendons, orthopedic tissue repair, and other woven textile structures.
BMS offers expertise in knitting, braiding, weaving, nonwovens, and composites, and utilizes a broad offering of biocompatible absorbable and non-absorbable materials in devices, drug delivery, and surgical systems for advanced applications such as bifurcated stent grafts, tapered tendon and ligament repair structures, and heart valve solutions.
Construction of the future training facility for Local No. 773 of the United Association of Plumbers and Steamfitters union is about three-quarters done.
The state-of-the-art building, which includes a working cleanroom in which to train members for work at high-tech facilities like the GlobalFoundries computer chip plant in Malta, is likely to be finished in mid-March, though some exterior work will continue as the union and its apprentices move into the new digs.
The 18,000-square-foot building reveals inner workings — plumbing, heating, air-conditioning and other infrastructure — that are the subject of study for the approximately 75 apprentices expected to train there this year.
Scott Martel, the union’s business manager, provided the tour of the facility, which is located in the city’s Tech Meadows business park at the intersection of Luzerne and Veteran roads. The park is surrounded by the town of Queensbury but belongs to the city of Glens Falls.
The 600 sq. ft. cleanroom training space is located just inside the main entrance to the building, behind glass panes that provide a view of the training soon to take place there.
Clean rooms are used by manufacturers of computer chips — as well as medical devices and other products — to minimize or eliminate contaminants in the manufacturing process. They require a level of climate control that results in contaminants being measurable in parts per million.
As a result, they require specialized construction and maintenance skills from the professionals hired to build them and keep them working.
“It’s nice because visitors will be able to see what’s going on in the cleanroom space,” Martel said of the glass wall.
The new facility will also include 18 “green” welding stations that capture all waste gases from welding projects, several offices for union officials, a computer lab for computer-aided design instruction, a multi-purpose meeting room and five other classrooms.
Martel said the construction project is on schedule and should be complete — including the exterior work — in April or May.
Pluristem Therapeutics, Inc. has initiated the final validation steps for its new manufacturing facility, including the validation of several installation systems such as heating, ventilation and air conditioning (HVAC), water, oil free air and sterile room systems.
Zami Aberman, chairman and chief executive officer of Pluristem, said, "I am extremely proud of our team in meeting milestones for the completion of the world's first commercial cell therapy manufacturing facility. Assuming the PLX cells product candidates are successfully developed and approved by the regulators, we believe that the new facility would have the capacity to produce PLX cells for the treatment of over 150,000 patients annually estimated by Pluristem at $1 billion in production value. Additionally, as clinical trials are approved by regulators for additional indications, our new facility will enable us to supply PLX cells to conduct these trials in parallel."
University of Oregon's (UO) new Robert and Beverly Lewis Integrative Science Building (LISB) was opened in November 2012. Named after the university's alumni, Robert and Beverly Lewis, the new facility was built at a cost of $65m.
The facility will carry out cutting-edge, interdisciplinary research activities. It will be home to biologists, psychologists and researchers of various disciplines.
Research activities form a core part of UO's functions. In 2011, the university sponsored $120m in research activities which fostered innovations. This in turn generated about $7.9m revenue through licensing for the university. These activities also supported the Oregon economy and generated new jobs.
The LISB will help in further expanding the university's research activities. It will address the need for additional research space required due to increase in enrolment and sponsored research activities.
The facility will enable researchers to focus on individual as well as collaborative research activities. It will bring different groups of researchers together to carry out fundamental research starting from cellular processes to finding cures for major ailments.
LISB is located within the university's Lorry I. Lokey Science Complex. It links all the other science buildings in the complex including Lokey Laboratories, Huestis Hall, Streisinger Hall and Klamath Hall.
LISB is spread over an area of 103,000 sq. ft. and includes five levels. Four levels are above ground and include laboratories, 46 faculty offices, wet and dry labs, ERPS booths, meeting areas and office space. About 30,000 sq. ft. of laboratory space in the facility is dedicated for life and materials sciences. The underground level houses mechanical equipment.
The facility has been designed to encourage collaboration between researchers. The labs have an open layout design with shared laboratory facilities. All the walls and doors of the building are made of glass enabling equipment and facilities to be viewed from outside. The atrium has glass walls and stadium style seating. The walls double up as a whiteboard inviting participation and sharing of ideas.
"The facility has been designed to encourage collaboration between researchers. The labs have an open layout design with shared laboratory facilities. "LISB houses the Support Network for Research and Innovation in Solar Energy (SuNRISE), the Center for Sustainable Materials Chemistry (CSMC), and the Robert and Beverly Lewis Center for NeuroImaging.
SuNRISE is an instrumentation facility which can be used by industrial and academic clients for a fee. The CSMC will carry out green chemistry research.
The NeuroImaging centre will carry out research in cognitive neuroscience and other disciplines. It is equipped with a Siemens MAGNETOM Skyra 3T magnetic resonance imaging (MRI) scanner, which can carry out full body scans. The scanner weighs nearly 12,716lbs and was installed by removing an exterior wall of the facility. It cost about $2.7m and will be used to carry out neuroscience research.
About $30m of the funding for the LISB came in through Article XI-G bonds, which is the biggest G-bond investment made in the university's history. The remaining $35m came in the form of grants and private donations. Donors included Robert and Beverly Lewis ($10m), Lorry I Lokey, William Swindells, the James R Kuse Family Foundation and Rosaria Haugland.
The MRI scanner was partly funded by a federal grant provided by the Telemedicine and Advanced Technology Research Center (TATRC).
Construction of a new neurosciences research building at Indiana University (IU) was initiated in August 2012, and is scheduled to be completed by 2014. It is located near 16th Street and Senate Avenue, near the IU Health Methodist Hospital.
LISB has been built according to Leadership in Energy and Environmental Design (LEED) Platinum standards. It makes extensive use of natural daylight and features a green roof. The roof includes a heat recovery unit which recovers heat from exhaust air. The majority of the heat required by the building is provided by the unit. A total of 28 solar panels are also installed on the roof top for preheating water.
The building is fitted with chemical fume hoods featuring automatic sashes. The sashes automatically close when idle and conserve energy by reducing exhaust flow.
Bamboo has been used for majority of the wood finish works in the facility. The energy usage by the building is reduced through use of chilled beams and radiators.
Other sustainable features include building control and daylight sensors, green lights, and reclaimed water usage.
HDR and THA Architects were the architects for the building. The construction manager was Lease Crutcher Lewis.
Flambeau Medical Markets Group has purchased a 16,000 sq. ft. building adjacent to the company's two-building campus in Phoenix, Ariz. The building is being renovated to accommodate a 3,600 sq. ft. Class 7 medical device assembly room. A separate Class 8 injection molding room will hold six all-electric molding presses.
Flambeau Medical Markets Group has recently attained its ISO 13485, the QSR for medical device manufacturing, and implementing recognized quality systems including RFID labeling, tracking and traceability for internal controls to meet FDA standards. Half of the company's processing capabilities are in blow molding and the other half in injection molding.
The company has a range of capabilities to serve the cardiovascular device, orthopedic device, respiratory care, fluid management, and packaging segments within the medical market. The Phoenix operation also provides mold/tooling design engineering and manufacturing providing SPI Class 101 multi-cavity molds for high volume production.
A rapidly growing Richmond biotech firm is moving forward with the massive second phase of an expansion to its downtown headquarters before even finishing the first phase.
Health Diagnostics Laboratory last week filed a plan of development with the city to tack on 100,000 square feet to its six-story, 112,000 sq. ft. new home that is under construction at the corner of Fifth and East Jackson streets in the Virginia Biotechnology Research Park.
The project, expected to cost about $24 million, will allow the company to accommodate 400 new employees that it plans to hire over the next two years, chief executive Tonya Mallory said.
“We’re popping at the seams right now,” Mallory said. “We will be in the new building in the first quarter of next year, and we’ve already filled it. So we are going to move ahead with the second phase, and we’ll be in there by 2014.”
HDL and its 607 employees currently occupy two buildings in park, the 76,000-square-foot Biotech 8 and Biotech 5. Biotech 5, at the corner of East Jackson Street and Navy Hill Drive, will be demolished to make way for HDL’s second phase.
Founded in 2009, HDL runs lab tests to detect various diseases and helps manage patients’ cases as a third party. It announced plans for its downtown expansion in November 2011 without a set timeline for the second phase.
Mallory said the push for the second phase is necessary to accommodate the company’s growth. The additional 400 employees will be hired before HDL cuts the ribbon on the second expansion.
“We’ll be up to 1,000 employees at that point,” Mallory said.
The second phase is being financed by Fulton Bank and StellarOne Bank, Mallory said.
Demolition on the second site should start in March. Whiting-Turner is the general contractor, and the Lingerfelt Companies is the developer.
Lingerfelt Companies head Al Lingerfelt said this is one of the largest developments he’s worked on and the largest his company is working on currently.
“It’s great to have this in our portfolio,” Lingerfelt said. “The biotechnology space is an area we want to specialize in, and obviously HDL and the other tenants down there are high-quality users.”
Lingerfelt is also the developer on the first HDL building being built at the biotech park. The result will be a 212,000-square-foot expansion with a combined cost of about $75 million, Lingerfelt said.
Bob Skunda, chief executive of the Virginia Biotechnology Research Park, said companies like HDL are an example of why the biotech park was started in the 1990s.
“The whole reason the park was created was for economic development,” Skunda said. “I think the most important thing HDL has added to Richmond is those 600 jobs, and they are still growing.”
He said that once HDL’s two projects are complete, Biotech 8 would be 288,000 square feet.
Mayor Dwight Jones said the second phase of expansion was even larger than HDL had planned when his office announced it last year. The city is contributing a $1.35 million performance-based grant for HDL’s expansion.
“When we originally announced the HDL expansion in November of 2011, it was estimated that Phase 2 would include an additional capital investment of $30 million and the creation of 300 additional net new jobs,” Jones said in an email to BizSense. “True to form, HDL continues to outperform expectations and we are delighted that we are now looking at the addition of 400 new jobs when the second phase is completed.”
Mark Douglas, a broker with Cushman & Wakefield | Thalhimer, said HDL’s expansion could be enough to drive development in the Jackson Ward area.
Mission Micro Molding Corp. is expanding its facility and adding new equipment to meet customer demands. The expanded Class 100,000 cleanroom facility improves the assembly capability space. The space for the assembly can service multiple lines of assembly and manufacturing including secondary component sub assembly and packaging to meet customers' needs.
The facility expansion also improves on the main business of Mission Micro Molding of providing micro and small part injection molded plastic components. The cleanroom molding is a standard for the company and with the new upgrades Mission Micro molding is adding several new lines of machinery to complement the existing molding lines.
"It is a great opportunity for us to expand and meet our customers' needs for both injection molding and assembly in a cleanroom environment," says Lisa Carr, president.
Mission Micro Molding specializes in .01 gram to 13 gram parts only. Services include injection molding, insert molding, over molding, and assembly. The equipment is specific for micro and small part molding. The company prototype, short run, and production of small and micro sized plastic parts in many materials including PEEK, Delrin, Santoprene, PP, PE, Polycarbonate, and PMMA.
The company is based in Mission Viejo, CA.
The upgrade houses the company's TPC-2 Pilot Coating line which offers multiple coating capabilities. This capability is designed to complement the capabilities of the company's other Pilot Coating line, TPC-1. The upgrade features GMP and cleanroom capabilities with segregated manufacturing areas for mixing, coating, and finishing processes. Other coating capabilities include web cleaning, online coating and substrate measurement, and multiple coating methods including slot die and roll coating.
The TPC-2 cleanroom facility was designed to produce custom PSA and other coated materials that Chemsultants develops for its clients' manufacturing medical diagnostics and devices, wound care, pharmaceuticals and transdermals, as well as the electronics and energy industries.
According to COO Gary Avalon, the cleanroom facility satisfies marketplace preferences for goods that have been produced in a cleanroom environment. "OEMs of medical products prefer doing business with suppliers whose operations are as clean as or cleaner than their own," Avalon says, explaining the rationale behind the new facilities and equipment.
Chemsultants is currently pursuing ISO 13485 certification for its manufacturing facility and expects to achieve this status by March 2013. This will complement the A2LA accredited laboratory that is ISO 17025 certified.
Chemsultants International is a researcher, developer, and tester of polymer-based products and technologies. The company is based in Fairfield, Ohio.
A new center for science and medicine at the Mt. Sinai Medical Center in New York opened housing areas of the medical center's "most influential institutes" focused on genomics, brain, cancer, heart, children's health, and imaging.
The Leon and Norma Hess Center for Science and Medicine has half-a-million square feet of space, increasing Mt. Sinai's research capacity by almost 30 percent, and resulting in the increased facilitation of collaboration between its researchers and clinicians across multiple disciplines, Mt. Sinai said.
The center will be the "focal point" of Mt. Sinai's research and clinical programs, Kenneth Davis, president and CEO of the medical center, said. "The combination of world-class faculty and state-of-the-art equipment and facilities will expand our ability to understand and treat the most challenging medical problems in areas such as cancer, heart disease, and brain and nervous system disorders."
Space for clinical research has increased to 50,000 square feet in the new center, and Steven Burakoff, director of the Tisch Cancer Institute, said that the setup "provides multidisciplinary care right in the building: radiation, infusion, imaging, and genomics will be there. We can share ideas with the cardiovascular institute, imaging, neuroscience, genomics, and child health — and be near the patients."
Isis Pharmaceuticals inaugurated a new research and development (R&D) facility at Carlsbad in California. The new facility is provided with sophisticated drug discovery and development facilities. It acts as both corporate headquarters and R&D centre for the company. It was built at a cost of $49m.
The facility is located at Carlsbad Oaks North Business Park, which is a 414 acre development in Carlsbad, built for corporate business development. The Carlsbad Oaks North is developed by BioMed Realty Trust. The completion of the new facility increased the total space rented by BioMed to Isis to 204,700 sq. ft.
The research laboratory at the facility is built over a floor space of 176,000 sq. ft.. It features modern laboratories for the promotion of innovation and to encourage interdisciplinary collaborations. It has ample outdoor space for informal meeting areas and for the exchange of ideas. It is also features laboratories with mobile bench cabinets.
The building is incorporated with modern design features such as maximum use of natural lighting, eco-friendly equipment such as solar panels and drought-resistant native landscaping. It is expected to qualify for Silver LEED certification from the US Green Building Council.
The new facility is used for carrying out research, discovery and development of new drugs by using antisense technology to treat various diseases. It is engaged in the development of RNA-based drug discovery.
The research facility was designed by DGA, an architectural firm based in San Diego. The general construction contract was awarded to DPR Construction, which is also based in San Diego. DPR also acted as construction manager and management advisor for the project. The civil engineering services were provided by O'day.
Isis Pharmaceuticals is a U.S.-based biopharmaceutical company engaged in the discovery and development of novel drugs. The company has a product portfolio of 24 drugs including those for the treatment of metabolic, cardiovascular, cancer, and neurodegenerative diseases. It primarily focuses on drug discovery and productivity.
The University of Rochester Medical Center (URMC) has opened the doors on a new facility that will enable researchers to create, study, and ultimately use stem cells and their offspring in early-phase experimental human therapies.
The Upstate Stem Cell cGMP Facility – which will be used by academic and private-sector scientists from across the state – was created with $3.5 million in support from the Empire State Stem Cell Board.
The Upstate Stem Cell cGMP (current good manufacturing practice) facility is located in the URMC's DelMonte Neuromedicine Research Institute. The facility, its operation, and the people that work in it meet federal manufacturing guidelines necessary to ensure that biological materials produced there are suitable for human clinical trials. These guidelines require that the lab is a cleanroom facility with strict air quality standards and is designed, maintained, and monitored in a manner that prevents contamination. In addition, personnel must follow strictly defined manufacturing protocols and the cellular products must be subjected to rigorous testing that ensures their quality, safety and reproducibility.
In order to meet these requirements the Upstate Stem Cell cGMP Facility incorporates several design features including redundant air handling systems, walls covered with a fiberglass gel coat that aids in cleaning, and a building monitoring system that enables staff to remotely monitor air quality and room and equipment parameters 24 hours a day. The facility is designed to utilize unidirectional flow, meaning that researchers and materials enter the lab through an air lock and depart through a different exit to ensure that contamination from the outside is not carried into the facility or among different labs.
"Our scientists have made tremendous progress over the last several years unlocking the potential of stem cells to treat a long list of diseases," says Bradford C. Berk, M.D., Ph.D., CEO of URMC and a member of the Empire State Stem Cell Board. "I anticipate that this new facility will accelerate research across that state and make Rochester a center for the development of new cell-based therapies."
There are more than 40 labs at URMC that are working with stem cells. These labs employ more than 260 scientists and technicians and collectively have more the $80 million in total research funding.
"This facility represents the key bridge to early stage trials in humans," says Mark Noble, Ph.D., director of the URMC Stem Cell and Regenerative Medicine Institute. "We are now poised for early stage clinical studies in a wide range of conditions, including efforts to repair damage to the central nervous system, re-grow bone and cartilage, and even selectively target and destroy the stem cells that are the source of some forms of cancer."
The 3,600 sq. ft. facility consists of three separate labs that can each support different cell production projects. Several pending projects will immediately begin using the facility, including the use of glial progenitor cells, which are responsible for generating important support cells in the central nervous system, to repair spinal cord damage; the use of glial progenitor cells to treat patients with multiple sclerosis; the development of a new method to grow mesenchymal stem cells, the cells responsible for healing bones and keeping them healthy; and the development of a new approach to use retinal stem cells to restore vision in persons with age-related macular degeneration, the leading cause of blindness in Americans aged 60 and older.
"This facility is a true boon to stem cell researchers across New York State," says State Health Commissioner Nirav R. Shah, M.D., M.P.H. "This state-of-the-art facility will help take the basic research findings of the state's outstanding scientists and help move them into the clinic, all the while ensuring that any cell products are produced in accordance with the strictest standards for use in human patients. Not only is the facility supported by the NYSTEM program, but it is a key component of several of the Consortia to Accelerate Therapeutic Applications of Stem Cells recently awarded by the Empire State Stem Cell Board. Together, the facility and the consortia will help bring therapies for devastating diseases to the people of New York State."
Impact Analytical will relocate to new facilities in Midland, MI early next year, increasing capacity by 20%. The new location will include new labs and expands the company's existing facility by more than 10,000 sq.-ft. The expansion will allow operation of more than 80 instruments and house 35 scientists across laboratories designed to provide elemental analysis, microscopy, molecular characterization, gas separations, liquid separations and thermal/mechanical properties.
“Impact Analytical is committed to exceeding customer expectations in every way,” said business manager Eric Hill. “Our new facility is being remodeled to create a laboratory space that is tailored to perform analytical testing services, incorporating design elements that maximize efficiency, safety and standardization. The result will be a world-class analytical testing laboratory in form and function.”
Cadence Inc., a provider of medical device outsourcing solutions, will open a finished medical device facility in Cranberry Township, Pa., in the first quarter of 2013. The 21,000 sq. ft. facility will include up to 10,000 sq. ft. of Class 10,000 cleanroom space, as well as 5,000 sq. ft. of office space.
The company expects to employ as many as 60 people in the new facility, which is located just outside of Pittsburgh. Pittsburgh was chosen for Cadence's newest facility because of the availability of employees with specialized medical device knowledge and experience, as well as the city's proximity to existing Cadence facilities.
Cadence creates medical technologies for minimally invasive devices. The company is headquartered in the Green Hills Technology Center in Staunton, Va.
Biogen Idec dedicated a new facility in Research Triangle Park (RTP), consolidating its 300-person Patient Services operation with the existing RTP campus. The new 190,000 square foot building is anticipated to achieve LEED-Gold certified status in the coming months and will accommodate increasing levels of manufacturing activity at the site. The official groundbreaking for the building was in April of 2011.
“With the opening of this beautiful facility Biogen Idec has united on one site more than 1,000 people dedicated to meeting the needs of patients with serious diseases,” said George A. Scangos, Ph.D. and chief executive officer, for Biogen Idec. “The expansion of our footprint in RTP underscores our commitment to providing a secure supply of medicines and to helping patients overcome obstacles to receiving them.”
As the “front door” to the Biogen Idec campus in North Carolina, the five-story Building 26 will initially house 500 employees.
“Our RTP site focuses on patient care – from manufacturing high quality therapies to providing patient support and financial assistance. With this new building, our employees are constantly reminded of our purpose through the patient stories that adorn the main areas and workspaces within the building,” said Machelle Sanders, vice president, Manufacturing and general manager, for Biogen Idec RTP.
“North Carolina is a leader in biotech and Biogen Idec is an important part of that success,” said Gov. Bev Perdue. “This new facility will further strengthen the company’s manufacturing and Patient Services operations, in addition to helping ensure its continued success in North Carolina.”
As the second largest independent biotech company in North Carolina and ninth largest employer in RTP, Biogen employs more than 1,000 people in the state.
Biotechnology company, Amgen Inc., said it plans to spend $200 million over the next several years to build a new antibody manufacturing facility in Singapore.
Amgen said the facility will make clinical and commercial products. The drugs will be monoclonal antibodies, which use a person's immune system to fight diseases. Construction is expected to start in the next few months.
Amgen makes several monoclonal antibody drugs, including the bone drug denosumab, cancer treatment Vectibix, and experimental products including the cholesterol drug AMG 145 and osteoporosis drug AMG 785. Denosumab is marketed under the name Prolia as a treatment for osteoporosis, and a different dose of the drug is marketed as Xgeva for the prevention of fractures in cancerous bones.
In April 2012, Amgen and British drugmaker AstraZeneca PLC agreed to jointly develop five monoclonal antibodies as treatments for inflammatory diseases.
Pfenex, Inc.’s manufacturing partner, Serum Institute of India Ltd., began construction of a new large-scale cGMP production facility for CRM197, which is used in a number of conjugate vaccines for diseases such as meningitis and pneumococcal bacterial infections. Pfenex CRM197 is a recombinant form expressed in Pseudomonas fluorescens using the Pfenex Expression Technology platform.
This new facility is scheduled for completion in 2014 and will be dedicated CRM197 production with annual capacity to produce in excess of 50 kg of cGMP-grade CRM197. Serum Institute uses Pfenex Expression Technology as the production platform, enabling high titers of high quality conjugate vaccine carrier protein.
“CRM197 is increasingly being used by the global vaccine development community, and this new facility allows us to not only meet the growing needs of our current partners, but also allows us to support new research and development efforts,” said Dr. Bertrand Liang, chief executive officer of Pfenex Inc. “By leveraging our long standing relationship with Serum Institute of India, we are able to further provide our partners with access to high quality vaccine components produced using the powerful Pfenex Expression Technology™, all the way from early stage research through the clinic and into commercialization.”
Idifarma, a Spanish contract development organization, has obtained authorization from the Spanish Agency of Medicines and Medical Devices to manufacture commercial batches of both conventional and high potency tablets.
With this authorization, the company can manufacture commercial batches of tablets with high level of specialization due to high containment requirements (cytotoxics, cytostatics, hormonals), or the need to manufacture small-sized batches.
Idifarma was previously authorized to manufacture batches for clinical trials, as well as for quality control and release of medicines for both commercial and investigational products.
General manager Luis Oquiñena said, “IDIFARMA will remain essentially a contract research laboratory specialized in the comprehensive development of medicines for our clients, but without any doubt, this new manufacturing authorization will allow us to offer an even more complete service beyond the elaboration of the registration dossier, and turns us into a long-term partner for our clients.”
Almac has expanded its drug product pharmaceutical development services with a new non-GMP formulation development facility and two new analytical labs at its headquarters in Craigavon, doubling current capacity.
Although dedicated to non-GMP development, the facilities will employ all of the company’s technical capabilities of its existing GMP pharmaceutical development facility, including high levels of control over environmental conditions, as well as extending current capabilities in processing potent compounds with low OELs. The new non-GMP facility will primarily focus on lab-scale experiments, with batch sizes ranging from <1kg up to an expected maximum of 15 kg scale for most technologies.
John McQuaid, vice president of Technical Operations, said, “Our priority was to ensure we had good integration of all technologies in both the non-GMP and GMP facilities. Duplicating equipment trains means that we can conduct non-GMP work efficiently and then transfer rapidly to GMP manufacturing for clinical and registration batches. We are finding that demand for non-GMP process development work has increased as clients seek to better understand their processes in line with the principles of QbD. This type of work also creates large sample sets for analytical testing and multiple stability studies, which is why it was also important that we doubled our analytical capacity in parallel.”
The pre-approval inspection was triggered when the plant in Bangalore was included in a new drug application (NDA) filed with the U.S. regulator by one of the contract manufacturing organization’s (CMO) customers.
The audit involved an in-depth review and evaluation of all systems, procedures and processes related to the development, validation and manufacture of oral solids at the Bangalore site.
The facility – which has been producing around 5 billion tablets a year since opening in 2005 – already supplies pharmaceutical industry customers in Europe and Australia. Kemwell said that it expects to start shipping to customers in the U.S. and Canada in the near future.
Anurag Bagaria, Kemwell Chairman and Managing Director, said the US FDA approval “confirms Kemwell’s cGMP manufacturing capability and regulatory compliance” adding that “we will continue to strive to provide excellent quality pharmaceutical products and deliver on the highest customer service expectations.”
Canada has invested C$575,000 (US$585,000) in the Delta Genomics Centre, a non-profit genomics services provider that supports livestock research to spur development of new genetic profiling technologies.
The Centre will use the funding to collect and analyze, profile, and catalogue cattle samples and to provide data to Canadian breed associations. The Centre provides biobanking, genotyping, and sequencing services for the livestock industry and for the academic research community.
Located in Edmonton, Delta Genomics is the services branch of Livestock Gentec, a research center supported by the provincial government and by the Alberta Livestock and Meat Agency that launched in 2011 with C$3.5 million in support from the Western Economic Diversification program.
"Using genomic tools for breeding and selection can help producers lower costs of production and deliver a better quality product to the market and boost their bottom lines," Parliamentary Secretary Pierre Lemieux said in a statement.
Colin Coros, VP of operations at the Delta Genomics Centre, added "This project is an essential stepping stone to get the benefits of genomics into the hands of producers on the ground. It will allow our project partners to adopt a new sire identification tool, which is fundamental to using more in depth DNA profiles for genetic improvement of Canadian cattle."
Belgian biotechnology firm UCB has awarded Emerson Process Management, a division of industrial engineering company Emerson, a US$6.1 million contract to provide integrated process automation and operations management systems for its new biopharmaceutical production centre in Bulle, Switzerland.
UCB is investing $228 million to construct the first phase of the plant, its first biopharmaceutical project in Switzerland. The 215,200 sq. ft. (20,000 sq. meter) facility, which will be one of the largest in Europe, will be the main production centre for Cimzia (certolizumab pegol), which is used to treat rheumatoid arthritis and Crohn’s disease.
The drug was approved in Japan for the treatment of adults with rheumatoid arthritis at the end of last year.
‘The state-of-the-art and largely automated facility at Bulle will be a model for the industry when it opens in 2015,’ said Michele Antonelli, UCB executive vice president. ‘To ensure the project meets its tight build-out schedule, we selected Emerson Process Management for its demonstrated ability to engineer and coordinate fast-track automation projects of this type.’
This is UCB's first biopharmaceutical project in Switzerland.
Emerson’s integrated solution includes its Syncade Smart Operations Management Suite, DeltaV digital automation system, and AMS Suite predictive maintenance software. Emerson will also provide related engineering services, including design, installation, testing, and commissioning.
The Syncade Suite software integrates real-time plant floor data with business processes, decisions, and asset management. It manages workflow processes, including electronic work instructions, equipment status and material tracking, recipe-driven operations, automated weigh and dispense operations, and exception reporting.
The Syncade software integrates with Emerson’s DeltaV automation system to facilitate operational activities and information flow from the plant floor up to UCB’s SAP system. In the UCB plant, the DeltaV system will control 163 process units including fermentation, purification, filtration, and bottling. Emerson’s new electronic marshalling technology with CHARMs (characterization modules) will help minimize installation time by eliminating up to two-thirds of the wiring and connections needed with traditional control systems.
Emerson’s AMS Suite predictive maintenance software that will be supporting HART instrumentation will make it easy for technicians to calibrate critical instruments, check their status, and detect potential problems before they affect operations.
‘Emerson is delighted that UCB has chosen us to automate this ground-breaking facility,’ said Steve Sonnenberg, president of Emerson Process Management. ‘Our proven ability to provide a single source for both plant automation and operations management systems will help UCB seamlessly manage operations from the plant floor to the head office.’
Innovent Biologics, Inc., a company dedicated to the development and manufacturing of monoclonal antibodies to be marketed in the rapidly growing China market and elsewhere around the world, has raised $25 million in a Series B financing to put toward the continued expansion of its pipeline and manufacturing capabilities. The money comes from Lilly Asia Ventures, part of the innovative global pharmaceutical company Eli Lilly, and from Fidelity Biosciences and Fidelity Growth Partners Asia, a division of Fidelity, one of the world's leading financial services companies. Fidelity is a follow-on investor from the Series A.
"We are fortunate to have world's premier investors believing in our team and business. Biologics are going to be a huge category in China just as they are worldwide, which presents a unique, once in a lifetime opportunity. Innovent has positioned itself to be a leading biologics company in China", Said Michael Yu, Ph.D., Co-founder, President and CEO of Innovent Biologics.
The team at Innovent brings extensive experience in the discovery, development and manufacture of biologics in the US, Europe and worldwide and were involved in the launch of such products as Bexxar, Conbercept, Humira, Natrecor, Oncorine, Orencia, and others.
Innovent has a GMP-compliant pilot plant for the production of clinical trial material and is building a new campus located in Suzhou near Shanghai China. In addition to laboratories and offices, the campus will house a commercial manufacturing plant with multiple 12,000 L bioreactors and a pilot plant, with two 1000L bioreactors, for production of clinical materials. The 90,000m2 (968,400 sq. ft.) biopharmaceutical facility will be the largest biologics production facility in China designed to comply with international requirements for cGMP as defined by the European EMA and the US FDA, as well as meet China SFDA cGMP regulations.
Companies who want to leverage the Innovent commitment to bring quality manufacturing and development to the expanding China biologics market have helped Innovent begin building a pipeline of biologics. The pipeline currently includes a CD20 antibody for Non-Hodgkins Lymphoma (NHL) and other B cell mediated diseases, a bispecific antibody for cancer and an antibody for oncology. Innovent continues to actively seek product candidates for in-licensing and co-development.
RLS d.o.o., a supplier of rotary and linear motion sensors, has tripled the size of its operations with a 6,890 sq. ft. facility in Komenda, Slovenia. The building includes a 590 sq. ft. ISO 8 cleanroom with electro-conductive flooring, representing an expansion to the design and manufacturing capability for RLS, an associate of the Renishaw Group.
Janez Novak, director of RLS, says, "We are drafting further company growth based on our own products, good manufacturing capabilities, and solid cooperation with associate company Renishaw. In the coming period, our company is going to invest a lot of effort into our excellence in engineering and into upgrading the quality system, especially because some of our products are designed for demanding, safety-critical applications. Our vision is to become a leading global manufacturer of innovative linear and rotary sensors and elements."
RLS designs and manufactures solid-state encoders for measuring speeds and rotary or linear position in harsh applications. Its products are used in gas pumps, robots, oil-field equipment, subsea systems, construction machinery, medical equipment, off-road vehicles, and "smart" machines of all types. Besides motor feedback and positioning control, the magnetic encoders are used for torque sensing, flow control, scanning, and instrumentation.
Renishaw took a 50 percent shareholding in RLS in 2000, giving them access to Renishaw's global distribution and applications experience.
Lonza plans to invest CHF14 million (€11.6 million) to expand its Antibody Drug Conjugate (ADC) manufacturing capacity in Visp, Switzerland.
The expansion, expected to be complete in the second quarter of 2014, will double the existing large-scale manufacturing capacity while allowing current operations to continue without interruption. The move could also create new jobs across all functions in Visp.
The Swiss supplier said oncology drugs including ADCs are one of the fastest growing segments of the industry, but because cGMP manufacturing of ADCs is challenging, facilities must be able to handle both biologics and cytotoxic small molecule drugs.
‘We have witnessed significant growth in the ADC market in the past 24 months and this investment is necessary to continue to support the growing product demands from our customers,’ said Stefan Stoffel, head of Lonza’s Chemical Manufacturing business unit.
‘Lonza Visp will continue to offer a fully integrated end-to-end development and manufacturing solution for ADCs, including the cytotoxic small molecules used in these products and all associated analytics. In addition, Lonza can support protein development and manufacturing via our global biologics development and manufacturing sites.’
Lonza has been a pioneer in the manufacturing of ADCs since 2006 when it established establishing manufacturing suites for small- and large-scale projects, dedicated R&D labs, and quality control facilities.
The company announced job cuts at the Visp plant last November; the majority will be from internal transfers, early retirements and a reduction in temporary contracts.
In July last year French contract manufacturing organization (CMO) Novasep said it would spend €3m ($m) to add ADC capacity at its facility in Le Mans, also citing customer demand.
More recently, Fujifilm Diosynth Biotechnologies entered the ADC sector through a partnership with Indian CMO Piramal Healthcare.
Lonza has been producing ADCs at the Visp facility since the mid-2000s when it established a laboratory-scale manufacturing suite and pilot plant.
The decision to double capacity at Visp fits with Lonza’s plan to make the facility more cost competitive by conducting more high value, high margin development and manufacturing work. These efforts have already seen Lonza undertake a number of ADC development and clinical-scale production projects at the Visp plant.
Lonza's suggestion the ADC investment "potential to bring new job opportunities across all functions in Visp" contrasts with the job cuts the firm carried out at the facility late last year.
Norbert Dentressangle has invested in a new cleanroom to accommodate “white glove” contract packing activities at its Eurocentral facility at Mossend, near Motherwell in Scotland.
The 6,500 sq. ft. facility provides a range of packing, inspection, and quality control services, primarily for premium and luxury products which require a clean environment and precise and careful handling, as well as providing additional capacity and flexibility within the existing contract packing operation at the site.
Established in 2009, the contract packing operation is a joint venture between Norbert Dentressangle and RESCU Solutions and provides a range of services including re-packing products from large to smaller cases, preparing and packing gift packs or glass sets, adding neck collars, ribbons or seals and decorating glass bottles, as well as quality inspection of bottles, cartons or cases, both for drinks companies and their suppliers.
Novartis launched construction of a new pharmaceutical manufacturing facility in St Petersburg, Russia in June 2011. The new facility is being constructed in the Novoorlovskaya Special Economic Zone (SEZ), located to the north of the St. Petersburg city centre. It is expected to start commercial production in 2014.
The new facility will produce high-quality generics and innovative pharmaceuticals for Russian patients. The total investment on the project is estimated at about $140m.
Novartis decided to tap the huge pharmaceutical market in Russia by setting up a manufacturing plant in St. Petersburg. The new project is part of the company's $500m investment plan for five years, which was announced in December 2010.
The company will spend about $140m for the construction of the plant and for setting up plant equipment and infrastructure. Novartis will use the investment to develop in three core areas of the Russia pharmaceutical market: local manufacturing, R&D collaborations and public health development.
The new manufacturing facility is being built in a land allocated to the company in the Novoorlovskaya SEZ. The SEZ, spread over 110.4ha in the Primorsky district, is meant to foster product innovation in science and technology.
The new facility is expected to produce about 1.5 billion units in a year. It will utilize local workforce and employ about 350 qualified professionals. It will focus on producing high revenue-generating drugs as well as drugs meant for state purchases.
The facility will feature sophisticated manufacturing equipment and technologies for producing innovative drugs and high-quality braded generics.
The new Russian facility will mainly produce drugs for the treatment of hypertension and cardiovascular diseases. The generics manufactured at the facility will include Ketonal, Biol, Fleksid and Persia. The innovative drugs portfolio will include Gielen, Afinitor and Sertikan.
The plant will also produce drugs related to neurology, transplantology, endocrinology, oncology and anti-infectives.
Novartis broke ground for the construction of the new manufacturing plant in St Petersburg in June 2011. The construction permit was obtained in March 2012. Construction of the main building and engineering building is expected to be completed by the end of 2012.
"The total investment is estimated at about $140 million."The import and installation of equipment is expected to be completed in 2013. The plant will be commissioned by 2014.
The pharmaceutical market in Russia has been growing at a rapid pace, as the demand for branded generics in the country has been on the rise. The Russian pharmaceutical market size in 2010 was $18.7 billion, and is expected to grow by 10 to 12 percent by 2015. The total value of the pharmaceutical market in Russia is expected to reach about $22.1 billion by 2016.
In 2011, many multinational pharmaceutical companies increased investments on new manufacturing plants for producing branded generics in Russia. Takeda has already established a manufacturing facility at Yaroslavl in Russia. AstraZeneca has started the construction of a pharmaceutical plant in Russia. Nine other multinational pharmaceutical companies have also invested on the construction of manufacturing plants in Russia.
Novartis is a leading pharmaceutical company headquartered at Basel, Switzerland. The company's healthcare products include innovative medicines, cost-saving generic pharmaceuticals, eye care, consumer health products, preventive vaccines and diagnostic tools. Its pharmaceutical products include more than 40 vital drugs. The company has an operational presence in 140 countries.
In June 2012, Novartis entered into an agreement with the Saint Petersburg Chemical and Pharmaceutical Academy (SPCPA). The scope of the agreement includes creation of a joint action plan on the development of scientific partnership and modernization of the system of training scientific, medical and pharmaceutical personnel.
The SPCPA will also help Novartis in designing new medical products on the basis of the St Petersburg pharmaceutical cluster.
SCHOTT opened the first GMP-compliant pharmaceutical packaging production facility in Russia in May 2011. The plant is located at Zavolzhe near Nizhny Novgorod, Russia. It produces primary pharmaceutical packaging made of glass. It is SCHOTT's second production site in Russia.
The production facility employed about 60 people initially and has been engaged in the manufacturing of premium quality ampoules and vials. SCHOTT plans to increase the employees at the facility to about 200 in the future.
The company has announced its plans to expand the Zalvolzhe plant by mid-2013 to reach the plant's full intended capacity.
The facility manufactures high-quality products as per Good Manufacturing Practice (GMP) standards. Before construction of this facility, customers in Russia used to depend on the pharmaceutical packaging supplies from SCHOTT's Hungary facility. The Zavolzhe facility thus fulfils the demands of the local pharmaceutical industry.
The pharmaceutical packaging product portfolio produced at the Zavolzhe facility includes ampoules, cartridges, coated vials, prefillable glass syringes, prefillable polymer syringes and vials. The plant also manufactures cyclic olefin copolymer (COC) containers.
SCHOTT manufactures Fiolax, high-quality glass used for the pharmaceutical packaging. It is manufactured with a high-resistant borosilicate type I glass.
The company also produces Densocan, which efficiently evades contamination both before and during processing.
Densopack, a scratch-free shrink wrap packaging developed by SCHOTT, is also manufactured at the Zavolzhe facility.
The TopLyo vials developed by SCHOTT were designed to maximize strength and minimize breakage. They also improve heat transfer during freeze-drying.
The plant produces the forma 3s and forma 2s brands of sterile and non-sterile syringe sets respectively. The TopPac sterile prefillable syringes made by SCHOTT are also produced at the facility.
In November 2012, SCHOTT decided to expand the production at Zavolzhe by at least 50% to reach full capacity. New vial and ampoule manufacturing lines will be added to increase the production capacity to 500 million to 550 million per year.
The production expansion will allow the company to provide shorter deliveries to its customers in Russia. It will also offer better export opportunities and provide an impetus to the Russian pharmaceutical industry to achieve quality and growth objectives.
SCHOTT is a leading technology group with its headquarters located in Mainz, Germany. It produces high-quality glass products for a range of industries such as pharmaceuticals, optics, transportation, electronics and solar power. The company has more than 17,000 employees worldwide.
SCHOTT Pharmaceutical Packaging offers glass tubing and primary packaging products for the pharmaceutical industry. It has more than 600 production lines located in 14 different countries across the world. It is engaged in manufacturing more than seven billion pharmaceutical packaging products in a year. It has four plants meant for tubing manufacturing, while 15 other facilities are meant for pharmaceutical packaging.
By the end of 2010, SCHOTT expanded the pharmaceutical packaging business in Japan, which has the second largest pharmaceutical market. It established the production plant in Japan in collaboration with Naigai Glass Industry. The company also expanded the business operations in other major markets in the world including China and Argentina. SCHOTT also has a pharmaceutical production plant in the US.
The pharmaceutical industry in Russia has been witnessing double-digit growth rate recently. In October 2009 Ministry of Industry and Trade in Russia adopted Pharma 2020 strategy, which encourages the local pharmaceutical companies to produce high-quality medications according to the GMP standards. It targets innovative conversion and competitiveness for boosting the Russian pharmaceutical sector and to improve the production capacity.
According to the new regulations that will be enforced in Russia from 2014, it will be imperative for the pharmaceutical companies to pursue GMP-compliant production procedures.
The local industry is expected to develop about 50 percent of Russian-consumed drugs if the pharmaceutical industry in Russia grows at the same pace until 2020. The Russian pharmaceutical market is expected to reach $10.7 billion value by 2014.
Immunovative Therapies Ltd. has completed upgrades to its GMP cell manufacturing facility in Jerusalem. The upgraded facility includes two Class 10,000 cleanroom facilities containing Class 100 clean operation areas for open procedures.
The facility has interlocked rooms with increasing levels of pressure and air quality. Separate rooms are designed for personnel flow and materials flow with airlocked rooms for sterile gowning for workers within the facility. Clean space for inventory and finished product storage, product packaging, and shipping is also included. Improved packaging and shipping methods have been transferred to the manufacturing facility, extending the shelf life of formulated AlloStim from the previous four hours to 72 hours. This technological advance allows the formulation to be conducted in Jerusalem under highly controlled GMP conditions and the finished product packaged and shipped by specialized overnight courier to the point-of-care.
The timely completion and validation of this GMP manufacturing facility enables the company, from a logistics standpoint, to launch a Pivotal Phase II/III trial as planned during early 2013.
The GMP facility, operations and quality systems batch and lot release safety, identity, and functional testing have successfully passed a mock FDA inspection performed by the Biologics Consulting Group. These facility and operational upgrades, including the results of the mock inspection and additional validation study reports of QC safety testing methods for sterility and endotoxin detection, have been submitted to the FDA in an informational amendment to the Chemistry, Manufacturing and Control section of ITL's Investigational New Drug application.
Avid has enhanced its Reverse Osmosis Deionized (RODI) and Water for Injection (WFI) systems, resulting in a 450% increase in water capacity to support increased production. Other projects include a contract with Advanced BioScience Laboratories to provide development and large-scale manufacturing services to support cGMP production of an HIV envelope protein.
"We have seen tremendous growth in the demand for services at Avid, based on both the success of our clients and the continued commitment to excellence by our dedicated team," said Steven W. King, president of Avid Bioservices. "We are strategically reinvesting some of these financial resources back into the business to further increase manufacturing throughput, reduce manufacturing risks and ensure continued reliability with redundant systems."
"This rollout of recent facility enhancements, as well as the plans for the next phases, requires timely, accurate and strategic execution across the organization. In completing this first phase ahead of schedule, teams from across the company worked together in unison to seamlessly implement these upgrades, while concurrently maintaining scheduled production, a reflection on the expertise and teamwork that we continually provide our clients," said Jeff Masten, vice president of quality for Avid Bioservices.
Abbott Laboratories has expanded its manufacturing capabilities for solid-dose potent and cytotoxic products, with the installation of a dry granulation roller compactor. The new compactor is housed in a dedicated manufacturing suite at the company’s multi-product potent facility in Sligo, Ireland.
According to the company, the new roller compactor offers precise process control; measuring all product quality relevant parameters (e.g., force, gap and roll speed) online, that are calibrated and validated. The compactor has a floating gap for consistent compaction force and the gap and torque adjustments are automatic. The compactor features a glove box for dispensing materials, bin blenders, and a Comil for uniform size reduction, deagglomeration, and particle size dispersion.
"With the substantial growth today of oncology and other high potency drugs, Abbott continues to upgrade our potent facilities and equipment to better serve the industry," said Timothy O'Sullivan, technical operations manager of Abbott's Sligo, Ireland facility. "Our new roller compactor contributes greater efficiency, flexibility and quality to potent drug manufacturing and development, offering customers distinct advantages."
Aptar Pharma has expanded production capacity in Eigeltingen, Germany, to support large-scale production services for preservative-free ophthalmic and nasal drugs. The expansion includes the scale-up of the Ophthalmic Squeeze Dispenser (OSD) technology as well as adds new capacity for the Advanced Preservative-Free System (APF) technology, Aptar Pharma reports.
Aptar Pharma’s OSD technology is designed for multiple administrations of unpreserved eye-care medications. Aptar Pharma has invested in additional state-of-the-art equipment and more than quintupled its production capacities since September 2011, it reports in a press release. OSD is manufactured in large quantities in ISO 7 cleanrooms with state-of-the-art assembly and testing technology.
“At Aptar Pharma, we are extremely pleased to announce the scale-up of the OSD technology. OSD is the result of innovation and continuous improvement to our preservative-free technology platform range and provides several benefits to patients and consumers. We still continue to improve our high quality devices and anticipate our customers’ future needs and expectations”, stated Matthias Birkhoff, Vice President Business Development for Aptar Pharma CHC Division, in the release.
Roche said it will invest CHF 240 million ($258.4 million) in a new diagnostics center at its Penzberg, Germany biotech center near Munich. The Diagnostics Operations Complex II is scheduled to be operational in December 2014 and will create 50 new jobs. Roche said the expansion is in response to "sustained global demand for the reagents used in immunoassay testing."
The Genome Institute of Singapore and Fluidigm announced the creation of a single-cell genomics research center.
The GIS-Fluidigm Single-Cell 'Omics Center is the first research center in Asia exclusively focused on accelerating understanding into how individual cells work, as well as how diagnosis and treatment could be improved by research into single cells, GIS said.
The center will bring together molecular and cell biologists and provide them with genomics and genotypic data for use in evaluating biological pathways, disease mechanisms, and characterizing healthy and diseased tissues.
Single-cell analytics will be provided to drug discovery firms, pharmaceutical and biotech companies, academia, and clinics. The center "is targeted to provide single-cell infrastructure across Singapore and Asia that will engage various disciplines in an adaptive multi-source platform," GIS said in a statement.
The center will be housed in dedicated laboratory space at GIS facilities in Biopolis and feature Fluidigm's C1 Single-Cell Auto Prep System and the BioMark HD System for gene expression analytics and validation. It also will have access to various next-generation sequencing capabilities.
One project being undertaken at the center will define early embryonic cellular state spaces using single-cell transcriptomics through mRNA sequencing. Led by GIS Senior Group Leader Paul Robson, the project seeks to define "a minimal set of signaling and regulatory genes capable of defining the attractor and transitional cellular states spaces in existence early in human development."
Robson and Bing Lim, a senior group leader as well as associate director of cancer stem cell biology at GIS will oversee the initial projects being conducted at the center.
"With the creation of the [center], we assemble a strong multidisciplinary consortium of academia and industry, and an interdisciplinary team of senior scientists, engineers and informatics specialists with very deep knowledge and skills in analyzing cellomics and genomics information," Michael Rossboch, head of the GIS Office of Business Development, said in GIS's statement. "This will create a platform for information-sharing in a collaborative manner designed to deliver fast execution from concept to results."
Gajus Worthington, president and CEO of Fluidigm added, "The Single-Cell 'Omics Center is a major boost to the emerging, burgeoning field of single-cell analysis. … GIS has a track record of publishing breakthroughs based upon single-cell research, so this center can act as an accelerant for more new science. In addition, we expect the [center] will stimulate more single-cell genomics research throughout Asia."
Shionogi & Co's new pharmaceutical research facility is located in Toyonaka City in Osaka, Japan. It is equipped with drug discovery research laboratories and laboratory equipment, as well as information technology capabilities.
The new facility was built with an investment of about ¥18.9 billion ($247 million). It will serve as the main research facility for Shionogi. With the construction of the facility, Shionogi has integrated drug discovery research operations into the Shionogi Pharmaceutical Research Centre (SPRC). These operations were earlier dispersed between four other sites in Osaka and Shiga Prefectures. The SPRC will now include the new facility and the existing three sites in Osaka.
The aim of establishing the SPRC is to achieve leading research productivity in drug discovery. The SPRC integrates different drug research functions of the company, such as basic to exploratory research, synthetic and early-stage formulation research, into a single location.
The research facility covers an area of 34,627.97m² (372,597 sq. ft.) spread over five stories. The built-up area of the research centre is about 9,800m² (105,448 sq. ft.) and it has a total floor space of about 43,000m² (3,268,000 sq. ft.). Operations at the new facility began in mid-August 2011.
Each floor of the facility provides space for about 160 researchers. The state-of-the-art drug discovery laboratories of the facility are equipped with sophisticated laboratory equipment.
The design of the new facility specifically stimulates creativity and supports innovation by increasing communication and mutual collaboration among the researchers. A wellhole space located in the building conveys a feeling of unity among the researchers. The facility also includes several meeting areas and relaxation corners.
The new facility provides support for maximum creativity and high productivity for drug discovery research functions.
The research facility features modern and sophisticated drug discovery equipment. It includes a 25l mini plant reactor system, which enables the researchers to perform medium-scale synthesis of candidate compounds. It also has a high-content screening system that provides high-throughput screening of compounds against novel drug targets.
The safety aspect was given top priority during the designing of the biochemistry laboratories, which are arranged functionally with respect to the measuring instruments.
The facility is located in the same premises as Shionogi's developmental research laboratories. Ground breaking for the facility took place in September 2008. Construction was completed in July 2011. It was constructed using quake-absorbing materials, steel and reinforced concrete.
The facility was built according to environmentally friendly standards. The environment-friendly triple skin structure of the facility reduces about 40 percent of the heat load from outside. The facility was adopted as a model project of housing and buildings for promoting carbon emission reduction by Ministry of Land, Infrastructure, Transport and Tourism in 2009.
Takenaka Corporation was responsible for design and construction of the facility.
Osaka-based Shionogi & Co is a leading pharmaceutical research company. It has over 5,277 employees and its core areas of activity involve research and development, production, and marketing activities, with a focus on prescription drugs, OTC drug and diagnostics. The company's operations are spread over Europe and North America.
Shionogi built the new drug research facility to upgrade its research capabilities and improve its global competitiveness. Through the facility, Shionogi will focus on tapping unmet medical needs by deploying various technologies such as small molecule drug discovery. It will continuously supply innovative pharmaceuticals to the patients in Japan and the world.
The new facility will also serve as the foundation for Shionogi's growth over the next 10 to 20 years. Shionogi's research is targeted on three main areas, which include metabolic syndrome, pain, and infectious diseases. The research facility will provide the company with top-class global research capabilities to focus on these areas.
Roche is planning to invest over 240 million Swiss francs (approximately $259 million) in its Penzberg biotechnology centre, near Munich, Germany, with the aim of constructing a new production facility to be known as Diagnostics Operations Complex II (DOCII). The facility is scheduled to be operational in December 2014 and will create 50 new jobs.
DOCII is expected to expand production capacity for diagnostic test and control reagents. The facility will have a total floor area of 26,000 square meters (279,760 sq. ft.) and consist of three structures: a central, six-story laboratory building with a basement level and two adjacent single-level plant buildings.
Roche Penzberg is located in Bavaria, Germany and has a workforce of nearly 5,000 people. According to the firm, it is its largest European site for biotech research and development (R&D) and production, combining R&D and production facilities for both the Pharmaceuticals and the Diagnostics division. The reagents and pharmaceutical active ingredients produced by biotechnology in Penzberg are made into in vitro diagnostics and finished pharmaceuticals at other Roche locations.
According to Roche, this further investment in the Penzberg site is a response to sustained global demand for the reagents used in immunoassay testing in laboratories and hospitals.
In October of 2008, Roche invested 215 million Swiss francs (approximately $232 million) in research, development, and production at its Penzberg site to construct a multi-purpose building for Roche Diagnostics that would house laboratories and production facilities for the Roche Applied Science and Roche Professional Diagnostics business areas. The building, called the Diagnostics Operations Complex (DOC), was designed to manufacture products ranging from biotech constituents for immunodiagnostics and the life science market through to complete immunodiagnostic test kits used in diagnostic systems such as COBAS and Elecsys.
Clondalkin Group Company Wentus, a provider of biodegradable flexible packaging solutions, has achieved ISO 14001 and ISO 50001 certification. Based in Germany, Wentus is widely regarded as the market leader in the supply of biodegradable films through the companies advanced range of variant products to this growing market, the company said in a press release.
Sustainability and environmental stewardship are core values within Wentus and the adoption of ISO 14001 and ISO 50001 enable a framework for the ongoing monitoring and improvement in process efficiency and energy, providing another signal to the market place of the company’s serious intentions to continue reducing environmental impact.
A six-month partnership with environmental management specialists, Professor Dr. Manfred Sietz and Thorsten Rudolph from the Hochschule Ostwestfalen-Lippe - University of Applied Sciences with senior management support and buy in from all areas of the business allowed a swift accreditation process.
Wentus Managing Director Jörg Söhngen said, “Our customers are increasingly alert to sustainable processes and packaging solutions and we are delighted to be leading the market with our products but also the processes we employ and our approach to energy management. Having environmental ethics at the core of our business supported by these new certifications means that our customers can be confident that our business is the right choice for a partnership that delivers quality product and helps to reduce their environmental impact.”
Commenting on the project, Professor Sietz said, “It is critically important that business leaders take this approach to environmental management. Working with Wentus was a very rewarding experience and the vigor with which they approached the project was encouraging. The certifications formalize their business approach to the market and make them a credible partner for companies wishing to form partnerships that reduce environmental impact.”
Clondalkin Group company, Wentus, is one of 20 production facilities operating throughout Europe and North America under Clondalkin Group’s Flexible Packaging Division. Specialists in biodegradable packaging, Wentus is a leading supplier of hygiene films, foils and laminates, as well as food packaging for dairy, meat and cereals.
Based in Hoxter, Germany, Wentus is an extrusion and integrated converting company offering mono, co-ex and multilayer barrier films, as well as cast polypropylene and fully biodegradable films. Wentus is a leading supplier of hygiene film, foils and laminates servicing the food, convenience goods, hygiene, agricultural and horticultural markets. Its biodegradable product range is the most developed and comprehensive in the market place. The company employs over 350 people and is ISO and BRC IOP certified.
Nypro Healthcare will further expand its medical device operations in Bray, County Wicklow, Ireland, with the opening of a new medical device development center and the creation of 100 new high quality jobs. The expansion will involve capital expenditures for cleanroom facilities and equipment such as injection molding presses.
The announcement was made by Taoiseach (prime minister) Enda Kenny along with Jobs Minister Richard Bruton. Nypro Healthcare has created 160 new jobs in the last 24 months, and these 100 additional jobs will bring Nypro Healthcare's total Irish workforce to 460. The increase in the company’s headcount comes following a complete transition from 2008 in Nypro Healthcare's focus from the electronic industry to that of the drug delivery and diagnostics industry.
The company is headquartered in Clinton, MA.
Harlan Laboratories Contract Research Services (CRS) is investing $4.5 million in its Itingen, Switzerland site. The investment will expand its range of testing and research services at the site and will include enhancements to the inhalation facility, upgrading the barrier protected area for chronic and subchronic studies and an entire floor dedicated to reproductive and rodent toxicology. The company will also build new lab areas for clinical diagnostics, biochemical analysis and fetal pathology.
The investment follows Harlan's consolidation of its Füllinsdorf operations into the Itingen site. Harlan has also launched a recruitment effort to expand its Histology expertise, along with new processing equipment.
“This is an exciting development which we believe will offer many benefits to our customers,” said Hans Thunem, chief executive officer of Harlan Laboratories. “We indicated last year that our commitment to our operations in Switzerland was strong but being tested by lack of profitability. With the results delivered by our employees over the last 12 months, it is rewarding to now be able to make new investments in our Swiss operations.”
Cellon, a provider of products and services to the vaccine production and bioprocessing industries based in Luxembourg, says its PharmaTainer bottles and carboys now meet USP 788 Particulate Matter in Injections, and the equivalent EP and JP quality standards.
The products are currently manufactured in PC and PET in sizes from 125ml to 20 liters in Cellon’s production molding facility in Luxembourg, which was opened in 2011. The plant is dedicated to the production of clean, single-use products for use in the vaccine and bioprocessing sector, and operates under an ISO 9001-2008 quality system.
The products are manufactured in an ISO Class 5 environment and sterilized by irradiation to a SAL of 10-6. Certification to USP 788 is based on liquid particle count analysis on a lot-by-lot basis.
Designed for the storage and transport of bulk vaccines, biopharmaceuticals, bulk intermediates and other biotech materials, PharmaTainer products also provide tamper evident packaging and provide labeling for individual bottle traceability and inventory control.
Richard Fry, managing director of Cellon, said, “The PharmaTainer range addresses directly the main quality concerns for single-use storage and transport containers in the industry, i.e., particulate and traceability. By dedicating our facility to production of clean products, we ensure that all our products are made to a single, high standard.”
Cambodia has inaugurated a food industry laboratory, built with Chinese aid, it sets out to assist food quality improvement, research and technology development.
The China-Cambodia Food Industry Laboratory is situated in the complex of the Industrial Laboratory Centre of Cambodia in Phnom Penh's Russey Keo district. It was built following calls by Chinese premier Wen Jiabao last year to establish a science and technology program between China and southeast Asian countries.
"The China-Cambodia Food Industry Laboratory is the first lab since the program was launched. It will help to improve food quality and safety in Cambodia," the Xinhua news agency reported visiting Chinese state councilor Liu Yandong as saying.
Cambodia's permanent deputy prime minister, Men Sam An, said Cambodia was the first country in the Asean bloc to begin implementing the Asean-China Science and Technology Partnership Program.
"I believe that the cooperation will help further enhance capacity for Cambodian specialists and private sector on science and technology, especially small and meddle-sized food enterprises, " she said.
"The lab will contribute to enhancing food quality and safety, related research and technology development," she added.
The laboratory's equipment was donated by China with a total value of US$465,000 as part of the first phase of a three-year cooperation.
TOT Biopharm Company Limited has completed the 18-month project constructing the first stage of its US$100 million factory complex in eastern China's Suzhou Industrial Park. The high-tech factory complex specializes in the research and development, production and marketing of anti-cancer drugs globally.
The inauguration ceremony of the new factory complex held on November 23 was attended by celebrities and guests from both mainland China and Taiwan, all of whom witnessed a milestone in the cooperation between the two regions in developing the bio-pharmaceutical sector.
TOT Biopharm's new factory complex meets the demand for developing the bio-pharmaceutical sector set forth in China's 12th Five-Year Development Planning for Strategic Emerging Industries. The company has leveraged the rapid growth of bio-pharmaceutical technologies in China to accelerate the building of a complete bio-pharmaceutical industry chain. With the support of both the mainland and Taiwan governments, TOT Biopharm chairman Lin Rongjin and general manager Huang Chunying worked closely with their professional teams to create a world leading 50,000-square-meter (538,000 sq. ft.) factory complex for specialty anti-cancer drugs. The company's core products include Liposomal technology-based specialty drugs, biologics and innovative drugs.
The first stage of TOT Biopharm's new factory complex includes an oral anti-cancer drug plant with separate production facilities for both cytotoxics and non-cytotoxics, an injected anti-cancer drug plant and a GMP bio pilot plant with a capacity of 500L cell culture/ purification/ filling. TOT Biopharm is set to initiate the second-stage construction to expand its production scale and improve its international competitiveness, building a position as a pharmaceutical R&D and marketing partner of choice for international bio-pharmaceutical innovators and devoting itself to major cancer treatments in China and to the well-being of people around the world.
Suzhou Pharma Services, a contract development and manufacturing organization has received the latest 2010 cGMP certification from the Chinese SFDA for their development and manufacturing facility located in the Suzhou Industrial Park, Suzhou, China. Situated 100km west of Shanghai, Suzhou Pharma Services is one of China's only U.S. FDA-approved and inspected facilities for solid oral dose manufacturing and now joins an elite group that can offer both operating quality standards.
"Suzhou Pharma is well positioned to offer our formulation and manufacturing services backed by our western experienced management team to companies in China and the Asia Pacific region looking for outsourcing partners operating under the latest GMP and quality standards" said Marc Finn, Director of Business Development. "It allows us to better support our local client's growing needs in outsourced drug development, clinical trial material and formulation services for the Chinese and Global markets".
Suzhou Pharma's recently upgraded and newly outfitted facility includes capabilities to support development of oral solid dose products with expertise in extended, sustained and modified release tablets and capsules.
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