PHARMACEUTICAL & BIOTECHNOLOGY
INDUSTRY UPDATE
February 2013
McIlvaine Company
Sil-Pro Expands Clean Room Facilities
Iroko Pharmaceuticals Global Headquarters, Philadelphia, PA, USA
Scripps Prebys Cardiovascular Institute, California, United States of America
Baxter Plans New Biotech Facility in Georgia
Almac Audubon Facility Passes FDA Inspection
Expansion and Renovate at PerkinElmer’s Center of Excellence
Cytovance Biologics Expands Production Capabilities
Children's Marcy Hospital Lands $1M for Clinical Sequencing Center
Elite Pharmaceuticals Has Expanded Facility
Trelleborg Sealing Solutions Expands Massachusetts Plant
GreenGate Fresh Opening New Facility
Novo Nordisk's Type I Diabetes Research Facility, Seattle, WA
Avrio Brought Under Irvine Brand
Salk to Launch Genomic Medicine Center
AAIPharma Expands Capacity of Parenteral Manufacturing Facility
NanoViricides Retains AES Clean Technology for Cleanroom Suite
NAMSA Expands Laboratories in France
Phillips-Medisize Completes Czech Republic Facility Expansion
SGS Life Science Services Laboratory, Mumbai, Maharashtra, India
MWV Expands Pharmaceutical Manufacturing Center
Patheon Invests in Milton Park, UK Facility
Rexam Healthcare Expands French Facility
RLS Triples Size of Operations
Raleigh Coatings Building Cleanroom
Pluristem Therapeutics’ New GMP Facility
ICR, London to Create Tumor Profiling Center
Dalton Initiates Sterile Filling Expansion
2013 Facility of the Year Awards (FOYA) Winners Announced
Sartorius PR Facility Receives LEED Certification
Gerresheimer Expands Swiss Facility
UCB Awards $6.1 Million Contract for One of Europe’s Largest Biotech Plants
Fera and Waters Open International Food Safety Training Laboratory
Sil-Pro continues their ongoing expansion and improvements by expanding the existing cleanroom with a 1,000 square-foot addition. The new cleanroom addition will be certified to ISO Class 7 the same as Sil-Pro's existing cleanroom.
This new expansion, which is isolated from the rest of the manufacturing cleanroom floor, will be used to centralize final wash and dry, inspection and packaging all into one location within the facility. This round of lean improvements helps to consolidate and streamline manufacturing and shipping processes, while also freeing up space in the main cleanroom production area for additional plastic presses.
Sil-Pro's internal testing shows that this new cleanroom isolation area will greatly diminish the risk of any particulate contamination, which could occur during the final wash and dry, inspection and packaging processes. The consolidation of these final three operations into this new cleanroom's centralized location, between the manufacturing floor and shipping department, will greatly streamline production processes and allow for the future expansion of these three processes when needed. This most recent round of lean improvements will also benefit Sil-Pro's customers by allowing faster throughput and the highest quality medical products possible, while reducing in-process inventory.
"This expansion rides on our spirit of continuous improvement and risk mitigation," reports Brian Higgins, Sil-Pro Vice President of Sales and Marketing. "We believe that this addition to our facility will result in an improvement to the quality of the products we manufacture and ship to our customers."
Sil-Pro is an ISO 9001:2008 and ISO 13485:2003 certified contract manufacturer specializing in molded and extruded silicone, thermoplastics and full-service medical device contract manufacturing and assembly.
Iroko Pharmaceuticals inaugurated its new global corporate headquarters in December 2012 at the Navy Yard Corporate Centre in Philadelphia, USA. 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 56,412ft². 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.
"The final construction was completed and the facility was opened for commercial activity in December 2012."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 U.S.-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 construction of Scripps Prebys Cardiovascular Institute began in June 2011 and is expected to be opened for patient care by 2015. It is being built at Scripps Memorial Hospital La Jolla campus in California, USA. It was named after Conrad Prebys, a local real estate developer who donated $45m for the development of the project.
The institute will serve as a destination for heart care and will meet the specific needs of heart patients. The project is being developed by Scripps Health.
It is estimated that more than 55,000 people will obtain cardiovascular care from Scripps Prebys institute every year.
The new cardiovascular institute will be a seven-story tower with a 383,000ft² heart hospital. It will have 108 inpatient beds, 60 intensive care unit beds and two hybrid operation rooms. Other facilities will include four cardiac catheterization labs, a new central energy plant and a sterile processing department. It will have space left for future expansion of the emergency department.
The institute will also have advanced diagnostic facilities as well as better treatment options for cardiovascular diseases. It will also be used as a centre to carry out medical research, clinical trials and graduate medical education. It will bring all the Scripps cardiologists, electrophysiologists, surgeons and Kaiser Permanente heart specialists to one location.
The institute will also be equipped with state-of-the-art machinery for accurate diagnostics. It will be facilitated to carry out critical cardiac procedures such as percutaneous cardiac valve replacement, vascular radiation therapy and rotablator, implantation of dual-chamber defibrillator, surgery for Wolff-Parkinson-White syndrome correction and open heart surgery.
The patient facilities at the institute will include care units with satellite nurses stations, slip and fall prevention elements, patient lift systems and genetic testing to determine treatment effectiveness.
The patients will be provided with single private rooms that include designated family spaces and advanced nurse call system. The patients and their visitors will have access to the rooftop garden. It will have heightened security with a single-point fixed control located at the main lobby of each floor.
The new cardiovascular institute broke ground for construction in June 2011. It is expected to be completed by 2015.
In January 2012, an LJ1300 crane weighing about 320t reached the construction site to carry out the next phase of construction. It was a Liebherr model crane, which was used to erect seven stories of structural steel. It has a multi-sectioned rigging boom for lifting weights up to 300t. The crane was brought on to the building site on 17 trucks. The crane was used to assemble and place the steel beams.
The construction crews began placing 5,900t of steel for the construction of the cardiovascular tower in February 2012. The last steel beam was placed and topping out was completed in May 2012.
The construction on the site is progressing fast and it is expected to be completed within three years.
The design of the cardiovascular institute building was provided by HOK Architects. The architects worked for more than 40 months to develop the design. HOK will also provide the interior design for the building.
The construction management contract for the Scripps Prebys Cardiovascular Institute was awarded to Jacobs Engineering Group. McCarthy Building Companies is acting as the general contractor for the project.
The total estimated cost of the project is $458m. Conrad Prebys donated $45m for the project in July 2011. Scripps Health will raise the rest of the investment through fundraising campaigns and philanthropic donations.
The cardiovascular building was designed to obtain LEED-NC Silver certification. It is being built in compliance with environmentally friendly construction methods.
Fluor Corporation announced that it is currently performing early construction management services for Baxter International Inc.’s new biotechnology facility near Covington, Georgia, about 45 miles southeast of Atlanta. Mass excavation and earth works are underway at the project site. Fluor previously booked its share of the project value in the third quarter of 2012.
“Fluor is proud that our project and construction management services will help Baxter make this facility a reality to create therapies to treat a number of chronic and acute conditions, including immune deficiencies and critical care patients around the world,” said Steve Dobbs, president of Fluor’s Industrial & Infrastructure Business Group.
Commercial production at Baxter’s new facility is scheduled to begin in 2018. The Covington site will have the flexibility and necessary infrastructure to expand further to support additional global market needs. Fluor’s Greenville, S.C. office will provide support to the onsite construction management team. The construction labor workforce is expected to total about 2,200 at construction peak.
Almac’s new commercial packaging operations in Audubon, PA have successfully passed an FDA inspection. The FDA concluded that the site is GMP-compliant with no 483 issued. Ian Markwell, Almac’s vice president of Quality, said, “We are very pleased with the outcome of our inspection, as it marks the establishment of our U.S. commercial packaging operations with FDA approval for bottle, blister, wallet and vial labeling/packaging.”
Jim McGibbon, U.S. director of business development for Almac, added, “We are now able to meet the growing market demand for quality led, flexible commercial packaging solutions in the U.S. Now having been successfully inspected by the FDA, we are ready to commence operations for our first client.”
For its first U.S. commercial packaging client, Almac will supply three commercial products, with bulk tablet and capsule manufacture taking place at its commercial facility in the UK, with final bottle and blister packaging taking place in Audubon.
The Audubon facility offers packaging solutions from primary packaging of solid oral dosage forms to customized secondary labeling and packaging of sterile biopharmaceutical products for both established U.S. products and niche/orphan drug launches
Tapemark, St. Paul, MN, has announced the addition of several new capabilities for transdermal patches, including the formulation, blending, and coating steps in the patch manufacturing process.
Combined with Tapemark’s existing converting and packaging expertise, Tapemark now is a fully-integrated transdermal contract development and manufacturing organization (CDMO), from active pharmaceutical ingredient (API) to the finished transdermal patch, the company said in a press release.
Andy Rensink, president and chief operating officer of Tapemark, explained that upon its 60th anniversary, Tapemark recently invested heavily in expanding both its capabilities and its physical facilities in the realm of transdermals. “Responding to customer demand for full vertical integration, we’re adding formulation, blending, and coating to our existing superior converting and packaging capabilities. Now we’re a full-service provider in the transdermal space,” said Rensink.
In addition to a significant investment in new equipment and the facilities build-out currently in progress, the company is adding staff to support the new capabilities. Rensink explains, “The industry really has been searching for a full-service provider such as Tapemark. We anticipate strong growth for Tapemark and for the pharma industry, especially as generic drugs continue their push for market share in transdermal patches.”
Tapemark is a full-service CDMO (contract development and manufacturing organization) providing web-based (flexible roll goods) manufacturing for drug, device, and combination products.
With the added new capabilities, Tapemark is now a fully-integrated transdermal CDMO, from API to finished transdermal patch. Additional supported single-use drug delivery formats include oral and transmucosal soluble film, topical patches and pads, and Tapemark’s patented Snap! and Snapplicator unit-dose packaging for semi-solids.
JM Coull is renovating and expanding two facilities located in Hopkinton, Massachusetts for PerkinElmer, a global technology leader dedicated to improving human and environmental health, as part of the development of the company’s new Personalized Health Innovation Center of Excellence. The Center will focus on accelerating scientific innovation to help researchers who are working to eradicate disease and extend the quality and longevity of life.
Working with Gorman Richardson Lewis Architects, JM Coull will transform an existing first floor into three new laboratories. The 16,000-square-foot space will house chemical, biochemical and vivarium laboratories.
The project also includes a two-story office addition. The 40,000-square-foot building will provide the company with additional office space, conference and training rooms, a dining hall and fitness and locker rooms. The office addition is projected to be completed this summer.
Across the street from the office building addition, JM Coull will add approximately 15,000 square feet to the south side of an existing single story, high bay PerkinElmer warehouse. The existing warehouse will be converted into offices and light manufacturing space.
JM Coull recently completed renovations for a suite of three cleanrooms plus a clean gowning room to accommodate the manufacturing of microfluidic cells, a process currently performed by PerkinElmer in the silicon valley of California. JM Coull has previously managed renovations and additions to two of the company’s facilities.
JM Coull is a construction management and design-build firm specializing in new construction and renovations for the life sciences industry. The firm uses an integrated approach to project management and focuses attention on the early phases of a project, using its proprietary StartSmart® process, to ensure overall success. The company works throughout New England from its offices in Maynard, Mass., and Shelton, Conn.
Cytovance Biologics will expand its current mammalian production capabilities to include a 1,000L single-use bioreactor (SUB), a 5,000L stainless steel bioreactor, and an automated fill/finish line. The new bioreactors expand the company’s existing manufacturing process trains, which include 100L, 500L and 1,000L bioreactors, a 100L wave system, 20L and 200L Sartorius SUBs and a 100L microbial manufacturing train. They will be operational by the end of 2013 or early 2014.
With the addition of the Chase-Logeman fill/finish system, the increased capabilities will support vial sizes from 2mL to 100mL, batch sizes ranging from a few hundred vials to 20,000 or more and includes 100% weight check. The automated fill/finish service line will meet all FDA and EU regulatory requirements.
“To meet market and customer demands, we have decided to expand our capabilities in 2013 with the larger bioreactor and fill/finish automation,” said Darren Head, Cytovance president and chief executive officer. “The increase in capabilities will allow Cytovance to provide clinical material to key clients as they move though the clinic and into commercial.”
Children's Mercy Hospitals and Clinics in Kansas City said that it has received a $1 million grant to fund its Center for Pediatric Genomic Medicine, which aims to use genome sequencing in the clinical care of newborns.
The gift from the William T. Kemper Foundation will support the expansion of a sequencing-based program that Children's Mercy has developed by enabling the hospital to buy new equipment and bring in additional staff.
CMH said the support will enable the genomics center to pursue a program to rapidly sequence and analyze the genomes of critically ill patients in the neonatal intensive care unit and those of their parents, with the aim of helping to diagnose and treat genetic diseases.
The hospital has been developing its STAT-Seq method to conduct the genomic analysis, and last fall published proof-of-principle study results showing that this method could provide results in around 50 hours for an estimated total cost of $13,500 and out-of-pocket cost of $1,250.
Scientists at the center developed the STAT-Seq method to run on Illumina's HiSeq 2500 instrument. "Up to one third of babies admitted to a NICU in the US have genetic diseases," Stephen Kingsmore, director of the Center for Pediatric Genomic Medicine, said in a statement.
"So often with these very rare genetic diseases, patients and physicians are on a diagnostic odyssey. Test after test, treatment after treatment, they don't know what's wrong," said Kingsmore. "Now by having the entire genome information in days instead of months, physicians can get a diagnosis quickly and definitively effect treatment."
Elite Pharmaceuticals, Inc. announced that Elite is now using and shipping packaged product from its expanded facility. The 15,000 square foot facility expansion includes cGMP manufacturing suites and packaging line. Packaging onsite provides a cost reduction for the company and the use of the new manufacturing suites allows additional capacity and larger scale production resulting in greater manufacturing efficiencies.
"Shipping packaged product and manufacturing larger batch sizes from our new manufacturing space was one of our publicly announced operational goals for fiscal year 2013. It means we are now a fully integrated FDA and DEA approved facility capable of manufacturing for ourselves as well as others," commented Jerry Treppel, Elite's Chairman & CEO.
Trelleborg Sealing Solutions plans to pour $7.3 million into an expansion and relocation of its life-sciences facility in Hudson, Mass. The company produces precision seals for the medical device industry among other markets. The new facility will be located in Northborough, Mass.
The new plant is scheduled to open in the first quarter of 2013, and will manufacture silicone products for original equipment manufacturers and end users in the life-science industry including pharmaceutical, medical device, biotechnology, and patient care fields. The company also intends to expand its precision liquid injection molding capabilities with more cleanroom space. The ISO Class 7 and 8 cleanrooms will be carried over from the Hudson location.
“It’s not just expanding capacity, but also bringing expertise in liquid injection molding with liquid silicone rubber from our Switzerland facility to the United States,” said James Henderman, the Trelleborg Sealing Solutions products manager for life sciences in North America. “Trelleborg’s drive is to broaden its serviceability and product offering in North America.”
Henderman went on to say the new facility will be one of the company’s most technologically advanced, with “full automation.”
“This will allow current employees and potential new employees in the local community to be a part of a growing market within a state-of-the-art facility,” he continued. “Having a strong presence in North America is critical. Much of the R&D [research and development] within life sciences is brought to market via North America and the United States. However, the need within life sciences industry is global. As a result, Trelleborg has seen the need to have the most technically advanced international facilities to address the marketplace.”
Trelleborg Sealing Solutions is owned by Trelleborg AB, a polymers company that is headquartered in Stuttgart, Germany.
GreenGate Fresh has purchased an 11-acre property centrally located in Salinas, Calif. The new facility will utilize cleanroom technology and a unique building concept - a building "inside" of a building.
GreenGate Fresh has purchased an 11-acre property centrally located in Salinas, Calif., within an Agriculture Industrial Park. GreenGate Fresh will transform an existing 50,000 ft2 concrete tilt-up structure into a state-of- the-art processing facility slated to open April 2013.
Travis Pendleton, COO, states, "We will be able to process all core items under one roof, maximize sustainability and meet all current and future food safety standards. Keeping with our values and mission statement we will continue to provide our customers and the foodservice industry with safe premium quality value added fresh vegetables all for an excellent value."
The facility will include a raw product room, finished goods cold room, an observation deck, offices for the operations team, conference rooms, employee break room with an outdoor patio, a food safety lab, quality lab, and a new product development lab.
The facility will also include a shipping office, with a parking lot and a 12-door loading dock. Sales and accounting will reside on the property in a separate building.
GreenGate Fresh, headquartered in Yuma, Ariz., provides the foodservice industry with salads, slaws, and tender leaf items.
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).
Catalent will invest $20 million to upgrade its U.S. pressurized Metered Dose Inhaler (pMDI) capabilities as part of a wider expansion of its inhaler business.
The money will be used to expand production capacity at Catalent’s facilities in Research Triangle Park, North Carolina and is indicative of the growth in the pulmonary and nasal drug delivery market.
A Catalent spokesperson said “pMDI’s will remain a core delivery platform drugs that treat lung diseases such as asthma and COPD (Chronic Obstructive Pulmonary Disease), there is significant development efforts being made into dry powder inhalers and nasal drug delivery devices too.”
He explained that the CMO already offers a broad range of development services across inhaled dose forms, including pMDIs, dry powder inhalers (DPIs), nasal sprays and inhalation solutions.
He added that “the investment is to meet the demand from branded and generic manufacturers and isn’t linked directly to any one customer or program.”
Irvine Pharmaceutical Services is incorporating its Avrio parenteral manufacturing facility into the Irvine brand as part of an effort to better align its service portfolio and streamline processes for clients.
The custom-built parenteral manufacturing facility includes three cGMP manufacturing suites, and a formulation lab and pilot suite. Features include passive restrictive access barrier system (RABS) for filling, dedicated air-handling in each suite, and video surveillance to view product development in real time.
“In addition to our 25-year history providing analytical CMC support, our offering of parenteral manufacturing services completes a seamless outsourcing solution for our pharmaceutical drug and device clients,” said marketing vice president Eric Hoffman. The Irvine campus, made up of three facilities, totals more than 75,000 sq. ft. of cGMP laboratories and manufacturing space
The Salk Institute for Biological Studies said that it plans to use a $42 million donation to create a new center that will focus on genome-based research into a range of human diseases.
The gift from the Leona M. and Harry B. Helmsley Charitable Trust will be used to establish the Helmsley Center for Genomic Medicine (HCGM), which will engage in interdisciplinary research into cancer, diabetes, Alzheimer's disease, and other illnesses.
The research teams at the HCGM will include scientists representing an array of disciplines, such as genomics, cancer biology, stem cell biology, metabolism, and endocrinology research.
The center aims to make discoveries about the common genomic basis for chronic conditions and study how genomic networks control stem cell development with the aim of finding new targets for potential therapeutics and manipulating stem cells for research purposes. The HCGM also will look into the impact that diseases can have on the human epigenome with the goal of finding out why some patients with similar genetic profiles have different responses to certain treatments.
"Chronic illness leads to distinctive changes at the genetic level and this gives us a new way to approach diagnosis and treatment," Ronald Evans, a professor in Salk's Gene Expression Laboratory, said in a statement.
"HCGM will allow experts in cellular genetics and genomics to team up and seek out common molecular signatures of disease. Chronic diseases are complex, and to understand them you need to blend science, medicine, and new advances in drug discovery by approaching them from different angles," Evans said.
"The scientific collaborations fostered by HCGM will far exceed the efforts of any individual participating laboratory," Salk scientist Inder Verma, who also will serve as project leader of the partnership between Salk and the Helmsley Charitable Trust, added. "The state-of-the-art core facilities made possible by this grant will offer access to technology and support that no researcher could get on their own."
This new funding is not the first investment the Helmsley Trust has made in the Salk. In 2009 it awarded the institute $5.5 million to found the Salk Center for Nutritional Genomics, and in 2010 it donated $15 million to fund a stem cell research collaboration between Salk and Columbia University.
AAIPharma Services Corp., a provider of pharmaceutical product development services, announced the expansion of laboratory service offerings, capabilities and instrumentation in its state-of-the-art laboratory Technology Center in Wilmington, N.C.
Following the company's opening of its Technology Center in May, 2012, AAIPharma has continued investing in its service offerings and acquired additional instrumentation to support its analytical and biopharmaceutical development laboratories.
"AAIPharma specializes in comprehensive service offerings and offers the latest in instrumentation for our clients," said Patrick Walsh, chief executive officer of AAIPharma. "Since its grand opening, the Technology Center has been recognized for its modern, efficient operations and has exceeded client expectations as a world class laboratory." AAIPharma continues to focus on serving clients' needs and has added new ICP-MS, GC-MS, LC-MS, UPLC and HPLC systems to its expansive list of instrumentation and capabilities to meet growing market demands. A Malvern Mastersizer 3000 particle size analyzer was added to support preformulation and material testing services.
AAIPharma also expanded its extractable and leachable (E&L) testing services to evaluate and qualify the materials used in the manufacturing process and final product configuration. AAIPharma's subject matter experts already provide exceptional E&L testing services, and new capabilities include a Foss Soxtec 2050 automated extraction system to enable reproducible and robust methodologies.
AAIPharma Services Corp. has announced that it is expanding the capacity and capabilities of its parenteral manufacturing facility in Charleston, SC.
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 and addition of on-site formulation development capabilities and enhanced analytical instrumentation.
“One of AAIPharma’s key offerings is the ability to provide our clients with low line loss techniques,” said Rob Goshert, vice president of sales and client services.
Goshert continued, “We are often challenged by our clients to minimize consumption of their expensive active ingredients, and one way AAIPharma has answered this challenge is through the use of specialized filling processes designed to minimize product loss.”
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 mL 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 twenty-thousand, 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 clinic™ strategy” said Paul Maffuid, Ph.D., vice president of pharmaceutical operations.
Maffuid continued, “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.”
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 a leader in turnkey design, manufacturing, and construction, of modular cleanroom systems. Modular cleanroom technology delivers more speed, cleanliness, quality, and repeatable performance to the cleanroom project. AES is the leading vendor in cGMP-compliant manufacturing facilities for Pharmaceutical and BioPharma Manufacturing industries.
"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.
NAMSA, the world’s leading medical device research organization, continues its steady growth with an expansion of its state-of-the-art laboratories in Lyon, France.
Increased demand for NAMSA’s biocompatibility and histopathology services has led the company to invest in building an additional 12,000 sq. ft. for its facility, which increases its capacity in Lyon by roughly 50 percent.
“We are growing quickly to support the needs of our customers,” says Dr. Jean Pierre Boutrand, general manager of NAMSA in Lyon. “This expansion will allow us to add staff and help meet increased demand for efficient testing and reporting during the medical device development and testing process.”
NAMSA employs a number of board-certified pathologists around the world to offer clients timely collection and processing of tissue samples, custom sample preparation and sectioning, specialized tissue-implant processing, and other services.
“The medical device research, regulatory approval and commercialization process is continuously taking longer and costing more, driving the need for efficiencies wherever possible and we are very focused on that,” says Boutrand.
With recent acquisitions and expansions, NAMSA is well positioned as a fully integrated provider for medical device manufacturers, having breadth and depth in consulting, non-clinical, and clinical services. NAMSA has expertise in cardiovascular, orthopedic, ocular, neurologic, gastroenterologic, urologic, combination product, and related medical devices, and can help manufacturers accelerate the process of bringing their devices to market.
NAMSA’s newly expanded space includes meeting rooms and offices opened in mid-December.
Phillips-Medisize Corporation has completed a 10,000 sq. ft. expansion to their Czech Republic Facility. This facility expansion provides more cleanroom production space while increasing the total footprint of this facility to enhance existing capabilities. The FDA-registered and ISO 13485-certified facility provides plastic, liquid injection molding, as well as catheter extrusion and full finished device assembly capabilities in class 7 and 8 cleanrooms.
Matt Jennings, President and CEO of Phillips-Medisize Corp said, “We are very excited about the completion of this expansion. Our Czech facility is an important part of our strategy of providing state-of-the-art medical facilities, equipped with the latest technologies, to our customers in regions around the world.”
As a direct result of the new business wins, Phillips-Medisize has increased the staffing at the Czech facility by over 60%. Today, 138 professionals are focused on meeting the needs of medical device customers in Europe and North America who have entrusted the manufacturing of their products to the Phillips-Medisize Czech facility.
In January 2012, SGS opened a new life sciences laboratory in Navi Mumbai, Maharashtra, India. It is SGS' second facility in India, the first being located in Chennai, Tamil Nadu.
The new facility provides analytical support to the steadily expanding pharmaceutical industry in India. It is spread over an area of 15,000 sq. ft. The facility adds about 10,600ft³ of stability storage space to SGS' operations in India.
About 20 highly trained scientific staff are currently working at the plant. In the next five years, another 90 positions are expected to be created at the facility.
"The facility adds about 10,600ft³ of stability storage space to SGS' operations in India."The facility is equipped with state-of-the-art technologies to carry out extractable and leachable laboratory studies.
Through the facility, SGS will provide biostatistics and data management, analytical method development and validation services, pharmacovigilance, mass spectrometry and immunoassays.
The Mumbai facility will also enable SGS to provide high-quality testing services including testing of raw materials, active pharmaceutical ingredients (APIs) and finished products, biopharmaceutical testing, environmental monitoring, and microbiological testing. It will also offer monograph testing, as well as stability testing as per the ICH guidelines or according to the customer specifications.
SGS began its life sciences laboratory operations in India from Chennai in 2005. The laboratory is GMP-certified and also has ISO 17025 certification. It received the World Health Organization’s prequalified status in 2011 to test and release drugs for treating HIV/AIDS, malaria and other diseases. The facility was inspected and registered by the US FDA.
"The facility is equipped with state-of-the-art technologies to carry out extractable and leachable laboratory studies."Many Indian pharmaceutical companies are now engaged in expanding their business and global presence in bio-similar products. The legal pathways involved in exporting these products to countries such as Canada, Australia, US, and European counties make it mandatory for these companies to use the kind of services provided by SGS.
SGS provides analytical support to Indian companies for the accelerated development and worldwide expansion of their businesses. Using SGS' services, Indian companies can improve the efficiency of their drug development processes.
SGS intended to capture the growing demand for its services in the Indian pharmaceutical industry by establishing a second facility at Mumbai. The facility is also part of SGS' global business expansion. SGS announced the construction of the second facility in May 2011. The facility's construction was completed in 12 weeks.
Many western pharmaceutical companies who previously used the services of SGS have also established their facilities in India. SGS also provides support to these companies.
The life sciences services provided by SGS in India constitute about 2.1% of its total life sciences revenues across the world. Revenues from its Indian operations are expected to increase to about 6% by 2014.
SGS is a primary inspection, verification, testing and certification company with its headquarters located in Geneva, Switzerland. The company has nearly 70,000 employees in 1,350 offices located across the world.
The life sciences division of the company has about 1,370 employees in 26 facilities across 14 different countries worldwide. It provides clinical research, analytical development as well as quality control testing services to pharmaceutical, medical device, biotechnology and cosmetics companies across the world. The division has about 18 laboratories located in America, Asia and Europe. It employs more than 1,200 scientists, physicians, technicians, investigators, analysts and nurses.
In November 2010, SGS acquired M-scan Group, a leading chemical and biochemical testing provider in Europe. As part of the worldwide life sciences services expansion program, SGS also acquired Exprimo, a Belgian life science consultancy company in July 2012. Exprimo's application of model-based simulations in pharmaceutical development will add to SGS' portfolio of services.
MeadWestvaco Corp. will invest $7.5 million in the expansion of its pharmaceutical manufacturing center in Germany. The project includes expanding cleanroom molding and assembly capacity.
Packaging company MeadWestvaco Corp. will invest $7.5 million in the expansion of its pharmaceutical manufacturing Centre of Excellence in Hemer, Germany. The project includes expanding cleanroom molding and assembly capacity and the introduction of a logistics system to control the flow of finished goods and components.
The center is the core for MWV's global pharmaceutical dispensing systems manufacturing network. The facility expansion will commence in early 2013 and is expected to finish by the end of the year.
"This investment underlines MWV's position as an innovation leader in healthcare dispensing systems and our commitment to manufacturing high-quality products in the appropriate regulatory environment," says Sven-Uwe Höhm, vice president and general manager, Medical Plastics Division.
The current Centre of Excellence consists of cleanrooms for precision injection-molding and high-speed component assembly, R&D Facilities with fluid dispensing, fluid atomization, design optimization and broad material knowledge, and project management support. The center also includes further customer service, technical laboratory, and regulatory teams. MWV's healthcare products are manufactured according to ISO 9001, Quality management System for Medical Devices ISO13485, GMP ISO15378, and 93/42/EEC Annex 5 Medical Device Directive standards.
MWV provides packaging solutions for the healthcare, beauty and personal care, food, beverage, home and garden, tobacco, and agricultural industries. The company also produces specialty chemicals for the automotive, energy, and infrastructure industries.
Patheon Inc., a leading provider of contract development and commercial manufacturing services to the global pharmaceutical industry, announced plans for additional investment in its Milton Park facility. Located in Oxfordshire, UK, Milton Park is a dedicated pharmaceutical development services facility focused on early development projects.
As part of its early stage offerings, Milton Park currently provides proof-of-concept and first-in-man development programs for oral dose forms. It also offers Quick to Clinic™, which provides clinical trial materials as fast as four months from receipt of active pharmaceutical ingredient (API). This service has been structured to provide support to emerging pharmaceutical companies with promising molecules.
With the first phase of additional investment to Patheon’s Milton Park facility, the company will be able to expand upon the early development capabilities currently being offered, including the introduction of the SoluPathTM program. SoluPath™ is the first fixed-price, multi-platform solution to improve bioavailability that allows parallel formulation screening using multiple leading edge technologies to review aqueous, lipid-based and solid state formulations. The result is a unique formulation development program for low solubility/bioavailability molecules, which should facilitate a faster route to the clinic. The purchase of a new HME screening tool and spray–drier will supplement existing technologies at Milton Park to provide the SoluPath™ service to emerging pharmaceutical companies with poorly soluble molecules.
“The introduction of Solupath™ into Milton Park’s existing capabilities is an exciting addition to Patheon’s service offering in Europe,” said Robin Platt, Senior Director, Operations for Milton Park. “Poorly soluble compounds are increasingly common in pharmaceutical development and we believe Solupath™ provides a mechanism for identifying the most effective way of improving bioavailability of molecule in these cases.”
Paul Garofolo, Executive Vice President, Global PDS Operations, added, “Solupath™ has been operating successfully in Patheon’s North American facilities. Establishing this capability in Europe is part of Patheon’s global strategy to expand early pharmaceutical development services for our customers.”
Four years after its first extension, Rexam is again expanding its La Verpillière site near Lyon, France, to create a building including approximately 7,800 sq. ft. of cleanroom space dedicated to the production of sub-sets of insulin injection pens for the Eli Lilly & Co. group.
Since 2008, Rexam Healthcare has been the European supplier for the Eli Lilly & Co. group of the sub-sets of their insulin injection pen. This production is carried out by Rexam Healthcare at its La Verpillière plant in Isère.
This site specializes in drug administration systems, such as inhalers for asthma and injection devices, which enable patients to self-administer their medicines. It also houses Rexam Healthcare’s European Technology Centre.
Four years ago, this collaboration between Rexam and Lilly led to the first extension of the site and created around 50 new jobs at La Verpillière with plans to double in size by the end of 2013. The project represents an investment of about $20 million over a three-year period.
Composed of over a dozen plastic parts and a metal spring, this insulin injection pen for the treatment of diabetes has two sub-sets: the dose selection mechanism, and the protective cap. The glass cartridge filled with insulin which is inserted in the pen is produced by the Eli Lilly & Co. group at their Fegersheim site near Strasbourg. This is also where the two sub-sets are assembled and the insulin cartridge inserted.
The components of the injection pen will be manufactured by a fleet of dedicated robots including injection presses, marking machines, assembly line with ultrasound welding, and packaging technology. Each phase will be controlled by a camera system. Designed to be produced by multi-imprint molds on electric injection presses, the plastic parts will be in a material chosen specifically by the Eli Lilly & Co. group.
More than 9,800 ft2 of the building is already reserved exclusively for the manufacture of this product, while 7,800 ft2 out of the additional extension of 12,000 ft2 will be cleanrooms complying with ISO 8 standards.
RLS, a Renishaw associate company based in Slovenia, has tripled the size of its operations with a new, 2,100 sq. meters (22596 sq. ft.) custom-built facility in Komenda.
The new building, which includes a 180 sq. meters (1,936 sq. ft.) cleanroom with electro-conductive flooring and conforming to the ISO 8 standard, represents a significant expansion to RLS’s design and manufacturing capability.
RLS has been an associate of Renishaw, a measurement, motion control, spectroscopy and precision machining specialist, since 2000, when Renishaw took a 50% shareholding.
Janez Novak, Director of RLS, said: “We are drafting further company growth based on our own products, good manufacturing capabilities and solid co-operation with 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.”
Sir David McMurtry, Renishaw’s Chairman and Chief Executive, added: “It has been a joy and a pleasure for me to visit RLS again and meet the staff – they are absolutely amazing. I am delighted how the company is growing, and driven by Janez, we are expecting a great future.”
RLS is a designer and manufacturer of solid-state encoders for measuring speeds and rotary or linear position in the harshest applications. Its products are used in medical equipment, gas pumps, robots, oil-field equipment, construction machinery, off-road vehicles and ‘smart’ machines of all types.
Raleigh Coatings has announced that it is building a third silicone-gel cleanroom coating production line, which will more than double its cleanroom production capacity.
Raleigh's range of specialist coating services includes its cleanroom coating facilities, operated to ISO 14644 Class 7 standards.
The company is in the field of medical adhesive coating and is a specialist in pharmaceutical and medical adhesive, as well as offering a lab-bench through to final production service for silicone gel, aqueous, and solvent based coatings.
"This sustained growth, investment and expansion means we will shortly be creating a number of highly skilled production roles within our new and existing cleanroom production lines," says general manager Peter Turton.
Based in Eccleshall, England, Raleigh is a coater of solvent and aqueous based adhesives. Its specialist coatings services include cleanroom coating, contract coating, slitting and converting, silicone gel coating, and a design and bespoke development service.
Pluristem Therapeutics, Inc., a developer of placenta-based cell therapies, said the company has taken possession of and is moving into its new state-of-the-art GMP facility.
The facility allows for the production of mass quantities of PLacental eXpanded or PLX cells that possess the advantages of being grown utilizing Pluristem's patented 3D bioreactor technology.
The new manufacturing facility will have the capability to produce different PLX product candidates with the potential capacity of over 150,000 doses annually.
The new facility allows increasing the yield from one placenta to over ten times the yield from the previous pilot facility.
Additionally, if regulators approve more indications for clinical trials, this new facility will enable the firm to supply PLX cells to conduct these additional trials in parallel.
Zami Aberman, Chairman and CEO of Pluristem said, "We are excited to begin work in our new plant. With this new manufacturing facility, our company is capable of combining the ideal characteristics of a supply source in the placenta with a proprietary expansion technology that successfully addresses the issues of reproducibility and cost to provide high numbers of reproducible batches of the highest quality PLX cells.''
The Institute for Cancer Research, London plans to launch a new center that will conduct genomic profiling of patients' cancer tumors, and it wants to raise £3.2 million ($5.1 million) to fund the venture.
ICR said that the money it raises for the new Tumor Profiling Unit will be used to attract scientific expertise to the center and to buy new equipment and to outfit its labs.
The center will help to advance ICR's personalized medicine-centered scientific strategy, which is based on three themes: genetics and epidemiology, molecular pathology, and therapeutic development.
The institute pursues its goals by working with The Royal Marsden cancer center and the Biomedical Research Centre for Cancer, by balancing its portfolio between basic and applied science, and by developing treatments based on patient and tumor genomes.
ICR, a college of the University of London, also partners with funding organizations that include Cancer Research UK, Breakthrough Breast Cancer, and the Wellcome Trust. In 2011, its budget totaled £87.4 million.
NSF International has acquired the INASSA Group of Lima, Peru, which includes technical analysis, laboratory and sanitation. INASSA is known as International Analytical Services S.A.C. Environmental Laboratories Peru S.A.C. (Envirolab) and Servicios Integrales de Saneamiento S.A.C. (Servisanea). The acquisition expands NSF’s reach in Latin America to include established pharma and seafood markets.
The NSF-INASSA Group will provide quality control, analytical testing, certifications, inspections, training and consulting services in the Peruvian market. The group provides services across the seafood, fish meal, pharmaceutical products, drinking water, and mining sectors, and works closely with regulators and government agencies. The NSF-INASSA Group employs more than 220 scientists, auditors and environmental health professionals.
NSF International has existing offices in Peru, Chile, Brazil, Mexico and Costa Rica, and will make NSF-INASSA Group its primary Latin American base for the full range of lab testing and technical services. Carmen Catter and Luis Bueno, founders of the INASSA Group, will serve as general managers of the NSF-INASSA.
“NSF-INASSA’s, NSF-Envirolab’s and NSF-Servisanea’s excellent reputation in both national and international markets for testing accuracy, turn-around time and customer service is a perfect complement to NSF International’s independence and integrity,” said Ms. Catter. “Together, we will continue to help improve food and environmental safety and quality in Latin America.”
Dalton Pharma Services began the first stage of its aseptic filling expansion plan to add high speed sterile vial processing and washing, an upgraded high purity water system, expanded vial depyrogenation, additional lyophilization capacity and automated vial inspection.
The upgraded GMP sterile manufacturing capabilities allow the company to handle larger volume commercial aseptic filling of sterile liquids and sterile powders. Later stages of the sterile processing expansion will include additional GMP manufacturing facilities, equipment and automation in order to provide fully integrated sterile manufacturing services from preclinical to commercial production, for both sterile API and finished doses.
”The expansion of our sterile liquid and sterile powder filling capabilities is in response to the requirements of our customers," said Peter Pekos, chief executive officer of Dalton. “These upgraded capabilities not only increase our overall capacity but allow us to offer more complete and efficient sterile manufacturing services. This will allow Dalton to provide more cost effective and flexible support for our client’s aseptic drug development and manufacturing requirements. Future stages of this expansion will add high-value capabilities supporting large and small molecule development, in line with the evolving needs of the sterile manufacturing marketplace.”
The Facility of the Year Awards Judging Panel has named six Category Award Winners in the 2013 Facility of the Year Awards (FOYA) program. The winning projects for 2013 were selected from 27 well-qualified entries and are located in Ireland, Switzerland, the United Kingdom and the United States.
“The FOYA program is about recognizing the pharmaceutical industry’s innovation and technical advances in facility manufacturing, which ultimately is about helping patients who need and depend upon us for a reliable supply of quality medications,” said Chaz Calitri, Vice President of Network Performance at Pfizer and chair of the 2013 FOYA Judging Panel. “The six facilities honored by this year’s awards program embody innovation, exemplified by advances in areas including flu vaccine manufacturing, which is very relevant in parts of the world right now where outbreaks have occurred, threatening public health. All of this year’s honorees are to be commended for their important contributions to our industry and, most importantly, to improving people’s lives.”
The winning companies and respective award categories are:
Biogen Idec - winner of the
Facility of the Year Award for Facility Integration for its Flexible Volume
Manufacturing (FVM) Project in Research Triangle Park, North Carolina USA.
F. Hoffmann – La Roche, winner of the Facility of the Year Award for Project Execution for its TR&D – Building 98 Facility in Basel Switzerland.
MedImmune - winner of the Facility of the Year Award for Equipment Innovation for its UK Automation Upgrade Project in Speke, Liverpool UK
Merck & Co., Inc. - winner of the Facility of the Year Award for Operational Excellence for its Vaccine and Biologics Sterile Facility (VBSF) Project in Carlow Ireland
Morphotek, Inc. - winner of the Facility of the Year Award for Sustainability for its Morphotek Pilot Plant in Exton, Pennsylvania USA
Novartis Vaccines and Diagnostics -
winner of the Facility of the Year Award for Process Innovation for its U.S.
Flu Cell Culture Facility in Holly Springs, North Carolina USA
More information about the 2013 Category Winners and their projects can be found at www.FacilityoftheYear.org/FOYAWinners2013.
About the Facility of the Year Awards Program: Sponsored by ISPE, INTERPHEX, and Pharmaceutical Processing magazine, the Facility of the Year Awards (FOYA) is an annual program recognizing state-of-the-art pharmaceutical manufacturing projects that utilize new and innovative technologies to enhance the delivery of a superior project, as well as reduce the cost of producing high-quality medicines. Now in its ninth year, the awards program effectively demonstrates the accomplishments, shared commitment, and dedication of individuals in companies worldwide to innovate and advance pharmaceutical manufacturing technology for the benefit of all global consumers.
Sartorius Stedim Biotech has been awarded the highest certification for ecological and sustainable building by the U.S. Green Building Council (USGBC) for its new facility in Yauco, PR. The LEED certification system is an internationally recognized green building program. Sartorius is currently the only company to have a LEED Platinum-certified manufacturing facility for the biopharma industry.
Sartorius invested $20 million in the new production building, which opened in the summer of 2012. The 55,000 sq. ft. building complex provides space for two new cleanrooms for filter and bag manufacture, labs and offices. The building was designed to save approximately 85 percent of water consumed in comparison with conventional facilities, and the climate control technology, building materials, and perforated metal fins and diaphanous screen walls contribute to energy savings. Also, the company covers approximately 10 percent of its energy needs with a photovoltaic system installed on the roof.
“We are very proud to have received this prestigious rating for our new facility in Yauco from the USGBC organization. It acknowledges the green building measures that Sartorius has taken to ensure protection of the environment. Our innovative building sets new standards and proves that careful planning enables ecological and economical concerns to be reconciled,” said Volker Niebel, member of the Executive Committee of Sartorius Stedim Biotech.
Gerresheimer AG, a supplier to the international pharmaceutical and health care industry, has added an ISO Class 8 cleanroom to its facility in Küssnacht, Switzerland. The cleanroom has been built for the production and assembly of auto-injection systems and is equipped with injection molding machines, robots, and highly automated assembly lines.
After completion of the expansion measures, the Küssnacht site will have a production area with a total of more than 12,000 sq. ft., about 9,500 sq. ft. of which will be set aside for cleanroom production to ISO Class 8 (100,000). Additionally, more than 2,600 sq. ft. will be designated as controlled areas to ISO Class 9.
The facility will be equipped to cover the entire production chain, from manufacturing and post-production finishing to assembly, testing, and packaging. The main focus of production operations at Küssnacht will be on the large-scale production of pharmaceutical products such as inhalers and auto-injection systems as well as products for laboratory and molecular diagnostics.
Other measures include investment into a new on-site logistics building, planned for this year.
Belgium-based UCB has awarded Emerson Process Management, a global business of Emerson, a $6.1 million contract to provide integrated process automation and operations management systems for a new biopharmaceutical production center in Bulle, Switzerland. Emerson’s technologies and engineering services will be crucial in meeting the very high standards expected by the UCB project team. UCB is investing $228 million to construct the first phase of a new plant, its first biopharmaceutical project in Switzerland. The 20,000-square-meter (215,200 sq. ft.) facility, which will be one of the largest in Europe, will be the main production center for Cimzia® (certolizumab pegol), which is used to treat rheumatoid arthritis and Crohn’s disease.
“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.”
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 – a key advantage in managing complex operations and extensive documentation required in pharmaceutical production. Syncade Suite manages workflow processes, including electronic work instructions, equipment status and material tracking, recipe-driven operations, automated weigh and dispense operations, and exception reporting.
“Typical biotech manufacturing can involve thousands of pieces of paper that can affect the ability to produce ‘right-first-time’ batches,” said Lorenzo Zampini, automation project manager. “With Emerson’s integrated operations management and control systems, we can automate the reporting process as well as gain tighter process control for increased productivity and smoother regulatory compliance.”
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 even detects 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. We look forward to working with them as they bring the Bulle facility to life.”
Following a wave of recent investment in ADC production, Synthon has opened an ADC manufacturing facility in Nijmegen, Netherlands, to help bring its first preclinical ADC program to clinical trials by 2014.
Synthon’s initial antibody drug-conjugate (ADC) program is focusing on tumors that over-express HER2. In preclinical studies the company found that in several xenograft models, including breast cancer and non-small-cell lung cancer xenografts, its HER2-ADC dosed alone induced complete tumor remission, whereas with the antibody alone produced no effect.
“We strongly believe that advancing this second generation ADC technology will lead to a new class of effective, targeted medicines in oncology,” Marco Timmers, chief scientific officer at Synthon Biopharmaceuticals said: “Our GMP plant will also accelerate future patient access to oncology products based on this pioneering technology.”
The ADC program “incorporates the HER2-binding antibody trastuzumab,” which aims to target tumors that over-express HER2, Dr. Timmers added.
Sabienne Douven, a spokesperson for Synthon, said the new facility includes:
Full view of all ADC activities
taking place in the grade C cleanroom and fumehoods from all directions
A flexible design allowing for
multiple unit operations at multiple scales, including chromatography if
required;
Access to buffer supply without
bringing these into the ADC clean room and therefore minimizing transportation
in and out the ADC clean room;
Fully integrated facility including
IPC lab and connected ADC development laboratories, quality control and
warehouse.
Application of single use product
contact materials only, which eliminates cleaning activities; and
In-house manufacturing of both linker-drug and ADC.
The new production facility will also work to develop two other ADCs, Douven said. The facility is “built to develop our ADCs, but we’re also open for partnering with other companies,” she added.
Earlier this month, Lonza announced plans to double its ADC capacity by 2014, while last July, Novasep increased its investment in a French ADC plant by €3 million. Fujifilm Diosynth Biotechnologies also entered the ADC manufacturing sector with a partnership with Indian CRO Piramal Healthcare.
Menarini and Oxford BioTherapeutics also recently hammered out a clinical development and manufacturing deal focusing on ADCs that is reported to be worth more than €800m.
But the investment in ADCs comes as the US Food and Drug Administration has only approved two – Pfizer’s Mylotarg (gemtuzumab ozogamicin), which was withdrawn from the US market in 2010 but it has remained available in other markets such as Japan, and Seattle Genetics’ Adcetris, which was also approved in the EU.
A major new international food safety training facility, aimed at improving compliance with EU food import standards, has been launched by The Food and Environment Research Agency and Waters®.
A significant proportion of food safety incidents reported in the EU are due to imports, therefore ensuring the legal compliance and safety of imported food is vital for protecting consumers. The EU and other international organizations have recognized the value of improving food safety testing globally, so that risks can be identified and tackled at source. In the EU alone the value of exports and imports of foodstuffs today exceeds £690 billion (over 860 billion Euros).
The Fera International Food Safety Training Laboratory (Fera IFSTL), based near York, will primarily train scientists concerned with exporting foods to Europe. Experts from Fera will lead training programs that teach best practice methods to analysts from overseas, using state-of-the art technology and equipment for determining chemical contaminants and residues in food. This will enable food producing countries around the world to implement their own solutions and gain access to the opportunities offered by trade with Europe.
Speaking as he formally opened the new Training Laboratory Lord de Mauley, Parliamentary Under-Secretary of State (Lords), said: “It’s very encouraging to see the public and private sectors working together to facilitate trade from outside the EU. This will improve food safety testing for food imported into the EU, ensuring food is safe before it reaches our tables.”
The new venture combines the respective regulatory and scientific expertise of both organizations. The Fera IFSTL draws on Fera’s extensive expertise as world leaders in the application of analytical chemistry to food safety testing and as the UK National Reference Laboratory for chemical contaminants in food, pesticide residues and veterinary drug residues.
Fera Chief Executive, Adrian Belton, commented, “We welcome this opportunity to be able to pass on our expertise in food analytical testing. This is underpinned by over 30 years scientific experience in the area, together with detailed knowledge of current and emerging regulations, and internationally recognized quality standards. All of our food analysis work is carried out in modern laboratories by highly trained scientists, using state-of-the-art analytical equipment.”
The Fera IFSTL is being launched as part of an international network of food safety training laboratories aimed at raising standards of food safety testing globally. The first IFSTL was opened in the United States in September 2011 by the U.S. Food and Drug Administration, University of Maryland and Waters®. The training facilities in the network will coordinate and share expertise. As new facilities are added to the network, they will do the same, increasing knowledge and the use of global best practices.
Said Waters Corp. Executive Vice President Art Caputo: “We are very pleased to partner with Fera in establishing this lab near York. We believe that this collaboration will lead to better science and technology, and this in turn will help us raise the bar on food safety. We know the scale of this challenge requires us to address it globally, which is why we are excited to expand the IFSTL network.”
As part of the collaboration with Fera, Waters helped establish the laboratory’s construction, provided analytical systems and assisted Fera in designing training programs. The facility is equipped with Waters’ state-of-the-art ACQUITY UPLC®-MS/MS systems, sample preparation components, and mycotoxin analysis tools.
Amgen Inc, the world's largest biotechnology company, announced on Wednesday plans to build a new manufacturing plant in Singapore.
Thousand Oaks, California-based Amgen said it plans to invest around $200 million in the project, which will initially focus on the production of antibody-based drugs.
Construction, in the Tuas Biomedical Park area of Singapore, is expected to begin in the next few months.
After Amgen announced plans to invest $200 m (EUR150m) into a new biomanufacturing facility in Singapore, in-PharmaTechnologist.com spoke to the Director of Biomedical Sciences at the SEDB, Kevin Lai, who explained to us the increasing appeal of the Asian island for the biopharmaceutical industry.
Lai said that “EDB’s vision is for Singapore to become a leading international biomedical sciences cluster, where companies can innovate, commercialize and produce medical drugs and devices, services and solutions to impact the future of global healthcare.”
He hoped "to achieve this vision by attracting more investments from global and Asian companies, fostering collaborations between industry, academia and government.”
Amgen’s first major manufacturing investment in Asia sees the California company join an international hive of biotech companies. Biomanufacturing is represented with over 50 commercial scale plants present, including facilities operated by Pfizer, Lonza, Roche and Baxter.
According to Lai, the sector “has grown over the last ten years from 6,000 to 15,000 employees. Manufacturing output has increased four-fold —from $6bn in 2000 to $27 billion in 2011.
“Singapore has positioned itself as an attractive location for biologics manufacturing by providing a strong and highly qualified base of local talent, demonstrating a proven track record in manufacturing activities, reliable infrastructural base and trusted supply chain network as well as stable and friendly business climate”
The rich talent pool was also a reason stated by Novartis’ CEO, Joe Jimenez after they announced a $500m new cell-culture based facility on the island last November. Amgen too has partnered with local universities in order to recruit a number of positions at its new plant.
As an entry point to Asia, the regional headquarters of Pfizer, Novartis, Sanofi and Abbott are based in Singapore. Lai explained: “Global multinational companies and mid-cap firms need a base in Asia to manage their pan-Asian operations, while fast growing Asian enterprises need a location from which to internationalize.”
Lai did not mention financial incentives but was guardedly upbeat about the future of the industry. “Despite the uncertain global environment, Singapore is cautiously optimistic about the outlook for 2013 as we remain flexible and responsive to meet the changing needs of global biopharmaceutical companies.”
New facility offers clients greater flexibility and speed in formulation and process development.
Almac has announced the expansion of our drug product Pharmaceutical Development services with the creation of a new non-GMP formulation development facility and two new analytical laboratories at our UK headquarters in Craigavon.
The new facilities double our current pharmaceutical development capacity allowing us to meet the growing demand for our services, both from existing and new clients.
The new non-GMP formulation development facility offers clients greater flexibility and speed in formulation and process development, creating an environment where development work can be progressed quickly and then easily transferred to the GMP environment at an appropriate stage.
Although the new facility will be dedicated to non-GMP work, it mirrors all the technical capabilities of Almac’s 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.
Whereas, the existing GMP facilities can support drug product manufacturing from phase I up to registration and commercial scale, 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, VP of Technical Operations explains “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.”
Marken announced the completion of its new, expanded pharmaceutical depot in Mexico City. The new state of the art facility is located closer to the Mexico City airport and provides a total of 1300 m² (13,988 sq. ft.) of GMP-compliant space for temperature controlled storage and distribution of clinical trial supplies. The recent expansion was a response to the significant client demand Marken is experiencing within that region.
“We are very pleased to announce the completion of this expansion which is a direct result of an increased demand for our services. In addition, we also enhanced our global project management team with experienced Project Leaders ensuring seamless set-up and coordination of all global clinical trial storage and distribution work. We will continue to push forward in enlarging our network to provide the most efficient and flexible solutions to our clients” said Gerit Offenhauser, Senior Vice President, Clinical Trials Distribution.
Marken’s depots provide secure temperature controlled storage and distribution for pharmaceuticals, biologics, medical devices and diagnostic equipment. The new depot will supplement Marken’s existing network of global depots in Germany, Singapore, USA and Argentina. Marken’s depot network is connected through the Solo platform, a global state-of-the-art, 21 CFR part 11 validated, cloud based inventory management system which tracks dosages at the patient level.
Wes Wheeler, Chief Executive Officer of Marken said “The completion of our new Mexico depot is another important milestone in our global depot network expansion strategy. Through further continued investment in facilities and technologies, we will continue to ensure that our clients are served with full service, global clinical supply chain solutions and that we provide the highest quality courier and logistics services to our clients.”
Marken is the leading global clinical supply chain solutions provider dedicated to the pharmaceutical and life sciences industries, supporting over 49,000 clinical investigators in more than 150 countries. Marken integrates Depot and Logistics services into solutions that extend the reach of clinical trials to even the most remote treatment in naive geographies.
McIlvaine Company
Northfield, IL 60093-2743
Tel: 847-784-0012; Fax: 847-784-0061
E-mail: editor@mcilvainecompany.com