PHARMACEUTICAL & BIOTECHNOLOGY
INDUSTRY UPDATE
April 2013
McIlvaine Company
Novum to Open State-of-the-Art Clinical Research Facility
CVS Donates for New Lab at Chicago State University
FBI's Computer Forensics Lab Gains Accreditation
Novartis Vaccine Manufacturing Facility Details
Altman Clinical and Translational Research Institute Details
Regeneron Pharmaceuticals Announces Expansion
Elastomer Technologies Adds Cleanroom
Texas A&M System and GlaxoSmithKline Establish Influenza Vaccine Facility
Middlesex Community College Plans for Biotech Expansion
BD Forms New Pharmaceutical Wing
Actavis Pharmaceutical to Expand
The Jackson Laboratory for Genomic Medicine
Argonne National Laboratory's Advanced Protein Crystallization Facility
Boyd Invests in Cleanroom Technology
Dow Plans Performance Plastics Facilities
AstraZeneca to Establish Strategic R&D
AAF International to Open R&D Center
Clinical and Translational Research Center at University of Buffalo
Ashland to Expand Delaware Formulation and Contract Manufacturing
Sil-Pro Installs Cleanroom Addition
G&F Industries Adds Class 8 Cleanroom
Spirit Pharmaceuticals Establishing New Facility
WVU Opens Clinical Research Center
Pall Opening Life Sciences Center of Excellence
BioMalta Life Sciences Park, San Gwann, Malta
Clinical and Translational Research Center Opened
Bactolac Pharmaceutical Facility, New York, U.S.A.
The Maurice Wohl Clinical Neuroscience Institute, United Kingdom
Rapak Opens Aseptic Bag Manufacturing Facility
CPR Pharma Expands APAC Capabilities
FDA Inspects Frontage Site in China
PPD’s Bioanalytical Labs Certified in Brazil
Vetter's Facility Successfully Completes FDA Inspection
Nypro Establishing Medical Device Manufacturing Facility in Ireland
Center for Arctic Research Opens at Univ. of Manitoba
Takeda Establishes Subsidiary in Ecuador
Quay Pharma Opens New Facility in Wales
Gulf Pharmaceutical Industries (Julphar) Insulin Production Facility
SAFC Expands Scottish Facility
AstraZeneca to Create New R&D Center in Cambridge, UK
Kyowa Hakko Kirin to Build Injectables Plant
Neuland Labs and APIC to Collaborate in Japan
Pivot Park and Spinnovation Analytical Join Forces
Pfizer New Project in Saudi Arabia
Catalent Focuses on Chinese Ventures
South Korean OK for BASF's Scottish Omega-3 plant
Marken Opens New Beijing Logistics Depot
Baxter to Invest in Puerto Rico Plant
Singapore R&D Campus Takes Top Honor in Lab of Year Competition
IFF Opens Facility in Guangzhou, China
Pathwork and Kindstar to Offer Tissue of Origin Test in China
Bruker Opens Two New Centers of Excellence
SGS Adds Stability Testing Services in UK
MicroVention Opens Costa Rica Facility
Patheon Announces First Phase of Additional Investment in Milton Park, UK Facility
Horizon Discovery has Three New Centers of Excellence
Sanofi to Manufacture API for DBV Drug
Novum Pharmaceutical Research Services, a leading contract research organization (CRO) serving the pharmaceutical industry in Phase I-Phase IV clinical trials and related services, announced the opening of a new early-stage clinical facility in Houston, TX. The 55,000 square foot facility is scheduled to be operational in August, 2013.
"This exciting new facility reflects Novum's continued growth and our deep commitment to our clients' needs," said Christopher H. Chamberlain, Novum's Chief Executive Officer. "Like our other research facilities, it will provide a safe, convenient, and pleasant environment for our study participants," he added.
The GCP-compliant facility is being custom-built in Houston's Westchase district, a short distance from Novum's current clinics. The new facility will have seven research units that are designed to make the most efficient use of its 225 beds. Additionally, a 12-bed intensive monitoring unit will allow for early phase research studies requiring continuous cardiac and other specialized safety monitoring. The floor plan and layout will provide a high degree of flexibility in space planning to handle multiple types of study designs.
"While our employees and study participants truly make the difference at Novum, bringing this state-of-the-art facility online will raise the bar for Novum and the industry," said Dr. Darin Brimhall, Novum's Vice President of Clinic Operations.
Chicago State Univ. announced it received a donation from CVS Caremark for a new student center in the College of Pharmacy.
CVS Caremark donated $250,000 for the development of the CVS Caremark Student Center and Technology Laboratory. "This donation will help to improve the College's physical space and technological resources, which greatly enhances student success within the College of Pharmacy.
CVS Caremark is the largest integrated pharmacy company in the U.S. and employs more than 24,000 pharmacists.
"CVS Caremark is pleased to support Chicago State Univ.'s College of Pharmacy and its mission to educate and train new generations of pharmacists," says Papatya Tankut, Vice President of Pharmacy Affairs at CVS Caremark. "The CVS Caremark Student Center and Technology Laboratory will help ensure that students are prepared for success in a rapidly evolving pharmacy industry.”
The grant, disbursed over a five year period will support pharmacy students by providing:
• Integrative learning– this laboratory will provide students with an opportunity for small group hands-on experiences in preparing for and conducting presentations and using new technology in their preparatory efforts.
• Development of practical skills to enhance scholarship– the new center will be used to enhance faculty-student engagement. Through this experience students will improve and expand upon their oral, writing and research skills.
• Social interaction– Students will work together to strengthen intercultural language, values and traditions to foster one-team spirit and quality objectives.
"This gift will create educational opportunities that will enable our pharmacy students to achieve success as individuals and contributors to the global healthcare community,” says CSU president, Wayne Watson. “We are grateful for the generosity of CVS Caremark, who supports our mission of teaching a diverse community of scholars," Watson says.
With Chicago States' latest donation, the university has received $500,000.00 in 2013.
The FBI announced that the Orange County Regional Computer Forensics Laboratory (OCRCFL) has earned International Accreditation from the American Society of Crime Laboratory Directors/Laboratory Accreditation Board (ASCLD/LAB), the world’s largest forensic science accrediting body. Accreditation demonstrates to OCRCFL customers and the general public that a laboratory meets or exceeds the rigorous standards established by the international scientific community.
Currently, only 38 laboratories worldwide hold International accreditation in the Digital and Multimedia Evidence-Computer Forensics discipline. Requirements are based on the International Organization for Standardization 17025-2005 standard and ASCLD/LAB supplemental requirements.
At an accreditation ceremony and press conference held at the OCRCFL in Orange, California, ASCLD/LAB Executive Director, Ralph Keaton, presented the official accreditation certificate to members of the Orange County RCFL Local Executive Board and FBI management.
The OCRCFL becomes the 13th laboratory in the RCFL Program to be accredited by ASCLD/LAB, and the fifth to earn accreditation under the International Program. It achieved this distinction only two years after its official opening. “We are very proud of the hard work and dedication to quality demonstrated by the Orange County RCFL team,” says Assistant Director in Charge of the FBI’s Los Angeles Division Bill Lewis. “Laboratory accreditation is a vital plank in our efforts to provide the finest digital forensic services available to the hundreds of law enforcement customers who rely on the OCRCFL to help fight crime.”
The OCRCFL is part of the RCFL Program, a national network of 16 FBI-sponsored digital forensic laboratories and training centers devoted entirely to the scientific examination of digital evidence. The national program represents one of law enforcement’s most successful partnership initiatives with representatives from 130 agencies working side-by-side to provide expert digital forensic services to any law enforcement agency in an RCF’s service area.
The OCRCFL is funded and administered by the FBI’s Operational Technology Division (OTD) and overseen by the FBI’s Los Angeles Division and FBI Headquarters RCFL National Program Office. Executives from 14 participating federal, state and local law enforcement agencies serve on the OCRCFL’s Local Executive Board.
Thirty-two personnel from the participating agencies are assigned to the OCRCFL. They undergo extensive training to become FBI-certified as computer forensics examiners and must strictly adhere to standard operating procedures and institutionalized peer review measures to provide consistent, accurate, repeatable and verifiable results.
OTD’s Assistant Director, Amy Hess, says, “We take great pride in our ability to provide the highest-quality digital forensic services to every law enforcement agency customer we serve. When launching the RCFL Program, the FBI pledged not only to expanding the digital forensic capacity nationwide, but to doing it the right way. The OCRCFL’s accreditation and the accreditation earned by our other labs is a point of pride and a testament to our unwavering commitment to quality. “
At the press conference, the OCRCFL also officially rolled out its new Mobile Forensic Laboratory (M-LAB). The M-LAB provides full digital forensic processing and examination capabilities in the field. The M-LAB is outfitted with multiple “state-of-the-art” computer workstations, servers, custom on-board power systems and specialized equipment to examine all types of mobile computing devices. The M-LAB can process, in real time, standalone computers, computer servers, all types of mobile computing devices such as cell phones, smart phones, iPADs and all other forms of digital evidence found during the course of a breaking investigation. The OCRCFL’s M-Lab is currently one of six mobile forensic laboratories that the FBI has deployed across the U.S. to provide onsite support on critical FBI and partner agency investigations.
In July 2006 Novartis announced that it would build a new vaccine manufacturing facility in Holly Springs, NC. The new 430,000ft² plant was inaugurated on 24 November 2009, and production commenced in 2012. The plant is employs approximately 500 people to produce flu vaccines using cell culture-based manufacturing technologies.
The facility was constructed on a 167-acre site in Holly Springs Business Park off the NC 55 bypass. A central corridor connects the five buildings of the plant, including a production house, warehouse, maintenance and office building. Construction started in the first quarter of 2007 with the first design phase completed in 2008. The plant became operational in 2012.
The initial investment was estimated at $267m but eventually reached $1bn with subsequent phases of expansion.
In January 2009, the U.S. Department of Health and Human Services, Biomedical Advanced Research and Development Authority (HHS BARDA) awarded a contract to Novartis to support the design, construction, validation and licensing of the Holly Springs facility. The eight-year contract was valued at $486m.
In February 2013, the plant received Facility of the Year Award (FOYA) award from the International Society for Pharmaceutical Engineering (ISPE).
Several states competed for the manufacturing facility. Novartis' selection of the town followed an intensive two-year effort by Holly Springs with assistance from state and county agencies.
Attracting the manufacturing facility required an incentives package that included $8.3m from Holly Springs. The Town Council approved the purchase of the 167-acre site for the facility in the business park for $7.3m from G&G Properties and transferred ownership to Novartis.
The council then approved an additional $1m spending for site clearance. Holly Springs also received an $800,000 grant from the Golden LEAF Foundation to help fund infrastructure improvements in the business park.
In total, Novartis Vaccines and Diagnostics, a subsidiary of Novartis AG of Basel, Switzerland, received cash grants, land, tax credits and other incentives worth more than $41m from state and local governments. The town property taxes that Novartis paid on the first phase of construction are expected to enable Holly Springs to recoup its investment within ten years.
Securing the project had been the culmination of five years of economic development groundwork by the town council to make Holly Springs attractive to the growing biotech industry.
Novartis had evaluated 15 sites before choosing Holly Springs. The city was chosen for the availability of infrastructure, a well-trained and educated workforce and quality of life, according to Dr Joerg Reinhardt, CEO of Novartis Vaccines & Diagnostics division. The town hired Jennings Consulting to help market the 400 acre business park for technology manufacturing companies, and this helped in the attraction of Novartis.
Extension of infrastructure was a key part of the process. In 1996 Holly Springs began studying how best to pipe water from Harnett County to supplement the flow from Raleigh.
Construction began in 2000 on a pipeline capable of carrying 10 million gallons a day.
The facility has approximately 8,000 process automation input / output points.
The line was increased to serve large-scale manufacturing operations such as Novartis while accommodating residential growth. With improved capacity, the town is arranging to pipe more water through the line.
The Novartis facility in Holly Springs is the first manufacturing plant in the US to produce cell culture-derived flu vaccines. The plant develops vaccines using cell culture-based manufacturing technology.
New flu cell culture vaccine manufacturing technology promises many advantages over traditional egg-based production, including greater reliability and a reduction in production time. Expected to be cleaner, the technology can be scaled up at a faster rate than egg-based manufacturing technology.
The cell culture technology for influenza vaccines was approved in the US. For developing the flu cell culture vaccine, however, the facility had received funds from the HHS as part of the contract between the two. A vaccine, named Flucelvax, was the first influenza vaccine introduced and approved by the US government in 2012. Flucelvax is a cell culture based vaccines grown in dog cells.
The facility can annually produce up to 50 million doses of seasonal trivalent flu vaccines, which are used in the US.
"The plant became operational in 2012."In the event of an influenza pandemic, the facility has planned to have a capacity of up to 150 million monovalent doses annually, within six months of a pandemic declaration. Novartis is also making investments in its site in Marburg, Germany, to expand capacity for flu cell culture vaccines production in Europe.
The facility also develops MF59, the Novartis proprietary adjuvant. Adjuvant-based studies are underway in the US.
The clinical trials conducted on the MF59 adjuvanted cell culture-based vaccine demonstrated that the levels of protective antibody can be raised against A(H1N1) infection, two weeks after a single dose of adjuvanted vaccine has been administered. Results also showed that MF59 offers cross-protection against similar strains of a H5N1 virus. The adjuvant was also found to strengthen the body's immune system to provide more protection from harmful pathogens and viruses. It is manufactured using shark liver.
Jacobs Engineering Group provided design, engineering, procurement and construction management services for the facility.
The University of California and San Diego (UCSD) initiated construction of Altman Clinical and Translational Research Institute (CTRI) building at La Jolla in San Diego, US, in January 2013.
The CTRI will provide laboratory and clinical researchers with an environment for collaboration and resource-sharing to better understand and treat diseases such as cancer, arthritis and diabetes.
The building is named after Lisa and Steve Altman, who contributed $10m in funding for the construction of the CTRI building in March 2011. The construction is expected to be completed by 2016.
The facility will provide employment to about 1,000 people, including about 100 principal investigators. It will be home to biomedical informatics specialists, telemedicine specialists, electronic health record technology specialists, imaging specialists and biomedical engineers.
The new facility will be a seven storey building with three floors below ground and four above.
The building will have a pentagonal structure, which will be enclosed with a terrace at street level, a courtyard on lower level three, and another terrace on the exterior of the auditorium at level one, which will feature a green theme.
The facility will be connected to the Sulpizio Cardiovascular Center by a pier-supported pedestrian bridge.
The new facility will be engaged in research to accelerate the development new technologies, drugs and procedures for patients. It will be equipped with state-of-the-art laboratory equipment and clinical research facilities. It will invite talented people from all disciplines, such as physicians, geneticists, engineers, immunologists and computer scientists, to carry out research and to collaborate cures for specific diseases.
The Altman CTRI will also be the new home for the UC San Diego pediatric diabetes research center.
The building will have a total floor space of 359,000ft2. It will include about 189,000ft2 of space for research and core laboratories, 66,000ft2 of space for the dry research, multiple conference rooms, a large lecture hall and other facilities.
CTRI administration offices will also be located in the building. Other facilities will include a vivarium, auditorium, and café.
The ground breaking for the construction of the CTRI facility was held on 17 January 2013. The preliminary construction works on the site are now underway. The actual construction work is expected to begin April 2013 and is scheduled to be completed in 30 months, by 2016.
The building will target to achieve LEED Silver (Leadership in Energy and Environmental Design) certification. It will be constructed in compliance with environmentally-friendly norms and will use zero energy strategies.
The new CTRI facility has been designed by Zimmer Gunsul Frasca (ZGF) architects. The construction contract has been awarded to Rudolph and Sletten, who will act as construction manager, with assistance from UC San Diego Facilities Design and Construction.
Rudolph and Sletten has invited bids for 38 subcontract works for the construction of the building.
The total estimated investment for the construction of the project is about $269m. It is financed with $10m funding by Steve and Lisa Altman, the San Diego-based philanthropists. The rest of the project costs will be met through external and public funding as part of research funding from the UCSD.
Regeneron Pharmaceuticals, Inc. announced that the company will expand the Regeneron corporate headquarters and laboratories in Westchester County and create more than 400 new high-skill jobs.
Today's announcement further cements the reputation of the Hudson Valley as an emerging epicenter for biopharmaceutical growth. "Today's announcement further advances New York's reputation as a leader in the biotech industry," Governor Andrew M. Cuomo said. "This administration has had a laser-like focus on creating an environment where companies, such as Regeneron, can grow and invest. The expansion of Regeneron's headquarters and the addition of hundreds of new high-skill jobs is great news for Westchester County and great news for New York."
"Our recently approved drugs and our robust development pipeline have transformed Regeneron into one of the largest and fastest-growing biopharmaceutical companies in the United States," said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer. "Regeneron has been based in since we began 25 years ago, and we are grateful to Gov. Cuomo and New York State for financial support that helps us to continue to expand and create jobs in New York."
The project will add two new buildings with 300,000 square feet of laboratory and office space to the Regeneron complex at the Landmark at Eastview in the Town of Mount Pleasant in Westchester County. Currently, Regeneron occupies approximately 590,000 square feet of space at the site and will occupy another 85,000 square feet of additional space there later this year.
The expansion will enable the company to continue to accommodate the rapid growth it has experienced over the last six years-- from 682 employees in 2007 to 2,000 today, including more than 1,300 employees in Tarrytown and nearly 600 at its industrial operations and product supply facility in Rensselaer, NY.
Last November, Governor Cuomo announced Regeneron's plans to invest nearly $70 million to expand its manufacturing capacity in Rensselaer and create 300 new jobs in the Capital Region. With the Rensselaer and Tarrytown expansions, the company is slated to create more than 700 new jobs in New York State and invest approximately $170 million in capital expansion in New York over the next few years.
The company had also considered expanding outside New York before the State stepped in with $8.5 million in tax credits through the Excelsior Jobs Program and the Town of Mount Pleasant Industrial Development Agency offered additional incentives.
Construction of the new buildings is anticipated to begin in late 2013 and to be completed in late 2015.
Elastomer Technologies Inc. has opened a new plant in Corona, Calif. A Class 100,000 cleanroom, designed to support liquid injection molding and compression molding of medical device components, is located at the new plant.
The company, a molder of rubber and silicone products, is also adding new equipment at the 17,000 ft2 facility. Improvements have been made to Elastomer's hydraulic systems that drive the compression molding equipment, Micro View Coordinate measuring equipment has been purchased to improve quality inspection, and an Arburg 50 ton LIM press has been added to improve delivery of liquid silicone injection molded products with the additional capability to run high constancy silicone rubber.
Life Technologies announced it will invest $18 million to expand its facility in Pleasanton, Calif., where the company will implement current good manufacturing practice capabilities for its genetic analysis products.
The expansion will occur over multiple phases and is part of the Carlsbad, Calif.-based company's efforts to broaden its product portfolio addressing the molecular diagnostics market. The project will break ground in the second quarter of 2013.
In the first phase of the expansion, 10,000 square feet of space will be repurposed for the manufacture of molecular probes and primers under cGMP standards, Life Tech said. In subsequent phases, 30,000 square feet of space will be added during a one- to three-year period for the production of materials, following regulatory standards, for qPCR workflows in the clinical space.
Life Tech said that it currently has nine facilities that follow cGMP standards and are ISO 9001/13485-compliant for the manufacturing of products such as instruments, reagents, assays, cell culture media, and sera.
"The expansion of the Pleasanton facility and plan to achieve cGMP certification underscores our growth strategy in new markets and our commitment to win in genetic analysis from discovery to diagnosis," Mark Stevenson, president and COO of Life Tech, said.
GlaxoSmithKline plc (GSK) and The Texas A&M University System announced that the U.S. Department of Health and Human Services (DHHS) has approved the establishment of a $91 million influenza-vaccines manufacturing facility as the anchor of the Center for Innovation in Advanced Development and Manufacturing (CIADM) in Bryan-College Station, Texas.
The TAMUS influenza vaccines manufacturing center will afford GSK the capabilities to eventually manufacture influenza vaccine based on a proprietary cell-culture line, [1]EB66(TM). Most existing influenza vaccine is manufactured using fertilized chicken eggs. The cell-culture process will supplement the vaccine supply from eggs, and facilitate a rapid national vaccine response in the event of a pandemic.
GSK Vaccines produces 30 vaccines worldwide, eleven of which are licensed by the FDA. The Texas A&M-GSK venture will complement and support the company's existing influenza vaccines operations, based in Quebec, Canada, and Dresden, Germany. GSK's operations hub in Marietta, Pennsylvania will package, inspect and distribute influenza vaccine manufactured at the Texas A&M Center. In 2012, GSK provided more than 20 million flu shots for the U.S. market and recently became the first major U.S. vaccines provider to gain FDA-approval for a broader-protection, four-strain (quadrivalent) influenza vaccine shot that will be available in time for the 2013-14 flu season.
One of only three CIADMs to be developed in the U.S., the Texas A&M Center is at the vanguard of U.S. pandemic-preparedness efforts and represents unprecedented public-health collaboration among state and federal governments, academia and private industry. Once constructed and operational, the Center's influenza manufacturing facility will be able to supply 50 million doses of pandemic influenza vaccine within four months of an outbreak. BARDA conceived the public-private formula to assure a strong biosecurity product development and manufacturing base on U.S. soil, ensuring that the nation would have rapid access to vaccines and therapeutics in the advent of influenza pandemics, or chemical, biological, radiological, and nuclear attacks.
"We are honored to welcome GSK to Texas A&M as a key partner in the Center for Innovation," said Sharp. "GSK's dedication to public service is well-aligned with the Texas A&M tradition of serving the nation and defining its future through research and scholarship. Equally important is the cultural and philosophical match between GSK and the A&M System, as reflected by GSK's desire to collaborate with academia and the U.S. government, and their ongoing commitment to helping address global health scourges such as pandemic influenza and malaria."
The Texas A&M Center for Innovation is lead by Dr. Brett Giroir, Vice Chancellor for Strategic Initiatives at the Texas A&M System, and a core team of A&M experts in biotechnology, infectious diseases, facilities planning and construction, federal acquisitions/contracting, and government affairs. The partnership with GSK was founded on a long, collaborative relationship between Texas A&M and the Wallonia Region of Belgium, with specific planning for this project beginning in the spring of 2010.
"GSK's decision to partner with Texas A&M and bring their vaccine manufacturing to our state is a testament to the investments that the A&M System and the State of Texas have made in the people, infrastructure and technologies, much of which came from critical state programs such as the Emerging Technology Fund," Giroir said. "GSK brings unequaled influenza vaccine development, manufacturing, and regulatory expertise to our Center. Equally important, GSK brings its cell based influenza vaccine development program, which we have assessed to be the most promising near term influenza vaccine technology to improve upon current egg based vaccines."
The Texas A&M Center for Innovation represents the largest commitment of a global biopharmaceutical company to partner within Texas, and will be an important catalyst to the future growth of this industry within the State.
The Massachusetts Life Sciences Center has issued a $50,000 planning grant for Middlesex Community College in Lowell to expand its biotechnology facilities.
The college has been granted the funds to complete a comprehensive planning study to identify the best approach for expanding its biotechnology facilities. This will include a cleanroom to support increased enrollment and workforce development, education, and training.
"The college is thrilled with the support this grant will provide to Middlesex to allow us to utilize both industry and technical experts to review and consider updates to our facilities which will benefit our students, our business partners, and the local economy," says MCC President Carole Cowan. "Biotech is one of the most exciting, successful and dynamic programs we have at the college, and this grant helps ensure that future graduates of the program will find continued success in this critical industry."
The Massachusetts Life Sciences Center is a quasi-public agency tasked with implementing the Massachusetts Life Sciences Act, a 10-year, $1-billion initiative that was signed into law in June 2008. The MLSC's mission is to create jobs in the life sciences and support scientific research.
Eli Lilly and Co. is planning to spend about $260 million to expand insulin production and make some other capital improvements to sites in its home city.
The Indianapolis company said it aims to spend about $180 million on some new construction, the addition of another insulin cartridge-filling line to an expansion it announced last fall and the installation of some new equipment.
The drugmaker also plans to spend about $80 million on some other projects, including a product inspection center. A company spokesman said the city's metropolitan development commission must approve tax abatements before construction can start.
Last fall, Lilly said it would expand its manufacturing operations in Indianapolis to make cartridges that deliver insulin to patients to help meet growing U.S. demand for diabetes treatments.
Diabetes is a chronic disease in which the body does not properly produce or use the hormone insulin, and treatments for it have long been a key element of Lilly's product portfolio.
The insulin Humalog was the company's third-best selling drug last year, bringing in about $2.4 billion in total revenue. Lilly also started teaming up in 2011 with German drug developer Boehringer Ingelheim to design and sell several diabetes treatments.
Medical device developer and manufacturer, BD (Becton, Dickinson and Company), has crossed the threshold into the pharmaceutical industry and formed the wholly-owned subsidiary BD Rx to develop, produce and market a new line of generic prefilled injectables.
President of BD Rx Mark Sebree said BD was fully prepared to enter the area as it “already has a well-organized market presence” from its core device, instrument and reagent business.
BD will formulate and manufacture injectables entirely in-house from a newly built facility in Wilson, North Carolina, a decision that Sebree told us was “a natural extension” of its “prefillable syringe device.”
“We do think we can compete with the other players,” he continued, informing us that BD intended to “price the products at a level which will ensure responsibility and sustainability.”
BD’s entry into the market comes a month after Mylan acquired Agila for $1.6bn (€1.2bn), propelling the company into the top tier of generic injectable providers.
The company got the nod from the US Food and Drug Administration (FDA) on Tuesday when the regulatory body approved the company’s first therapy, Diphenhydramine Hydrochloride Injection, an injectable antihistamine. BD plans to launch between 20 and 30 products in the next few years.
The injectables market has recently had its fair share of issues relating to quality, many of which have caused drug shortages. Just in the last two months the industry has seen violations, contaminations and serious quality concerns from some of the biggest companies and manufacturers in the industry, including: Pfizer , Jubilant HollisterStier , Hospira , Nihon Pharmaceuticals and Ben Venue .
Sebree denied BD was entering the market in response to the rising problems. “Quality has always been a differentiator, even before recent drug shortages,” he said. “Our thinking has always been steeped in quality concerns but the path was embarked on long before the quality issues.”
He also cited a recent paper written by Director of the Center for Drug Evaluation and Research at the FDA, Janet Woodcook, who attributed much of the recent spate of drug shortages and quality issues to aging facilities, first used in the 1960s.
Therefore BD decided to go down the route of building a “completely new facility” so it “could be compliant with the highest standards possible.” The Wilson facility has been operational for a while and, following the FDA’s approval, is ready to begin full production.
“These new capabilities offer a real opportunity to advance the progress on how these types of drugs are administered,” Sebree added, continuing to say that the ease of use of the drugs would combat against potential risk of error.
The prefilled injectables will cut down the steps clinicians perform from 20 (with traditional syringe/vial technology) to approximately 12. This advance in drug administration is similar to BD’s ‘flush’ device line which changed the way drugs were delivered by IV lines and, according to Sebree “planted the seed of thought that BD can do the same” for fully formulated drugs.
Actavis, a global pharmaceutical company formerly known as Watson Pharmaceuticals that had nearly $6 million in revenues last year, plans to expand its pharmaceutical manufacturing plant and warehouse in Davie, creating 220 jobs, the Governor's Office and Greater Fort Lauderdale Alliance announced.
The expansion is another step toward Broward County developing its medical manufacturing sector, part of a burgeoning life sciences industry in South Florida.
Companies like Acatvis are expanding in Broward because it offers the "perfect mix of talent, cultural diversity in the workforce and consumers," said David Coddington, vice president for development with the Alliance. He said South Florida offers an aging and diverse population, which is attractive to pharmaceutical research and development firms.
Broward already has Mako Surgical Corp., a medical device manufacturer in Davie, and Nipro Diagnostics, a diabetic-testing product company in Fort Lauderdale. ECI Pharmaceuticals in Fort Lauderdale is expanding and the owner brought BioRamo, a specialty pharmaceutical firm from Texas. Two other manufacturers are considering locations in Coral Springs and Tamarac, according to the Alliance.
The Parsippany, N.J.-based company, which makes FDA-approved drugs in tablet and capsule form, will build a 30,000-square-foot addition with about 16,700 square feet of pharmaceutical manufacturing space and 13,000 square feet of warehouse space, according to the Alliance.
Actavis brands include products ranging from male testosterone replacement to treatment for an overactive bladder. The company also makes generics of drugs including Lipitor, Plavix, Nicorette, Percocet and many others.
The jobs will be technical manufacturing and warehouse jobs paying an average of $56,000 a year, which is above Broward's average wage, the Alliance said.
The company will invest about $40.5 million at the Davie site. Construction is slated to begin in the third quarter of 2013, with completion expected in one year.
Actavis already has packaging and distribution functions in Sunrise and pharmaceutical research and development operations in Weston. Its Anda Inc. division, the fourth largest distributor of pharmaceuticals in the U.S., also is located in Weston.
The company currently employs about 1,400 people in Florida, Actavis president and CEP Paul Bisaro said in a statement.
Based on meeting its performance goals, Actavis will receive $690,000 in funds from the Governor's discretionary Quick Closing Fund as well as $1.1 million in job-creation incentives, which is $3,000 per job created. The Town of Davie is contributing $440,000 and the company is eligible for $584,500 in training grants.
The jobs, which won't be available until late 2014, will be posted on the company's website, actavis.com.
The company considered expansion at its other plants across the globe, including California and New Jersey, before deciding on Davie, said spokesman Charlie Mayr. The expanded plant will allow Actavis to increase its volume of production and do additional research and development for new products, he said.
Watson Pharmaceuticals acquired Actavis Group in October 2012 and changed the corporate name to Actavis. The company has operations in more than 60 countries. Actavis reported $5.9 billion in revenues for 2012, a 29 percent increase over the prior year.
The Jackson Laboratory (JAX), a non-profit mammalian genetics research organization based in the US, started construction on a new laboratory facility for genomic medicine at the University of Connecticut Health Center (UCHC) campus in Farmington, in January 2013.
The new laboratory will enable JAX to develop new medical treatments tailored to the genetic makeup of each patient. The lab will also help in making Connecticut a leader in the fast growing genomic medicine field. The project is being sponsored by the Jackson Laboratory and the State of Connecticut.
The genomic facility is expected to create about 661 research jobs, 842 construction jobs during the construction phase and about 6,200 spinoff and indirect jobs.
The new lab facility will be a four level building with a total floor space of about 189,000ft2. It will be constructed in a 17-acre site belonging to the UCHC campus. The lab will provide space for 300 biomedical researchers, technicians and support staff by 2020. It will be equipped with sophisticated computing facilities and laboratories.
The new genomic medicine facility will have flexible laboratory spaces, computational biology areas and scientific support services. It will have a data processing center, private offices and shared areas for scientists belonging to different streams. The oval shaped building will be located adjacent to the main research building. The new building will have auditorium, conference rooms, media training areas and administrative offices.
The new laboratory will bring together doctors, patients, scientists and industry members to indentify genetic problems and develop individualized treatments. The research will be focused on treatments for conditions such as cancer, diabetes, heart disease and Alzheimer's disease.
The scientists belonging to the Jackson Laboratory will coordinate with UCHC and other institutions to develop new treatments. The collaboration with UCHC will help scientists in the new facility to achieve new patents and market products based on the discoveries by using biotech business incubator programs.
The UCHC will also help the new research facility by providing support from its academic disciplines, such as medicine, nursing, dentistry and pharmacy, to carry out clinical trials and genomic research.
The new lab will also collaborate with other researchers, hospitals and insurance companies based in Connecticut to engage them in the rapidly growing area of genomic medicine research.
The Jackson Laboratory for Genomic Medicine broke ground for construction in January 2013. It is expected to be ready by fall 2014.
The preliminary construction works, which include demolition of some structures in the 17-acre site, began in October 2012. The site preparation works for the new genomic medicine facility's construction began at the end of November 2012. The foundation works began in January 2013.
The new building features novel design aspects. It will utilize as much natural light as possible. The new facility will aim for LEED-certification by adoption of environmentally friendly and energy efficient measures.
Gilbane was appointed as program manager for the genomic medicine institute project in February 2012.
The architectural and engineering design for the new facility was provided by Centerbrook Architects, Tsoi / Kobus & Associates, BVH Integrated Services and BR+A.
In May 2012, Whiting-Turner Contracting was awarded with the construction management contract for the new genomics facility. The scope of the contract includes supervising the site preparation, utilities development and overall building and site construction efforts.
Financing the construction and running of the genomic medicine laboratory
The financing for the construction of the genomic medicine facility, as well as a budget for research facilities for a period of over 20 years, is expected to be about $1.1bn.
The Jackson Laboratory will contribute about $809m, which will be funded through sources such as philanthropy, service income and federal research grants. The State of Connecticut will provide about $291m, which will include $192m for the construction and $99m for the research activity.
Argonne National Laboratory is building a new advanced protein crystallization facility (APCF) in Illinois, US. The $34.5m facility will help scientists across the world study the structure and function of different types of proteins. It will also help accelerate the development of new medicines based on this research to fight various diseases.
The project is being funded by the State of Illinois. Groundbreaking for the facility was held in August 2011. Building construction began in August 2012, and is expected to be completed by October 2013.
The project is expected to generate 825 jobs during construction and another 550 indirect jobs upon opening. It will help in expanding research activities at the University of Illinois and also support genomics studies at the US Department of Energy's Structural Biology Center and the Midwest Center for Structural Genomics.
Protein crystallography is a key technology used by researchers for developing drugs. It provides researchers with three-dimensional (3-D) structures of proteins which are involved in diseases.
Using these structures, researchers identify the sites on the protein where the drug needs to attach and cause reaction. The technology enables researchers to understand the interaction between a new drug and a protein.
Computational methods can be used to predict the interaction of the drug and the protein, but the action needs to be proved experimentally. Existing technologies are very time-consuming and produce just one or two usable crystals for every 100 attempts.
The APCF will address this problem and aid in the development of drugs which can be marketed by pharmaceutical firms. It will use robotics to produce, purify and crystallize proteins five times faster. The proteins to be analyzed by researchers can be produced more accurately.
The insights provided by the APCF about proteins will also help in developing new strategies for environmental management, which can be applied in fields such as energy production, agriculture and remediation.
The APCF is a single-storey circular steel structure spread over an area of 55,551ft². It is split into two areas - office space and laboratory space. The laboratory space can accommodate 76 researchers and will have a flexible and modular layout enabling re-arrangement of space at no extra cost. It will include open labs, lab support, shared core lab facilities and a highly specialized crystallization suite.
The open labs will provide large flexible spaces for researchers to carry out their activities. It will also promote collaboration and discussion between the researchers. The open labs will feature height adjustable, movable tables with adjustable shelves.
The lab support areas include lab equipment and feature fume hood and chemical storage alcoves to improve safety. Placing the equipment in the lab support areas also helps in reducing noise levels in open labs.
The state-of-the-art laboratory space will be used for determining the 3-D structures of proteins. It will be connected to the Argonne National Laboratory's Advanced Photon Source, enabling access and exchange of research between the two centers.
The APCF will use microfluidics and robotics technologies to promote research. Microfluidics includes the use of extremely small droplets of protein solution of 10 to 20 nano liters. Researchers can examine these droplets and choose the best ones that are capable of promoting crystal growth.
The robotics technology will automate the process of crystallography. It includes the use of a crystal mounting robot which will automatically calculate and analyze the protein structures.
The office space of the APCF will include workstations, offices, administrative areas, four conference rooms and a lobby. The conference rooms will feature audio visual equipment and can accommodate medium size gatherings of people.
The office space also includes common areas to promote collaborative discussion. The exteriors of the office space will be clad with glass and metal. Glass will provide views of the surroundings and also cut down energy costs by allowing natural light into the building.
SmithGroup provided conceptual and preliminary designs for the facility. Cotter Consulting provided commissioning services for the project.
In August 2012, Clark Construction Group in partnership with Jacobs Engineering was awarded a $22.8m contract for the construction of the facility. KJWW was hired as the commissioning agent for the project.
Boyd Technologies, South Lee, MA, has launched a capital investment program, marking the official launch of its five year strategic growth plan, which has been underway since 2012 and aims to double the company’s top line revenue over the next five years. The growth strategy aims to achieve balanced profitable growth in the company’s core target markets through focused investments in the company’s manufacturing capabilities and management team.
The first phase of Boyd’s growth strategy began this year with an investment of approximately $1.5 million in a new cleanroom facility and capital equipment. The assets are targeted for completion during the third quarter of 2013. The initial investment is part of Boyd’s continued focus on the fast growing medical device industry, which in 2011 had U.S. sales of $100 billion and $300 billion globally. The company operates in the biopharmaceutical filtration and advanced wound care market spaces. Growth in these areas is being fueled by increasing demands of an ageing population, the need for advanced technologies to reduce health care costs, and more patient focused drug development and delivery systems.
Boyd plans to validate its new ISO Class 7 cleanroom in the third quarter of 2013 and immediately begin operations. “We are in a number of high level dialogues now with strategic partners which will put these new assets immediately to work,” says Matthew Boyd the company’s EVP of Business Development. “We’ve spent a great deal of time specifying and customizing these investments to meet the needs of our partners so we are thrilled to see these efforts coming to fruition.”
Commenting on the capital investment the company’s president, Stephen Boyd, says, “We plan to continue investing in the expansion of our assets and capabilities over the next five years. This includes equipment, people, and infrastructure to support our targeted growth objectives.”
Boyd Technologies has a long track record of precision manufacturing in high tech markets. The company’s experience in the personal care market is extensive with a number of health and oral care product launches under its belt. “We are capable of operating three shifts in our facility with upwards of 150 staff, which allows our equipment to run 24-7 and facilitate very attractive growth,” comments Stephen Boyd.
Boyd Technologies is a leading international supplier of advanced flexible materials. Global OEM partners rely on Boyd Technologies for material sourcing, product realization, and precision converting. Together these capabilities provide design and development, commercialization support, and production of products which are made from advanced flexible materials. The Company is ISO 9001 and 13485 certified.
The company works with nonwovens, membranes, films, foils, foam, technical papers, extruded netting, technical textiles, and nanofiber materials. These flexible materials are used in technical applications across the medical, electrical, and consumer markets. The Company’s core technologies and developments are in biopharmaceutical filtration, advanced wound care, and power storage and delivery products and applications.
The structural steel frame of the 40,000 ft2 addition for PerkinElmer in Hopkinton, Mass., was recently completed as part 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, construction management and design-build firm JM Coull recently completed renovations to an existing suite of cleanrooms and gowning room for PerkinElmer and continues to work on renovations and other additions to the site.
PerkinElmer provides knowledge, expertise, and innovative detection, imaging, software, and services solutions for human and environmental health
The Dow Chemical Co. will build several specialty material production units aligned to its performance plastics franchise on the U.S. Gulf Coast.
The facilities are in the Front End Engineering and Design (FEED) phase that will be completed in 2014. These facilities will manufacture materials for several market segments, including packaging; hygiene and medical; electrical and telecommunications; transportation, sports and leisure, and consumer durables. Specific production units include ELITE Enhanced Polyethylene for flexible packaging and hygiene and medical applications.
"These new facilities will include a wide range of technologies that will produce differentiated, high performance materials for the fastest growing segments in Dow's existing markets, while providing access to new markets and applications," says Jim Fitterling, Dow Executive Vice President. "These investments are also aimed at businesses that have consistently delivered a higher return on capital, which is clearly aligned with our long-term strategy. This, coupled with an enhanced market and value chain focus in our high value performance pPlastics franchise, will deliver faster growth with lower earnings volatility."
AstraZeneca announced that Gaithersburg, Md., will be one of three global research and development centers to improve pipeline productivity and to establish the company as a global leader in biopharmaceutical innovation. Additionally, US-based global marketing and specialty care commercial functions will be centered in Gaithersburg, currently the site of MedImmune's headquarters and the primary location for AstraZeneca's biologics activities.
The relocation of research and development, global marketing and specialty care positions from Wilmington will be carried out through 2015. The North America commercial headquarters, along with several corporate-based support functions, will remain in Wilmington.
The changes are part of AstraZeneca's announcement to invest in strategic research and development centers in Cambridge, UK; Gaithersburg, Md.; and Mölndal, Sweden. The proposals are designed to co-locate teams to improve collaboration and put science and the patient at the heart of everything the company does. The changes will also simplify the company's global site footprint.
Pascal Soriot, Chief Executive Officer, AstraZeneca said: "The changes we are proposing represent an exciting and important opportunity to put science at the heart of everything we do because our long-term success depends on improving R&D productivity and achieving scientific leadership. This is a major investment in the future of this company that will accelerate innovation by improving collaboration, reducing complexity and speeding up decision-making. The strategic centers will also allow us to tap into important bioscience hotspots, providing more of our people with easy access to leading-edge academic and industry networks, scientific talent and valuable partnering opportunities."
The consolidation of AstraZeneca's global R&D footprint will have an impact on sites in the United States. About 1,200 positions will leave Wilmington, while there will be an increase of about 300 positions in Gaithersburg. The changes announced today will lead to an estimated overall reduction of about 650 positions in the U.S., while around 170 will relocate to other AstraZeneca sites in the US or overseas.
"I recognize that our plans will have a significant impact on many of our people and our stakeholders at the affected sites. We are fully committed to treating all our employees with respect and fairness as we navigate this important period of change," Pascal Soriot said.
AAF International announces a series of strategic moves designed to increase supply chain efficiency, expand operations in high-end product lines, and create a research and development center near its headquarters in Louisville, Ky.
As part of the plan, AAF will close the Lebanon, Ind. manufacturing plant scheduled to be complete by the end of May 2013. AAF customers purchasing from the Lebanon plant will be supplied from other AAF plants and distribution centers. The restructuring will allow AAF to more effectively serve its entire customer base in North America with a more responsive manufacturing and distribution footprint. AAF will work with local resources to assist with employees impacted by the closing. In addition, AAF plans to add extra shifts as it expands operations at nearby facilities.
AAF will also carry out several expansion investments to meet current and future customer requirements. AAF began construction on a cleanroom upgrade and expansion in the Columbia, Mo. manufacturing plant in support of the growing pharmaceutical and life sciences markets. This cleanroom will be a cGMP facility making products such as the MEGAcel and AstroCel product lines. The Columbia cleanroom adds to AAF's current cleanroom facilities in the Netherlands, China, Malaysia, and Japan. Next, AAF plans to build a R&D and testing facility to be more responsive to North American customers and increase product development speed. This facility will focus on development for local markets in North America, while AAF continues to use its global research and development in Japan to develop global product platforms. The facility will be co-located with manufacturing to optimize testing and development efficiency. Lastly, AAF plans to expand its current Louisville plant to a new location in Louisville, Kentucky, or southern Indiana. This site will house AAF manufacturing for the Power & Industrial division, the Air Filter division, and the new R&D facility.
AAF International, based in Louisville, Kentucky, has more than 3,000 employees, 22 manufacturing facilities, and five R&D centers worldwide. AAF designs, develops, and manufactures air filtration solutions for commercial, industrial, cleanroom, transportation, and nuclear power applications. AAF also provides inlet air cooling and sound attenuation solutions for high-speed rotating machinery.
The clinical and translational research center (CTRC) was inaugurated in September 2012. It is located in the University at Buffalo (UB) medical campus in Buffalo, New York.
The CTRC helps researchers engage in translating basic biomedical research discoveries into new treatments. The research center was jointly developed by UB and Kaleida Health.
The new CTRC is located in the ten-storey UB-Kaleida Health building's top portion, between the fifth and eighth floors. The facility has a total floor space of 170,000ft² for research activities.
The new research center has administrative, clinical / translational research training and community engagement offices. It also has a clinical research center, which provides exclusive support to the investigators for carrying out research. It will enable the physician scientists to carry out research on top floors of the building, while they can also work with clinicians in Kaleida's Gates Vascular Institute, which is located downstairs in the same building.
The center is designed to have most sophisticated open-plan laboratories provided with ample research space for more than 20 principal investigators. It also has nine examination rooms for patient observation. It also has support space dedicated for laboratory processing, blood drawing and specimen collection, as well as safe record storage capabilities.
The research center features technically sound infrastructure and is well-equipped with state-of-the-art biorepository and specimen processing laboratory. It has an imaging facility supported with MRI, CT scanner and PET-CT scanner. It has a biosciences incubator with laboratories and office space. It also has an animal research facility.
The CTRC is equipped with a sophisticated hardware data management and sharing system. The research data is assimilated through computational research at the center of excellence in bioinformatics and life sciences.
Construction on the ten-storey UB-Kaleida building was started in August 2009. The foundation works were finished and first steel at the building was erected by February 2010.
UB invested $118m as its share for the construction of the CTRC. The construction of the building continued for a little over three years.
The exterior of the building features a glass box form with curvilinear finishes. The north and south facades of the building were clad with glass and the east and west facades were endowed with shade curtain wall.
The building features an atrium at fifth floor. It also has fibreglass-reinforced wall panels and terrazzo floor tiles. Natural colors such as white metal, concrete and gray are used throughout the building.
Cannon Design was the architect for the UB-Kaleida Health building. The design of the building was completed in two years. Cannon Design also provided mechanical, electrical and structural engineering support for the building, along with DiDonato Associates, who provided civil engineering support. The interior designs were provided by AIA and ASID.
The building construction and management contract was awarded to Turner Construction and LP Ciminelli. Bega, Kim Lighting and Voight Lighting provided the exterior lighting at the building, while the interior lighting system was provided by Edge Lighting, Forum, Kurt Versen, Mark Architectural Lighting, Visa Lighting, Pinnacle Architectural Lighting and Pure Lighting.
The doors were supplied by Algoma. The workstations and seating facilities were provided by Arcadia, Cabot Wrenn, Harter, Herman Miller, Knoll, Krug and Versteel.
The glass for the building was supplied by Archetype Glass, McGrory Glass, Skyline Design and Viracon. The window treatments provided by Colvin Draperies.
The flooring suppliers included Dura-a-flex, Forbo, General Polymers/Sherwin-Williams and Wausau Tile.
The chemical company - a supplier of formulations and services for the Pharma industry - has announced plans to expand capabilities at its Center of Excellence in Wilmington, Delaware and will be able to offer its customers formulation development contract manufacturing services for solid dispersions and oral solid dosages.
Richard R. Ruberti, Sr, Global Communications manager at Ashland, said, “Overall, we're seeing a significant opportunity develop in solubilization and other drug delivery technologies in which we have an industry-leading portfolio of existing products and services.”
Furthermore Ruberti said “By investing in early stage contract manufacturing including hot-melt and spray-drying capabilities,” the company “will become a unique resource positioned to help customers solve their formulation challenges and speed their overall time to market.”
The expansion will combine Ashland’s ingredients with its technical support and will also benefit early-stage clinical trials by including spray-drying and extrusion processes, moved to Delaware from the company’s facility in Maryland.
In a press release President of Ashland Speciality Ingredients, John Panichella said that a “recent decision to provide incentives” by Delaware as a “commitment to business expansion” in the State had been “integral” to the expansion.
The Delaware Strategic Fund provides a number of incentives to encourage industry across the state and accounts pharma giant AstraZeneca as one of its early uptakers. Recently, containment manufacturer for the pharma industry ILC Dover has applied to take advantage of the state-sponsored grant.
Ruberti said that Ashland is “seeing a strong opportunity for long-term growth” by “investing in very early-stage contract manufacturing,” adopting a model that couples Ashland’s excipient portfolio with its formulation services.
Last year Ashland, announced it had a string of investments in the pipeline to accelerate its pharma unit growth following the purchase of ISP (International Specialty Products) for $3.2bn (€2.5bn). The purchase was intended to streamline supply chains for a number of players in both the pharma and cosmetics industry.
14 months ago Ashland increased capacity of tablet binder polyvinylpyrrolidine at its Texas plant and three months later announced it would be using its own technology, combined with coatings acquired in the ISP deal, in order to launch a new product line in the pharma excipients space.
Sil-Pro continues its ongoing expansion and improvements by expanding its existing cleanroom with a 1,000 ft2 addition. The cleanroom addition will be certified to ISO Class 7, the same as Sil-Pro's existing cleanroom.
This 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 cleanroom isolation area will 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 cleanroom's centralized location, between the manufacturing floor and shipping department, will streamline production processes and allow for the future expansion of these three processes when needed.
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. The company is based in Delano, Minn.
Plastic injection molding company G&F Industries has installed an internal cleanroom for injection molded plastics at its facility in Sturbridge, Mass. Adding over 2,000 ft2 of dedicated Class 8 cleanroom manufacturing, the molding area is equipped with multiple electric horizontal plastic injection molding machines utilizing closed loop microprocessor controls and scientific molding principles.
With equipment size ranging from 55 to 110 tons, along with designated assembly and packaging areas, G&F's installation is able to handle almost any medical molding or cleanroom plastic injection molding requirements.
FDA-registered, GMP-compliant, and certified to ISO 9001, the internal cleanroom molding facility is equipped with regulated temperature, humidity control, and HEPA filters that efficiently remove airborne particles as small as 0.5 microns creating a pristine Class 8 molding environment. In addition to a full range of value-added and secondary finishing operations, cleanroom plastic injection molding capabilities include high-volume production, tight tolerances, material and product traceability, robotics and automated assembly, specialized packaging, and automated material handling.
Spirit Pharmaceuticals, a maker of generic pharmaceuticals, announced that it will locate its new facility in Columbia, Clarendon County, South Carolina. The more than $12.2 million investment is expected to generate 296 new jobs.
"It's an exciting time for our company. We are pleased to move forward with plans for our new facility in Clarendon County. South Carolina offers us an excellent business climate, a talented workforce and the infrastructure we need to be successful. We appreciate all the support we've received from state and local officials," said Ajoy Joshi, CEO of Spirit Pharmaceuticals.
Spirit Pharmaceuticals will establish a new packaging and manufacturing facility in Summerton. The company produces a range of generic pharmaceuticals for retailers such as Walgreens, Dollar Tree and CVS.
"Spirit Pharmaceuticals' decision to locate its new operation here in South Carolina is another big win for our state, and one of our rural areas in particular. We celebrate the company's decision to invest $12.2 million and create 296 new jobs in Summerton. Announcements like this one show that South Carolina is increasingly becoming the 'it' state for business," said Gov. Nikki Haley.
Since 2011, South Carolina has recruited more than 2,000 jobs and more than $400 million in capital investment in the life sciences industry, which includes secondary sectors such as medical and health IT.
The company will occupy the former Federal Mogul building located at 9104 Alex Harvin Hwy. The new plant is expected to be operational in the first quarter of 2014.
"We welcome Spirit Pharmaceuticals into Clarendon County. This business is significant in several ways. First, it will occupy a landmark building. Most importantly, however, is that Spirit will bring a historical number of jobs and the quality of those jobs is unprecedented. The location of this business has been a team effort and the County Council would like to thank the Clarendon County Development Board and the state of South Carolina for their hard work and diligence," said Clarendon County Council Chairman Dwight Stewart.
West Virginia University has launched a research center to conduct human clinical trials on new drugs that are being developed, and its first partner is the generic drug maker Mylan Inc.
The Clinical and Pharmacological Research Center will recruit volunteers from Morgantown and beyond to participate in the trials, which could lead to partnerships with other companies in the pharmaceutical and biotechnology industries, said WVU Health Sciences Chancellor Christopher Colenda.
"This is an important investment for the economic future of our community," he said.
The venture was created by the WVU Research Corp. and the WVU Health Sciences Center. It already has a contract with Pennsylvania-based Mylan, which has a manufacturing facility in Morgantown.
Mylan officials didn't immediately comment on what kind of drugs the center would test first or when those trials would begin. Nor was it immediately clear whether participants will be paid.
WVU estimates the center could have a $7 million impact on the local economy. The center has already created 21 full-time jobs, it says, and expects to employ up to 60 part-time staff.
Fred King, vice president for research at WVU, calls the center "a critical part of the research ecosystem" that will help attract and retain pharmaceutical and biomedical companies in the region.
Dr. Dorian Williams, interim director, said the center's top priority will be the health and safety of volunteers, and all will be fully informed of the risks.
The center will give drug makers assurance that their products have been tested to rigorous Food and Drug Administration standards in a short time and at a reasonable cost, Williams said.
Although the center is new, WVU says pharmaceutical research has been done in Morgantown for more than three decades.
Dr. Thomas Clark set up a research unit in 1979 and conducted the first trials in 1982. His facility became a part of Kendle International Inc., which was acquired last year by INC Research LLC.
INC Research closed the Morgantown location last summer, leaving the community without such a facility for the first time in three decades.
Williams was affiliated with Kendle and INC Research from 1982-2012 and served as medical director of the Morgantown facility for 12 years. The new center is in the former Kendle building.
Ashland is expanding its R&D Center of Excellence in Wilmington with additional formulation development and GMP manufacturing capabilities for solid dispersions and oral solid dosages to support early-stage clinical trials. The expansion will include spray drying and extrusion processes previously located in Columbia, MD and approximately 20 positions will be relocated to Wilmington. The new facility is expected to be operational by summer 2014.
“This expansion highlights our ability to provide high-value ingredients backed with superior technical support," said May Shana’a, vice president, Technology and Growth Strategy, Ashland Specialty Ingredients. “This Center of Excellence, combined with our multiple technical support labs around the world, will enable Ashland to deepen our relationship with customers and allow us to quickly solve customer problems.”
The new Marlborough (Mass.) Hospital Cancer Pavilion is connected to the existing hospital by a CMU shear wall that contains grouted cells and bond beams that are impermeable. This situation left minimal space for 12 individual services to pass from the hospital to the new wing. The key trades met over a 12-week period to find a workaround and untangle the limited space above the ceiling. Everyone talks about the need to bring together building information modeling, virtual design and construction, and integrated project delivery in the design and construction of complex projects. This is especially true in the healthcare realm, but so far there have been few cases of true integration, where Building Team members are bound by a written, performance- and incentive-based IPD agreement and where BIM/VDC is a crucial factor in fulfilling the IPD.
It is therefore refreshing to report how a healthcare system and its Building Team united to create a sterling example of BIM/VDC-based IPD. The case in point is the Marlborough (Mass.) Hospital Cancer Pavilion, a new 14,000-sf, $12.7 million cancer treatment center nearing completion on the site of the existing hospital, 30 miles west of Boston. The project is the first using such an agreement between the University of Massachusetts Memorial Medical Center; Tocci Building Cos. (CM), Woburn, Mass.; The S/L/A/M Collaborative (architect), Glastonbury, Conn.; and their key trade subcontractors and consultants.
The new wing will have a linear accelerator for radiation oncology, a CT simulator for diagnostic imaging, and outpatient medical oncology services to create a unified treatment experience for cancer patients. The nearest linac facilities are at Massachusetts General Hospital, 30 miles away in Boston, and in Middlesex, Conn., more than 90 miles away.
Owner UMass Medical wanted to get the new oncology center open to the public as quickly as possible, to lock in the suburban Boston market for this treatment technology. The availability of local radiation oncology services is particularly appealing because many cancer patients require radiation five days a week for four to eight weeks in a row.
Both the S/L/A/M Collaborative and Tocci are well-established 3D parametric BIM practitioners. S/L/A/M has delivered 40 BIM projects to date and was the first architect to fully document and deliver a project using BIM for the State University of New York system. Tocci is an industry pioneer and leader in virtual design and construction; the company uses BIM on every project. The Marlborough hospital project was Tocci’s second IPD job, having delivered the LEED Platinum Autodesk AEC Headquarters in Waltham, Mass., in 2008.
UMass Medical, Tocci, S/L/A/M, and several key subcontractors entered into a modified version of construction lawyer Howard Ashcraft’s three-party agreement. The IPD united them in an incentive-focused, project-based entity where profits could only be unlocked if the team achieved specific project goals.
Early in the collaboration, Tocci, S/L/A/M, and UMass Medical created a project manual that defined how the team would approach the agreed-upon objectives. The manual covered communication methods, project execution, and BIM execution, with the overarching goal of leveraging the BIM model toward a more efficient design and delivery process. The parties decided to share a federated Revit model that would be used by all participants over a website. Co-location was performed at S/L/A/M’s Connecticut office at the design stage and progressed to the job site during construction.
The linear accelerator, which represented about half the total cost of the Marlborough Hospital Cancer Pavilion, required a containment vault formed from rebar and nearly 500 cubic yards of concrete. BIM/VDC were instrumental in planning penetrations for services to eliminate the need for any vault coring.
The design team responded to requests from Marlborough Hospital that the Pavilion embrace the “healing environments” ideal. The finishes are very spa-like. S/L/A/M specified soft-colored, open environments with large amounts of millwork and straight, narrow hallways on a grid pattern.
“There was a significant collaborative effort that contributed to target-value design and maintaining the budget,” says Laura Handler, Director of VDC at Tocci. “Some of that happened in a substantial part of the design phase, but also in delivering exactly what the hospital needed. Had the owner not been involved, it would have been much harder to bring the project closer to feasibility.”
Even with an expert core BIM team, the project was still at a scale where not all subcontractors were equally BIM-savvy. Fire protection engineer Covenant Fire Protection and mechanical/plumbing subcontractor Youngblood Company had experience modeling in Revit, so they were able to perform their own modeling scope. However, Senecal Electric and Renaud HVAC & Controls, the other two IPD partners, had virtually no previous BIM experience.
“One of the facets of our agreement was that whoever was most capable to perform the scope of a job should perform it,” says Tocci’s Assistant Project Manager, Jeremy Garczynski. Thus, Tocci modeled the VDC portions of the contractor’s scope with input from other members of the Building Team. For the HVAC systems, Renaud took the lead, with Project Manager Jay O’Neil reviewing the Tocci Revit model twice a week to ensure it performed as specified. “It was field experience working alongside 3D modeling experience,” says Garczynski.
With narrow hallways and not a great deal of ceiling space, fitting in the HVAC and electrical and plumbing systems was a design conundrum requiring careful sequencing. The new Cancer Pavilion is connected to the existing hospital by a CMU shear wall, through which any services from the existing building to the new wing had to pass. However, the CMU contained grouted cells and bond beams that were impermeable, leaving minimal space for 12 individual services to pass through.
The key trades met over a 12-week period to untangle the problem of the limited space above the ceiling. From these meetings, the mechanical/electrical team decided to combine the services to reduce the number of penetrations to four. Through weekly model uploads and online meetings, the MEP and fire-protection teams figured out where to install the services. By the time Tocci signed off on the final sequencing plan, all the trades knew the order in which they were to finish their work, and understood what the other trades would be doing on site at the same time.
Light, spa-inspired colors and finishes convey a feeling of serenity in the Cancer Pavilion. An extensive use of millwork helps make the treatment spaces more homelike and less institutional.
“In a lot of cases, it’s better to have subcontractors speaking directly to the architect and not through us,” says Garczynski. “For the ceiling space, we needed an intense, intimate coordination process. The roof drains weave around ductwork in the corridors. The exact layout pattern in the model was in the coordination drawings. They matched in-field conditions. It sounds like a small victory but it saved time and frustration.” Garczynski credits Youngblood, the mechanical/plumbing contractor, with making it work: “Their capability with Revit and the coordination aspect of this really played well together.”
Installing the linear accelerator presented its own problems. The unit specified by Marlborough Hospital—TrueBeam radiation therapy and radiosurgery—is an integrated system that coordinates imaging, patient positioning, motion management, and treatment to administer extremely precise radiation dosages. The technology gives physicians the ability to tackle complex treatments, including radiosurgery and tumor removal, with greater patient safety and comfort. The linear accelerator accounted for nearly half the cost of the whole project.
“With a linear accelerator, the vault is critical to ensure that radiation doesn’t escape the room,” says Handler, a member of the 2010 class of BD+C’s “40 under 40.” “We did a lot of detailed modeling to confirm that all requirements were being met, and also detailed drawings for penetrations into the vault for execution. Any penetration had to meet very specific criteria.”
After the vault was formed in rebar, Tocci had 50 mixing trucks ready to place almost 500 cubic yards of concrete. The layout of equipment and accessories was vetted again and again to ensure that no coring would have to take place through the four-foot-thick walls or through the rebar.
“It’s a huge piece of equipment,” says Garczynski. Due to code requirements, the facility housing the linac had to be virtually 100% completed and inspected before the linac could be installed. Garcynski and other members of the Tocci team worked with S/L/A/M to create a sequencing diagram for the riggers to move the linear accelerator into the finished space. It was successfully placed on its moorings last month.
“On this project, the IPD helped us make decisions much more quickly by having all of the stakeholders in the room,” says David Neal, Principal-in-Charge for The S/L/A/M Collaborative.
The IPD process also helped the team clear numerous regulatory hurdles in the documentation and notification for commissioning with state and local agencies. While the project did go through some funding starts and stops, it is on schedule to open this spring after breaking ground a year ago.
There is an incentive-compensation component in the IPD agreement. With the project nearing completion, the Building Team is on target to unlock that shared profit.
Pall is opening a Life Sciences Center of Excellence at its new Harbourgate site in Portsmouth, UK, where capabilities in cell culture, purification, analytical solutions, protein characterization, and microbiological tools will be offered. The center is anticipated to open in mid-2013 and will complement similar centers of excellence in the US and centers previously announced in China, Singapore, and India.
Sofrigam opened its factory in Arras, France, in January 2008. The factory is used to test and manufacture temperature-controlled logistics packaging for the European market, and produces cold chain solutions for companies including GSK, Astra Zeneca and Pfizer.
In 2013, the site was expanded to create additional space for the company's growing e-commerce business.
Sofrigam located the facility in Artoipole industrial estate, Monchy-le-Preux, Arras, northern France, due its proximity to major motorways and the Belgian border. The main site consists of a 7,000m² (75,320 sq. ft.) production facility, which includes a store for raw materials such as polyurethane, a storage space for completed boxes and a production line.
The facility, which produces 250,000 units of packaging a year, utilizes automated and manual production techniques. An automatic warehouse feeder loads the material onto one of three Holtz-Her cutting machines, which use specialized software to cut with 1mm accuracy. Any unusual or difficult details or angles are finished on a Charly Pro 2030 cutting machine, and the boards are transported by forklift truck to an assembly space.
Boxes are then assembled using a combination of manual and automatic methods, with hand-finishing required to fulfill customer-specific specifications. An industrial freezer is used to store gel packs, the cold source used in the packaging, for ten days, before the packs are transferred to the packaging, ready for use.
The factory also has a short-term warehouse, which is used to store fully assembled boxes for up to a week. Stock production varies throughout the year to correspond with seasonal changes in demand for cold chain logistics solutions.
The facility also houses manufacturing and storage for the company's ecommerce websites, La Boutique Du Froid and Coldshop. Designed for the French and UK markets respectively, these sites sell small volumes of temperature-controlled packaging to individuals as well as the pharmaceutical, healthcare, food and cosmetics industries. These are typically designed for short-term transportation, such as from a pharmacy to a patient's room, and include fabric bags, which are manufactured at the Arras facility.
The facility also houses the Ater Metrologie laboratory, which is used to simulate real-time climate conditions during transportation, and provide product temperature information. This facility tests packaging containing pharmaceuticals, food and simulated human organs. Consisting of a preparation area, loading space and testing chambers, the 400m² (4,304 sq. ft.) laboratory undertakes 2,000 tests per year.
The testing space includes eight testing chambers for up to 3,000l of material, which can be configured to any temperature between -25°C and +50°C. Temperature profiles in these rooms can be programmed to match a client's logistics data, or set to follow a season or region-specific temperature profile.
Several of the chambers are equipped with direct monitoring equipment, designed by Eratis, allowing scientists to monitor changes to product temperature in real-time, while two can be equipped with sensors that are analyzed after the tests have been run. The rooms are also equipped with alarms that are triggered if the internal packaging temperature goes above a pre-defined limit.
The laboratory is also equipped with three test spaces for products up to 50l, a dry ice store at -80°C and a loading space, which simulates packaging loading environments at any temperature between 0°C and 40°C.
Pharmaceuticals that are used for testing are kept between 2°C and 8°C in a refrigerated chamber. The temperature in this chamber is continuously monitored, and an alarm linked to the lab managers' phones will sound if the temperature deviates from this range.
In anticipation of business growth from its UK e-commerce website Coldshop, which was launched in January 2013, the company has expanded the facility to include a new 3,000m² (32,280 sq. ft.) warehouse. This will house products for the Coldshop and La Boutique Du Froid websites, freeing up space in the existing warehouse to increase production facilities. Constructed in July 2012, the new warehouse will begin operation in mid 2013.
Following plans to expand its range of products to include very precise temperature-controlled containers that will be rented to customers, the company is also expanding to an adjacent site. Sofrigam plans to sign a deal on the second 5,000m² (53,800 sq. ft.) building at the end of April 2013.
Sofrigam's new warehouse has been built to be environmentally friendly. Using wood cladding and polyurethane insulation, the building has been designed to be energy efficient. It will also be fitted with energy-saving lighting and a rainwater collector for the toilets. The warehouse has been equipped with an 11kW wind turbine, which the company estimates will provide approximately 5% of the factory's power.
The company has also embarked on a two-year green project with an ex PwC employee to reduce waste and increase recycling within the facility.
The Government of Malta is funding a state-of-the-art life science center, named the BioMalta campus, in San Gwann. The center is being developed to foster the growth of the country's life sciences industry.
The life sciences center will provide laboratory space to new as well as existing companies. It will also extend business advisory services, financial incentives and tangible support to companies intending to set up operations.
The development plan of the project was approved by the Malta Environment & Planning Authority in June 2011. Construction of the BioMalta campus is expected to be completed in 2014. The project will create more than 500 jobs by 2019.
"The life sciences center will provide laboratory space to new as well as existing companies."The BioMalta life sciences center project was launched in May 2010 by the Finance and Economic Development Ministry. The project is aimed at attracting foreign direct investment into the bio-technology and life sciences sectors of the country.
Malta Enterprise is the government agency responsible for attracting foreign investors and promoting industrial development in Malta.
The project will be completed in two phases. It will form part of a larger biotechnology park proposed to be built in the Sam Gwann Industrial Estate.
The project is estimated to cost €38m ($50m). It is being co-financed by the Government of Malta, Malta Enterprise and the European Regional Development Fund (ERDF). The European Union alone will fund 80 percent of the project cost.
The BioMalta campus is being built over ex-Yorkie and disused VF jeans factories in the San Gwann Industrial Estate. Malta Enterprise also has an office building at the site. The office will be relocated to create space for the BioMalta campus. The existing buildings are being demolished to make way for the construction of the research and development park.
The project site is strategically located in proximity to the University of Malta and Mater Dei Hospital, enabling operating companies to work in collaboration with the university staff and the hospital.
The BioMalta campus will initially consist of four buildings comprising of 10,000m²
(107,600 sq. ft.) of laboratory space and 3,500m² (37,660 sq. ft.) of business incubation facilities. There will be 61 lab units, including 11 incubation units.
"The BioMalta life sciences center project was launched in May 2010 by the Finance and Economic Development Ministry."One of the four buildings will be dedicated for retail, conference and meeting facilities. It will also have food and beverage outlets, exhibition space and an auditorium with 150 to 200 seats capacity. The lab space will be leased to companies involved in biological and chemical research.
The campus is proposed to include wet laboratories designed in accordance with the standards of BS/EN 12128:1998, which suggests the containment levels to be maintained in biotechnology laboratories.
The design of the labs will be modular, so that contracting companies can modify the space arrangement to suit their requirements. The containment level of the labs will be maintained by using ventilation and extraction systems with high efficiency particulate air (HEPA) filters.
The contract for the design of the campus was awarded to TBA Periti. The foundation stone was laid for the project in February 2013. Construction is expected to be completed by March 2014.
The research laboratories at the BioMalta campus will carry out Containment Level 2 fields of research, which means working with biological agents, hazardous chemicals and genetically modified organisms with a medium level of risk.
The BioMalta campus will be involved only in research and development activities. Malta Enterprise plans to set up a similar facility near the campus to attract biotechnology manufacturers to the country.
The clinical and translational research center (CTRC) was inaugurated in September 2012. It is located in the University at Buffalo (UB) medical campus in Buffalo, New York.
Bactolac Pharmaceutical's new manufacturing facility in New York, is located alongside its existing facility in Hauppauge. Launched in August 2009, the new facility has doubled Bactolac's total facility space and daily production capacity.
The Maurice Wohl Clinical Institute will be located within the Psychiatry institute at King's College London's Denmark Hill campus. Construction of the institution started in 2011.
The institute will form a crucial link between laboratory research and the development of new therapies. It is being jointly developed by the King's College London and King's College Hospital.
The institute will be a five-storey building with a total floor space of about 7,600m². The facility will accommodate about 250 clinicians and scientists. It will have space for office facilities and a 100-seat flexible seminar hall. A public court will be located between the James Black Center and the Weston Education Center.
The researchers at the institute will focus on establishing the major genetic risk factors for neurodegenerative disorders. They will identify early diagnostic tests and predictive biomarkers of diseases. The next phase of the research will involve development of innovative cellular and animal disease models to speed up drug discovery.
The facility will provide new approach for the people who are affected by all kinds of psychiatric and neurological conditions. It will be a leading European facility for neuroscience research. It will also be a key research facility for developing fast-track and new treatments for patients suffering from diseases such as Alzheimer, Parkinson's, epilepsy and other neurological conditions.
Few treatments are currently available for neurological diseases such as stroke, dementia, Parkinson's disease, motor neuron disease, brain tumors, epilepsy, schizophrenia and depression. The new facility will be used to engage in the research to understand neurotic and psychotic diseases and their treatment mechanisms in order to develop new therapies.
The new facility will be equipped with sophisticated clinical laboratories and diagnostic tools to find new therapeutic interventions. It will be supported by PET imaging and radiochemistry laboratories.
The construction of the neuroscience building is expected to be completed by spring 2013. The construction involves building a large basement area, bulk excavation and in-situ concrete works to the substructure and superstructures.
The building will be a framed structure resting on pile footings. It will feature glazed, concrete-faced and metal-clad elevations.
The design for the institute was provided by Devereux Architects in association with Allies and Morrison Architects. The scope of the institute's design contract included developing the shell, façade and public realm proposals of the building. Devereux Architects were also given a £1m ($1.51m) contract to provide the design for new landscape and public realm at the institute.
In February 2011, Morgan Sindall was awarded a £26m ($39.25m) contract for the construction of the neuroscience research building.
The building is being constructed to achieve BREEAM rating. It will feature with a variety of permanent automated sun-shading structures.
The new building will also include other sustainable features such as natural ventilation with active chilled beams, ground source heating and combined heat and power.
The total estimated investment for the construction of the project is about £42m ($63.41m). The project will be funded by the Maurice Wohl Foundation, the Higher Education Funding Council England, the Wolfson Foundation, the King's Medical Research Trust, and South London and Maudsley NHS Foundation Trust
Sanofi has unveiled plans to build a new manufacturing facility in Vietnam as it expands its operations in South-East Asia.
The plant, at the Saigon High Tech Park in Ho Chi Minh City, will cost US$75m, which represents Sanofi’s largest investment in Vietnam to date. With an initial capacity of 90 million units per year – and a possible extension up to 150 million units – the facility will produce pharmaceuticals and consumer healthcare products. The plant is scheduled to be fully operational by the end of 2015.
The company said the new plant would join Sanofi’s existing network of 40 manufacturing sites in emerging markets.
Christopher Viehbacher, Chief Executive of Sanofi, said: ‘This new production and development center illustrates our commitment to bringing high-quality medicines to a broader population in Vietnam.’
He added that Sanofi has had a presence in Vietnam for more than 50 years and has built a leading position in one of the most dynamic South-East Asian countries. The new investment will also further strengthen Sanofi’s leading position in emerging markets, he said.
Sanofi has around 1,200 employees in Vietnam and is the only foreign pharmaceutical company with two WHO-GMP certified facilities in Ho Chi Minh City, manufacturing 80% of the firm’s products marketed in Vietnam.
Sanofi said it has established a strong partnership with local group Vinapharm since 1993. Last year Sanofi Vietnam was market leader in the country with a market share of 4%.
The move is part of a fast-growing trend among major international pharmaceutical companies to put factories and research centers in emerging markets that the industry increasingly is targeting for growth.
Medicine sales growth is declining in Western countries — long the industry's key markets — as government and private insurance plans there push for discounted prices as part of an effort to rein in health care spending. That's because those countries are squeezed by weak economies, budget deficits and older, sicker populations needing more medical care.
Years ago, drugmakers mainly operated sales offices and distribution centers in emerging markets, countries including China, India, Russia, Turkey, Mexico and Brazil.
Now, governments and a rising middle class in such countries are increasing spending on health care, and most big drugmakers have set goals of producing 25 percent or more of their total sales from emerging markets.
Those companies have found that setting up factories and research centers that hire local workers and collaborate with local research institutions helps sway their governments to buy more medicines from Western drugmakers, rather than just favoring local drugmakers, whose products often are of inferior quality.
And because of lower labor, land and other costs in emerging markets, the big drugmakers can sell their products at much lower prices than what they charge in the West.
Sanofi, headquartered in Paris, France, the maker of diabetes drug Lantus and injected anticlotting drug Lovenox, noted that the new Vietnam factory will join its network of 40 manufacturing plants in emerging markets.
Rapak, a business unit of DS Smith Plastics, has opened a manufacturing facility in Chachoengsao, Thailand. The facility is built to standards that can accommodate cleanroom environments for manufacturing aseptic bag-in box products.
"Bag-in-Box packaging solutions are expected to continue to grow as customers and end users become more familiar with its demonstrated environmental credentials, variety of dispensing applications and cost advantages over other traditional forms of liquid packaging," states Simon Mander, Managing Director of Rapak Asia Pacific. "These factors will underpin the growth of our business here in the South East Asian region and beyond."
DS Smith Plastics businesses are focused on six main areas: liquid packaging and dispensing; rigid packaging; fresh produce packaging; temperature-controlled packaging; foam products; and print solutions.
CPR Pharma Services has expanded its services in the Asia-Pacific region with a new lab in Adelaide, Australia that offers ligand binding assay services for biomarkers, monoclonal antibodies, biosimilars and biologics for early and late phase development.
The new large molecule immunochemistry analytical service will be run by John Chappell, an expert in ligand binding assay development, validation and implementation. Mr. Chappell is a member of the AAPS Committee and has more than 20 years of CRO experience having held positions with Covance, ClinTrials BioResearch, BAS Analytics, Veeda and ICON.
CPR’s chief executive officer, Jason Valentine, said, “John’s appointment with CPR will bring unparalleled expertise in biologic and biosimilar assay development and validation to the Asia/Pacific region. Monoclonal antibodies, proteins, biologics and biosimilars are the new growth areas in drug development and will progressively occupy a larger share of drugs developed globally. Couple this with the increased emphasis on biomarker monitoring in clinical trials and large molecule quantification is critical to any modern bioanalysis laboratory.”
The U.S. FDA has completed an inspection at Frontage Laboratories clinical research center in Zhengzhou and bioanalytical labs in Shanghai under its new combined clinical trial and bioresearch monitoring program. The two-week inspection took place late February to early March 2013 and supports an ANDAs and NDAs.
No FDA Form 483 notices were issued for the inspection of the bioequivalence study for the ANDA application. One Form 483 was issued for the bioanalytical operations, which Frontage is currently resolving with the agency.
“We are pleased that the FDA has approved of our efforts to bring industry-leading drug development practices to China,” said Dr. Song Li, chairman and chief executive officer of Frontage. “As more pharmaceutical companies seek to expand business in China, they are looking for a company that can provide clinical and bioanalytical research services with globally accepted quality standards. Frontage is the first company to offer such a combination in China that has been inspected by the FDA.”
PPD’s bioanalytical operation has been certified by Brazil’s Agencia Nacional de Vigilancia Sanitaria (ANVISA), having met the agency’s biopharmaceutical safety guidelines and allowing the company to conduct bioanalytical work for clients’ compounds that will be marketed in Brazil.
“This certification uniquely positions us to conduct bioanalysis on behalf of our clients who plan to market their products in Brazil and enhances our portfolio of laboratory services in Latin America,” said Bob Nicholson, vice president of bioanalytical labs for PPD. “Having established our first office in Latin America in Brazil in 1996, we have a thorough understanding of the country’s drug development environment. The long-standing history of our bioanalytical labs, coupled with our ability to offer more than 450 validated assays, enables us to provide clients expedited timelines, important cost efficiencies and high-quality study data.”
Vetter, a contract development and manufacturing organization, announces that its new German center for visual inspection and logistics has passed its first GMP inspection by the U.S. Food and Drug Administration. The inspection was conducted March 11-14 to ensure the facility is in compliance with good manufacturing practices.
The 59,000-ft2 facility, known as Ravensburg Vetter West, began operations in April 2012. The site provides high-bay warehousing for cold storage and room-temperature products, as well as visual inspection. Featuring state-of-the-art technology, which helps adapt to the needs of the separate supply and manufacturing processes, RVW also harnesses extensive use of renewable energy sources, including photovoltaic and geothermal.
Nypro Healthcare will establish a medical device manufacturing facility in Ireland. The company is buying and refitting an existing 210,000 ft2 building in Waterford.
The investment is supported by the Irish Government through IDA Ireland.
Nypro's facility will manufacture advanced respiratory and injectable devices for global healthcare and pharmaceutical customers.
This facility will result in the creation of over 200 jobs in phase 1, which is expected to increase in subsequent years. Among the new positions created are operations managers to ensure cleanroom validation, healthcare automation engineers and technicians, and healthcare quality engineers and technicians.
The University of Manitoba's Clayton H. Riddell faculty of environment, earth, and resources has had its home building, the Wallace Building, extended to house a fifth floor, which contains the brand-new Nellie Cournoyea Arctic Research Facility.
The faculty hosted a grand opening ceremony for the new labs, offices, and classrooms on Mar. 18. The event began with a panel discussion featuring Arctic research scientists David Barber and Soren Rysgaard, as well as Clayton H. Riddell and Nellie Cournoyea. The panel discussed the future of Arctic research and the importance of involving northern communities, as well as pursuing the dream of a far-north university.
Following the panel discussion, attendees were invited to an open house and tour of the center. Stations were set up in some labs, where graduate students and their supervising researchers could present their research interests and display new equipment. Among these 14 stations was a Google Earth tour of CEOS research in the Northern Hemisphere, a demonstration of field equipment used for sea ice sampling, and an Ultra-Clean Trace Elements Laboratory (UCTEL) used for the study of trace element contaminants in Arctic ecosystems.
According to the university, the Class 100 (ISO Class 5) cleanroom is the first of its kind in Canada, and is capable of analyzing chemical forms of contaminants in sea ice, seawater, and biota at ultra-trace levels.
Rysgaard says that the new addition not only provides students and faculty with a new space to work, but also increases the range of activities and tests they are capable of performing. "[Researchers] will have the possibility to grow sea ice under experimental conditions, both in microcosms and in a larger ice tank (SERF) at campus."
The Sea-ice Environmental Research Facility, or SERF, includes a large outdoor pool with a retractable roof and equipment for real-time monitoring of the conditions in the pool.
Vindon Scientific (Ireland) has made an unspecified ‘substantial’ investment in the country’s only IMB certified, GMP-compliant stability storage facility in Tramore, County Waterford.
By trebling capacity at the facility to 350m3, Vindon is now able to offer clients stability storage, freezer storage and – 80ºC ultra-low temperature storage.
Vindon Scientific, a leader in controlled environment storage services and equipment, is also investing heavily in a new storage facility in Orange County, California, US. This facility is scheduled for completion by June. Vindon Scientific (USA) will also provide full logistics support from its California base to ensure a comprehensive and complete service. This builds on the company’s US presence in Atlanta, Georgia.
‘These investments are an investment in our partnership with both our Ireland and US customers,’ said Patrick Jackson, Vindon Business Development Director. ‘The expansion has broadened our operational base in both countries and underscores our dedication to retaining our global reputation.’
Vindon Ireland’s business strategy is based on establishing strategic alliances with major biotech and pharmaceutical companies with operational facilities in the country. Vindon says it can manage all storage of needs of clients, including palletized product and large bulk chemical storage down to a single sample.
The investment at the County Waterford facility comes as demand for pharma and biopharm storage services increases. With the pharmaceutical sector in Ireland currently contributing around €55bn to the Irish economy, the need for controlled environment storage and Vindon’s services has never been greater.
Vindon now provides stability storage at a complete range of ICH conditions as well as unique conditions. The company also provides cell, tissue and biological storage services at –5ºC, –20ºC, –70ºC and –80ºC. Vindon’s HTA licensed UK Cryobank also provides cell storage at cryogenic temperatures down to – 196ºC.
Takeda Pharmaceuticals has further expanded its presence in Latin America with the launch of a wholly owned subsidiary in Ecuador. Headquartered in Quito, Takeda Ecuador will handle the sales and marketing of Takeda’s products in the country.
Takeda now has a direct presence in Brazil, Mexico, Argentina, Venezuela, Colombia and Ecuador, and is looking at further opportunities to expand its footprint in the region.
In line with Takeda’s strategy in emerging markets, Takeda Ecuador will build a product portfolio based on the medical needs of the population, focusing on gastroenterology, cardiology, metabolism, oncology and respiratory diseases.
The subsidiary plans a steady stream of product launches from Takeda’s existing portfolio and R&D pipeline. It will initially focus on Zurcal (pantoprazole), Faktu (policresulen, cinchocaine hydrochloride), Alevian Duo (pinaverium bromide, dimeticone) and Tecta (pantoprazole magnesium) and gynaecology product, Albothyl (policresulen), which Takeda repatriated following the acquisition of Nycomed.
Carlos Haro has been appointed Country Manager for Ecuador. He joins the company from Sanofi, where he was General Manager for Ecuador. He will lead the start-up team that Takeda says will grow steadily as the company expands its portfolio and enters new therapeutic areas.
‘The launch of our subsidiary in Ecuador reinforces Takeda’s position in Latin America and will enable us to meet the diverse healthcare needs of the population. We have an established product portfolio, which will give us a strong starting point and we look forward to launching our novel medicines into the market,’ said Norbert Oppitz, Takeda’s Senior Vice President, Latin America.
UK-based pharmaceutical outsourcing specialist Quay Pharma is enhancing its support for clinical trials with the establishment of a dedicated packing and distribution facility at its Deeside headquarters.
The new £100,000 area, approved by the UK Medicines and Healthcare Products Regulatory Agency (MHRA), will allow Quay to respond to client requirements for both bulk delivery of product and to meet increasing demands for just in time deliveries to support randomized and blinded studies.
Quay offers the filling of primary packs including bottles, tubes, blister packs, sachets and oral dosing syringes, followed by secondary packing. As well as providing multi language labeling, blinding and randomization, working with its sister company, Chester Medical, a commercial packaging provider, Quay can provide individually designed patient packs to aid patient compliance and assist in trial success.
Quay also supports cold chain management, including shipping and storage to ensure product quality and security are maintained throughout the distribution process. The inclusion of tamper evident seals and code break labels can be incorporated as part of the packing process.
The new facility is the latest development for Quay’s purpose-designed £2.5m factory in Deeside, which was opened in June 2010 and offers a specialist services including formulation development, novel drug delivery design, analytical method development and clinical trial manufacture.
‘Quay has developed this service to assist a number of our clients for whom we have developed products, as they move through to Phase II and Phase III clinical trials,’ said Maireadh Pedersen, Chief Executive of Quay Pharma. ‘This is an important enhancement to our client offering, enabling us to continue to support our customers throughout their development phase.’
Gulf Pharmaceutical Industries, known popularly as Julphar, inaugurated the first ever insulin production facility in the Middle East in September 2012.
The plant is located in the city of Ras Al Khaima, UAE, where the company's headquarters is also located. The construction of the plant required an investment of $136m. Julphar broke ground for the insulin production plant in January 2008.
The insulin products are being sold in the Middle East and exported to 40 countries worldwide, including, but not limited to, those in North Africa and Asia. The plant will conform to the latest European Medicines Agency (EMEA) regulations in order to comply with international quality standards. Upon approval by the EMEA, the insulin will be exported to European Union (EU).
"The plant is located in the city of Ras Al Khaima, UAE, where the company's headquarters is also located. The construction of the plant required an investment of $136m."The UAE stands second worldwide, after Narushima Island, in the number of diabetics, with an estimated 32.6 million. The World Health Organization (WHO) estimates that nearly one-fifth of the region's population is diabetic. The demand for insulin has, therefore, been high in the region.
Julphar saw significant opportunity in insulin production as the Middle East region has no domestic insulin producer and is totally dependent on imports. It has partnered with the International Diabetes Federation (IDF) to execute the project. The IDF estimates the number of diabetics in the UAE will increase by 80 percent by 2030.
The plant was constructed to boost the local production of insulin to reduce the dependency on imports and bring down the cost of insulin for patients.
The new insulin production facility has a floor space of 20,000m² (215,200 sq. ft.). It is an independent complex with separate buildings for production and auxiliary operations. It has 5,000m² (53,800 sq. ft.) cleanrooms and 15,000m of clean piping.
The sub plants are connected through central corridors, shafts and underground tunnels. The central corridor also connects the main building to main production area, other areas and the central control room.
Insulin is produced in six operational suites which include a media preparation area, buffer preparation area, buffer storage suite, fermentation suite, recovery area and two purification suites.
Julphar's Projects and Engineering Department has designed the plant in collaboration with Linde-KCA, a European engineering consultant.
GEA Diesel installed the process piping and plant equipment. Belgium-based Isocap installed the cleanrooms. Plant automation based on Simatic PCS 7, control systems and instrument validation services were provided by Siemens.
The process equipment was supplied by GE Healthcare (chromatography purification systems), Pall (Tangential Flow Filtration systems), GEA Westfalia (cell separators), Abec (fermentors and process vessels), Martin Christ (lyophilisation), Fedegari (Autoclaves) and Veolia (RO system, WFI Distiller & Clean Steam Generator).
The plant produces Julphar's recombinant human insulin, branded as Jusline. Julphar has been producing Jusline for more than eight years using insulin crystals imported from the EU. The product is registered in more than 14 countries and is available in three variants, namely Jusline 30/70, Jusline n and Jusline r.
The Ras Al Khaima insulin production plant has a capacity of 50 million vials of insulin and 1,500kg of insulin crystals.
Insulin in the plant is produced by cell based fermentation using recombinant DNA (rDNA) technology. The production process encompasses fermentation, recovery, purification and crystallization.
"The insulin products are being sold in the Middle East and exported to 40 countries worldwide, including but not limited to those in North Africa and Asia."The biotechnology production process begins with the insertion of the insulin gene into a suitable vector, usually a non-pathogenic weakened strain of the E. Coli bacterium. The genetically modified host cells are stored to frozen state.
The host cells are thawed and transferred to a flask containing growth medium. Upon attaining a specific cell density that is sufficient for cell culture inoculation, the cells are transferred into a production scale fermentor. The rapid growth of cells in the fermentor is further intensified by continuous stirring and the addition of air and nutrients. The cells mature to produce insulin.
Pro-insulin from the inclusion bodies, after the cells are broken, is extracted by a folding reaction through incubation.
Purification is done by flowing the cell culture fluid and impurities through a number of chromatography columns. The desired protein from the growth medium and other proteins are separated from the impurities through different modes of selectivity in the columns.
The purified insulin is filtered and concentrated to the required level by ultra filtration / diafiltration (UF / DF) process before final crystallisation. The resultant insulin is treated in Class C cleanroom conditions to obtain the dried insulin in crystal form.
The entire production process is monitored and controlled using a process control system with a capacity of about 10,000 items of input and output information.
High quality of the end product is ensured by using deionized, purified water in all stages of production.
Sigma-Aldrich Corp. announces that SAFC, its custom manufacturing and services business unit, will expand its manufacturing plant in Irvine, Scotland to include large-scale production of bulk dry power media and reagents.
SAFC Irvine is used for the manufacturing of liquid media, buffers, and reagents used in the biopharmaceutical industry. The 36,000 ft2 cGMP facility consists of liquid production facilities capable of producing a broad range of batch sizes, quality control laboratories, and dedicated temperature controlled raw materials and finished goods warehousing. The facility currently houses steam-in-place and clean-in-place systems, as well as multiple cleanroom, vessels, and process water systems ensuring continuity of supply. Batch manufacture is completed in a
Grade C cleanroom.
The addition of the dry powder milling and blending capability to the Irvine facility will complete the five-year Capital Expansion Plan SAFC initiated as part of its long-term commitment to supporting customers in the industrial biopharmaceutical market. SAFC will construct a purpose-built Animal Component Free (ACF) dry powder media manufacturing facility to complement the existing liquid cell culture media, buffers, and reagents capabilities in Irvine. Ground breaking for the new facility is expected to commence in March 2013 and should be manufacturing-ready in Q1 of 2014.
The facility expansion will include additional raw material and finished goods warehousing as part of the new manufacturing capability. As with the current Irvine manufacturing and warehouse facilities, the expansion will also be fully compliant with appropriate U.S. FDA and EU cGMP requirements and comply with local requirements with regard to safety and environmental regulations.
Biopharmaceutical giant AstraZeneca has announced it will establish a new global R&D center and corporate headquarters in Cambridge, UK, by 2016, creating 2,000 jobs in the process.
The company will invest £330m ($500m) to establish a purpose-built site in the area, as well as reshuffle some jobs from its other UK sites to Cambridge and abroad.
Under AstraZeneca's proposed future plans, its small molecule and biologics research and development activities will be concentrated in three strategic centers around the world by 2016: in Cambridge, UK; Gaithersburg, Maryland, US and Mölndal, near Gothenburg, Sweden.
AstraZeneca Chief Executive Officer Pascal Soriot said; "I believe that the investment we are announcing today greatly increases the chances that the next generation of innovative medicines will be invented and manufactured in Britain."
Other UK AstraZeneca sites will be affected over the next three years.
Research and development work will no longer be carried out at its Alderley Park, Cheshire facility, resulting in about 700 job losses and approximately 1,600 roles being relocated to Cambridge, a nearby Macclesfield facility or sites overseas.
The company's Paddington, London, offices are expected to close by 2016 with employees being asked to move to the new Cambridge facility.
In a press release the company stressed it will continue to have a strong presence in the North West with some 3,000 employees at Alderley Park, its Macclesfield manufacturing site and the MedImmune vaccine manufacturing facility in Speke.
Soriot added; "I recognize that our plans will have a significant impact on many of our people at our sites in Cheshire and London and the surrounding communities. We are fully committed to treating all our employees with respect and fairness as we navigate this period of change."
Kyowa Hakko Kirin says commercial production of biopharmaceuticals will begin rolling out of its new plant in 2017.
The HA5 plant at the Japanese drug company’s Takasaki facility will commence operations in 2016 with commercial amounts of injectable drugs available the year after.
Spokesman for Kyowa Hiroki Nakamura said the company plans to manufacture its own products “for European, US, and Japanese” markets and will comply with Good Manufacturing Practices (GMP) for all three regulatory bodies.
The company said that the new plant was commissioned in order to strengthen stability of the supply chain.
The plant – which will see an investment of approximately Y4.6bn ($48.9m) – will be four stories tall with a total floor space of approx. 4106 m2 (44,180 sq. ft.) and will produce some of the injectables being made at Kyowa’s Fuji plant as well as those being produced at the current Takasaki plant.
As a part of its production site reorganization, the manufacture of some products currently made at the Fuji plant will be transferred to the new HA5 Plant. In addition to these production transfers, the new HA5 Plant is also scheduled to manufacture those drug products currently produced at the Takasaki plant's existing drug manufacturing facility, as well as new products that the company will hereafter develop. The HA5 Plant is designed for the manufacture of multiple products, with a focus on biopharmaceutical injection drugs. It will comply with the Good Manufacturing Practices for European, U.S., and Japanese drug products, and will thus be able to supply products globally. The HA5 Plant also has been built to be base isolated system and has an emergency power supply to ensure continued operation in the event of a natural disaster. It will start operation in 2016, and begin commercial production in 2017.
Indian drug manufacturer Neuland Laboratories is expanding its presence in the Japanese market as a result of a new collaboration with Mitsubishi Healthcare unit API Corp (APIC) in Tokyo, Japan. APIC is investing in Neuland‘s facilities in Hyderabad to provide dedicated capacity that will enable Neuland to produce pharmaceutical ingredients and related products for APIC’s customers in Japan. No financial details have been released.
Neuland will operate the facility and the two companies will share oversight and management responsibilities.
‘We are impressed with Neuland’s long history of quality production and regulatory excellence. In addition, their business model of being solely focused on API and intermediates manufacture makes them an ideal partner for APIC,’ said Taiichi Emura, President of APIC.
Dr. D. R. Rao, Chairman and Managing Director of Neuland Labs, said: ‘This alliance will allow us to raise our profile in Japan while enabling our partner APIC to grow their business in a cost-effective way.’
Neuland also intends independently to continue to expand its already-sizeable business in Japan, building on its significant customer base for both generic API manufacturing and contract manufacturing of APIs and intermediates.
Dr Rao added, “Our work with APIC has already been valuable in increasing our understanding of the unique requirements of the Japanese market. We are confident that we have adequate production capacity to serve both existing and new customers and believe that this collaboration will further enhance our ability to serve all of our customers around the globe.”
For more than 25 years Neuland Labs has been manufacturing APIs at its cGMP manufacturing facilities, working with customers in 85 countries. The company has developed more than 300 processes and 60 APIs, and has filed more than 40 US drug master files (DMFs), 10 EU CEPs and a total of more than 400 DMFs worldwide. Its manufacturing facilities are approved by the US FDA and other leading regulatory agencies.
Dutch contract research organization Spinnovation Analytical has agreed with Pivot Park to supply analytical services at a newly established life sciences park in Oss, the Netherlands.
Pivot Park, located on the former Organon/Schering Plough/MSD research site is a center for open innovation, where facilities, instruments and knowledge are made available to the pharmaceutical and biotech companies based on the site. It was officially opened in December 2012.
Spinnovation will further support the park’s research and productivity with its portfolio of analytical services that address the needs of both the small-molecule pharmaceutical and the biopharmaceutical industries.
The agreement will allow Spinnovation to expand and complement its technology platform, thanks to exclusive access to several high-end analytical instruments.
Spinnovation will cover the analytical needs of medicinal chemists focused on discovery programs and pre-clinical development, as well as those of Contract Manufacturing Organizations (CMOs), by supporting Chemistry Manufacturing Control (CMC) activities. The extra NMR capacity provided by Spinnovation, including 400MHz and 500MHz with cryoprobe and high-throughput sample changers, will enable cost effective shared-access to routine NMR analyses. The advanced NMR screening methods that Spinnovation will provide will also eventually facilitate access to rapid ‘hit-validation assays’ as follow-ups to screening campaigns conducted at Pivot Park Screening Facility.
Mass spectrometry capabilities at the park will be increased by the addition of advanced Q-TOF applications, which support drug metabolite identification and biologics characterization.
The advanced facilities available at Pivot Park will also help Spinnovation further strengthen and develop Spinnovation Biologics, a service offered to the European and US biopharmaceutical industry. Spinnovation Biologics supports upstream process development, including the profiling of cell culture media for the production of biotherapeutics using Spedia-NMR, troubleshooting issues in bioprocess with Spedia-Predict and performing profiling and characterization of raw material, biologics and biosimilars.
US pharmaceuticals giant- Pfizer - revealing some indicators on its new project in Saudi Arabia now scheduled to start production by 2015.
That was reported in the media on the occasion of lying the project's ground stone days ago. It would occupy 32,200 M2 area (346,472 sq. ft.) at King Abdulla Economic City in Rabegh, in the western part of the Kingdom, on the Red Sea.
It would host an annual design capacity to produce & package about 18 million pharmaceutical packs & the output in mainly targeting the Saudi market.
The first prong of the push into China will see Catalent Pharma Solutions introduce its drug delivery services into the Chinese market as the New Jersey headquartered company agrees to acquire the Chinese nutritional softgel producer Zhejiang Jiang Yuan Tang Biotechnology Company.
The second prong sees Catalent Pharma Solutions forming a joint venture with contract research organization (CRO) ShangPharma Corporation, in order to provide clients end-to-end solutions for clinical trial supplies.
Spokesman for Catalent Chris Halling said, “These two investments are the first steps to enable Catalent to meet the needs of local, regional and global pharmaceutical and consumer health companies.”
“Growing our capabilities in China and Asia more broadly,” he continued, “is a key strategic goal for Catalent and has commanded substantial focus from Catalent senior management over the last year and will continue to in the future.”
In both areas Halling said continued investment was likely. “The Clinical Trial Site – a
31,000 sq. ft. facility in Shanghai - is now under construction” while there are further investments planned “to expand and upgrade the Softgel subsequent to the transaction completion “which is expected in the next few months.
Furthermore he added that “as the Clinical Supply activity in China and Asia grows, we will expand the workforce to meet demand.”
Regarding this investment, Halling said it gives Catalent the opportunity “to build upon [its] existing softgel network in the Asia Pacific region” while complementing “existing facilities in Asia Pacific.”
Catalent has softgel sites in both Japan and Australia.
The newly acquired facility in Haining currently employs 120 staff which Halling said may be supplemented with rotations from the company’s global team to “align its operational, quality and regulatory approach with Catalent sites across the globe.” Catalent hopes to use the site to move into the softgel manufacturing of OTC and prescriptions in China.
There is a “strong trend towards outsourcing in China,” according to a 2012 CRO Industry Report, Catalent’s deal with Shangpharma is just one of a number of recent acquisitions and collaborations in the region as both Asian and Western CROs have been increasing activity in this sector.
Just within the last week, Chinese CRO WuXi has announced significant growth in its clinical services offerings and has said it expects trends to continue. Logistics company Marken, too, has opened a Beijing depot in response to demand from clinical trials and even the purchase of Radiant Research’s CRO division by Accelovance cited China as a key market made accessible by the deal.
As Halling said, “China is one of the fastest growing pharmaceutical markets globally with rising customer needs for clinical trials and locally produced modern and traditional treatments.”
The approval follows a Korean Food and Drug Administration (KFDA) inspection of the German chemical giant’s BASF Pharma Callanish omega-3 unit on the Isle of Lewis and increases its presence in a key market according to spokesman Andres-Christian Orthofer.
He said that: “South Korea has an interesting omega-3 drug market both in terms of volume and value and we see opportunities to further grow the market with new omega-3 drug products.”
BASF already has ‘significant’ pharmaceutical-grade omega-3 sales in the country according to Orthofer continued, explaining that this was largely due to its recent acquisition, Norway-based manufacturer Pronova Biopharma.
One of the things that makes South Korea such an interesting market for BASF is 2012 legislation recommending that Koreans consume at least 2 grams of omega-3 fatty acids per day as part of a healthy diet, which is roughly eight times the minimum daily amount advised in Europe.
The South Korean approval is part of a wider BASF effort to grow its pharmaceutical omega-3 fatty acid business globally that began with its purchase of Equateq and the Callanish facility in May last year.
Alan Poon, Head of BASF Pharma Ingredients & Services in Asia Pacific said: “We expect approvals in other Asian markets to follow, as we broaden our offering of omega-3 concentrates for the pharmaceutical sector even further.”
Orthofer echoed this, explaining that: “The market for omega-3 based drugs is relatively young with only a few drugs approved in a few countries.
“Therefore, there are many opportunities globally to obtain regulatory approvals for existing omega-3 drugs and for future products.”
The new depot provides 850m2 (9,146 sq. ft.) of GMP-compliant space for temperature controlled storage, as well as distribution, and is positioned next to the logistics company’s branch office in Beijing, China in order to offer a fully integrated service, focusing especially on the clinical trials market.
“There are not a lot of solutions at present and there’s a lot of demand,” said Senior VP Commercial Operations at Marken, Ariette Van Strien. “China’s an area which we see growing quickly” and with “more and more clinical trials” there is the need for a fully encompassing distribution service.
Marken has had a presence in China for over ten years yet recent shifts in strategy are leading the company to form a complete network for supporting its Asian clients. Van Strien explained that the company was recently granted a 12 year logistics license by the Chinese State Food and Drug Administration (SFDA) meaning Marken could consolidate its network for long-term operations.
She admitted there was some local competition in the distribution industry in China and that “World Courrier has always been [the] main rival” but overall the “goal is not to just compete but we are developing this whole new network within China to provide the best infrastructure.”
The Beijing depot had initially been scheduled to open in the second quarter of 2012 but Van Strien told us that Marken’s priorities changed as the company opted to first open the doors to depots in Argentina , New York, Frankfurt and New Mexico.
She said: “Our plan is driven by our strategic customers and their needs, so our plan is very flexible. The set-up was finally on plan, only our priorities changed.”
This supports comments by CEO Wes Wheeler last February: The Company “is in the process of shifting its strategy to expand services and geographies. We plan to transform from a premium courier to a full service supply chain services company.”
In the last year, Marken’s global footprint spread not only to the sites listed above but saw the announcement of plans to set up offices in India. Marken are also working on plans to set up depots in other key emerging markets, namely Brazil, Chile, Columbia and Russia.
Baxter International will be investing $35m (€27m) into its Aibonito, Puerto Rico facility in order to build a new full-scale line for solutions manufacturing and filling yet despite this second investment – Baxter invested $2.5m last year in a small-scale production line – the company will be laying off 400 of the 900 workers.
Jill Carey-Hargrave, Global Corporates Communication at Baxter, said the reduction in workforce is a result of “new solutions manufacturing operations” which “require higher levels of technology and automation than existing work performed at the facility.”
She continued, adding: “the company will be transforming the facility from its current focus – production of sets and components used to administer intravenous solutions and medications – to more advanced manufacturing of intravenous solutions and medications.”
Over the next few years, current manufacturing at Aibonito will be transferred to a facility in the Dominican Republic and headcount will also be reduced, though Baxter says it will attempt to “offset impact” by managing staff “through attritions/retirements and the use of temporary labor.”
Puerto Rico
Recent years have seen a string of quality failures in manufacturing plants on the island, regulated by the US Food and Drug Administration (FDA), with a number of large pharma manufacturers receiving FDA warning letters.
Research in 2011 discovered that difficulties in transferring knowledge between US Pharmas and their facilities on the island may have been responsible for the quality issues on Puerto Rico.
Baxter itself received a letter about its Jayuya plant, and Mylan and Warner Chilcott have both been recipients. Furthermore, CMO Patheon shut down its Caguas plant on the island after years of underperformance.
When Outsourcing-Pharma.com asked Carey-Hargrave about the endemic QA/QC problems on the island, she remained confident in Baxter who has had a manufacturing presence in Puerto Rico since 1958.
“Our confidence in the technical abilities of the Aibonito employees and high regard for the long-term value of the facility,” she said, “are reflected in the continued investment we are making to expand into solutions manufacturing.”
The Campus for Research Excellence and Technological Enterprise (CREATE), Singapore, has been named Laboratory of the Year by R&D Magazine. Now in its 47th year, the competition recognizes excellence in research and science laboratory design, planning, and construction.
Designed by Perkins+Will, the CREATE facility is a collaborative project led by the Singapore National Research Foundation, involving Singapore-based research institutions as well as participating international universities and multinational corporations. The campus, encompassing ~67,000 sm (720,920 sq. ft.) in four buildings, is intended to support the work of ~1,200 researchers. Current participants include the National University of Singapore, MIT, the Swiss Federal Institute of Technology, the Technical University of Munich, Technion-Israel Institute of Technology, UC-Berkeley, the Hebrew University of Jerusalem, Ben-Gurion University, Peking University, Shanghai Jiao Tong University, and Cambridge University. The buildings take advantage of the tropical climate, using wind turbines, green roofs, and daylighting as integral parts of the design.
The Georgia Institute of Technology Carbon-Neutral Energy Solutions Laboratory, Atlanta, received High Honors. The 42,000-sf LEED Platinum lab, incorporating interdisciplinary high-bay space, was designed by HDR Architecture. Sustainable features include passive energy technologies, high-tech glazing including a PV screen wall, high-efficiency lighting, energy recovery, radiant heating, and displacement ventilation.
Two Special Mentions, honoring aspects of a project, were awarded. The District of Columbia Consolidated Forensic Laboratory, by HOK, was given for the facility's excellence in providing space for collaborative science. This 287,000-sf building supports public health and forensic science departments for Washington, D.C., and is targeting LEED Gold.
The Sherman Fairchild Biochemistry Laboratory at Harvard University received a Special Mention for renovation. Payette Associates designed the project, which created a new home for the Stem Cell and Regenerative Biology Department in a lab built in 1981. The renovation achieved LEED Platinum.
International Flavors & Fragrances (IFF) has opened a new flavors facility in Guangzhou, China, as part of a $100m investment in Greater Asia as it looks to increase its presence in emerging markets.
Commercial production at the 19,000m2 (204,440 sq. ft.) site - which comprises sales and administration offices, laboratories, factory buildings, and support services - will begin in Q3, 2013.
Its projected annual capacity is approximately three times that of the existing manufacturing site, said IFF CEO and chairman, Doug Tough, who said the facility was built with an emphasis on energy efficiency, low water consumption and minimal waste.
“With the opening of our Singapore and Delhi facilities in 2012 and our Guangzhou site in 2013, IFF is well-positioned to support our customers’ growth now and into the future, both regionally and globally."
Over the coming months, the plant will undergo testing and production trials to help ensure products meet the highest global standards before they are available commercially, he said.
'The emerging markets have been growing at 2 to 3 times the rate of the developed markets'
IFF, which generated revenues of $2.8bn and delivered a $488m adjusted operating profit in 2012, told delegates at the recent Consumer Analyst Group of New York (CAGNY) conference that 47% of its sales were generated in "the fast-growing emerging markets... which is among the highest of any of our competitors".
This is important, said CFO Kevin C. Berryman, "because as our customers expand into these markets, they have the ability to leverage our long standing presence and our extensive market knowledge to drive their brands".
He added: "The emerging markets have been growing at two to three times the rate of the developed markets, and this is primarily due to the expanding middle class and their increased levels of disposable income, which is allowing them to increase their purchase of consumer packaged goods."
However, growth will also come via innovation, said Berryman, pointing to IFF's tie up with Switzerland-based Evolva to produce natural vanillin via a yeast-based fermentation method.
Natural vanillin is a compound from the vanilla bean, the ‘fruit’ of the flowering vanilla orchid, which provides vanilla flavor. However the vanilla orchid must be propagated by hand, which is very labor intensive. As demand for vanilla flavors is increasing all the time, global vanilla production is struggling to keep up.
Under the terms of the collaboration, IFF will commercialize the product and Evolva will receive royalties on product sales.
"Vanillin is a key flavor ingredient used in many, if not the majority, of flavor food products, and so a dependable, and cost-effective source of this key material will be very welcomed by our customers", said Berryman.
Pathwork Diagnostics announced a deal to offer its Pathwork Tissue of Origin Test for cancer diagnosis in China.
The deal with Kindstar Global, which claims to be the largest esoteric diagnostic testing business in China, expands the Redwood City, Calif.-based company's international network of test and service providers, Pathwork said. The agreement is the first international in vitro diagnostic deal for the company, it added.
Kindstar will offer the IVD kit version of the Tissue of Origin Test, which is cleared by the US Food and Drug Administration and covered by Medicare.
The molecular diagnostic test uses a tumor's genomic information to help clinicians diagnose difficult cancers, such as those that are metastatic or have a complex clinical history, Pathwork said. It measures gene expression levels of 2,000 genes, and by using proprietary algorithms compares the tumor's gene expression pattern to that of 15 tumor types, representing 58 morphologies and 90 percent of all solid tumors.
"Having access to this test will allow us to expand the current testing services we offer Chinese physicians and position our business as the leading diagnostic company in the fastest growing market in the world," Kindstar Founder and CEO Shiang Huang said in a statement.
Financial and other terms of the deal were not disclosed.
Bruker celebrates the grand openings of its new Mumbai and Bengaluru Centers of Excellence (CoE). For over three decades, Bruker has grown its presence in India, with sales and service capabilities in most major cities in India, including New Delhi, Mumbai, Bengaluru, Chennai, Kolkata, Lucknow and Hyderabad, as well as several other Indian cities. This year, Bruker is expecting approximately $50 million in revenue in India, employing over 100 staff, complemented by several high-quality distributors with service capabilities for some of Bruker’s product lines.
Bruker’s new Centers of Excellence in Mumbai and Bengaluru now offer a new, even higher level of customer support in the important and growing Indian markets for scientific and analytical instrumentation. Bringing together a wide range of Bruker divisional operations in India, the new CoE facilities offer our customers access to multi-technology applications, training and demonstration capabilities. These Centers of Excellence will also aim to support research collaborations between Bruker and key customers in India. Their locations were chosen for their proximity to major academic, government and industrial research laboratories, and also to major hubs for the strong Indian pharma, biotechnology and CRO industry, as well as to major clinical research centers, and to important centers for the cement, metals, manufacturing, food and other industries.
Dr. Frank Laukien, Bruker’s President and CEO, commented: “With this significant investment in our two new Centers of Excellence, Bruker has taken a major step forward in India to provide highest-level support for the outstanding and rapidly growing Indian research, industrial and clinical communities.”
SGS Life Science Services is developing integrated formulation and stability testing services in the UK, expanding its current capability for characterization-based analytical testing for biologics. The new services will be offered from a dedicated suite in its M-Scan facility in Wokingham, UK and is scheduled to be fully operational by 4Q13.
The 1,100 sq.-ft. suite will include a temperature and access controlled room for the stability units and a large separate instrumentation and wet lab. These new services extend SGS’s formulation and stability services currently provided in Lincolnshire, IL, and stability testing services from its Center of Excellence in Berlin, Germany.
“Customers require preparation and testing of their samples at one site. Sample shipment involved in multisite testing is not ideal because of the potential effects that shipping may have on sample integrity,” said Andrew Reason, group manager, SGS M-Scan Europe. “These studies are also an iterative process whereby data is fed back to the formulation scientists prior to generation of further samples for testing.”
Anne Hays, executive vice president, SGS Life Science Services, said, “There is an increasing trend for biologics manufacturers to outsource testing of their products and SGS strives to provide new services in response to the market’s needs in a timely manner.”
Catalent Pharma Solutions has formed two joint ventures in China for its Softgel Technologies and Clinical Supply Solutions businesses.
The company has agreed to acquire, pending regulatory approvals, a majority share in Zhejiang Jiang Yuan Tang Biotechnology Co., Ltd. The Haining-based, privately held business produces nutritional softgel products for Chinese and Asia Pacific markets, and employs 120 staff. Catalent intends to work with regulators for future expansion into OTC and prescription softgel manufacturing in China.
Catalent has also formed a joint venture with ShangPharma Corp., to be called Catalent (Shanghai) Clinical Trial Supplies Co., Ltd. According to a Catalent statement, the JV's new 31,000-sq.-ft. facility in Shanghai, currently under construction, will be the first in China to provide end-to-end solutions for clinical trial supplies, including comparator sourcing, primary and secondary packaging and labeling, and storage and distribution.
Commenting on both investments, Catalent’s president and chief executive officer, John Chiminski, said, “As part of our growth strategy, these initial steps enable us to better serve the important Chinese market for both global and domestic customers. Our clients and their patients will benefit from access to Catalent’s advanced technologies and solutions, together with best-in-class innovation, reliable supply and quality compliance.”
“We are delighted to be working with Catalent, a world leader in drug development services and clinical supply services,” said Michael Hui, founder and chief executive officer of ShangPharma. “This cooperation will enable both ShangPharma and Catalent to better serve our multinational pharmaceutical customers through tailored, integrated solutions.”
Jiang Renfei, the chairman and chief executive officer of Zhejiang Jiang Yuan Tang Biotechnology Co., Ltd., commented “The combination of Catalent’s unparalleled track record of Softgel innovation and commercial success, and our deep understanding of the local market, will provide extensive benefits for our customers.”
Financial terms of the investments were not disclosed. In a statement, Catalent noted that it intends to make additional investments in these two facilities during the next several years to broaden its offerings in the Chinese market.
Intertek, a global leader in quality and safety solutions for a wide range of industries, has expanded its GMP Pharmaceutical Microbiology Testing Services from its laboratory in Athlone, Ireland.
Intertek’s GMP Quality Control (QC) microbiology services enable the firm to help manufacturers meet the regulatory quality standards required for raw material testing and release testing of oral medicines (e.g. liquid, tablet and capsule), topical (creams and ointments), injectables, transdermal, ophthalmic products and purified water.
The scope of services extends to microbial limit testing/validation, preservative efficacy testing/validation, disinfectant efficacy testing, endotoxin testing, validation of water systems and incubation of environmental monitoring.
Intertek has broad experience using internationally recognized methods such as compendial methodology; however, the transfer of client-specific methods or bespoke method development is also offered.
The expansion brings the capability to perform identification of bacterial cultures using a Biolog MicroStation Identification System. A Phenotypic Identification System can be used to identify the following isolate types: gram negative rods (e.g. Pseudomonas, E-coli), gram positive rods (e.g. Bacillus), and gram positive cocci (e.g. Staphylococcus aureus).
‘Businesses across Europe benefit from consolidating service provision for chemical and microbiological QC testing by using Intertek’s efficient ‘one-stop shop’,’ said Dr Ben Cliff, Laboratory Director, Intertek Pharmaceutical Services, Ireland.
‘This expanded capability to perform identification of bacterial cultures strengthens our ability to help our pharmaceutical and healthcare clients with a much more comprehensive microbiology QC support service for their production and R&D needs.’
Sandoz officially opened its new facilities in Kundl, Austria, thereby expanding the production of sterile penicillin at the site significantly and creating 30 new jobs.
Production expansion will create 30 new jobs at the site and reinforces the Kundl site's position as a leading producer of sterile injectables
With the expansion, Kundl has added two new floors to its existing building and increased its powder facilities from 10 to 12 with a planned annual capacity of more than 150 million vials. Approximately 190 million packs of medicinal products are distributed annually from the Kundl site to around 100 countries. Kundl is Sandoz's largest production site and one of the world's leading antibiotics manufacturers as well as the last remaining fully integrated penicillin producer in the western world. Currently 200 employees work in the sterile penicillin production.
The size of the two new floors is approximately 22,500 m3 which equates to about 22 single-family homes. Together with the current space of 26,300 m3, the site will be equivalent in size to 48 single-family homes.
Jeff George, Global Head of Sandoz, said: 'Expanding our sterile production in Kundl demonstrates our focus on differentiated products and our commitment to Austria. The significant expansion of our sterile production will also play a major role in strengthening innovation at the Kundl site.'
'We have decided to expand our production of sterile penicillin due to strong worldwide demand for antibiotics. The additional lines increase security of supply for the market and allow us to respond quickly to changing needs in the fast-paced generics business.' said Ernst Meijnders, Chairman of the Executive Board of Sandoz GmbH in Austria.
The guests at the opening included local politicians, representatives from industry, Kundl village's priest, Dr. Piotr Stachiewicz, as well as Tyrol's Governor Gunther Platter.
MicroVention Inc., a subsidiary of Terumo Corp., has opened a manufacturing facility in San José, Costa Rica. The facility is 80,000 ft2 and will include a 25,000 ft2 cleanroom.
The plant represents MicroVention's first manufacturing facility outside the United States and the first neurovascular manufacturing facility in Costa Rica, which is located at the Coyol Free Zone in the Alajuela region of Costa Rica.
The plant's opening ceremony was attended by numerous dignitaries and executives from the business district, including the vice president of Costa Rica, Luis Lieberman Ginsburg.
The facility will support the growth and expansion of products offered under the MicroVention and Terumo brand, and the company has hired approximately 150 associates with plans to expand in the coming months/years.
"We are very excited about the initiation of our first manufacturing facility in Costa Rica and commemorating the opening with many of our new partners celebrating with us. Our intent was to create a world-class facility extension of our corporate manufacturing plant in Tustin, Calif., and we have achieved that goal," says Richard Cappetta, president and CEO of MicroVention.
Patheon, 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 SoluPath™ 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."
Horizon Discovery has established three new Centers of Excellence for gene editing in Asia. The new Centers are at Aichi Cancer Center, Japan; Seoul National University, South Korea; and the National Cancer Center, Singapore. Horizon said that it will support the three research centers in their application of its proprietary gene engineering technology, called Genesis, to generate human isogenic cell lines harboring specific genes/mutations relating to cancer.
Sanofi and DBV Technologies have entered a strategic manufacturing agreement under which Sanofi will produce the API for DBV’s Viaskin. Sanofi will provide scale-up, process validation, and commercial scale supply.
DBV selected Sanofi for its expertise in biologics development and manufacturing in the field of plant extraction and purification of therapeutic proteins. Also, Sanofi’s manufacturing site in Aramon, France, has all the necessary capabilities to support the registration of Viaskin for both the EU and U.S. markets.
Dr. Pierre-Henri Benhamou, chairman and chief executive officer of DBV Technologies, said, “The strategic manufacturing agreement with Sanofi is an important step for DBV in the light of Viaskin’s late-stage development and potentially fast-coming commercialization. We believe that the extraction and protein expertise of Sanofi, notably at the Aramon site, will highly benefit DBV, thereby securing our API procurement in the years to come. We were very impressed by the quality and reactiveness of the Sanofi teams, which match perfectly with DBV’s culture and look forward to working closely with them in the months to come.”
WuXi PharmaTech Inc. and Open Monoclonal Technology, Inc. (OMT) have entered a second agreement to expand WuXi's use of OMT's OmniRat and OmniMouse technologies aimed at strengthening the development and commercial opportunities for WuXi's Asian regional and global clients.
WuXi has duplicated the OmniRat platform at its Shanghai facility, allowing it to generate antibodies for customers from its own labs. WuXi's clients can now choose to develop and commercialize products globally or regionally in China, Korea, Japan or other Asian territories. Clients that opt for regional rights can assume global rights prior to the first human dose. OMT retains the global product rights until and unless each option is exercised.
"This new agreement allows WuXi to further expand its service offerings with the OmniRat and OmniMouse platforms," said Edward Hu, chief operating officer and chief financial officer of WuXi PharmaTech. "WuXi is proud of the confidence OMT has shown in the quality of WuXi's antibody research capabilities and intellectual property protection practices in authorizing WuXi to host the OmniRat and OmniMouse platforms in our laboratories."
Dr. Roland Buelow, founder and chief executive officer of OMT, said, "This second agreement with WuXi continues the global deployment of OMT's human antibody technologies. The deal structure enables OMT to tap into the economics of rapidly growing Asian companies and, when global rights are not exercised by WuXi's clients, to leverage their data for OMT product development and/or partnering outside Asia."
Pharmatek is expanding its GMP facilities with three additional cGMP manufacturing suites, a new automated packaging line and further drug product and cold storage, increasing production capacity by 50%. The packaging line can produce batch sizes of 10,000 bottles per day and is designed to handle highly potent and cytotoxic compounds, control humidity between 20% and 60% RH, and includes client manufacturing viewing areas. The project is scheduled for completion in 4Q13.
"Matched with our recent equipment purchases, the addition of automated packaging and larger suites enables us to handle larger scale clinical trial material productions, providing a higher level of customer service," said Kevin Rosenthal, director of manufacturing at Pharmatek. "The ability to serve our clients longer, as they advance their compounds down the development pipeline, reduces their overall costs and time-to-clinic."
"This expansion plays an important role in our continuous efforts to meet our clients' needs and our ongoing efforts to broaden our manufacturing capabilities," said Tim Scott, president of Pharmatek. "As we move toward becoming a more fully integrated CMO at all phases of the development pipeline, we will continue to invest in new equipment and our facilities
Patheon, a leading provider of contract development and commercial manufacturing services to the global pharmaceutical industry, today 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 SoluPath™ 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."
McIlvaine Company
Northfield, IL 60093-2743
Tel: 847-784-0012; Fax: 847-784-0061
E-mail: editor@mcilvainecompany.com