PHARMACEUTICAL & BIOTECHNOLOGY INDUSTRY
UPDATE
August 2013
McIlvaine Company
S. Korea to Spend Combined 10 Trillion Won on New Drug Development by 2017
MHRA Approves Molecular Profiles' Clinical Manufacturing Facility
AstraZeneca Selects Cambridge, UK for New Global R&D Center and Corporate HQ
Thanks to Paul Woolford, AIA, IIDA, LEED AP BD+C, design director in HOK’s San Francisco office, for this post describing the design of the new National Oceanic at Atmospheric Administration Pacific Regional Center in Pearl Harbor, Hawaii. Scheduled to open in December, this will be one of the country’s most environmentally innovative national historic landmarks.
Our National Oceanic and Atmospheric Administration Pacific Regional Center project is in Honolulu on Oahu’s Ford Island, where the Pearl Harbor attacks occurred.
When it opens later this year, all the administrative functions that NOAA requires to monitor the weather across the Pacific Ocean will be headquartered here. The facility includes offices and labs, a tsunami warning center, the national marine sanctuaries, national monuments under the sea and state parks.
The project is renovating and adapting two giant World War II-era aircraft hangars and constructing a new building between them on a national historic landmark site. The hangars were designed by Albert Kahn and built for the war effort.
To inspire the design, we looked to the mission of the NOAA, which is responsible for monitoring climate, weather, oceans and coasts. This led to design ideas featuring air, light and water.
We repurposed and restored the hangars with a design that treats them as a giant shed, or shell, that is three stories tall, 700 feet long, 250 feet wide and open inside. A simple glass-and-steel pavilion unites these two historic structures and mediates the open space between them. The new architecture is distinct from the historic buildings while providing a quiet complement.
Inside the shed is a 350,000-square-foot government office and research campus. It has a central quadrangle and interior courtyards that allow us to drive daylight and ventilation deep into the building. The physically occupied space is stepped up in the middle of the structure so that it appears to be hanging in the rafters.
The Economic Assistance Coordinating Council of Massachusetts has approved numerous projects for participation in the Economic Development Incentive Program (EDIP), which are expected to create 2,347 new jobs and retain 3,102 existing jobs, in addition to leveraging nearly $406 million in private investment and supporting construction projects across the Commonwealth.
Among them is a tax increment financing project for Boyd Technologies Inc. in Lee, Mass. The company will invest $1.5 million for new Class 7 cleanroom and capital equipment. The expansion will create eight net new full-time jobs and retain 41 full-time jobs in Massachusetts. The Town of Lee is supporting the project with a five-year Tax Increment Financing agreement valued at $5,523.
Boyd Technologies is a precision converter and contract manufacturer of advanced flexible materials, primarily in high-tech markets. The company launched its five-year strategic growth plan in 2012 and this expansion represents the first phase of the plan, which is focused on their medical device industry product lines in biopharmaceutical filtration and advanced wound care.
Johnson & Johnson has opened its J&J Innovation center in Boston, the third of four regional hubs being established to identify early-stage innovations and collaborations aimed at speeding drug development. The Boston Innovation Center provides scientists, entrepreneurs and emerging companies focused on early-stage opportunities with access to J&J experts, who can facilitate collaborations across its pharmaceutical, medical device and diagnostics and consumer companies.
"The East Coast's significance as a hotbed for life sciences innovation grounded in collaboration is indisputable, and continues to grow," said Paul Stoffels, M.D., J&J chief scientific officer and worldwide chairman, Pharmaceuticals. "With the establishment of our Boston Innovation Center, we look forward to further fostering collaboration with some of the world's leading scientists, renowned academic centers, and influential entrepreneurs to enable future innovations that will advance human health."
The Innovation Center's first collaborations and new initiatives include a research alliance with Mount Sinai to advance the discovery of next generation therapeutics for inflammatory bowel disease (IBD), a collaboration with Rodin Therapeutics to advance novel therapeutics for neurological disorders such as Alzheimer's disease, and an investment in Vedanta Biosciences aimed at advancing a first-in-class preclinical candidate for autoimmune and inflammatory diseases such as Inflammatory Bowel Disease (IBD). Additionally, J&J has established Janssen Labs in Cambridge, MA.
"We are thrilled to officially open the doors to the Boston Innovation Center today, deepening our long-held commitment to supporting this vibrant life science ecosystem," said Robert Urban, Ph.D., head, Boston Innovation Center. "We look forward to serving as a single point of entry for innovators to efficiently and creatively explore relationships and investment opportunities across the Johnson & Johnson Family of Companies, with the ultimate goal of bringing new innovations to improve health and patient care."
The new medical research complex at University of Washington (UW) School of Medicine in South Lake, Seattle was completed in March 2013. The new facility will house many of the university's biomedical research laboratories. It is expected to receive certifications by spring 2013.
The construction was primarily sponsored by UW School of Medicine, Vulcan Real Estate and the National Development Council.
The new phase three research centre has a total floor space of about 330,000ft2, in a seven storey building. The research complex is surrounded with beautiful landscape and features a tree-lined sidewalk. It has two spacious seminar rooms with videoconferencing capabilities and also features 266 parking spaces located in two bays.
The third phase has laboratories for kidney research, vision sciences, rheumatology, immunology and infectious disease investigations. The scientists at the new facility will focus on a number of medical conditions, including multiple sclerosis, blindness, malaria, lupus and renal failure.
The new facility will be engaged in developing life-changing therapies and medical breakthroughs that will positively impact the health of future generations. The facility can accommodate between 1,000 and 1,200 researchers and support staff.
The construction of the research complex was completed in three phases. The total floor space of the medical research complex in all the three phases is about 800,000ft2.
The design and planning for the construction of the research complex began in September 2003. The facility broke ground for construction in 2004. The first phase of construction was completed in January 2005. It included a total floor space of 215,000ft2.
The facilities constructed in the first phase included laboratories intended to carry out research in microbiology, biomarkers, biologic imaging, cancer vaccines, heart regeneration, inflammation and proteomics.
The second phase of construction began in 2006 and was completed in 2008. It included 170,000ft2 laboratory building and 86,000ft2 office building.
The research facilities opened at the complex during the second phase included biology, therapeutic delivery systems, neurobiology, genetics, and regenerative medicine. The research facilities are specifically focused on diseases such as Parkinson's and Alzheimer's, diabetes, hearing loss, strokes, heart regeneration, liver diseases, and bone and joint regeneration and repair.
The Board of Regents approved the third phase of the medical research complex's construction in April 2010. The third phase broke ground in July 2011 and was completed in March 2013.
The building design and architectural support was provided by Perkins+Will. The landscape design was provided by Gustafson Guthrie Nichol (GGN). The construction contract for the building was awarded to Sellen Construction.
The structural engineer for the second phase of construction was Magnusson Klemencic Associates. The electrical and mechanical engineer was Affiliated Engineers NW. The civil engineer for the second phase was Coughlin Porter Lundeen.
The first phase of construction was sponsored by philanthropy funding from Jeffrey H Brotman. The second phase of construction was contributed by Tom and Sue Ellison, Lynn and Mike Garvey, the Oki Foundation, Quellos, Safeco and the Orin Smith Family Foundation.
The total investment on the third phase of the medical research complex construction was $165m. The construction cost of the building was $113m. The National Development Council sponsored the third phase.
The Jill and John Freidenrich Center for Translational Research was officially opened in October 2012. The research centre is located at 800 Welch Road, in Stanford University School of Medicine, California.
The centre has advanced facilities for conducting the vital clinical research to advance the development of scientific discoveries, lifesaving treatments and diagnostics.
It is currently Stanford's hub for medical studies and clinical trials involving the testing of new drugs and other therapies with human participants. The research and clinical trials were previously distributed across seven buildings on and off campus. Much of the work is consolidated at one site with the opening of the new research centre.
The design of the building was inspired by the Li Ka Shing Center for Learning and Knowledge, which is located at the heart of the medical school campus.
The facility is designed to optimize teamwork and to create a pleasant environment for clinical trial subjects and healthy research volunteers.
The facade of the building features limestone and Stanford-red clay.
The research centre has a total floor space of 30,690ft². It is used for researching new treatments, developing clinical trials and testing new drugs and other therapies on humans. It is located near Stanford Hospital, Lucile Packard Children's hospital and several other research centers within the university.
The research centre building has three floors. The ground floor has patient intake area that includes 16 patient bays, four hospital beds and three pediatric study rooms. It features a sample-collection lab, two phlebotomy rooms, and an outdoor play area with a separate entrance for pediatric subjects. The ground floor also has rooms for remote observation, sleep studies and exercise physiology testing, and specialized rooms for informed-consent discussions.
Floor two of the building is used for office space, while the third floor is used to carry out clinical trials by the Stanford Cancer Institute.
Construction on the Jill and John Freidenrich Center building was started in July 2011. It was completed and opened in October 2012.
The Jill and John Freidenrich translational research centre was designed by San Francisco-based architectural firm WRNS Studio. The landscape was designed by Interstice Architects.
The general contract for the construction of the research centre was awarded to Devcon Construction. Universal Structural Engineers was awarded with a contract to provide structural engineering support for the building.
Jill and John Freidenrich donated $25m to realize the project and support cancer research at Stanford.
The research infrastructure in the building received major funding support from the National Institutes of Health through its Spectrum Clinical and Translational Science Award, and from the National Cancer Institute.
The building was constructed to achieve LEED Silver rating. It was constructed in compliance with California Green Building Standards Code. The building is 31.5% more energy efficient with use of efficient integrated building systems and other conservation measures that can reduce carbon emissions and save energy costs.
Reflective paving and roofing materials were used in order to reduce the heat-island effects associated with the building materials.
The building features a landscape that is developed to create play areas for children and meeting places for faculty, staff and visitors.
The construction of the Louisiana Cancer Research Centre was initiated in April 2009 and completed by 2012. The research facility is located at Tulane Avenue in the New Orleans Medical Research District, USA. The facility was sponsored by the Louisiana Cancer Research Consortium (LCRC) which consists of Tulane University, the Louisiana State University Health Sciences Center, Xavier University, and Ochsner Health System.
The centre includes core research facilities in the fields of immunology, genomics, imaging, proteomics and adult stem cell core. It was constructed with an investment of $102m.
The faculty at the research centre engages in the discovery and development of innovative cancer therapies that can lead to innovative clinical treatment programs.
Tulane University was the first to move into the new facility in May 2013. It occupied half of the seventh floor and the complete eighth floor in the building. The Tulane University cancer research team, consisting of over 80 staff, has moved into the building.
The facility will also be occupied by Louisiana State University Health Sciences Center and Xavier University researchers to carry out cancer research activity.
The research facility has a total floor space of 175,000ft2 spread across the 10-storey building. Six floors are designed to provide administration and research activities, while two floors are unfinished and will be used in future.
A big conference room is located at the first floor of the building. The conference room is facilitated with sophisticated communication equipment, and can accommodate up to 500 people. The spacious lobby of the building is used for receptions.
The building also has about 25,000ft2 of space allocated for offices of LCRC staff and investigators, and other public usage.
The centre is designed to provide standard and modern research facilities that can help investigators to communicate and collaborate more frequently.
The facility brought all the LCRC research faculty and lab resources under one roof. It is facilitated with open-format labs and state-of-the-art research equipment.
The building has over 32,000ft2 of laboratory space spread across three floors. The laboratory facilities include procedure rooms, linear lab bays, freezers and a centralized wash area. They also include access to glassware and sterilization facilities, darkrooms and an environmental room.
Louisiana Cancer Research Centre broke ground for construction in April 2009. The building was constructed using concrete from the ground floor to the fifth floor, and using structural steel from the fifth to tenth floor. The construction crews used two sets of concrete columns measuring 24in x 30in up to fifth floor, and used transfer beams to support the structural steel from the fifth to tenth floor.
The ten-storey research building was initially planned to be constructed in October 2005, but the construction was postponed due to Hurricane Katrina.
The new research facility building was designed by RMJM in association with Lyons & Hudson Architects.
The general construction contract for the project was awarded to Brice Building Company. Miller Masonry was awarded the masonry contract. The Concrete Products Group was awarded a contract to provide its Spec-Finish concrete masonry wall units inside the building.
The Louisiana State Legislature created funds for the construction of the cancer research centre by increasing the sales tax on tobacco. The Louisiana State Legislature also contributed $38m in cash and $64m in House Bill 2 (HB2) for building the facility.
Packaging Coordinators, Inc. (PCI), formerly AndersonBrecon, is further investing in its Rockford, IL facilities, adding equipment capacity, facilities infrastructure, and employees. PCI has hired approximately 160 associates since January of 2012, including hourly, skilled labor, as well as management.
The company is also expanding its machine capacity, warehousing, and facilities infrastructure, including multiple blister packaging and bottling lines for prescription and OTC pharmaceuticals. PCI is investing to support commercial biotech medicines and clinical medicines and has expanded on-site refrigerated cold chain storage capacity at 2° to 8° Celsius, -20° Celsius, and -80° Celsius.
PCI operates nine facilities in Rockford totaling more than one million sq. ft. and employing more than 1,300 associates. PCI is owned by affiliates of investor Frazier Healthcare.
EMD Millipore announced that it has opened a new R&D center for formulation in Darmstadt, Germany. The facility, which includes state-of-the-art formulation, analytical and synthetic laboratories as well as a customer training center, will focus on bioavailability enhancement and oral dosage formulations.
With EMD Millipore’s expertise in developing oral dosage formulations and drug delivery systems, the center will focus on addressing bioavailability and formulation challenges by using the company’s portfolio of innovative technologies and products. It will provide hands-on support to assist customers in their drug development.
EMD Millipore’s core areas are inorganic carriers, solid dispersion formulation techniques and excipients for controlled release, with technologies in granulation, tableting, film coating, direct compression and freeze drying.
The South Korean government will spend a combined 10 trillion won ($8.9 billion) on the project to develop 20 new drugs over the next five years in collaboration with private local drug makers, the health ministry said.
The government will also form a fund of 500 billion won to help the local pharmaceutical companies expand their presence in the global drug market by acquiring promising overseas drug makers during the same period, the ministry said.
The new drug development project aims to export 11 trillion won in drugs by 2017 and become one of the global top 10 pharmaceutical powerhouses, it said.
The government-led five-year project is the first stage of the plan of "Pharma 2020 Vision" released by the government last year, which is aimed at helping the country grow into one of the global top seven drug powerhouses by 2020.
To that end, the government plans to provide tax breaks to the local drug makers that invest in research and development for new drugs.
In particular, the joint drug-development project between a local company and overseas renowned laboratory will get more subsidies from the government than the private company's own project, the ministry said.
Penn Pharma is to invest in additional specific tablet manufacturing and coating capacity to meet customer demand. The latest £3m spend is in addition to the £14m recently invested in a solid dose contained manufacturing facility to handle potent active pharmaceutical ingredients.
‘We are making this additional significant investment to meet our growing customer demands. It is fuelled by our demonstrated ability to provide pragmatic and timely solutions for their needs,’ said Penn Pharma Chief Executive Officer, Richard Yarwood. ‘At a time when many businesses are struggling we are continuing to grow the Penn business and our recent investments give us the platform to provide even better services to our customers.’
The new investment follows the recent completion of Penn Pharma’s new 15,000ft2 site for the clinical and commercial manufacture of tablets and capsules. The new industry-leading facility will deliver both the clinical and commercial contained manufacturing needs of its clients.
Roche says increased staffing at its Swiss packaging hub has led to a CHF 100m ($106m) investment in a new training centre.
CHF 86m will be spent on constructing the centre at Roche’s current packaging, quality testing and manufacturing site in Kaiseraugst, Switzerland, and approximately CHF 23m more will be invested in infrastructure and site preparation.
“The number of employees in Kaiseraugst increased by 30 percent over the past five years,” said Roche spokesperson Štěpán Kráčala. “As a result the training needs have risen accordingly and we are now responding to this need.”
The site, which the Pharma Giant describes as an important hub in Roche’s global production and logistics network, currently employs 1,600 staff members. It also houses a centre of expertise for sterile production and a packaging facility that supplies around 130 markets each year.
Kráčala added, “We consider internal training of utmost importance for the professional development of our staff. This new facility in Kaiseraugst will be used for internal staff training purposes. It will also feature high-class labs which will be used for the training of our apprentices.”
Construction will commence in September with completion anticipated by October 2014.
Switzerland is home to a number of Big Pharma who have shown commitment to manufacturing in the landlocked European country of late, even as facilities scale down elsewhere.
In May, Novartis said it was to downsize its Lincoln OTC plant in Nebraska, US with a job reduction of 300 with its Swiss plant in Nyon – once earmarked for closure – picking up on lost product lines and manufacturing volumes.
Services firms like Lonza are also increasing capacity in the country. Earlier this year, the firm announced plans to invest CHF 14m into its high-value manufacturing plant in Visp, doubling its antibody-drug conjugate (ADC) capacity, though issues with competition and the strength of the Swiss Franc have led the firm to cut 400 jobs at the site.
This latest investment for Roche is further evidence of commitment to the country where it employs over 11,000 people.
“Roche is strongly committed to Switzerland where our global headquarters is located.” Furthermore, Kráčala continued, “approximately one fourth of our global R&D expenditure of over CHF 8 billion is invested in Switzerland.”
On 13 June, AAF inaugurated the new cleanroom facility for HEPA filter manufacturing at its main European production location in Emmen, the Netherlands. In the presence of the Management Team of AAF Air Filter Europe, delegates of the Municipality of Emmen and the invited regional press, the opening ceremony was performed by AAF’s COO Johan Langius. The official opening of the cleanroom facility marks a new milestone in AAF’s pursuit of continuously improving manufacturing productivity, product quality and therewith maximizing customer satisfaction.
It is commonly understood that the quality of the HEPA filter directly affects process performance and output quality of critical cleanroom environments, such as those found in the pharmaceutical and microelectronic industries. Even the smallest contamination here can make the difference between success or failure, especially when taking into account latest developments in nanotechnology. Not only does this mean that the particulate collection performance of the HEPA filter needs to comply with functional specifications, also contamination resulting from the HEPA filter itself is to be eliminated. This context requires manufacturing of HEPA filters under clean conditions for aligning with the strictest customer expectations. AAF has acknowledged this importance and has built a fully new cleanroom for its European HEPA manufacturing facility.
The new cleanroom is constructed as a separate area inside the largest European manufacturing facility of AAF, which is located in Emmen, the Netherlands. The total floor area covers 900 square meters and consists of four core process steps: media pleating, filter assembly, testing and packaging. For pleating the media, assembly into HEPA filters and filter testing according to the EN1822:2009 standard, an ISO 7 controlled environment has been designed. Packaging of the HEPA filters will be done in an ISO 6 controlled environment, through which AAF wishes to minimize any contamination risk from the filter itself, once entering the cleanroom at the customer’s site. Both cleanroom areas are designed, constructed and validated following the principles as defined in the ISO 14644 standard.
The UK is investing £10 million ($15.1 million) to create a new center to drive the translation of synthetic biology research into industrial applications.
The new Innovation and Knowledge Center (IKC) called SynbiCite will be based at Imperial College London. Richard Kitney and Paul Freemont, professors at the university, will head the center, whose goal is to act as an industrial translation engine "that can integrate university and industry-based research in synthetic biology into industrial process and products."
The Engineering and Physical Sciences Research Council, the Biotechnology and Biological Sciences Research, and the Technology Strategy Board are providing funding for SynbiCite. The center will receive initial grant funding of £5 million, with the remaining £5 million to be dispersed during the next two years.
The announcement follows on a pledge by the UK government made in November to provide £10 million in funding for an IKC specifically focusing on synthetic biology, as part of the government's push into the field. A year ago, a report advised the UK government to support funding for synthetic biology, and the UK Minister for Universities and Science David Willetts has identified synthetic biology as one of the Eight Great Technologies that the country needs to prioritize.
In announcing the funding at the Biobricks Foundation's Sixth International Meeting on Synthetic Biology conference, Willetts said, "Synthetic biology has huge potential for our economy and society in so many areas, from life sciences to agriculture. But to realize this potential we need to ensure researchers and business work together.
"This new Innovation and Knowledge Center will help advance scientific knowledge and turn cutting edge research into commercial success," he said.
The center, which will serve as a national resource, is supported by 17 academic partners, including Bangor University; University of Birmingham; University of Bristol; University of Cambridge; Cardiff University; and University of Edinburgh.
Other academic partners are University of Exeter; University of Glasgow; Imperial College; King's College London; Newcastle University, University of Oxford; and Queen's University, Belfast.
It also includes University of Sheffield; Swansea University; University College London; and University of Warwick.
More than a dozen industry partners also support SynbiCite: Agilent Technologies UK; GlaxoSmithKline R&D; Hockley International; Lisk and Jones Consultants; Microsoft Research; New Food Innovation; and Oil Plus.
Other industry partners are Oxitec; Pulse Medical; Royal College of Art; Shell Global Solutions UK; Suterra; Syngenta; and Visbion.
Molecular Profiles has received the regulatory thumbs up on a second manufacturing facility and says it can offer its clients a breadth of services uncommon for CMOs.
Built over the last year, the £9m ($13.5m) clinical manufacturing plant in Nottingham, UK - which adds six GMP suites, laboratories and a clinical packing area in order to support Phase I and Phase II clinical trial projects – opened its doors recently after receiving approval from the Medicines and Healthcare products Regulatory Agency (MHRA).
The new facility will expand upon the contract manufacturing organization’s (CMO) capabilities in analytical services, said CEO Nikin Patel, allowing the firm to support client projects all the way through to clinical trial supply.
“With 15-6 years of experience in high end pharmaceutical analysis,” he said, “Molecular Profiles has a breadth of offerings not commonly found in CMOs.” As an example, Patel said the firm would be able to support a client itself if there were issues in the development stage.
The 30,000sq ft facility will handle mostly solid dosage form manufacture for human clinical trials and can deal with highly potent compounds up to OEB 4 level with manufacturing batch scales of up to 30kg.
Molecular Profiles Vice President, Steve Kemp, also spoke regarding the ongoing strategic alliance with Onyx Scientific.
“We have a very good partnership with Onyx, who do early stage synthesis of and manufacture of APIs,” he said. Onyx’ parent body – Indian company IPCA – manufacture large scale volumes of APIs and solid dose and therefore, Molecular profiles fits right between making the formulation for phase I and II trials.
As for future partnerships, Patel said the CMO would be reluctant to duplicate the early phase synthesis and solid state capability provided in the Onyx/IPCA alliance but instead hoped to complement its client services by adding packaging capabilities through another collaboration.
“We are looking to make a deal soon and are currently in talks with several potential packaging partners.”
WIL Research has acquired Ricerca Biosciences’ pharmaceutical services business in Lyon, France. The 18,000-sq.-m. facility expands WIL Research’s service offerings in Europe and adds to its nonclinical safety assessment capability, as well as expands its portfolio of specialty services. The site, renamed WIL Research Europe - Lyon, will retain its approximately 280 employees. Stéphane Bulle, managing director of the facility, will continue to lead the site with his current senior leadership team.
“As we listened to our clients and analyzed emerging trends in the pharmaceutical marketplace, it became clear that expansion of our biologic capabilities in Europe was the right move for us,” said David Spaight, WIL Research’s chairman and chief executive officer. “The Lyon operation leverages our existing capabilities in the U.S. and the Netherlands and creates a powerful new platform to deliver exceptional value to our clients. This definitive acquisition will double our capacity in Europe, strengthen our offerings to clients and enable WIL Research to accelerate the healthy growth rate we have achieved over the past three years in a challenging market environment.”
Dr. Michael Placke, president, Ricerca Biosciences, said, “This divestiture will fund significant capital investment into our Concord, OH business allowing us to expand and re-invigorate our integrated drug development services in chemical development, drug substance production, and drug safety and metabolism.”
Nolato is expanding its Chinese production facility with an additional 7,000 ft2, of which around 2,600 ft2 will be a Class 8 cleanroom.
“China is the fastest growing market for pharmaceuticals and medical devices, which means that more and more of our customers are discussing expanded production in China for the Asian market,” says Christer Wahlquist, President of the Nolato Medical business area. The expansion will accommodate around 30 injection molding machines.
“Our philosophy is to be a close, long-term and reliable partner who can offer our customers global development and production facilities. The new facility will satisfy even the most demanding requirements of our customers,” Wahlquist adds.
Nolato Medical has been active in China since 2008. Overall, Nolato Medical has around 82,000 ft2 of cleanroom capacity in a range of classes at nine facilities in Asia, Europe, and North America.
Global packaging provider SteriPack has expanded in Malaysia to offer a range of pharmaceutical packaging services in its new cGMP-compliant Grade D facility. Pharma now accounts for 50% of the Klang, Selangor, facility's business exports to more than 52 countries, the company reports. SteriPack now offers blister packaging services all over the globe.
“Companies from the pharmaceutical and healthcare sector have to comply with very strict safety rules,” explained John Ward, Managing Director, SteriPack Malaysia, in a statement. “As well as ensuring the best protection of the drugs and allowing full traceability, the contribution of the packaging to greater efficiency and cost reduction has become a major factor.”
Ward added that “the days of air freighting finished product all over the world are starting to end. The ability to be able to offer state of the art packing facilities in Asia is a major attraction for our global customers.”
The company sees growing demand for contract blister packaging among pharmaceutical client base. “We have plans to expand our pharmaceutical packaging service offerings in 2013 to allow for bulk bottle filling, powder filling and liquid filling, all within a cGMP environment,” Ward said in the statement. “This extra facility will be fully operational by January 2014.”
SteriPack also offers cleanroom-manufactured barrier foil packaging solutions to the pharmaceutical industry.
Globally, the company serves the medical device and pharmaceutical industries and has grown steadily, with manufacturing facilities located in Ireland, Poland, Malaysia, and the United States. The group’s headquarters is located in Clara, Co. Offaly, while the U.S. business, specializing in flexible medical packaging and contract manufacturing service solutions, is based in Lakeland, FL.
Teva says it will reap the benefits of changing attitudes to generic drugs in Japan as it doubles its production capacity in the country.
Spokeswoman Denise Bradley said the Japanese generic drug market is one of Teva’s growth targets, explaining that: “We will be looking at the strategic rationale for product development and deployment.”
The expansion plan – which will see Teva plough ¥20bn ($200m) into new manufacturing capacity– contrasts with the firm’s earlier efforts in the country where the “the strong brand culture of Japanese people” had previously put it off making such investments according to Bradley.
“As the socio-economic conditions in Japan continue to change [especially due to current market conditions], so does the belief that price equals quality.”
“People are looking for lower cost items that have good quality,” added Bradley. “This is where Teva can and will have an advantage.”
Teva currently has five manufacturing sites in Japan, at Takayama (Teva’s second largest facility worldwide), Kasukabe, Koka and two in Nagoya.
The expansion is in keeping with policy set out in Teva’s 2012 end-of-year report in which the company discussed its increasing presence in key markets, including Japan. As for manufacturing in the country, Teva intends to increase production to 8-9bn tablets by 2018.
To do this, Teva has been pursuing an active acquisition strategy with Japan’s third largest generic firm, Taiyo Pharmaceuticals, being purchased in 2011 for $460m . A second acquisition of Taisho Pharmaceuticals followed later that year, and – following on from a joint venture set up in 2008 – the company also bought out Kowa Company .
Since 2012, all Teva’s Japanese subsidiaries have operated under one company, Teva Seiyaku.
According to the report, the generics market is in the process of consolidation, and though competition is increasing with an increased presence of both global and local companies, “the four leading generic pharmaceutical companies now capture approximately 50% of the market”
Oliver-Tolas Healthcare Packaging will be expanding its operations on three separate continents – an expansion of the cleanroom manufacturing area in its facility in the Netherlands, the acquisition of a facility in the United States, and the launch of manufacturing in China.
The expansion of the cleanroom manufacturing area in the facility in Venray, Netherlands includes a 1,300 ft2 ISO 8 certified cleanroom and 16,000 ft2 warehouse. Oliver-Tolas currently produces lids and pouches utilizing both its Xhale and SealScience adhesive coated products at the Venray facility. The added space will be utilized for preparation of printed roll stock products and additional capacity for lid production.
The newly acquired 50,000 ft2 American facility is adjacent to Oliver-Tolas' current operation in Feasterville, Pa. "Utilization of the additional warehouse space has begun and plans are underway to construct an ISO 7 and an ISO 8 cleanroom totaling 5,000 ft2," says Jerry Bennish, President and CEO. Oliver-Tolas' Feasterville operation manufactures pouches, roll stock, lids, and zone-coated lids. The expansion will allow for improved product flow, added capacity, and additional cleanroom space. The company is planning to purchase equipment for this facility that will support increasing demand for sterile-grade packaging.
The sales office in Suzhou, China was opened in 2006 to support demand from China-based medical device and pharmaceutical manufacturing. "Now we are bringing die-cut lid manufacturing to China paired with our core adhesive technologies and robust quality system," says Jeff Murak, Vice President of Sales and Marketing. "This allows Oliver-Tolas to improve and localize service to existing customers in the region and support demand from medical device and pharmaceutical manufacturers moving into China." The 12,000 ft2 facility includes an 1,800 ft2 registered ISO 8 cleanroom.
Merck Millipore announced the opening of its new Research & Development Center for Formulation in Darmstadt, Germany. The center for Formulation combines state-of-the-art formulation, analytical and synthetic labs and a fully-equipped customer training center in a single facility. The center will accelerate growth of the company's portfolio of innovative technologies and products that overcome bioavailability and formulation challenges and will provide hands-on support to assist customers in their drug development.
"To better address the needs of our pharmaceutical customers, we are expanding our capabilities for bioavailability enhancement," said Burghard Freiberg, Senior Vice President, Pharma Chemicals Solutions. "There is a clear market need for a comprehensive set of innovative products and technologies to support bioavailability enhancement. At our new center for Formulation, we can help customers overcome formulation-related challenges, such as insufficient API performance due to poor solubility and life cycle management developments, in a more effective and efficient manner."
Expertise offered by Merck Millipore includes oral dosage formulation development and drug delivery systems. Core areas are inorganic carriers, solid dispersion formulation techniques, and development of other excipients and excipient systems. Technologies include granulation, tableting, film coating, direct compression and freeze drying. When requested by customers, formulated products can be analytically characterized in the new laboratory.
The aim of the Centre is to accelerate growth of the company's portfolio of technologies and products that overcome bioavailability and formulation challenges.
Otsuka Pharmaceutical Co., Ltd. has formed Otsuka Europe Development and Commercialization Ltd. (OEDC) to support its European pharmaceutical business. OEDC will be Otsuka's European R&D headquarters, working with Otsuka Pharmaceutical Europe Ltd. (OPEL) for the development and commercialization of its products. OEDC and OPEL are separate operations based just outside London. This business model aims to increase collaboration of the company’s global business.
"We are delighted to establish this new company in the UK," said Dean Haubrich, president and chief executive officer of OEDC. "We believe that Otsuka has a great deal to contribute to the health and well-being of people in Europe and we look forward to reinforcing our strong, positive presence."
"The opening of OEDC is a very important milestone for Otsuka in Europe," said Ole Vahlgren, president and chief executive officer of OPEL "This significant long-term investment will strengthen Otsuka Europe's continued efforts to bring Otsuka's innovative medicines to patients across Europe."
SGS has invested in its laboratory and testing network with a new food laboratory in Germany to meet testing service demand.
To meet the need for testing services SGS relocated and expanded its food laboratory to a new location in Freiburg. It is almost twice as big as the previous site, so offers more space for food and beverage analysis equipment.
This laboratory, located in South West Germany, close to France and Switzerland, offers a range of product assessment services, said SGS. The SGS laboratory in Freiburg offers testing services for food and non-alcoholic and alcoholic beverages. It also focuses on microbiological testing and chemical analysis for drinks such as wine, distilled liquors and liqueurs, juices, soft drinks and other non-alcoholic beverages.
The laboratory offers the same testing for food, like meat and meat products, fresh fruit and vegetables, cocoa and chocolate products, cakes and pastry products, diet foods, frozen food products and shelf life tests for frozen and non-frozen products.
At the site 80 employees, laboratory staff and customer service, will work in the SGS Institut Fresenius lab, which is located in the innovation centre in northern Freiburg’s BioTech Park.
The personnel are also specialized in the analysis and testing of flavors as well as for residues of veterinary medicines in meat products.
Director of Agricultural Services and Consumer Testing Services Food, Dr Christian Hummert, opened the facility on 20 June. It features facilities with bigger rooms for sensory panels that can accommodate up to nine testers, who can work simultaneously without affecting each other and a separate preparation room for sensory samples.
With rooms built according to the German Industry Standard (DIN), accredited tests can be offered.
Originally founded in 1960, the laboratory was one of the first private food labs in Germany and SGS acquired it in 2007.
AstraZeneca has announced that Cambridge, United Kingdom will be the location for the company's new UK-based global R&D center and corporate headquarters. The new £330 million ($516 million) facility in Cambridge will bring together AstraZeneca’s small-molecule and biologics R&D activity.
The purpose-built facility, which will be located in the Cambridge Biomedical Campus, is part of the company’s previously announced plan to create strategic global R&D centers in the UK, US, and Sweden. By 2016, the new site will house a workforce of approximately 2000. The site will be the new UK home for biologics research and protein engineering carried out by MedImmune, AstraZeneca’s biologics arm. MedImmune already employs approximately 500 people at Granta Park, to the southeast of Cambridge.
The new facility will also become the company’s largest center for oncology research and will also focus on cardiovascular and metabolic diseases, respiratory, inflammation, and autoimmune diseases as well as conditions of the central nervous system. Work carried out in Cambridge will include medicinal chemistry and high-throughput screening, and the facility will accommodate a number of AstraZeneca’s preclinical research capabilities. Other global functions will join the research and development teams at the new facility, and Cambridge will become AstraZeneca’s corporate headquarters.
The Cambridge Biomedical Campus site is home to research, academic, and healthcare organizations, including the University of Cambridge School of Clinical Medicine, Addenbrooke’s Hospital, the Medical Research Council (MRC) Laboratory of Molecular Biology, the Wellcome Trust–MRC Institute of Metabolic Science, and the Cancer Research UK Cambridge Institute. The AstraZeneca facility will occupy approximately 11 acres of the 70-acre campus.
“Cambridge competes on the global stage as a respected innovation hub for life sciences, and our choice of site puts us at the heart of this important ecosystem, providing valuable collaboration opportunities,” said AstraZeneca CEO Pascal Soriot, in a press statement.
The Danish pharmaceutical group Novo Nordisk has chosen Bürkert, the fluid control specialists, to equip its latest production line for the formulation of insulin vials at its site in Chartres, France.
A technical solution supported by Bürkert allows the pharmaceutical leader to simplify their processes and increase productivity. This plant is dedicated to the production and packaging of insulin products with nearly €20m invested to increase their capacity and build the latest in vial production facilities.
"Our Chartres site is divided into three activities - NNP1 unit assigned to the production of 3ml cartridges, NNP3 unit reserved for packaging products and the new unit will be NNP2, dedicated to the production of bottles," said Olivier Gilles, technical project manager of onsite vials formulation Novo Nordisk Chartres.
"The new production line will allow the site in Chartres to be a major focus for the production of insulin vials for the Novo Nordisk Group."
To build its production line, Novo Nordisk started from scratch. The former production unit has been completely redesigned in order to establish a production strategy which is more easily operable, productive and modern. For the project, the group consulted with several pharmaceutical equipment manufacturers before opting for Bürkert.
"It is the only company among the suppliers we met, to have arrived with a team of specialists for each technology sought," recalls Olivier Gilles. "They came armed with full demonstration equipment and also invited us to see their technology in use at one of their client's installations."
The result led Novo Nordisk to join forces with Bürkert to supply their on/off piston valves and ELEMENT diaphragm valve range.
"One of the main criteria for selection is that this type of valve has super bright LEDs to give status feedback, visible from afar, even in a very compact space," said Olivier Gilles. "In addition, they are equipped with on-board piloting solenoid valves and position sensors, embedded to give decentralized control. But an important point is the ease of getting started. These valves have a great feature called "teach-in" for easy, automatic control within a few seconds, for instance after changing a diaphram, instead of several minutes with other valve designs.
"These valves were also chosen for their durability," said Yves Chenard, said sales manager for the France's central region at Bürkert. "The controller heads maintain a slight positive pressure, avoiding the formation of moisture, thereby minimizing downtime."
Another criterion for selecting Bürkert was flexibility, as this project employs a different manufacturer of valves in contact with the insulin.
"We also wanted to have the same functions for the visualization and control of these valves. We then proposed to adapt their control head onto these types of valves," said Olivier Gilles.
Thus the NNP2 unit was equipped with a total of nearly 370 valves and almost 675 control heads from Bürkert. Novo Nordisk has not only sought Bürkert valves for their line formulation technologies, but also Bürkert's conductivity probes - type 8221.
"We chose these sensors for their wide measuring range, reliability and repeatability. We use them to monitor the discharge for our CIP fluids and also to control the final rinse lines from our tanks and piping after acid washing," explains Olivier Gilles.
In all, there are 44 probes and 15 controllers supplied by Bürkert for the NNP2 unit at Novo Nordisk, specified in close collaboration with Bürkert's Engineering team.
Through its partnership with Bürkert, Novo Nordisk was able to devise a process solution that improved production yield, whilst simplifying its operability and maintenance. Validation of the installation is scheduled to be completed in September 2013, and production of the first batch of vials of insulin in 2014. Due to this successful collaboration, the pharmaceutical leader is planning to partner with Bürkert for a possible NNP1 unit revamp.
"This unit is still based on the old technology. If ever we were to revamp NNP1, I have no doubt that we will try to transfer the benefits of the technologies used on the NNP2 unit," added Olivier Gilles.
Decentralized automation is a ground-breaking idea where the intelligence is mounted directly on the valve. The control head integrates features such as the pilot valves for pneumatic control, position feedback and bus communications - all on-board.
In a traditional centralized automation design, this type of information and intelligence is typically located remotely in a control cabinet. Individual runs for both electrical and pneumatic connections are then made to each valve. By contrast, decentralized automation uses a single pneumatic connection and a single bus connection into the field.
The ASI gateway is connected to a central PLC and can send the information further onto a SCADA system. As this intelligence is placed directly in the process environment, it needs to perform in high humidity, high temperature ambient conditions.
The ELEMENT range has been designed in accordance with EHEDG guidelines, featuring stainless steel and thermoplastic construction, to offer the highest level of chemical resistance. The control head type 8691 has been developed for our ELEMENT valve range - however by employing a simple adapter, designed in our Systemhaus, the control head can be installed onto every type of valve used in pharmaceutical plants today.
McIlvaine Company
Northfield, IL 60093-2743
Tel: 847-784-0012; Fax: 847-784-0061
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Web site: www.mcilvainecompany.com