PHARMACEUTICAL & BIOTECHNOLOGY
INDUSTRY UPDATE
July 2013
McIlvaine Company
TABLE OF CONTENTS
Johnson & Johnson Announces Opening of Boston Innovation Center
AMRI's Burlington Plant Given Controlled Substance Status from DEA
Thermo Fisher Scientific Creates the China Innovation Center
AstraZeneca Selects Location for New Global R&D Center and Corporate Headquarters
Ardmac Has Built a Cleanroom and Laboratory for Novartis in Liverpool
Nucelis officially commissioned its first, state-of-the-art fermentation facility. The new pilot plant was custom-designed and fabricated to enable Nucelis to run virtually any fermentation process. "This facility will allow us and our partners to very efficiently and accurately test our production processes, and gives us the unique ability to take our projects from the lab bench to a commercially-relevant scale," said Dr. Sean O'Connor, Nucelis' President and CEO. "Commissioning of this plant is a significant milestone for Nucelis and allows us to demonstrate the effectiveness of our breakthrough gene editing technology in microorganisms."
"This ribbon cutting is the christening of a new company developing exciting new non-GMO technologies in intermediate and specialty chemical processing, which we believe is going to be very important in the evolution of these industries over the next 10 years," remarked Rory Riggs, Chairman of the Board. "Nucelis is the result of a tremendous amount of work to develop this RTDS technology which allows us now to develop non-transgenic products using plant and biologic sources. As more and more products get labeled GMO, to have a technology to create non-transgenic products in an efficient way is critically important. In the last couple of years the global community has recognized RTDS as the gold standard for non-GMO technology."
Nucelis' pilot plant is capable of simultaneously running multiple fermentation processes, and it can accommodate a variety of microorganisms such as yeasts, bacteria, or algae. In addition to the fermentation plant, Nucelis has also built a solvent-capable purification suite for a range of downstream processing needs. This will allow the company to extract and recover their target products on-site for further optimization, testing, and sample-generation. Similar to the pilot plant, this facility is flexible in design, and it will accommodate the various products fermented in the pilot plant. Having this functionality at their disposal will substantially improve Nucelis' speed and ability to get their products to market. "The first product in line for pilot-scale production is our high-purity squalane, which we expect to be available to customers for testing in the next few months," said Dr. O'Connor. He added that several other products are already in the pipeline, and that they will make their way through the pilot plant in the near future.
UPM Pharmaceuticals, a Baltimore, Maryland-based drug development and contract manufacturer, announced that they will be acquiring the 500,000 square-foot commercial manufacturing facility that Pfizer Inc. (PFE) currently operates in Bristol, TN. The acquisition of the Pfizer facility will provide UPM with large scale commercial capabilities for manufacturing and packaging of solid oral dosage tablets and capsules, as well as semi-solid manufacturing of creams and ointments. The facility will also provide for comprehensive tech transfer support, pilot plant scale-up capabilities, analytical and microbial testing, as well as dedicated suites for potent compounds. As part of the purchase, UPM will continue to manufacture Pfizer's current portfolio of products within the facility for two years. The acquisition will allow UPM Pharmaceuticals to offer a full range of development, testing and manufacturing capabilities to its existing and new clients.
"We are pleased to complete the sale of our Bristol site to UPM Pharmaceuticals," John Kelly, Vice President, Strategy and Transitioning Sites, said. "UPM leaders have experience with this site, and are familiar with our colleagues and the products we manufacture there; they share our commitment to quality and have a long history of success. We look forward to an ongoing relationship with UPM. We also think this is a boost for the Bristol community, as the managing partner of SJ Strategic Investments and Chairman and CEO of UPM is Dr. John Gregory, who is a well-known member of the Bristol community and he and other members of his family will be involved in the ownership and management of this facility."
UPM's President, James E. Gregory, said, "The acquisition is a very exciting opportunity for our organization. With the new facility, UPM will now be able to offer clients a seamless transition from early stage formulation development to commercialization along with all associated comprehensive lab support. The new facility will give UPM the capability to annually produce 3.5 billion tablets and 680 million capsules; this will be a dramatic growth opportunity for our company and our clients."
The Pfizer facility was once home to King Pharmaceuticals before being acquired in late 2010. King Pharmaceuticals was founded by UPM's current Chairman and CEO John Gregory.
About UPM Pharmaceuticals®
UPM Pharmaceuticals®, Inc. history includes successful collaborative interactions with virtual to multi-billion dollar companies providing them with customized product development services and solutions. UPM focuses on drug development for dosages with oral routes of administration, in solid dosage forms such as capsules and tablets. UPM's clients enjoy service that is customized and fast with total quality management characteristic of a customer-focused business.
Pharmaceutical Product Development, LLC (PPD) is expanding its cGMP cell-based assay laboratory in Middleton, Wis., to meet the growing needs of clients seeking to validate bioassays for product release and stability testing of biological products, both as novel drugs and as biosimilars. The Middleton cell lab will now support a significantly greater volume of bioassay development, validation and testing projects and provide a broader range of product testing capabilities.
“Biotech and pharmaceutical companies are shifting their strategies to developing high-value, niche therapies utilizing biologics, a trend that is expected to generate significant growth in characterization of biologics, as well as biosimilars,” said Magdalena Mejillano, Ph.D., vice president of cGMP labs for PPD. “Expanding our capabilities to perform additional cell-based assays that establish the potency and stability of these biologics gives clients greater capacity, flexibility and efficiency in testing their products.”
PPD’s cell-based lab initially was created to address and respond to requirements for development, validation and testing under established U.S. Pharmacopeial Convention, International Conference on Harmonisation and U.S. Food and Drug Administration cGMP guidelines. The cell lab facility has been expanded to approximately 6,800 square feet, which will allow for a much broader range and increased volume of testing capabilities. The expansion will add the following capabilities: ability to handle ISO-certified cleanroom growth and qualification of cell lines; quarantined segregation of early development projects; increased bioassay capacity and segregation of projects; and BL2/3 isolation for working with viral-based products.
PPD is a leading global provider of CMC testing across all phases of drug development with services ranging from early characterization and formulation and method development through commercial release and stability testing. Services are performed in Athlone, Ireland; Wayne, Pa.; and Middleton. The company’s industry-leading facilities are equipped with state-of-the-art laboratory instrumentation to carry out a vast array of analytical methods that have been developed for small and large molecules.
Catalent Pharma Solutions has opened its new biomanufacturing Center of Excellence in Madison, WI. The new facility quadruples current biologics manufacturing capacity and allows the company to extend its offerings as well as enhance the efficiency and output of its GPEx cell line engineering technology and other mammalian cell lines. Catalent has moved its 89 employees to the 100,000-sq.-ft. Madison site, and eventually plans to employ more than 100 people at the site.
Also, Catalent has recently acquired an exclusive license to market Redwood Bioscience’s SMARTag precision protein-chemical engineering technology for the development of advanced antibody drug conjugates (ADCs). Redwood’s site-specific protein modification and linker technologies enable the generation of homogenous bioconjugates engineered to enhance potency, safety and stability. Catalent will combine its GPEx cell line expression system with SMARTag for the rapid development of stable, high yielding cell lines, and a broad range of analytical and fill-finish services.
The facility is designed for flexible cGMP production from 10L up to 1000L, and non-GMP production up to 250L, and features single-use technologies and unidirectional flow. Manufacturing is supported by integrated analytical, formulation development and viral clearance capabilities, small-scale and large-scale process development labs, and separate microbiology and Quality Control functions.
“Our new biomanufacturing Center of Excellence has been specifically designed to meet our customers’ needs through improved delivery of integrated services in the areas of biologic development and manufacturing, and we will be pleased to welcome many of them on site at the official opening,” said Barry Littlejohns, president of Catalent’s Biologics business. “The extensive application of single-use technology greatly reduces the risk of cross contamination and gives us huge flexibility and scale, while our on-site capabilities enable us to provide our customers with solutions for even the most difficult to express proteins.”
Cytovance Biologics, Inc. is expanding its microbial manufacturing capabilities with the purchase of a second 100L and a 1000L Fermenter, along with applicable processing and downstream equipment upgrades to support this larger scale. Facility expansion plans to house these new systems are currently underway.
"This increase in microbial manufacturing capacity is to meet growing customer demands for microbial fermentation services," said Darren Head, Cytovance president and chief executive officer. "This marks another milestone in our contract manufacturing strategy of providing clinical material to key clients as they move though the clinic and into commercial manufacturing."
Cytovance also recently expanded its mammalian manufacturing capabilities with the inclusion of a 5000L stainless steel bioreactor, complementing its existing manufacturing process trains that include 100L, 500L and 1,000L bioreactors, 100L wave system and 50L and 200L Sartorius subs.
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that the company will expand the Regeneron corporate headquarters and laboratories in Westchester County and create more than 400 new high-skill jobs.
The 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 New York 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, New York. 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, New York.
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.
Clemson University and the Greenwood Genetics Center plan to expand an existing genetics research center by adding 17,000 square-feet of new lab space in Greenwood, SC, Clemson said.
The planned Clemson University Center for Human Genetics will house research programs studying and developing new genetic diagnostic tools and epigenetic therapeutics.
Clemson's goal is to create a center that will serve as a core campus for recruiting R&D companies developing diagnostics and other tools aimed at a range of disorders, such as birth defects, autism, cancer, and inflammatory and other diseases.
The new center will be an expansion of the J.C. Self Research Institute at GGC and will be built on land donated by Greenwood County and the Greenwood Commissioners of Public Works. The nearly 15-acre site is adjacent to GGC, located within the Greenwood Research Park, around 60 miles from Clemson. Work on the site is expected to begin in about nine months.
The new center will be open to Clemson researchers, who will work with GGC investigators. In addition, the project will expand Clemson's current human genetics doctoral program.
Clemson said the center also will seek to develop novel diagnostics that can predict the efficacy of therapeutics and early diagnostics for chronic diseases that are prevalent in South Carolina, such as diabetes, cancer, and cardiovascular disease.
Johnson & Johnson announced the opening of the Johnson & Johnson Innovation center in Boston, the third of four regional hubs being established in the world's leading life science hotspots. A part of Johnson & Johnson Innovation, the goal of the Boston Innovation Center is to advance healthcare by catalyzing collaborations in science and technology between regional innovators and the Johnson & Johnson Family of Companies across a diverse spectrum of early-stage opportunities.
The Boston Innovation Center is home to a team of business, science and transaction experts who are focused on identifying and building novel early-stage collaborations with emerging companies, entrepreneurs and academic centers across eastern North America. This team has full and broad deal-making capabilities, with flexibility to adapt deal structures to match early-stage needs and opportunities.
"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., Johnson & Johnson 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." Representatives of Johnson & Johnson Development Corporation (JJDC), the venture capital subsidiary of Johnson & Johnson, are co-located at the Boston Innovation Center to identify and invest in external opportunities. Since its inception in 1973, JJDC has been among the top-tier healthcare venture capital companies investing in and developing new businesses that create leading technologies, products and services.
In addition to the new Johnson & Johnson Innovation center in Boston, a center in London opened in March, a center in California opened in early June, and a fourth is planned to open in Shanghai by the end of the year. Each city was selected for its robust life sciences community, which provides a rich environment for identifying investment, in-licensing and collaboration opportunities.
The Boston Innovation Center is located at One Cambridge Center, Cambridge, Massachusetts, 02142
The American Association for Laboratory Accreditation (A2LA) ISO/IEC 17025:2005 backing for the Missouri Laboratory builds on the previous accreditation for mycotoxins analysis.
ISO 17025:2005 accreditation demonstrates Romer Labs’ technical competence for food allergen analysis and the operation of a laboratory quality management system that is dynamic, flexible and focused on customers and suppliers.
Michael Prinster, CEO of Romer Labs America, said: “Romer Labs continues to expand its offerings in food safety diagnostics with a strong focus on quality and innovation.
“As a result we are building a leadership position in the Food Allergen testing market with a full suite of qualitative and quantitative test kits and now ISO-accredited laboratory services.”
Impact Analytical Inc., a Midland, Mich.-based contract analytical testing laboratory, has begun operations in a new 17,000-square-foot facility in Midland.
“This facility is truly state-of-the-art for laboratory testing and expands our capacity by more than 20 percent,” said Impact Analytical Business Manager Eric Hill. “It was designed to maximize efficiency, safety and standardization, so we are able to better serve our customer’s needs. The laboratory spaces were designed specifically to match our work process.”
The new facility provides the space and capability for 35 scientists to operate more than 80 instruments in elemental analysis, gas separation, liquid separation, microscopy, molecular characterization, and thermal and mechanical property study.
“Demand for our services has been rising every year, so we have been hiring additional staff and shortening turnaround times,” Hill said. “Our new facility enables us to continue to improve our services to our clients.”
Impact Analytical is a contract testing laboratory established within the Michigan Molecular Institute, an advanced polymer research and education organization.
The DEA has approved AMRI’s Burlington facility to work with Schedule 2 controlled substances, placing it in a competitive position to win contract manufacturing bids, the company says.
The US Drug Enforcement Agency (DEA) has rules covering the production of five classes of controlled substances. The Burlington, Massachusetts facility has registration covering 3, 3N, 4 and 5 substances, and this expansion will allows the handling of substances including a number of products defined as those with high potential for abuse, potentially leading to severe psychological or physical dependence.
The registration covers certain opiates (Schedule 2), and amphetamines (Schedule 2N) - non-narcotic but still with an abuse potential - and will complement AMRI's (Albany Molecular Research Inc) Rensselaer, NY site which is licensed to handle Schedule 1 through to 5 APIs.
Senior Director of Burlington Operations for AMRI, Christian Phillips, said license, though not tied to a specific contract for now, builds on the current controlled substance registration at the plant and “allows the site to bid on the larger body of available controlled substance work.”
“We continue to receive client inquiries and believe this approval puts AMRI Burlington in a competitive position to offer our services to this expanded segment of the controlled substances market,” he continued to add.
The expanded license allows AMRI to build on its Smartsourcing program in the area of manufacturing which, according to Phillips, offers its clients “an interconnected and cross-functional global network with supporting services and the added benefits of flexibility and adaptability.”
He said: “Too often in prior years, outsourcing decisions have been driven by lowest price and not best outcomes and this has contributed to the productivity drought of the last few years.”
Therefore, he continued to add: “This latest announcement allows AMRI Burlington to offer formulation development and parenteral filling services to more of the projects that our API production units might bid, enabling customers to take full advantage of this integrated service offering.”
The expansion brings good news to the site which, following revenue loss and costs to fix manufacturing issues raised in a 2010 warning letter from US Food and Drug Administration (FDA), was described as “a money pit” by Jeffries & Co. analyst David Windley.
However, AMRI’s CEO Thomas D’Ambra told stakeholders in February the facility is fully operational and was audited by perspective customers 13 times in 2012, and just awaits a final FDA audit.
Phillips confirmed this and told this publication of the boost the DEA license has given the plant:
“This accreditation is separate from FDA review, but clearly demonstrates our commitment to put in place the systems, safeguards and procedures necessary to serve our clients as a high quality partner.”
ATMI has opened a 1,076 sq. ft. development and testing lab in the US to let customers test its single-use production and technologies.
The new laboratory, which is located in its manufacturing facility in Bloomington, Minnesota, is modeled after the facility the firm set up in Brussels, Belgium in 2006 to try and drum up business for its range of Integrity iCellis and Xpansion bioreactors.
Like the Brussels site the Bloomington lab will also provide customers with support services, which will include a 15-strong team of scientists that will advise on bioprocess development and implementation as ATMI general manager Mario Phillips explained.
“The laboratory is fully equipped with ATMI technologies and equipment to perform cell culture, and it is staffed by experts in the field.
Phillips added: “The team at this site has extensive experience in cell culture bioprocesses development and scale-up, as well as more than 20 protein, virus and cell production processes that have been developed in ATMI's proprietary bioreactors.”
The decision to start offering testing and development services for single-use biomanufacturing techs to customers in North America fits with what ATMI told in-Pharmatechnologist.com when we visited the firm’s Belgium facility earlier in the year.
Spokesman Eric Isberg told us that, unlike their European counterparts, biomanufacturing firms in the US have been slow to adopt single-use production technologies and switch from the stainless steel technologies with which they are more familiar.
He told us that: “Europe is ahead of the US in terms of innovation and single-use."
Isberg also predicted that if Asian firms start to embrace single-use technology for drug production, manufacturers in North American would also be forced to adopted it.
Sequenom, Inc., a life sciences company providing genetic analysis solutions, announced that its wholly owned subsidiary, the Sequenom Center for Molecular Medicine (Sequenom CMM), has completed the build-out and validation of an additional laboratory location in Raleigh-Durham, NC, and is now processing patient samples commercially. This new laboratory location adds capacity and redundancy to the existing Sequenom CMM laboratory locations in California and Michigan.
With an initial capacity of 100,000 tests per year, the North Carolina facility will primarily support processing of the MaterniT21 PLUS laboratory-developed test (LDT) and will immediately increase Sequenom CMM's total MaterniT21 PLUS testing capacity to over 300,000 test samples per year. This practice-changing prenatal LDT analyzes the relative amount of chromosome 21, 18, and 13, as well as X and Y material in cell-free fetal DNA obtained from a maternal blood sample as early as 10 weeks of pregnancy.
"We are excited about the opening in North Carolina of our third US-based laboratory location. Our investment in establishing this new presence on the East coast will allow us to better meet the needs of health care providers by providing critical additional capacity and geographic back-up needed to address the rapidly growing adoption of our testing services," says William Welch, President and COO, Sequenom, Inc.
The new laboratory location received its Clinical Laboratory Improvement Amendments (CLIA) registration for operation earlier this year.
The MaterniT21 PLUS LDT is intended for use in pregnant women at increased risk for fetal aneuploidy. Estimates suggest there are about 750,000 pregnancies at high risk for fetal aneuploidy each year in the U.S. The MaterniT21 PLUS test is available exclusively through the Sequenom CMM as a testing service provided to physicians.
The Washington University School of Medicine plans to break ground this summer on a new 138,000 square-foot building to house genomics, genetics, and regenerative biology labs, as well as labs for its Departments of Medicine and Developmental Biology.
The six-story, $75 million building will be home to the Center for Genome Sciences and Systems Biology, and will consolidate most of the department of genetics faculty in one location, Washington University in St. Louis.
The new facility, which is expected to be completed in the summer of 2015, will be located near other research facilities on the site of what is currently a parking lot.
Building a new, energy-efficient facility to replace 46,000 square-feet of research space that is currently in another building, will save money over the long haul, the university said, because it will be cheaper than operating and upgrading antiquated labs and retrofitting office spaces. The new facility also will host "highly flexible" lab space that can accommodate new research teams and interdisciplinary projects.
"The open lab design of the new research building provides a wonderful opportunity for us to jointly recruit faculty with preclinical departments," Professor Victoria Fraser, head of the Department of Medicine, said in a statement.
"We can embed faculty from medicine with investigators from genetics, developmental biology, genome sciences and systems biology, and we expect that significant scientific synergies will evolve by encouraging research interactions between clinical and preclinical departments," Fraser said.
WUSTL said that the recently constructed BJC Institute of Health building, which has 240,000 square feet of research space, is already occupied.
Saladax Biomedical has been certified as a registered CLIA laboratory from the Office of Clinical Standards and Quality, a division of CMS. The certification allows the company to start clinical laboratory operations for the MyCare portfolio of products at its Bethlehem, Pa., facilities. The company's Saladax Biomedical Laboratories division will initially offer testing services for chemotherapy exposure optimization assays, such as My5-FU, MyPaclitaxel, and MyDocetaxel in the US, it said.
Thermo Fisher Scientific Inc. has opened a new product contamination evaluation facility in Sugar Land, Texas, to help food and pharmaceutical manufacturers address safety and quality issues.
Called Product Assurance Services and Solutions (PASS), Thermo Fisher offers rapid response for companies requiring thorough offsite packaged product evaluation due to foreign object contamination concerns. Additionally, the PASS facility can review products for processing anomalies (such as clumps), as well as missing components (empty pharmaceutical blisters, partially-filled candy trays, etc.).
"We are here to help customers get answers quickly and accurately so that product recalls are avoided," explains Carl Palmer, PASS manager, North America. "Since we manufacture and sell state-of-the art metal detectors and X-ray equipment globally, we have access to the very latest technology and know the ideal operating parameters. If needed, we also can quickly obtain additional equipment to facilitate rapid evaluation of multiple truckload quantities."
Typically, food and pharmaceutical manufacturers don't have the time, capability, or access to multiple idle detection machines and/or the floor space required to do a thorough review so they look to an off-site solutions provider. The objective is to quickly evaluate, identify contaminants, remove the problematic packages, and return the "good" product back to the manufacturer so that it can continue on its distribution journey. As a leader in product contamination technology, Thermo Fisher offers food and pharmaceutical manufacturers multiple advantages over small local and regional entities offering similar services.
Companies send product to the PASS facility for three main reasons. The first is that they suspect their inspection system missed a contaminant due to calibration or other issues. Secondly, they have reason to believe a contaminant may be present, but they don’t have the means to detect for it. A perfect example is trying to find a piece of glass when all you have is a metal detector. The third reason is they suspect a contaminant may have entered the package after detection took place. For example, they notice that a bolt is missing from the production line downstream from the metal detector and prior to final packaging.
PASS facility inspection capabilities can handle a broad range of metal, glass, plastic, or paper packaging types. This includes both rigid and flexible structures such as steel cans, metalized film, plastic bottles, blister packs, folding cartons, multilayer materials, and more.
The new suburban Houston facility is the company's second U.S. PASS location, following the opening of a facility in Barrington, Ill. in 2010. The new geographic location will help reduce product transport costs for manufacturers located in the South and Southeastern United States. Additionally, the company has a PASS facility located in Rugby, Warwickshire which serves the United Kingdom and Europe.
Catalent says customers are applying controlled release technology to transform drugs into better treatments across all stages of development as it expands its Kentucky manufacturing site.
Construction began on expanding Catalent’s controlled release drug manufacturing facility in Winchester, Kentucky in a $35m (€26m) project which will add 80,000 sq. ft. of manufacturing space and 90 new jobs to the site.
Catalent spokesperson Chris Halling noted the expansion is in response to client demand for higher quality, complex controlled release formulations across the drug development process, from pilot to commercial scale.
“Controlled release technology applications are being applied broadly to transform drugs into better treatments,” he said, “through improved therapeutic profiles, enhanced efficacy and safety, and increased patient compliance.”
He added: “It has also sparked resurgence in research and development for further product applications of innovator modified release formulations such as Zydis ODT (orally disintegrating tablet) fast-dissolve tablets.”
Zydis is a proprietary formulation from Catalent which requires no water to disperses instantly in the mouth, used, for example, as a form of drug delivery for Eli Lilly’s bipolar drug Zyprexa .
Halling also said the Winchester expansion followed a number of other investments from Catalent in order to meet growing customer demand, including last year’s expansion of its Schorndorf, Germany facility and a major capacity development at its Somerset, New Jersey headquarters.
As for the company’s strategy, Halling said it was focusing on growing core areas of the business, specifically: “Development solutions and advanced delivery technologies, clinical trial supplies, advanced blow/fill/seal aseptic delivery technology , as well as offering integrated solutions for the development and supply of injectable biologics and complex pharmaceutical products.”
The contract manufacturer has been expanding its biologics offerings of late, with the license of ADC (antibody-drug conjugate) technology and the opening of a new biomanufacturing plant in Wisconsin .
However, this direction was confirmed by Halling to be at the cost to other business areas including Catalent’s US commercial packaging operations which was sold last year to Frazier Healthcare .
Commenting at the time, president of Catalent’s Medication Delivery Solutions segment Barry Littlejohns said the sale was “another step in advancing our strategy to focus on our leading drug development and delivery businesses in core segments.”
Sequenom said that it has opened a new CLIA lab in Raleigh-Durham, NC, and has begun processing patient samples at the facility.
The San Diego-based molecular diagnostics and genetic analysis tools firm said that the new lab will have an initial capacity of 100,000 tests per year and will primarily support processing of its MaterniT21 Plus lab-developed test. It added that the expansion will enable its wholly owned subsidiary, the Sequenom Center for Molecular Medicine, to immediately increase its MaterniT21 Plust testing capacity to more than 300,000 samples per year.
Last week at the Jefferies Global Healthcare Conference in New York, Sequenom CEO Harry Hixson said that the North Carolina lab had recently underwent CAP inspection and was expected to be operational in 30 to 45 days.
The company has set an internal run rate of 150,000 tests for 2013, and by the end of the first quarter it had already reached an annualized run rate of 140,000 tests.
"Our investment in establishing this new presence on the East Coast will allow us to better meet the needs of healthcare providers by providing critical additional capacity and geographic back-up needed to address the rapidly growing adoption of our testing services," Sequenom President and COO William Welch said in a statement.
Sequenom noted that the new lab received its CLIA registration for operation last month.
Blackrock Microsystems has opened its 60,000 ft2 headquarters in the University of Utah's Research Park in Salt Lake City. The new site features a built-in cleanroom facility to service the fabrication needs of the company's clean-tech implantable systems.
The cleanroom will also facilitate the product development and manufacturing needs of the residents of Blackrock's incubator space, which will comprise approximately half of the facility’s physical space. Blackrock will explore opportunities for collaborative value creation with the companies in its incubator and other potential strategic partners.
Blackrock Microsystems provides enabling tools for the neuroscience, neural engineering, and neuroprosthetics research and clinical communities. Recently, the company's technology provided the neural interface that enabled the creation of the first artificial arm with sensory feedback through the DARPA Revolutionizing Prosthetics Program, RP 2009. The project resulted from a partnership with the Johns Hopkins Applied Physics Laboratory and the University of Pittsburgh.
Thermo Fisher Scientific this week announced the creation of the China Innovation Center in Shanghai, expanding the company's R&D and training capabilities to support high growth markets in Asia-Pacific.
Thermo Fisher said it has invested $9.5 million into the new center to support its growing R&D organization. The center is anticipated to hire 200 to 300 engineers in the next two to three years, and the center is to include a technology training center that will provide training to 2,500 customers annually in the use of chromatography and mass spectrometry systems, as well as other technologies.
The center also includes more than 30,000 square feet of biology, design-verification-test, and application labs, and 10,000 square feet of training space. Thermo Fisher said that its revenues in China grew by more than 20 percent in 2012. In total, it has 2,300 employees in the country.
Covance Inc., a leading provider of drug development services, announced completion of the expansion of its central laboratory facility in Singapore to enhance the company's current service offerings and position it to meet current and future growth of drug development in the Asia Pacific region. The expansion is the latest in Covance's continued investment in Singapore, and an important element of the strategic investment plans for the Asia Pacific region that also includes recent growth in operations in China and Japan.
The laboratory, at approximately 2,700 square meters (29,000 square feet), is the largest of its kind in Singapore, providing clinical testing services to clients in Asia, including South Korea, Taiwan, Hong Kong, the Philippines, Australia, and India. This laboratory expansion doubles the size of Covance's genomics footprint in Singapore, while also adding capabilities in anatomic pathology and nutritional chemistry. Like Covance's central laboratories in Indianapolis, Indiana; Geneva, Switzerland; Shanghai, China; and Tokyo, Japan, the Singapore facility continues to provide a full-service offering that includes chemistry, immunology, hematology, flow cytometry, genomics, anatomic pathology, and microbiology.
"For the last 13 years Covance has provided central laboratory testing services in Singapore, where we have seen increasing demand for efficient, high-quality clinical trial data and support," said Jon Koch, Corporate Vice President and Global General Manager, Central Laboratory Services, Covance. "This expansion will help us better serve both our local and multinational customers' R&D needs in key therapeutic areas like oncology and metabolic diseases while reflecting Covance's continued commitment to the Asia Pacific region."
"Covance's expansion reaffirms Singapore's proposition as a strategic location for CROs to base their regional operations as they expand to tap on the fast growing opportunities in Asia," said Kevin Lai, Director, Biomedical Sciences Group, from the Economic Development Board of Singapore. "Its investment is a strong vote of confidence in our efforts in developing Singapore as a leading biomedical sciences hub with strong capabilities to support translational and clinical research."
"In addition to providing our clients in Asia the broadest access to clinical trial testing services, Covance's facilities in the Asia Pacific region also offer preclinical services together with a comprehensive range of clinical development services to support both regional and global trials. Being the only CRO with the expertise to develop a molecule from discovery through all preclinical and clinical milestones makes Covance a preferred provider for companies wishing to develop drug candidates in Asia and around the globe," added Deborah Keller, Executive Vice President and Group President, R&D Laboratories, Covance.
DSM Pharmaceutical Products will open its new cGMP custom biopharmaceutical manufacturing facility in Brisbane, Australia in June 2013. The facility was built in cooperation with the Queensland and Commonwealth Governments of Australia.
The site will provide cGMP mammalian cell-culture contract manufacturing services from process development through to commercial manufacturing. DSM Biologics operates with all standard technologies and has a portfolio of proprietary technologies for the optimization of biopharmaceutical manufacturing. The facility has an annual output capability of 500kg and has expansion space available for further capacity utilization.
Karen King, president of DSM Biologics, the biopharmaceutical manufacturing business of DSM Pharmaceutical Products, said, “We are thrilled to announce the June opening our of new cGMP facility in Brisbane. This operation combines DSM's 25 years of experience and high quality track record in mammalian cell culture manufacturing with a state-of-the-art commercial and development facility. Our partnership with the Government of Queensland and the Commonwealth of Australia has led to this important addition to the Australian biotechnology industry and will be a key contributor to the entire Asia-Pacific region."
Recipharm’s solid dose facility in Fontaine, France has been approved for supply of manufactured products to the Japanese pharmaceuticals market following a recent inspection by the Japanese drug agency, PMDA. The Fontaine site, acquired in 2009 from Solvay Pharma (now Abbott), is also approved to supply to the U.S. and has a distribution center for delivery to pharmacy level in France.
Stéphane Guisado, general manager of the Fontaine site, said, “We are very pleased to have secured this approval. Supplying products to Japan involves carrying out a substantial number of additional activities and meeting stringent requirements for enhanced quality control and we have met these challenges head on. We were also able to draw upon experience from other Recipharm sites, which are already supplying this key market. As a result of this approval, we are now in a good position to further support other customers with their plans to penetrate and expand sales in specific pharmaceutical markets within Japan.”
Bischof + Klein, a packaging and film specialist based in Lengerich, Germany, has added additional production cells to its Class 5 cleanroom. The company offers flexible packaging solutions for medical products and pharmaceuticals in this purity class.
The cleanroom production facility has been extended to cover over 8,800 ft². The production cells, including a module with a high-performance automatic punching machine, are connected to an intermediate warehouse. This machine produces single- and two-ply Tyvek cover sheets for the disposable syringe industry. The adjacent packaging line enables the bundle's initial protective packaging to be applied fully automatically. The closed-loop cleanroom chain also includes lines for extruding polyethylene films and for converting sacks and bags as well as a laboratory. The personnel air lock has also been extended.
In an opening ceremony performed by Chief Operating Officer Johan Langius, AAF has inaugurated the new cleanroom facility for HEPA filter manufacturing at its main European production location in Emmen, the Netherlands. The official opening on 13 June of the cleanroom facility marked a new milestone in AAF’s pursuit of continuously improving manufacturing productivity, product quality and maximizing customer satisfaction.
The new cleanroom is constructed as a separate area inside the Emmen facility, AAF’s largest European manufacturing plant. The total floor area covers 900m2 (9,684 sq. ft.) 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 is done in an ISO 6 controlled environment to minimize any contamination risk from the filter itself, once it enters the cleanroom at the customer’s site. Both cleanroom areas are designed, constructed and validated following ISO 14644 principles.
‘AAF has significantly upgraded its manufacturing facilities over the last few years with the aim of better meeting customer expectations and simultaneously enhancing operational excellence,’ said Langius. ‘The new cleanroom facility exemplifies the positive development of our organization and strengthens AAF’s leading position in the high-end air filtration market.’
Prior to the official opening of the cleanroom, which is fully operational, several customers from the pharmaceutical industry audited the new cleanroom area for compliance with their own internal quality procedures. The AAF cleanroom passed these audits with very positive results.
To coincide with the official opening of the cleanroom, AAF has begun the manufacture of HEPA filters featuring NELIOR Filtration Technology in Europe. The award-winning technology is a patented membrane filtration media, developed and exclusively offered by AAF. HEPA filters with NELIOR Filtration Technology are said to provide significant benefits over traditional HEPA filters, such as greater robustness and lower energy consumption. The filters are applied in critical cleanroom applications, such as in the pharmaceutical, food and beverage, and microelectronic industries.
Previously, HEPA filters with NELIOR Filtration Technology destined for the European region were produced in AAF’s manufacturing facility in Asia. With the transfer of the filter assembly from Asia to the new cleanroom facility in Emmen, flexibility and availability will now be significantly improved.
Besides the plant in the Netherlands, AAF has also implemented upgrades to its other European manufacturing locations in France, the UK and Slovakia. All facilities follow the Six Sigma improvement principles and are ISO 9001, ISO 14001 and OHSAS 18001 certified.
AstraZeneca announced that its new UK-based global research and development center and corporate headquarters will be located at the Cambridge Biomedical Campus on the southern outskirts of the city. By 2016, the new site will house a workforce of approximately 2,000.
As announced on 18 March 2013, the investment in a £330 million facility in Cambridge is part of the company’s move to create strategic global R&D centers in the UK, US, and Sweden to improve pipeline productivity.
The purpose-built site in Cambridge will bring together AstraZeneca’s small molecule and biologics research and development activity, opening up opportunities to exploit the promise of small and large molecule combinations. The Cambridge Biomedical Campus will be the new UK home for biologics research and protein engineering carried out by MedImmune, AstraZeneca’s biologics arm. MedImmune already employs around 500 people at Granta Park, to the south east of the city.
The new site will also become the company’s largest center for oncology research as well as hosting scientists focused on cardiovascular and metabolic diseases, respiratory, inflammation and autoimmune diseases, and 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 pre-clinical research capabilities. Other global functions will join the research and development teams at the new facility and Cambridge will become AstraZeneca’s corporate headquarters.
Pascal Soriot, Chief Executive Officer of AstraZeneca said: “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. Moving to the Cambridge Biomedical Campus means our people will be able to rub shoulders with some of the world’s best scientists and clinicians carrying out some of the world’s leading research—that’s a really exciting prospect. We hope that our move will contribute to the growing success of Cambridge.
Professor Sir Leszek Borysiewicz FRS, Vice-Chancellor of the University of Cambridge, said: “I am delighted with AstraZeneca’s choice. It is a measure of the world-class environment that Cambridge offers to knowledge-based industries and it reflects AstraZeneca’s commitment to making new discoveries. Over 1,500 companies in the Cambridge cluster of high-tech industries have found that proximity–to the University, to our NHS partners, and to each other–enables productive relationships and stimulates competition. As a global player, AstraZeneca will add tremendously to that environment and we look forward to the creative collaborations that will surely follow.”
SCM Pharma's $10 million pharmaceutical contract manufacturing facility has been given the go ahead for commercial production following a successful inspection from the Medicines and Healthcare products Regulatory Agency (MHRA). With commercial scale cleanrooms, which include a potent suite, dedicated commercial suite, and Grade C/D rooms, the new site massively increases SCM Pharma's current and future capability and capacity.
The UK-based contract development and manufacturing organization (CDMO) will use its 26,000 ft2 site for the supply of licensed commercial products and to complement its nearby clinical manufacturing facility for projects requiring scaled-up clinical trial supply quantities.
Based in Northeast England, the contract drug manufacturing site is able to handle highly potent, flammable, and toxic products along with controlled drugs. It houses technology for aseptic processing and terminal sterilization capabilities and is equipped for ampoule filling, vial filling, and syringe filling.
Independently-owned, SCM Pharma specializes in the sterile manufacturing of drug products that require high containment. Most of the CDMO's contract filling projects assist companies requiring products for clinical trials or licensed drugs needed in niche commercial markets such as orphan drugs.
The site includes a range of packaging and labeling areas, temperature controlled warehousing, raw materials and engineering preparation, visual inspection, and leak testing. A dedicated, enclosed cleanroom suite has also been built that houses an automated syringe filling and packaging line with full track and trace capability.
The company's headquarters is dedicated to development and clinical trial supply projects that involve investigational medicinal products and also supports ADME studies requiring the supply of C-14 radiolabeled compounds.
Boehringer Ingelheim will build a biomanufacturing facility in Shanghai in a strategic alliance designed to cater for Pharmas nervous about setting up plants in China.
The Germany-headquartered pharma company plans to invest €35m ($46m) and will partner Zhangjiang Biotech & Pharmaceutical Base Development Company in building a cGMP plant to offer a range of development and clinical services to both Chinese and multi-national customers
“China is in its infancy stage with regards to the production of affordable high-quality structure-complex biological drugs such as antibodies,” spokesman Steven Zhang told Outsourcing-Pharma.com. “A great deal of processing elements await significant improvements, which might make foreign companies think twice before setting up facilities in China.”
He added that the site in Pudong, Shanghai - which is scheduled to commence operations in 2016 and will create 65 new jobs. - will be the first facility utilizing mammalian cell culture technology established by a foreign biopharma manufacturer.
According to the R&D Based Pharmaceutical Association Committee - a division of China Association of Enterprises with Foreign Investment - the current Chinese biopharmaceutical market is worth 18bn RMB ($2.9bn) and will continue to grow.
Local CMO Wuxi capitalized on such demand when it opened what it said was China’s first EU and US GMP biologics facility last October, partnering with MedImmune – AstraZeneca’s biologics unit – in a joint venture to develop autoimmune disorder treatment MEDI5117.
However, unlike the Wuxi venture, this deal - described as “a win-win cooperative venture” by Zhang - will bring Boehringer’s biological services and capital investment together with “powerful government support” from Zhangjiang. Furthermore, both companies spoke of the benefits the deal could have to the Chinese biopharma industry as a whole.
Zhang said: “Through the co-operation, Boehringer Ingelheim is set to introduce the most advanced biopharmaceuticals technology and top-notch talents into China to help elevate the domestic manufacturing standard, train high-caliber professionals and provide better quality medicines for Chinese patients.”
Zhangjiang's General Manager, Lanzhong Wang, said a CMO manufacturing framework would be implemented at the plant on a trial basis, adding: “This will provide an effective platform for middle and small-sized companies to industrialize their innovations. Thus, it will greatly prompt the development of China’s biopharmaceuticals manufacturing industry.”
Rexam is upping its delivery device capacity at a plant in Normandy and says its new nasal spray pump is safer and more consistent.
The company who manufactures drug delivery devices for the pharmaceutical and biotechnology industries will invest a total of €20m ($26m) into its Le Tréport, France site, upping capacity for a number of delivery systems.
Though spokesperson Laurence Quesdeville could not tell this publication whether the expansion was being led by any specific clients – as was the case with Eli Lilly at Rexam’s La Verpillière site near Lyon, France earlier this year – she did say Rexam had been “entrusted with some major projects that will be manufactured in Le Treport.”
The expansion will see a new production building of 3750 m2 (40,350 sq. ft.) including a clean room of 2900 m2, (31,204 sq. ft.) as well as 1500m2 (16,140 sq. ft.) housing the machine and mould maintenance workshops, metrology unit, laboratory and administrative premises.
A new cleanroom is due to open in November, and the site intends to be inaugurated by early 2014. Quesdeville also said the project supports Rexam’s recruitment plan which has already seen an increase of 15 jobs since it was implemented last year, driven by stronger manufacturing activity.
Though the expansion will support a number of Rexam’s device offerings including spray pumps, metering and continuous valves and applicators, one new addition being manufactured at Le Treport is the Advancia pump.
The pump was the outcome of close cooperation between Le Treport and La Verpillière. “They have optimized and rethought pump technology to create a completely new reference in the nasal spray sector,” said Quesdeville.
“The pump's dosing function has been modified to spray extremely accurately and consistently, even when the pump has not been used for several weeks,” she continued, adding it “guarantees a consistent spray regardless of the user” due to the modular approach applied to the pump's design.
Furthermore, the issue of safety has been addressed. Quesdeville added: “Rexam has removed all forms of contact between the drug and metal parts, such as springs, and rubber seals. The risk of introducing foreign bodies into the delivered dose has thereby been minimized.”
Almac has plans to further expand commercial manufacturing capabilities. Together with the recent completion of a new non-GMP drug development facility at the Craigavon site, this dual expansion represents a total investment of £13.7million, and the addition of 229 jobs during the next three years.
Almac’s existing facilities are at full capacity following the success of a laxative product contract manufactured by Almac. Almac plans to focus all production in Northern Ireland with additional equipment and Resources in Craigavon. The investment will provide blending equipment, an automated packing and integrated cartoning line, which will enable high volume bulk commercial manufacturing scheduled to begin in November 2013.
At the Craigavon site Almac created a new 13,400 sq.-ft. formulation development facility and analytical labs. This facility focuses on the development of tablet and capsule formulations for new drugs in the early stages of development. According to the company, a new “non-GMP” facility will enable greater speed in formulation and process development, by creating an environment where development work can be progressed quickly and efficiently.
Graeme McBurney, president and managing director of the Almac business unit said, “The laxative product has been a great success in the UK and increasingly in European markets. The marketing and promotion of the product by our contract customer has been very effective and significant growth potential in several new territories such as China has been identified. Centralizing and expanding our production in Craigavon will mean more cost effective manufacturing and optimal quality control and distribution.”
“We are also delighted to see the completion of the new non-GMP facility on site which, alongside Almac’s existing GMP capability, will enable us to operate with improved speed and efficiency in the early stages of projects. This latest addition makes Almac a much more attractive proposition to international clients who seek streamlined, one stop drug development solutions.”
Ardmac has been commissioned to build a new Grade 8 cleanroom at Nypro Healthcare’s new facility in Waterford, Ireland.
The new plant will manufacture advanced respiratory and injectable devices for global healthcare and pharmaceutical customers while creating more than 200 highly skilled jobs.
“We have a long-standing relationship with Nypro Healthcare following previous cleanroom works at its Bray site. The success of these projects gave both parties the confidence to work with each other again on this major project,” said Finbarr Marrett, Ardmac’s Engineering Manager.
A subsidiary of US group Nypro, Nypro Healthcare specializes in the development and manufacture of medical devices for the healthcare sector and will produce advanced respiratory and injectable devices for global healthcare and pharmaceutical customers.
Meanwhile, the Novartis plant in Liverpool, Merseyside is the location for another cleanroom and laboratory environment built by Ardmac. The facility is to be used for the development of new vaccine products by the pharmaceutical company.
Ardmac had responsibility for the complete execution of the works including design and co-ordination, construction of the cleanroom and laboratories, commissioning and co-ordination of client’s new equipment.
The project scope included architectural fabric to include walk-on ceilings, mechanical and electrical, clean coldroom and a 12m high modular firewall. The 600m2 (6,456 sq. ft.) project was completed within the 25-week timeframe and delivered within the client’s budget.
Leatherhead Food Research’s new Pathogen Pilot Plant, in Leatherhead, England, otherwise known as DirtyLab, was officially opened this month. This new facility, with category II containment capabilities, allows the specialist food research services organization to deliberately contaminate both conventional and new food products with pathogens in order to investigate the fate of such micro-organisms under selected processing conditions.
The research organization says DirtyLab will be used to validate the effectiveness of methods, processes and equipment against known micro-organisms.
For example, complex food production processes can be undertaken, such as the manufacture of a charcuterie product, and the manufacturing process itself can be challenged, as well as the final product. On the opposing side of food production, the cleaning and disinfection process for specific equipment can also be validated; for example, the cleaning methodology for drinks dispenser units can be assessed and evaluated.
DirtyLab is an important facility to have, both for Leatherhead and for Leatherhead’s Members and the food industry in general.
For food itself, products can be produced and stored in controlled temperatures and humidity conditions over the product shelf life. DirtyLab also facilitates the verification of processing methods, preservatives and different packaging technologies on a pilot plant scale, which is a key area of interest for its industry members.
Dr Paul Cook of the Microbiological Food Safety Branch, Food Standards Agency, opened DirtyLab in front of more than 100 Leatherhead Members and associates on 23 May.
“DirtyLab is an important facility to have, both for Leatherhead and for Leatherhead’s Members and the food industry in general. I know from personal experience, having worked in a Food Science laboratory at a university, the challenge of doing experiments on a pilot scale from the benchtop through to full-scale production. It is important that we are able to look at how a product behaves, not only at the benchtop but also in situations that simulate what happens in real processing facilities. I think this is an exciting opportunity for Leatherhead and I wish them all the best for the future in this venture,” he said.
Celerion, a specialist in early clinical research headquartered in Lincoln, Nebraska, has added a Containment Room at its UK facility in Belfast, Northern Ireland.
The expansion will allow the firm to develop programs that require studies using biologics, as well as vaccines with primary and secondary containment. The modular Containment Room comprises a negative pressure processing room, which houses a Biosafety Level (BSL-2) cabinet. Its addition further enhances the current GMP licensed site by enabling the firm to process live class 2 and class 3 biological products.
‘The addition of the Containment Room, coupled with our ability in the Belfast clinic to recruit large numbers of study participants, places Celerion in a strong position to conduct studies requiring biologics and vaccines,’ said Phil Bach, Celerion’s Vice President of Global Clinical Research.
This announcement builds on the recent addition of a Bronchoscopy Suite and expansion of Celerion’s services in the respiratory therapeutic area.
The Belfast facility also has extensive early stage clinical capabilities based on first-in-human experience with both NCEs and biologics, as well as bioequivalence, biosimilars, obesity, ophthalmic and gastro-intestinal studies.
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