PHARMACEUTICAL & BIOTECHNOLOGY
INDUSTRY UPDATE
February 2012
McIlvaine Company
TABLE OF CONTENTS
MRPC Expands Capabilities with Cleanroom
Kerry to Expand with New Cell Science Laboratory
Xceleron Moves to Laboratories
Perfecseal Facility Certified To Class 7 Cleanroom Standards
Absorption Systems Expands Ocular Testing Facility
Pharmaceutics International Inc (Pii) has Started Construction
InVivo Therapeutics Gets Research and cGMP Manufacturing Facilities
Rollprint to Convert Pouches in Cleanroom
Fall River Biomanufacturing Plant Expands
Wake Forest BioTech Place to Open
Rutgers Opens New Proteomics Center
Sanovas Expands Headquarters and Opens Manufacturing Site
Novo Nordisk Plans Diabetes R&D Centre in Seattle, WA
JGI, Berkeley Lab's Biosciences to Relocate to Nearby Richmond
Almac Has Opened a New Building
NantWorks Plans a New Pharmaceutical Manufacturing Plant
BASF Moves Plant Science HQ to U.S.
Construction has begun at Wishard Health Services
Pioneer® Surgical Technology, Inc. Announces Expansion
Bigelow Labs Opens New Biotech Center
IDBS has Opened a New Healthcare Center
Janssen Starts Open Innovation Lab in San Diego
CIRM to Put $40 Million into Stem Cell Genomic Centers
SAFC Verona HPAPI Manufacturing Facility
SteriPack Building Facility in United States
Particle Sciences Expands Extrusion Capabilities
CoreRx, Inc. New Facility Nearing Completion
GlaxoSmithKline to Expand Melbourne Site
Taiwan Vaccine Manufacturer Building Facility
Donation to Expand Stem Cell Research at McMaster University
Shanghai Pharmaceuticals Expands with Acquisition
Foster Delivery Science has Added Services
Excella Achieve SafeBridge Certification
RohnerChem Expands API Process
Medicago Announces Investment in Production Facility
Catalent Expands Capabilities at Schorndorf Facility
Granules-Omnichem to Start Construction of Plant
Shemberg Marketing of the Philippines has Softgel Facility
Jabil Unites European Facilities, Opens Cleanroom
Surat, India to Get Stem Cell Hospital
Dishman Considers Chinese API Plant
Sensient Opens Factory in Sao Paulo, Brazil
Novartis Remains Open in Switzerland
Granules and Omnichem Work on New Manufacturing Facility
SGS Opens Second Facility in Mumbai
2012 Facility of the Year Awards Winners Announced
Quintiles Launches Center in Dalian, China
Pherecydes Pharma Receives Funding
MHRA Issues GMP Certificate to AMRI Plant in Wales
Wallace Wurth Biomedical Research Centre, Australia
Roche New Research and Development Facility, Switzerland
Kilitch Drugs Manufacturing Plant, India
Thermo Fisher Scientific Activates Global Food Safety Response Center
Molecular Profiles Expands Manufacturing Capabilities
IAH Opens Interim Lab as it Pursues Two Expansion Plans
BioCity Scotland Opens on Former Merck Site
Airborne Lab will Measure Snow Fall From Space
Sanford Consortium for Regenerative Medicine's Stem Cell Research Facility
Wisconsin-based MRPC, a single-source provider of medical device components and assemblies, has completed construction of a new cleanroom for the molding of medical components. The 2,000-square-foot Class 100,000 cleanroom will allow MRPC to add additional liquid injection molding (LIM) machines to increase their liquid silicone rubber molding capabilities.
“With this cleanroom addition, we are able to increase our LIM capabilities and remain at the forefront of molding innovation,” said Greg Riemer, MRPC president. “We’ll utilize this new cleanroom space to continue expanding our two-material overmolding capabilities using liquid silicone, a complex process that is not commonly available.”
MRPC now has a total of five cleanrooms for processes such as LSR molding, gum silicone molding, silicone extrusion, custom rubber molding, thermoplastic molding and secondary assemblies.
“As a 90-year-old company, it is exciting that we continue to evolve and expand our capabilities,” said Mark Brandstaetter, vice president of sales and marketing for MRPC. “With this expansion, we’ll be continuing to provide many of our customers with services they can’t find anywhere else.”
New Cell Science laboratory will serve bio-pharma customers globally, situated at the company’s customer centre of excellence in Beloit, Wisconsin.
Building on the success of its companion site in Almere, The Netherlands, the new Cell Science laboratory will incorporate state-of-the-art technologies and media supplementation expertise to engage globally with Kerry's bio-pharma customers and technology partners.
"The new Cell Science laboratory expands our Media Enhancement Services capabilities for Cell Culture, Vaccines, Microbial Fermentation, and Diagnostics. Additionally, this new research and applications center with leading R&D expertise will advance our ability to customize cell media supplements to meet the evolving needs of the bio-pharma market globally," stated Christopher Wilcox, Kerry's Director of R&D overseeing Cell Culture & Media Supplementation technologies.
Kerry is investing more than $10 million in the expansion of the Cell Science laboratory and Kerry customer center of excellence, which includes a consumer nutrition center, extensive flavor labs and product ideation and customer collaboration suites.
"Expanding our Cell Science laboratory in the Kerry center allows us to advance our media ingredients and supplements portfolio while capturing greater synergies with Kerry's extensive analytical, research, development and applications expertise," stated Edmond Scanlon, President of Kerry's pharma and bio-pharma ingredients business. "This ultimately helps us deliver greater innovation and overall value for customers."
The expansion is expected to be complete by August 2012 and will add nearly 50 new jobs and an additional 30,000 square feet to the existing 260,000 square foot facility.
Kerry will be looking for researchers with knowledge and capabilities in both microbial fermentation and mammalian cell culture development.
News of the expansion comes just a few months after the Irish firm bought Cargill’s flavors division in a deal which – while focused on the food sector – did include several technologies used in drug production, such as the Maxens range of taste masking excipients.
Huttinga cited both the culture lab expansion and the Cargill acquisition indications of Kerry’s plans to build in the pharmaceutical production sector.
Micronic America and Micronic Manufacturing USA will work in tandem at new production facility to efficiently provide distributors high quality traceable product portfolio.
Micronic Holding BV, a leading manufacturer of innovative sample storage tubes and accessories based in Lelystad, The Netherlands, announced the launch of Micronic America, the new supporting entity for the company's traceable product portfolio in the U.S. and Canada. Micronic America will operate in conjunction with Micronic Manufacturing USA, Micronic's U.S.-based production facility, to efficiently produce and provide its distributor network with industry-leading sample storage solutions.
"Micronic is deeply committed to its distributor network in North America by providing superior products, and the launch of Micronic America, combined with the backing of more than 25 years of leadership in the industry, enhances our ability to deliver on that promise," said Gerrit van der Gaag, CEO at Micronic Holding BV. "Producing sample storage tubes, caps and racks domestically with our manufacturing facility enables us to ensure the integrity of materials and processes throughout every step of production and will improve turnaround times for distributors."
Located within a Keystone Innovation Zone in the Philadelphia, PA region, Micronic America supports the sales and marketing of North America while working in conjunction with the company's adjacent manufacturing plant, which boasts a Class 7 cleanroom environment. Beyond ensuring quality and product consistency, Micronic uses a proprietary laser etching system to imprint barcodes directly onto sample racks and a unique 2D Data-Matrix code on the bottom of each tube for simplified and durable sample identification.
Distributors supported by Micronic America in the United States and Canada include E&K Scientific, USA Scientific, Nova Biostorage Plus (formerly Micronic North America), MJS Biolynx and D-Mark Biosciences.
"This expansion not only represents our investment in U.S. operations, but is also symbolic of a larger corporate investment in manufacturing and production enhancements, including the construction of a state-of-the-art cleanroom facility and system innovations at our home office that will significantly improve productivity," added van der Gaag.
Xceleron, a company involved in accelerating drug development using ultra-sensitive bioanalytical analyses, announced that existing investors Albion Ventures and Solon Ventures have invested $2.4MM to locate all of the company’s business in its custom-built facility in Germantown, MD which is expected to be fully operational by 31st March 2012.
Xceleron is relocating senior analytical staff to Germantown from York, hiring new staff in Maryland and retaining a strong study design and project management presence in the UK. The Germantown facility was opened for business in 2008 and has conducted a range of customer studies including absolute bioavailability, metabolism and general pharmacokinetic investigations. 12,000 samples have been analyzed on site for a growing client base of pharmaceutical and biotech companies.
Xceleron intends to augment its analytical capability in Germantown with the latest in highly sensitive LC-MS/MS technology. This addition will create the first laboratory of its kind in which all forms of microtracer and microdose investigations can be conducted in one custom-built facility.
Stuart Best, Vice President Analytical Operations added: “The combined ruggedness of AMS and the specificity of the most sensitive LC-MS/MS will enable a highly cost-effective and safe bridge from discovery to the clinic.”
Xceleron CEO Michael Butler commented: “Our customers told us that they want access to the best analytical platforms in translational science. We are providing that access with the most experienced team in the business and in one highly efficient and purpose built location. This is a first-of-a-kind combination from Xceleron that we believe will add to our customers’ drive for Phase 2-readiness”
Perfecseal has certified its Oshkosh, WI sterile medical pouch and bag manufacturing facility to ISO 14644-1 (1999) Class 7 cleanroom standards. Though already operating the facility at a Class 7 cleanroom standard since 1997, it did not seek certification until 2011. Testing and certification was performed by CSI Testing, Inc., Plymouth, MN.
The cleanroom certification is part of an ongoing continuous improvement plan focused on risk reduction for Perfeseal customers. This plan involves further cleanroom certifications for Perfecseal’s other production facilities as well as further investment in vision inspection systems for its production lines, the company said.
Perfecseal’s medical, diagnostic, and pharmaceutical packaging production plant in Northern Ireland and its custom thermoforming plant in Mankato, MN have both been ISO Class 8 certified for several years.
“Our packaging products protect some of the most important and sensitive healthcare products in the world such as drug coated implantable stents and powerful pain reducing transdermal patches. Our mission continues to be focused on eliminating any packaging related risk that could negatively impact the efficacy of the products we protect that are used in various therapies, diagnostic tests, and medical procedures, said Perfecseal’s President, Paul Verbeten.
“We continue to invest in our facilities and capabilities using the model of our customers’ facilities and capabilities for our direction,” he added.
Vision inspection systems have already been installed on several production lines including the large coating line that applies industry recognized heat seal coatings like Perfecseal® CR27 to medical packaging substrates like DuPont™ Tyvek® brand medical wrap.
The company said additional vision inspection systems have been purchased and will be installed in 2012 on several more pouch and bag production lines, a blown film line, and a foil laminator. As expected, Perfecseal has found that vision inspection systems greatly reduce the number of defects shipped and have become a basic expectation of its customers in the medical device, diagnostic, and pharmaceutical markets.
Absorption Systems is upgrading its AAALAC-accredited and GLP facility in San Diego, CA, expanding in vivo testing capabilities for drugs and medical devices. The expansion includes the construction of a dedicated ocular testing lab with a Heidelberg Spectralis optical coherence tomography (OCT) unit, an instrument that produces detailed digital images of the retina, enabling more precise monitoring of the efficacy and toxicity of drugs and medical devices.
The company’s preclinical ocular test portfolio includes in vivo ocular pharmacokinetics, efficacy, and safety in multiple species, as well as in vitro ocular permeability and metabolism.
Patrick Dentinger, president and chief executive officer of Absorption Systems, said, “For Absorption Systems, being a market leader in whatever endeavor we pursue is a cornerstone of our business philosophy. This requires scientific expertise, state-of-the-art equipment and facilities, and access to emerging technologies. These factors, combined with Absorption Systems’ customer-centric approach, make our commitment to being a top-tier ocular service provider a reality in 2012.”
Drugmaker Watson Pharmaceuticals has broke grounds on an R&D lab in New Jersey, US.
The firm plans to spend an initial $4.5m (€3.4m) to kit-out the 19,000 sq. ft. plant, which will focus on development and analytics. A further 13,000 sq. ft. on the site will be used for future expansion.
CEO Paul Bisaro said the facility’s location in North Brunswick was chosen to establish bonds with “educational centers of excellence as Rutgers University”.
The company has also been expanding its generics offering after taking over Strides’ Australian subsidiary Ascent Pharmahealth.
Shortly afterwards, Watson was granted a stay of the preliminary injunction, which was blocking it from marketing a generic version of Sanofi’s deep vein thrombosis medication, Lovenox.
Pharmaceutics International Inc (Pii) has started construction of a new 24,000 sq. ft. aseptic fill/finish manufacturing facility at its site in Maryland, US. The new facility will more than double capacity sterile GMP production capacity, said the company, which expects to complete the expansion before the end of 2012. The fill/finish suites will feature automated vial and syringe filling, inspection and labeling equipment capable of producing batch sizes of 100,000-plus units.
The facility expansion closely follows the company's recent US FDA pre-approval inspection (PAI) as a result of which Pii has been approved to manufacture commercially an aseptic vial in its existing Hunt Valley aseptic facility.
Steve King, senior vice president of Pii, said the additional facilities would enable the firm to support its clients from pre-clinical to commercial-scale production and meet growing demand for fill/finish services for potent compounds and oncology drugs.
InVivo Therapeutics Holdings Corp., a company focused on the development of groundbreaking technologies for the treatment of spinal cord injuries (SCI), announced that it has entered into a multi-year lease for a 21,000 square-foot facility at One Kendall Square in Cambridge, MA.
The new facility will serve as the Company’s fully integrated global corporate headquarters. Bringing all of InVivo’s business units under one roof for the first time, the facility will house corporate offices, lab space, a rodent vivarium, and a cGMP cleanroom to meet the needs of InVivo’s planned human studies for three different products anticipated to begin in 2012.
The Company expects to occupy the new facility in early 2012.
According to Frank Reynolds, CEO of InVivo Therapeutics, the new headquarters will allow InVivo to continue to contain costs and improve time-to-market for the Company’s products. Said Reynolds, “In 2005, we started on a mission to engage multiple disciplines of science to treat spinal cord injuries. Now we have the facility to fully support our teams and to conduct our human studies.”
In addition to office and administrative space, the facility provides significant additional scientific resources for advancing InVivo Therapeutics’ product pipeline, includes:
A chemistry lab for formulations and chemical synthesis of the company's hydrogel and polymer-based scaffold technologies;
A cGMP cleanroom for manufacturing and packaging of the company's biomaterial devices for clinical studies and early product launch;
A rodent vivarium to evaluate the safety and efficacy of various devices and treatment combinations in SCI for other nervous system injury models which the company believes to be one of the largest dedicated to spinal cord injury research in the world;
A biology lab for developing cell therapies used in combination with the company's biomaterial devices;
A surgeon training facility to educate the medical community, prepare for product launch, and engage physicians for research and product development purposes; and,
The ability to expand to additional space as the company grows.
Continued Reynolds, “As a company that emerged from MIT, are remaining close to our roots and will continue to be located just a few hundred yards from MIT’s Langer Lab. Our new headquarters represents an important step in our Company’s corporate development and improves our ability to continue to recruit the best talent available. Recently, we added four world-class neuroscientists to our team and this facility will provide them with an innovative work environment. We’ll have critical resources for accelerating our development while maintaining FDA-compliant manufacturing processes.”
M AKO Surgical Corp., a medical device company specializing in robotic arms for orthopedic surgery, recently expanded in Ft. Lauderdale, Fla. The company will build its Robotic Arm Interactive Orthopedic system at the facility and plans to create 100 jobs.
Founded in 2004, MAKO currently does business with approximately 82 Florida-based suppliers. The company markets both its Robotic Arm Interactive Orthopedic system and implants for orthopedic knee and hip procedures. MAKO was recently ranked as the number one fastest growing company in North America on Deloitte's 2011 Technology Fast 500.
"Our company is built and thrives upon a culture of innovation," said Maurice R. Ferré, M.D., president and CEO of MAKO Surgical Corp. "As MAKO continues to revolutionize the approach to orthopedic surgery and restoration of patients' quality of life, we are also committed to the South Florida community. We look forward to expanding our business in the region, establishing new job opportunities and seeking top talent for MAKO to add to our current team, which has contributed to MAKO's overall success."
Paris-based pharmaceutical company Ipsen is moving forward with two major expansion plans with Biomeasure, its U.S.-based subsidiary. Ipsen is expanding in Milford, Mass., and is relocating its U.S. headquarters from Brisbane, Calif., to Bridgewater, N.J.
The company's existing 77,000-sq.-ft. (7,153-sq.-m.) Milford facility serves as a center for Ipsen's U.S.-based peptide and toxin R&D platforms, as well as a manufacturing facility focused on production of recombinant proteins for the treatment of hemophilia. The expansion and renovation project, currently in the design phases, includes a new three-story, 62,000-sq.-ft. (5,759-sq.-m.) building, to be constructed while completely renovating one of the site's two existing buildings. Ipsen plans a groundbreaking for mid-2012, with the new building targeted for completion in early 2014. The new facility will house R&D and Process Sciences laboratories that support Ipsen's strategic objectives.
"Ipsen's Milford-based facility is at the cutting edge of innovative, impactful and high-performing research, development and manufacturing capabilities focused on delivering new treatments for serious and life-threatening diseases to patients," said Biomeasure's president. Cynthia Sylvestre. "We are confident that investing $45 million in this unique site, in such close proximity to the impressive concentration of scientific skills and talent in Massachusetts, will enable Ipsen to expand its bio-therapeutic technological platforms and pipeline."
The Milford site has a current staff of 150, which includes chemists, biologists and translational science experts and also a full technical operations team specializing in the manufacture of recombinant products targeting hemophilia.
The latest bioSTATus report from Richards Barry Joyce & Partners, released Nov. 30, said the number of Phase I clinical trials attributable to Massachusetts-based research initiatives has more than doubled since 2005, from 25 to 56.
Ipsen is also moving its U.S. headquarters cross-country to a 30,000-sq.-ft. (2,787-sq.-m.) facility in Bridgewater, N.J. Ipsen said relocating, under a six-and-a-half-year lease, reflects its commitment to strengthening its U.S and global presence and providing specialty-care expertise to underserved neurological and endocrine disease communities.
"New Jersey is the leading biopharmaceutical center in the U.S., and Ipsen is ready and eager to be a part of that community of innovators," said Sean McKercher, president and general manager, Ipsen North America. "This move was a natural choice for Ipsen, given New Jersey's ready access to international travel hubs, deep pool of pharma talent and business incentives for the biopharma sector — and it reflects our commitment to champion medicines for patients with severely debilitating diseases in need of therapeutic options."
Ipsen, which expects to begin operations in Bridgewater by April, plans to hire more than 100 people.
Ipsen's total global sales were more than €1.1 billion (US$1.3 billion) in 2010. The company, with drugs marketed in 115 countries, employs about 4,500 worldwide. Known as an innovative company, Ipsen committed 20 percent of its sales to R&D in 2010.
Rollprint Packaging Products, Inc. said it will be the first sterile packaging manufacturer to convert pouches in a certified cleanroom environment in the United States. The company is announcing the construction of a 6,000 sq. ft. clean room expected to be fully operational in the second quarter of 2012.
The ISO Class 8 cleanroom will be enhanced via Rollprint’s vertical integration which means that the rollstock from which the pouches are made is also produced at the same facility in Addison, Ill. No other pouch manufacturer has both vertical integration and cleanroom capabilities in the United States, making it another “first” for Rollprint, the company said.
By definition, a cleanroom environment has a controlled level of contamination that is specified by the number of particles per cubic meter at a specified size. ISO Class 8 Cleanroom certification dictates the following maximum concentration limits for airborne particulate (particles/m3) according to ISO 14644-1: 3,520,000 at 0.5 µm; 832,000 at 1 µm, and 29,300 at 5 µm.
“We started preparing for this two years ago with investments in vision systems, web cleaners, and other equipment and procedures to minimize particulates in our film converting area. We wanted to properly address upstream criteria before taking the next step,” said Dwane Hahn, vice president of sales and marketing, Rollprint.
The upgraded capability has been driven by customer demand for domestic supply that has been produced in a clean room environment. Pharmaceutical, medical device, and diagnostic/life science manufacturers are constantly looking for ways to reduce the number of contaminants that come in contact with their products.
“There is a big difference between ‘cleanroom environments’ that some manufacturers claim they have, and actual cleanroom certification. In a few months time, we expect to be able to announce to the industry that we have met the rigorous certification criteria and are producing pouches in our cleanroom,” Hahn explained.
The cleanroom will house five production lines capable of producing a variety of pouch structures for which Rollprint is known. This includes header bags, chevron, vented, three-side weld seals, and corner peels.
“Many of the packaging structures used today for pharma and medical device applications—such as film and foil header pouches, coextruded, peel able heat-seal films and silicon oxide/aluminum oxide composites—were first introduced to the industry by Rollprint. The new cleanroom capability builds on that legacy,” said Hahn.
True to its word from a year ago, the state of Massachusetts has contributed nearly $15 million for a new biomanufacturing plant tied to UMass Dartmouth.
In a press release, the Massachusetts Life Sciences Center board of directors gave final approval to a $14.6 million capital grant to fund the building of the new Massachusetts Biomanufacturing Center in Fall River, MA.
The 32,000-square-foot facility will house early stage life sciences companies and span four acres of city-donated land, while 150 acres will be held for potential expansion. The Massachusetts Biomanufacturing Center will anchor the new 300 acre SouthCoast Life Science and Technology Park in Fall River. Companies graduating from the center will be encouraged to expand on abutting land set aside in the Life Science Park.
The state has finished a $36 million exit ramp off Route 24 to direct cars into the bio-park. The state backing and approval of the facility was announced in January 2011.
The University of Massachusetts Dartmouth, within its College of Engineering, will create new programs that “match the education needs of the facility.” That ties in to the newly launched undergraduate and graduate program of studies in Biomaterials and Biomedical Engineering, which officials say is the only one of its kind in the UMass system.
A pivotal piece of the economic transformation of downtown Winston-Salem — Wake Forest BioTech Place — is ready for its debut.
But that doesn't mean the developer, Wexford Science and Technology LLC of Baltimore, is through with helping to flesh out Piedmont Triad Research Park once the 242,000-square-foot building opens in February.
Wexford owns BioTech Place and is leasing it to Wake Forest Baptist Medical Center, which oversees the park.
The $100 million renovation of Building 91, a former R.J. Reynolds Tobacco Co. manufacturing plant near Fifth Street and Patterson Avenue, is considered the park's biggest project since plans for the park surfaced in 1994.
Dan Cramer, a regional executive for Wexford, said that besides the investment cost — up $13 million from when the facility was announced — the project has contributed about 1,000 construction jobs, with 75 percent coming from the Triad.
Cramer said Wexford has no specific phase-two projects on the table, but expressed confidence Wexford will remain active since "we're not as attracted to one-and-done projects."
"We're very positive and excited about what our investment will produce in BioTech Place," Cramer said. "We believe it is not only transformational to that part of the city, but a cutting-edge facility unlike anything else in the state."
The park is considered the leading new-economy engine for Forsyth County and the Triad, with about 925 employees currently on its campus.
Wake Forest University Health Sciences has said it plans to move 320 positions from its Hawthorne campus and other offices into BioTech Place. The health-sciences division has longed for years for expansion space for its research departments.
Wake Forest will occupy about 85 percent of BioTech Place, while about 25,000 square feet has been set aside for wet laboratories for startup companies, Cramer said. Allegacy Federal Credit Union said that it is moving its downtown branch across the street into the building, and there are plans for other retail presence that could include a café, the developer said.
Phase two of Wexford's involvement is considered pivotal by local economic and elected officials and the community given the project's potential for providing not only life-sciences research space but also momentum for downtown housing, retail and other economic shots in the arm.
Cramer identified the former Reynolds "60" and "90" downtown buildings, all under the park's control, as the most logical next steps for redevelopment. Those buildings would likely provide speculative laboratories for companies ready to grow out of local incubator space.
U.S. Bank is investing up to $18 million in the project, while Blue Cross Blue Shield of N.C. is investing up to $16 million.
Rutgers University has opened the doors of a new 75,000 square-foot, $47 million facility to house its core proteomics resources and research programs, as well as multi-disciplinary programs, the university said.
The four-story Center for Integrative Proteomics Research will house Rutgers' Protein Data Bank, a repository of information on the 3D structures of large biological molecules and complex assemblies, and the BioMaPS Institute for Quantitative Biology, which supports research and education in computational biology.
The CIPR, located near the Center for Advanced Biotechnology and Medicine, will house core facilities for mass spectrometry, nuclear magnetic resonance, cryo-electron microscopy, and computational biology. Its development is part of an ongoing effort to consolidate Rutgers' life sciences facilities in one area of the Busch Campus in Piscataway, NJ.
"With the completion of this building, we can integrate the university's academic and research work on proteomics and enable Rutgers in the years ahead to play an even stronger and more dynamic role in this field," Rutgers President Richard McCormick said in a dedication for the facility.
Professor of Chemistry and Chemical Biology Helen Berman, who will direct the proteomics data bank, said that the facility will support research across the "proteomics pipeline."
Rutgers said it plans to recruit a scientist for the CIPR who will develop clinical applications for the center and build relationships with other institutions within and beyond the university community.
Sanovas, a manufacturer of micro-surgical devices for diagnosing and treating cancer and chronic diseases, is expanding its corporate headquarters and opening a manufacturing site in Sausalito, Calif. The facility initially will manufacture components of Sanovas’ technology ahead of filing for U.S. Food and Drug Administration (FDA) approval and ultimately would serve to produce Sanovas’ commercial products.
“Sanovas’ headquarters is a natural choice for our manufacturing site, as it allows us to maintain the highest level of quality control over the most proprietary components of our technology platform,” CEO Larry Gerrans said. “These facilities will provide us with the ability to attract the very best talent from within the life-sciences community right here in the Bay Area.”
Privately held Sanovas’ micro-surgical technology platform is designed to give surgeons the ability to access and understand previously inaccessible areas of the body, enabling them to diagnose, treat and deliver drug and immune therapies to small-diameter anatomy. The company's micro-surgical technology uses the world’s smallest surgical camera to visualize and treat difficult-to-reach areas of the body, according to a press release. The camera is connected to the end of a steerable catheter that is further used to deliver additional tools for collecting tissue samples, analyzing and removing tumors and delivering drug and immune therapies to targeted locations within the deepest reaches of the body.
Sanovas plans to file a 510(K) submission with the FDA within the next six months for approval of its technology, and if approved would begin full-scale manufacturing by the end of the year. Initially, Sanovas intends to market its micro-surgical tools for the treatment of lung cancer and pulmonary disease.
Sanovas, Inc., based in Sausalito, Calif., is a leading developer of innovative micro-surgical devices for diagnosing and treating cancer and chronic diseases. Sanovas' micro-surgical technology platform is designed to give surgeons the ability to access and visualize previously inaccessible areas of the body; enabling them to diagnose, treat and deliver drug and immune therapies to small diameter anatomy in entirely new ways. The company plans to commercialize its technology platform, which will initially address the unmet needs in lung cancer and pulmonary disease, in 2012. Privately held Sanovas was founded by the pioneers in minimally invasive surgery. The company has more than 25 multi-national patents pending.
Collagen Matrix’s production capacities and to relocate them to a new space. HCC teamed with HL Turner Architects and RDK Engineers to provide the design services for the project.
The project included demolition of 10,000sf of existing cleanroom room and 30,000 sq.ft of existing lab space and the renovation of these into new cleanroom and labs meeting Collagen’s needs.
HCC provided complete new HVAC systems including chillers, boilers, makeup air, recirculating air and all duct and exhaust system. HCC provided new electrical distribution throughout the facility for all the process as well as HVAC equipment. HCC provided new partitions with epoxy floors with cove base throughout the cleanrooms and laboratory areas.
The manufacturing suites were built to Class 10,000 standards and were divided into multiple zones for pressure control in accordance with the process of requirements.
HCC provided new emergency generator to run critical components of manufacturing during power outages. Included on these services were freeze dryers, freezer storage units and other critical components. HCC provided an independent process cooling water system for cooling of the freeze dryers. Because the facility did not have any town sewer, HCC provided evaporators with holding tank and pump stations to allow for all clean wastewater to be pumped to a central location and evaporated to meet the flow requirements of the facility without overflowing the existing sanitary leach and field.
As part of HCC’s construction process we also had to add pads with fencing on the exterior for the emergency generator, chiller, makeup unit and pumps. HCC built a chemical storage building and created pads for exterior walk in freezers.
Novo Nordisk is to establish a Type 1 Diabetes R&D Centre in Seattle, WA, US, combining the Danish firm’s history of innovation and leadership in diabetes treatment with its growing expertise in immunotherapy.
The Centre will combine basic research and early proof-of-concept trials, giving it the necessary scientific foundation to move early-stage discovery projects rapidly from animal models into small clinical exploratory trials in type 1 diabetes.
Mads Krogsgaard Thomsen, executive vice president and chief science officer at Novo Nordisk, said: ‘It is part of our mission to take Type 1 diabetes research to the next level. With the new Type 1 diabetes R&D centre, we hope to accelerate the process of finding new, innovative ways of treating people with this disease. Our vision is to prevent, treat and ultimately cure diabetes.’
Matthias von Herrath, a world-renowned researcher in auto-immune diseases, will head the new centre.
Von Herrath is currently director of the Centre for Type 1 Diabetes Research at La Jolla Institute for Allergy and Immunology. He has been with the institute since 2001 and will continue to hold a part-time faculty position there.
The Type 1 Diabetes R&D Centre will open this summer, staffed by approximately 20 researchers who will be supported by corporate functions in the US and Denmark. It will be located on the same premises as the Novo Nordisk Inflammation Research Centre in Seattle to foster natural research synergies between the two sites.
Globally, around 6,000 employees are involved in research and development activities at Novo Nordisk. The firm has research facilities in Malov, Denmark, Beijing, China, and Seattle.
Work is moving forward on Southwest Tennessee Community College’s long-planned Nursing, Natural Sciences, Biotechnology Building at its Union Avenue campus Downtown.
A $14.6 building permit application has been filed with the city-county Office of Construction Code Enforcement for the three-story building, which also will include two mechanical penthouses. W.G. Yates & Sons Construction Co. is the project’s general contractor.
The Southwest Foundation in late 2010 received $8.4 million in state appropriations for the building.
The foundation by that point had already raised about $10 million from individuals, corporations, organizations and federal appropriations. Those include a $1 million pledge from Medtronic Inc., the Minneapolis-based company whose Spinal and Biologics Business is based in Memphis, and $2 million from FedEx Corp. – the largest donation in STCC’s history. Other significant contributors include Baptist Memorial Health Care Corp. and Methodist Le Bonheur Healthcare.
The building, which was designed by Fleming/Associates/Architects PC, is slated to have about 61,000 square feet with two wings: one for nursing and one for natural sciences and biotechnology. It will include a 250-seat teaching auditorium, four lecture rooms, a 100-seat computer laboratory, nursing skills and biotech labs and an office suite for faculty and staff.
STCC’s nursing program has outgrown its 8,500-square-foot building. It can accept about 250 students every two years and must turn away another 250 or so because there’s no room to accommodate them, the school told The Daily News in late 2010.
The new facility will allow for 45 percent increases in students each in the nursing and biotech program.
The Lawrence Berkeley National Laboratory's bioscience programs will be moved into a new location in Richmond, Calif., near Berkeley as part of a consolidation process, the University of California Berkeley said.
The University of California said it has chosen Richmond Field Station, a 152-acre site which was already owned by the university system, after a months-long process during which it seriously considered five other Bay Area sites to house the second campus.
Berkeley Lab is creating the new campus to pull together its bioscience programs, including the Joint Genome Institute and the Joint BioEnergy Institute, into one space that will house nearly 800 employees who will engage in life sciences studies focused on biofuels and health and provide research services such as the Community Sequencing Program.
JGI conducts sequencing-based research and provides resources through several programs focused on bioenergy, fungal genomics, metagenomics, microbial genomics, plant genomics, and other 'omics technologies.
"Our [JGI facility] in Walnut Creek is the most productive sequencing center in the world by nearly every measure," Berkeley Lab Director Paul Alivisatos wrote in a posting on LBNL's website in July. "We are making outstanding strides in biofuels at the Joint BioEnergy Institute. Our Life Sciences program, primarily housed on Potter Street in Berkeley, brings the unique abilities of a national lab to areas of human health, and this rich interplay between the energy and health missions is a tremendous source of scientific strength in the biosciences at Berkeley Lab."
Almac has opened a new £3-million ($4.6 million), 30,000-ft2 building at its Craigavon, United Kingdom, headquarters. The operations and departments at the new location will include packaging and distribution of medicinal supplies for clinical studies, business development, marketing, human resources, and information systems.
In addition, Almac’s sciences business unit and the biopharmaceutical company MGB Biopharma have entered into a collaboration where Almac will manufacture the production of their lead gram positive antibacterial compound MGB-BP3. The compound is a DNA minor groove binder and is currently in preclinical development with IND filing targeted for the third quarter of 2012.
NantWorks, a technology company, has announced plans to locate a new pharmaceutical manufacturing plant in Terre Haute, Indiana. The company plans to invest $85.5 million to redevelop the former Pfizer facility in Terre Haute. The new manufacturing plant, which is expected to be operational in 2015, will produce critical-care injectable and oncological drugs. NantWorks was founded by Patrick Soon-Shiong, who previously developed two pharmaceutical companies: APP and Abraxis Biosciences.
BASF employs about 780 at its Research Triangle Park campus, which will now welcome the relocation of its Plant Science headquarters from Germany.
Europe's reluctance to accept genetically modified foods is giving a boost to the fast-growing ag-bio sector in North Carolina. BASF announced on Jan. 16 that it was retreating from the European plant biotechnology market in favor of markets in North and South America. In the process, the company plans to move 123 positions to its Research Triangle Park campus over the next two years.
The headquarters of BASF Plant Science will be moved from Limburgerhof, Germany, to Research Triangle Park. The company will halt the development and commercialization of all products that are targeted solely for cultivation in the European markets. These include genetically modified starch potatoes (Amflora, Amadea and Modena), a potato resistant to the disease late blight called Fortuna as well as a late blight-resistant starch potato and a wheat variety resistant to fungal disease. To maintain all options for the potato products, BASF Plant Science will continue the regulatory approval processes for the products already started.
"We are convinced that plant biotechnology is a key technology for the 21st century," said Dr. Stefan Marcinowski, a member of the Board of Executive Directors of BASF, responsible for plant biotechnology. "However, there is still a lack of acceptance for this technology in many parts of Europe — from the majority of consumers, farmers and politicians. Therefore, it does not make business sense to continue investing in products exclusively for cultivation in this market . .. We will therefore concentrate on the attractive markets for plant biotechnology in North and South America and the growth markets in Asia."
BASF's RTP campus comprises 125 acres (51 hectares) with about 40,000 sq. ft. (3,960 sq. m.) of greenhouse space. BASF operates two business units at RTP, Plant Science and Crop Protection, with a total of 780 employees. About 200 are with the Plant Science division.
BASF Plant Science is part of a burgeoning collection of companies in plant biotechnology in the RTP. These include Bayer Crop Science and Syngenta. BASF Plant Science's primary partner is St. Louis-based Monsanto, which operates some greenhouses in RTP. The company also has other collaborations, such as a partnership with Bayer related to rice.
"We have a number of different partners," says Fran Castle, BASF Plant Science spokeswoman. "Our business strategy is that we are a technology provider. We currently have a partnership with Monsanto and it's a very strong partnership in terms of developing traits for yield and stress. As a partner, they will take products to commercialization."
BASF's partnership with Monsanto includes development of corn, soy, cotton, canola and wheat. Castle says acceptance of genetically modified crops is much lower among consumers, farmers, politicians and government authorities in Europe than in the U.S.
"We do not see this acceptance changing in the near term," Castle says. "We are focusing our business on growing markets. If you look at surveys of farmers here in the U.S. as well as in South America, there is a high percentage of acreage that is growing genetically enhanced crops. When you look at the realities of food production needed in the next decade and on out, many technologies, including plant biotechnology, will be needed. There is a limitation on land, obviously, so you have to get more out of plants than is currently possible."
Currently, 157 employees work for BASF Plant Science in Limburgerhof. The company plans to close its sites in Gatersleben, Germany, and in Svalöv, Sweden. Currently 57 people work in Gatersleben and six in Sweden. The company plans to transfer 123 positions from Limburgerhof and Gatersleben to other BASF Plant Science sites, mainly RTP, and to reduce 78 positions over the next two years. BASF will maintain research facilities in Germany and Belgium.
Castle says the company has not determined how many employees will transfer to RTP and how many might be new hires.
European environmental group Friends of the Earth Europe applauded BASF's decision and released the following statement:
"This is another nail in the coffin for genetically modified foods in Europe. No one wants to eat them and few farmers want to grow them. This is a good day for consumers and farmers and opens the door for the European Union to shift Europe to greener and more publicly acceptable farming."
Duke Realty has begun construction on Wishard Health Services' new faculty office building as part of the planned 37-acre (15-hectare), $754-million Eskenazi Health campus in downtown Indianapolis. The five-story, 274,000-sq.-ft. (25,455-sq.-m.), Fifth Third Faculty Office Building will house support functions for the hospital, including office space for administrative staff and Indiana University (IU) School of Medicine faculty physicians who will practice at the campus, as well as work space for both research and various academic support programs. Along with an 11-story hospital tower and a planned ambulatory care building, the new facility will enable Eskenazi Health's physicians and staff to be consolidated on one modern campus.
Pioneer Surgical doubles the size of its Greenville, North Carolina biomanufacturing facility to accommodate growth of its biologics line, which includes the flagship product nanOss® Bioactive and the recently launched nanOss Bioactive 3D.
Pioneer Surgical Technology announces the grand opening of its newly expanded Greenville manufacturing facility. The location houses the primary manufacturing operations for Pioneer Surgical’s biologic products sold in the United States and Europe.
Regarding Pioneer’s latest expansion, Mr. Shane Ray, General Manager of Biologics for Pioneer stated, “Since the creation of our biologics business unit in 2007, Pioneer has seen robust sales growth for our spine, orthopedic, and biologic products. Expanding our biomanufacturing facility to increase our capacity will assist in our aggressive future growth plans within and outside the USA. This expansion shows our commitment to the North Carolina area as well as our commitment to being a top tier provider of surgical products for bone and soft tissue procedures.” Mr. Ray’s announcement comes on the heels of the launch of Pioneer’s nanOss Bioactive 3D, the newest addition to its flagship bone graft product line, nanOss Bioactive.
Pioneer Surgical Biologics now offers a full line of synthetic bone grafts, human tissue products including machined lateral, traditional lumbar and cervical allograft, human demineralized bone matrix (DBM) bone grafts, as well as bone graft delivery accessories.
The Bigelow Laboratory for Ocean Sciences celebrated the opening of its Bigelow Center for Blue Biotechnology at a ribbon cutting ceremony Dec. 19.
The new 24,740 square foot research facility is the first part of Bigelow Laboratory's planned Ocean Science and Education Campus.
When completed, the Campus will have an additional two wings, the Center for Ocean Biogeochemistry and Climate Change and the Center for Ocean Health. The Center for Ocean Biogeochemistry and Climate Change is expected to open during the summer of 2012. The Center for Ocean Health, including new dock and shore facilities, will open later that year in November. Both wings are currently under construction.
The Bigelow Center for Blue Biotechnology is a multipurpose facility with four high-tech divisions: The Bigelow Single Cell Genomics Center a first-of-its-kind lab dedicated to DNA research on individual microbial cells, the Provasoli-Guillard National Center for Marine Algae and Microbiota, a facility with the world's first combined collection of marine algae, bacteria, archaea, and viruses; the J.J. MacIsaac Facility for Aquatic Cytometry, a "state-of-the-art" flow cytometry lab, and the Geomicrobiology Research Laboratory.
The two-and-a-half-year campus construction project will contribute $57 million to the local economy and create over 200 jobs, according to a press release from Bigelow. The completed facility will provide 223 jobs and $17.5 million annually to the regional economy.
Construction on the Bigelow Center for Blue Biotechnology began in fall 2010. The project was made possible by a combination of public and private funds, including a $9 million from the National Institute of Standards and Technology and $4.4 million from the Maine Technology Asset Fund.
In Nov. 2007, Maine voters approved the creation of the MTAF in a $53 million bond. Bigelow was one of 35 projects chosen to receive money from the new fund.
"We owe a huge debt of gratitude to the State of Maine," Bigelow Executive Director Graham Shimmield said.
IDBS has opened a new Healthcare Center of Excellence in Burlington, Mass. The Guildford, UK-based informatics firm said the center is "dedicated to the advancement of personalized medicines and improved patient outcomes through the delivery of advanced translational medicine and biomarker research informatics that bridge the worlds of clinical, molecular and image data."
Janssen Research & Development opened Janssen Labs, a 30,000-square-foot life science innovation center in San Diego located within the company’s Janssen West Coast Research Center. The facility will provide a capital-efficient, flexible lab environment for startup companies pursuing new technologies and research platforms, according to Janssen.
The following companies are the first to be selected to become residents of Janssen Labs: Diomics, which focuses on diagnostics, forensics, and DNA analysis; Neurolixis, which is working on small molecule drugs for CNS diseases; Tem Systems, which develops diagnostics to measure coagulation profile; and Yolia Health, an optometry device firm.
“A thriving biotech ecosystem is crucial for the success of the pharmaceutical industry as a whole,” notes Diego Miralles, M.D., site head for the West Coast Research Center. “Recent challenges in the economic environment have made it difficult for many emerging biotech companies. We believe that supporting and nurturing these companies will be good for the entire industry. By providing a flexible and cost-efficient way to test new ideas, Janssen Labs provides early-stage companies a way to overcome the typical hurdles faced by start-up companies, which are even greater in the current economic climate.”
The Janssen Labs will enable firms to license space and equipment like modular wet lab units on a short-term renewable basis. Companies would pay for the space they need and have an option to expand when they have the resources to do so. The firms will also have access to core research labs hosting specialized capital equipment and core administrative areas maintained by Janssen Labs operations management team.
“This arrangement allows the companies to focus on the development of the science instead of setting up and managing the labs,” said Miralles. “We believe this open innovation model will minimize cost and time and is an effective way for companies to develop and focus on research.”
Because Janssen Labs is an open innovation model, the agreement for the space does not grant Janssen any stake in the companies nor will the companies have a guaranteed future affiliation with Janssen. If either Janssen or a residing company is interested in furthering the business relationship, the process would be the same as for any external partnership or collaboration.
To date, the management team of Janssen Labs has received and reviewed more than 100 applications. Companies are evaluated based on criteria such as compelling science and/or technology, area of significant medical or market need, credible science/technology team, demonstrated financial solvency, etc. The applying companies represent diverse sectors across healthcare including biotech, pharmaceuticals, medical devices, instrumentation, and diagnostics. The facility can accommodate a maximum of 18 to 20 companies, and the application and assessment process will continue throughout 2012.
“We are pleased by the overwhelmingly positive response since we announced our plans to open Janssen Labs at San Diego a few months ago,” says Miralles. “Across sectors, stages, and geographies, entrepreneurs and startup companies are interested in this ‘no-strings-attached’ capital-efficient model to progress their scientific work. Our goal with Janssen Labs is to give novel technologies a greater opportunity to reach the patient by reducing some of the hurdles of early-stage discovery.”
The California Institute for Regenerative Medicine’s (CIRM) governing board approved spending $40 million to fund one or two Stem Cell Genomics Centers of Excellence in California. The aim is to create genomics resources for California scientists who might otherwise not have access to such resources.
“Access to genomics tools will give California researchers unprecedented opportunities for better understanding the cells they are working with and advancing those cells toward therapies for patients,” says CIRM president, Alan Trounson, who has been increasing CIRM’s focus on clinical development. “We expect these centers will lead California into the next generation of cell biology and medical applications, leveraging the incredible advances evolving from advances in human genomics.”
The governing board is also discussing recommendations for strategies to reach the objectives set forth in CIRM’s draft of a strategic plan for the next five years. The final version of the strategy will be presented to the governing board at a March meeting
SAFC, a business division of Sigma-Aldrich, is a custom manufacturer and services provider for pharmaceutical and biopharmaceutical companies.
The company develops and commercializes biological drug products and complex small-molecule active pharmaceutical ingredients (APIs).
The company supports all the stages of drug development from the pre-clinical stage to the commercial stage. It develops cell culture products, high-purity inorganic materials for technology applications, organic synthesis of APIs and key intermediates, biochemical production and biopharmaceutical manufacturing services.
SAFC is also involved in emerging technologies in the chemical-biological API conjugation, solid state chemistry research, high potency APIs and viral products.
The SAFC HPAPI Verona facility near Madison in Wisconsin, US, was opened in April 2010. It has been specifically built to meet the increasing demand for Phase III and commercial HPAPI requirements from pharmaceutical companies.
The company also has operations in St. Louis, Arklow, Gillingham, Buchs, Sheboygan, Bangalore, Carlsbad, Kansas, Jerusalem and Wuxi.
SAFC Madison project:
"SAFC, a business division of Sigma-Aldrich, is a custom manufacturer and services provider for pharmaceutical and biopharmaceutical companies."The new 51,000 sq. ft. current good manufacturing practice (cGMP) pharmaceutical manufacturing plant is located on a 15-acre greenfield site in the Verona Technology Park.
The land was acquired from Livesey Co. for $2.3m. Construction of the SAFC Verona facility was started in October 2008 and completed in December 2009.
The Verona Technology Park site was chosen for the new facility due to its proximity to the existing SAF plant and readily available infrastructure. It was built at an investment of $31m. The Verona facility is the second SAFC site in the Madison area, the other being a 63,000ft2 facility in the University of Wisconsin's Research Park. The Research Park Tetrionics 23,500ft2 facility was built in 2000.
It was acquired by Sigma-Aldrich in June 2004. The facility underwent a 38,000ft2, $12m expansion in 2006 for its current size. It has eight process development laboratories, eight GMP kilo laboratory suites, two HPAPI drying and packaging rooms, a 200l pilot plant suite, 400l pilot plant suite and 800l main pilot plant suite, analytical laboratories, one hydrogenation suite and a solvent storage area.
SAFC Wisconsin's Research Park facility has about 85 employees. The Verona facility will have 30 employees by 2013.
The project received seven-year, $1.2m tax incremental financing from the Verona's Common Council in October 2008 and $292,500 from the Wisconsin Enterprise Development Zone in tax credits.
Verona Technology Park-based facility:
The Verona site is a commercial-scale facility established to increase the production capacity of highly potent pharmaceutical ingredients. It has been designed, built and validated for safe handling and maximum efficiency of highly potent pharmaceutical ingredients.
The facility has two 200l mini processing reactor suites, two 2,000l reactors suite and two 4,000l reactors suites to produce the HPAPI compounds in batches. Other facilities at the plant include quality control laboratories specifically designed for HPAPIs, storage areas, a warehouse for refrigerated finished products and personnel offices. The facility design allows for future expansions.
Both of the Madison area facilities are dedicated to the production of primary, potent ingredients for the development of new and commercial production of pharmaceutical drugs.
The facilities produce HPAPIs for oncology and low-dose Vitamin D analogues for cardiovascular and autoimmune diseases.
The indications are expected to grow due to development of new potent compounds. The high potency market is also growing at a rate of double digits because of the advancements in clinical pharmacology and oncology.
SAFC outsources production from small and emerging pharmaceutical companies to major life-science corporations.
The manufacturing plant complies with the HPAPI containment and handling standards for category IV and cytotoxics compounds. It also meets the quality standards set by the US Food and Drug Administration (FDA) for pharmaceutical production.
"The SAFC HPAPI Verona facility near Madison in Wisconsin, US, was opened in April 2010."The facility received the SafeBridge Certification from SafeBridge Consultants in October 2011.
The certification was awarded based on the review of safety, health, training, management, communication and education programs at the facility.
Vogel Bros. Building was the lead design-build contractor for the SAFC Verona facility. Flad Architects was the designer.
Affiliated Engineers was the engineering consultant. General Heating and Air Conditioning provided the HVAC design and installation services for the facility.
SteriPack, an international company converting medical packaging materials and providing contract manufacturing, contract engineering, and ISO 17025 accredited testing services, has purchased a facility for its first U.S. based operations. The 40,000-sq-ft building sits on five acres in Lakeland, FL, near two international airports and major ports, reports Tony Paolino, president, SteriPack USA. The location positions SteriPack to serve both U.S.-based manufacturers looking to export as well as international firms seeking to serve the U.S. market, Paolino states.
“Many of the global medical device companies we have been servicing for the last 18 years have been urging us to fill out our global presence with a U.S. location,” he adds, referencing SteriPack’s existing facilities in Ireland, Poland, and Malaysia. “Many of these are in fact U.S. companies that have been using SteriPack elsewhere,” he adds.
The new facility in Lakeland, FL - SteriPack will fashion its Lakeland facility after those other locations. “We are gearing up to bring SteriPack’s concept to the United States,” Paolino explains, describing it as being “transparent with all the necessary monitoring and security. Our concept entails situating the office for operation management and support right in the cleanroom, allowing for immediate interface,” he says. “Visitors to the facility will be able to enter the lobby and look right into the ISO Class 8 cleanroom production facilities.”
Over the next several months, SteriPack will be installing what Paolino calls “the same equipment used in our other facilities, purchased to our specifications. We will also be following the same processing and quality standards, so that we offer customers consistency from facility to facility. Everyone wants back-up manufacturing today, so this new location will add to our ability to offer continuity of supply.”
The first lines will include slitting, cutting, and printing equipment for producing chevron-style and corner-peel pouches, header bags, and the firm’s Steribag, an alternative to header bags. “Using uncoated Tyvek and polyethylene, the Steribag can save users up to 15%,” he adds.
SteriPack USA will run the same equipment used in its other facilities to offer customers consistency.
Converting in Lakeland should begin by the end of Summer 2012, Paolino reports. “We should have two to three complete lines running, and the facility will be set up to be able to quickly expand,” he says.
The facility can also expand to accommodate contract packaging and manufacturing.
“Contract manufacturing will be driven by market demand, so today we are not sure what that will be yet,” says Paolino. “We provide injection molding and assembly services at our other locations, and we have also assisted customers with FDA 510(k) applications and CE marking. We are not afraid to make investments to meet customer needs.”
Contract engineering and package and material testing services may also be available in the future, as they are in Ireland and Poland.
SteriPack is also pursuing ISO 13485 certification, which Paolino expects to happen in time for the late summer opening.
SteriPack USA will situate operation management and support in the cleanroom, as it does in its other facilities.
Gary Leonard, SteriPack’s technical manager in Ireland, will move to oversee operations as vice president of operations in Lakeland. “He understands the DNA of our company,” Paolino says. In addition, Paolino expects to employ 20–25 employees.
Other SteriPack facilities continue to evolve, too. “Poland is on the cusp of expansion,” says Paolino. “And we just received our pharmaceutical license from the Malaysian governing body to store and pack pharmaceutical products on site, allowing us to offer blister packaging services of tablets and capsules for pharmaceuticals.”
Bayer HealthCare announced that it has opened a new, expanded facility for the Interventional franchise within its Medical Care's Radiology and Interventional business. Located at its Coon Rapids headquarters site, the new facility features new research and development laboratories as well as manufacturing cleanrooms. The Interventional franchise discovers markets and manufactures therapeutic medical devices for the treatment of vascular occlusions.
"This expansion nearly doubles our infrastructure in Minnesota, home of our Interventional franchise, and provides room for future growth in our cardiovascular and peripheral vascular disease device lines," said Alan Main, president of Bayer HealthCare's Medical Care business, which includes the Radiology & Interventional and Diabetes Care businesses of Bayer HealthCare.
The new building comprises roughly 80,000 square feet of space. Scientists and research technicians are now working in new laboratory space and the company plans to use new clean rooms to expand production of Cotavance®, a drug-eluting balloon for the treatment of peripheral artery disease presently approved for use in the European Union, as the company introduces it into additional markets.
Particle Sciences Inc. (PSI) has added a Brabender Mini-Compounder 12 mm twin-screw extruder, plus an ATR Torque Rheometer with single screw extruder for co-extrusion applications, to its development and production lines.
Mark Mitchnick, PSI’s chief executive officer, said, “The demand for cGMP extrusion is increasing. Needs range from hot melt extrusion for solid oral dosage forms to drug eluting devices. Particle Sciences is the leading CRO in this area having invested heavily in equipment, high potency compound handling infrastructure and proprietary modeling software. While there are several fine extruders on the market, Brabender Pharma has focused their 12 mm on the pharmaceutical development space. Its ease of cleaning, full cGMP compliance and extensive data capture capabilities make it a valuable addition to rapid product development efforts.”
Kevin Van Allen, Brabender Pharma’s vice president of sales and marketing, said, “Particle Sciences is an innovative leader in pharmaceutical extrusion and we are very pleased to be working with them. With the placement of the Mini-Compounder at Particle Sciences, Brabender Pharma clients will now have a U.S. site for evaluation and development of their APIs from early stage and into cGMP production, including highly potent compounds. As pharmaceutical extrusion processes are continually being refined, we feel that the 12 mm Mini-Compounder plus added co-extrusion capabilities will give PSI a world of future product development possibilities.”
CoreRx announced it has continued to expand its manufacturing capacity, adding an entire Cytotox processing suite, a low humidity processing suite, and two unique dedicated suites for both the Xcelodose® and the Quantos® at their new 35,000 sq. ft. facility nearing completion.
In early 2012, just five short years after starting their business, CoreRx Inc. will operate a new state-of-the-art dedicated potent and cytotoxic drug development space within its new facility. As part of CoreRx’s $5-million expansion, the new dedicated suite will provide total engineered containment of pharmaceutical processes through customized hard-wall isolation technologies.
“To meet our client’s growing needs, CoreRx is making a major capital commitment to enhance the services we are able to offer to our clients,” said CoreRx’s Vice President of Manufacturing, Mark Licarde. “In response to an increasing number of requests for the production of potent compounds, CoreRx is building a unique suite for handling of manufacturing processes associated with potent compounds.”
CoreRx’s new potent and cytotoxic facility will feature processing rooms that are complete with an independent entry and exit airlock and access to a dedicated equipment washroom and storage room. The ‘cyto-suite’ is designed for one-way flow of materials, personnel and equipment.
A dedicated air handler will bring in 100-percent outside air with HEPA-in and HEPA-out filtering at the rate of over 10,000-cubic-feet per minute and at least 24 air changes per hour. There are pass-throughs for the export of product and waste as well as dedicated equipment storage. Equipment and change parts will be dedicated exclusively to potent and cytotoxic use, and containment will be achieved at levels below 50 nanograms per cubic meter of room air.
After every campaign, CoreRx staff will conduct comprehensive health-based cleaning verification of shared surface areas. The isolated equipment that is permanently housed inside the potent facility will include:
Patterson-Kelly V-shell blender (0.5 to 16 quart)
Vector High Shear Granulator with 1L, 2L, 4L and 8L bowls
Vector FLM1 fluid bed dryer / top-spray granulator
Quardro Comil
10-station tablet press
Capsule filling devices
Tablet film coater.
As a provider of services in support of First-in-Man studies using the latest API-in-capsule technologies, CoreRx also has designed a set of suites for utilizing both the Capsugel Xcelodose® and the Mettler Quantos® for processing and encapsulation activities.
Finally, CoreRx is incorporating a suite for the production of products requiring low humidity.
All of which makes the new CoreRx facility unique within its industry. “CoreRx’s new facility will raise the industry bar in providing potent handling capabilities for clients,” said Brian McMillan, VP of Formulation Development. “Given the enormous growth in demand for potent handling capabilities, I am confident that our facility will attract clients because of the safety, security and reliability CoreRx offers for client studies and our employees alike.”
Because of its $5-million facility expansion, CoreRx is increasing staff, adding at least 55 pharmaceutical scientists and technicians, among them industry veterans with the experience to oversee projects from conception through completion. Dr. Todd R. Daviau, CoreRx’s President and CEO added “With the multitude of services being provided by our skilled formulation, manufacturing, analytical, and Quality Assurance teams, combined with our customer-centric focus, CoreRx’s business has been growing at an impressive rate. As confirmation, we were recently notified that we won the 2011 CMO Leadership Award recognized as a category leader for Reliability, Regulatory and Productivity. CoreRx scored this in three categories: Solids, Semi-Solids and Liquids. This new facility, and the added capabilities, will allow us to keep pace with our clients’ needs and continue our commitment to speed and quality in the services we provide.”
The CMO Leadership Award is based on industry research conducted by Nice Insight and presented by Life Science Leader Magazine.
A year after opening its US Innovation Center, Bayer HealthCare is opening the CoLaborator, a 550m2 shared lab for start-up life science companies whose technologies, drug targets or drug candidates align with Bayer’s portfolio.
Bayer Healthcare plans to open the CoLaborator by late summer in Mission Bay, California, US. It is expected to house three to four small companies.
‘The CoLaborator is a natural extension of our unique approach to research partnerships where we recognize that innovation is a collaborative process and focus on sharing risks and rewards – stepping beyond the confines of a traditional life science incubator,’ said Andreas Busch, member of the Bayer HealthCare Executive Committee and Head of Global Drug Discovery.
According to the California Biomedical Industry 2011 report from BayBio and the California Healthcare Institute, researchers at the University of California (UC) produce, on average, four new inventions a day, and UC develops more patents than any other university in the US. This high level of research productivity has resulted in 461 start-ups since 1976.
‘Mission Bay is becoming well known as a thriving zone for bioscience entrepreneurs, with 38 start-ups already on or around the UCSF research campus, but the demand for new start-up facilities continues to exceed our space,’ said Jeff Bluestone, Executive Vice Chancellor and Provost of the University of California, San Francisco (UCSF).
‘Bayer’s new incubator will augment that ecosystem, offering lab space and access to commercial knowledge to help more scientists translate their work into products that improve patients’ lives.’
With the CoLaborator, Bayer aims to help start-ups establish their research labs, with academic researchers spinning out new firms and venture capital groups being the likely sources of these companies.
In addition to lab facilities, access to the global expertise and equipment of Bayer’s research network will be available to CoLaborator scientists.
In return for low-cost, ready to use lab space and access to its global expertise, Bayer would seek preferred access to partner with the emerging companies.
NantWorks, a US-based company focused on scientific research and healthcare, will locate a new pharmaceutical manufacturing plant on former Pfizer property south of Terre Haute, IN, creating up to 234 new jobs by 2016.
The California-based company plans to invest US$85.5m to redevelop the former Pfizer facility on around 210 acres.
The new facility, called NantWorks Terre Haute is expected to be operational in 2015, and will produce critical care injectable and cancer drugs.
The Indiana Economic Development Corporation offered NantWorks up to $2m in conditional tax credits and up to $100,000 in training grants based on the company's job creation plans. These tax credits are performance-based, meaning until workers are hired, the company is not eligible to claim incentives.
Patrick Soon-Shiong is chairman and CEO of NantWorks. His net worth is estimated at $7bn, which he made by selling two drug companies in 2008 and 2010.
‘As a country, we need to develop and enhance our capabilities to manufacture injectable and next generation drugs in America,’ said Soon-Shiong.
‘This plant [in Vigo County] is a sign of NantWorks' commitment to that objective.’
NantWorks plans to convert the site to a pharmaceutical manufacturing for drug compounding, aseptic and terminally sterilized drug product filling, lyophilisation, laboratory operations, product development, research, process engineering and cleanroom operations.
Products to be manufactured include pre-filled syringes and vials.
Expected start-up date is 2015.
Boston Mayor Thomas Menino led a tour of the National Emerging Infectious Diseases Laboratory (NEIDL), better known as the Boston Univ. biolab. The tour was designed to highlight both the safety features and the prospective economic impact of the facility, which the city estimates at $98 million per year. NEIDL, one of only two biosafety level-4 labs in the country, has largely lain dormant since its completion in 2008 because of legal and regulatory hold-ups. Concerns stem from the fact that part of the facility would be used to study exotic, fatal infections including the Ebola virus.
Biolab backers say once the 192,000-square-foot, seven-story facility is fully operational it will have a total economic benefit of $98 million per year, including $45 million in research grants from agencies such as the National Institutes of Health. The project will create 297 new jobs, Boston Univ. administrators say, and 30 to 40 of those jobs have already been filled. Backers estimate that the facility will create an additional 380 ancillary jobs in retail, construction and other local industries. Menino says it would also be a boon for the local life sciences industry.
“There are great opportunities for collaboration between the private sector and the public sector,” Menino says. “We’re going to be able to attract more of the world’s renowned researchers to help find the cures to some of these diseases. We’ve always been an innovator in this area and this is another step forward.”
Boston Univ. recently received a waiver from state regulators to begin work in the less-controversial biosafety level-2 labs, which will include research on infections that are less contagious and for which there are available treatments, such as Dengue fever and measles. There are a number of other biosafety level-2 labs in the state, at both academic institutions and life sciences companies. Researchers already have grants in hand for BSL-2 work, which will begin within the next few months.
“We are looking to add three or four more teams of researchers to support the biosafety level-2 work in the next several months,” BU Associate Provost Ron Corley, who led the tour, says. Each team will include between 3 and 12 researchers.
Security features include hundreds of cameras throughout the facility, background checks for workers, and very limited access to only those areas where the researcher directly works. Stairwells between floors are off limits. Each floor has an eye scanner to identify the worker, and controls that prevent an extra person from “piggy-backing” on the entry of an authorized worker.
In terms of safety for the workers and the general public, researchers in the BSL-4 labs would have to wear $2600 space suits, breathe filtered air and take a seven minute chemical shower in the suit before leaving the most sensitive part of the lab. A negative air flow system is designed to drive any airborne agent back into the inner sanctum of the labs, rather than out into the corridors.
Menino struck back at critics of the plant, saying “We probably have more stringent rules and regulations of any city in the country.” Asked by reporters about incidents of spills at biosafety level-2 labs elsewhere at BU, Menino says, “BU reacted immediately, the Public Health commission reacted immediately, we put procedures in place to deal with the issues. We’re concerned about public safety.”
While the tour was billed as an opportunity for community leaders to view the safety and security features of the facility, there appeared to be only friendly organizations represented. BU officials say that a number of other organizations, some of which are skeptical about the safety of the plant, were invited but could not attend. The Conservation Law Foundation, the plaintiff in one of the two lawsuits opposing the lab, was not invited. BU officials say there would be future tours they could attend.
The National Institutes of Health is in the final stages of a risk assessment of the facility, which will include a public hearing in Roxbury. Once that is completed, BU can apply to the Massachusetts Environmental Protection Agency for permits for the biosafety level-3 and level-4 labs. BU spokesman Steve Burgay says he anticipates at that point the plaintiffs in the two pending lawsuits would ask the judges to review the risk assessment. He says it is unlikely the level-3 and level-4 labs would be up and running before 2013.
UK-based pharmaceutical major GlaxoSmithKline (GSK) has announced plans to invest A$60m to expand its manufacturing and drug development activities at its Boronia facility near Melbourne, Australia.
The facility is already GSK's largest in Australia and GSK's largest sterile manufacturing facility, and the expansion will see the creation of 58 new highly skilled jobs by 2017.
The investment will support the creation of a pilot-scale industrialization facility for the development of new powder and sterile-liquid pharmaceuticals, whilst the plant will also become accessible as a contract manufacturing facility for local companies.
The Boronia facility's core function is the company's 'blow-fill-seal' technology, an advanced antiseptic process used to create containers in differing sizes for the delivery of unpreserved sterile products.
Additional equipment, earmarked for purchase as per the investment, will allow GSK to potentially double the plant's current BFS capacity.
GSK contributes significantly to the local economy in Victoria, with the company offering employment and manufacturing, as well as spending an average of A$30m per year on local research and development.
Adimmune Corp, a vaccine manufacturer based in Taiwan, could be listed on the stock market by March, the company announced.
The company, which is in the process of completing the clinical test of an influenza vaccine in Europe with Netherlands-based Crucell, said that the Taiwan Stock Exchange approved its application.
The H5N1 vaccine has completed animal testing and will go into human testing in the second quarter of this year.
Adimmune is currently building a cell culture plant in the Central Taiwan Science Park in order to produce an Enterovirus 71 vaccine and vaccines against diseases such as dengue fever and Japanese encephalitis.
Construction on the facility is expected to be completed in 2014 and to start production in 2015.
Over 3 million vaccine doses are expected to be produced annually, which will generate NT$2 billion ($66 million) in production value per year, the company said in December last year.
Adimmune is in the process of completing a clinical test of an H5N1 vaccine in Europe.
McMaster University has $30 million to invest in stem cell research thanks to a generous donation by a local family.
The Marta and Owen Boris Foundation made the donation so the Hamilton University can build the $24 million Boris Family Centre in Human Stem Cell Therapies.
The centre will accelerate the commercial development of breakthroughs made at McMaster’s Stem Cell and Cancer Research Institute, where Mick Bhatia is scientific director.
“In a short time we’ve become world renowned for our human stem cell discoveries,” said Bhatia. “Now is the time to move these discoveries to the patient.”
The six-year-old institute is responsible for the ability to turn human skin into blood.
“It made perfect sense to make this investment in this world-class university,” said Les Boris, on behalf of his parents’ foundation. “McMaster University has proven its ability to fast forward discoveries from the lab bench to the patients’ bedside.”
Owen Boris was the founder of Hamilton’s Mountain Cablevision and before dying last April, he was negotiating the donation with McMaster. His family has now completed his vision.
The remaining $6 million will go towards a clinic where patients can see several specialists and have related tests completed during one visit.
“Too often patients go from office to office to receive essential medical care from several specialists,” said Dr. Akbar Panju, deputy chairman of the department of medicine. “This clinic will ensure they will get everything they need in one place.”
Aptar Pharma, world leader in the development and manufacturing of nasal and pulmonary drug delivery devices, announces the opening of a new facility near Mumbai, India.
Established in 1999 in Mumbai, Aptar Pharma is the market leader in India.
Aptar Pharma provides innovative and proven aerosol, spray and dispensing systems to biotechnology, healthcare and pharmaceutical companies in India.
Located at Rabale, Navi Mumbai, this new facility is the first of its kind. It will be key to furthering Aptar Pharma’s commitment to provide world class quality products coupled with the outstanding responsiveness requested by our Indian customers.
The facility will fully support our customers’ growth in the pharma market.
This new state-of-the-art manufacturing site was officially inaugurated on January 21st, 2012
This site includes an ISO 7 cleanroom where main production will focus on the DF30 metering valve platform for pMDIs and on spray pump assembly.
Currently Aptar Pharma India has some 30 employees. With the opening of the new Mumbai manufacturing site, this team will be reinforced with a number of different employment profiles.
Recognized as the market leader in Asia, including India, Aptar Pharma will become a key local employer and will continue to expand its activity, leveraging an in-depth network of local partners to forge strong links with a wide range of local players, including those in research, industry, academia and regulatory bodies.
“With the launch of the second Aptar Pharma manufacturing site in Asia, after Suzhou in China, we are on track to meet our main objective of better serving Indian customers by providing locally manufactured devices”, said Marc Prieur, President Aptar Pharma Asia. “This state-of-the-art manufacturing site, along with a highly skilled local team, shows Aptar Pharma’s strong commitment to the Indian Pharmaceutical industry”.
Shanghai Pharmaceuticals has bought a 70 per cent stake in ingredients developer and manufacturer Changzhou Kony Pharm in a bid to boost its standing in the API market.
Under the deal, the firm will gain access to Kony’s APIs (active pharmaceutical ingredients), produced for anti-virus and cardiovascular therapy areas – which are “new generation, high quality, high capacity, high efficiency ingredients with low pollution”.
In a press statement executive director and chairman Lu Mingfang said the investment will “optimize the pharmaceutical industry full value chain and achieve synergy” for Shanghai Pharmaceuticals.
Kony’s estimated revenue for 2011 is expected to hit $182m, and the firm forecasts rapid growth in the future.
Kony currently exports 50 per cent of its products to India, South America, Europe and the US.
Shanghai Pharmaceuticals says it will now consider extending its global reach by making the facility compliant with WHO (World Health Organization) good manufacturing practice (GMP).
“One has to be included in the WHO procurement plan in order to be a WHO GMP compliant. We would like to be if the opportunity arises,” the board member told us.
The news is the latest in a buyout spree for the firm after it unveiled plans to raise $550m (€418m) for acquisitions from investors including Temasek Holdings and Pfizer.
The spokesperson told us that up until recently, Shanghai Pharmaceuticals has had a relatively small involvement with APIs, but that we should expect more deals in the same vein as Kony and Jinhe biotech.
“Even though we have an integrated industry chain, Shanghai Pharmaceuticals develops a relatively small amount of APIs,” the spokesman told us.
“Our recent acquisitions of API companies can enrich our API product line. They can also accelerate our new launches as a base for our R&D and pilot testing.”
Mingfang added: “We believe that after our acquisition of Jinhe Bio-Technology, the takeover of Kony Pharma will help us optimize the pharmaceutical industry chain and achieve synergy, which will in turn drive our business growth as well as profitability and create greater value for shareholders and investors.”
He said the firm is now hunting further mergers and acquisitions.
Foster Delivery Science has added characterization services for solid dose drugs produced using the increasingly popular manufacturing technique hot melt extrusion.
The US firm – a specialist CMO that focuses on hot-melt extrusion - has set up a lab at its facility in Putnam, Connecticut that will characterize customers’ drug-polymer candidates using a range of thermal analysis, spectroscopy and chromatography techniques.
Company managing director Tony Listro said: “In the pharmaceutical industry there are really no other contract service providers that focus only on this process for solid dose drug delivery.
“The addition of in-house characterization services allows us to accelerate time to market for our customers with rapid data-based decision making throughout the development cycle.”
Excella has become the first company worldwide to achieve SafeBridge certification for the synthesis of potent ingredients and oral solid dosage (OSD) forms after the US manufacturing standards firm granted OKed it for API production
The certification – which applies to Excella’s facility in Feucht, Southern Germany and covers the production and handling of potent APIs – follows a detailed review of manufacturing operations, containment procedures and controls that took place late last year.
The plant is one of only nine worldwide to have met SafeBridge’s criteria for potent ingredient and Excella is only 11th manufacturer to have been grated such accreditation since the program was launched in 1999
In other manufacturing news New Jersey-based contractor Catalent has completed the expansion of its over-the-counter (OTC) dosage form facility in Italy.
The plant in Aprilia, central Italy produces a range of solubility enhancing products, including Catalent’s Vegicaps technology.
Swiss CMO RohnerChem has expanded its API process development capabilities through a partnership with German enzyme production technology specialist evocatal.
The aim is to provide a ‘cost competitive’ service process development for active pharmaceutical ingredients (API) synthesis that can be rapidly scaled-up and – according to the firms – reduce commercialization timelines.
The non- exclusive partnership – financial terms of which have not been disclosed – is similar to the deal RohnerChem agreed with analytical and solid-state chemistry services firm Solvias in October last year.
GlaxoSmithKline Pty Ltd. (GSK) will invest $60 million to expand its manufacturing and drug development activities in its Victoria, Australia base, creating 58 jobs by 2017.
Each year, the company spends $30 million on R&D in Victoria and exports $300 million in pharmaceutical products from the state.
GSK’s Boronia site in downtown Melbourne is also the company's largest site globally for the production of sterile and non-sterile liquid products that utilize blow-fill-seal (BFS) technology, an antiseptic process that produces container sizes suitable for the delivery of sterile product. The $60 million investment will allow GSK to potentially double its current BFS manufacturing capacity by installing new production technology.
The investment will also support the creation of a pilot scale facility for the development of powder and sterile liquid pharmaceutical products. The facility will support the continuation of GSK’s R&D collaboration with the Monash Institute of Pharmaceutical Sciences in developing next generation pharmaceutical products. GSK also plans to make the facility accessible for local companies for contract manufacturing, further supporting skills development and technology transfer opportunities for Victorian researchers and companies.
Medicago Inc., a biotechnology company focused on developing highly effective and competitive vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), announced it plans to invest approximately $4 million to enhance the capacity of the pilot production facility located in Quebec City. The Company expects this
investment to accelerate preclinical and clinical development timelines of future product candidates. This new investment includes capital expenditures and labor costs, as well as preclinical studies for a rabies vaccine and other products.
"Investing in our Quebec City facility is an important step for Medicago as we look towards expanding our product candidate pipeline," said Andrew Sheldon, President and CEO of Medicago. "We are happy to invest in our local community with the addition of approximately 20 new employees in 2012."
"We would like to thank CQDM for their past support of the VLP platform, which has allowed us to accelerate our discovery and development of new vaccines," said Louis-Philippe Vezina, Chief Scientific Officer of Medicago. "The VLP platform is now a key component in the development of our new products."
In 2009, Medicago was awarded $1.77 million in funding by the Quebec Consortium for Drug Discovery (CQDM) to support the development of VLP, an automated high-throughput platform enabling the rapid expression, purification and testing of VLPs to identify the best antigen presentations for a disease-causing agent within ten weeks.
"Medicago was one of the recipients of the first CQDM competition. Our financial support and unique collective approach allowed Medicago to strengthen its leadership position and increase its capacity to develop new products," said Max Fehlmann, President and CEO of CQDM. "We are very proud to be a part of Medicago's remarkable success. This reinforces the role of CQDM in promoting innovation and creating economic value for the research community in Quebec."
Medicago is a clinical-stage biopharmaceutical company developing novel vaccines and therapeutic proteins to address a broad range of infectious diseases worldwide. The Company is committed to providing highly effective and competitive vaccines and therapeutic proteins based on its proprietary VLP and manufacturing technologies. Medicago is a worldwide leader in the development of VLP vaccines using a transient expression system which produces recombinant vaccine antigens in plants. This technology has potential to offer more potent vaccines with speed and cost advantages over competitive technologies, enabling the development of a vaccine for testing in approximately one month after the identification and reception of genetic sequences from a pandemic strain. This production time frame has the potential to allow vaccination of the population before the first wave of a pandemic, and supply large volumes of vaccine antigens to the world market. Medicago also intends to expand development into other areas such as biosimilars and biodefense products where the benefits of our technologies can make a significant difference.
The Québec Consortium for Drug Discovery (CQDM) is a meeting ground for all stakeholders in biopharmaceutical research. Its principal mission is to fund research projects carried out in partnership between the academic and hospital milieus in the public sector and the pharmaceutical and biotechnology industries in the private sector. An innovative Canadian initiative, the CQDM has a twofold goal: to accelerate the drug discovery process and to develop safer and more effective drugs. Project funding is made possible through contributions from the Ministère du Développement Économique, de l'Innovation et de l'Exportation (MDEIE) du Québec, the Fonds de recherche Québec – Santé (FRQ-S), the Business-Led Networks of Centers of Excellence (BL-NCE), Pfizer Canada, AstraZeneca, Merck, Boehringer Ingelheim (Canada) Ltd., GlaxoSmithKline and Eli Lilly Canada Inc. For more information: www.cqdm.org
Catalent Pharma Solutions is expanding its drug development and delivery capabilities with significant investments at its Schorndorf, Germany facility. The expansion includes the addition of R&D and commercial scale fluid bed technology, OptiMelt hot melt extrusion, and elevated cGMP compliance for handling of OEB class 3 customer products.
“This expansion follows recent investments in OSDrC OPTIDOSE optimized controlled release dose delivery technology at our Winchester, KY site in the U.S., and Lyopan fast-dissolve lyophilized tablet technology, representing Catalent’s commitment to continue innovating and furthering its position as the industry’s leading global partner in oral drug delivery technologies,” said Dr. Ian Muir, president of Catalent’s Modified Release Technologies business.
Granules-Omnichem, a joint venture set up last year by Granules India and Ajinomoto Omnichem, says it will start construction in early February of a new active pharmaceutical ingredient (API) and intermediate manufacturing facility in Visakhapatnam, Andhra Pradesh, which is scheduled to start production in 2013. It will initially serve the needs of Omnichem's existing customers and eventually moving on to custom manufacture of new chemical entities.
Seaweed specialist Shemberg Marketing Corp of the Philippines is trying to forge alliances with pharmaceutical capsule suppliers to help develop softgel capsules based on seaweed constituents such as carrageenan. The company is already carrying out test production runs and hopes to have a commercial-scale process worked out within the next six months, it said.
Jabil Healthcare & Life Sciences (St. Petersburg, FL), which provides design and manufacturing services to the medical device industry, has created a unified European design engineering organization to combine capabilities and streamline processes for OEMs. The organization unites Jabil’s design centers in Hasselt, Belgium; Jena, Germany; and Vienna, Austria, under the leadership of Peter Landbauer, senior director of design engineering for Europe. The organization will offer services and features including project management; design engineering for high-precision mechanics, software, electronics, and optics; labs; and new product introduction services. Jabil has also opened a Class 1,000 cleanroom at its Vienna facility. The new capabilities will support the company’s design, process development, and prototyping of drug delivery devices, according to a press release.
SURAT: The city has taken a major leap in medical field. A stem cell hospital to be developed at a cost of Rs 90 crore will become operational within three years.
The entire project will be undertaken and financed by the government health department and Rs 30 crore will be released this year as the first installment.
The 160-bed hospital will also carry out extensive research on stem cell.
The seven-storey building will come up adjacent to the Cancer Research Centre in New Civil Hospital campus. The posts of microbiologist, pathologist, pediatrician and administrator have already been approved and process of recruitments is underway.
"We have already started work for constructing the laboratory. The entire project is going on at a good speed," said M K Vadel, superintendent of NCH.
San Diego, California-based Global Institute of Stem Cell Therapy and Research will provide the necessary technical assistance, train the local staff and assist in research activity.
"We are working on the design of the project which is the in final stage and once the grant is received we would start the construction work full steam. The project is being developed in Surat keeping the health issues related to tribals," said Vadel.
Sickle-cell anemia being a prevalent problem in the tribal belt of south Gujarat, research in using stem cell technology can help in controlling it, experts believe.
"Currently, the hospital will focus largely on sickle-cell anemia and spinal cord problems," added Vadel.
The NCH authorities are yet to get details about the treatment charges for citizens. The project will be another major development at the Surat NCH after initiation of leptospirorsis laboratory and cancer research.
Ingredient maker Dishman Pharmaceuticals has confirmed that it may offload its Chinese API (active pharmaceutical ingredients) factory.
Earlier this month Dow Jones Newswires reported that Dishman is in ‘advanced talks with a prospective buyer” for the facility at the Shanghai Chemical Industry Park, suggesting that failure to gain local regulatory approval promoted the move.
Dishman has pumped $20m (€15m) into the Shanghai plant since 2007, adding four segregated suites; two of which are dedicated solely to the production of category III HPAPIs (high potency API) with the plan being to supply drugmakers in Europe and the US.
The India-headquartered contract manufacturing organization (CMO) originally predicted that the facility would gain Chinese Food and Drug Administration (SFDA) approval for manufacturing in September 2008.
However, according to Dishman spokesman Christian Dowdeswell SFDA approval was not achieved in line with the expected timescale, which prompted the firm to start examining its options.
He told in-PharmaTechnologist.com that: “It is estimated that it will take up to 3 years for the SFDA to grant GMP status” adding that “Dishman is therefore working on two options.
“The first option is to retain the Shanghai plant for the production of category III HAPI (Safebridge Category III) and the second option would be to divest the Shanghai plant and focus on API manufacture in India."
Wisconsin-based colors, flavors and fragrances giant Sensient Technologies has signaled its ambitions in the fast-growing Brazilian food market with the opening of a new color and flavor complex in Jundiaí, Sao Paulo.
The new facility includes a state-of-the-art factory with production housed in a controlled environment, an application technology center, R&D laboratories for colors and flavors, a quality control laboratory, a warehouse and offices.
The facility will improve service to local food and beverage manufacturers, and significantly boost lead times, said chief executive Kenneth Manning.
“This new facility will enhance Sensient’s ability to participate in the expected growth of the Brazilian market. Sensient entered the Brazilian market in 2003 in Sao Paulo. This additional investment further supports our confidence in Brazil’s prospects and the potential of the South American market.”
Sensient, which recently opened a new CO2 extraction plant at its flavors HQ in Indianapolis, posted a 12.3% rise in diluted earnings per share to 64 cents for the third quarter ended September 30, 2011.
Its colors business reported a 6.8% rise in sales to $121m, driven by growth in natural colors, while operating income surged 14.2% to $22.9m.
Meanwhile, a strong performances from US flavors helped Sensient’s flavors & fragrances division post a 6.7% rise in sales to $221.2m and a 4.5% rise in operating profit to $33.6m.
Novartis has backtracked on its decision to close its OTC (over-the-counter) drug manufacturing plant in Nyon, Switzerland.
The company, who first announced it would shut the facility in October, now expects to spend $42m ($41.8m) over the next four years to bring the plant up to scratch.
Extra funding for has been taken from a planned pay rise for the 320 workers, some of whom will work an extra two and a half hours per week for no additional wages.
The firm has also received support from the local authorities, who will provide a “cantonal tax relief over a limited period”.
Granules and Omnichem have announced that work on their new manufacturing facility in Visakhapatnam, India, is expected to begin February 2.
The plant, a $30 million joint-venture between Indian-based Granules and Belgian Omnichem, is expected to be completed by the end of FY13.
It will target production for oncology, CNS (central nervous system) and cardiovascular drugs – a first for Granules’ portfolio offering.
"This 50:50 joint venture on high value low volume model will also open opportunity for us in formulations," said A. Bhaskar Krishna, CEO, Granules.
SGS has opened a second Life Science Services facility in Mumbai, India. The 15,000-sq.-ft. analytical lab establishes a dedicated GMP lab to provide a wide range of analytical development and quality control testing services. The new lab expands the company's current service portfolio in India by adding 10,600 ft3 of stability storage space. The facility offers the latest generation Q-TOF Quadrupole mass spectrometer for performing Extractables and Leachables studies. Also, in addition to microbiological testing, in-process sample testing and water system validation, the new site will also develop some capabilities to test biopharmaceuticals for mycoplasma and endotoxin.
“We are pleased that the realization of the Mumbai laboratory was done within a short timeframe," said Anne Hays, executive vice president for SGS Life Science Services. "This new analytical lab demonstrates SGS's commitment to serve the growing demand in the India market and to support the development of the top western pharma companies that have operations in Mumbai - many of which are already SGS clients in other regions"
The Facility of the Year Awards Judging Panel has named five Category Award Winners and selected one project for Special Recognition in the 2012 Facility of the Year Awards (FOYA) program. The winning projects for 2012 are located in Germany, India, Ireland, Italy, and the USA. The winning companies and respective award categories are:
- Chiesi Farmaceutici S.p.A., winner of the Facility of the Year Award for Sustainability for its Chiesi Farmaceutici Research and Development Centre facility in Parma, Italy
- Eisai Pharmatechnology & Manufacturing Pvt. Ltd., winner of the Facility of the Year Award for Project Execution for its Eisai Knowledge Centre facility in Visakhapatnam, Andhra Pradesh India
- Merck & Co., Inc., winner of the Facility of the Year Award for Facility Integration for its Merck Vaccine Bulk Manufacturing Facility (VBF) Program of Projects in Durham, North Carolina USA
- Rentschler Biotechnologie GmbH, winner of the Facility of the Year Award for Equipment Innovation for its REX III manufacturing facility in Laupheim, Germany
- Roche Diagnostics GmbH, winner of the Facility of the Year Award for Operational Excellence for its TP Expand project in Penzberg, Germany
- National Institute for Bioprocessing Research and Training (NIBRT), winner of the Facility of the Year Award Special Recognition for Novel Collaboration for its New Greenfield facility in Dublin, Ireland
The FOYA program is the pharmaceutical industry’s premier awards program dedicated to celebrating innovation and accomplishments in facility design, construction, and operation. The Facility of the Year Awards program recognizes state-of-the-art pharmaceutical manufacturing projects that utilize new and innovative technologies to enhance the delivery of a quality project, as well as reduce the cost of producing high-quality medicines. Now entering its ninth year, the awards program effectively spotlights the accomplishments, shared commitment, and dedication of individuals in companies worldwide to innovate and advance pharmaceutical manufacturing technology for the benefit of patients worldwide. The Facility of the Year Awards program is sponsored by ISPE, INTERPHEX, and Pharmaceutical Processing magazine.
“Our 2012 Category Winners reflect the true spirit of the Facility of the Year Awards program,” said Judging Panel Chairperson and upcoming “Lessons from 483s” conference keynote speaker Chaz Calitri. “The winning projects exemplify innovation in pharmaceutical manufacturing for the benefit of patients all over the world, who depend upon us for medications that are high quality, available and affordable. Our winners come from 5 different countries and include novel, low cost biologics facilities, creative and visionary industry-academia-government collaborations, and hyper-fast track investments made to ensure vaccine’s get to patients in need. We are also proud this year to recognize facilities that seek to speed up drug development as well as facilities that greatly reduce the environmental “footprint” of manufacturing in the communities in which they reside”
The Facility of the Year Awards program is truly global, as submissions over the past eight years have been received from more than 25 different countries and territories. Each of the submissions was reviewed by an independent, blue-ribbon judging panel consisting of global senior-level executives from all aspects of the industry. The judging panel met personally in December to select the Category Awards Winners and select the 2012 overall winner, which will be announced to the world for the first time at ISPE’s Annual Meeting in November.
2012 Facility of the Year Events - There will be several opportunities to learn first-hand about the facilities being honored as “best in their class.” These opportunities include:
- INTERPHEX2012 – Attendees will be able to meet the Category Award Winners at the Facility of the Year Awards Display Area near the front of the exhibit hall of the Jacob K. Javits Convention Center in New York City, New York, USA. Team members from winning companies will be on-hand to discuss the success stories associated with these pharmaceutical manufacturing facilities. More information, including registration information, can be found at www.interphex.com
- ISPE 2012 Annual Meeting – Category Winners will give presentations about their winning projects during ISPE’s 2012 Annual Meeting, 11-14 November in San Francisco, California USA. The highly anticipated announcement of the 2012 Facility of the Year Awards Overall Winner will also take place during the Keynote Session of this event. Information and updates on this global event can be found at www.ISPE.org
- Feature Articles – Comprehensive coverage will appear in Pharmaceutical Processing magazine and ISPE’s Pharmaceutical Engineering magazine.
Comprehensive details about each of this year’s award-winning projects and their support teams, plus additional information on the awards program itself, can be found at www.FacilityoftheYear.org
Quintiles announced the opening of a business process outsourcing (BPO) and project management center of excellence in Dalian, a major city in northeast China with a multilingual workforce and location ideally suited to serve the Japanese, Chinese and South Korean biopharmaceutical markets.
The Dalian office will provide data management, biostatistics, medical writing, pharmacovigilance, post-marketing safety surveillance and back-office support for administrative functions for global and local biopharma companies. The office also will support clinical operations for study sites in northeast China.
Dalian's strategic location and talent pool will allow Quintiles to provide clinical services in English, Japanese, Korean and Mandarin (Dalian's local workforce is not only multilingual but also has a cultural understanding of its neighboring countries), a valuable offering for both North Asian and global customers seeking to expand in the region or who want to ensure business continuity through resource diversification.
“Following the success of Quintiles' Bangalore BPO center, which has over 1,000 people supporting global studies, the Dalian Center of Excellence will provide a North Asia support structure for our growing business in Japan, Korea and China,” said Anand Tharmaratnam, Senior Vice President and Head of Asia Markets, Quintiles. “Furthermore, the Dalian team will be well-suited for clients seeking to diversify their outsourcing locations for business continuity assurance.”
Quintiles anticipates growing the center to 500 staff in the next several years once all services are fully established. It will be the company's fourth hub office in Greater China (in addition to Beijing, Shanghai and Hong Kong).
Pherecydes Pharma, a French biotechnology company specializing in the research and development of lytic bacteriophages for therapeutic and diagnostic purposes, has received funding of €900,000 from France’s General Directorate for Armaments (DGA).
The funding will part-finance the Pacoburns project, which is exploring the use of bacteriophages to combat bacterial infections that are resistant to antibiotics, especially skin infections.
The Institute of Genetics and Microbiology of the University of Paris XI and the Armed Forces Institute of Biomedical Research (IRBA) are also involved in this project. The University will handle electronic microscopy and bacteriophage sequencing, while IRBA will provide a mouse model adapted to the initial preclinical evaluations.
Using relevant animal models, Pacoburns will evaluate the therapeutic efficacy, safety and pharmacodynamics of two cocktails of bacteriophages.
The first is for infections caused by escherichia coli type bacteria, and the second for infections caused by pseudomonas aeruginosa, and more specifically for treating open burn wounds infected by these resistant germs. Trials on humans are scheduled to begin during 2013.
‘Despite optimizing the use of antibiotics, situations of therapeutic impasse are increasingly common in the case of multi-resistant bacteria,’ said Patrick Jault, head of the burns treatment centre of Percy military hospital near Paris, and the future coordinator of the multicentre trial in man.
‘It is thus essential to explore new avenues, and bacteriophages are one of the most promising. It is now crucial to evaluate their merits and their therapeutic potential in humans.’
The Pacoburns project will enable Pherecydes Pharma to speed up the development of its leading therapeutic products, in particular through facilitating their future evaluation in man by the major burns units of military and civilian hospitals. The company then intends to extend the topical application of its cocktails to other skin pathologies (such as varicose ulcers), after that to test new products administered by aerosol and lastly by the internal route.
The UK Medicines and Healthcare regulatory Agency (MHRA) has issued a Good Manufacturing Practice (GMP) certificate to AMRI’s plant in Holywell, Wales, following an inspection in October 2011.
The MHRA inspection follows a U.S. Food and Drug Administration audit of the facility in June 2011, in which no formal observations were issued. The successful completion of both inspections means that AMRI’s Holywell facility can now produce registered intermediates and active ingredients for use in humans and expands the range of projects that the contract manufacturer can now conduct at this facility.
AMRI received the formal closeout of the MHRA inspection this month. The certificate covers general GMP manufacturing operations, and laboratory controls designed for the production and release of active pharmaceutical ingredients (APIs) and intermediates. The successful audit confirms AMRI’s compliance with European Medicines Agency GMP regulations and further demonstrates the company’s commitment to operational quality.
Steven Hagen, AMRI vice president of pharmaceutical development and manufacturing, said: ‘This certification completes an excellent year of regulatory cGMP audits for the Holywell facility and places it in a prime position to attract new business.’
In 2010, the FDA inspected AMRI’s Rensselaer, New York facility, which provides large-scale cGMP manufacturing, and no formal observations were issued. In the same year, the Italian Medicines Agency (AIFA) approved the Burlington, Massachusetts facility to manufacture a commercial drug product for a customer in the European Union.
The Wallace Wurth Building is the most recognizable building at the Kensington Campus in the premises of the University of New South Wales (UNSW) in Sydney, Australia. The building is home to the teaching and research staff of the Faculty of Medicine at the UNSW.
It has been named after the first Chancellor of UNSW Wallace Wurth, for his contribution towards the establishment of the Faculty of Medicine at the UNSW.
The five-storey Wallace Wurth building is situated in the wing 'M' of the UNSW Campus. It is located in the corner of the campus and runs in the north and south directions along Botany Street and the High Street.
The biomedical research building is being expanded to create additional space for the academicians and students of the Faculty for Medicine to focus on research practices. Biomedical research at UNSW is focused and more practiced in the fields of neuroscience, molecular biology and pharmacy, epidemics, cardiovascular and cancer.
The new building will also house the National Centre in HIV Epidemiology and Clinical Research (NCHECR) which will be shifted from the Darlinghurst Campus.
The project was approved by the New South Wales Government in January 2011 and is currently underway construction. The project work commenced in August 2011 and is scheduled to be completed in March 2014.
The existing building is 12,800m2 in size. The expansion project will witness the addition of 10,000m2 to make way for a single building size of more than 22,800m2.
The facility's design will meet Green Star Education v1 star certification requirements. The existing facilities will be retained wherever possible and the ones that need to be changed will be refurbished.
The redeveloped building will have six levels with a roof plant excluding the lower ground floor and the floor above it.
The completed facility will accommodate 1,400 research staff and 700 students of the Faculty of Medicine's School and the Kirby Institute.
The redeveloped Wallace Wurth Building will complement the new Lowy Cancer Research Centre and the Biological Sciences Building that was completed recently at the UNSW Campus. It will facilitate sharing of knowledge and resources within the UNSW campus.
The facility houses wet and dry research areas for undergraduate and postgraduate medical teaching and research staff.
The ground floor and level one will be dedicated to the undergraduate medical teaching staff. It will comprise of the lecture and seminar rooms with audiovisual facilities, small group spaces, clinical teaching rooms and wet research area.
The lower ground floor has already been refurbished. It now has a new morgue with walk-in stainless steel cold rooms equipped with -20°C freezers. Special laboratory services and back-up generators will be stationed at this level.
Levels two to six will comprise of wet and dry research areas and also house a laboratory, write-up space and research equipments for use by the postgraduate students and academicians.
Other facilities at the renovated building will include special purpose areas such as animal facilities and administration and infrastructure support.
As of December 2011, the medical administration and gas store building located near the project site was demolished. The 'M' wing was vacated and hazardous materials removed from the wing. The facade and the internal partitions were removed from the wing to give way for expansion.
The new building has been designed by LahzNimmo Architects and Wilson Architects. Lend Lease was awarded the A$122.5m ($122.1m) project management contract for the expansion in June 2011.
Taylor Thomson Whitting and AECOM are the structural and mechanical engineers respectively. The morgue in the lower ground floor was refurbished by the Buildplan Group.
Other contractors signed for the project are Aurecon as electrical engineer, Design Coalition as lighting specialist, LHO Group as hydraulic engineer, Meinhardt as fire engineer, The ENTS as arborist and Spackman Mossop Micheals performing as landscape architect.
Roche's new R&D facility is located in Wettsteinallee near Basel, Switzerland. It was officially inaugurated in November 2011. Roche made an investment of $271m in the Wettsteinallee site.
"Roche's new R&D facility is located in Wettsteinallee near Basel, Switzerland. It was officially inaugurated in November 2011."Designated as Building 97, the new facility replaces one of Roche's older buildings - Building 60. The facility will be used for producing pharmaceutical formulations and also manufacturing samples for clinical trials.
The plant will employ 100 people who will be moved from Roche's plants at other locations. It strengthens Roche's presence in Basel where the company employs nearly 9,000 people.
Various functions of the pharmaceutical value chain already exist in Basel. The new plant will be an important addition to Roche's facilities and establish Basel as a global research and development centre.
The new plant will also help in increasing Roche's workforce in Basel. Several big pharmaceutical companies including Roche have been on a cost cutting spree due to increasing competition. Roche cut several sales and manufacturing jobs especially in the US in 2010.
Roche's R&D activities are centered on developing a new medicine which is safe, tolerable and stable. Once a medicine is discovered, further research is carried out to market the drug in the form of a tablet, capsule, liquid or a pre-filled syringe.
Formulation is an important step in the development of a medicine as it enables it to be administered to patients. It also enables the active ingredient in the medicine to reach its target and optimizes the amount of time it stays in the patient's body.
The new facility will specialize in this research and help bring innovative drugs to the market. It will carry out R&D to transform new active substances into various solid and liquid dosage forms. The plant will also produce samples of new investigational drugs to be used in global clinical trials.
The new R&D facility was designed to blend in with the existing buildings in Wettsteinallee. A glass facade similar to Roche's other buildings was, therefore, not chosen for the plant.
The design of the facility is clear and compact featuring ribbon windows and white parapets. Its architecture is based on the Bauhaus tradition.
The northern part of the facility is spread over four stories and is 20m high. The southern part includes nine stories and is 40m high. Gross floor area of the building is 22,705m2 (244,306 sq. ft.).
The main structure of the R&D plant was constructed out of steel and reinforced concrete. It is capable of supporting heavy loads of up to 35t.
The plant includes 670 rooms including 239 cleanrooms and features 42km of piping and 676km of cabling. It also includes three basement stories. The facility has been designed to be energy efficient and earthquake resistant.
Construction activities at the Wettsteinallee site commenced in August 2008 with the demolition of Building 60. In January 2009, Roche laid the foundation stone for the plant.
The plant required pouring of 32,500t of concrete, use of 1,750t of steel reinforcement and 530t of steel girders. For the construction of the basement, 25,000m3 of material was excavated. A major part of the supporting structure was prefabricated enabling construction to be completed quickly.
Contractors with a role in Roche's Swiss R&D facility project:
The main engineering contractor for the facility was M+W Process Industries. The company was also responsible for HVAC, process and mechanical engineering and clean room engineering.
"The facility will be used for producing pharmaceutical formulations and also manufacturing samples for clinical trials."Herzog & de Meuron was the architect for the project. The company also provided planning and construction development services.
Structural engineer for the facility was ZPF Ingenieure. Proplaning Architekten was the quantity surveyor.
Dr. Heinekamp Labor und Institutsplanung was responsible for laboratory engineering. IB Albrecht was responsible for plumbing engineering services. KIWI Systemingenieure & Berater, Dübendorf was responsible for providing electrical engineering services.
Emmer Pfenninger Partner was the facade consultant for the project and Zimmermann + Leuthe was responsible for the building physics.
Fire protection and safety consulting services were provided by Sicherheitsinstitut. Martin Lienhard was responsible for designing the building acoustics.
Indian pharmaceuticals manufacturing company Kilitch Drugs produces and markets drug formulations in solid, liquid and parenteral dosage forms. The company owns two formulation manufacturing plants in India, one in Paonta Sahib in Himachal Pradesh and one in Navi Mumbai in Maharashtra.
The Paonta Sahib facility is spread over 14 acres and has a built-up area of 230,000 sq.ft. It contract manufactures sterile injectables.
In October 2011, Kilitch signed an agreement to sell certain assets to US-based pharmaceutical company Akorn, including the Paonta Sahib facility, a few products from the Navi Mumbai plant and its NBZ Pharma affiliate.
Under the agreement, Akron will pay $52m and make future contingent payments up to $6m. Approval from the Indian regulatory authorities is expected in early 2012. Once granted, the Paonta Sahib facility, along with its contract manufacturing and international business, will become a part of Akorn.
The Paonta Sahib facility includes five blocks, of which two are operational and three are under construction.
"The Paonta Sahib facility includes five blocks, of which two are operational and three are under construction."The two blocks in operation are dedicated to the manufacturing of cephalosporins and general injectables. Operations in the blocks under construction, which will be known as Hormones block I, Hormones block II and Carbapenem block, are scheduled to start in 2012.
The cephalosporins block is spread over 69,122 sq. ft. and has 62 air-handling units, one for each critical process, while the general injectables block occupies 30,773f sq. ft. and has 49 air-handling units. The latter is being expanded to include ophthalmic capabilities.
Each block has two floors, with a mezzanine floor in between the two. The ground floor houses the personnel entrance and production equipment. Pipelines, cable trays and ducts run in the mezzanine floor. The air-handling units are housed in the first floor.
All the core areas in the plant have monolithic epoxy flooring and a walkable RCC ceiling. The rooms are separated by modular prefab partition internal walls.
The Paonta Sahib facility has been built to meet the US and European standards. It complies with cGMP requirements, and a building management system has been put in place to maintain environmental control.
CCTV, a public address system, an access control system and a fire detection system support the security and safety functions at the plant.
There is a dedicated air-handling unit to feed filtered fresh air to all the other air-handling units in the plant. Active and non-active active pharmaceutical ingredients have separate dispensing areas.
The personnel working in the core production area have segregated changing rooms, and there is an air shower facility for personnel working in the cephalosporins plant.
"Kilitch undertakes contract manufacturing for over 20 pharmaceutical companies including Ranbaxy Laboratories, Sandoz India, Zydus Cadila, Nicholas Piramal India, USV and Merck."The cephalosporins block is used to manufacture dry-powder injectables, dry syrup, tablets, capsules, ready mixes and sachets. It has a production capacity of about 570 million units per year.
The general injectables block produces liquid injectables in vials and ampoules, dry-powder injectables and prefilled syringes. It has an annual capacity of 187 million units.
Hormones block I will be used to manufacture tablets, oral liquids in bottles and sachets, soft gelatine capsules, dermal patches and vaginal ointment. Hormone block II will be used to produce liquid injectables in ampoules/vials and lyophilized ampoules/vials, while Carbapenem block will manufacture dry-powder injectables and dry powder tablets.
Kilitch undertakes contract manufacturing for over 20 pharmaceutical companies including Ranbaxy Laboratories, Sandoz India, Zydus Cadila, Nicholas Piramal India, USV and Merck.
It has product registrations in over 25 countries in Latin America, Asia, Middle East, Europe and Africa, and its portfolio consists of about 300 formulations.
The acquisition of the Paonta Sahib plant, along with its clientele, will enable Akorn to enter the growing Indian pharmaceutical market. Akorn plans to tap the domestic demand for anti-infectives and cancer drugs as well as grow in the global general injectables manufacturing market.
Akorn currently has two manufacturing facilities in the US, in Decatur, Illinois, and Somerset, New Jersey. It produces ophthalmic and injectable pharmaceuticals at these locations.
SGS’ new analytical lab in Mumbai, India will open later this week just six months after the analytical services firm began its construction.
The 15,000 sq.ft. lab – SGS’ second in the country and 18th worldwide – houses 10,600 sq. ft of space for product stability testing, a Q-TOF Quadrupole mass spec for extractables and leachables analysis as well as capabilities for microbiological sampling.
SGS said the investment was motived by growing demand from both local companies and multinationals for the analysis of innovative and generic drug products and added that the decision to set up the facility has already generated business.
“As a result of its initiative to open the new facility, SGS recently entered into a preferred partnership with one such multinational pharmaceutical firm with a Mumbai subsidiary.” Specifics of the deal were not disclosed.
SGS said it also plans to develop mycoplasma and endotoxin testing capabilities for biopharmaceuticals at the site – which fits with its previously stated aim of becoming a leader in biodrug testing by 2014.
Company executive VP Anne Hays said: “This new laboratory demonstrates SGS’ commitment to serve the growing demand in the Indian market and to support the development of the top western pharma companies that have operations in Mumbai.”
The opening in Mumbai will come just a few days after SGS posted a pretty decent set of annual results – with profits climbing 4.9 per cent to SFr534m ($562m) in 2011. Revenue for the year increased 13.7 per cent to SFr4.8bn.
Of this life science services contributed SFr192m, up just under 12 per cent on last year driven, according to SGS, by laboratory activities which now generate around half of the divisions earnings.
SGS said: “Overall margins for the laboratories have remained stable, with good profitability improvements in the UK, USA, India and Singapore.”
However, in Western Europe the story was different. SGS described the market for bioanalysis services as ‘tougher’ as a result of overcapacity.
It added that: “Startup costs were also incurred during the period to expand our services into new activities such as immuno-analysis and biomarkers.”
SGS’ clinical research business also has a tough time of it in 2011 with continued weak demand for its early-phase services business as a result of delay investments by customers. Late-phase activity - in contrast - increased.
The Scottish central lowland region has boosted its available space for hosting life sciences companies after MSD, which operates in the US and Canada as Merck, donated a research facility to house BioCity Scotland, a joint life sciences biopark and incubator venture run by BioCity Nottingham and the Roslin BioCentre.
Located between Glasgow and Edinburgh, the facility in Newhouse, Lanarkshire will provide over 130,000 square feet of labs on a 23 acre site that will house and support bioscience, pharmaceutical, medical technology, and healthcare companies.
BioCity Scotland provides research and development facilities, including processing, storage, equipment, business, and financial support to start-up companies.
"BioCity Scotland is much more than a property proposition — it will be a unique, vibrant community of scientific companies," BioCity Scotland Chairman Louis Nisbet said in a statement.
"The ongoing commercial operation of the site will attract investment to the local area generating employment opportunities for local communities and the success of this development will play a significant role in securing the future of Life Sciences in Scotland," added Chris Hill, MSD VP and former head of the MSD Newhouse facility.
Thermo Fisher Scientific Inc. announced that it has activated its global Food Safety Response Center, located in Dreieich, Germany.
The activation follows the U.S. Food and Drug Administration (FDA) announcement on Jan. 10, 2012, that it will begin testing shipments of imported orange juice from all over the world for the fungicide carbendazim.
Scientists at the Food Safety Response Center are working around the clock to develop a method for detecting carbendazim in orange juice. Once developed, the detection method will be made widely available to the food testing industry.
“Our Food Safety Respond Center is activated when we identify a credible food-related threat anywhere in the world,” said Vincent Paez, director of food safety at Thermo Fisher Scientific. “Now that the threat is known, our scientists are working to develop a new analytical method for detecting carbendazim in fruits so that the industry can respond as quickly as possible.”
Molecular Profiles has begun construction of a new manufacturing facility at its site in Nottingham, investing $13.8 million to expand its current manufacturing capabilities. The expansion covers all services including formulation development, polymorph and salt selection, analytical services, materials characterization and clinical trial manufacturing.
The new GMP facility, planned to open in late 2012, will provide an additional 30,000 sq. ft. of space, including six new GMP suites, new labs and a clinical packing suite. The facility will have capabilities to manufacture highly potent compounds up to OEB 4 level, as well as handle dosage forms including solids, liquids, semi-solids and inhaled products. The expansion allows the company to cover Phase I and II trial requirements with manufacturing batch scale of 30kg.
Nikin Patel, chief executive officer of Molecular Profiles, said, “The construction of significantly larger manufacturing and laboratory facilities is a strategic decision based on customer demand. Our strategy for expansion is well underway and securing the regional growth funding is a clear endorsement of our strategic growth plans. Following our double win of the Queen’s Award in 2007 and 2011 in the category of innovation, we have once again affirmed our ambition and continuous development.”
The Institute for Animal Health in Pirbright, UK has opened a new £10 million ($15.3 million) interim high containment lab to support its research on dangerous pathogens while the institute completes a project to build a larger, £100 million lab that should be completed in 2014.
The new Interim SAPO (Specified Animal Pathogens Order 1998) 4 Laboratory, or IS4L, will support IAH's core efforts to study animal virus diseases such as foot-and-mouth disease (FMD), African swine fever (ASF), and African horse sickness (AHS), and which use genomics, proteomics, and bioinformatics technologies.
The IS4L was built to replace the main lab at IAH, which was closed down in 2007 following an outbreak of foot-and-mouth disease at Pirbright that was contained, IAH said recently.
"This facility will ensure work on AHS, ASF and FMD can continue under the best conditions possible," Michael Johnson, head of estates at the IAH, said in a statement.
The £10M for the IS4L lab was provided by the Biotechnology and Biological Sciences Research Council and by the Department for Environment, Food, and Rural Affairs (DEFRA).
IAH said that the new lab has a secondary monitoring system that interrogates the primary building management system with real-time information on critical controls, such as air pressure and filtering systems, in order to ensure that no pathogens can escape into the environment.
"This is critically important to our work," Johnson said. "We want to make sure we are operating safely within the laboratory and so we have a number of layers of protection between ourselves and the environment."
The IAH also has undertaken a second £100 million-plus campaign, for which it has already secured £80M, to build more high containment labs, experimental facilities, and infrastructure for studying avian and other animal diseases.
BBSRC Chief Executive Douglas Kell sees the investment at IAH as an economic boost to the Pirbright region.
"The new facilities for studying avian and other diseases will help to protect huge sectors in the UK economy and protect hundreds of thousands of jobs that would be at risk during an animal disease outbreak," he said in a statement when the latest funding round was announced last fall.
BioCity Scotland, a joint venture between BioCity Nottingham and Roslin BioCentre in Midlothian, has acquired the former MSD research facility at Newhouse, Lanarkshire. The plan is to turn the site into a dedicated base in central Scotland for bioscience, pharmaceutical, medical technology and healthcare companies.
MSD closed the site in 2010 with the loss of 250 jobs following its £30m takeover of Schering-Plough.
The site includes 130,000 sq. ft. of purpose-built laboratories on the 23-acre site, which are capable of supporting pre-clinical drug discovery and development by a range of independent companies. It will complement the existing provision of space for life science firms in Scotland by catering for start-up and growing companies wanting a central base on the M8 just 15 miles from Glasgow and 33 miles from Edinburgh city centers.
In addition to the laboratory and office space, BioCity Scotland provides access to state-of-the-art equipment, including high-throughput screening, nuclear magnetic resonance machines, mass spectrometers, HPLCs, electrophysiology and cell culture suites, centrifuges and freezers, which will be available to rent at competitive rates.
A compound management system and a library of 100,000 compounds is also part of the offering.
BioCity Scotland chairman, Louis Nisbet said, “BioCity Scotland is much more than a property proposition – it will be a unique, vibrant community of scientific companies. Just a short drive from Scotland’s two largest cities, it is ideally situated to attract the cream of life science talent. BioCity Nottingham’s success in nurturing and growing more than 70 new companies since 2003, and Roslin’s expertise in life sciences innovation and facilities management makes this team the perfect commercial partnership. The work starts now, the prospects are boundless.”
Chris Hill, MSD vice president and the former head of MSD’s Newhouse facility, said, “This is a fantastic outcome for the life sciences community in Scotland and the wider UK. The ongoing commercial operation of the site will attract investment to the local area generating employment opportunities for local communities and the success of this development will play a significant role in securing the future of life sciences in Scotland.”
Beginning Jan. 17, NASA will fly an airborne science laboratory above Canadian snowstorms to tackle a difficult challenge facing the upcoming Global Precipitation Measurement (GPM) satellite mission- measuring snowfall from space.
GPM is an international satellite mission that will set a new standard for precipitation measurements from space, providing next-generation observations of worldwide rain and snow every three hours. It is also the first mission designed to detect falling snow from space.
"Snow is notoriously hard to measure as it falls," says Walter Petersen, the GPM ground validation scientist at NASA's Wallops Flight Facility in Virginia. "Snowflakes contain varying amounts of air and water, and they flutter, wobble and drift as they leave the clouds."
Knowing how "wet" a snowflake is allows scientists to measure overall water content. A wet, heavy snow can shut down a city, and melted snow is a crucial source of freshwater in many areas.
Working with Environment Canada, NASA's GPM Cold-season Precipitation Experiment (GCPEx) will measure light rain and snow in Ontario from Jan. 17 to Feb. 29. The field campaign is designed to improve satellite estimates of falling snow and test ground validation capabilities in advance of the planned launch of the GPM Core satellite in 2014.
NASA's DC-8 airborne science laboratory will fly out of Bangor, Maine, carrying radar and a radiometer that will simulate the measurements to be taken from space by GPM. At an altitude of 33,000 feet (10 km) the DC-8 will make multiple passes over an extensive ground network of snow gauges and sensors at Environment Canada's Center for Atmospheric Research Experiments north of Toronto.
The GCPEx field experiment will help scientists match measurements of snow in the air and on the ground with the satellite's measurements.
"We will be looking at the precipitation and the physics of precipitation, such as snowflake types, sizes, shapes, numbers and water content," Petersen says. "These properties affect both how we interpret and improve our measurements."
GPM's Core satellite is being built at NASA's Goddard Space Flight Center in Greenbelt, Md., with instruments provided by NASA and its mission partner, the Japanese Aerospace and Exploration Agency (JAXA). The spacecraft will orbit Earth at a 65-degree inclination, covering the world from the Antarctic Circle to the Arctic Circle.
GPM will carry a microwave radiometer and a dual-frequency precipitation radar that distinguishes a snowflake's size and shape, which affects how much water it holds. Knowing these microphysical properties will lead to more accurate estimates of rain and snowfall, especially during winter and at high latitudes where snow is the dominant form of precipitation.
The Ontario region is prone to both lake effect snow squalls and widespread snowstorms. If the opportunity exists, the DC-8 also will fly over blizzards along the northeastern United States. While the DC-8 flies above the clouds, two other aircraft, one from the Univ. of North Dakota and another from Canada, will fly through the clouds, measuring the microphysical properties of the raindrops and snowflakes inside.
Advanced ground radars will scan the entire air column from the clouds to the Earth's surface.
"These multiple measurements of snowfall provide a complete picture, a complete model, of the snowfall process from top to bottom," Petersen says.
Source: NASA
The Sanford Consortium for Regenerative Medicine (SCRM) inaugurated a new stem cell research facility in La Jolla in the state of California, US, in November 2011. The project broke ground in March 2010 and required an investment of $127m. The facility will carry out stem cell research to develop new medicines for various diseases.
SCRM is a non-profit consortium formed by five research institutions including the Sanford Burnham Medical Research Institute, the Salk Institute, the Scripps Research Institute, the University of California, San Diego (UCSD), and La Jolla Institute for Allergy and Immunology.
The research institutions in the consortium are known for their scientific excellence and supported by 14 Nobel Prize winning scientists.
Basic research carried out by these institutions has created more than 200 spin-off companies and brought 24 new products to the market.
The new facility, also termed Collaboratory, will enable these five institutions to share their research work and enhance stem cell knowledge. It will help in developing new therapies to fight various diseases, repair damaged organs and fix spinal cord injuries.
SCRM was originally founded in 2006 as the San Diego Consortium for Regenerative Medicine. In September 2008, T Denny Sanford, a businessman and philanthropist, donated $30m to the consortium.
In the honor of this donation, the San Diego Consortium for Regenerative Medicine was renamed as the Sanford Consortium for Regenerative Medicine.
The main goal of the consortium is to invent research tools which will aid in stem cell research and lead to discovery of new diagnostics, therapies and cures for chronic diseases and injuries.
The consortium will focus on different research areas such as stem cell growth and differentiation neuroscience, cardiovascular biology, hematopoiesis and vision science.
"The Sanford Consortium for Regenerative Medicine (SCRM) inaugurated a new stem cell research facility in La Jolla."The new research facility has been built on a 7.5 acre site located next to the Salk Institute and UCSD. It is spread over four-stories and has a total area
of 150,000 sq. ft.
The facility has space to house 335 scientists, research labs featuring movable equipment, administrative areas, a 16,000 sq. ft. vivarium, office space and two two-story break rooms.
It also has conference rooms, a 150-seat auditorium and an enclosed space for observing plant and animal life. The facility provides access to animal models of disease, advanced imaging and robotics equipment, as well as protein and nucleic acid analysis.
The design of the facility encourages interaction among the scientists and helps in knowledge sharing. The research areas face each other, creating opportunities for scientists to meet and exchange ideas.
The shared two-storey break room at each end of the building also assists in idea sharing. The stairway of the facility has also been designed to encourage interaction. They connect the research labs on various levels, enabling scientists to meet and interact.
Financing the Sanford Consortium for Regenerative Medicine's stem cell research facility
Construction of the facility was financed through state and private funds. The project was awarded $43m facilities grant award from the California Institute for Regenerative Medicine. It also received $65m from the sale of tax-exempt bonds.
Private funding came in the form of the $30m donation made by T. Denny Sanford.
The facility has incorporated several sustainable features into its design which conform to the LEED Gold certification standards.
"SCRM was originally founded in 2006 as the San Diego Consortium for Regenerative Medicine."The design allows natural daylight into the facility improving the energy efficiency. It also features shading devices, displacement ventilation and low-flow plumbing fixtures.
Certified wood has been used in the construction of the facility. Use of potable water has been eliminated for irrigation, increasing efficiency of water-usage by 40%.
Alternative transportation and public transit are encouraged by incorporating changing rooms and facilities in bikes parking area.
The facility was designed by Fentress Architects in collaboration with Davis Architects. The development was handled by a consortium of Lankford and Associates and Phelps Development.
HOPE Engineering provided structural engineering services for the project and Hensel Phelps Construction was the general contractor. Jacobs' Consultancy-GPR was the lab programmer.
ShangPharma, a China-based R&D outsourcing company, has opened a new facility to meet the growing needs of one of its largest customers, Eli Lilly. ShangPharma also announced that it has signed a multi-year extension of its contract with Lilly.
The newly opened facility adds 110,000 sq. ft. of laboratory and office space to the company's overall capacity, and is fully dedicated to supporting Lilly's ongoing and future projects. ShangPharma's services consist of discovery chemistry, discovery biology and preclinical development, pharmaceutical development and biologics services.
"We are delighted to extend and deepen our highly productive relationship with Lilly," said Michael Xin Hui, founder and chief executive officer of ShangPharma. "Renewing our agreement to serve as a key support partner for Lilly's discovery services is a clear indication that international pharmaceutical companies appreciate the high quality of ShangPharma's team and the excellence of our R&D capability."
Zhongxi Sunve has bought a stake in a Chinese oncology API manufacturer and has further takeovers in the pipeline.
Buying a 51 per cent stake in Shanghai-based Jinhe Bio-Technology gives Zhongxi Sunve a foothold in the market for oncology APIs (active pharmaceutical ingredients). Having agreed the deal Zhongxi Sunve will shift its focus to other takeover targets and expects to make more acquisitions ‘soon’.
“We will continue to…capitalize on opportunities presented by the industry consolidation to seek potential acquisitions in order to enhance our investment value”, LU Mingfang, chairman of Shanghai Pharmaceuticals, the parent company of Zhongxi Sunve, said.
Zhongxi Sunve lists APIs for cardiovascular, diabetes and other diseases in its portfolio and is now investing in Jinhe Bio-Technology to strengthen its presence in oncology. Jinhe Bio-Technology manufactures irinotecan, podophyllotoxin, docetaxel and paclitaxel APIs in China.
Shanghai Pharmaceuticals plans to add capabilities having bought the stake. “The investment mainly covers the construction of new plants that meet China's good manufacturing practice and US Food and Drug Administration requirements”, Shanghai Pharmaceuticals said in a press statement.
In September Shanghai Pharmaceuticals expanded its antibiotic business through the acquisition of Shanghai New Asiatic Pharmaceutical. Shanghai Pharmaceuticals made another acquisition, of CITIC Pharmaceutical, in April. A 2011 interim company report called for acceleration of takeover activity.
Shanghai Pharmaceuticals also has a memorandum of understanding with Pfizer for the “registration, commercialization and distribution of an innovative drug” developed by the big pharma. The deal was made in the first half of 2011 and Shanghai Pharmaceuticals hopes its scope will expand in time.
China-based Shanghai Pharmaceuticals listed on the Hong Kong stock exchange in May 2011, raising HK$16bn ($2bn), but since then its share price has halved. Shares in Shanghai Pharmaceuticals closed up very slightly following news of the investment in Jinhe Bio-Technology.
Over the first half of 2011 Shanghai Pharmaceuticals’ drug manufacturing business achieved sales of RMB4.2bn, a double-digit year-on-year increase, but operating margins slipped. Margins will face further pressure as expected increases to manufacturing costs take effect.
“Manufacturing costs will surge substantially under pressure from eco-friendly measures, rollout of new GMP and the increase in raw material prices, transportation costs and salaries”, the company said in its 2011 interim statement.
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