Sure Laboratories is an independent clinical cytogenetics service laboratory providing dedicated microarray-based comparative genomic hybridization (arrayCGH) screening for detection of copy number imbalance and aneuploidy.

Established in early 2010 by BlueGnome – the specialist developer of microarray solutions for human cytogenetic investigations – the laboratory has rapidly established itself as the leading provider of clinical arrayCGH screening services, thanks to its combination of low cost, rapid turnaround of results and a team of highly trained specialist staff.

Independent fertility specialist CARE Fertility Group is already taking advantage of Sure Laboratories pre-implantation genetic screening (PGS) service using the breakthrough 24sure technology, as Managing Director Dr. Simon Fishel explained: “We are very happy with the excellent customer service we receive from the dedicated team at Sure Laboratories. Their unmatched service quality, combined with the industry leading, proven 24sure technology, ensures rapid sample analysis, significantly enhancing implantation rates while minimizing the risk of multiple pregnancies for our patients.”

Sure Laboratories has been designed from the ground up to provide a broad range of cytogenetic tests, with purpose-built facilities and state-of-the-art workflows to ensure rapid turnaround of results and the highest quality standards, for both UK and international clients. The Company uses BlueGnome’s advanced CytoChip technology and industry-standard BlueFuse Multi software, and offers a library of over 26,000 fluorescent in situ hybridization (FISH) probes for crucial follow-up investigations.

“It is vital that microarray investigations are performed to the highest possible standards, and the rapid growth of Sure Laboratories supports our belief that this is best provided by a dedicated service organization,” commented Nick Haan, co-founder of BlueGnome and acting CEO of Sure Laboratories.

Bigelow Lab Expansion

A $50 million expansion/relocation of the Bigelow Laboratory for Ocean Sciences will mean improved facilities, five new hires, and possibly new equipment, for a component of the research institution, the Single Cell Genomics Center.

The genomics center will relocate from its current 700 square-foot space within Bigelow's existing facility in West Boothbay Harbor, Me., about 8 miles northwest to the 64-acre East Boothbay, Me., campus that will eventually house all of the laboratory's operations.

The first phase of that relocation is set for November 2011, when construction is completed on the $10 million first phase of the campus or Bigelow Center for Blue Technology, which includes SCGC and several other Bigelow facilities. There, the genomics center would occupy 1,100 square feet of laboratory space in a new building, plus offices and dedicated rooms for cryostorage and a computer cluster.

"First of all, the new space will enable us to maintain and expand our current research, which would be difficult in the current location," the director of SCGC, said Ramunas Stepanauskas. "In addition, the new space provides novel opportunities for technology transfer activities together with industrial partners."

While SCGC now occupies about 700 square feet of lab space, the size of the space is less a problem than its quality, according to Stepanauskas. SCGC's operations are now spread among three structures — a former truck garage and two modular houses — on the current campus, which Bigelow Lab leases from Maine's Department of Marine Resources.

"Not surprisingly, the infrastructure inside these buildings and the need for walking between the buildings with sensitive samples is not ideal for SCGC operation," Stepanauskas said. "The new facility will consolidate SCGC under one roof and will include state-of-art air handling for the SCGC cleanroom and a dedicated space for a computer cluster, both of which are critical to our work."

Stepanauskas is one of two senior research scientists within SCGC, whose workforce includes a research scientist, two postdocs, and four technicians.

"In the next five years we expect hires of two additional postdocs and three additional support staffers," Stepanauskas told GWDN.

SCGC's new space, he added, could see new equipment as well.

"Pending funding, additional equipment may include a greatly expanded computational center, a next-gen DNA sequencer, an anaerobe chamber, next-gen cell/liquid handling instrumentation, and additional sample storage capacity," Stepanauskas said.

SCGC's current equipment includes MoFlo (Beckman Coulter) and inFlux (BD) cell sorters; a BD FACScan cell counter; a FlowCAM imaging cytometer; bright-field and epifluorescence microscopes; Bravo (Agilent Technologies) and Freedom EVO (Tecan) robotic liquid handlers; a high-throughput plate reader (BMG); LC480 (Roche) and IQ5 (Bio-Rad) real-time PCR cyclers; and a small computer cluster.

In addition to SCGC, the Bigelow Center for Blue Biotechnology would feature an expanded Provasoli-Guillard National Center for the Collection of Marine Phytoplankton, several laboratories, offices, conference space, and a cafe. Bigelow Lab administrators and local dignitaries joined in a Sept. 7 groundbreaking ceremony marking the start of construction on BCBB.

In 2005, Sen. Susan Collins (R-Maine) secured $1.46 million in federal funds toward Bigelow's purchase of the new East Boothbay campus site from the National Oceanic and Atmospheric Administration. Private contributions of $1.5 million completed the purchase.

Last year, Bigelow Lab received funding toward BCBB when it won a $4.45 million Maine Technology Asset Fund award from the Maine Technology Institute, an industry-led non-profit corporation created by the state to advance tech research and commercialization in Maine. The fund is a two-year, competitive award program created by a $50 million economic development bond approved by Maine's state Legislature and voters in 2007.

BCBB will consist of a single 25,600-square-foot building to contain approximately 17,000 square feet of laboratory space to house 24 senior researchers and their science staff, as well as more than 8,000 square feet to house support infrastructure.

Bigelow Lab says its long-range plan for the Ocean Science and Education Campus is to build three interconnected science "wings" — the BCBB is the first of these; the two other science wings planned for the campus will be the Center for Ocean Health and the Center for Ocean Biogeochemistry and Climate Change.

Future plans for the campus include a fourth administrative wing with a public auditorium, a shore facility and dock for research vessels, education facilities, and housing for visiting scientists and students.

When completed, Bigelow Lab will occupy 16 of the campus' 64 acres to be developed to the second-highest "gold" Leadership in Energy and Environmental Design certification. The laboratory says the remainder of the property will be preserved as wildlife habitat, wetlands, and open space, including more than a mile of public walking trails to be maintained by the Boothbay Region Land Trust.

The private non-profit Bigelow Lab expects the new campus to help it grow its revenues from $13 million to $28 million, and from 100 to 200 direct and indirect jobs. Over the next five years, the new campus is expected to attract $34 million in new investment to Maine through activities that include generating new patents, licensing new technologies, developing products, and creating startup companies, according to the Lincoln County Economic Development Office.

Grants for Equipment at Cold Spring Harbor Labs

Cold Spring Harbor Laboratory will receive a combined $7 million in grants from New York state's economic development agency that will pay part of the cost of new microscopes and genetic analysis equipment for the campus-within-a-campus that opened last year.

Members of the Empire State Development Corp.'s board of directors approved for CSHL a $5 million Downstate Regional Projects grant, as well as a $2 million grant from ESD's Economic Development Fund.

CSHL will house the equipment at Hillside Laboratories — the $100 million mini-complex of six buildings completed in 2009 — where it will be used for research into cancer, neuroscience, and bioinformatics.

"The scientific equipment which has been or plans to be purchased includes numerous microscopes, centrifuges, incubators, animal cages, animal testing machines, freezers, and autoclaves. Additionally, there are anesthesia machines, mass spectrometers, laser scanners, chameleon systems, and genome analyzers," said Hema Bashyam, a CSHL spokeswoman.

"The majority of the equipment has been purchased and placed in service. We expect to purchase the remainder of the equipment which the state funds are supporting by the end of this year," Bashyam said.

Also included, she said, is the new computer networking equipment required after CSHL relocated its central network facilities to Hillside Labs, and a new backup/storage system for the supercomputer that was moved there.

The total cost for the equipment is $20 million.

"Without assistance, the project scale would have been reduced, hindering the Lab's ability to attract top researchers," ESD said in its Sept. 14 announcement of the CSHL grants.

CSHL has about 950 employees, up from the roughly 800 it had when it first requested state funding for the equipment — a staff increase largely due to the opening of Hillside Labs, Bashyam said.

As a result, ESD has acknowledged, CSHL has exceeded its commitments to the state of creating at least 80 new jobs and retaining at least 800 existing jobs in return for the state funding.

Q Chip Gets Money for cGMP Production

Q Chip is using new funding to scale up its Q-Sphera technology for cGMP production of sustained release peptide and protein therapeutics.

Securing an initial £2m ($3.1m) of a planned £3m funding round allows Q Chip to invest in scale-up of current good manufacturing practice (cGMP) compliant production of materials for preclinical development.

“With this funding in hand, Q Chip is now able to establish manufacturing capability, a major milestone for our programs. It will also allow the development of a sustainable pipeline of partnered programs”, said Ken Powell, executive chairman of Q Chip.

Production occurs in MicroPlant, a semi-continuous microfluidic device for the bioencapsulation of biological materials within polymer microspheres. Using MicroPlant Q Chip can produce solid, monodisperse microspheres.

The device forms droplets by combining dissolved polymer and peptide with a biocompatible oil at an engineered junction. Droplets are then frozen by passing from the ambient section into a cooler area. The final step is extraction which uses an anti-solvent to remove the microspheres.

Q Chip claims MicroPlant offers encapsulation efficiency of up to 95 per cent, very low inter-batch variability, reduced production costs and quantitative product recovery. Production is scaled up without compromising sphere uniformity by increasing the number of fluidic channels.

Using MicroPlant Q Chip can produce 80-200µm microspheres. The size of a microsphere affects administration and drug release kinetics. Consequently, by controlling their size Q Chip is able to modify drug release.

Preclinical development of biosimilars Q-Leuprolide, for prostate cancer and endometriosis, and Q-Octreotide, a treatment for acromegaly, will be supported by the capacity expansion. Q Chip plans to begin a bioequivalence study of Q-Leuprolide in 2011.

The financing round was led by Curzon Park Capitol and Finance Wales. Jon Moulton and Harry Solomon also invested in the company. To date Q Chip has secured investment totaling £7.5m.

RTS Life Science Announces New U.S. Headquarters

RTS Life Science, a worldwide supplier of automated sample management and pharmaceutical testing systems, is pleased to announce new U.S. Headquarters and the formation of ‘RTS Life Science LLC’. Following the acquisition earlier this year of Hatch Science, a Massachusetts based life science company, both products and services have now been successfully integrated into the Group.

RTS Life Science LLC is based just south of Boston and is headed up by Martin Schwalm, President and Larry Chin, VP of Sales, North America. With a US team of approximately 20 mechanical, electrical, software, sales and support staff and an impressive design engineering and manufacturing facility, RTS is now able to provide localized sales, engineering and support services to its US client base of sample management, biobanking and pharmaceutical testing customers.

Gary Walsh, CEO of RTS commented. “Our strategy is to strengthen our capabilities in the US which has always represented a substantial part of our business. We now have an extended localized team and have fully integrated our US operations into the business. Our principle objective is to support our customers efficiently and locally and continue to deliver the high standards of service and attention that has become a hallmark of RTS”.

In addition to increasing the product offering and adding manufacturing capabilities, another key factor in the acquisition was in-house product development skills. Having worked together on the development of the RTS Tube Auditor^™, RTS Life Science LLC is continuing to work on several other product development initiatives that have recently received RTS investment, including capital, for new machinery and equipment for RTS’ R&D Prototyping Centre.

Zeus Entire Biomaterials Facility ISO Class 7

Zeus, Inc., an international leader in material science and the manufacture of fluoropolymer tubing, announces that its entire Biomaterials Facility, including synthesis and processing, is now ISO Class 7 certified. Staffed with a team of leading scientists, engineers, and quality control professionals, the 5,000 sq. ft. facility is dedicated exclusively to the extrusion, analysis, and characterization of bioabsorbable polymers and other advanced materials.

"The certification is paramount in that all processes, from conception to production, for our bioabsorbable line will take place in a very tightly controlled environment. Going beyond a standard cleanroom, our ISO Class 7 Certification spans the entire square footage of the facility," said Dr. Bruce Anneaux, Corporate Manager, Research & Development.

All aspects of bioabsorbable processing occur at the Biomaterials Facility, including raw material handling, synthesis, compounding, extrusion, inspection, and packaging. In addition to ISO Class 7 Certification, the facility is ISO 13485 certified with state-of-the-art analytical and testing apparatus.

"For our customers, the Class 7 Certification provides added confidence that they are receiving the highest-quality products and is a testament to Zeus' continued efforts to remain at the forefront of material science," said Josh Ridley, Business Development Manager, Biomaterials.

Medical Research Institute of Infectious Diseases (USAMRIID) Replacement Facility Plans

The U.S. Army Corps of Engineers has awarded the joint venture of CUH2A/Smith Carter/Hemisphere a $14.5-million firm-fixed-price contract for construction and administration support services for the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) replacement facility at Fort Detrick, Md. The institute plays a key role as the only laboratory equipped to safely study highly hazardous infectious agents requiring maximum containment for biosafety. This project will design the replacement, expansion and renovation of the existing USAMRIID facilities, which comprises approximately 686,787 sq. ft. of new biomedical research and vivarium facilities. The project is expected to be completed by May 2014.

UCSF Medical Center at Mission Bay Plans

The University of California at San Francisco Medical Center is planning to build the UCSF Medical Center at Mission Bay, a 289-bed, 878,000 sq.ft. facility. The project comprises three six-story buildings, a 183-bed family-centered children’s hospital, a 70-bed adult cancer hospital, and a women’s hospital for cancer care, specialty surgery, a 36-bed birth center and clinics. The complex, located on a 14.5-acre site south of UCSF’s 43-acre Mission Bay biomedical campus, will include an energy center, a helipad and parking facilities. Estimated cost is $1.5 billion for a 2014 completion. UCSF has selected architects Anshen + Allen and William McDonough + Partners to design the medical center.

NCI to Break Ground on Satellite Campus

The National Cancer Institute plans to break ground tomorrow on a $200 million satellite campus in Rockville, Md., that will serve as a new home base for the agency.

The NCI campus will rise on a nine-acre portion of Johns Hopkins University's Montgomery County campus, within the Shady Grove Life Sciences Center — the business park that houses much of the life sciences sector in Maryland's Montgomery County.

JBG was selected in February by the US General Services Administration to build the satellite campus, a 575,000 square-foot complex consisting of twin, seven-story buildings with a parking garage and shops. JBG would develop and own the campus under a ground lease it has signed with Johns Hopkins.

NCI has said it needs the satellite campus to allow for anticipated future growth in programs and personnel.

"The new campus will allow for growth in NCI's scientific research and for expansion of its current and new programs," Daryl Paunil, director of NCI's Office of Space and Facilities Management, said in a statement earlier this year. "These first-class facilities will be designed to allow for easier renovations and new configurations to foster more scientific collaboration."

NCI has said it expects to house 2,100 employees at the Shady Grove campus when it completes its relocation there in 2013. Those employees are now scattered between the agency's headquarters in Bethesda, Md., within the campus of the National Institutes of Health, and offices further north in Gaithersburg, Md.

JBG will build NCI's new campus with energy efficient features designed to earn the second-highest "gold" Leadership in Energy and Environmental Design, or LEED, certification.

UC Merced's Stem Cell Facility Finishing

Construction on the UC Merced Stem Cell Instrumentation Foundry is expected to be finished by late December, yet the university is still in the process of raising money for equipment.

UC Merced needs $1.3 million to buy research equipment. The school already has $75,000 in private and public donations, said Maria Pallavicini, dean of the UC Merced School of Natural Sciences.

Pallavicini said she hopes to get enough donations for equipment by the time the foundry is completed.

UC Merced stem cell foundry, which costs $7.5 million, is being built on campus in the school's Science and Engineering Building. The university received a $4.36 million grant from the California Institute for Regenerative Medicine toward construction of the facility.

The facility, which costs $7.5 million, is being built on campus in the school's Science and Engineering Building.

It was originally slated to be built at the former Castle Air Force Base, but plans changed in 2009.

When completed, this facility will allow investigators to study the behavior of individual stem cells in precisely controlled environments, Pallavicini said.

"This facility is going to enable investigators at UC Merced and elsewhere to study cell behavior," she said. "It's a unique facility because it will not only provide tools, but will facilitate collaborations between other scientists. It's a unique facility because it provides the tools and the capabilities to investigators who wouldn't be able to do this work otherwise, because this will allow scientists to custom design labs-on-a-chip."

In 2008, UC Merced received $4.36 million from the California Institute for Regenerative Medicine (CIRM) toward construction of the facility.

CIRM was created in 2005 with the passage of the California Stem Cell Research and Cures Act, which provided $3 billion in funding for research at California universities and research institutions.

When completed, supporters hope the lab will be a catalyst for the formation and growth of the biotechnology industry in the Merced area.

The state-of-the-art facility will also be a tool shared with researchers across the state, members of the stem cell committee said at their meeting at UC Merced.

In August, U.S. District Judge Royce C. Lamberth froze all spending on projects related to embryonic stem cell research.

CIRM issued a statement late last month saying that the decision will disrupt some of the advances happening to bring human embryonic stem cell research-based therapies to patients in need.

Pallavicini said she hopes that by the time the lab is completed, the ban will be lifted, but that there are other ways of studying stem cells.

"The ban is on a use of human embryonic stem cells; there are other types of human stem cells that can be used in research," she said. "The fact that there is a current ban on human embryonic stem cells will not preclude the use of this facility to answer some of the questions in stem cell biology."

Meanwhile, researchers are eagerly awaiting the completion of the facility, she said. Faculty members are waiting to perform a number of experiments once it's open.

QuantRx Biomedical Will Relocate Its Headquarters

QuantRx Biomedical said that it will relocate its headquarters from Doylestown, Pa., to Portland, Ore., as the firm consolidates its operations. The firm said that the move and consolidation reflects its "transition from the developmental stage to an enterprise focused on the marketing and manufacturing of innovative products for advanced diagnosis of serious disease and health conditions." It also noted that its CFO, Sasha Afanassiev has declined to relocate with the firm.

QuantRx is developing rapid point-of-care diagnostics, and also makes microarrays and molecular imaging agents.

Cold Spring Harbor Laboratory Plans Upgrade

Cold Spring Harbor Laboratory has received a $497,423 grant from the National Science Foundation to renovate and upgrade its plant growth facilities, where it conducts work on Arabidopsis and other crop plants. CSHL said that its current facilities are "inadequate to meet the demands of current genome-driven plant biology research." The funds were awarded under the American Recovery and Reinvestment Act of 2009.

Smartest Buildings in America Announced

Siemens Industry Inc on Aug. 26, 2010, identified the four smartest buildings in America, winners of its inaugural Smartest Building in America Challenge. Grand prize winners are the Duke Energy Center, Charlotte, N.C., and the Iowa Central Community College, Fort Dodge, Iowa. Runner-up winners are the Cold Climate Housing Research Center, Fairbanks, Alaska, and the Rasmussen Building at Grand View University, Des Moines, Iowa.

Five industry experts chose the winners from finalists that included a wide range of facilities from across the U.S.

Grand prize winners will receive $25,000 in products and services from the Building Technologies Division, according to Vogel, or a $25,000 contribution to qualified charities of their choice. Runner-up prize winners will receive $15,000 in products and services or a $15,000 contribution to qualified charities of their choice. Here is a brief summary of the two grand prize winners and the two runners-up:

2010 Grand Prize Winners

The Duke Energy Center is a LEED Core and Shell 2.0 Platinum certified office tower with 48 stories and 1.5 million sq. ft. Using Siemens APOGEE Building Automation System, it creates operational efficiencies that have reduced energy consumption by 22 percent.

The Iowa Central Community College Biotechnology and Health Science Building is a LEED Gold building that relies on the Siemens TALON AX system to integrate six mechanical systems and operate equipment such as water to air heat pumps, pumping systems, water to water heat pumps, and air handling units.

2010 Runners-Up

Alaska’s Cold Climate Housing Research Center is in the process of receiving LEED Platinum certification, which would make it the furthest north LEED Platinum building in the world. Using the Siemens APOGEE system to handle Alaska’s extreme climate, the research center has more than 1,200 sensors that monitor everything from the walls to the roofs, rainwater, foundations, permafrost, and HVAC.

The Rasmussen Building at Grand View University ensures the comfort of faculty and students while supporting Art Department needs to showcase student work and talents. Using the Siemens TALON system, the building automatically operates VAV boxes for the entire facility, raises and lowers window shades based on time of day and interior room temperatures, and adjusts lighting for the Art Gallery and main conference room.

The Smartest Building in America Challenge recognizes how people use the sophisticated Siemens technology that keeps America’s buildings operating in a smart way to reduce cost and energy usage. Open to any facility that operates either APOGEE or TALON building automation systems, the Challenge looks for innovative and creative approaches taken by facility managers. Entries from the winners and other entrants can be viewed at www.smartestbuildinginamerica.com

Ricerca Biosciences Completes cGMP Prep HPLC Purification

Ricerca Biosciences say newly developed HPLC process offers drug firms API production that surpasses regulatory purity guidelines.

The US contract manufacturing organization (CMO) made the comments after using Prep HPLC to produce 525 grams of pure active pharmaceutical ingredient (API) from 800gms of raw material composed of three differed chiral isomers.

The final compound, the identity of which was not disclosed, had a chiral purity of more than 99.7 per cent, and over 99 per cent achiral purity; a result which exceeds the high expectations of FDA, EMEA, or Ministry of Health (MoH) guidelines, which typically call for levels of 98 per cent for drug products.

The technique has wide ranging implications for drugmakers according to Ricerca vice president of chemical development Richard Donaldson who said that APIs of this kind can be “used in every drug for any disease.”

“Every approved drug has its own API, and we have worked with hundreds of different APIs,” he said, adding “we continue to work with pharmaceutical and biotech companies to help develop additional APIs for every disease group you can think of.”

Donaldson explained that APIs are manufactured under contract in collaboration with a pharmaceutical or biotech company with a specific process developed for each API for purification.

“Multiple methods of purification are used depending upon the specific API,” said Donaldson, adding: “If it is a solid, we try to purify by crystallization, but oftentimes, chromatographic purification is required.”

Such analytical procedures are carried out at Ricerca’s 40 acre US site, located in Concord, Ohio, where a Prep High-Performance liquid chromatography system has been installed.

Capable of processing as much as 1-2kg of material under cGMP controls, this equipment is fully expandable to 6-8kg capacity, and comes with an automated fraction collection system to aid the purification process. In addition to this, the APIs are purified in glass, glass lined steel, and various metal reactors, and following this, filtrations are completed, and solids are dried in vacuum ovens.

Ricerca expects demand for business to increase as the company continues to offer its custom API purification service.

“API development is the basis of our business,” said Donaldson, explaining how work at Ricerca is contracted with clients seeking “our expertise to help them develop an API into a new drug, and purification is a very important part of that development.”

Vetter Opens Sales Office in Illinois

Vetter has opened a new sales office at the Illinois Science + Technology Park in Skokie, IL, home of its first U.S. manufacturing facility. The office will be managed by Troy Carpenter, who was appointed as president of Vetter Pharma International USA Inc. The new office replaces its Yardley, PA sales office, founded in 1983 as Vetter Pharma-Turm Inc.

In a company statement, Vetter noted that the Midwest region is an emerging “hotspot” in biotechnology, and that the new office will help push business growth in North America. The manufacturing facility in Skokie — an expansion of Vetter Development Service — is scheduled to be operational in the beginning of 4Q10.

Alpha Packaging to Be Acquired by Irving Place Capital

Irving Place Capital (IPC) is announcing that it has agreed to purchase Alpha Packaging (St. Louis, MO), a blow molder of plastic bottles and jars for the nutraceutical, pharmaceutical, and personal care markets. The transaction is expected to close in September of 2010.

Alpha Packaging manufactures plastic bottles and jars at five U.S. manufacturing facilities and has a new plant in the Netherlands. The company’s Technigraph division provides container decorating services to personal care brands.

Stonebridge Partners (White Plains, NY) previously grew Alpha with significant capital investments that tripled the company in size during their investment period. Dave Spence, President and CEO of Alpha, said in a press release: “I am enormously proud of the business we have grown over the last 25 years and excited about the bright future that we have in front of us with Irving Place Capital. We are constantly looking for ways to support our customers’ growth by offering new products and technologies. We are committed to making our network of distributors and direct customers more competitive through additional investments in our existing operations and the completion of add-on acquisitions.”

COO Dan Creston added in the release: “Alpha’s growth strategy will be accelerated when the company is recapitalized. Having IPC as an equity investor will allow us to continue our growth and make even larger acquisitions than those that we have made in the past.”

Phil Carpenter, a Senior Managing Director at Irving Place Capital, said in the release: “Alpha is an excellent platform for growth and is a great complement to our packaging portfolio. The company has a strong position in attractive end-markets, and we look forward to working closely with Alpha’s management team to further expand the business.”

IPC’s other investments in packaging include Multi Packaging Solutions, Inc., Chesapeake Corporation, and Mold-Rite Plastics, Inc. Under the agreement with IPC, Alpha’s top management team will stay in place. Dave Spence will remain as Alpha’s President and CEO. Upon transaction close, Dan Creston will oversee all acquisition integration as the Executive Vice President of Corporate Development. Mike DeFazio, who currently serves as Vice President of Operations, will become Chief Operating Officer. Alpha’s Chief Financial Officer, Gary Seeman, and its Executive Vice President of Sales, Jack Baily, will remain in their positions.

Alexion Gets FDA Approval

The FDA has approved Alexion Pharmaceuticals’ Rhode Island, US plant for commercial supply of Soliris (eculizumab), giving the biopharm a second source.

Approval by the US Food and Drug Administration (FDA) gives Alexion a second source of Soliris. Relying on one source can lead to drug shortages if manufacturing difficulties occur.

Genzyme highlighted this risk when Cerezyme (imiglucerase) and Fabrazyme (agalsidase beta) faced manufacturing problems. Alexion has sought to mitigate the threat by getting a second source approved, first by the European Medicines Agency (EMA) and now the FDA.

With both approvals in place Alexion has two sources, the Rhode Island plant and Lonza, which can meet all forecasted commercial and clinical needs in the US and Europe. In 2009, the US and Europe accounted for more than 90 per cent of revenues.

Stephen Squinto, executive vice president and head of research and development at Alexion, said: "Since before the launch of Soliris in 2007, we recognized the critical importance of ensuring the continuity of treatment for patients with ultra-rare and life-threatening diseases.”

Soliris is the only drug specifically indicated for treatment of paroxysmal nocturnal hemoglobinuria (PNH), an ultra-rare, debilitating and life-threatening blood disorder. Consequently, disruptions to manufacturing or distribution could result in patients being unable to access treatments.

Alexion is trying to increase use of Soliris by gaining regulatory approval in other countries, such as Japan, and demonstrating its efficacy against other indications. A number of clinical trials are underway to investigate the use of Soliris in treating other severe and ultra-rare disorders.

Indications covered by the clinical trials include atypical hemolytic uremic syndrome (aHUS) and transplant patients at elevated risk of antibody-mediated graft rejection.

Disposable Manufacturing Drives CMC’s Seattle Expansion Plans

A fully-equipped disposable manufacturing facility has been added to CMC Biologic’s Seattle, WA site, as the first stage of a major expansion plan.

CMC claim the new facility, supplied with processing equipment under the partnership with Hyclone, will enable early-phase clinical manufacture of biopharmaceuticals, including monoclonal antibodies and other mammalian cell culture-based recombinant proteins.

“Disposable technology offers the advantages of increased flexibility and efficiency,” said Andy Walker, senior director of manufacturing at CMC.

Walker went on to explain that in order to counter risk of cross-contamination, and to eradicate the need to clean or sterilize the facility - an essential procedure for traditional steel tank facilities - the plant has been fitted with a 100L and two 500L single-use bioreactors (SUBs) and disposable mixers.

"Consequently,” he continued, “[the facility] provides a cost-effective strategy for reducing the speed to market for many biologics."

Gustavo Mahler, company president, believes demand for costly high-volume stainless steel tanks will wane for some products as process yields grow following advances in protein expression, cell culture and purification techniques.

"We believe this trend will continue to push bioprocessing toward single-use technology," Mahler said.

The staged expansion at CMC’s Seattle site is going ahead to increase production capability, and to cater for the rising demand for cGMP manufacture of biopharmaceuticals. As part of this, the company has invested in a second 3,000 L bioreactor train, matching the existing line.

Furthermore, client demand has prompted the advancement of plans toward build-out of a pre-existing structure which is set to house two 5000L commercial-ready lines.

The company added that the expansion will eventually involve extending the US workforce by over 30 per cent.

Spaulding Completed Pharmacology Expansion

Spaulding Clinical has renovated its Phase I pharmacology unit, citing both sponsor and regulatory demand for centralized cardiac monitoring as drivers.

The work, which involved a refit of the second floor of Spaulding’s Wisconsin, US facility, increased capacity to 96 beds making the firm the largest provider of Montara Surveyor telemetry capability in the “clinical research world.”

Company spokeswoman Amanda Baltz said that pharmaceutical industry demand for efficiency in Thorough QT (TQT) monitoring trials has increased markedly in recent years.

Baltz said that such trials “are typically one of the most costly Phase I studies that sponsors conduct, and therefore, there is little tolerance for issues related to quality or execution.”

These factors, she explained, were the primary motivations for the both the new expansion and an ongoing construction project that will “increase [Spaulding’s] capacity to over 150 beds in the very near future.”

Baltz also suggested that the ability to conduct large cohort early-phase work under one roof fits with the current opinion among regulators worldwide on the benefits provided by centralization.

“The concept of centralized services removes so much variability within the cardiac measures and results themselves, and allows the study physicians and the sponsors better insight into the effects of the drugs.”

This belief is in keeping with the trends highlighted by other centralized electrocardiogram (ECG) service providers in recent months, including rivals like Celerion, Clinlabs and ERT .

The Phase I expansion was also a motivation for Spaulding’s recently announced adoption of Medidata’s remote access Rave electronic data capture (EDC) platform.

Baltz explained that: “Data capture points are electronically fed into our EDC System which also allows for sponsors to view near real-time access to all study data.

Enzo Lab Approved

Enzo Biochem announced that its clinical lab has been approved by Pennsylvania.

The Enzo Clinical Labs is CLIA approved and CAP accredited but in order to operate in Pennsylvania needs separation approval from regulators in that state.

The company also has pending license application in Maine, Maryland, and California.

The license from Pennsylvania is a "significant step in our ability to solicit business and accept specimens from locations" other than the metropolitan New York City area," Kevin Krenitsky, president of Enzo's Clinical Labs division, said in a statement. The lab is also approved by New York State.

"Patient care ins moving increasingly to predictive diagnostics utilizing markers and gene-based programs, and Enzo Clinical Labs, owing to its highly regarded New York state certification, is increasingly focused on developing into a national leader for the application of esoteric testing and the diagnosis of these specimens," Krenitsky said.

The company is developing its ColonSentry colon cancer risk-stratification assay, multiplex DNA sequencing, alternative amplification/detection methods for pathogens, and other diagnostic tests.

Jackson Laboratory Opens Bar Harbor HQ

Jackson Laboratory has opened a $10 million building at its headquarter campus in Bar Harbor, Maine, that will house a new importation and isolation facility, including a receiving center for mouse models from other research institutions.

The three-story, 22,500-square-foot research building will replace an existing facility that will be converted into additional R&D space. Nearly half the project cost, $4.7 million, came as a grant from the Maine Technology Asset Fund, a $50 million fund approved by state voters in 2007 and overseen by the non-profit Maine Technology Institute.

“This project was more about providing adequate space for the growing Reproductive Sciences area, and for creating new opportunities for commercialization, which is what made it especially attractive to the Maine Technology Institute,” said Joyce Peterson, a spokeswoman for the Jackson Lab.

“While mice and equipment are still being moved in, the new building is already up and running,” Peterson said. “The cryopreservation tanks have been installed and some mice are already in the importation area.”

One commercialization opportunity, she said, came after Jackson Lab scientists in 2008 developed a simple, cost-effective process to freeze mouse sperm and enable it to achieve high fertilization and recovery rates with mouse eggs. The breakthrough in developing mouse sperm cryopreservation led to Jackson Lab partnering with Maine Manufacturing in Sanford to create kits allowing other laboratories to use the technology.

Joining Maine Manufacturing in collaborating with the laboratory in the project are the University of Maine Advance Manufacturing Center in Orono, as well as Maine firms Masters Machine in Round Pond; Clear H2O in Portland; and Lane Conveyors & Drivers in Brewer.

Sequenom Building New Lab

Sequenom is building a new 7,000-square-foot CLIA laboratory at its headquarters in preparation of a planned launch of its Trisomy 21 diagnostic test.

Ian Clements, senior director of investor relations for the San Diego-based molecular diagnostics company, said that the lab is slated to be up and running in the fourth quarter and will be outfitted with sequencing platforms from Illumina.

The new lab will perform validation for Sequenom's T21 non-invasive Down syndrome test. The company is currently collecting samples as part of a clinical study, and about 4,000 samples will be run at the new facility in connection with the final validation of the T21 test, Clements said.

After the launch of the test, planned for the latter half of next year, the test will be run out of the new lab.

Sequenom has a CLIA-certified and CAP-accredited lab, the Sequenom Center for Molecular Medicine, in Grand Rapids, Mich., which runs the company's cystic fibrosis and SensiGene Fetal Rhesus D Genotyping tests. A test for age-related macular degeneration, to be launched in the first half of 2011, will also be run out of the Grand Rapids facility.

Those tests are run on Sequenom's MassArray technology, however, while the T21 test will run on sequencing technology.

"This is basically an expansion of our lab network," Clements said. "The core of our sequencing expertise and knowledge is here in San Diego, hence it made sense to expand our network and build a CLIA lab here."

Sequenom anticipates getting CLIA certification and CAP accreditation for the San Diego lab in Q4 2010, he added.

It has not yet been decided whether the new space will be outfitted with Illumina's newest platform, the HiSeq systems, or its Genome Analyzer technology, though Sequenom has both platforms, Clements said.

He declined to disclose the cost of the new facility, but said "it's a reasonably modest investment." Space for the new lab is being converted from existing space that had been used for other R&D research.

BD Biosciences Opens New Miami Facility

Animal- and Antibiotic-Free Plant Will Produce Cell Culture Media and Supplements

A new cell culture media and supplement production facility will be opened by BD Biosciences in Miami-Dade County. The building was designed to support a number of advanced technologies and operating procedures.

GEN interviewed William James, the director of operations at BD Biosciences-Advanced Bioprocessing, to learn more about the company’s new AF2^™ facility.

GEN: What drove the need to set up this facility?

James: Our customers were the driving force behind building this animal-free, antibiotic-free manufacturing site. For them, this facility is all about risk reduction throughout the supply chain, especially those associated with animal-origin materials.

The Advanced Bioprocessing team worked with our customer advisory board representing top global biopharmaceutical companies, which provided the input that documented the need, the concept, and, ultimately, the facility’s design.

One key insight was the increasing global regulatory requirements that lead our customers toward stricter control of their raw materials in light of BSE and other biological contaminant concerns. This reinforced our belief that a significant and growing need exists today in the biopharmaceutical industry to eliminate the presence of animal-origin raw materials completely in the facility and the supply chain. Input from our customer advisory board also steered us toward the next level of risk reduction—a new stand-alone facility— rather than segregating an area at an existing plant.

With this input from our customers as well as an assessment of our capabilities and the competitive landscape, BD decided to establish the facility in Miami. The building had been constructed by a pharmaceutical company to industry standards, but it never entered operations. We, therefore, were able to take a building that met many of our needs and retrofit it for our specific customer requirements. It allowed us to bring the facility online in a shorter time frame for our customers.

GEN: What types of operations will take place in the new facility?

James: AF2 offers both dry powder and liquid cell culture media and supplement manufacturing. It has the capability to produce aseptic fill solutions in customized flexible packaging. As a fully integrated production facility, it integrates cell culture media and supplement manufacturing capabilities, with the ability to produce both complete catalog and custom formulations for microbial fermentation, mammalian cell culture, and stem cell culture.

The facility employs state-of-the-art pin milling and blending technologies to help ensure product integrity and consistent performance. It also has a rigorous cleaning program, including clean-in-place (CIP)/sterilize-in-place (SIP) procedures, that is consistent with pharmaceutical standards to help reduce the risk of cross-contamination and maintain product safety.

GEN: What are the new facility’s key distinguishing features?

James AF2 is the industry’s first and only fully dedicated, integrated, animal-free and antibiotic-free cell culture media and peptone/supplement production facility for liquid and powder products.

The facility’s technology is complemented by high levels of process and environmental controls that enable us to produce high-quality products while helping to minimize overall supply chain risk for our customers. For example, all materials and workers entering the facility follow a strict unidirectional flow to prevent contamination. Processed products leave the facility in a similar fashion. In addition, the production of liquid and powder products is segregated to help prevent cross-contamination.

When our biopharmaceutical customers visit the facility, they immediately recognize how much it resembles their own manufacturing facilities. The plant was designed with our biopharmaceutical customers in mind from the physical layout to the equipment and systems.

GEN BD points out that with this new facility, the company has instituted the industry’s most stringent, tertiary-level animal-free policy. How was this accomplished and what does this mean to your customers?

James: It’s remarkable that no industry standards exist regarding the definition of “animal-free.” As a result, biopharmaceutical companies may have trouble determining what animal-free really means when they are dealing with their suppliers. Our policies and protocols help make this information clear and transparent for our customers, raising the bar by which raw materials are sourced and measured.

We designed the AF2 facility to help significantly reduce the risks that could be associated with mixed-use plants and to help provide consistently high-performing formulations and chemically defined media. We expect that this level of safety will help speed our customers’ product development cycles by reducing risk and regulatory uncertainty.

The Advanced Bioprocessing team implemented a raw material and supplier qualification and management program to help ensure that all ingredients (primary), ingredient components (secondary), and ingredient subcomponents (tertiary) utilized in the facility are not of animal origin.

To accomplish this, all raw material suppliers are qualified through a process that involves collecting detailed information on the raw material, including manufacturing processes, and capturing this information in the quality system documentation. This means that we ensure that primary-, secondary-, and tertiary-level raw materials for our cell culture media and media supplements are animal-free. In addition, the facility has never had antibiotics in the manufacturing areas, and our procedures will help ensure that it never will.

GEN: Talk about the “pharma-like” manufacturing setup and operational aspects of the new facility. What features were incorporated into this design and what are the main benefits of taking this approach?

James: We set out to construct a facility that, in essence, would serve as an extension of our customers’ own manufacturing facilities. In AF2 our customers find completely segregated liquid and powder manufacturing areas with zoned air-handling systems and terminal ULPA (ultra low particulate air) filters. They also see advanced modular cleanroom systems and a continuous nonviable particle measurement system for environmental control and monitoring, as well as automated CIP and SIP cleaning processes.

Our water system meets USP requirements, generating USP pure water for injection and pure steam. The facility design promotes unidirectional flow of raw materials, personnel, and products, including separate areas for gowning, de-gowning, and material air locks. Finally, we have full-viewing corridors throughout manufacturing areas to facilitate audits while maintaining environmental control.

Of course, having the facility is only part of the answer to customers requesting safe and effective products. We designed and implemented our quality system with biopharmaceutical requirements in mind and consistent with our customers’ own systems. From equipment and process validation that is consistent with FDA and ICH guidelines to rigorously managed incoming material controls and inspections to an automated change-notification system that provides customers with advance notice of significant product changes to fully validated quality-control methods, our quality system is based on the GMPs defined in 21 CFR Part 210/211.

Supplier confidence is critically important in any industry. This is especially true in the heavily regulated world of biopharmaceuticals, where problems could have serious consequences for patients and the companies that make the therapies and vaccines.

Biopharmaceutical companies spend a considerable amount of time and resources validating that their suppliers follow established, quality-controlled processes and use advanced technologies to help mitigate risks. Biopharmaceutical companies that have seen AF2 have expressed confidence in our ability to help them manage risk in this important part of the supply chain.

REST OF WORLD

Q Chip Scaling Up cGMP Production

Q Chip is using new funding to scale up its Q-Sphera technology for cGMP production of sustained release peptide and protein therapeutics.

“With this funding in hand, Q Chip is now able to establish manufacturing capability, a major milestone for our programmes. It will also allow the development of a sustainable pipeline of partnered programs”, said Ken Powell, executive chairman of Q Chip.

Q Chip, which is based at Cardiff Medicentre at the University Hospital of Wales, raised the funding through new and existing investors, including Curzon Park Capitol and Finance Wales. It is the first phase of a planned total £3m funding round.

The financing round was led by Curzon Park Capitol and Finance Wales. Jon Moulton and Harry Solomon also invested in the company. To date Q Chip has secured investment totalling £7.5m.

Novo Nordisk Unit Expanding in China

Danish biopharma giant, Novo Nordisk is expanding its R&D Centre in China by introducing a new Diabetes Research unit and doubling its quota of employees from 100 to 200 by 2015.

China now has the second largest diabetes population after India, with nearly 40 million sufferers of the chronic condition; a number expected to rise to 59m, say the Ministry of Health. “It is very important that [Novo Nordisk] works together with the government to help find a way to rectify the problem,” said Matt Thompson, a spokesperson from Novo Nordisk.

Novo Nordisk said it will strive to help overcome this problem by conducting local research and studying the Chinese population for differences in the genes of westerners and easterners, in addition to developing new technologies for global applications.

In 1997, Novo Nordisk became the first international biopharmaceutical company to establish R&D in China, and is now about to swipe another 100 employees from the country’s huge and inexpensive talent pool. The new additions to the R&D Centre at Zhongguancun Life Science Park in Beijing will develop drug candidates for clinical studies.

Mads Krogsgaard Thomsen, executive vice president and chief science officer at Novo Nordisk, commented that “By doubling the current staff at our R&D Centre, we demonstrate our long term commitment to take part in the scientific and technological development of China,” as wells as gaining “access to the tremendous resource of talents, ideas and innovation in China.”

China’s Ministry of Commerce say the number of foreign R&D centres in the country has rocketed from 200 four years ago, to 750 today, with multinational drug giants such as Pfizer, Roche, Merck and Sanofi all having capitalised in building R&D capacities in China in recent years.

The company plan to broaden its horizons in biopharmaceutical research by developing new treatments and conducting pharmaceutical trials to meet demand in its fastest-growing market and contribute solutions to China’s increasing problem with diabetes.

Annual sales growth for Novo Nordisk in China met 30 per cent and its sales in the country are predicted to top $700m this year; a figure which contributes to 7 per cent of its global business.

Covance Expands Asia-Pac Presence

Covance and BML Inc., a Japanese testing company, have opened the CB Trial Laboratory, a new central trial lab in the BML General Lab in Kawagoe City, Saitama Prefecture. Through an exclusive, five-year agreement, this lab will be used solely for the testing of clinical trial samples for studies conducted by Covance in Japan.

The central lab conducts safety and HbA1C testing and uses the same methods, instrumentations, reagents, standards and controls used in Covance’s four other central labs (Indianapolis, IN; Geneva, Switzerland; Singapore; and Shanghai), to help ensure quality and fully combinable global data for Covance’s clients. BML is providing a suite of complementary, market-specific client services, including kit customization, local logistics services and on-site logistics training, to meet the unique client needs in the country.

“We have successfully served the Japanese market for a decade. Recent efforts by Japanese regulators to reduce drug development timelines have created significant interest among pharmaceutical companies to conduct clinical trials in the country. Collaborating with BML created the best opportunity to service the growing needs of our clients and to meet the unique requirements of studies in Japan,” said Deborah Tanner, corporate senior vice president and president, Central Laboratory Services and Discovery & Translational Services.

Black & Veatch Constructs Biological Safety Lab in Ukraine

Black & Veatch recently completed the Ukraine’s first level 3 biological safety lab under a contract with the U.S. Defense Threat Reduction Agency. The new facility enhances the Ukraine government’s existing disease surveillance systems to detect, report and respond to bioterrorism attacks, epidemics and potential pandemics.

The Interim Central Reference Laboratory (ICRL), located in Odessa at the Mechnikov Anti-Plague Institute, was designed and constructed by Black &Veatch using in-country subcontractors. It is the first biological safety laboratory to be commissioned, accredited, and operational under the U.S. Defense Threat Reduction Agency’s Biological Threat Reduction Program.

“This new facility helps keep the world safe by enhancing security and collaborative biological research measures to combat bioterrorism and the proliferation of biological weapons-related technology,” said Bill Van Dyke, President of Black & Veatch’s Federal Services Division. “As the integrating contractor, Black & Veatch not only managed the designed and building of the facility, but is training local Ukrainian staff so they are able to sustain necessary procedures and safeguards going forward.”

The ICRL is specially designed and constructed to support work with especially dangerous pathogens that can be naturally occurring or introduced through a bio-terrorism attack. It serves as a central location for research, consolidation and training on proper handling of dangerous pathogens. The lab also provides the Ukrainian Ministry of Health with a safe environment to confirm diagnosis of suspected dangerous pathogens, enhancing public health while deterring bio-terrorism.

As integrating contractor, Black & Veatch is responsible to the Defense Threat Reduction Agency and the Ukraine Ministry of Health for the full rollout of the Biological Threat Reduction Program in Ukraine. With the completion of the facility, Black & Veatch will provide three years of sustainment and transition support for the ICRL that involves training Ukrainian professionals to manage their network, system and repository.

The U.S. Defense Threat Reduction Agency (DTRA) awarded Black & Veatch one of its Biological Threat Reduction Integrating Contracts (BTRIC) in 2008.The 10-year contract has a collective ceiling of $4 billion among the five selected contractors.

The Ukraine ICRL is the first level 3 biological safety lab commissioned in the Former Soviet Union under the Nunn-Lugar Global Cooperative Threat Reduction Program.

A biosafety level is the level of the biocontainment precautions required to isolate dangerous biological agents in an enclosed facility. The levels of containment range from the lowest biosafety level 1 to the highest at level4.

The Ukraine ICRL is co-located with the Mechnikov Anti-Plague Institute in Odessa. The 124-year-old institute was the second biological safety lab of its kind in the world at the time, second only to the Pasteur Institute of Paris.

In partnership with the Nunn-Lugar Biological Threat Program this lab will be used in the coming years to facilitate research on anthrax, tularemia, Qfever, and other dangerous pathogens of mutual concern to the United States and Ukraine.

Black & Veatch has continuously worked with the DTRA to safe guard against the proliferation of weapons of mass destruction, including biological, chemical and nuclear weapons, in Former Soviet Union states since 1993.

CAP for Tokyo Lab

Quintiles says, CAP accreditation for Tokyo central lab strengthens their position in Japan’s fast growing innovative drug development sector.

The laboratory, set up earlier this year to house operations previously based in Saitama, received the designation after what SVP of global central labs Thomas Wollman said had been an extensive audit process.

Wollman said that: “The certification process is intended to improve patient safety by advancing the quality of pathology and laboratory services through education, setting standards and ensuring laboratories meet or exceed regulatory requirements.”

“College of American Pathologists (CAP) accreditation,” Wollman continued,” has become a global quality standard and is proof of good technical and management practice.”

He also suggested that accreditation will boost Quintiles’ lab business in Japan, explaining that since entering the market in 2008 in a deal with Medeca the industry has changed significantly.

“Japan is quickly becoming a key destination for biopharmaceutical development and innovation and we are seeing customer demand for our services continue to grow.”

Wollman’s comments, and the upswing in demand for lab analysis services, are in keeping with the expansion seen in Japan’s clinical trials sector in recent years.

While in previous years the strict rules governing research in Japan put many drugmakers off conducting trials in the country, in the last few years government measures designed to accelerate the process have changed the market.

Initially this resulted in a large number of international contract research organizations (CRO) forming partnerships with Japanese firms to access the market.

More recently however the focus has been on ancillary trial services and preclinical development. For example both Thermo Fisher Scientific and Lab Research have expanded their business in the country in recent months.

Merck Chooses Poland for New Research Center

The Warsaw Business Journal reports international pharmaceutical company, Merck & Co., Inc., has chosen Poland as its favored location for investing in a new clinical research center. The U.S.-based firm already has a strong presence in Poland with 700 employees, which ranks the company in the top 10 pharmaceuticals with operations in Poland. The new center is expected to employ 100 new workers, in addition to the total number of employees for Merck worldwide which is around 100,000 in 140 countries. A spokesman for the company said that this center would be a high volume research center able to analyze studies on 100,000 people. Currently the company has only three such centers in the world – in Colombia, the U.S. and China. The Polish base will analyze results of research for all of Europe.

Aptuit Buys GlaxoSmithKline’s Italian R&D Labs

Adding to a drug-industry-wide trend of outsourcing research functions, GlaxoSmithKline is selling its Verona, Italy, research site to Aptuit, a Connecticut-based contract research organization.

The sale is part of GSK’s previously announced plan to downsize its R&D footprint. Aptuit will take on the roughly 500 GSK employees at the Verona labs—the majority of whom are scientists—bringing its overall headcount to 3,000. Aptuit will also become a preferred provider to the British drug company, scoring a contract to provide R&D services out of Verona.

The deal is similar to a pact forged between Eli Lilly & Co. and Covance. In 2008, the drug development firm bought Lilly’s Greenfield, Ind., R&D facility and hired 265 of the site’s 800 employees. Covance was rewarded with a 10-year contract worth $1.6 billion to perform toxicology and other services for Lilly, an arrangement the big pharma firm claims will eventually save it tens of millions of dollars per year.

Aptuit CEO Timothy C. Tyson says the cost savings big pharma can achieve by selling sites to contractors are related to improving capacity utilization. GSK was putting only about 20 molecules through the Verona facility annually, he notes. Aptuit expects to cut costs by handing the Verona researchers some of the 2,000 other compounds it studies for customers each year.

Although the outsourcing sector did not grow much in the past year because of capital constraints in the biotech industry, Tyson expects an upturn going forward. “With rationalization going on at all of the pharma companies, I expect a significant increase in outsourcing,” he says.

Novo Nordisk to Double Scale of R&D Centre in China

Novo Nordisk announced that the company will expand its Research and Development Centre China in Beijing from currently 100 to 200 employees by 2015. The expansion will mainly be dedicated to a new Diabetes Research Unit.

Novo Nordisk was the first international pharmaceutical company to establish R&D in China in 1997. Until now, the Centre has been an integrated part of the Biopharmaceutical Research Unit at Novo Nordisk and as such has worked closely with colleagues in Denmark to build up expertise in protein engineering and purification, as well as immuno-technologies like generation and improvement of monoclonal antibodies.

By doubling the current staff at the R&D Centre, Novo Nordisk acknowledges the achievements of the Chinese staff since the Centre was established in 1997. And once again, we demonstrate our long term commitment to take part in the scientific and technological development of China, while at the same time helping Novo Nordisk to get access to the tremendous resource of talents, ideas and innovation in China said Mads Krogsgaard Thomsen, executive vice president and Chief Science Officer at Novo Nordisk.

The future research scope will now be broadened to include biopharmaceutical approaches to develop new treatments against diabetes as well as the conduct of pharmacological studies. The R&D team in China will eventually take part in all aspects of drug discovery, from innovation to developing drug candidates for clinical studies in humans.

New R&D Centre Grupo Siro

Leading Spanish food company Grupo Siro has opened a €6m research and development facility in El Espinar, northern Spain to develop a range of new products including ones suitable for consumers who are intolerant to gluten and for children.

A statement from the Madrid-based confectionery and baked goods producer said that the facility will be used for “… the development of new technologies and products to offer consumers the best and most original alternative, ensuring the highest quality of all processes, products or services at lowest cost.”

The 3,000sq. meter (32,280 sq. ft.) facility includes offices, meeting rooms, cleanrooms, workshops, laboratories and tasting and testing areas.

The new centre will be staffed by a team of 40 researchers dedicated to new product development and product assessment. The group is said to work on about 100 new projects each year.

As well as running assessment tests for Grupo Siro products, the R&D centre is already conducting research commissions from other food companies.

Company president Juan Manuel González Serna said at the opening ceremony: "…(research) development is the engine of the Spanish economy in any business. We have the tool (new R&D facility) to achieve excellent results…with these pioneer facilities... "

The company’s food scientists also work in partnership with other researchers based at the Universities of Castilla y León on product development, training and the professional development of students and recruitment of talent.

Other key partners include the horizontal technology agencies CARTIF, AINIA and CETEC.

Formed in 1991, Grupo Siro is a leading manufacturer of confectionery, pasta, biscuits, snacks, bakery, bread, and pastries. Its products are marketed under the brand names such as Rio, Reglero, Castello, La familia, and Duran & Hidalgo.

The company is the sixth largest food company in Spain and has one of the best corporate reputations, according to MERCO; a firm which monitors corporate profiles.

Last year, Grupo Siro acquired three Spanish bakery plants from US bakery and beverage company Sara Lee.

A total of about 600 workers are employed at the three plants located in Briviesca (Burgos), Antequera (Malaga) and Aguimes (Gran Canaria).

NextPharma Expands Microbiology Lab in Germany

NextPharma has expanded its microbiology facilities at its site in Göttingen, Germany. The expansion includes the addition of three new labs equipped with modern air ventilation, laminar-flow benches and temperature-controlled incubators linked to a computerized monitoring system designed to ensure a constant temperature.

The new labs will be used to develop and validate microbiological methods as well as to test non-sterile pharmaceutical products, medical devices and cosmetics for microbial purity and preservative efficiency. Additionally, the new labs can work sequentially to process samples enabling a high throughput of testing. The Göttingen microbiology department now has the capacity to test 40,000 samples per year. Microbiological testing of sterile products will continue to be undertaken at NextPharma’s Belgium facility.

Sean Marett, managing director, NextPharma Technologies, Product Development Services, said, “We are delighted to expand our microbiology department in Göttingen, which will enable us to grow our Product Development Services offering in this field of expertise. We look forward to working with new and existing customers in the pharmaceutical, medical device and cosmetics markets.”

Finished Modular Cleanroom Facility Installed in Denmark

The new cleanroom facility completed for the multinational company Ferrosan is a truly modular facility – designed and constructed in the United Kingdom and installed in Denmark.

The cleanroom facility for Ferrosan was completed within a tight time schedule of just 14 weeks. The 325 sq. meters ( 3,497 sq. ft.) cleanroom facility was pre-manufactured as a whole in the UK, shipped to Denmark and positioned on site, with final hook-up, finishing module connections and services, commissioning and validation being completed on site in Denmark.

Ferrosan is an international consumer healthcare & medical devices company selling its products in more than 60 countries worldwide. The company is continuously looking to offer more innovative and diverse products to its customers. In order to reduce time to market, Ferrosan chose for innovative construction methods to accommodate their latest product line.

The new cleanroom facility is fully compliant with EU GMP cleanroom standards and Danish and European building standards. Initial product trials have been completed successfully. Ferrosan will be conducting further product trials over the next months and plans to launch its new product within a year. The new cleanroom facility will ensure that Ferrosan will continue to offer innovative products to its customers.

Colorcon Adds Turkey Coating Lab

Colorcon says proximity to emerging drug manufacturing markets was key driver for new Turkey technical service lab.

The unit, in Atasehir southern Istanbul, will provide drugmakers operating in the country with capacity for laboratory-scale immediate and modified-release film coating trials according to spokeswoman Donna Marano.

She said that: “Colorcon's focus… is to anticipate and provide local service in every region where pharmaceutical manufacturing growth is expected.”

Recent data from the Pharmaceutical Manufacturers Association of Turkey (IEIS) indicate that the country’s drug market, worth some €6.5bn ($8.3bn) in 2009, is growing at a rate of 3 per cent a year.

And this expansion, while not as rapid in some areas, may present Colorcon with opportunities for its release coating business, particularly from firms keen to access the country’s well established generics market by developing new formulations of off patent products.

Middle East access

However, Marano also suggested that the new lab will help Colorcon grow more widely, explaining that “Turkey’s central location between Europe and Asia and its proximity in the Middle East” was a factor in its selection.

Targeting the Middle East should also serve Colorcon well, given that the pharmaceutical sector in the top five markets in the region is expected to be worth some $36bn by 2015, according to a recent Espicom survey.

In the report, published in May, the analysts predicted that: “[although] the population in these five MENA markets is still young and is expected to reach 240.4 million in 2015… there is a sizeable elderly population which will demand more healthcare services.”

Further support for the prediction comes from the number of Big Pharma firms that have invested in manufacturing capacity in the region in recent years including, in June , Sanofi Aventis who unveiled plans for a plant in Saudi Arabia.

In broader terms, Geographical expansion has been something of a focus for Colorcon of late, with the new Istanbul unit following just a few months after it set up another coating formulation development laboratory in Brazil.

UKCMRI Submits Plans for Facility in London

The UK Centre for Medical Research and Innovation has applied to officials in London's Borough of Camden for approvals to build a new building it hopes to open in 2015.

The application is expected to be heard before the end of the year by members of the Camden Council's Development Control Committee, following a formal consultation by the council. If approved, construction will begin next year, the center said in a statement.

"UKCMRI is perfectly positioned to bring together a wealth of expertise to tackle some of the biggest challenges in beating cancers, heart disease, stroke, flu and neuro-degenerative diseases," the UKCMRI Chair Sir David Cooksey said in the statement. "This is an unprecedented opportunity for UK science."

UKCMRI is a £600 million ($926 million) research partnership whose members are Cancer Research UK (CRUK), the Wellcome Trust, University College London, and the Medical Research Council. According to a scientific vision and research strategy outline released in June, UKCMRI will maintain "a strong focus" on cancer, heart disease, and stroke, as well as disorders of the immune system and later-life diseases of the nervous system.

In July, UKCMRI appointed the chair of its Scientific Planning Committee, Sir Paul Nurse, to be its inaugural director and chief executive, effective Jan. 1, 2011. Nurse is a Nobel laureate and the president of New York's Rockefeller University since 2003.

UKCMRI seeks to build its facility on 3.6 acres of land at Brill Place, north of the British Library, in the St. Pancras and Somers Town area of north London. If approved, construction will begin next year with completion in 2015. The center is projected to employ 1,500 staffers, including 1,250 scientists, and operate on a £100 million annual budget.

Until now, the center's proposal has met with opposition from many residents living near the site, who have cited the center's plans to operate a high category 3 lab; test on smaller animals; and supplant affordable housing once envisioned for the site. Some officials have also expressed concerns about the design and density of the 79,000-square-metre (850,000-square-foot) facility.

UKCMRI said its application followed more than two years of consultation with scientists, business leaders, politicians, and planners. Local residents and community groups commented on the proposals at more than 70 events held by the team focused on developing the center. More than 500 people attended those events, according to UKCMRI.

UKCMRI said it responded to the consultations and public comment in part by locating about one third of the building below street level, reducing the building's overall height. The main public entrance has been lowered, a change the center said was made to improve access.

Also more accessible now, according to UKCMRI, are the building's teaching laboratory, conference facility, and exhibition space. Some scientific functions were moved to make ground-floor activities more visible.

And to enhance openness, a north-south atrium has been introduced, while the building has been set back to give views from St. Pancras International to the local Purchese Street Open Space, and to encourage pedestrians to walk from St. Pancras to Euston. The roof has been changed to a shell-like curved form, with the goal of reducing the effect on local views.

A community facility also has been included in the building, while a new east-west route has been developed between UKCMRI and the British Library.

CLC Bio, World Fusion Create Sequencing Analysis Center

Japanese informatics management firm World Fusion announced it has created a sequence analysis service center with a bioinformatics infrastructure based on CLC Bio's enterprise platform for high-throughput sequencing data analysis.

CLC Bio's platform will be coupled with World Fusion's Life Science Knowledge Bank database system. The LSKB database contains annotated information about genes, proteins, compounds, and their structures and literature information.

Terms of the deal were not disclosed.

World Fusion is now also CLC Bio's integration partner in Japan and will assist with the bioinformatics company expansion into that country. In 2009, CLC Bio created a subsidiary in Japan to service the market.

David Leangen, CEO of CLC Bio Japan, said the partnership with World Fusion will help establish CLC Bio "as the leading provider of high-throughput sequencing data analysis software in Japan."

ACG Expands Barrier Film Manufacturing

To support the growing need for barrier films worldwide, ACG recently launched a new 200,000 square foot manufacturing facility. The facility in Shirwal, Pune (India) triples ACG Pharmapack's films output while maintaining high quality. The facility is ISO 9001:2000 and ISO 1400:2004 certified, conforms to cGMP norms and is on par with class 100000 guidelines. In addition, ACG Pharmapak has a DMF registration with the US FDA, meets EC norms, has an EMS certification, and is registered with SFDA-China and the Canadian Health Department.

ACG Pharmapack is dedicated to a full range of films from mono PVC and Aclar and other laminates, to PVdC suppository films, Barex, calendarable PETG and more, the company said.

Michael Franklin, CEO of ACG Pharmapack said, "We are using the latest technology in this plant, keeping in mind the requirements of our domestic and overseas customers. We are planning 300 percent expansion in the next three years. Currently the production capacity of this plant is more than 18000 tons - or 40 million pounds -- per year."

"Some of the technologies that we are using here are complex laminations to provide specific barrier properties. We are also using new calendar books like PETG and BAREX," Franklin added.

ACG Worldwide (formerly known as the Associated Capsule Group) has served the global pharmaceutical, OTC and dietary supplement markets for more than 40 years. The company's innovative product range includes non-halogenated blister films, films with high MVTR and OTR barriers, as well as suppository films.

Ranbaxy Opens New Manufacturing Facility in South Africa

Ranbaxy SA Pty has opened its new manufacturing facility, Be-Tabs Pharmaceuticals Manufacturing Plant, at Roodepoort, Johannesburg, South Africa. This is the company's second manufacturing facility in South Africa and the third on the African continent. The new facility, built with an investment of $30 million will manufacture analgesics, cold, cough and flu preparations, anti-histamines, anti-hypertensives, central nervous system drugs, vitamins and minerals as well as a comprehensive range of over-the-counter medication. The products manufactured will comprise tablets and hard gelatin capsules.

Ranbaxy is the latest firm targeting South African growth with a new £30m (€24m) Johannesburg tablet and capsule manufacturing plant.

Ranbaxy said that, when fully operational, the plant will be capable of producing and packaging up to 2bn tablets and hard gelatine capsules a year and added that there is potential to expand.

Saxen van Coller, Ranbaxy’s CEO in the country, said the additional capacity meets with “South African government’s intention to strengthen the local pharmaceutical manufacturing industry.”

In February the South African government said that to boost drug manufacturing in the country was an important part of its strategy to increasing its exports and reducing its national trade deficit.

And, while these calls have benefitted local players like Aspen Pharmacare, they have also attracted interest from a number of Indian manufacturers, which was a trend acknowledge by president Jacob Zuma in June.

Zuma described India as “an important partner of South Africa at many levels, politically, socially and economically,” and highlighted Aurobindo Pharmaceuticals and Cipla among the country’s most important investors.

Ranbaxy’s investment and efforts to become a “significant provider of pharmaceuticals to the State” also come at a time when generics firms are facing increased competition from Big Pharma players.

This increase in competition has seen firms like Merck & Co and GSK partner, with Adcock Ingram and Aspen, respectively, to increase their access to the country’s drug market in the last 12 months.

Framed in these terms, Ranbaxy's investment seems like a timely move as additional manufacturing capacity will surely help it compete more effectively in South Africa's $2bn a year drug market.

BI Opens ‘Centre of Competence’

Boehringer Ingelheim has opened its ‘Centre of Competence’ (CoC) in Shanghai to optimize API and chemical intermediates sourcing in China.

Spokeswoman Heidrun Thoma said that the CoC, which covers a 2000square meters (21,520 sq. ft.) area at Waigaoqiao Free Trade Zone, Pudong, is part of the company’s €100m investment plan in China.

“BI’s headquarters in China are located in Shanghai,” Thoma continued, explaining how this location will be suited to CoC, as the facility “can get full support in terms of finance HR and IT.”

The German company has been dynamic in sourcing APIs in East Asia, and establishing the CoC will allow the company to “further optimize the production process of local partners and secure the quality of the intermediates procured in China," said Thoma.

These thoughts were echoed by David Preston, CEO of Boehringer, who said: “optimizing the production process of [the company’s] partners and securing the quality of the intermediates, China will play a stronger role in the company’s global procurement efforts.”

Activities at the new facility are split into two divisions: Process Development (PD) and Quality Control (QC), which will focus on process optimization and technology transfer to Boehringer’s partners in China; areas the company hope will improve operational efficiency.

Alongside this, Boehringer’s QC department will provide full analytical supports for PD and will test and release all chemical ingredients originating from China to ensure they comply with active pharmaceutical ingredient (API) production standards.

In 2009, Boehringer posted net sales of €12.7bn, spending 21 per cent of this in its largest business segment, prescription medicines, on research and development.

In 2009, the company announced a EUR 100 million expansion plan in China to expand its production capacity in Shanghai Zhangjiang High-Tech Park and to set up the center of competence which is now being opened.

German Clinical Lab Will Start Using 454 Sequencers

A German clinical diagnostic lab in January will begin offering four assays that run on Roche 454's GS FLX and GS Junior next-generation sequencing platforms, the lab's director said.

Hanns-Georg Klein, director of the Center for Human Genetics and Laboratory Medicine, said the lab will soon begin validating the assays, whose initial indications will be for cardiovascular, connective tissue, and neuropsychiatric disorders that involve between 20 and 100 genes, as well as HLA typing.

CHGLM's decision to invest in the tools, on which it initially expects to run as many as 50,000 patient samples annually for the HLA-typing indication alone, could — and should — add pressure to US-based clinical labs to invest in similar platforms.

It can also embolden labs seeking to extend their market reach overseas by forging international collaborations. LabCorp and Quest either currently, or soon hope to, have a presence in countries such as Canada, Belgium, France, Singapore, China, Brazil, India, Ireland, Mexico, Puerto Rico, and the UK, some through the help of international partners.

Germany is not on that list, and CHGLM's plan to offer next-gen sequencing-based clinical tests could offer collaborative opportunities for intrepid clinical labs. The country, whose economy is the largest in Europe and the fourth-largest in the world, has a robust clinical-testing market and a rapidly ageing Baby Boomer population — a potentially lucrative combination.

CHGLM, based in Martinsried, was founded in 1998 as a spin-off from the university hospital Grosshadern in Munich. The lab and its sister company, IMGM Laboratories, tsaid they plan to use the 454 instruments to co-develop "workflows for targeted re-sequencing applications in the field of human genetics" — purely a research application.

But according to Klein, who is CEO of both CHGLM and IMGM, the lab will finish developing the assays and will validate them over the next few months in time to launch them as clinical molecular tests in January.

"At the moment we are validating assays for connective-tissue diseases and cardiac disease," while in the near-term pipeline there is an assay for HLA-MHC-locus allele typing and a panel of neurological diseases, he said.

The validation phase will include "checking several pre-analytical procedures" of the 454 instrument, which it will perform via target re-sequencing using a Fluidigm multi-channel PCR platform, according to Klein.

The PCR products will then be run through the 454 sequencer "to ensure that whatever exons or whatever you're looking for can be found with absolute … accuracy," he said.

The lab will validate the 454 sequences with Sanger sequencing. If a mutation fails to surface on the GS FLX, "we would anticipate that this is a true result."

Klein said CHGLM also intends to pre-clinically test the assays on between 20 and 30 patients, and if the results are suitable the lab will begin offering the tests broadly in January.

He said he expects the lab initially to run between 100 and 200 samples of the connective-tissue, cardiac-disease, and neurological assays each month. The HLA assay, on the other hand, "totally depends on the bone-marrow registries." If they adopt these technologies "we could run up to 30,000 or 50,000 samples each year," he said.

"I think it has a great potential" — but at a huge cost. Klein reckons the cardiac and neurological disease tests will run around $10,000 apiece, while the HLA-typing assay would cost around $500.

"The question is whether [the tests] will be cost-effective," he said.

It wasn't immediately clear whether the lab currently runs assays for these indications or what platforms it uses.

According to Ralph Oehlmann, IMGM's director of business development, IMGM actually holds the 454 instruments in its third-floor facility. It will perform the initial test runs on them and design best practices, while CHGLM, located one floor above, will exclusively perform the clinical testing once the assays become available.

The instruments are "well under [CHGLM's] control," he said.

Oehlmann also said IMGM plans to develop and sequence samples to all comers, including clinical labs in the country that have been accredited to perform such assays in Germany.

Facilities in Germany that want to use IMGM's sequencing capabilities on patient samples must know how to draw sequences, design and validate the assays, and compare the 454 results with Sanger sequencing. Oehlmann said IMGM could help labs with some of these steps.

CHGLM is one such lab, and is actually an IMGM client through a contract that enables them to co-perform revenue-sharing R&D and clinical testing.

Stirling Pharma’s Canadian Production Plant to Open

Stirling Pharma’s state-of-the-art Canadian plant will open its doors in late September, and first to come off the production line will be the drug, acetaminophen.

The company already has 13 tons of the active ingredient needed to manufacture acetaminophen, and plans to market the product in Australia, Canada and the US under its ‘Stirling Health’ brand.

Peter Boonen, Managing Director of Stirling Products, said that in addition to producing the company’s own brand of drugs: “We will also be manufacturing for third parties on an outsource contract basis; [producing] anything, ranging from supplements to pharmaceutical products.”

The new plant, located in Cape Breton, Nova Scotia has been fully fitted with extensive laboratory, drug manufacturing and packaging facilities and will initially be staffed by 20 employees.

Boonen said plans are on the way to “scale up employment” to 150 members, and of these, 25 will be scientists working on developing pharmaceuticals and neutraceuticals both for the Stirling brand and on an outsourced contractual basis.

After the recent cooling of the economic climate, Stirling is optimistic demand for third party manufacturing is starting to recover.

“We look at this situation as one of a significant opportunity, and accordingly, we have no shortage of interest in securing contract work for the plant,” said Boonen.

Despite the deep-set fear of a cruel economy for most growing businesses, Boonen is positive “the global health sector is powering on.”

He explained: “In most western countries, as well as developing economies, health concerns and the better servicing of populations are near the top of [their] stated agendas. Canada is a good example, as is Obama’s commitment to health, and Putin’s announcement of a US$16bn overhaul in Russia.”

The decision to open the pharmaceutical facility in Canada came after Stirling was offered the plant “on very attractive terms,” with total control to manufacture products for the ‘Stirling Health’ brand.

Rose Opens Facilities to Korean, Chinese Students

The Rose-Hulman Institute of Technology opened its campus to more than 60 students, professors, and administrators from Korea and China as part of educational collaborations.

These visitors feature 15 students from Korea’s Seoul National University of Technology participating in a four-week educational experience; seven students from China’s Huazhong University of Science and Technology serving as technical advisors for Rose-Hulman’s Operation Catapult program; and 42 rising high school seniors from China’s Jiangsu Province exploring American college options.

Fifteen students from Korea’s Seoul National University of Technology (also known as Seoul Tech) are participating in a four-week educational experience. They are learning about Micro-Electro-Mechanical Systems.

The Korean students are taking an Introduction to MEMS course and receiving valuable learning experiences in Rose-Hulman’s MEMS Laboratory. The group is also expanding its English skills through a course being taught by Indiana State University professor. Seoul National University of Technology teaches many engineering courses in English.

The visiting students came to Rose-Hulman because the college offers a combination of English language and cleanroom experience. The cleanroom experience is rather difficult to achieve in Korea because of the laboratory’s high maintenance expense. Cleanrooms in Korea are used for commercial production, rather than educational experience. Students will be using Rose-Hulman’s cleanroom approximately five hours per week.

Seoul National University of Technology plans to return the favor next spring when Rose-Hulman students get the opportunity to attend classes at the Korean college and participate in internships with international high-tech companies.

Japan Plans Science Institute

The Japanese government is planning to build a new, publicly-financed university in Okinawa dedicated to science, reports the Chronicle of Higher Education's David McNeill. The Okinawa Institute of Science and Technology will be headed by Stanford University particle physicist Jonathan Dorfan, classes will be given in English, and the faculty will be at least half non-Japanese. "It is an attempt to build an entirely new graduate institute that will attract the brightest minds from around the world," McNeill says, adding that it's also Japan's answer to critics that say the country's universities are failing to internationalize and are falling behind the rest of Asia. The school, which is scheduled to open in 2012, will offer classes in neuroscience, developmental biology, and marine science and ecology, he adds. In an interview with McNeill, Dorfan calls the venture "bold," and says it's a chance to promote international and interdisciplinary research and education.

Icon Opens Purpose-Built UK Unit

Clinical CRO Icon officially opened a purpose-built clinical pharmacology unit within the U.K.’s Central Manchester University Hospitals Foundation Trust campus in Manchester. Ireland-based Icon says the 34-bed hospital-based unit means it now has a global capacity for Phase I trials of over 280 beds.

In addition to 24-hour in-patient and emergency services, the new facility includes a sample-handling laboratory and four environmentally controlled pharmacodynamic testing units for continuing work in the field of modeling complex pathologies to identify early signs of compound efficacy in disorders such as neuropathic pain, anxiety, and cognitive degeneration.

“The opening of this translational medicine unit further demonstrates our commitment to streamlining the process that guides new compounds through the early phases of development into treatments that improve human health,” states Icon group president, Alan Morgan. “Our collaborative relationship with the CMFT and the location of the new unit on one of the largest teaching hospitals in the U.K. facilitates unrivalled access to the expertise, specialist procedures, and patient populations necessary to bring life-saving medicines to market faster.”

Icon offers a broad range of services for pharmaceutical, biotech, and medical device development. The firm specializes in development services for preclinical and Phase I trials, together with a full range of integrated services for Phase II through IV studies as well as laboratory and bioanalytical services.

At the end of June Icon opened its new Central Laboratories facility in Tianjin, China, in partnership with Fountain Medical Development. The Chinese laboratory is the firm’s third in the Asia-Pacific region. It will offer a range of testing services including chemistry, haematology, coagulation, and immunology. The site is CAP (College of American Pathologists) accredited and NGSP Level I certified.

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