Helsinn’s facility in Dublin, Ireland has been cleared to package, test and store clinical trial supplies by the country’s medicines board, expanding on the US FDA approval it gained earlier this year.

The Irish manufacture of investigational medicinal products (IMP) license allows Helsinn to bring primary and secondary packaging operation in-house.

The Swiss firm’s strategy is to license early-stage new chemical entities, develop them through to market approval and then out-license them to distribution partners worldwide. Prior to this news the firm had relied upon third parties to package its clinical trial supplies.

Late last year Helsinn added trial scale good manufacturing practice (GMP) standard active pharmaceutical ingredient (API) manufacturing facilities at the plant, which are capable of producing batch sizes in the 0.5kg to 2kg range.

The clearance will help the firm control costs and enables it to react to the last minute changes that can often occur during clinical development projects.

Helsinn has already completed the first packaging run at the Dublin site, preparing stocks of its anti-nausea drug Aloxi (palonosetron) for ongoing US trials in breast cancer.

Blue Springs, MO, To Develop Innovation Park; Secures U of Missouri as Anchor Tenant

The Blue Springs (Mo.) Economic Development Corporation said it will partner with the city of Blue Springs to develop the Missouri Innovation Park at Blue Springs, a 500-acre science and technology innovation park.

The Blue Springs EDC also announced that the University of Missouri has signed on as the park’s anchor research tenant and development partner.

The EDC said in a statement that the park will bringing “significant job opportunities” to the Kansas City region “by linking the science and technology sectors of the animal health industry and the alternative energy industry with research based organizations along the I-70 corridor.”

MU will establish the Mizzou Innovation Center at the park, which will consolidate various activities at its Columbia campus. The Mizzou Innovation Center will ultimately provide the basis for scientific collaboration and commercial innovation links between the MU campus in Columbia and the research and private industrial community that will be located at the Missouri Innovation Park from throughout the Kansas City Metropolitan Area, the United States, and potentially the world.

Kansas City Power and Light provided initial seed capital of an undisclosed amount for the project.

The development partners have issued a request for qualifications from developers to provide planning, development, management, and financing resources for the project. The planning phase for the project is expected to last for four to six months, followed by an 18- to 24-month design and development period.

Financing for the project will come from “a combination of public tax increment financing, other economic development financing tools, private financing arranged by the ultimate developer, and other funding sources under study,” the partners said.

Emisphere to Close Tarrytown, NY, Facility in Restructuring

Cedar Knolls, NJ-based biopharmaceutical firm Emisphere Technologies said it will shutter its Tarrytown, NY, facility as part of an effort to reduce its cash burn rate by more than $11 million annually, or more than 60 percent from current levels.

Emisphere has two products in Phase III for osteoporosis and osteoarthritis with its partner Novartis and the company also has an early-stage partnership with Novo Nordisk for the treatment of Type 2 diabetes.

Effective Jan. 1, 2009, Emisphere will start using third-party contractors for more of its activities, while retaining its resources in chemistry, process chemistry, applied biology, formulation and animal testing, and business development.

The company plans to maintain a single corporate location in Cedar Knolls.

Emisphere said that “overall headcount will be reduced while maintaining scientific, financial, and commercial development capabilities,” but did not provide further details on its headcount.

MPI Lays off 200, But Still Plans to Renovate Two Pfizer Buildings

Contract research firm MPI Research is laying off 200 people from its Mattawan, Mich., workforce, but still plans to purchase two Pfizer buildings in downtown Kalamazoo, Mich., before the end of this month and renovate them during 2009.

Bill Harrison, president and COO of MPI, said that the company will end 2008 with more than 1,500 employees — a net increase over the 1,400 workers it employed at the beginning of the year.

Harrison told the paper that the national recession and credit crisis have led its customers to scale back the number of potential compounds they are trying to develop. He added, however, that many of those clients are delaying contracts with MPI until next year, rather than canceling them.

Meanwhile, MPI expects to soon finalize a deal with Pfizer under which it will buy two of the pharma giant’s downtown Kalamazoo laboratory buildings for $2. Building 126, on Lovell Street, is ready to occupy, but “is not the one we need in the short term,” Harrison told the Gazette, while Building 267, on Portage Street, is needed right away but requires “substantial renovation.”

MPI employees will start moving into the new buildings in early 2010, Harrison said.

Patheon Opens RTP Headquarters, Development Lab

Patheon, a drug development and manufacturing service provider, opened its new US headquarters and analytical lab facilities in Research Triangle Park, NC.

In addition to its new headquarters facility, the company also opened a new pharmaceutical development laboratory in RTP to support its operations in Cincinnati.

In June, the company announced its plans to relocate its headquarters from the Toronto suburb of Mississauga, Ontario, Canada.

SL Green/Gramercy Venture Sell Interest in NJ Sanofi-Aventis Office for $230 Million

SL Green Realty and Gramercy Capital has signed an agreement to sell their interests in a three-building, 670,000-square-foot property at 55 Corporate Drive in Bridgewater, NJ, for $230 million.

The transaction, negotiated by Inland Real Estate Acquisitions on behalf of Inland American Real Estate Trust, includes the assumption of a $190 million mortgage.

The 150-acre property is located at the crossroads of Route 206, I-78, and I-287, and serves as the North American headquarters, under a long-term net lease, for Sanofi-Aventis.

SL Green purchased and retenanted the property from AT&T in 2005 for a reported $125 million as part of a venture with the Gale Companies. Gramercy acquired its interests from the Gale Companies in 2006, and has since been the owner through a 50/50 joint venture.

Max Planck Taps Zimmer Gunsul Frasca as Architect, Jones Lang LaSalle as Program Manager for Florida Facility

The Max Planck Florida Institute said it has selected Washington, DC-based Zimmer Gunsul Frasca Architects to design its 100,000-square-foot biomedical research facility on six acres at Florida Atlantic University’s MacArthur Campus in Jupiter, FL

Financial services firm Jones Lang LaSalle Americas will serve as the program manager to oversee development and construction for the project, which has received a total of $188 million from the state of Florida’s Innovation Incentive Fund and Palm Beach County.

Colorado State to Break Ground on Innovation Center, Biotech Incubator

Colorado State University is scheduled to begin construction on its $53 million, 72,000-square foot Research Innovation Center, located in the Judson Harper Research Complex on the university's Foothills Research Campus.

The three-story building is expected to be completed in April 2010. Research at the center will involve faculty and students as well as startup companies and other private-sector scientists. The top floor will serve as a biotechnology incubator for startups looking to translate university research into new products.

The Research Innovation Center will be an addition to CSU's 38,000-square-foot Rocky Mountain Regional Biocontainment Laboratory, completed on the Foothills Campus in October 2007.

Cook Medical to Open Facility in Canton, IL; Will Hire up to 300 Staffers

Bloomington, Ind.-based medical device manufacturer Cook Medical said it will open Cook Canton, a new manufacturing plant to be located at the former International Harvester plant in Canton, Ill.

In collaboration with the city of Canton, Cook Medical plans to invest more than $5 million in a 45,000-square-foot facility in the fall of 2009.

Cook Medical said it plans to hire 50 to 75 employees once the building is complete, with employment increasing to around 300 jobs over the next few years.

Recruitment for positions will begin by June of 2009.

The company has requested a $750,000 Community Development Assistance Program grant and a $1.1 million Illinois Department of Transportation Grant from the Illinois Department of Commerce and Economic Opportunity for infrastructure improvements in the areas surrounding the new construction.

Schott Expanding Glass Manufacturing in Mainz Germany

Schott plans to add two giant glass melting tanks at its facility in Mainz, Germany, continuing the expansion of pharmaceutical tubing production capacity and creating 135 new jobs in the process.

The investment will be on the double-digit million Euro scale and, according to company chairman Udo Ungeheuer, represents a further strengthening of the firm’s business after the glass ceramics competence centre that was recently established at the site.

Schott said that the decision to set up a new tube manufacturing base, rather than increase capacity at its existing facilities in Germany, Brazil, India and Spain, meets with customer demand that it ensures supply stability using multiple production sites.

The first of the new 10,000 tons capacity melt tanks being installed at Mainz is due to become operational in September next year, although Schott added that completion of the project depends on “future business developments” through to 2010.

When operational the tanks and associated batch warehousing and production space will be used to make Schott’s brand of Filox tubing products in 1.5 meter long Densopack bundles that will then be shipped to clients for further processing. At present, Filox tubes are widely used in the pharmaceutical manufacturing sector to make syringes, vials and sterile bottles.

Earlier this year, a Freedonia report predicted that growth of the vial and syringe sector, which currently generates revenues of around $9.6bn (€7.1bn) a year, would continue. They argued that demand in “pharmerging” markets, coupled with the new injection only biologics, would drive the expansion.

Michigan Projects Expected to Receive Tax Incentives

More than 2,150 jobs could be created in southeast Michigan and $1.1 billion invested in existing and new businesses with the expected approval today of tax incentives from the Michigan Economic Growth Authority.

The authority board was expected to approve a batch of incentives that would spur $2 billion in investment in 20 projects statewide, said Bridget Beckmann, public information officer for the Michigan Economic Development Corp. Statewide, more than 7,000 jobs would be created or retained, Beckmann said.

The authority provides tax credits for companies expanding or locating operations in Michigan or the redevelopment of brownfield sites -- areas that have environmental contamination.

The projects expected to receive tax incentives are:

Northern United Brewing LLC in Ann Arbor: The start-up microbrewery plans to manufacture and bottle beer, distilled spirits and wine in Ann Arbor, Dexter and Peninsula Township. The company will invest approximately $5.8 million in the project, which is expected to create 158 jobs. The expected state tax credit is valued at $931,000 over eight years to help convince the company to expand in Michigan instead of in Ohio and Indiana.
City of Detroit: State and local tax capture valued at more than $1 million will support a proposed redevelopment of the former Greater Detroit Hospital. The development is to include a modern medical office and assisted-living facility. The project will generate $8.9 million in new capital investment and up to 251 jobs.
Global Wind Systems Inc. in Novi: A $7.3-million state tax credit over nine years is expected to be approved to help the company that plans to invest $32.3 million to build its first facility in Novi. The wind turbine generation system manufacturer plans to create 356 jobs.
Novixus LLC in Novi: The company will invest approximately $3.4 in its Novi center and create 192 jobs. The expected state tax credit is valued at $3.1 million over seven years.
Hemlock Semiconductor Corp. in Saginaw: According to a Senate Fiscal Agency analysis, the company has proposed a $1.4-million investment that would spur 270 jobs.

Kauffman Foundation Gives U of Kansas $8.1 Million to Create Biomed ‘Innovation Center’

The new Institute for Advancing Medical Innovation will receive matching funds from the KU Endowment Association, and will provide seed funding for as many as 24 proof-of-concept projects per year by researchers from KU and Kansas City’s Children’s Mercy Hospital, while pairing researchers with industry experts to help drive commercialization.

ReceptoPharm Gets Contract to Supply Clinical Trials Materials

U.S. biopharmaceutical company ReceptoPharm has won its first contract to manufacture a developmental medicine for a third party.

The contract, with Irish company Celtic Pharma, is for the supply of clinical trial materials of Celtic’s experimental cancer drug CB-24. The drug candidate is scheduled to start Phase I testing in Europe shortly.

ReceptoPharm, which since April of this year has been wholly-owned by Nutra Pharma, is one of a number of biopharmaceutical companies that try to develop a revenue stream from their manufacturing facilities to offset the costs of developing its own pipeline.

"Expanding our business into outsourced drug production allows ReceptoPharm to fully utilise its GMP-qualified production facilities and provides the company with an additional revenue stream," said Rik Deitsch, chairman and CEO of Nutra Pharma.

"We plan to offer this service to other developmental stage biotechnology firms in addition to continuing our own clinical development initiatives," he added.

ReceptoPharm’s primary business is in developing therapeutic protein products for the prevention and treatment of viral, autoimmune and neurological diseases, and the company’s research is based upon receptor-binding proteins found in natural sources such as cobra venom.

ReceptoPharm's offices, manufacturing, and R&D facilities are located in a single building totalling approximately 5,400 sq. ft. in Plantation, Florida.

Recently, ReceptoPharm announced the completion of a Phase IIb/IIIa clinical trial of RPI-78M, a modified alpha cobtratoxin, in the treatment of adrenomyeloneuropathy. The firm has agreed to supply the drug to participants on a compassionate-use basis after the study concludes. Data from the trial is expected to be published in early 2009.

Its second drug candidate is RPI-MN, modified cobra venom which inhibits the entry of several viruses that cause neurological damage in diseases such as rabies, encephalitis and HIV.

The manufacturing contract will supply “the necessary quantities of GMP-certified CB-24 required to complete our planned Phase I clinical trial in France," explained John Reid, managing director of Celtic Biotech.

PRA International Has Agreement with Frontage Laboratories to Expand Lab Services

The Contract Research Organization has joined a number of its peers in broadening the portfolio of services offered in order to provide a comprehensive suite that can attract large drugmakers wishing to find a ‘one-stop-shop’ for trials. It already operates a comparable full-service offering in Europe and is bringing its North American operations into line.

PRA said the deal would allow its US Clinical Pharmacology Center, part of the PRA Early Development Services business, to offer “a full complement of analytical lab testing services to its existing Phase I - IV clinical trial services in North America.”

In the bioanalytical area, Frontage specialises in method development and validation, biological sample testing, synthesis and characterisation of reference standards and metabolites, as well as pharmacokinetic testing and bioequivalence studies. The company operates a bioanalytical and biomarker research centre in Malvern, near Philadelphia, that houses 17 mass spectrometers and other instrumentation.

The company’s CEO, Song Li, said that the firm can now offer specialised bioanalytical services through PRA’s customer network.

The aim is to build “a collaborative relationship with PRA that not only streamlines project execution but also places a strong emphasis on project management," he said.

PRA said Frontage’s services will complement the activities of PRA’s 80-bed Lenexa clinical facility near Kansas City, Missouri, which runs a multitude of Phase I and Phase IIa studies each year, with a particular focus on first in human studies and other complex pharmacokinetic studies.

The new collaboration also offers pharmacokinetic and biostatistical consultancy and data support (including data management, biostatistical and PK/PD analysis and ICH-compliant report writing).

The firm said it “now offers pharma and biotech sponsors and other CROs the ability to align the clinical and laboratory processes, thus saving time by avoiding unnecessary clinical trial delays.”

Meanwhile, PRA has also added another office in Munich, Germany, as it continues to tap into the European contract research market. This is PRA’s third office in Germany, a country which was home to the first European branch of PRA, established in Mannheim 27 years ago.

Earlier this year the company relocated some of its German operations into a facility in Berlin that at the time tripled the size of the previous site, on the back of what it described at the time as “exceptionally fast” growth in its European Phase I trials business.

Patheon Opens Lab in Research Triangle Park

Patheon has opened its new U.S. headquarters and analytical lab facilities in the vicinity of Research Triangle Park (RTP), NC. The new pharmaceutical development laboratory will support Patheon's current U.S.-based pharmaceutical development operations in Cincinnati and will initially offer stability studies, validation testing and analytical chemistry services.

Wes Wheeler, chief executive officer and president of Patheon Inc., remarked, "North Carolina is a rapidly growing center for the pharmaceutical industry, which now boasts 334 biotechnology-related companies. It is a pro-business community which combines attractive corporate incentives with a high quality of life for our employees. We are delighted to open our new U.S. headquarters and our new laboratory here, in the vicinity of Research Triangle Park."

The company recently announced that JLL Patheon Holdings, a holding company of private equity investors JLL Partners, is considering a bid to take Patheon private.

Almac Completes and Passes Regulatory Inspection for EU GMP

Almac Clinical Services completed a successful inspection of its Durham, NC operations by the UK Medicines and Healthcare products Regulatory Agency (MHRA). This marked the final inspection covering the group’s main sites for clinical supplies and follows inspections performed at the Craigavon, UK and Audubon, PA facilities within the last four months.

The voluntary inspection, which occurred in November 2008, observed that the Durham site was fully compliant with EU GMPs, with no critical or major failures noted, according to an Almac statement.

Paul O’Connor, vice president, quality at Almac Clinical Services, commented, “The inspection at our Durham site is the third and final outcome in demonstrating global GMP compliance for Almac Clinical Services. Once again we have proven our company-wide attitude towards a total quality ethos and this has been reflected in the results of the recent inspections. I would like to thank all of our staff for their hard work towards achieving this success.”

Robert Dunlop, the group's president, added, “Congratulations to all staff across our three sites who have put significant effort into the design and implementation of our quality systems. This result gives our client base an assurance of high standards and consistency across all of our operational sites. Quality is one of Almac’s core values and we use the strength of our systems, facilities and people to differentiate ourselves in the marketplace.”

SUNY Buffalo Performing $70 Million Renovation for School of Pharmacy

The State University of New York (SUNY) (Buffalo, New York) is in the midst of a $70 million transformation of Kapoor Hall in the university's Natural Science Complex. Formerly known as Acheson Lecture Hall, the building was renamed earlier this year in honor of SUNY Buffalo Pharmacy alumnus, John N. Kapoor. Turner Construction (Buffalo, New York) is serving as construction manager of the project, which will deliver both research and teaching laboratories.

Thermo Fisher Scientific Opened Clinical Services Facility in India

From the $17 million, 150,000 sq. ft. facility located in Ahmedabad in western India Thermo will offer packaging, global distribution and logistics management.

The services are aimed at companies looking to supply pharmaceutical samples to patients participating in clinical trials and have been designed with consideration to regulatory requirements.

The opening of the facility complements Thermo’s existing clinical trial services facilities located in the US, Europe and Asia. It also expands on Thermo’s capacity in India, which has undergone considerable development since it first established its presence in 2000.

In 2005 Thermo opened a facility in Mumbai offering laboratory services. Since then this has been supplemented by facilities offering manufacturing, biospecimen storage, life sciences research and environmental analysis.

Thermo has also made two acquisitions to expand its presence in India. Last year the company bought Qualigens Fine Chemicals and this was added to earlier this year through the acquisition of Chemito.

By making these two acquisitions Thermo established itself as a supplier of laboratory chemicals and analytical instruments in India. The company now employees 600 people at its 20 facilities in the country.

Duke Energy Awards $250K Grant to Rowan-Cabarrus Community College for Facility at NC Research Campus

Duke Energy has awarded a $250,000 grant to Rowan-Cabarrus Community College, toward the cost of an aseptic bioprocessing suite — both equipment and prep rooms — for a new 60,000-square-foot RCCC biotech facility planned for the North Carolina Research Campus in Kannapolis.

The research campus’ developer, billionaire food and real estate magnate David Murdock, is pursuing financing for the building. Representatives of RCCC and the campus have told several North Carolina news outlets they still hope to break ground on the building by year’s end or early in 2009.

Harvard Mulls Delay of Allston Campus Development as Endowment Losses Mount

Harvard University has raised the possibility that it may delay development of its planned campus in Boston’s Allston Landing section, as a consequence of its losing $8 billion, or 22 percent, of its endowment funds since June 30.

Faust and Forst cited a projection that the endowment may fall further, to 30 percent below the $36.9 billion recorded on June 30 of this year, or about $25.8 billion, by the time the current fiscal year ends on June 30.

Harvard uses its endowment to fund about 35 percent of its operating budget – up to $1.6 billion during the last fiscal year — and up to 50 percent of the budgets of some of its schools.

Last year Harvard broke ground on the first facility within Allston, a 589,000-square-foot building that will house the university’s stem-cell initiative. That building is the first of four buildings in what is to be the four-building, 1 million-square-foot Harvard Allston Science Complex. And the complex, in turn, is part of a larger, 20-year university plan to develop up to 5 million square feet of space on 215 of its 352 acres in Allston Landing for educational facilities and student housing.

Biogen Shifting HQ from Cambridge to Weston, MA; Inks 350K-Sq.-Ft. Lease

Biogen Idec said it will move its corporate headquarters in 2010 from Cambridge, Mass., to a 350,000-square-foot building being built in Weston, Mass., near Routes 128 and 20, by developer Boston Properties.

Biogen Idec will move there between 400 and 600 administrative staff in finance, legal and human resources from its current headquarters at 14 Cambridge Center in the late summer or early fall of 2010. The company employs 4,500 people worldwide, of which 1,800 are based in Massachusetts.

Biogen Idec will remain in about 400,000 square feet of lab space and about 200,000 square feet of manufacturing space in Cambridge. The company plans, over time, to convert the roughly 375,000 square feet of office space being vacated into laboratory facilities, the Globe reported.

Jennifer Neiman, a Biogen Idec spokeswoman, told the Boston Business Journal the move will allow the company to continue to grow lab and research operations in Cambridge, where it now occupies 960,000 square feet. The move out of 14 Cambridge Center will provide the company with additional space to expand lab functions while locating office workers in cheaper suburban space, she said.

Biogen will likely pay rent of close to $45 per square foot, versus the more than $60 per square foot rents typical within Cambridge, the Globe reported, citing several unnamed brokers.

For $28.5 Million Cash, Developer Buys Bethpage, NY, Grumman Site Eyed for Life-Sci, Tech from Nassau County

Nassau County officials have selected an entity of Bethpage, NY, developer Steel Equities to redevelop the 101-acre former Grumman property in the hamlet, five months after it answered a formal request for proposals from the county, which took title to most of the site from the Navy on April 3.

Steel K has signed a contract to purchase the property for $28.5 million in cash. Under the agreement, Nassau will sell 92 of the 96 acres it owns, and assign its rights as tenant to another nine county-leased acres owned by the Navy. About 6.4 of the 92 acres being sold by the county will be conveyed free to the town of Oyster Bay for a public recreation area and a Bethpage Fire District training facility. The town will oversee redevelopment of the property.

Nassau County will retain four acres for use as a drainage facility. County Executive Thomas Suozzi and other officials have said they envision the site being redeveloped as a center for biotechnology, nanotechnology, development of alternative fuels, and homeland security.

Located at the northeast intersection of South Oyster Bay Road and the Long Island Rail Road, the property has multiple buildings totaling about 1.3 million square feet. While owned by the Navy, the manufacturing site was operated by Grumman and successor Northrop Grumman, which shut the facility down during the mid-1990s military drawdown.

Steel Equities has converted about 2 million square feet of space on about 120 acres of mostly light industrial former Grumman land into Bethpage Business Park.

WuXi Shutting Down Philadelphia Biologics Manufacturing Operations; Refocusing on Testing, Cell Therapy Services

Shanghai-based WuXi PharmaTech, a pharmaceutical, biotechnology and medical device research and development outsourcing company, said it would end its US biologics manufacturing operations in Philadelphia, in a cost-cutting measure that will cost 100 employees their jobs.

WuXi Chairman and CEO Ge Li said in a statement the company will shift its Philadelphia operations to biologics testing and laboratory services, “which continue to show strong customer demand. Our biologics testing, cell banking, and cell therapy operations in Philadelphia and our St. Paul and Atlanta operations will be unaffected by these actions."

WuXi said it expects the shutdown to cost it $2.5 million to $3.5 million, and then generate about $10 million in annual cost savings. WuXi acquired the Philadelphia facility following its takeover of AppTec, which gave WuXi biologics capacity and a base in the US.

Monsanto Inks 116,000 Sq. Ft. Built-to-Suit Office Lease in Maryland Heights, MO

Monsanto has signed a five-year agreement to lease all of a 116,000-square-foot build-to-suit class A office building to be constructed for the agricultural biotech giant by Duke Realty on the remaining 8.5-acre parcel at its Lakeside Crossing Business Park in the St. Louis suburb of Maryland Heights, Mo.

The deal will nearly double the presence of Monsanto at Lakeside Crossing, where it now occupies 127,778 square feet at the business park’s Office One. The new building is scheduled for completion by December 2009. Whitaker Varley, Duke’s vice president of leasing, represented Duke in Monsanto's new lease deal.

Monsanto’s deal brings to full occupancy the 14-building, 100-acre Lakeside Crossing, a $55 million complex consisting of 916,551 square feet of office, service and warehouse space.

Hard Times Cloud Expansion Plans for Gateway Park in Worcester, MA

Gateway Park — a technology park in Worcester, Mass., being co-developed by Worcester Polytechnic Institute and the public-private Worcester Business Development Corp. — faces a pair of obstacles on its path toward expansion, the newspaper Mass High Tech reported.

The tech park, whose tenants include life-sci employers, is seeking financing to begin construction on two permitted buildings totaling 200,000 square feet, and comprising Gateway Park’s second and third buildings. But with credit markets now all but frozen due to the economic upheaval, Gateway Park cannot secure the financing needed to break ground.

Without the additional space, Gateway Park cannot accommodate tenants growing out of their existing spaces — let alone 20 prospective tenants, two of them anchors, seeking space in central Massachusetts, Gateway vice president for business development D’Anne Hurd told the newspaper. Talks with the anchors have chilled, she said, as the economy has brought down “asking” rents quoted by landlords of other lab space sites, blunting Gateway Park’s cost advantage.

While tenant demand has grown, the requirements for construction financing have tightened, she added; lenders seeking tenant commitments for 70 percent to 80 percent of the new space, versus the 50 percent benchmark that has been traditional since the early 1990s recession.

To get construction going, Gateway has begun seeking an anchor tenant from outside the science or technology spheres, Roberta Brien, senior project manager with WBDC, told the newspaper.

Among companies watching the situation closely is Blue Sky Biotech, Gateway Park’s second-largest tenant with 7,500 square feet. The company projects it will need to double its current space to 15,000 square feet by 2010, and double that amount to 30,000 square feet by 2014, based on recent annual growth of 30 to 60 percent, said founder and CEO Paul Wengender.

Biotech Company Cerexa Relocating from Alameda, CA, to Oakland

Cerexa, a biotechnology company focused on development of anti-infective therapies, has inked a 38,000-square-lease with CIM Group of Los Angeles to take the top two floors of the 10-story, 215,000-square-foot 2100 Franklin St. in Oakland.

Cerexa will move from Alameda to the building, one of five buildings CIM acquired from Brandywine Realty Trust last summer for $412.5 million. The company’s new space has sat empty for more than a year.

2100 Franklin St. is certified as meeting the gold standard of the Leadership in Energy and Environmental Design rating system of the US Green Building Council.

Yourway Transport Relocates To Larger Quarters Within Allentown, PA

Yourway Transport, a provider of transportation for special handling needs in the pharmaceutical, biotechnology and medical/healthcare industries, said on Dec. 5 it has relocated within Allentown, Pa., to a larger 20,000 square-foot facility at 7346 Penn Drive.

The company transports medicines, blood specimens, cryogenic shipments, food, machinery, and human organs, among other sensitive materials.

University of Kansas Medical Center to House R&D for Nebraska Drug Company

BioTarget, a Nebraska-based drug company specializing in cancer treatments, will lease 1,100 square feet on the University of Kansas Medical Center campus for a new research and development facility projected to create 13 new jobs and generate $1 million in capital investment, the Kansas Department of Commerce announced.

The facility is scheduled to open in spring 2009, with the 13 new employees to be phased in over three years.

BioTarget’s 1,100-square-foot facility will be housed in the Kansas City Biotechnology Development Center, a life-sci incubator owned and operated by KUMC. The drug company will partner with KUMC for in vivo diagnostic preclinical studies of encapsulated biomaterials to identify and characterize cancer biomarkers for in vitro diagnostic applications.

BioTarget was formed to commercialize an advanced innovation in biomaterial encapsulation technology. The company will work primarily with the University of Kansas Cancer Center’s Office of Therapeutics, Discovery and Development on these studies.

The Kansas commerce department said in a press release it joined with KUMC and the Kansas Bioscience Authority to give BioTarget an unspecified “combination of financial and technical assistance for the project.” The Wyandotte Economic Development Council and Kansas City Area Development Council provided additional technical support.

With New CEO, WIL Research Labs Plans another Expansion to Ashland, Ohio, Campus

WIL Research Laboratories, a non-clinical contract research organization, has begun planning for a 10,000-square-foot addition to its Ashland, Ohio, flagship campus on George Road, the company’s new president and chief operating officer said.

The new space would be built in addition to a previously announced expansion now under review by the city — the addition of 80,000 square feet to the north side of WIL’s laboratory facility, which the company hopes to complete by August 2009. WIL employs more than 700 people, making it one of Ashland’s largest employers.

WIL Research serves the pharmaceutical, biotechnology, chemical, agricultural, veterinary, and food and consumer products industries.

BIND Biosciences, Peptimmune, AVEO Sublease Cambridge, MA, Space from Alkermes

Three life sciences companies have subleased portions of space from Alkermes at 64 Sidney St., within University Park at MIT in Cambridge, Mass., over the past five weeks, according to Colliers Meredith & Grew, which represented Alkermes in all three deals.

In the latest lease, announced last week, BIND Biosciences has subleased 26,148 square feet. BIND is a biopharmaceutical company developing a new class of targeted therapeutics based on multifunctional nanoparticles.

That deal, announced Dec. 2, surfaced less than two weeks after Peptimmune subleased 13,596 square feet. And last month, Alkermes subleased a 7,407-square-foot portion of space at 64 Sidney to AVEO Pharmaceuticals.

Colliers Meredith & Grew professionals Joseph Flaherty, Tucker Hansen, and Ben Coffin represented Alkermes in all three deals, as well as Peptimmune in that lease transaction. Jon Varholak and Eric Smith of Richard Barry Joyce & Partners represented BIND Biosciences and AVEO.

The deals address about one-third of the 145,000 square feet that Alkermes placed for sublease during the first half of 2008. Alkermes has been shedding space for much of this year, following the decision by partner Eli Lilly to terminate its AIR inhaled insulin program; in March it closed an AIR manufacturing facility in nearby Chelsea, Mass., and reduced its workforce by 150 people.

Jones Lang LaSalle to Market Mann Research Center in Port St. Lucie, FL

Commercial real estate firm Jones Lang LaSalle has been selected to market the Mann Research Center — a $100 million, 22-acre complex to consist of six buildings totaling 400,000 square feet — within the 150-acre Florida Center for Innovation, a section of the Tradition mixed-use master planned community being developed in Port St. Lucie, Fla. by Core Communities.

The Mann Research Center includes three three-story and two two-story research and development buildings, all totaling 290,000 square feet — as well as a single-story retail facility of about 10,000 square feet, and a four-story medical office building of about 100,000 square feet, according to a JLL marketing brochure.

The center is a venture of pioneer biomedical entrepreneur-philanthropist Alfred Mann, and will rise near the 100,000-square-foot headquarters of the Torrey Pines Institute for Molecular Studies, set to open later this month.

U.S. Dept. of Energy Dedicates $135 Million Joint BioEnergy Institute in Emeryville, CA

A $135 million Joint BioEnergy Center in Emeryville, Calif. — charged with a five-year mission to develop the next generation of biofuels from plants — was dedicated Dec. 2 in a ceremony headed by US Secretary of Energy Samuel Bodman.

JBEI is a partnership led by Lawrence Berkeley National Laboratory, and including Sandia National Laboratories, the University of California campuses of Berkeley and Davis, the Carnegie Institution for Science, and Lawrence Livermore National Laboratory.

Located at 5885 Hollis St., JBEI is one of three new “bioenergy research centers” created by the energy department at a total cost of $375 million.

AIDS Vaccine Design and Development Lab Completed in New York

The nonprofit International AIDS Vaccine Initiative recently completed a $17 million, 36,000-square-foot AIDS Vaccine Design and Development Laboratory at New York’s Brooklyn Army Terminal. BioRegion News recently spoke with Michael Goldrich, IAVI’s executive vice president and chief operating officer, about the group’s move to BAT and its significance in the initiative’s overall AIDS vaccine effort.

WuXi PharmaTech to Discontinue its U.S. Biologics Manufacturing Operations

In an attempt to cut costs, 100 WuXiPharmaTech employees are due to lose their jobs.

The move will affect employees at WuXi’s facility in Philadelphia, which will now focus solely on biologics testing, cell banking and cell therapy services. This facility was acquired in the takeover of AppTec, which gave WuXi biologics capacity and a base in the U.S.

WuXi says it initiated the change as it anticipates that its US biologics manufacturing operations will account for less than four per cent of total revenues in 2008. The company believes that it will realise $10m in annual cost savings as a result of the move.

The cessation of biologic manufacturing in Philadelphia will be complete by the end of 2008, costing the company an initial $2.5m to $3.5m before savings are realised in 2009.

WuXi’s action comes after disappointing third quarter results that led to the company knocking $20m to $40m off its expected yearly revenues. This downturn affected many of WuXi’s divisions but had not been anticipated by its biologic manufacturing operations.

At this time it is not clear how stopping biologic manufacture at Philadelphia will impact on existing clients or whether WuXi intends to create additional capacity in China.

Staff from the Philadelphia facility assisted in the setting up of WuXi’s molecular biology lab in Shanghai and the company is also planning on constructing a microbiology and packaging testing laboratory in China.

Liverpool, UK-based Eden Biodesign has Three New Manufacturing Contracts - Worth a Total of £3m (€3.5m)

The contracts cover a combination of development and contract manufacturing services.

Two of the contracts are with new clients, one based in Asia and the other in Continental Europe. The third contract is for a new therapeutic with an existing UK client

Eden's National Biomanufacturing Centre in Speke, Liverpool, was cleared in May 2006 by the UK's Medicines and Healthcare products Regulatory Agency (MHRA) to produce investigational medicinal products for clinical trials.

Earlier that year Eden won the contract to operate the NBC – which is owned by the Northwest Development Agency and at the heart of a £34.25m government-funded initiative to help biotechnology start-ups get their product ideas into clinical trials and also establish England's Northwest as one of the top biomanufacturing hubs in Europe.

Earlier this year the company announced plans to build another manufacturing facility at Research Triangle Park in North Carolina, US, in order to offer its services more efficiently to companies on both sides of the Atlantic.

Brown said that Eden is accelerating its development plans in North America, with additional recruitment planned to support the growing client base and expanding project portfolio.

The U.S. and Saudi Arabia Form Pact to Increase Scientific Research

The United States and the Kingdom of Saudi Arabia have formed a pact that will enable greater cooperation between the two nations across a range of scientific research programs, including plant genomics and biotechnology, health, agriculture, water purification, and other areas, the US Department of State said.

The memorandum of understanding, signed on Tuesday, “will permit greater agency-to-agency cooperation” and will “formalize the decades-long relationship between the two countries,” according to the State Department. The countries “have a long-standing relationship in science and technology involving cooperation between technical agencies, academic institutions, and private industry.”

The agreement will give US researchers “greater access to new research opportunities, provide US academic institutions the opportunity to form new partnerships with centers of learning in the Middle East, and provide new ways for the US science and technology business community to be more globally competitive,” the State Department said.

Saudi Arabia is planning to implement a five-year, $30 billion effort to upgrade its science and technology infrastructure, the State Department also noted.

Unilever Cutting 70 Jobs at a UK Plant

The Port Sunlight site in the Wirral is to become one of the company’s key research and development centres, although organisational changes will result in 70 redundancies.

The site will join plants in Colworth (UK) Vlaardingen (Netherlands), Trumball (US), Bangalore (India), Shanghai (China) to make up the company’s six key global research centres.

The moves are part of the company’s ongoing ‘One Unilever’ strategy to reorganise and streamline its business operations.

According to the company, the focus on six R&D centres will help Unilever focus on fewer and bigger innovations, reduce overlap in activities between sites and increase the speed and impact of innovations.

For product design and deployment Unilever will be consolidating food activities in the Americas to Englewood Cliffs (USA), Valinhos (Brasil) and Mexico City (Mexico), whereas global laundry R&D will be consolidated in Vlaardingen (NL), Port Sunlight (UK) and Mumbai (India).

The company has announced it expects the changes to result in the loss of approximately 250 full time staff, although the moves could impact up to 390 full time members of staff.

Louisiana State University and Veterans Affairs Shared Hospital Site

Louisiana State University and the U.S. Department of Veterans Affairs confirmed they intend to build their new teaching hospitals in downtown New Orleans.

The two institutions in recent months have expressed a strong preference for building a joint medical campus in the downtown area, a collaboration that will let them share medical equipment and expertise among their respective physicians.

Yet LSU and the VA remain apart in one critical respect. Congress has fully financed the new veterans’ hospital, but LSU is still scrambling to piece together nearly a billion dollars for its half of the project. That financing gap means the VA portion could proceed faster.

The state had expected to make a down payment on the new teaching hospital with FEMA reimbursements for Katrina damage to Charity Hospital. But the two agencies have tussled over the amount, with the state requesting $494 million and the feds promising only $23 million.

FEMA administrator indicated publicly for the first time that the agency has revised its damage estimate for Charity upward. Although he would not name a figure, others said after the news conference that the agency is willing to pay $150 million.

Paul Rainwater, executive director of the Louisiana Recovery Authority, said the state continues to negotiate in earnest with Washington over the Charity reimbursement. At the same time, he and other state officials have made overtures to several people rumored to be on the short list for FEMA director under incoming President Barack Obama.

Although LSU has not secured the money for its hospital, exultant federal, state and local leaders greeted the announcement of the medical center's location as a turning point for the region's recovery. The two hospitals will be a training ground for future generations of doctors and nurses, and they could help position New Orleans as a world-class center for biosciences research.

The joint LSU-VA medical campus will span 70 acres bounded by Claiborne Avenue, South Rocheblave Street, Tulane Avenue and Canal Street. South Galvez Street divides the LSU portion of the campus from the VA side.

The campus sits within a national historic district, and construction of the new hospitals will force the demolition of scores of houses and small businesses. Preservation groups have pressed both LSU and the VA to consider alternative locations that would not involve the displacement of residents or the loss of historic assets.

The Foundation for a Historical Louisiana circulated a news release Tuesday criticizing both institutions for selecting a site before the Obama administration had a chance to review the issue and before LSU had secured money for its portion of the project. Richard Moe, president of the National Trust for Historic Preservation, said in an interview that choosing to build on top of a neighborhood would introduce "needless" costs and disruptions into the project.

The VA expects to have its hospital open and treating veterans by 2013. The Nagin administration has pledged to acquire land for the new veterans’ medical center, and it has one year to move out the residents and small businesses and present a site ready for construction. The city expects to spend $79 million to do that.

Ed Blakely, the city's recovery czar, said at the news conference that the city would try to preserve homes with "infill techniques" -- moving them to vacant lots in another part of the city. But preservationists said afterward that the city and the VA had earmarked money to move only 20 houses out of about 200.

No demolitions will take place for at least 30 days on the VA site. The federal agency plans to spend that time seeking suggestions from preservation groups and others on how it might incorporate some historic buildings, such as the former City Hall annex and the defunct Dixie Brewery, into the design of the new hospital.

Charles Zewe, a spokesman for LSU, said the state planned to begin property acquisition immediately for the university's portion of the development. The LSU area includes a larger concentration of parking lots and empty land than the VA portion does, but it does contain several notable buildings, including the Deutsches Haus, which could be incorporated into the footprint of the new teaching hospital.

Actavis Opens More R&D Labs

Actavis South Atlantic (ASA), a United States division of the international generic pharmaceutical company Actavis, has opened new analytical and R&D laboratories to expand the Company's research and development efforts for controlled release (CR) and other technically difficult generic pharmaceutical products.

The new analytical labs have been expanded by 3,000 sq. ft. and the new R&D labs have been expanded by 1,500 sq ft. As part of the Sunrise, FL expansion, appropriate office space was also added to support both of the lab expansions.

Actavis U.S. CEO Doug Boothe said, "Actavis in the United States is focused on our vision and commitment to be on the cutting edge of new technology. The expansion of our South Atlantic R&D facility ensures that we remain well-positioned to develop and manufacture XL (extended release) and CR (continuous release) drugs."

Actavis is one of the leading companies in the U.S. market in the development of CR products, with more than EUR 50 million (USD 74 million) expected to be invested in CR development in 2008 and 200 employees dedicated in the development of CR products. Actavis has 13 pending ANDAs for CR products with the FDA.

Azopharma Unveils New UK Laboratory and EU plans

Azopharma Product Development GroupTM announced its entrance into the European market with the addition of new laboratory facilities and office space located in Welwyn Garden City, UK. The new facility will provide analytical, QP release testing, preformulation and formulation development services to the European market.

This is Azopharma’s first venture outside the USA.

Azopharma is a leading Contract Research Organization based in North America which provides comprehensive product development services from post discovery to commercialization. Azopharma is able to provide total product development services for the pharmaceutical, biotechnology and medical device industries.

Azopharma brings together the best scientists in the field, state-of-the-art facilities and a focus on quality that provides client partners an unbeatable combination in total product development.

Azopharma Product Development Group Includes:

Azopharma Contract Pharmaceutical ServicesTM - Integrated product development and CTM manufacturing for all dosage forms.
ApiCross Drug Delivery TechnologiesTM - Proprietary drug delivery platforms to solve difficult molecular challenges.
Cyanta Analytical LaboratoriesTM - Analytical chemistry and inhalation services from development to quality control testing.
AniClin Preclinical ServicesTM - Preclinical services in support of early product development.
IQsynthesis TM - Synthetic chemistry services from discovery to clinical API supplies including large scale API synthesis.
AvivoClin Clinical ServicesTM - Human clinical pharmacology services for Phase I/II/III clinical trials.
ADMEquant Bioanalytical Services TM - Bioanalytical research analysis of pharmaceutical compounds in all matrices.
Acromon Clinical Research OrganizationTM - Clinical monitoring, data management and statistical services.

Infinity Molding Adds Cleanroom

Infinity Molding & Assembly a custom molder in their 27th year of operation with annual sales of approximately $15 million recently broke ground for a new cleanroom facility in Mt Vernon, Indiana on their existing manufacturing campus.

The new business unit will operate under the name, “Infinity CleanRoom Solutions” and focus mainly on medical customers whose molded and assembled product requires a certified “class 100,000” or “class 10,000” cleanroom.

Approximately 3 years ago the management team made a conscious decision to develop a more diversified customer base with medical being a priority. In order to progress to the next level, they recognize the necessity of creating an entirely new culture that focuses on cleanroom molding and assembly.

In July of this year, the Board of Directors at Infinity approved a plan to construct a new cleanroom plant that will be capable of being registered to class 10,000 (ISO 7). Formal ground breaking took place October 6, 2008

Further, a direction to pursue ISO 13485 was approved. Infinity received ISO 13485 registration (the medical ISO quality system) certificate at the current facility in September.

Infinity expects to have the new 11,500 sq ft cleanroom molding and assembly plant operational June 1, 2009. Current medical business will transition from Infinity’s existing molding plant in Mt Vernon to the new cleanroom facility upon completion. Infinity is also in discussions with other medical companies that require cleanroom manufacturing to move new programs in upon completion of the new facility.

Alexandria Real Estate Equities Halts Work on Boston, Cambridge, MA, Projects

With the frozen credit market for new construction projects and reluctance by tenants to commit to space among factors, Alexandria Real Estate Equities told local newspapers that it was postponing construction on new lab space projects in Boston and Cambridge, MA.

The delays reflect Alexandria’s new policy, announced to analysts last month, of halting groundbreakings on new projects beyond those already under construction pending improvement in the credit market.

Alexandria and partner National Development have halted work on the $300 million, 425,000-square-foot Longwood Center project set for a 1-acre site land owned by the Joslin Diabetes Center at Brookline and Longwood avenues, in Boston’s pricey Longwood Medical Area. Longwood Center will remain on hold at least until spring.

The delay will push back by a few months the project’s completion date, set for 2011.

To date, developers have demolished two buildings and leveled the construction site, but work has yet to begin on laying the foundation for the nine-story building.

In Cambridge, Alexandria has postponed the redevelopment of 75,000 square feet of lab space at 215 First St., comprising approximately 20 percent of the building’s floor area.

The renovation would more than double the current 30,000-square-foot lab space now in place at 215 First St., a 380,000-square-foot building also called the Atheneum. About 15 companies are currently seeking between 5,000 square feet and 20,000 square feet of lab space in the area.

Alexandria planned to build out incubator lab space on a speculative basis — or without solid lease commitments from tenants.

Meanwhile, Brigham and Women's Hospital said it is delaying plans to renovate its patient’s tower and may scale back the project as tightening finances begin to restrict what has been a prolonged building boom in the Longwood area.

Hospitals in the Longwood Medical Area have undergone rapid expansions in the last several years. Currently, more than 1.6 million square feet of construction is either approved or already underway, but hospital executives said they are now becoming increasingly focused on paring expenses.

MedImmune Plans Near-Doubling of Gaithersburg, MD, HQ Campus Space

MedImmune is designing a seven-story building, including five finished floors and 300,000 square feet, as the next phase of its campus expansion designed to nearly double the space of its headquarters campus in Gaithersburg, MD.

The division of AstraZeneca expects to break ground on the project in the first half of next year with a late 2011 opening date. MedImmune said it needed the new space to accommodate hundreds of new employees hired this past year and expected to be hired in 2009.

MedImmune, the largest biotech in Maryland’s Montgomery County, now has 361,000 square feet of space in its HQ campus.

URI Scrambles to Plug $5 Million Shortfall for Biotech Center Construction at Kingston Campus

The University of Rhode Island is weighing proposals and “aggressively” talking to potential donors interested in plugging a $5 million shortfall in the cost of constructing the 140,000-square-foot Center for Biotechnology and Life Sciences taking shape on the Kingston, RI, campus.

The shortfall will not stop the planned January opening of the biotech center — but will prevent the completion of office space planned for the fourth floor. Administrative offices for Jeffrey Seemann, dean of URI’s College of the Environment and Life Sciences, and other faculty and staff will remain in Woodward Hall until the fourth floor can be finished.

Rhode Island voters approved a $50 million bond to finance construction of the center in 2004. Two years later, URI administrators said the university would raise private funding to cover the difference between the bond and the cost, whose estimates ranged from $58 million to $60 million.

The center will open next month with facilities that include a 400-seat auditorium; equipment to support genomics, proteomics, and DNA sequencing activity; a biosafety level-3 lab; and a lab to keep saltwater fish for testing and research.

Integrated Biomolecule Sells Oro Valley, AZ, Facility to Ventana Medical for $6.5 Million

Biotechnology firm Integrated Biomolecule Corp. has sold its Oro Valley, Ariz., facility to Ventana Medical Systems for $6.5 million.

The 18,000-square-foot building, at 2005 E. Innovation Park Drive, had been Integrated Biomolecule’s main base of operations. The company is currently in transitional space and is looking for new headquarters soon.

Founded in 1992, Integrated Biomolecule specializes in development and analytic services for diagnostics and pharmaceutical trials. Ventana Medical is owned by Swiss-based Roche Holding, which announced last month it would hire about 250 additional employees as part of an expansion of its Tucson operations.

Three Life-Sci Startups Eye Soon-to-be-Vacated City Hall in Surprise, AZ

Three startups with specialties in biotech and pharmaceutical production have expressed an interest in leasing space within the 58,000-square-foot City Hall that is to be vacated next year by officials in the city of Surprise, Ariz., when they move into a $61 million new facility under construction and set to be completed in the spring.

The three wish to be among tenants in an incubator they envision for the building at 12425 W. Bell Road. The city initially hoped to sell the building, at a minimum price of $8.6 million.

The city will not disclose the names of the tenant prospects pending the outcome of discussions. A committee of city employees is expected to interview the applicants on Dec. 5. The Surprise City Council could address a proposal as soon as early January.

Northern Arizona Center for Emerging Technologies Opens in Flagstaff

The 10,000-square-foot Northern Arizona Center for Emerging Technologies — an incubator on McMillan Mesa focusing on the life sciences, cleantech and other tech specialties — was opened in a ceremony attended by Gov. Janet Napolitano on Nov. 24, a week before President-Elect Barack Obama announced he will nominate her for secretary of homeland security.

One of the incubator’s first tenants is SenesTech, a fledgling biotechnology company started six years ago by Northern Arizona University alum Loretta Mayer. The company has one of the largest presences in the incubator, with several employees working out of a total of seven labs and offices.

SenesTech is working to manufacture a nontoxic alternative to the poisons currently used against rice-field rats. The company recently signed a contract with the Australian government to produce the compound.

NACET will also be the home to Northern Arizona University’s tech-transfer office, which will help the school develop and commercialize inventions made by NAU faculty.

The U.S. Food and Drug Administration Opened Offices in Three Chinese Cities – Beijing, Shanghai and Guangzhou

The FDA’s main office will be in Beijing, with the Shanghai and Guangzhou locations serving as inspection stations. This is part of a major plan by the agency to expand its international presence, with additional branches due to open in Europe, Latin America and India before the end of the year.

By having a presence in other parts of the world, they can work more closely with manufacturers and other governments, better share best practices and further ensure that quality and safety are built into ... products at the point of manufacture.

The opening of the new offices is timely, coming at the tail end of a series of scandals involving Chinese products in the US and other world markets, including contaminated medicines, foods, and personal care products such as toothpaste. China is also at the top of the list of countries for products which have had import permission to the US refused.

With a headcount of just eight, plus five Chinese nationals, the FDA’s presence in China is considered mainly advisory, providing advice on US quality standards and training local inspectors, although it will also maintain an inspection function.

That said, a permanent FDA presence in China will help the agency to “address the challenges presented by globalisation," said von Eschenbach, FDA Commissioner. In particular it would allow the FDA to respond more quickly to any problems that occur.

The FDA has been under fire from US politicians in recent weeks, with questions raised about the agency’s oversight of the pharmaceutical supply chain in the wake of the heparin scandal, which saw product from around the world recalled after contaminated heparin sourced from China found its way into medicines, the ongoing probe into quality standards at India’s Ranbaxy and slew of food safety incidents.

One of the persistent criticisms is that the agency should do more inspections of overseas plants. The FDA carried out 13 visits to Chinese production facilities, out of more than 700 sites in 2007. That compared with 24 to France, which has 162 drug manufacturing plants.

Meanwhile, the European Union and China are also looking at working more closely in the future. The SFDA is planning to send a delegation to the EU next year to meet with regulators and industry groups.

The visits had been planned to take place in 2008, but were held back after the massive governmental budget drain which came about as a result of the earthquake in Chengdu earlier this year.

Isogen Starts Operations at New Contract Facility in Delaware

Isogen will starts operations in January at a new contract facility in Delaware that will provide small-scale sterile filling services to the pharmaceutical industry.

The sterile process engineering consultancy announced it would start up its own manufacturing operations back in April, in order to plug what it said was a major gap in injectable manufacturing.

Isogen said the Phase I facility will address “the process, facility and capacity problems commonly associated with the $2bn highly-niched, low-volume clinical and early-stage commercial sterile filling market segment.”

Isogen's facility will provide Good Manufacturing Practice (GMP) vial and syringe filling, ranging in fill size up to 4,000 units per shift in fully segregated, isolator-based fill lines in a potent capable facility. Isolator-based lyophilisation capacity is planned for later in 2009.

Large contract fillers have focused on commercial filling, which is more lucrative, while smaller players often lack the breadth of expertise needed to service the complex needs of biopharmaceutical companies.

Isogen will be using barrier isolation technology in each of the seven manufacturing suites in the plant "to provide best-in-class sterile processing for potent and non-potent compounds," said CEO Les Edwards.

Isolator technology won the endorsement of the technology by the European Medicines Agency in May 2003, and the US Food and Drug Administration (FDA) in September 2004, as a suitable technology for use in aseptic manufacturing. The high capital cost of installing isolators can be set against the high operational costs of running cleanrooms.

Regulators in the US and Europe increasingly require sterile clinical trials supplies to be manufactured in accordance with cGMP standards.

Isogen will offer an integrated GMP clinical and early commercial contract filling service comprising sterile process development, analytical laboratory services and pharmaceutical engineering consulting.

Isogen's Advanced Sterile Filling offers full product segregation and isolator-based sterile processing. The facility meets global regulatory standards and operates according to cGMP. Isogen's industry subject matter experts and a combination of its analytical pharmaceutical laboratory and engineering service functions make Isogen a fully integrated Contract Development and Manufacturing Organization (CDMO) capable of supporting client contract from formulation to distribution.

AstraZeneca Announces Divestment to Recipharm of Sweden

AstraZeneca has announced the divestment of the AstraZeneca Biotech Laboratory (ABL) in Södertälje, Sweden, to Recipharm AB of Sweden, a leading contract development and manufacturing organization. Under the terms of the agreement, Recipharm Biotech AB (a newly formed subsidiary of Recipharm) will lease the ABL from AstraZeneca for an initial period of 12 years. Recipharm Biotech AB will also purchase all associated equipment, and the majority of the existing ABL staff will transfer employment to Recipharm Biotech AB. AstraZeneca will retain a significant minority stake in the new company, in addition to entering into a supply arrangement for Phase I and Phase II material for one of its development projects. No financial terms were disclosed.

The divestment of the ABL follows AstraZeneca's recent acquisition of MedImmune through which it gained extensive biotechnology manufacturing capabilities. As a result, AstraZeneca has consolidated all biotech activities within MedImmune at their sites in the UK and the USA.

This acquisition by Recipharm follows the company's recent purchase (August 2008) of lyphilisation facilities from Inotech Labor AG, located in Basel, Switzerland. Together, these allow Recipharm to offer a one-stop-bio-manufacturing shop, taking customers projects from cell-line development based on their gene of interest, right through to their finished products for pre-clinical and early clinical studies.

The handover date for the facility is set for 1 January 2009.

AstraZeneca is to Cut 1,400 Jobs and Close More Manufacturing Facilities by 2013

AstraZeneca is to cut 1,400 jobs and close more manufacturing facilities by 2013, as it attempts to slim down in preparation for impending generic competition for some of its cornerstone drugs.

The move, which is in addition to the 7,600 jobs the firm will eliminate over the next two years under its 2007 restructuring plan, will see it close facilities in Porrino, Spain, Destelbergen, Belgium and Umeaa, Sweden.

Jobs at the company’s plants in Macclesfield in the UK and Sodertaije, Sweden will also be affected although further details are not being released at present.

The news comes just days after the drugmaker won a case temporarily blocking a generic version of its asthma drug Plumicort Respules made by Israeli firm Teva Pharmaceutical Industries.

AstraZeneca, which has halted sales of a generic version of Plumicort that it sells with Par Pharmaceuticals, said that the final outcome of the patent trial, due to begin again tomorrow, is likely to impact on its earnings for the year.

Astra looks East

AstraZeneca also fell in line with another trend sweeping big pharma, announcing plans for further investment in its operations in South East Asia. The firm plans to increase its investment in its manufacturing facility in Wuxi, China.

The additional funds, details of which have not yet been released, is designed to expand the plants drug formulation capabilities and establish it as a packaging hub for its all of its manufacturing facilities in the region.

AstraZeneca PLC said it plans to close three plants in Spain, Belgium and Sweden and cut 1,400 jobs in Europe by 2013 to improve efficiency and expand investment in Asia to serve the growing market there.

It said it is investing in its Wuxi plant in China to turn the plant into its packaging center for the entire Asia Pacific region.

AnaSpec Has New GMP Facility

In response to increased demand for GMP peptide production, AnaSpec has established a new facility dedicated to GMP manufacturing. Located adjacent to its current San Jose, California-based headquarters, the expansion provides an additional 5000 sq. ft. of dedicated GMP space including two Class 10,000 clean rooms (ISO Class 7).

AnaSpec offers GMP peptides in milligram to kilogram quantities. Optimized for bulk API manufacturing, AnaSpec's GMP peptide services offer greater than 98 percent purity peptides with QC product release testing, stability studies, and full documentation for drug master files.

DuPont Opening Knowledge Center in India

DuPont opened the DuPont Knowledge Center (DKC), 17 months after breaking ground last summer. Located on 15 acres in the ICICI Knowledge Park in the city’s Genome Valley, the center will be a research hub for India and the Asia Pacific region in the areas of agricultural and industrial biotechnology as well as engineering design and will grow to serve a broad range of DuPont businesses.

The center will include a biotechnology center, materials research center and global engineering design center, making it the first integrated knowledge center outside the United States. DKC brings together basic research, applications development, engineering design, bioinformatics and patent services to serve the Asia Pacific region, a key growth market for the company. DuPont 2007 net sales in Asia Pacific were $5.18 billion. With 25 percent average annual growth rates, India is an emerging growth market for DuPont.

DKC research will use the DuPont integrated science approach of creating valuable products and technologies using unique combinations of biology, chemistry, materials science, engineering and other science disciplines to further develop the company’s application pipeline. DKC is home to more than 180 scientists today and is expected to accommodate more than 300 scientists and other employees by next year. At full capacity, about 600 scientists, engineers and other employees will work at the DKC.

In 2007 DuPont announced plans to invest more than $30 million to construct its first R&D center in India to focus on delivering new products and technologies across the company. Research is already under way for Pioneer Hi-Bred, DuPont Crop Protection and DuPont Applied BioSciences, including discovery research for the DuPont-BP biobutanol advanced biofuels program.

The DKC is the sixth major DuPont R&D facility outside the United States. DuPont has more than 50 R&D facilities throughout the world with 20 in the United States and more than 30 in 11 other nations. Other major DuPont R&D facilities are located in Wilmington, Del.; Shanghai, China; Utsunomiya, Japan; Hsinchu, Taiwan; Wuppertal, Germany and Meyrin, Switzerland. DuPont invests an average of $1.4 billion annually on global research and development in a diverse range of technologies for many markets including agriculture, automotive, construction, electronics, chemicals and industrial materials. Today, DuPont has more than 5,000 scientists and engineers around the world.

DuPont is a science-based products and services company. Founded in 1802, and operating in more than 70 countries, DuPont offers a wide range of innovative products and services for markets including agriculture and food; building and construction; communications; and transportation.

Pfizer Launches New Global Research Unit

Pfizer launched an independent research unit known as Pfizer Regenerative Medicine. The unit, led by CSO, Ruth McKernan, Ph.D., is expected to employ around 70 researchers and will build on recent scientific progress in understanding the biology of stem cells. The scientists will operate in small, flexible teams, with the capability to make decisions quickly and effectively.

Researchers at Pfizer Regenerative Medicine will explore the use of stem cells to develop future treatments that may prevent disability, repair failing organs, and treat degenerative diseases. The ultimate goal will be to deliver new medicinal products that can pave the way for the use of cells as therapeutics.

Pfizer Regenerative Medicine will be co-located in the biotech hubs of Cambridge, U.K., and Cambridge, MA, in the U.S. The U.K. unit will focus on neural and sensory disorders, and the U.S. site on endocrine and cardiac research.

Pfizer Regenerative Medicine will operate as one of the company’s new small, independent research units aimed at bolstering the biotechnology culture and environment. The unit will be co-located in the biotech hubs of Cambridge, UK and Cambridge, MA. It is expected to expand to employ 70 researchers. According to the company, these scientists will operate in small, flexible teams, with the capability to make decisions quickly and effectively. The Cambridge UK site will focus on neural and sensory disorders. The Cambridge, MA site will focus on endocrine and cardiac research.

PacificGMP Enters cGMP Contract Manufacturing

PacificGMP has entered into a cGMP contract manufacturing agreement with Actinium Pharmaceuticals, a biopharmaceutical company developing new targeted therapies for cancer. PacificGMP will manufacture and perform fill/finish of Actinium's HuM195 monoclonal antibody for a Phase I/II clinical trial. A stability study of the final product will also be conducted. HuM195 is a monoclonal antibody that is currently being tested in a Phase I trial to treat acute myeloid leukemia.

ImClone Receives FDA Approval

ImClone Systems has received approval from the FDA to manufacture multiple products at its BB50 manufacturing facility. This approval significantly expands ImClone’s total available production volume capacity for its proprietary pipeline of novel antibodies, which are now entering late-stage clinical development.

This multi-product FDA approval of BB50 significantly enhances ImClone’s operational flexibility for scale up production of proprietary antibodies for the growing number of Phase II and III trials that will be commencing in the next year.

ImClone’s 250,000-sq.-ft. multi-suite BB50 facility received FDA approval to manufacture Erbitux in August 2007. Together with the company’s BB36 manufacturing facility, ImClone has a total production volume capacity of up to 140,000 L at its Branchburg, NJ campus. This is among the largest antibody manufacturing capacities in the biotechnology industry and is a key component of ImClone’s fully integrated operations supporting the development and commercialization of the company’s antibodies, according to an ImClone statement.

Parexel Opens Facility in Lima, Peru

Parexel International has opened an office in Lima, Peru to provide regulatory consulting and clinical research capabilities. With the addition of the Peru office, Parexel now has locations throughout five important biopharmaceutical centers in Latin America, which also include Argentina, Brazil, Chile, and Mexico. This expansion further strengthens the company's position as one of the largest biopharmaceutical services providers in this emerging region for clinical development, according to a company statement.

Capabilities provided by Parexel's Latin American locations include regulatory advice for clinical development, as well as a broad range of services including project management, site management, data management, medical affairs, biostatistics, and bioanalysis for the conduct of Phase II-IV studies.

Thermo Fisher Marks Expansion of Lenexa, KS, Facilities; Set to Add 90-180 Jobs

Thermo Fisher Scientific celebrated the completion of a 30,000-square-feet expansion of its Lenexa, Kans., facility at 12230 Santa Fe Drive.

The Kansas facilities, which include four buildings in Lenexa, manufacture the Remel brand of products sold by Thermo Fisher. Those products include microbiology lab products and diagnostics that are sold into the clinical, industrial, and research markets.

The Kansas Bioscience Authority, a state-run initiative aimed at attracting and retaining bioscience research in Kansas, awarded $1.25 million to Thermo Fisher in September 2007 to help pay for the facility expansion. According to the KBA, the Remel business intends to add between 90 and 180 employees through 2012 to its Lenexa operations, where more than 500 people are now employed.

KBA was created by the Kansas Legislature in 2004 to reinvest roughly $580 million in tax revenue from the state's bioscience industry in the next 10 to 12 years, toward an expansion of that industry within Kansas.

The renovation project made room for additional general office space, information technology operations, a state-of-the-art chemistry lab, facilities for evaluating raw materials and finished-product quality assurance, and manufacturing of a product called dehydrated culture media.

The expansion was reported by the Business Journal to cost $4 million, but a spokesperson would not confirm that figure when contacted.

Joint Venture Seeks Approval for $200 Million Bio/IT Park in Jinja, Uganda

Lake Victoria Information/Communication Technology and Biotechnology Limited or LAVIT, a joint venture between India's United Telecoms Limited and Uganda's Jinja Institute of Technology, has applied with authorities for a license to build a $200 million biotech/IT park in Uganda.

According to the IDG News Service, which cited documents filed with the Uganda Investment Authority, LAVIT would build a biotechnology innovation center, a hardware and software innovation center, and a multinational engineering design center on a campus intended to revive the Ugandan town of Jinja. LAVIT hopes to develop Uganda's pool of telecom and IT workers, as well as bring IT and biotech jobs to the Common Market for Eastern and Southern Africa or COMESA region.

The park will be given a special economic zone status and serve as one of the first projects of its kind in East and Central Africa, UIA official Sheila Karungi told IDG. A feasibility study, which commenced in January, is currently underway and will be completed before breaking ground on the park.

LAVIT hopes to capitalize on Uganda’s preferential access to the US, Canada, Japan, and the European Union. The agency said the center hopes to step up Uganda’s trade with the UK, Italy, Kenya, Tanzania, South Africa, and Mauritius, citing Uganda’s reduced tariffs.

UTL is a Bangalore-based ICT solutions company with wide experience in setting up telecom networks, e-governance networks and solutions in the transport sector. UTL boasts more than eight manufacturing facilities spread throughout Bangalore, which has grown into India’s IT hub.

VisEn Medical Moves into Larger Biotech Facility in Massachusetts

VisEn Medical, a molecular imaging company, will more than double its space when it moves in August 2009 to the 23,000 square feet for which it recently signed a lease at 45-47 Wiggins Ave. in Bedford, Mass. VisEn will relocate from the 11,000 square feet it now occupies at 12 Cabot Road in Woburn, Mass.

45-47 Wiggins Ave. is a 38,000-square-foot, single-story flex building that has been renovated by owner Alexandria Real Estate Equities into a biotech laboratory facility.

Signature Genomic Moves to a Larger Headquarters and Laboratory in Spokane

Signature Genomic Laboratories has relocated its headquarters and laboratory within Spokane, Wash., to a new building in the city’s north side. Signature moved June 2 into the new headquarters at 2820 N. Astor St., an 18,500-square-foot former Sears Roebuck and Company distribution center.

Designed by Matthew Collins at Spokane architectural firm Nystrom Olson Collins, the new headquarters features 9,000 square feet of wet lab space, compared to 5,000 square feet of wet lab space in its current location. Spokane-based Doric carried out remodeling work to remodel the building.

Signature has doubled in size in the 18 months since it moved into its current home base, in the Sirti Technology Center at 120 N. Pine St. in downtown Spokane. The center is operated by Sirti, a state-funded economic development organization founded as the Spokane Intercollegiate Research and Technology Institute.

“With the increasing diagnostic use of our oligonucleotide microarray and our expanding Genoglyphix service, we anticipate even more growth in the next few years," said CEO Lisa Shaffer.

Founded in 2003, Signature provides microarray-based chromosome analysis to clients that include clinical geneticists, neurologists, pediatricians, neonatologists, obstetricians, and the research community.

BASi Opens European Office

BASi has opened a new European laboratory and office in Warwickshire, UK. The relocation to a new, upgraded facility with expanded labs provides clients with enhanced capabilities throughout Europe.

The new 10,000-sq.-ft. facility offers a comprehensive bioanalytical capability, as well as providing access to the BASi Group’s full range of preclinical and pharmaceutical analysis services for pharmaceutical and biotechnology companies. BASi Europe also distributes the complete line of BASi instruments and equipment, as well as providing support for customers and distributors throughout Europe.

Laureate, Tolerx in Bio-Manufacturing Pact

Laureate Pharma has entered into a cGMP contract manufacturing agreement with Tolerx, Inc., a biopharmaceutical company engaged in the discovery and development of novel therapies for the treatment of immune-mediated diseases. Laureate will produce Tolerx’s humanized anti-GITR antibody known as TRX518, which is currently in development for cancer and chronic viral indications. Details of the agreement were not disclosed.

Metrics to Open Potent & Cyto Facility

In early 2009, Metrics Inc. will open a dedicated potent and cytotoxic drug development facility in early 2009. The new facility, part of Metrics’ recent $18-million expansion, will provide total engineered containment of pharmaceutical processes through customized hard-wall isolation technologies, according to the company. These technologies have allowed Metrics to eliminate any need for the use of powered air purifying respirators (PAPRs) in the new potent facility. Equipment and change parts are dedicated exclusively to potent and cytotoxic use, and containment is achieved at levels approximately 30 nanograms per cubic meter of room air.

Metrics’ new potent and cytotoxic facility will feature two processing rooms that come complete with independent entry double airlocks, independent decontamination showers and exit airlocks,independent equipment airlocks, and access to an dedicated washroom. It is designed for one-way flow of material, personnel and equipment. A dedicated air handler will bring in 100-percent outside air with HEPA-in and HEPA-out filtering at the rate of 11,000-cubic-feet per minute and 25 air changes per hour. There are pass-throughs for the export of product and waste as well as dedicated equipment storage.

“We’ve increased our capacity to safely work with more potent active pharmaceutical ingredients by reducing exposure to 30 nanograms per cubic meter, making us a leader within our industry,” company president Phil Hodges said.

The company's recent 47,000-sq.-ft. facility addition also included four new analytical laboratories, bringing to seven the total number of analytical laboratories. The labs are fully operational, validated and ready for projects. Metrics also added stability storage with environmental specialties chambers complete with redundant mechanical systems and strictly limited personnel access. The company brought antibiotic assay and sterility testing online, enhancing its ability to offer full microbiological support of sterile products.

DPT Receives Innovation Award

DPT Laboratories received the 2008 North American Pharmaceutical Contract Research and Manufacturing Services Healthcare Innovation Award from Frost & Sullivan as part of the consulting firm’s annual Best Practices Awards.

“DPT has a unique set of service lines and an exceptional marketing and positioning strategy that the company has generated and sustained growth for several years,” said Frost & Sullivan Industry Analyst Barath Shankar Subramanian. “Our Best Practices awards recognize companies throughout the world that demonstrate outstanding leadership, technological innovation, customer service and strategic product development, and DPT has exhibited superior performance in each of these areas.”

DPT recently repositioned itself as a contract development and manufacturing organization (CDMO) after establishing itself with the traditional CMO sector. According to a company statement, its focus on R&D capabilities in tandem with its manufacturing competencies, "provides a proven template for growth, as more contract companies try to establish themselves as comprehensive business partners and not just service providers."

“As pharmaceutical and biotechnology companies scale back the number of service providers they work with, we have been able to showcase our ability to take a product from preformulation all the way through FDA approval and commercialization, which helps companies achieve productivity, efficiency and a better use of resources,” said DPT president and chief operating officer Paul Johnson. “We are confident in our business model, and we are honored and humbled to receive this recognition of our practices.”

Penn Pharma Wins Malaria Drug Contract

Penn Pharma Services has won a contract to manufacture a new anti-malarial drug for use in clinical trials. Currently named OZ439, this drug shows great promise against the malaria parasite Plasmodium falciparum.

Penn was awarded the project by Medicines for Malaria Venture (MMV), a Swiss not-for-profit organization that brings public and private sector partners together to develop effective and affordable anti-malarial drugs.

In December, Penn will start work on developing and manufacturing capsule and tablet formulations of OZ439 for use in clinical trials in the U.S. in 2009. The trials will later roll out to Africa and Asia.

Peter George, Penn Pharma's chief executive officer, commented, “To be involved with such a significant project from a major organization to help in fighting a world-disease is a great win for Penn. It’s very motivational for our staff that Penn has been awarded this contract and we look forward to working with MMV and contributing to the development of a drug that has the potential to make a positive difference to millions of people on a global scale.”

Tim Wells, chief scientific officer of MMV, said, “MMV expects an exciting outcome from OZ439 - possibly as part of the much sought-after single-dose oral cure for patients with uncomplicated malaria. However, there are many challenges to overcome before we know how effective the medicine will be in patients. Penn Pharma will manufacture the first lot of the drug to international standards for the first set of trials. We look forward to working with Penn, receiving a high quality product, and launching the Phase I clinical trials on time.”

ICON Acquires Prevalere

ICON plc has acquired Prevalere Life Sciences a wholly owned subsidiary of ORS Labs Inc. ICON will make an initial cash payment of $35 million, but may pay another $8.2 million in performance milestones.

Prevalere is a provider of bioanalytical and immunoassay laboratory services and operates from a 49,000-sq.-ft. facility in Whitesboro, NY. The acquisition is intended to complement ICON’s existing European-based bioanalytical lab capabilities, where ICON Development Solutions recently moved to a new, purpose-built bioanalytical and immunoassay laboratory in Manchester, England.

Colorcon Opens West Coast Facility

Colorcon has moved its West Coast regional office and technical laboratory to a 10,000-sq.-ft. facility in Irvine, CA. The new state-of-the-art regional site houses Colorcon's tablet design, coating and research laboratories, as well as its West Coast Customer Service Center and customer education facilities. Colorcon provides advanced technologies, products and technical support, for formulated coatings and excipients in all phases of oral solid dose design and development.

The West Coast facility will offer educational courses and seminars to help customers succeed in today's highly competitive global pharmaceutical market, according to a company statement.

Cirrus to Provide Batch Release Testing Solvay Propellants

Cirrus Pharmaceuticals has been qualified and designated by Solvay Fluor as its exclusive provider of batch release testing services to perform independent analyses of Solvay’s Solkane propellants, HFA-134a and HFA-227 in the US.

With this designation, Cirrus now has the ability to conduct the analysis on HFA-134a and HFA-227 using Solvay’s proprietary validated test methods that were transferred to Cirrus’ facilities in Research Triangle Park, NC. This will allow Cirrus to provide clients with an independent quality review of Solvay’s Solkane propellants for HFA testing purposes. This type of testing is an FDA requirement for release of a drug product into the U.S. market.

Abingdon and Stason Extend Alliance

Stason Pharmaceuticals and Abingdon Life Sciences have extended their strategic alliance announced on August 4th, 2008. Abingdon will utilize the resources of Stason Pharma Japan Co. Ltd. to enhance business development and IP licensing opportunities in Asia. Abingdon will also offer strategic planning, clinical development and regulatory science support for companies in Japan and throughout Asia wishing to register pharmaceuticals, biotech products and medical devices in the U.S. via Stason Pharma Japan.

Bilcare GCS Expands Capabilities

Bilcare Global Clinical Supplies has enhanced its ability to develop formulation dosage forms for preclinical and early-phase drugs with the addition of fluid bed granulation technology and the In-Cap capsule system.

The fluid bed granulation technology extends Bilcare's solid-dosage formulation capabilities. The system is equipped with Wurster coating inserts, enabling the delivery of specialized, high-precision coating processes for granules and non-pareils for the creation of sustained- and controlled-release tablet and capsule formulations.

The In-Cap capsule system for preclinical and early-stage development is capable of filling several thousand capsules per hour in multiple permutations. This equipment adds development and clinical manufacturing capabilities for various formulation types, including powders, pellets, tablets and liquids.

Irvine to Launch Avrio Subsidiary

Irvine Pharmaceutical Services will launch Avrio Biopharmaceuticals in January 2009. The new subsidiary will offer formulation development and aseptic fill-and-finish services. Avrio will be focused on developing optimized production processes and providing dependable filling, lyophilization and packaging capabilities for early phase clinical trial materials.

DSM, Duska Therapeutics in PSVT Manufacturing Pact

DSM Pharmaceuticals and Duska Therapeutics have entered into a preliminary agreement to collaborate on the manufacture of commercial batches of ATPace for Duska’s planned Phase III clinical trial in paroxysmal supraventricular tachycardia (PSVT). ATPace will be produced at DSM’s commercial facilities in Greenville, NC.

ATPace, a stable liquid formulation of adenosine 5’-triphosphate (ATP) for intravenous injection, is an investigational drug for the acute termination of PSVT. The bradycardic effect of ATP, in particular its blockade of atrio-ventricular nodal conduction, has been shown in numerous published clinical studies to safely and effectively terminate re-entrant PSVT involving the atrio-ventricular node. Design of a pivotal Phase III clinical trial for ATPace in PSVT is in the planning stage. Currently, adenosine is the only approved treatment for PSVT in the U.S.

Laureate Enters Manufacturing Pact with Tolera

Laureate Pharma has entered into a cGMP contract manufacturing agreement with Tolera Therapeutics, a biotechnology company that develops and offers targeted therapies and safer solutions for immune modulation and related medical needs. Laureate will produce Tolera’s TOL101 monoclonal antibody under cGMP conditions to be used in clinical trials. Terms of the manufacturing agreement were not disclosed.

McIlvaine Company,

Northfield, IL 60093-2743

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