PHARMACEUTICAL/BIOTECHNOLOGY

& MEDICAL DEVICE

UPDATE

 

September 2007

 

McIlvaine Company

www.mcilvainecompany.com

 

TABLE OF CONTENTS

 

Picatinny Arsenal Starts Building $200 Million Research and Office Campus

Baxter BioPharma Completes Lyo-Expansion

$15 Million Gift Launches Center's Expansion

Genzyme Begins Boston Facility Expansion

Baptist Health Begins Construction of New Tower Addition.

Diagnostic Hybrids Preparing for Athens Relocation

Advanced BioNutrition Wins DoD Contract

AMRI’s $8 Million R&D Facility in India Opened

SAFC Plans $10 Million Revamp of European Sites

Foster Wheeler Awarded Contract by GlaxoSmithKline Biologicals in Singapore

Georgia Tech’s Georgia Institute of Technology to Add an $80 Million Nanotechnology Center

VA Selects Three Firms to Work on Hospital Design for New Orleans Facility

AMRI Opens New Research Facility in Hyderabad

BioServe Triples Its Space with New Labs

Watson Receives First FDA Approval for Manufacturing at Its Goa, India Facility

Children's Hospital to Get $100 Million Donation for New Site with New Name

CDC Suspends A&M Research

Millipore Updates Manufacturing Facility in Illinois

Draxis Pharma Expands with Contract from Johnson & Johnson

Brown University Connects Campus after Adding Life Sciences Center

Lonza Expands Presence in China with New Plant

IsoRay Medical to Transfer Production to Expanded Facilities

 

 

 

Picatinny Arsenal Starts Building $200 Million Research and Office Campus

Construction is expected to begin on a research and office campus at Picatinny Arsenal, a project the Army predicts will save it money and bring new ideas and hundreds of private-sector jobs to the base.

 

Advance Realty Group of Bedminster will break ground on the beginning of the Picatinny Applied Research Campus at the post in Rockaway Township.

 

When complete, the $200 million PARC could include up to 1 million square feet of offices, laboratories and light-manufacturing facilities at Picatinny and create hundreds of jobs over the next decade, say those involved.

 

Its tenants would be limited to companies and university researchers who complement the arsenal's work designing and testing weapons.

 

The Army's goal is to make use of the surplus land and buildings at the 6,500-acre base and create partnerships with private industry, while also defraying Picatinny's operating costs.

 

The deal also indirectly makes money for the base. Under a revenue-sharing agreement with Advance Realty, Picatinny ultimately could reap $500 million in services during the 50-year deal.

 

The money would not go directly to the Army but instead flow to a nonprofit group set up to oversee PARC. That company, InSitech, will manage the project and guide the relationships between private industry and the Army.

 

InSitech's goal is to transfer Picatinny's ideas and products to private companies and to bring in technologies that the Army needs.

 

Although Picatinny develops guns and bullets for the military, the base's work often has applications in the private sector, in areas such as homeland security, electronics, even medicine.

 

InSitech and its contractors, in turn, will provide maintenance and construction services at the base, such as paving roads, repairing facilities and even building new ones, said Timothy Teen, InSitech's chief executive officer. That work should help defray part of the post's annual $78 million operating expenses.

 

In its first phase, Advance will knock down three old lab buildings in the heart of Picatinny and construct three facilities totaling 100,000 square feet. Advance Realty will pay $1.7 million to lease that land from Picatinny, Banashefski said.

 

The developer said it is in discussions with tenants for the first building, which is expected to open in late spring.

 

When that is complete and leased, Advance Realty expects to build the next two facilities. The agreement with Picatinny calls for future construction of up to 900,000 square feet on 120 acres on the base's southern end.

 

Advance Realty's president and chief executive officer Peter Cocoziello predicts Picatinny's brain trust and its testing facilities and labs - many of which are unique to the base - will lure tenants.

 

Advance Realty and InSitech are confident they will find tenants for PARC even though the overall market for office space in Morris County is lackluster. There was a 20.8 percent office vacancy rate in Morris County in the second quarter of this year, according to Cushman & Wakefield.

 

Advance Realty Group of Bedminster will break ground on the beginning of the Picatinny Applied Research Campus at the post in Rockaway Township.

 

When complete, the $200 million PARC could include up to 1 million square feet of offices, laboratories and light-manufacturing facilities at Picatinny and create hundreds of jobs over the next decade, say those involved.

 

Its tenants would be limited to companies and university researchers who complement the arsenal's work designing and testing weapons.

 

Baxter BioPharma Completes Lyo-Expansion

Baxter BioPharma Solutions recently completed the lyophilization capacity expansion at their cytotoxic contract manufacturing facility in Halle, Germany. The expansion increased their total cytotoxic lyophilization capacity to four dedicated lyophilizers and more than 1,100 sq.-ft. The expansion was designed to meet EU, U.S. and JP requirements.

 

Two large-scale lyophilization units were added to freeze-dry clients’ cancer therapy drugs. The expansion includes technologies to safely handle organic solvents including a state-of-the-art fully automated loading cart and in-process quality analysis technology. The cart navigates in the building with sensors, transporting the cytotoxic vials from filling without human attendance, and auto-loads the freeze driers.

 

$15 Million Gift Launches Center's Expansion

Gov. Brad Henry provided the Oklahoma Medical Research Foundation with a $15 million head start on an ambitious $125 million expansion plan that includes an eight-story research tower and 300 new jobs on the Oklahoma Health Center Campus.

 

The governor presented a $15 million Oklahoma Opportunity Fund check to OMRF President Dr. Stephen Prescott in a ceremony attended by scores of foundation employees, state officials and first lady Kim Henry, who serves on the not-for-profit foundation's board of directors.

 

The Oklahoma Opportunity Fund was created by the state Legislature in 2006 to help bring new jobs and businesses to the state by providing seed capital for projects such as that announced by OMRF. The foundation is the third recipient to receive funding from the fund, which is administered by the Oklahoma Department of Commerce.

 

OMRF signed a contract with the Oklahoma Department of Commerce that requires it to meet certain milestones in exchange for the funding.

 

Current average salary at the foundation is $47,676, well more than the state's average full-time wage of $31,856 annually. For the new jobs that are part of the expansion, OMRF projects the average annual salary to be $58,000.

 

The site for the new 195,000-square-foot tower will be at 825 NE 14, just north of its current research facility on the Oklahoma Health Center campus. OMRF bought the John W. Keys Speech and Hearing Building in 2006 but has leased it to the University of Oklahoma Health Sciences Center through June 30, 2008.

 

Prescott said he does not anticipate construction will begin on the new tower until 2009. The foundation has launched a capital campaign to raise the total amount needed to finance construction, he said.

 

The addition of new research space is critical for the foundation that already employs 543 people with an annual payroll of $31 million. Foundation scientists won $30 million in competitive grants and contracts last year, and foundation scientists filed 11 new invention disclosures and 16 patent applications.

 

Discoveries at OMRF led to the first FDA approved drug for the treatment of sepsis, which claims the lives of more than 200,000 Americans each year. OMRF researchers have identified the enzyme believed responsible for Alzheimer's disease, and a drug based on that discovery began human clinical trials this year.

 

The foundation has spun off 12 biotechnology companies and claims an annual economic impact on the state of $46 million. It expects that number to grow to $73 million after the expansion is in place.

 

"What we are doing in advance is we are recruiting aggressively for scientists,” Prescott said. "We recruited four new scientists this last year from across the country and last week we got an acceptance from a fifth one in North Carolina. There are probably four or five other recruitments under way right now. We are recruiting aggressively because we want to have people here and working as soon as we can.”

 

Genzyme Begins Boston Facility Expansion

Genzyme Corp. broke ground on a $150 million expansion project at its Allston Landing manufacturing facility in Boston that will add space for manufacturing support functions and will create 90 jobs.

 

Commercial production at Allston Landing, which began in 1996, was initially intended to produce Cerezyme and has grown to include four additional products: Fabrazyme for Fabry disease, Myozyme for Pompe disease, as well as the filling and packaging for Aldurazyme for MPS I disease and Thyrogen, used for screening patients who have had thyroid cancer. This growth in manufacturing capacity now requires additional space for manufacturing support operations, offices and mechanical equipment.

 

The expansion project includes 86,000 sq. ft. of new office and manufacturing-support space. The company is also building a 26,000-sq.-ft. underground co-generation facility, which will generate steam to run the plant's process operations and will also produce electricity. The company plans to seek certification for the expansion under the U.S. Green Building Council's LEED (Leadership in Energy and Environmental Design) Green Building Rating System.

 

Baptist Health Begins Construction of New Tower Addition.

On September 25, 2006, Baptist Health Systems, Inc. began the countdown to its 100-year anniversary with the groundbreaking of a new tower located on the west side of Baptist Medical Center. The 205,000 square foot, six-level tower, now under construction, will have dedicated entrances for both a women’s and a heart hospital. There will be no additions to the Medical Center’s inventory of 649 beds. Completion of the tower is anticipated to be September 2008. Estimated construction cost is $40 million.

 

Diagnostic Hybrids Preparing for Athens Relocation

With the flu season approaching — a busy time for Diagnostic Hybrids Inc. — company officials are eager to get the Athens business relocated into the former McBee building.“We are optimistic that we will be in a position to be operational at the new facility in late November,” said Geoff Morgan, vice president and chief financial officer of DHI.

 

DHI develops test kits for identifying infectious agents and is working on cell culture development.

 

“The time line for completion of this (renovation) project from start to finish is a very aggressive plan, but is absolutely vital for us to be in a position to move prior to our anticipated busy respiratory season,” Morgan said, explaining that season runs from December to March.

 

Diagostic Hybrids will be taking up 50,000 square feet of the 215,000-square-foot McBee building. The company also has an option to expand an additional 25,000 square feet, Morgan said. That additional space could be used for DHI’s research and development.

 

Construction is ongoing, with work being done by Seifert Construction to get the new facility ready for move-in.

 

The “clean” rooms for manufacturing cell culture product lines are nearing completion, Morgan said. Construction crews are working feverishly to get HEPA filters in place. The clean room space will encompass 2,500 square feet, which is 50 percent more than what DHI has now in the Ohio University Innovation Center.

 

The move itself may be a tricky effort, since the company’s cell culture product has a one-week shelf life, Morgan said. Further, DHI’s customers order products on a weekly standing-order schedule. Because of this, the company cannot shut down its current site at the Innovation Center while they move, he said.

 

“Our approach essentially involves having two operating facilities, with production slowly migrating from West State Street to East State Street over a period of four weeks,” he said. “The administrative operations will move just prior to manufacturing.”

 

Advanced BioNutrition Wins DoD Contract

Advanced BioNutrition (ABN) was awarded a $1.7 million contract from the DoD for the first phase of development of a shrimp-based production system for vaccines and mAbs.

 

The contracts from the Defense Advanced Research Projects Agency (DARPA) and the Defense Threat Reduction Agency (DTRA) could reach $5.9 million over 42 months if all phases of the agreement are completed successfully, according to the company.

 

Arun K. Dhar, Ph.D., a molecular virologist at ABN will be leading the three-phase program with a goal of producing three million doses of vaccine or immunological-based therapeutic within 12 weeks of the first recognition of a new pathogen, ABN reports.

 

During the first phase of the contract, ABN plans to validate the use of crustaceans as biofactories using its transfection technology. The company reports that it is also developing a high-density GMP-capable production system for shrimp cultivation as well as methods for the isolation and purification of the final products.

 

AMRI’s $8 Million R&D Facility in India Opened

AMRI opened its $8 million, 50,000 sq. ft. R&D center in Hyderabad, India. The facility includes laboratories for conducting early-stage research such as custom chemical synthesis and analytical chemistry.

 

During this first phase of expansion, the R&D building will add approximately 100 employees to AMRI’s operations at this location, which currently has 35 scientists. The company reports that infrastructure is in place that will allow it to add a second facility, which would more than double employee headcount.

 

Also, scale-up laboratories for preparing both preclinical and clinical trial supply active ingredients are expected to open later this year and 2008, respectively, according to AMRI.

 

AMRI states that the opening marks another milestone in the company’s global expansion. In May, AMRI acquired two pharmaceutical manufacturing sites, along with additional land for expansion, in Aurangabad and Navi Mumbai, India. “We look forward to achieving synergies between these new development laboratories and our large-scale manufacturing facilities,” remarks Thomas E. D’Ambra, Ph.D., chairman, CEO, and president.

 

SAFC Plans $10 Million Revamp of European Sites

SAFC is spending $10.1 million to expand facilities in Ireland and Switzerland. The company reports plans to increase cGMP commercial-scale API manufacturing capacity at its Arklow, Ireland, plant and to expand production and storage at the Buchs, Switzerland, buildings.

 

These developments come shortly after SAFC’s decision last month to enhance the high-potency intermediates production and solid-form research at its Madison, WI, facility. In April the company also reported the completion of two new protein purification and extraction API facilities at its St. Louis, MO, manufacturing campus.

 

Scheduled for the first quarter of 2008, the $4.7 million Arklow investment will increase production capacity and capability. The pilot plant will be upgraded and vessels will be added to increase chemistry capacity for API products. SAFC expects to complete other enhancements later this year that will increase utility capacity and the site’s environmental performance.

 

SAFC will provide another $5.4 million for a 17,200 sq. ft. expansion to its existing cGMP production plant at Buchs. Production capacity will go up 25% through improved materials flow and separation and increased materials storage, according to the company. The two-level storage building is expected to become fully operational in spring 2008 and will reportedly provide logistical infrastructure to support future expansion.

 

Foster Wheeler Awarded Contract by GlaxoSmithKline Biologicals in Singapore

Foster Wheeler Ltd. announced that its Singapore subsidiary Foster Wheeler Eastern Private Limited, part of its Global Engineering and Construction Group, has been awarded an engineering, procurement, construction management and commissioning services contract by GlaxoSmithKline Biologicals for a new biotechnology production facility in Singapore.

 

The value of the contract was not disclosed. The engineering and procurement services were included in Foster Wheeler’s first-quarter 2007 bookings and the construction management and commissioning services will be included in its third-quarter 2007 bookings.

 

This state-of-the-art facility includes two production buildings, a quality control and administration building, and a utilities building, all on a site of more than 8.8 hectares in Tuas Biomedical Park, in Singapore.

 

“This latest award from GSK Biologicals reflects our client’s continued confidence in the quality of our people and in our biotechnology expertise and track record,” said Franco Anselmi, chief executive officer of Foster Wheeler Asia Pacific. “Key to our success in winning this contract was the performance of the Foster Wheeler team on GSK Biologicals’ new vaccine facility in Hungary, which is now complete, and our ability to leverage this successful experience for the new Singaporean facility. In addition, our 30-year track record of delivering safe and successful projects in Singapore strongly demonstrates our position as one of the leading engineering, procurement and construction contractors in Singapore.”

 

Foster Wheeler Ltd. is a global company offering, through its subsidiaries, a broad range of engineering, procurement, construction, manufacturing, project development and management, research and plant operation services. Foster Wheeler serves the upstream oil and gas, LNG and gas-to-liquids, refining, petrochemicals, chemicals, power, pharmaceuticals, biotechnology and healthcare industries. The corporation is based in Hamilton, Bermuda, and its operational headquarters are in Clinton, New Jersey, USA.

 

Georgia Tech’s Georgia Institute of Technology to Add an $80 Million Nanotechnology Center

Georgia Tech’s Georgia Institute of Technology (Atlanta, Ga.) is poised to add an $80 million nanotechnology center that will bring together the physical and biological sciences in a fusion of the disciplines. The Marcus Nanotechnology Building (NRCB) will feature two cleanroom facilities that fuse a waffle slab deck design built using custom FRP (fiberglass reinforced plastic) dome forms to provide the load rigidity and airflow requirements essential to next-generation nanotechnology research operations.

 

Groundbreaking was in August 2006 and construction is scheduled for completion in summer 2008. The facility consists of two separate areas split by an expansion joint, a five-story lab/office area and a 30,000 sq. ft. tri-level design cleanroom. Approximately 20,000 sq. ft. of cleanroom space will be dedicated to nanotechnology physical sciences and engineering, adjacent to a 10,000-ft2 facility dedicated to biological and biomedical nanotechnology research.

 

The projects’ architectural firm, M & W Zander (Stuttgart, Germany; Plano, Texas, U.S.), specified the waffle slab design for the NRCB cleanrooms to optimize airflow and utility (gas/water) exhaust services throughout the flooring system. The design’s end-result was to provide cleanroom filtering by pushing air through the building with uniform velocity and minimum turbulence. Additionally, the dome configuration was specified very deep to ensure the slab’s load per square foot strength to support the cleanrooms’ end-use equipment load requirements.

 

The general contractor, The Whiting-Turner Contracting Co. (Baltimore, Md.) enlisted the project’s concrete trade contractor Untied Forming (Austell, Ga.) to source the formwork solution for the waffle slab. Having eliminated wood and steel options, United Forming awarded the bid to Molded Fiber Glass Construction Products (MFG, Independence, Kans.) which manufactured a complete range of custom one-piece fiberglass reinforced plastic (FRP) forms which could provide a strong, flexible design that could meet the unique configurations, reduce labor and had the added benefit of re-usability for future projects.

 

VA Selects Three Firms to Work on Hospital Design for New Orleans Facility
During a visit to New Orleans, the secretary of the U.S. Department of Veterans Affairs announced that his agency has chosen three architecture firms to design the new hospital it plans to build downtown.

 

Secretary Jim Nicholson said a team consisting of NBBJ of Columbus, Ohio; Eskew+Dumez+Ripple of New Orleans; and Rozas-Ward of New Orleans would draft the plans for the new medical center.

 

Nicholson delivered the news in front of the old veteran’s hospital on Perdido Street, which closed after Hurricane Katrina pushed water into the basement and destroyed the electrical and mechanical systems.

 

Although consultants advised against refurbishing the building for use as a hospital, Nicholson said the city has proposed taking it over in exchange for helping the VA acquire land for its new medical center.

 

The VA plans to build the new hospital on 34 acres bounded by South Rocheblave to the north, South Galvez to the south, Tulane Avenue to the west and Canal Street to the east. The parcel sits next to 37 acres where Louisiana State University plans to build its new teaching hospital.

 

Nearly 200 residential and commercial properties populate the area where the VA wants to build. In May, the city and state offered to acquire the land on the federal government's behalf to ensure the VA would not build its new hospital in the suburbs.

 

Under the arrangement, the state would take title to the land, using eminent domain if necessary, and the city would reimburse the state for the cost of the property. The city has not provided an estimate on the cost of the land.

 

A VA spokeswoman said Friday that the city may provide the 34 acres to the VA for $1 per year in exchange for use of the existing hospital.

 

The spokeswoman, Alison Aikele, said the VA "is carefully evaluating that proposal" and trying to determine whether the arrangement would require approval from Congress.

 

AMRI Opens New Research Facility in Hyderabad

AMRI announced  the opening of its new 5,000 square meter (50,000 sq. ft.) research and development centre at the Shapoorji Pallonji Biotech Park in Hyderabad, India.

 

The new R&D centre, located near AMRI's existing chemistry facilities in Hyderabad in the ICICI Knowledge Park, will provide additional space for AMRI's laboratory-scale Indian operations. The new facility includes laboratories for conducting early stage research such as custom chemical synthesis and analytical chemistry. Additional scale up laboratories for preparing both preclinical and clinical trial supply active ingredients are expected to open later this year and 2008, respectively. Those larger laboratories will be used to develop efficient methods to produce active pharmaceutical ingredients and intermediates. The new facility also is equipped with extensive environmental controls and a state-of-the-art wastewater treatment unit. AMRI has invested approximately U.S. $8 million in construction and equipment During this first phase of expansion, the new R&D centre will add approximately 100 employees to AMRI's operations in the ICICI Knowledge Park, which currently has 35 scientists. Additionally, infrastructure has been added at the new site to allow a second facility to be added in the future, which would more than double employee headcount. Rajesh Shenoy, Ph.D., director of AMRI's Hyderabad operations, will oversee these facilities.

 

BioServe Triples Its Space with New Labs

The company, which provides genetic and other services to the bioscience industry, is moving into a new 40,000-square-foot facility in Beltsville. The space includes expanded offices and wet and dry laboratories; and will also house the company’s repository of more than 600,000 human DNA, tissue and serum samples.

 

The privately held company occupies nearly 65 percent of the new space and expects to expand soon into the remainder, said CEO Kevin Krenitsky. The Laurel office will be retained as a backup storage facility.

 

BioServe’s customers include pharmaceutical and other biotech companies, the government and academic research institutions. Recent company projects include a public health study in India to understand the link between lead exposure and children’s intellectual development, a study to identify the genetic cause of thoracic aortic disease, and the development of a serum-based diagnostic test to identify colorectal cancer.

 

Krenitsky expects 2007 revenues of $5 million to $10 million. BioServe was founded in 1989 and grew out of a University of Maryland incubator in College Park. It eventually moved into 12,000 square feet of space in Laurel, then expanded overseas in 2002 by opening a 20,000-square-foot lab in Hyderabad, India.

 

The operation in India has some overlap and redundancy in genomic services, Krenitsky said. The company has about 60 employees, with about half in Maryland.

 

In April, BioServe acquired Genomics Collaborative from publicly held SeraCare Life Sciences in Massachusetts.

 

Although the biotech industry has grown predominantly along the Interstate 270 corridor in Montgomery County, there is a cluster of activity at the University of Maryland biotech incubator. The incubator, which opened about 20 years ago, was the state’s first.

 

Of the nearly 10 companies now in the incubator, about half are biotechs.

 

The U.S. Food and Drug Administration is consolidating its offices at White Oak in eastern Montgomery County, which could boost the biotech industry in nearby Prince George’s. With nearly 7,000 to 8,000 FDA employees there, the demand for wet lab space may increase.

 

Watson Receives First FDA Approval for Manufacturing at Its Goa, India Facility

Watson Pharmaceuticals, Inc. a leading specialty pharmaceutical company, announced recently that it has received its first U.S. Food and Drug Administration (FDA) product approval at its Goa, India facility. During the next several months the company plans to seek FDA approval to manufacture additional solid dosage products at the facility. By early 2008, the Goa facility is expected to be producing over 1 billion tablets and capsules annually for the U.S. market.

 

Children's Hospital to Get $100 Million Donation for New Site with New Name

Children's Memorial Hospital in Chicago, IL will change its name in honor of a $100 million donation from Chicago philanthropist Ann Lurie to help build its new hospital in the Streeterville neighborhood east of Michigan Avenue.

 

Children's said the gift is the largest in the hospital's 125-year-history and the largest by an individual given to a children's hospital in the U.S. Hospital executives said the gift will provide much needed financing toward the $850 million new hospital, which is being relocated from its longtime Lincoln Park home.

 

When the new hospital opens in 2012, it will be named Ann & Robert H. Lurie Children's Hospital of Chicago in recognition of the gift, Children's Memorial officials confirmed this morning. Lurie's late husband, Robert Lurie was a real estate magnate who died in 1990.

 

Children's has outgrown its more than 50-year-old facilities, forcing hospital staff to turn away more than 200 children a year. The new facility will be bounded by Chicago Avenue on the north and Superior Street on the south and will sit just west of Northwestern Memorial HealthCare's new Prentice Women's Hospital, schedule to open this fall.

 

CDC Suspends A&M Research

U.S health officials have suspended Texas A&M University's research of dangerous infectious diseases.

 

A report by the U.S. Centers for Disease Control and Prevention said lax oversight by the university resulted in hazardous working conditions and security breaches at the university's federally funded laboratories.

 

The order, which bans the university from conducting research on regulated toxins or microbes, affects five labs at the university's National Center for Foreign Animal and Zoonotic Disease Defense. The labs are part of an $18 million federal effort to study vaccines to counteract biological weapons.

 

The investigators found at least seven cases in which A&M allegedly allowed unauthorized access to the biological agents. The university is also accused of allowing former employees to enter the labs and of failing to secure the inventory of biological agents.

 

A&M's problems began in February 2006 with the university failed to report a researcher's exposure to the Brucella bacterium immediately after the incident happened.

 

Millipore Updates Manufacturing Facility in Illinois

The first phase of Millipore Corp.'s plant modernization project is complete at its facility in Kankakee, IL. The plant manufactures certain key products including Probumin brand Bovine Serum Albumin and other products derived from bovine serum or plasma.

 

The project included installation of new, state-of-the-art-control and processing equipment, helping the company to enhance control over product quality and existing proprietary and validated processes. Critical equipment was replaced with modern equivalents of the same configuration and processing characteristics, so there will be no change in the reactivity or other characteristics of the affected products. This initiative does not impact the Ex-Cyte focus factory also located at the Kankakee facility.

 

Phase 2 of the modernization project will begin immediately and will include enhancements to plant capacity and to filling and packaging capabilities.

 

Draxis Pharma Expands with Contract from Johnson & Johnson

Draxis Pharma has expanded its existing contract manufacturing relationship with Johnson & Johnson Consumer Companies, Inc. to provide commercial manufacturing services for multiple non-sterile specialty semi-solid products currently marketed in the U.S.

 

The new contract runs to the end of 2013 and includes approximately two years of manufacturing site transfer and process validation activities followed by five years of commercial production, which is scheduled to begin in 2009. Commercial production during this five-year period is expected to generate more than $120 million in revenues. The transfer of equipment and production technologies is expected to generate approximately $6 to $8 million in revenues during 2007 and 2008.

 

Commercial production of the products is scheduled to start in late 2008 and ramp up to achieve near full utilization of existing capacity for non-sterile semi-solid products by mid-2009. A second Draxis facility in the Montreal area will be required to meet increased logistics and secondary packaging activities and is expected to open during the summer of 2008. All products will be formulated and filled in the existing facility in Kirkland, Quebec.

 

Brown University Connects Campus after Adding Life Sciences Center

Brown University is constructing a $5-million walkway to connect the former Pembroke campus with Brown’s main campus with a series of greenways. Last year, Brown dedicated a $95-million life sciences research center, the largest construction project in the university’s history.

 

Lonza Expands Presence in China with New Plant

Lonza's $147 million investment in China is continuing to shape up as the firm announced its new small-scale exclusive synthesis manufacturing plant will be up and running next month.

 

The plant is designed for production of quantities from 10 kilograms up to several hundreds of kilograms, and closes the gap between the kilo lab and the commercial production facilities it already has in the vicinity.

 

The Swiss contract manufacturer, which is also expanding its facility at Pease International Tradeport in Portsmouth, has had a 10-year presence in China, with manufacturing facilities in Nansha Guangzhou and Liyang, but the country's low operating costs and expertise in raw materials have lured Lonza into infusing more cash in the region of late.

 

In April of last year, the company signed a letter of intent with authorities in Nansha Guangzhou to build, over a three- to five-year period, a multipurpose active pharmaceutical ingredient (API) and International Standards Organization (ISO)-regulated intermediate plant complex to deliver large scale and pilot scale production capabilities.

 

The first phase of this program will be complete once the small-scale plant is fully operational. The firm said it boasts six small reactors including distillation and filtration units that are capable of handling a broad range of technologies, and additional capacity can be added without impacting running operations.

 

The larger commercial-scale API facility is still under construction and will eventually house up to 200m3 in reactor volume, the firm said.

 

Meanwhile, as its activities in china gain momentum, Lonza is also partial to neighboring Singapore, with an active biologics program in the country.

 

In December, the company announced a joint venture with Singapore's Bio*One Capital to build a $350m large-scale biologics manufacturing facility in Singapore, and this new project is the second partnership between the two organizations; they signed their first joint venture in February last year to build a similar production plant.

 

Biologic drugs are one of the key growth drivers of the pharmaceutical and biotechnology industries, and the sector is booming, with approximately one-fourth of new drugs coming on the market being biopharmaceuticals and generating in excess of $35 billion in 2004, with annual sales projected to surpass $52 billion by 2010.

 

Lonza is one of the early Western pioneers in Singapore's biologics industry, which the country is actively trying to nurture.

 

IsoRay Medical to Transfer Production to Expanded Facilities

IsoRay Medical, Inc., the manufacturer and distributor of Proxcelan (Cesium-131) seeds used in brachytherapy for the treatment of prostate cancer, plans to transfer production in September to expanded production facilities 75 days ahead of schedule. The facility is located at Energy Northwest’s Applied Process Engineering Laboratory (APEL) in Richland, WA. IsoRay Medical, Inc., is a wholly owned subsidiary of a public company, IsoRay, Inc. (AMEX:ISR).

 

“This expansion is just one element in our strategy to expand production of Proxcelan (Cesium-131) brachytherapy seeds as well as develop other medical isotopes to treat cancer and other diseases,” said IsoRay Chairman and CEO Roger Girard.

 

Under the brand name Proxcelan, IsoRay Medical, Inc., is expanding the marketing of its Cesium-131 seeds used in low dose radiation (LDR) permanent brachytherapy for prostate cancer. The fast-acting, high energy medical isotope has demonstrated strong initial clinical results.

 

The 15,340-square-foot expansion brings the total production space to approximately 20,000 square feet, consolidating IsoRay’s current U.S. operations into a single location. It will allow IsoRay to more than double its seed production capacity to approximately 100,000 seeds per month, said IsoRay’s Executive Vice President of Operations David Swanberg.

 

The expansion was constructed as a tenant improvement entirely within an existing high bay structure. It will combine IsoRay’s radioactive and non-radioactive production facilities, along with some administrative offices, into one location.

 

According to Swanberg, the finished seeds will be handled, assayed and packaged in the facility’s class 10,000 clean room environment. Proxcelan seeds will be offered in a full range of custom, pre-loaded configurations for IsoRay customers based in ambulatory surgical centers, hospitals and major medical universities across the U.S.

 

Bruce Berglin was the construction manager for the complex construction project. Craig Maloney of IsoRay is Associate Project Manager, overseeing equipment procurement and installation scheduling.

 

APEL is a community economic development initiative to incubate new companies. It opened in 1998, the result of a strategic collaboration between Energy Northwest, the Pacific Northwest National Laboratory, the City of Richland, the US Department of Energy, the Port of Benton, The Tri-Cities Development Council, and Washington State University.

 

IsoRay currently employs 70 people in the U.S., with most employees located in Richland.

 

Although IsoRay Medical’s Proxcelan seeds have been used exclusively for the treatment of prostate cancer to date, the technology received Food and Drug Administration 510(k) clearance in March 2003 for the treatment of all malignancies (e.g., lung, ocular, melanoma, head and neck, brain, breast, prostate, etc.).

 

 

McIlvaine Company,

Northfield, IL 60093-2743

Tel:  847-784-0012; Fax:  847-784-0061;

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