nov 07 update

Baxter Healthcare Corp. has expanded lyophilization capacity at its Halle, Germany facility to support the growth of its Baxter BioPharma Solutions (BPS) cytotoxic contract manufacturing business. Two large-scale lyophilization chambers will be added to freeze-dry cancer therapies for its pharma and biopharma partners. The expansion will be complete and fully validated by mid-2007.

The lyophilization chambers, which will include technologies such as handling of organic solvents, will be designed to optimize product quality and safety to ensure product integrity. An automated vial loading system and new in-process quality analysis technology will provide advanced control over the manufacturing process to help ensure the highest quality product is produced.

The University of Queensland and Australian Government Will Invest $500 Million in Key National Research Infrastructure

The Minister for Education, Science and Training, Julie Bishop has announced National Collaborative Research Infrastructure Strategy (NCRIS) investment plans for major national research facilities and infrastructure that will underpin Australia's research capability in nine different areas. The Minister also foreshadowed future expenditure in three areas.

UQ will play a role in establishing six of the nine multi-nodal facilities that were announced.

The National Imaging Facility will house one of the world's first combined animal positron emission tomography (PET)/magnetic resonance imaging (MRI) facilities.
Research using this facility will lead to a better understanding of cellular functions, which could in turn be a building block for new developments in disease prevention and treatment. It also provides a significant opportunity for collaboration with clinical researchers in Queensland, and promotes the development of new technology for clinical research and patient management.

Elements of this facility build on UQ's research strengths through the Centre for Magnetic Resonance and the Queensland Brain Institute. It will give Australian researchers access to the most appropriate imaging methodology for their scientific problem.

The National Microscopy and Microanalysis Research Facility will give researchers access to the latest microscopy and microanalysis instrumentation.

In part, this facility will build on the role of UQ's Centre for Microscopy and Microanalysis a national centre for high resolution biological electron microscopy.

The Australian National Fabrication Facility has potential to bolster areas of the economy including manufacturing, healthcare, electronics, communications and energy.

The Queensland base will be UQ's new $70 million Australian Institute for Bioengineering and Nanotechnology and UQ's Centre for Organic Semiconductor Research. It will produce nanometer patterned surfaces for needle-free drug delivery, novel conducting polymers for polymeric electronics, and smart microdevices for disposable health diagnostics.

Recombinant proteins are a new class of drugs with the potential to address a variety of diseases, but they must be produced in mammalian cell cultures, which are notoriously difficult and slow to grow. This project will enable the stable expression of these proteins in quantities large enough for pre-clinical and clinical trials. UQ will help transform laboratory success into marketable pharmaceuticals by hosting a facility to produce pre-commercial quantities of recombinant proteins.

Growth in Washington and Wyoming

Spokane-area business advocates say that as the next Washington state legislative session nears, their top priorities will include more than $302 million in capital projects, and they’ll be seeking funding for job-training programs, health-care research, and education.

Among the top priorities in the higher-education arena are securing $110.5 million for Community Colleges of Spokane (CCS), including a planned $32.9 million technical-education building at Spokane Community College. Other projects for CCS include a new $29.8 million chemistry and life-sciences building for Spokane Falls Community College, and another $21.9 million project at that campus that would include two new buildings to house the early learning center and the Headstart child-care center.

Interest groups will seek funding for construction of a new $10.8 million classroom building at Eastern Washington University, in Cheney, and a $58 million biotechnology-life sciences research facility at Washington State University’s campus in Pullman.

Almac Pharma Services Extends UK Facilities

Almac Pharma Services are extending their formulation facilities with the opening of a refurbished 10,500-sq.-ft. building at the company’s UK headquarters. The company invested $10.5 million to strengthen its offering to the global pharma and biopharma industries.

The custom-designed facility will operate to full cGMP, providing extended formulation development services in solid oral dosage forms from pre-clinical through to pilot scale. This advancement will provide classified facilities (ISO 8 / Class 100,000) including labs with independent temperature and humidity controlled zones and self-contained suites—many with high containment capabilities.

Growth in Canada

Edmonton has recently staked its place as a focus of international attention in the growing field of nanotechnology, with the University of Alberta at the forefront since the new National Institute of Nanotechnology (NINT), a partnership between the National Research Council and the U of A, officially opened their new facility in June 2006.

Construction of NINT, the new 15 000 square metre facility on the U of A campus, cost approximately $40 million. The building can accommodate 120 staff and 45 guest workers from industries and universities. It also provides training opportunities for up to 275 graduate students and post-doctoral researchers.

Apart from the U of A, nanotechnology companies have been making Edmonton’s 99 Street their home base. The newly dubbed “Nano Way” facilitates the economic approach to nanotech applications.

Nanotechnology has a multidisciplinary effect on the fields of medicine, science and engineering. Projects currently being developed range from improving the efficiency of the oil sands industry to targeting diseases in more effective and less invasive ways for patients. All done with particles 50,000 times smaller than the width of a human hair.

CyGenics Develops Artificial T-Cells

CyGenics Ltd., a global biotechnology group, today announced that it will collaborate with the Blood Center of Zhejiang Province to develop artificially-produced human T cells to treat HIV. (Xinhua)

PhosphoSolutions LLC

PhosphoSolutions LLC is a biotechnology company that is developing products to benefit the health of millions worldwide. The company produces antibodies that facilitate the research of proteins. Since proteins play a central role in the life of an organism, Phospho's products are instrumental in the development and production of target-based drugs.

Its 'products' give health scientists and researchers insight into how proteins regulate important bodily processes, such as cell division in cancer and neuronal communication in Alzheimer's disease.

The company also is playing an important role in the development of the Bioscience Park Center on the Fitzsimons campus-currently utilizing more than 6,000 square feet of the complex and poised to expand even more.

Webb Hospital Expands Facilities

Four new digital operating rooms complete with voice activation and image-guided surgery capabilities are part of the many additions to Sun Health’s $89-million expansion project.

Sun Health Del E. Webb Memorial Hospital will add a 175,000-square-foot, six-story tower, which will open on the north side of the hospital by December 2008.

The hospital is in the process of obtaining permits from Maricopa County and will start sight preparation on the expansion in January with construction set for June. When the first four floors of the new tower initially go into service, 76 additional surgical beds and a new emergency department — as well as the four new digital operating rooms known as Stryker i-Suites or “smart suites” — will become available.

These beds are in addition to 24 beds that were converted last year from skilled-nursing to acute-care use for medical and surgical patients.

Renovation is already under way to add 21 medical and surgical beds in former office space atop the existing Louisa Kellam Center for Women’s Health.

Smart suites

The smart suites, complete with high definition, flat-panel LCD television screens, are among the first 10 of their kind in the country, allowing surgeons to operate lights, cameras, pumps and other equipment by simple voice commands.

The new technology allows surgeons to perform image-guided surgeries with pinpoint accuracy and with minimal incisions, said orthopedic surgeon John A. Brown, of the CORE Institute that partners with Sun Health.

An additional $5 million is being raised by Sun Health Foundation to fully fund construction of a new three-story laboratory building at Sun Health Research Institute.

Eisai Breaks Ground for R&D Facility

Eisai, Inc. has broken ground for a production and formulation R&D facility for parenteral oncology treatments in Research Triangle Park (RTP), NC. Eisai has a number of drugs in development for patients with cancer and recently entered the market through the acquisition of four oncology-related products from Ligand Pharmaceuticals.

Eisai will invest $90 million in the 65,000-sq.-ft. facility, which will have aseptic processing suites, labs and other support functions. A separate $15 million central utilities building is planned to supply power, steam, chilled water and compressed air to existing and new operations. Operations are expected to begin in 2009, leading to 59 new jobs during the next three years and a total of 84 new jobs in the next five years.

The new facility will support the existing 190,000-sq.-ft. facility, which is devoted to manufacturing Aricept and Aciphex tablets and to formulation R&D and manufacturing of compounds for use in clinical trials.

Genzyme Increasing Research and Development and Amgen Releases Long-Term Enbrel Data

Genzyme (Nasdaq:GENZ) Oncology is investing $1.9 million to renovate and expand its facilities in the Texas Research Park. The cancer-drug development company is in the process of working on four construction projects at the park. Genzyme already completed construction of a stability lab in the Siberry Technical Center and a modification to the Clinical Trial Materials storage facility in Building 200.

These two projects will allow Genzyme to expand its research and development capabilities beyond oncology to support other business units.

In the first project, a chemistry lab has been converted to a control room for storage. In addition, five stability chambers have been built to control temperature and humidity. This will allow researchers to study how well a drug can withstand natural storage conditions for purity, strength and efficacy.

In the second project, modifications to Building 200 have tripled the size of the work space to accommodate increased labeling and packaging activities for drug substances and to store supplies and clinical materials.

Genzyme also has begun development on a new High Potency Lab that the company will use to develop new drugs that are cytotoxic, or toxic to cells. The lab will protect the researcher from exposure to these compounds.

Construction is also set to begin soon on a new Preclinical Research Facility that will be used to investigate the pharmacological activity of specific agents. This will help guide the development of future drug candidates. This facility should be complete in 2007.

San Antonio-based Kell Munoz Architects designed the projects. Metropolitan

Contracting is the general contractor. The new construction will bring Genzyme's lease space at the Texas Research Park in western Bexar County to nearly 21,000 square feet.

Celltrion Supplies Pharmaceuticals after Expansion

Celltrion, a representative biotechnology company in Korea, entered into a long-term agreement for the supply of new pharmaceutical products with Bristol-Myers Squibb, a multinational pharmaceutical company, on July 31. A ground-breaking ceremony for the expansion of the 150,000-liter manufacturing facility and R&D center was held.

Noted Biologist Plans UCSD Lab

Biologist J. Craig Venter, whose role in the Human Genome Project brought him international fame and fortune, hopes to build a lab at UCSD for developing drugs from ocean microbes, the university's officials and researchers have confirmed. Regents for the University of California are expected to consider the proposal late this year or early in 2007. Many details of the partnership between the University of California San Diego and the nonprofit J. Craig Venter Institute, based in Maryland, have not been released.

The University of California would provide land and Venter would pay for the construction of a research lab, Haymet said. The building would be situated between UCSD's main campus and Scripps.

Venter's institute has joined with UCSD, the Salk Institute, The Scripps Research Institute, all in La Jolla; the Battelle Memorial Institute in Columbus, Ohio; and Iowa State University to apply for a 10-year, $500 million grant from British Petroleum for studying how to convert organic matter into fuel.

As part of the grant bid, Venter's institute and his biotech company, Synthetic Genomics, have leased about 18,000 square feet of lab and office space in Torrey Pines.

New Science Buildings Considered for Construction

With the increase in student enrollment and more need for classrooms, Binghamton University has begun planning the construction of two new campus buildings. Both projects are expected to contribute to a major expansion of the science and engineering departments at BU.

The first of these projects is a Science V building, which is to be located in the courtyard between Science III and Science IV. According to Karen Fennie, spokeswoman for Physical Facilities, preliminary schedules have construction beginning in the spring or fall of 2008, with the project being completed by late fall of 2010. A consultant has been hired, and design for the project is currently in the beginning stages and is scheduled to continue through next year.

The Science V building is being built to provide additional research space on campus, as well as provide surge room to allow for renovations to the other, older science buildings. The renovations are expected to take place in phases, following the construction of Science V.

The second project is a new engineering building to be built in the Innovative Technologies Complex (ITC), which opened last month. Construction for the engineering building is slated to begin either in the summer or fall of 2008, and to be completed in 2011. Both programming and design for this building are currently underway.

The new engineering building is necessary due to the growth of the Thomas J. Watson School of Engineering and Applied Science. Watson was founded in 1983 and has been one of the fastest growing engineering schools in the country. It has doubled its enrollment since 1996, despite a national decline in engineering enrollment, and now has 1,580 students. The school’s surge in popularity has means that current facilities can no longer accommodate the needs of its faculty members and students.

The new building will contain both the mechanical engineering and the electrical and computer engineering departments, and will allow for the expansion of research and economic development activities.

Cambridge Antibody Expands Operations

Cambridge Antibody Technology (CAT) is expanding its operations in Cambridge, UK, by leasing the building currently known as Unit GP15 on Granta Park, the science park near Cambridge where the company has two facilities.

Unit GP15, which was previously occupied by Millennium Pharmaceuticals and was vacated in 2003, will provide CAT with an additional 92,000 sq. ft. of state-of-the-art laboratory and associated open-plan office space. The company plans to alter the internal layout of the building prior to occupation in the next 12 to 15 months.

DPT Expands In San Antonio

DPT Laboratories, Ltd., a DFB company, has opened its new, 258,000-sq.-ft. research, development, manufacturing, and distribution facilities, in San Antonio.

The new facilities at Brooks City-Base enable the company to expand its formulation development and analytical chemistry capabilities while continuing to provide development solutions to clients. In addition to the new research center, functions of the new campus include front-end manufacturing processes, quality control labs, storage of raw materials and finished goods, and worldwide product distribution.

The $24 million project was developed for DPT under an 18-year build-to-suit lease agreement with the Brooks Development Authority, which owns the buildings and is leasing them back to the company. The two buildings encompass 224,000 sq. ft. and 34,000 sq. ft., respectively.

DSM, Crucell Open Development Center

Crucell N.V. and DSM Biologics have opened the Percivia PER.C6 Development Center as part of a previously announced joint venture between the two companies. Percivia was designed to advance the PER.C6 cell line and provide solutions for the production of pharmaceutical proteins to licensees utilizing the PER.C6 human cell line in the biopharma industry.

Genentech, Lonza Enter Manufacturing Pact

Genentech, Inc. has entered into an agreement with Lonza Group, Ltd. for the sale of Genentech's manufacturing facility in Porrino, Spain for $150 million. The company has also entered into a supply agreement for the manufacture of certain products at Lonza's facility that is currently under construction in Singapore. Genentech will also have the right to exercise an exclusive option to purchase the Singapore facility.

Under the terms of the agreement, Lonza will acquire Genentech's FDA-licensed Porrino facility, which has 40,000 liters of biologic manufacturing capacity and is currently dedicated to the production of Genentech's Avastin. Lonza plans to retain the facility's 310 employees and will continue to produce Avastin for Genentech under the terms of a supply agreement.

Genentech plans to purchase Avastin and other oncology products from Lonza's planned 80,000-liter Singapore facility. FDA licensure for producing Avastin at Lonza's Singapore plant is expected in 2010. The terms of the option to purchase the facility allow Genentech to acquire the facility during the period from 2007 to 2012 for $290 million, plus an additional $70 million in milestone payments if certain performance milestones are met.

Tufts Study Estimates Bio-Drug Development at $1.2 Billion

The Tufts Center for the Study of Drug Development estimates the average cost of developing a new biotechnology product to be $1.2 billion, which reflects the costs of drugs that fail in testing and the time costs associated with bringing a new biopharmaceutical to market. Of this amount, out-of-pocket preclinical cost totaled $615 million, while similar clinical period cost totaled $626 million.

According to the Tufts CSDD analysis, clinical development and regulatory review for a new biopharmaceutical product took 97.7 months on average, about 8% longer than for pharmaceuticals.

University Seeking Incentives to Attract Company

Indian mustard plants that pull lead from the soil, sugar beets that absorb salt and sodium chloride, ferns that purify pollutants from the ground, and hybrid sunflowers capable of removing arsenic and uranium contaminants from the earth — these may sound like creations of a science-fiction author, but they're very real.

They're all products of research into phytoremediation, a cutting-edge biotechnology field that utilizes environmental phytotechnologies, that is, the development of plants specially grown and cultivated to remove impurities from the soil.

Virginia-based biotechnology company Edenspace Systems Corp. has become one of the growing leaders in the field of phytoremediation in recent years, and they've been put in the cross-hairs of Northwest Missouri State University.

Northwest has targeted Edenspace as its premier candidate for recruitment to occupy the college's new Center of Excellence for Plant Biologics, which is under construction.

The building is a $15.65 million project — with $11.4 million to be provided by funds generated by the Lewis and Clark Discovery Initiative — that is designed to combine research and education.

With office space, laboratories, classrooms and wet labs, the center will be poised to help the occupying biotechnology firm advance their scientific research in a state-of-the-art facility, while at the same time providing Northwest students with practical, hands-on laboratory experience while still in school.

Schering-Plough Expands Discovery Operations

Schering-Plough has expanded discovery operations in Cambridge, MA with a new research facility to support the discovery and development of new therapeutic treatments. The state-of-the-art lab will accommodate approximately 200 scientists and support staff, more than twice that of the prior Cambridge location, and it provides more than triple the amount of lab space.

Schering-Plough Research Institute (SPRI) Cambridge focuses on the early stages of the drug discovery process, conducting research to develop a portfolio of small molecule drugs and provide efficiency in lead discovery through the use of proprietary affinity-based screening technologies and an integrated chemistry library.

Temple U. Starts Biggest Building Project in its History

Temple University broke ground Wednesday on its $150 million medical school building, the largest construction project in the North Philadelphia College's history.

The 480,000-square-foot building will be 11 stories and serve as the primary teaching and research site for the Temple University School of Medicine. The medical school building is scheduled to open in 2009 and provide additional space for more than 100 faculty researchers. Temple has recruited more than 260 new faculty members during the past three years under the direction of Dr. John Daly who was named dean of the medical school in 2002.

The project will be funded through the combination of $50 million from the state, a $50 million dollar Temple University bond issue and philanthropy. Health-insurance provider Independence Blue Cross of Philadelphia donated $3.5 million to support heart research in part of the building that will be known as the Independence Blue Cross Cardiovascular Research Center. Cephalon Inc., a Frazer, PA, biotechnology company, is contributing $1 million.

The medical school building will be the first new structure on the medical school campus in 36 years. It is part of more than $400 million in capital projects at Temple.

Temple's School of Medicine opened in 1901 as the first coeducational medical college in Pennsylvania.

SAFC Pharma Expanding its cGMP Protein Purification Capacity

SAFC, a member of the Sigma-Aldrich Group announced that its SAFC Pharma business segment is expanding its cGMP protein purification capacity to meet increased market demand for therapeutic proteins from plant- and animal-sourced starting materials. Upon completion in April of 2007, the natural and recombinant plant protein purification facility will be one of the world’s largest therapeutic protein production sites.

The new operations, part of a 400,000 sq. ft St. Louis, Missouri manufacturing campus, will feature completely separate plant and animal protein processing facilities to eliminate potential cross-contamination. A dedicated natural and recombinant (transgenic) plant proteins facility will occupy 22,000 sq. ft. for its upstream and downstream processing operations. A separate animal-sourced proteins facility will encompass over 20,000 sq. ft. for upstream processing and be supported by an area that contains over 300,000 sq. ft. of total capacity. Downstream animal-sourced purification will take place in an adjacent 5,000 sq. ft. cleanroom suite.

SAFC is working closely with numerous transgenic plant platform companies to develop commercial-scale processes for proteins previously available only from animal-sourced materials and for therapeutic proteins and monoclonal antibodies. The company is also experiencing strong demand for cGMP proteins from animal-sourced materials for use in medical device applications and APIs.

This announcement follows recent SAFC capacity and technology expansion activities. These include: the purchase of the SAFC Arklow, Ireland facility; a large-scale API manufacturing site with 90,000 liters of total cGMP capacity; the acquisition of SAFC Pharmorphix, a Cambridge, U.K. based solid-state research studies company; and an $18 million dollar expansion of the SAFC Madison high-potency chemistry facility. Additionally seven-day-per-week workshift extensions have been introduced at the company’s SAFC Gillingham U.K. API manufacturing site and its SAFC Manchester U.K. medicinal chemistry and development facilities.

Millipore Opens $50 Million Research and Development Center

Millipore Corporation, a leading provider of products and services that improve productivity in the laboratory and in biopharmaceutical manufacturing, today announced the opening of a new $50 million research and development center in Bedford, Massachusetts. The center will enable Millipore to leverage cutting edge technologies, further extending its applications expertise and positioning it to meet the growing demands of the global biopharmaceutical market and the life sciences industry.

The state-of-the-art 110,000 square foot building, designed by ARC/Architectural Resources Cambridge, contains 47,000 square feet of lab space, and consolidates multiple functions, fostering an even more collaborative approach for the up to 500 professionals who will work there. Millipore chose to build the center in Massachusetts due to its leadership in the biotechnology sector, its unrivaled talent pool, and its proximity to customers and leading academic institutions.

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