PHARMACEUTICAL
UPDATE
July 2007
McIlvaine Company
TABLE OF CONTENTS
Azopharma Expands cGMP Manufacturing Capacity
Horiba to Build Development Facility
California-Based Medical Products Company to Build in University Research Park
SGS Passes FDA Inspection in India
Hudson-Alpha Institute for Biotechnology 'in home stretch'
Sun System Expands Healthcare Facilities
Azopharma Expands cGMP Manufacturing Capacity
Azopharma has reached an agreement to purchase Kos Pharmaceuticals' R&D facility along with assets in Hollywood, FL. This acquisition will significantly increase their ability to support customers and Phase I Express process, which enables customers to move quickly and efficiently toward clinical trials. Phase I Express includes preclinical, preformulation, formulation development, analytical R&D, QC release, stability,
The FL facilities are cGMP compliant and FDA registered and inspected, as well as DEA approved for testing all schedules of controlled drugs and for manufacture on an as-requested basis.
Horiba to Build Development Facility
HORIBA, Ltd. established a new development facility, the "HORIBA Technology Center" on July 13 in Silicon Valley (Santa Clara, California), following the Group's concerted efforts to meet the needs of the American hi-tech market for products such as
semiconductors and biotechnology.
With the objective of conducting joint development with hi-tech corporate clients and offering collaborative proposals for solutions, the center will be set up amidst the world's frontier technology companies. The facility is complete with laboratories and clean rooms that are furnished with the latest equipment from Horiba's Group companies and will be joined by HORIBA STEC, Inc.
Staffed by a new R&D team, this facility will provide the venue and the opportunity for the kind of collaboration between vendors, integrators, and customers that is necessary to meet the challenges of next generation processes by providing value and enabling technology from Horiba's vast range of core technologies. Initially, a group of 10 engineers from Japan and the US will work together to develop fluid controlling devices and vacuum analyzing devices for subsystems on semiconductor producing equipment.
The Technology Center will identify not only the needs of the semiconductor industry but also those of hi-tech companies located in Silicon Valley.
The initial investment, including plants and equipment, will amount to approximately 400 million yen and the building will be one-story above the ground, with an approximate gross floor area of 20,444 sq. ft.
California-Based Medical Products Company to Build in University Research Park
University Research Park (URP) Madison, WI, announced that Mentor Corp. a California-based global leader in the development, manufacturing and marketing of science-based medical products, will expand its presence in Madison with the construction of a 37,000-square-foot manufacturing facility in the park.
Construction of Mentor’s facility has begun and is expected to be completed during the summer of 2008. The manufacturing facility is one of the largest investments in the park in its history. Mentor will employ approximately 40 at the expanded site when it becomes fully operational upon completion. Subject to regulatory approvals, the Mentor facility will produce the company’s botulinum toxin product for use in cosmetic wrinkle correction, the most-often performed non-surgical cosmetic procedure in the United States. More than 4 million of the procedures were performed in 2006, according to the American Society of Plastic Surgeons.
The project will be designed by Strang Architects and constructed by Vogel Bros. Building Co. The two firms have collaborated on several research and development projects located in University Research Park and have enjoyed a long working relationship with Mentor. The new Mentor building is intended to be LEED certified and will incorporate energy conservation measures and Vogel Bros.’ Waste Management Program.
About University Research Park
University Research Park, established in 1984 and located three miles west of the University of Wisconsin-Madison campus, is home to more than 100 companies that employ over 4,000 people. It contributes more than $680 million each year to the state’s economy. The non-profit, internationally-recognized research and technology park has 35 buildings with more than 1.5 million square feet of office and laboratory space used by a broad range of start-up companies, many of which are focused on biotechnology.
DSM subsidiary DSM Nutritional Products Ltd. has acquired privately owned Pentapharm Holding Ltd. Pentapharm is a developer and producer of active ingredients and system solutions for the cosmetics industry but also has a presence in pharmaceutical and diagnostics markets, offering specialized products for niche applications in the context of human blood coagulation disorders. The company posted sales of approximately $50 million last year. Financial terms were not disclosed.
SGS Passes FDA Inspection in India
SGS India Ltd.'s Chennai facility has passed an FDA inspection conducted in February 2007. It was both a pre-approval and a GMP inspection. The facility is classified as "acceptable." This was the first FDA inspection of the SGS QC testing laboratory in Chennai.
The SGS Chennai site began pharmaceutical testing in 1995, and received local GMP government approval at that time. In 1997, the facility obtained ISO 17025 certification for chemical, mechanical, and biological fields. In February 2005, the Life Science Services operations moved to Ticel Biopark, a purpose-built lab facility dedicated to R&D and drug development services. SGS occupies approximately 25,824 sq. ft. of state-of-the-art lab space for chemical, microbiological and toxicological testing. The current QC testing staff consists of more than 40 employees.
The Chennai facility provides testing services in the GMP and GLP areas: raw material and finished product testing, microbiological testing, stability testing, toxicology, biotechnology and medical device testing.
Hudson-Alpha Institute for Biotechnology 'in home stretch'
With 75 percent of the work completed, a director choice committed, an opening date in sight and some world-class investigators signed up, the waiting may the hardest part for Hudson-Alpha Institute for Biotechnology President Jim Hudson.
The 270,000-square-foot institute is scheduled to open in November, about a month later than first projected, but within 20 months of the groundbreaking on a building that is unique in design, requires a vast array of technical and laboratory capabilities and is aimed to foster interaction between the scientists and companies it will house.
The institute in Cummings Research Park broke ground in January 2006 and now has 325 workers engaged in the building's construction.
Along with the work going on outside, Hudson is aggressively pursuing talent to work within the institute's walls and successfully recruiting two of the four principal investigators.
The state's commitment to the project was based in part on spurring the development of biotech work in Alabama and the economic impact of bringing in a number of high-paying scientific jobs to the state.
Hudson expects the research facility to open with about 45 employees, including four principal investigators, and that will expand over the next two years to 100 to 120 researchers. He expects the institute side to top out with abut 150 employees.
There are 10 companies set to move into the facility, and they will begin with about 200 employees, total. Hudson said that number will increase to 450 to 500 over the next three years.
Sun System Expands Healthcare Facilities
Sun Health Del E. Webb Hospital will build a six-story, 175,000-square-foot patient care tower as part of an $85million investment. The tower will include an emergency room, 70 additional surgical beds and two floors that can be built out to accommodate another 76 beds. The new emergency room will be able to service about 85,000 patients a year.
Sun Health Boswell recently opened 72 additional critical-care beds as part of a $25million expansion project. The expansion also includes an additional clinical lab, an imaging facility and expanded emergency room services.
In Surprise, Sun System will build a 135,000-square-foot medical center at Greenway Road and Civic Center Drive. The facility opens in the second quarter of 2008, and will include an urgent care center, an ambulatory surgery center and physicians' offices.
Sun System will build a 60,000-square-foot facility in north Peoria at Jomax Road and Lake Pleasant Parkway that will include an urgent care center and physicians' offices. The medical center, which should be open in the second quarter of 2008, also will provide diagnostic and women's services.
In north Buckeye, Sun System will build an 8,000-square-foot facility that includes an urgent care center, opening in the third quarter of 2008.
Along with its many construction projects, Sun System plans to recruit 15 physicians in 2007 and 20 in 2008.
McIlvaine Company,
Northfield, IL 60093-2743
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