Tag Archives: Clean Rooms

May 16, 2007 — /PRNewswire/ — BETHLEHEM, PA — Digestive Care, Inc (DCI) announced today that it is quadrupling the capacity of its manufacturing, research and development facility in order to meet the growing demand for PANCRECARB(R) (pancrelipase), a pancreatic enzyme for the treatment of pancreatic insufficiency.

“This expansion is essential to ensuring that there is ample supply of PANCRECARB(R) for patients whose lives are dependent on the availability of this medication,” said Dr. Tibor Sipos, president and founder of DCI. “Our continued success is a result of PANCRECARB(R)’s market acceptance and an outstanding multidisciplinary team entirely dedicated to providing support to healthcare providers and patients.”

The PANCRECARB(R) expanded manufacturing and research facility, located in Bethlehem, PA, will also enable DCI to research, develop, and manufacture other therapeutic products, including those for managing digestive disorders associated with cystic fibrosis and cholestatic liver diseases.

About PANCRECARB(R)
PANCRECARB(R) is an exocrine pancreatic insufficiency drug product. It is the only enteric coated and bicarbonate buffered pancreatic enzyme which is protected by several U.S. patents. In April 2004, the FDA determined that prescription exocrine pancreatic insufficiency drug products are medically necessary and, accordingly, allowed the drug manufacturers four years (April 2008) to obtain approved new drug applications. PANCRECARB(R) is on track to fulfill these requirements.

About Digestive Care, Inc.
DCI is dedicated to developing unique pharmaceutical products to alleviate complications and symptoms of gastrointestinal disorders. DCI was founded in 1990. The company holds 15 U.S. and foreign patents and has a national distribution network. The Company’s technology is based on the ability to commercially develop unique drug delivery systems for delivering bioactive molecules to their target site. DCI’s research into the controlled delivery of gastric acid resistant digestive enzymes and buffered bile acids through micro encapsulation led to the development of the highly successful drug product, PANCRECARB(R) (pancrelipase).

Source: Digestive Care, Inc.

Contact:
Maggi Campbell of Digestive Care, Inc.,
Tel:+1-610-882-5950 (office)
Email: [email protected]
Web site: http://www.digestivecare.com/

May 16, 2007 — /PRNewswire-FirstCall/ — MINNEAPOLIS, MN — Hawkins, Inc. today announced an agreement to acquire New Jersey-based Trumark, Inc., a growing company in the area of antimicrobial products for the food industry. The acquisition is designed to enhance research and development activities, add scale and expanded territory to production, service, and distribution activities while complementing product offerings in a growing market.

“Acquiring Trumark is a strategic move for Hawkins as we increase our focus on manufactured food ingredients and expand our presence nationwide. Trumark is a high quality lactate manufacturer that is well regarded in the industry and has an excellent track record with its customers. We intend to leverage those aspects of the business, retaining the Trumark name, utilizing a multi-plant production and distribution network and combining Hawkins product offerings with those of Trumark,” said John R. Hawkins, chief executive officer of Hawkins. “The strategic value of this acquisition is created from combining Hawkins chemical expertise, scale, customer base, production capabilities and distribution channels with the product development activities and reputation of Trumark. Both companies have a strong presence in providing lactate blends to the meat industry as microbial inhibitors.”

“Trumark, which was founded in 1977, has earned a positive reputation for product quality, on site customer service and custom blending to meet functional requirements of customers. This combination provides excellent resources to grow the business, expand our manufacturing presence and provide the additional capital to develop new and enhanced performance products,” said Jeff Wales, president of Trumark. “We feel fortunate to find a partner that shares our strategic direction, is dedicated to grow the antimicrobial business and is committed to providing customers with solutions for their processing needs.”

About Trumark, Inc.
Trumark is a privately held concern, incorporated in New Jersey that has developed and marketed antimicrobial agents since 1977. It provides on-site customer service and expertise to solve problems associated with food safety and shelf life issues with particular skills in meat processing applications.

About Hawkins, Inc.
Hawkins, Inc. is a highly focused regional company, which provides a full range of bulk industrial products complemented with the technical competence and ingenuity to formulate and blend specialty chemicals. The company sells and services related products and equipment to safely dispense chemicals in highly controlled environments. Hawkins serves customers in a wide range of industries, including chemical processing, electronics, energy, environmental services, food processing, metal finishing, pharmaceutical, medical devices, pulp and paper, and water treatment. Hawkins is headquartered in Minneapolis, Minnesota. The company operates fifteen facilities in Iowa, Illinois, Minnesota, Montana, Nebraska, South and North Dakota and Wisconsin and services customers in Upper Michigan, Kansas and Wyoming as well.

Source: Hawkins, Inc.

Contact:
Marvin E. Dee, chief financial officer of Hawkins, Inc.
+1-612-617-8571
[email protected]

Jennifer A. Weichert
Weichert Financial Relations, Inc.
+1-651-686-9751
[email protected]

May 16, 2007 — /PRNewswire/ — AGAWAM, MA — A new, free white paper, addressing the challenges of new U.S. Food and Drug Administration (FDA) regulations awaiting combination products manufacturers, is now available for download at www.microtestlabs.com/combinationpaper.

“The combination products market — medical devices embedded with pharmaceutical or biologics components — is rapidly moving forward with a new direction and emphasis regarding product safety and FDA requirements,” said Steven Richter, Ph.D., Microtest president and chief dcientific officer. Richter, a former FDA official, is author of the announced new white paper, “Combination Products: Navigating Two FDA Quality Systems.”

Navigant consulting, estimating the combination products market at $5.9 billion in 2004, predicts a nearly $9.5 billion market in 2009. In 2005, the FDA received 275 combo product submissions, and an estimated 30% of new products under development today are combo products.

“On the forefront, a new crop of experimental heart stents have been filed with the FDA. The Abbott Labs ‘absorb’ product represents a significant change to existing drug eluting stent technology. Along with new breakthrough technologies like absorb, FDA regulatory centers are struggling with the changes and challenges that these new technologies present,” Richter said.

“For manufacturers, the convergence of devices and drugs or biologics also brings a host of FDA testing guidelines, practices, and regulations unique to the development and production of combination products,” he said.

The challenges are discussed in the new, free white paper, “Combination Products: Navigating Two FDA Quality Systems.” The paper’s contents include: Defining the Convergence, FDA Responsibility, QC Drug Release Criteria, Biologics, New Developments in FDA Thinking, and Future Considerations.

Download the free white paper at: www.microtestlabs.com/combinationpaper. Or for more information, visit Microtest on the Web at www.microtestlabs.com, or call toll-free 1-800-631-1680.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, biotechnology industries. Based in Agawam, MA, USA, the company’s expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

Source: Microtest

Contact:
Don Goncalves
Tel: +1-781-793-9380
Email: [email protected]

Brandie Gerrish
Tel: +1-781-793-9380
Email: [email protected]
both of Tiziani Whitmyre, Inc., for Microtest

May 16, 2007 — EAST HILLS, NY — As part of its global initiative to align with customers worldwide, Pall Corporation today inaugurated its newest Life Sciences Centre of Excellence in Bangalore, India. The center will drive process optimization innovations for the global life sciences market to meet the evolving opportunities and challenges of this fast-growing industry throughout Asia.

The new center includes a state-of-the-art proteomics laboratory to help customers speed the drug discovery process. It also houses a validation laboratory and a training facility with specialty experts to support Indian and regional customers as they increasingly enter the stringently regulated drug export market. India was strategically chosen as the location for Pall’s new Centre of Excellence in Asia because of the country’s highly regarded reputation in life sciences spanning biopharmaceutical research, development, and production.

Additionally, India’s diverse market opportunities coupled with a large pool of qualified scientists and engineers provide an ideal climate for fuelling innovation and growth. “Pall’s growth in the Asian life sciences market is a reflection of our focus on this important region and our continuing commitment to undertake several customer-centric initiatives there,” says Roberto Perez, president, Pall Life Sciences Worldwide. “The new Centre of Excellence will be instrumental in helping the life sciences industry in India and throughout the region apply the latest technologies and services to their operations, so they have the optimal tools and expertise to bring new and innovative drugs to market more efficiently.”

As Indian-based companies address the health care needs of their nation’s billion-plus population and also expand into the global marketplace, they constantly seek new approaches to broaden and improve their drug pipeline and their ability to produce them to a world-class standard. The new center will provide the pharmaceutical, biotechnology, and discovery markets throughout the region with a full range of total fluid management solutions to help them achieve their goals. Led by a highly specialized team of professionals, the new center joins other Pall Life Sciences Centres of Excellence throughout Europe and the Western Hemisphere in bringing together the latest technologies with process optimization knowledge and expertise.

With the opening of the center Pall Life Sciences also expands its customer technical support system. Customers anywhere in the world will be able to have immediate access (24 hours, 7 days a week) to Pall scientists and technical experts. “The success of our customers depends on their ability to carry out all stages of drug development — research, discovery and full-scale production — efficiently and cost-effectively,” says Vinay Joban, general manager, Pall BioPharmaceuticals India. “The new center provides the region with a complete range of services to support their operations from upstream through downstream while also facilitating their ability to comply with increasingly rigorous global requirements.”

The biopharmaceutical industry throughout Asia is experiencing a major surge in activity. The Indian pharmaceutical industry is one of the world’s largest, ranking 4th in terms of volume. According to Opportunities in Indian Pharma Sector (July 2006), India holds US$6 billion of the $550 billion global pharmaceutical industry, an annual increase of 10 percent compared with the 7 percent annual growth of the overall world market. The biotechnology market is also booming in India and is expected to continue on a fast pace with the support of the government through its comprehensive national biotechnology policy. Indian Biotechnology Market Outlook (February 2007) reports that the Indian biotechnology industry has grown 28.09 percent from 2005, and is likely to touch the US$5 billion mark by the end of 2010.

“Our new Centre of Excellence is the latest demonstration of Pall’s long-term commitment to grow and invest in Asia and align with our customers worldwide,” says Vinay Gupta, managing director and head of Pall Life Sciences in India. “It is key to our global strategy of working as a partner with the pharmaceutical and biotechnology industries and the academic research community to provide them with a full range of total process management solutions for improved optimization.”

About Pall in India and Asia
Pall Corporation has been present in India for more than two decades and was incorporated as Pall India in 1996. Headquartered in Mumbai, the company serves both life sciences and industrial markets where it provides total fluid management solutions for a broad range of critical applications to a diverse customer base. With staff strength of more than 200 people drawn from various disciplines and expertise, Pall continues to enhance and expand its operations in India. Currently, plans are underway to set up a new center in Pune to provide complete engineering solutions to the global market for Pall’s housings and systems portfolio. In addition to its operations in India, Pall serves the Asia-Pacific region with facilities in China, Indonesia, Japan, Korea, Malaysia, Australia, New Zealand, Philippines, Singapore, Taiwan, Thailand and Vietnam.

About Pall Corporation
Pall Corporation is the global leader in the rapidly growing field of filtration, separation and purification. Pall is organized into two businesses: life sciences and industrial. These businesses provide leading-edge products to meet the demanding needs of customers in biotechnology, pharmaceutical, transfusion medicine, energy, electronics, municipal and industrial water purification, aerospace, transportation and broad industrial markets. Total revenues for fiscal year 2006 were $2.0 billion. The company headquarters is in East Hills, New York, with extensive operations throughout the world. For more information visit Pall at www.pall.com.

May 17, 2007 — /PRNewswire-USNewswire/ — WASHINGTON, DC — An Export-Import Bank of the United States (Ex-Im Bank) $610 million loan guarantee approved by the bank’s board of directors Wednesday will finance U.S. exports of wafer fabrication equipment to expand Chartered Semiconductor Mfg. Ltd.’s Fab 7 facility in Singapore.

Chartered will use the financing to buy U.S.-manufactured equipment from Applied Materials Inc., Santa Clara, CA; Novellus Systems Inc., San Jose, CA; LAM Research Corp., Fremont, CA; Varian Semiconductor Equipment Assoc., Gloucester, MA; KLA-Tencor Corp., Milpitas, CA, and numerous other U.S. exporters. JPMorgan Chase Bank, New York, NY, is the guaranteed lender on the transaction.

The equipment will be used in Phase 2 of the Fab 7 facility. When fully completed, Fab 7 will be able to fabricate up to 45,000 300-mm non-DRAM wafers per month. The wafers will use processing technology from 90 nm to 45 nm over the life of the project.

“We supported Phase 1 of Fab 7 and welcome participation in Phase 2,” said Ex-Im Bank chairman and president James H. Lambright. “This export sale will help create and sustain jobs at the U.S. exporting companies involved in the project and their sub-suppliers throughout the country.”

“Chartered is pleased with the continued support from Ex-Im Bank,” said George Thomas, senior vice president and chief financial officer of Chartered. “Today’s announcement follows the US$653 million term-loan facility we signed with Ex-Im Bank in 2004 and have been utilizing for our capacity expansion. This new financing will help us further build the capacity that is needed to support our customers in the U.S. and elsewhere in the world.”

“We are delighted to support the development of Phase 2 of Fab 7 and to further the support of U.S. exports,” said Margo Gill, JPMorgan Chase’s Ex-Im Bank program manager.

The Ex-Im Bank financing is a corporate finance transaction, with Chartered being the primary source of repayment. Chartered is an independent specialized contract manufacturer of semiconductors in the world.

Ex-Im Bank is an independent U.S. government agency that assists in financing the export of U.S. goods and services to markets around the world through export credit insurance, loan guarantees, and direct loans. In fiscal year 2006, Ex-Im Bank authorized over $12.1 billion in transactions supporting an estimated $16.1 billion in U.S. exports.

Source: Export-Import Bank of the United States

Contact:
Marianna Ohe of Ex-Im Bank, +1-202-565-3200
Web site: http://www.exim.gov/

May 15, 2007 — /PRNewswire-FirstCall/ — PASADENA, CA — Jacobs Engineering Group Inc. announced today that it received a contract from Biogen Idec to provide engineering, procurement, validation, and site support services for the first cell culture manufacturing facility at the greenfield biotechnology plant in Hillerod, Denmark. The manufacturing facility is expected to produce TYSABRI(R) (natalizumab), which is used in the treatment of multiple sclerosis.

Officials did not disclose the contract details but noted that the plant is scheduled to be completed in 2009.

Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. The company creates new standards of care in therapeutic areas with high unmet medical needs and has significant products serving patients in more than 90 countries. This will be its first manufacturing facility in Europe. Jacobs performed conceptual design for the facility and will execute this new scope of work from its office in Reading, England.

In making the announcement, Jacobs Group vice president Phil Stassi said, “We are very enthusiastic about continuing our collaboration with Biogen Idec to help them bring this important drug treatment to market. This award strengthens our position as the leading engineering contractor for large European biotech projects.”

Jacobs, with over 46,000 employees and revenues exceeding $8.0 billion, provides technical, professional, and construction services globally.

Contact:
Mary Bloom, Jacobs Engineering Group
626-578-6992
Web site: http://www.jacobs.com/

May 15, 2007 — Austin, TX — Members of the International SEMATECH Manufacturing Initiative (ISMI) have agreed to draft a “green fab standard” aimed at building semiconductor factories that will use less energy and water, minimize waste and air pollution, and ultimately save money for chipmakers.

Simultaneously, ISMI members have compiled a set of best practices and tactics for conserving energy in current factories, using activities as simple as turning down tool exhaust fans, and as complex as writing software to automatically control equipment pumps. Potential cost reductions from these refinements are significant: A typical fab can save at least $100,000 per year for each 1 percent reduction in energy consumption.

Both initiatives stemmed from ISMI’s Green Fab Workshop and Fab Energy Conservation Workshop, held recently in Austin. The two back-to-back meetings brought together industry manufacturers and suppliers in a concentrated effort to drive environmental learning into current chip factories, while defining the requirements for building eco-friendly fabs in the 21st century.

“Being ‘green’ in terms of products, processes, and facilities is mandatory for any industry that wants to thrive in our current environment,” said Scott Kramer, ISMI director. “Chipmakers recognize that eco-friendly manufacturing is a clearly established part of corporate responsibility — something that is expected by investors, customers, and communities around the world.”

At the Green Fab Workshop, representatives from universities and the fab design and construction industry joined ISMI members in comparing current best practices for sustainable fabs to guidelines in the Leadership in Energy and Engineering Design (LEED[R]) rating system established by the U.S. Green Building Council.

Workshop chairman James Beasley explained that LEED(R) certification has proliferated throughout several industries, but is just starting to be developed for the chip sector. To help accelerate this process, the workshop formed task groups to create a “green fab” building standard compatible with LEED(R). Planned elements of that standard would include:

  • “Right-sizing” of facilities and systems
  • Energy supply efficiency and management
  • Safety and risk management
  • Fab environmental monitoring
  • Decreased water usage comparable to that of other industries
  • Innovative wastewater treatment and recovery systems

“Creating a green building standard for fabs compatible with LEED(R) will help proliferate the construction of sustainable factories and shareholders,” said Beasley. “It also will be a key step toward introducing LEED(R) into the high-tech sector.”

During the related Fab Energy Conservation Workshop, ISMI members joined by selected equipment suppliers spent two days sharing results of their energy-conservation projects. These practices were compiled into a list of “golden nuggets” that included:

  • Replacing compressor-based chillers with solid state chillers, which not only save energy but also produce better temperature control in wet processes, provide increased process control in etch chambers, and eliminate the need for refrigerants.
  • Developing a factory automation interface to automatically idle vacuum pumps when not in use, and utilizing the energy efficiency offered by AC pump motors.
  • Reducing excessive exhaust requirements in some tool specifications.
  • Using innovative equipment components, such as a replacement diffusion furnace element with potential to save up to 20 percent in power consumption, and a thermal annealer that uses one-fourth the energy required by conventional, lamp-style annealers.

“Taken together, these golden nuggets define a pathway to ever-greater efficiencies in energy conservation,” said Dale Wilt, workshop chairman. “From the intuitive to the imaginative, these kinds of practices reflect a new age of eco-friendly practices for our members and the industry.”

Commissioner of Food and Drugs Dr. Andrew C. von Eschenbach has announced the creation of a new Food and Drug Administration (FDA) position-assistant commissioner for food protection-to provide advice and counsel to the commissioner on strategic and substantive food safety and food defense matters.

David Acheson, M.D., F.R.C.P., is the first to be assigned to this senior leadership role, reporting to Dr. Murray Lumpkin, deputy commissioner for international and special programs. Acheson serves as chief medical officer and director of the Office of Food Defense, Communication and Emergency Response at FDA’s Center for Food Safety and Applied Nutrition (CFSAN). In his new role, Acheson will work with individual FDA product centers, as well as the Office of Regulatory Affairs to coordinate FDA’s food safety and defense assignments and commitments.

The agency says Acheson will also serve as the commissioner’s direct liaison to the Department of Health and Human Services, of which FDA is a part, and to other U.S. departments and agencies on food safety and food defense related inter-agency initiatives.

“The protection of America’s food supply and therefore the safety of Americans eating food of domestic or international origin is of utmost importance to me as a physician, and to the mission of this agency,” von Eschenbach says. “We’ve seen a rapid transformation of the food safety system due to advances in production technology, rapid methods of distribution, and the globalization of food sources. Dr. Acheson’s wealth of experience, and knowledge of the science behind food protection, will help the agency keep pace with this transformation in order to ensure that the safety and nutritional value of our food supply is second to none.”

One of Acheson’s first assignments will be the development of an agency-wide strategy for food safety and defense that will identify and characterize changes in the global food safety and defense system, and identify current and future challenges and opportunities. It will also name potential barriers, gaps, and the most critical needs in a food safety and defense system.

As a CFSAN office director, Acheson currently has the lead for emergency response, as well as outreach and communications to industry, state, and consumers on issues pertaining to the center. He manages a staff of epidemiologists, biostatisticians, and others in providing risk assessments, aid in epidemiological investigations of foodborne illness outbreaks, and other important center-wide functions.

Pall Corporation has inaugurated its newest Life Sciences Centre of Excellence in Bangalore, India, which is intended to drive innovations in global life sciences processes throughout Asia.

The new center includes a state-of-the-art proteomics laboratory to help customers speed the drug discovery process. It also houses a validation laboratory and a training facility with specialty experts to support Indian and regional customers as they enter the highly regulated drug export market. Pall says India was strategically chosen as the location for the Centre of Excellence in Asia “because of the country’s highly regarded reputation in life sciences.”


Pall’s Bangalore Life Sciences Centre of Excellence houses a state-of-the-art proteomics laboratory designed to help customers speed the discovery process, as well as a validation laboratory to assist pharmaceutical companies in meeting stringent regulatory requirements. Photo courtesy of Pall.
Click here to enlarge image

The company says the center will provide the pharmaceutical, biotechnology, and discovery markets throughout the region with a full range of total fluid management solutions to help them achieve their goals. Led by a specialized team of professionals, the new facility joins other Pall Life Sciences Centres of Excellence throughout Europe and the Western Hemisphere in bringing together the latest technologies with process optimization knowledge and expertise.

Pall Life Sciences is also expanding its customer technical support system with the center’s opening. Customers worldwide will have immediate access to Pall scientists and technical experts. “The success of our customers depends on their ability to carry out all stages of drug development-research, discovery, and full-scale production-efficiently and cost-effectively,” says Vinay Joban, general manager, Pall BioPharmaceuticals India. “The new center provides the region with a complete range of services to support their operations from upstream through downstream while also facilitating their ability to comply with increasingly rigorous global requirements.”

The biopharmaceutical industry throughout Asia is experiencing a major surge in activity. The Indian pharmaceutical industry reportedly ranks fourth in terms of volume. According to Opportunities in Indian Pharma Sector (July 2006), India accounts for US$6 billion of the $550 billion global pharmaceutical industry, an annual increase of 10 percent compared with the 7 percent annual growth of the overall world market. The Indian biotechnology market is also growing, supported by the government’s comprehensive national biotechnology policy. Indian Biotechnology Market Outlook (February 2007) reports that the Indian biotechnology industry has grown 28.09 percent from 2005, and is likely to touch the $5 billion mark by the end of 2010.

Air Liquide Electronics, a leader in industrial and medical gases and related services, and Aviza Technology, Inc., a supplier of advanced semiconductor capital equipment and process technologies for the global semiconductor industry and related markets, have extended their joint development agreement (JDA). The JDA, which now has been extended through 2010, centers on advanced films and process development for semiconductor fabrication. The original agreement between the two companies was announced on April 4, 2005.

“We joined forces with Aviza as a partner for innovative materials development and integration so that we could offer chipmakers manufacturing-worthy process solutions to meet their roadmap requirements,” says Christophe Fontaine, vice president of Air Liquide Electronics. “The JDA has proven to be a mutually beneficial partnership for both companies and we look forward to continuing our development efforts with Aviza.”

Continuous integrated circuit (IC) device scaling poses certain critical manufacturing challenges, with new materials playing an integral role in successful sub-90-nm IC production. Ongoing industry collaboration is important for early development of process and technology solutions to overcome these next-generation challenges. Aviza and Air Liquide’s collaborative partnership enables the companies to combine their knowledge in the areas of advanced films, process technology, and hardware to help address deposition challenges for increasingly smaller and more complex IC devices.

As part of the JDA, Air Liquide’s ALOHA™ organization will produce the chemicals, perform the associated analyses and characterizations, and evaluate them through its Precursor Screening Program when necessary. Aviza will use selected precursors in developing fully characterized films to support advanced applications for sub-90-nm manufacturing.

“To date, Aviza has experienced quite a successful collaborative partnership with Air Liquide,” says Helmuth Treichel, vice president of advanced applications at Aviza. “Both Aviza and Air Liquide have benefited from our ongoing JDA and we feel there is much more opportunity to expand and enhance our research and development efforts by working with industry experts like Air Liquide in the materials arena.”