Company’s filtration products will use RFID tags to help customers develop and validate process steps

April 13, 2007 — Billerica, MA — Millipore Corporation, a leading provider of products and services that improve productivity and results in biopharmaceutical manufacturing and in clinical, analytical, and research laboratories, today announced that it is the first company to successfully integrate radio frequency identification (RFID) technology with filtration products used to manufacture biopharmaceutical drugs. The new RFID capability will be branded as SMART Technology and will be introduced at the upcoming INTERPHEX 2007 Conference, which is being held April 24-26, 2007, at the Jacob K. Javits Convention Center in New York.

By using RFID technology in filtration products, Millipore’s customers can increase speed by quickly and reliably retrieving critical information, such as when and how the product was manufactured. Additionally, when the filters are coupled with sensors, RFID can deliver real-time information about product performance and identify which fluids are present during the manufacturing process. This information will help customers to ensure regulatory compliance and make recording and conveying manufacturing data faster and more reliable.

Unlike previous labeling methods such as barcodes, RFID enables customers to automatically document product and process information, eliminates the risk of losing critical information, and provides the ability to rewrite their own information into embedded RFID tags.

Other key benefits of the RFID technology include:

• non-line-of-sight, enabling improved readability and non-linear access to information
• rewritable and encryptable
• difficult to remove and thus provide greater security
• mechanically and thermally stable
• gamma irradiatable

Millipore has recently entered into an exclusive license with Tack Smart Filter Technology BV to embed the RFID technology in its filters and filtration apparatuses for biopharmaceutical applications. Additionally, Millipore has formed relationships with Tagsys RFID for tags and reader components; the Tech Group for injection molding and fabrication; and Northern Apex-RFID for RFID integration services and instrument development.

“Using RFID technology to record and convey valuable product and process information allows our customers to more efficiently develop and validate key process steps,” said Roland Heinrich, Ph.D., vice president, R&D of Millipore’s Bioprocess Division. “In an industry where time-to-market and compliance are crucial, RFID improves the speed and confidence with which critical data is exchanged for these steps.”

“This license agreement is a milestone for Tack Smart Filter Technology and confirms the importance of this technology for the worldwide filtration and separation industry,” said Eduard de Haan, president of Tack Smart Filter Technology B.V. “We are proud to support Millipore to retain its leading position in biopharmaceutical filtration and we expect that this agreement will further boost the interest for this technology in other segments of the filtration and separation industry.”

Millipore’s Bioprocess division delivers integrated solutions and services for every application, every step and every scale of the drug development and manufacturing process. With more than 50 years of experience, Millipore provides leading biotechnology and pharmaceutical companies with resources designed to improve yields, process economics and speed to market. For more information, visit http://www.millipore.com/bioprocess.

About Millipore

Millipore is a leading provider of products and services that improve productivity and results in biopharmaceutical manufacturing and in clinical, analytical and research laboratories. The Company is organized in two operating divisions. Its Bioprocess Division helps pharmaceutical and biotechnology companies to optimize their manufacturing productivity, ensure the quality of drugs, and scale up the production of difficult-to-manufacture biologics. Its Bioscience Division helps optimize laboratory productivity and workflows by providing reagents, kits and other enabling technologies and products for life science research and development. Millipore has a deep understanding of its customers’ research and manufacturing process needs, and offers reliable and innovative tools, technologies and services. The Company is part of the S&P 500 Index and employs approximately 5,800 employees worldwide. For additional information on Millipore Corporation, please visit its website at: www.millipore.com.

Contacts:
Joshua Young
Director, Investor Relations
Millipore Corporation
978-715-1527
800-225-3384
[email protected]
Lynn Garvin
Vice President, Corporate Communications
Millipore Corporation
978-715-1043
[email protected]

April 16, 2007 — /ISPE NEWS/ — TAMPA, FL — ISPE will present several industry-impacting sessions this year at its Washington Conference June 4-7, 2007 at the Crystal Gateway Marriott in Alexandria, VA.

On June 6-7, the US Food and Drug Administration (FDA) and ISPE will co-sponsor practical, industry-impacting sessions on product quality lifecycle implementation (PQLI) and interactive workshops that will turn theory into reality. These sessions will allow industry professionals to help guide the future of the industry.

ISPE Facility Summit 2007: Innovative Ideas for Accelerating Performance held June 4-5 will be an intensive briefing and forum to interact and inspire leading industry professionals, and will feature the Facility of the Year Awards (FOYA) 2007 Category Winners, who will provide insight and real life case studies into the world of facilities.

Other important sessions during the four-day conference include:
a. 16th Annual Barrier Isolation Technology Forum
b. Critical Utilities: The Latest on Water, Steam, and Gas Systems – Regulatory Updates, Commissioning and Qualification, Design and Operational Issues
c. Newly Released API (Bulk) Baseline^® Guide, Review by Developers and Application Implications
d. Containment Technology Forum: Risk MaPP and Applying ICH Q9 Principles
e. GAMP Validation of Automation and Computerized Systems related to Manufacturing Systems, and Round Table Discussions

FDA Co-Sponsored Sessions on Product Quality Lifecycle Implementation (PQLI)
Participate in two days of foundational, interactive sessions June 4-5 with the FDA and industry leaders on “Product Quality Lifecycle Implementation” (PQLI) that will help create a pragmatic approach to harmonizing Q8 and Q9. These are the first in a series of meetings that will ultimately result in guidances produced by ISPE for the industry. Leaders from science, manufacturing quality and engineering will be able to engage with the FDA and other regulatory agencies.

“The PQLI session is at the forefront of the industry, providing the framework for a pragmatic approach to how to really implement Q8 and Q9, while helping shape the future thinking of the industry,” said Bruce Davis, a session leader, and Global Capital Director at AstraZeneca.

The goal of these sessions is to begin to define areas where industry will be able to provide the technical framework for the implementation of Quality by Design (QbD) in regulatory submissions. This ground-breaking event will comprise six break-out sessions for working groups to comment on and capture industry input, including API Design Space, DP Design Space, API Critical versus Non-Critical, DP Critical versus Non-Critical, API Control Strategy versus Quality by Design, and DP Control Strategy Traditional versus QbD. For more information on this session, please visit http://www.ispe.org/PQLI.

ISPE Facility Summit 2007: Innovative Ideas for Accelerating Performance
As the international expert on pharmaceutical facilities, ISPE will offer presentations and innovative case studies from leaders in the field at the ISPE Facility Summit 2007: Innovative Ideas for Accelerating Performance. This multi-day, multi-track program will be a unique “town hall” gathering of top thinkers and service practitioners delivering content in three key areas of project delivery, regulatory, and manufacturing technology/operations, using breakouts, panel discussions and armchair case study presentations, as well as lectures. These breakouts will target both advanced and beginning levels, focusing on challenges, what the hottest trends are now, and what is ahead for the future.

The two-day program is designed around 30-minute, intense, content-rich sessions including Facility of the Year Awards 2007 Category Winners with virtual facility tours. Participants can learn how they solved everyday problems, and can participate in interactive discussions on practical solutions to facility design (new or renovated), construction, building green, and qualification for operational excellence. For more information on this session, please visit www.ispe.org/facilitysummit.

16th Annual Barrier Isolation Technology Forum
ISPE will host the 16th Annual Barrier Isolation Technology Forum–Innovation Updates and New Case Studies—the longest running barrier isolation technology forum in the world. ISPE’s Barrier Isolation Technology Forum, which will be held June 4-5, is the standard by which all others are measured, and continuously build upon the foundation of knowledge and best practices set in place during previous years, providing a vital opportunity to gain updates and examine new case studies. For more information on this session, please visit http://www.ispe.org/barrier.

Containment Technology Forum: RiskMaPP and Applying ICH Q9 Principles
Regulators in the US and Europe are currently working on regulations that would dictate dedicated facilities for certain classes of compounds. Help make history—participate in this interactive session that will show industry and regulators how science-based risk assessments can be used to determine when multi-product facilities can safely be employed. Concepts from the ISPE Risk-MaPP Baseline^® Guide in development will address how to set safe limits for cross contamination and apply the appropriate containment technology to control within these limits. Plus, industry experts in toxicology, cleaning, quality, engineering, IH and containment will present a multi-disciplinary approach to applying ICH Q9 to determine risk controls, with a half-day dedicated to cleaning and cleaning validation.

Newly released technical documents
The Conference will offer seminars examining three newly released ISPE Good Practice Guides. Delegates will discuss techniques and solutions from the teams that developed ISPE’s just released pharmaceutical industry-impacting technical guides. These include:

• Commissioning and Qualification of Water and Steam Systems Good Practice Guide, June 4-5
• Newly Released API (Bulk) Baseline^® Guide, Review by Developers and Application Implications, June 4-5
• GAMP^® Validation of Automation and Computerized Systems Related to Manufacturing Systems, and Round Table Discussions, June 5

For more information or to register for the Washington Conference, please visit http://www.ispe.org/washingtonconference.

About ISPE
ISPE, the International Society for Pharmaceutical Engineering, is the Society of choice for more than 23,000 pharmaceutical manufacturing professionals in 81 countries around the globe. ISPE aims to be the catalyst for “Engineering Pharmaceutical Innovation” by providing Members with opportunities to develop technical knowledge, exchange practical experience, and collaborate with global regulatory agencies and industry leaders. Founded in 1980, ISPE has worldwide headquarters in Tampa, Florida; its European office in Brussels, Belgium; and its Asia Pacific office in Singapore. Visit www.ispe.org for additional Society news and information.

Contact:
Marsha Strickhouser
Public Relations Manager
813-960-2105, ext. 277
[email protected]
http://www.ispe.org

April 18, 2007 — /PRNewswire/ — CORK, IRELAND — Campbell Informatics and PIC Consulting (PIC) announced today that PIC will use the Avenio^TM engine and methodologies as its preferred design, validation, standardization and quality engineering process control solution for engineering design and C&Q projects in global pharmaceutical and biotech firms.

“PIC envisage that Avenio will be the central point of access for all plant and engineering related data representing significant cost savings and operating efficiencies,” said Marc Willems, Managing Director, PIC Consulting. “The powerful capabilities behind the Avenio engine deliver a new and ingenious form of data access, process control and right-first-time philosophy.”

The Avenio system was chosen by PIC Consulting on its ability to model data based on the customers’ commissioning, validation master plan and process validation documentation requirements. The Avenio philosophy that validation should be data-driven and that facilities and processes must be identified and characterized before they can be verified were key factors in the decision to adopt Avenio in terms of structuring a plant’s engineering design strategy.

“This licensing deal marks an extension of the relationship between PIC Consulting and Campbell Informatics,” said Donagh Kiernan, CEO of Campbell Informatics. “By broadening the existing relationship between the two companies, PIC’s European pharmaceutical and biotechnology clients can further benefit from data standardization, data re-use, supporting the design process and auto-generating C&Q documentation.”

Campbell Informatics’ patented Avenio^TM engine allows for the definition and management of process technology systems and data throughout the engineering and operational life cycles using proven Quality by Design (QbD) methodologies. Avenio flexibly integrates into current business processes, allowing for seamless migration from discontinuous engineering and compliance work practices to coordinated processes that are self-validating and self- documenting. The benefits include eliminating duplicate data, standardization of technical records, modular, front-loaded compliance, with corresponding efficiency gains and agility and flexible response to industry and regulatory changes.

About PIC Consulting
PIC Consulting (PIC) delivers consulting, engineering and validation services to the European pharmaceutical and biotechnology industry specialized on aseptic and mono-septic applications. As a mid size consulting company PIC is following a “specialized – innovative – individual” strategy targeting mid size projects of the industry. Together with its various partner companies, PIC is able to cover full project life cycle services from early consulting to validation including a broad range of measurement services and the delivery of skid mounted process units. PIC Consulting was founded in 2004 and is based in Heidelberg, Germany; Pardubice, Czech Republic; and Monthey, Switzerland. Further information: www.pic-ger.com

About Campbell Informatics
Campbell Informatics, founded in 1990, delivers systems modeling and engineering data management products and services to the regulated life science manufacturing sector. The company’s patented Avenio^TM engine lets you define and manage process technology systems and data throughout the engineering and operational life cycles using proven Quality by Design (QbD) methodologies. Avenio flexibly integrates into current business processes, allowing for seamless migration from discontinuous engineering and compliance work practices to coordinated processes that are self-validating and self- documenting. The benefits include eliminating duplicate data, standardization of technical records, modular, front-loaded compliance, with corresponding efficiency gains and agility and flexible response to industry and regulatory changes. Campbell Informatics’ professional services include agile, risk-based compliance, systems modeling, structured protocol assembly, life cycle data management, Process Analytical Technology (PAT) frameworks and technical data exchange between enterprise applications. With a blue chip client base in Ireland, Europe and USA, Campbell Informatics’ solution standardizes and unifies the corporate compliance process, controls the associated master-data and stage-gates the total GEP/GMP life cycle. www.campbellinformatics.com

Source: Campbell Informatics

Contact:
Donagh Kiernan of Campbell Informatics
+353-21-4291336 [email protected]

Sticks packs (single-serve packets) are making a transition into the nutraceutical and pharmaceutical markets with the help of T.H.E.M., Technical Help in Engineering & Marketing, a Marlton, NJ-based company.

April 13, 2007 — /PRWeb/ — MARLTON, NJ — Stick packs are already a staple of the packaging world. While the food and beverage categories are the biggest proponents of single-serve, go-anywhere convenience, the stick pack phenomenon is starting to mushroom in new soil. And the commitment being made to stick packaging by Garden State Nutritionals, a leading national and international custom nutritional manufacturer, is proof positive that single-portion packaging is the new wave of the future in yet another major product category.

According to Peter Hefele, senior vice president of Garden State Nutritionals, the company has a healthy mix of flexible stick packaged products in its pipeline. “We currently produce, and have clients marketing, numerous products available in the stick pack,” says Hefele, “with several others in various stages of product development. All will be marketed through traditional national and international channels of distribution with heavy sampling support and an ad budget for each.”

Making it easy for Garden State Nutritionals is the company that brought stick pack technology to the U.S., Technical Help in Engineering and Marketing (T.H.E.M.) of Marlton, NJ. In fact, you can credit T.H.E.M. for having a hand in almost every stick pack product on the market in North America today.

“Garden State developed a strategic alliance with T.H.E.M in order to deliver to its clients the industry’s best-in-class packaging solution focused on portability. Together we are stimulating unprecedented growth in new products and condition-specific categories,” explains Hefele.

Hefele credits his business development and product development teams for identifying the need to use stick packs and for following up on recommendations that identified T.H.E.M as the company to bring Garden State into the age of portion-perfect packaging.

“T.H.E.M. has done wonders in supporting our reputation in the area of customer service,” says Hefele. “They’ve been terrific in every phase of product development, including R&D, regulatory and supplier/component management. And they haven’t needed much lead time at all, going from test phase to batch development in a matter of weeks. I can honestly say they exceeded my expectations.”

That’s saying something considering that expectations have been pretty high for T.H.E.M. of late. T.H.E.M. was recently honored as one of the packaging industry’s “Most Influential” by Packaging Strategies magazine.

Of course, T.H.E.M. has a reputation for rising to expectations. The company recently increased its production capacity by almost 50% to meet the demand for stick packaging products in just about every conceivable form. As many in the industry will tell you, anything that can be put in a jar, a can, a carton, a tube or a bottle can be put in a stick pack. Formats can include liquids, pastes, creams, agglomerations, lotions, and gels. And the nutraceutical industry has product in every one of those forms and consistencies.

One reason why T.H.E.M. has been such an influence on the packaging world is the company’s willingness and ability to help marketers get into stick packaging without getting over their heads. T.H.E.M. is the only U.S.-based company that enables marketers to test and evaluate stick packaging in small volumes. Each of T.H.E.M.’s packaging suites is equipped with state-of-the-art HEPA air handling systems with humidity control.

It’s also well known in the industry that all of T.H.E.M.’s facilities meet the industry’s highest standards for quality and consistency, and include comprehensive laboratory support to evaluate, test, and launch products in flexible stick packaging. In other words, they are perfectly suited to repackage the world of neutraceuticals into handy stick packs.

Neil Kozarsky, president of T.H.E.M., offered his perspective on why the nutraceutical industry can’t get its product into stick packs fast enough. “When you put a product in a stick pack, no one but the end user touches that product before it is used, and each pouch can be made to hold the exact portion for one use,” explains Kozarsky. “There’s no guesswork when it comes to how much you should use, and there’s no waste.”

So what’s after the neutraceutical market for T.H.E.M and their stick packs? According to Kozarsky, the real model for the future of stick packs in North America is Japan and he should know. He brought the technology from Japan only a few years ago. “Stick packs are already very popular in the nutraceutical, vitamin, and pharmaceutical product categories in markets beyond the U.S., especially in Japan and Europe,” says Kozarsky. “But we’ll catch up.”

As a matter of fact, T.H.E.M. is already working with a number of pharmaceutical companies. Kozarsky explains, “They recognize that if we can meet the quality control demands of the food and nutraceutical markets, we can meet their needs as well.”

Founded in 1973 and located in Marlton, New Jersey, T.H.E.M. has served as the gateway for North American companies to find innovative packaging solutions. By monitoring packaging trends globally, T.H.E.M identifies innovations from all over the world and has put them to work for a wide range of companies in North America. Visit http://www.them.net.

Contact:
Colleen Morrill
T.H.E.M.
5A Stow Road
Marlton, NJ 08053
856-988-8436, x47

April 11, 2007 — /MARKET WIRE/ WHEAT RIDGE, CO –GeneThera, Inc. announced today that a female cow imported into the United States in 2002 was born in the same Canadian herd as a bull diagnosed in February with Mad Cow disease, the Agriculture Department said Tuesday.

The cow was slaughtered in Nebraska before it was 30 months old and showed no signs of the brain-wasting disease, said Karen Eggert, a spokeswoman for the Animal and Plant Inspection Service. However, the meat from the animal probably entered the food supply and was never tested for Mad Cow.

In February, Canada confirmed its ninth case of Mad Cow disease since 2003. There have been three confirmed cases of Mad Cow disease in U.S. animals.

Source: CTV.CA

ABOUT GENETHERA, INC.:
GeneThera, Inc. is a molecular biotechnology company located in Wheat Ridge, CO. The Company provides genetic diagnostic solutions for the veterinary and agricultural industries with future plans to include the health-care industry. The Company’s proprietary diagnostic solution is based on a genetic expression assay, GEA^TM, a protocol designed to
function on a highly automated Fluorogenic PCR platform. This platform enables GeneThera to offer tests that are presently not available from other technologies. The GEA is designed for a host of individual diseases, the current priority being Mad Cow Disease, Chronic Wasting Disease, a disease affecting elk and deer in North America; E.Coli 0157:H7 and Johnne’s Disease, diseases affecting cattle worldwide.

SOURCE: GeneThera, Inc.

Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA

April 5, 2007 — /FDA NEWS/ — The Food and Drug Administration (FDA) today warned consumers not to use American Bullie A.B. Bull Pizzle Puppy Chews and Dog Chews manufactured and distributed by T.W. Enterprises, Ferndale, WA, because they have the potential to be contaminated with Salmonella, which can cause serious infections in dogs and cats, and, if there is cross-contamination, in people, especially children, the aged, and people with compromised immune systems. Consumers who have the pet treats manufactured or distributed by T.W. Enterprises listed below should not feed them to their pets, but instead dispose of them in a safe manner (e.g., in a securely covered trash receptacle).

Salmonella can potentially be transferred to people handling these pet treats, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products. Healthy people infected with Salmonella should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. Rarely, Salmonella can result in more serious ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye irritation, and urinary tract symptoms. Consumers exhibiting these signs after having contact with this product should contact their healthcare providers.

Pets with Salmonella infections may be lethargic and have diarrhea or bloody diarrhea, fever, and vomiting. Some pets will have only decreased appetite, fever, and abdominal pain. Well animals can be carriers and infect other animals or humans. If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian.

The products covered by this alert include all sizes and lots of American Bullie A.B. Bull Pizzle Puppy Chew and Dog Chew (made from all American beef pizzle). Following is a list of the affected products:

• A.B. Small Chew, small, 3-4 inch
• A.B. Puppy Chew, 4-6 inch
• A.B. Dog Chew Medium, 6 inch
• A.B. Dog Chew Large, 10 inch
• A.B. Dog Chew XL, 13 inch
• A.B. Dog Chew Mega, 16 inch
• A.B. Dog Chew Jumbo, 26 inch

FDA collected samples of packages of three different sizes of bull pizzle (beef) dog chews manufactured by T.W. Enterprises and, after analysis, found Salmonella in one of them. FDA is including in its alert all sizes and all lots of bull pizzle chews manufactured by T. W. Enterprises because pizzles used in manufacturing the chews are processed at the same time, cut into chews of the desired sizes, and then packaged for sale. Differently sized chews are thus obtained from the same batch or lot of pizzles and manufactured under conditions that facilitate cross-contamination within batches or lots. It is impossible to differentiate chews manufactured by T. W. Enterprises by lot or batch numbers or dates of manufacture because packages of the firm’s chews are not coded with batch or lot numbers, and do not specify the dates of manufacture or bear expiration dates.

FDA is actively investigating this matter to determine the source of this problem, and will issue future updates as appropriate.