Pall Ultrafiltration Technology Simplifies Production of Vaccines
Conjugate vaccines that protect infants and young children from infectious diseases will become more widely available now that the complicated and expensive production process has been simplified. Ultrafiltration technology can reduce production time and costs by streamlining many of the 30-or-more steps often required to separate and purify conjugate vaccines.

 The development of conjugate vaccines has enabled protection of children at an earlier age against serious infectious diseases, such as meningitis, invasive pneumonia, and ear and blood infections, caused by the pneumococcus bacteria. The vaccines combine foreign protein and polysaccharides that help the immature immune system recognize and remember the needed immune response.

Despite the benefits of conjugate vaccines, the complex and expensive manufacturing process has presented a barrier to wider-scale use.

“Pall’s innovative purification technologies are used in critical processing steps to manufacture these life-saving vaccines more efficiently and economically,” says Ian Sellick, director of marketing for Pall Life Sciences. “With the emergence of drug-resistant bacteria and the increasing number of infectious diseases, the need for conjugate vaccines is even more critical.”

A core step during conjugate vaccine production is fractionation, which is used to separate polysaccharides into specific size classes for attachment to proteins. While fractionation is traditionally performed using size exclusion chromatography, ultrafiltration provides a faster, simpler method of capturing specific size polysaccharides. Ultrafiltration also eliminates the need for costly chromatography resins.

Pall’s Mustang® technology and ion exchange membrane chromatography provide an efficient polishing step with speed and cost benefits over conventional beaded resin column chromatography.

Contact: Pall Corp (516) 484-5400

AHRQ Awards Millions in Challenge Grants to Help Hospitals Improve Safety

The Agency for Healthcare Research and Quality (AHRQ) awarded almost $4 million to fund 13 projects designed to improve patient safety in hospitals. Six of the grants will assess patient safety risks and devise ways to prevent them; the remaining seven will implement safe practices that show evidence of eliminating or reducing known hazards to patients.

 “These grants not only will help hospitals put proven remedies in place to reduce errors, but also will provide a wealth of information on where risks still occur and what can be done to eliminate them,” says Tommy Thompson, health and human services secretary for AHRQ. “Efforts like these will help hospitals and other parts of the health care system make meaningful progress to improve the quality of care for patients.”

The 13 grants build on the agency’s 3-year, $165 million investment in patient safety research. AHRQ currently has more than 100 other research projects that comprise an extensive, user-driven patient safety research agenda designed to improve patient safety and enhance quality of care.

“We see these challenge grants as an exciting opportunity to provide hospitals with the resources to identify and confront the causes of medical errors,” says AHRQ Director Carolyn Clancy, MD. “The findings of this research will help us reach our ultimate goal of ensuring that Americans receive high-quality, safe health care.”

The agency will provide as much as 50% of the total cost of the projects, while grant recipients will be required to provide a minimum of 50% of the total costs. The implementation project awarded to John Hopkins University in Baltimore and Blue Cross and Blue Shield of Michigan will provide up to $10 million in incentive payments to hospital participants in Michigan, in addition to the commitments made by participating Michigan hospital teams and the Michigan Health and Hospital Association.

Contact: Agency for Healthcare Research and Quality (301) 427-1364

 COLA and TÜV America Form Accreditation Certification Alliance
COLA and TÜV America have formed a strategic alliance to offer ISO9000 management systems certification and laboratory accreditation services to medical laboratories worldwide.

Under CLIA 88, the federal requirement for clinical laboratory quality assurance, laboratories must be inspected in order to obtain Medicare and Medicaid reimbursement. COLA is one of six private organizations permitted by the federal government to accredit laboratories. ISO 9001:2000 is a quality management system standard with its roots in industry. The ISO standard is used as part of the certification process whereby organizations demonstrate the quality of their management approach through this process. Many laboratories seek both forms of certification and the alliance between TÜV and COLA combines the process.

“The new accreditation alliance will provide laboratories with a harmonized process for laboratory accreditation in compliance with CLIA 88, and the quality management review process of ISO 9001:2000,” says Doug Beigel, CEO of COLA. “Previously, these two services have been offered by two separate organizations, independent of one another, requiring two different audits, certifications, and fee structures. By harmonizing these processes, we can now reduce both fees and management involvement for our customers, while helping to improve their operations and ensure regulatory compliance to CLIA 88.”

Contact: COLA (410) 381-6581

ESA Acquires Assets of Cypress Systems

In a move to increase its presence in the academic and life-science arena, ESA Inc has purchased virtually all of the assets of Cypress Systems Inc, a provider of potentiostats and electrodes for electrochemical research, life science research, and teaching applications. ESA plans to retain the Lawrence, Kan location and its personnel.

“We look forward to the opportunities this acquisition opens up for us,” says Walter DiGiusto, ESA president and CEO. “Cypress Systems’ products and expertise in electrochemistry will augment our similar expertise and already significant presence in the academic environment.”

ESA offers high-performance liquid chromatography–based applications of electrochemistry in the academic, medical, and life science research communities. Cypress Systems has a strong position in core teaching and classroom experiments in electrochemistry.

Contact: ESA Inc (978) 250-7000

Chemicon and Genome BioSciences Collaborate on Gene-Targeting Technology

Chemicon International Inc has entered into an exclusive licensing agreement with Genome BioSciences Inc for the use and application of Genome BioSciences patent-pending positive-positive selection gene targeting technology. Under the terms of the agreement, Chemicon will have the exclusive right to utilize the technology for generating genetically modified cell lines and mice for its customers. In addition, Chemicon will retain exclusive rights to grant third-party technology sublicenses.

The positive-positive selection gene targeting technology represents the first in a series of platform technologies expected to be licensed by Chemicon for the establishment of a new functional genomics initiative focused on the development and marketing of products and custom services centered around defining gene function. Dr Rob Burgess, Genome BioSciences president, will join Chemicon as senior director of functional genomics and will oversee the implementation of gene targeting and other genomics initiatives, while remaining a director of Genome BioSciences.

“We are pleased that the alliance between Genome BioSciences and Chemicon has evolved to this extent and is now the driving force behind Chemicon’s functional genomics efforts,” says Dr Burgess. “This agreement will broaden the access that researchers around the world have to positive-positive selection gene targeting products, mouse disease model development services, and related technology.”

Contact: Serologicals Corp (678) 728-2000

 Biosite Receives FDA Clearance to Market the Triage BNP Test for Beckman Coulter’s Immunoassay Systems
Biosite Inc has received clearance from the FDA to market the Triage BNP test for Beckman Coulter’s immunoassay systems. The Triage BNP test measures B-type natriuretic peptide (BNP). The Triage BNP test for Beckman Coulter’s immunoassay systems was recently launched in Europe and is now available to customers in the United States through Biosite’s direct sales force and Fisher Healthcare. Under the terms of the agreement, Beckman Coulter will manufacture the test for Biosite, and Biosite will exclusively sell and market the product.

“With this addition to Biosite’s gold standard BNP product line, a customer can perform BNP testing using either our rapid, portable Triage MeterPlus system or any of Beckman Coulter’s automated immunoassay testing platforms, and expect standardized values,” says Kim Blickenstaff, Biosite president andCEO. “Offering this range of standardized Triage BNP assays will make it easier for patients to move between treatment environments that use either platform—from emergency departments to inpatient acute care facilities to heart failure centers to physician offices.”

Designed to provide results standardized to match Biosite’s existing portable Triage BNP Test, the newest BNP test is available for use on Beckman Coulter’s systems, including the Access and Access 2 immunoassay systems. Also compatible is the SYNCHRON LXi 725 combination chemistry and immunoassay workstation and the new high-throughput UniCel™ DxI 800 Access immunoassay system.

Biosites’s Triage BNP Test has received FDA clearances for three indications: use in the diagnosis of CHF, use in the assessment of disease severity, and use for the risk stratificaion of patients with acute coronary syndromes, all of which apply regardless of the system on which the test is performed.

Contact: Biosite (858) 455-4808

 ARUP Laboratories Named One of Fortune Magazine’s 100-Best Companies to Work For
For the second consecutive year, Salt Lake City–based Associated Regional and University Pathologists Inc (ARUP) has earned a place on Fortune magazine’s annual list of the 100-best companies to work for. ARUP placed 65 on the list, and is Utah’s only company to be included.

The survey, conducted by the Great Place to Work® Institution in San Francisco, compared data from the 304 companies asked to compete in the 2003 decision. Scoring was based primarily upon the more than 46,000 employees surveyed on such topics as benefits, practices, policies, and workplace culture.

In addition to providing its employees low-cost medical and dental insurance, ARUP also offers a variety of other benefits, such as profit sharing, life insurance, disability insurance, tuition reimbursement, medical and laboratory training, continuing education programs, a free on-site health clinic for employees and their immediate family, an on-site fitness center, and a health-and-wellness program that provides mental health, financial, and legal counseling. Additionally, ARUP is one of the few employers in Utah that offers benefits to domestic partners.

“We’re very pleased to be included alongside so many outstanding companies,” says Carl Kjeldsberg, MD, CEO and chairman of the board for ARUP. “From the start, ARUP has recognized the importance of supporting its employees in all aspects of their lives.”

ARUP’s family-friendly philosophy also allows employees to balance family, work, and school by choosing from a wide variety of flexible job schedules, including traditional hours, days, nights, weekend shifts, four- or three-day workweeks, or seven days on, seven days off.

Contact: ARUP Laboratories (801) 583-2787

ADVR Granted US Patent for Treatment of Human Papillomavirus Infections

Advanced Viral Research Corp (ADVR) has been awarded US patent number 6,670,118 entitled Method for Treating Papillomavirus Infections. The patent describes the use of AVR118 for the topical treatment of patients suffering with lesions resulting from human papillomavirus (HPV) infections, including genital warts.

HPV is a common, worldwide sexually transmitted infection. The American Social Health Association estimates there are approximately 5.5 million new cases of sexually transmitted HPV infections reported each year and at least 20 million Americans are currently infected.

 The most common clinical manifestation of HPV is warts, which are benign tumors. The most common infections caused by strains of HPV are digital and plantar warts—warts on the hands and feet—commonly seen in children. These warts represent one of the most prevalent dermatologic infections. Several strains of HPV are associated with the appearance of cervical cancer, which is one of the most common malignancies affecting women. An estimated 500,000 cases of invasive cervical cancer are diagnosed worldwide each year.

Patients suffering from immunodeficiencies, such as patients with AIDS, are particularly susceptible to infection with HPV. Disseminated HPV infection is one of the opportunistic infections complicating AIDS and is manifested by eruption of generalized, often very painful warts over the body.

“Use of AVR118 in the treatment of HPV infection is a potentially significant contribution to the therapy of a prevalent and troublesome viral infection that is responsible for much morbidity over the world. The potential of AVR118 as a therapy for disseminated HPV infection in patients with AIDS merits further clinical study,” says James T. D’Olimpio, MD, a clinical consultant to ADVR.

ADVR’s AVR118 represents a biopolymer chemistry that processes novel immunomodulator activity. This peptide-nucleic acid, which has shown no indication of human toxicity to date, appears to stimulate the proinflammatory responses required to combat viral infections, such as AIDS and human papillomavirus, and to dampen aberrant autoimmune-type inflammatory responses, such as those that occur in patients with rheumatoid arthritis. AVR118 is in clinical trials in Israel for the treatment of cachexia in patients with AIDS.

Contact: Advanced Viral Research Corp (914) 376-7383

 Pall Helps Thai Red Cross Reduce Shortages of Equine Antirabies Immunoglobulins
With an advanced purification technology from Pall Corp, the Thai Red Cross Society has increased production and purity of equine antirabies immunoglobulins (ERIG) used to cure rabies in humans. Postexposure treatment of rabies with antirabies immunoglobulins is still very important in order to reduce deaths in Thailand. Many companies in Europe have stopped production of equine rabies immunoglobulins and products are in short supply to hospitals. Pall’s automated ultrafiltration technology reduces the time it takes to purify immunoglobulins from 1 week to 1 day, while increasing yield levels. The new technology enables Thailand to supply ERIG to the Centers for Disease Control in Thailand.

Pall’s purification technology was part of a $4.5 million modernization of the Queen Saovabha Memorial Institute (QSMI), in Bangkok, Thailand, the manufacturing facility of the Thai Red Cross. The modernization makes the institute the first good manufacturing practices (GMP)-compliant biologics facility in Thailand, and it recently received GMP certification from the Thai Food and Drug Administration.

“Pall engineered an innovative purification process that will enable the Thai Red Cross to produce and distribute more than 100,000 doses of equine antirabies immmunoglobulins per year, in addition to other critical medicines,” says John Westbrook, Pall Corp’s managing director in Thailand. “This reinforces Thailand’s leadership position in biological manufacturing in Southeast Asia.”

In addition to equine antirabies immunoglobulins and snake antivenoms for poisonous snake bites, the QSMI produces BCG (a tuberculosis vaccine) and tuberculin solutions used for TB skin tests.

Pall’s purification technology uses specific filtration media to separate undesirable proteins from the immunoglobulin complex used to make both equine antirabies and antivenom immunoglobulins. The centerpiece of the Institute’s modernization is the incorporation of Pall’s Centrasette™ 5 (C5) tangential flow filtration system. It replaces the dialysis bags and tubing that were used to remove contaminants from the immunoglobulins. The C5 system is automated and significantly accelerates removal of unwanted proteins and salts. The system is fully compliant with GMP and current good manufacturing practices guidelines and enables QSMI to achieve higher purity levels.

Equine antirabies and snake antivenom immunoglobulins are produced by immunizing horses with low concentrations of rabies vaccines and snake venoms. The antibodies produced in the blood of these horses are then purified and further sterile-filtered according to GMP serum production.

Contact: Pall Corp (516) 801-9104

Mayo Clinic Receives $10 Million from Philanthropists

For the first time in the institution’s history, the Mayo Clinic received a $10 million donation for its Alzheimer’s disease research fund. The gifts form the largest contribution the Mayo Clinic has received at one time for its Alzheimer’s disease research.

Edward and Lesley Phillips, the son and daughter-in-law of “Dear Abby” advice columnist, Abigail Van Buren, donated a portion of the sum. The other family wishes to remain anonymous.

 This funding will enable Mayo to accelerate its research and understanding of Alzheimer’s disease and ultimately to develop effective treatments. “We are enormously grateful for the generosity of these families,” says Denis Cortese, MD, president and CEO, Mayo Clinic. “Clearly, these families believe in the mission of Mayo Clinic—to heal the sick and advance the science—and their support will enable us to realize significant achievements.”

The gifts will be used for three multifaceted research initiatives and to recruit and evaluate a large group of elderly Rochester, NY residents.

“We will address important aspects of Alzheimer’s disease research using resources that Mayo Clinic can uniquely bring to bear through our basic science and clinical capabilities,” says Ronald C. Petersen, MD, PhD, Alzheimer’s disease research leader, Mayo Clinic. “This generous gift will aid us immeasurably as we seek to identify therapeutic targets for Alzheimer’s disease, drugs that hit those targets, and animal models in which to do preclinical testing to evaluate therapeutic efficacy. The resources made available through this gift will enable the research teams to approach this challenging task coordinately.”

Contact: Mayo Clinic (507) 284-5005

Tips to Safely Store and Transport Medical Equipment
Zero Manufacturing recently released a discussion of factors that should be taken into account when developing or purchasing cases for housing sensitive medical devices and equipment.

“Many people in the medical community feel that cases, trays, and other equipment enclosures are relatively standard items,” says Don Saak, business and development director for Zero Manufacturing (North Salt Lake, Utah). “The fact is that custom cases are not only practical, but are often critical for the protection, performance, and efficient use of the equipment they contain.”

What criteria should manufacturers and users of medical equipment consider in the specification of cases for their products? While that depends on specific applications and the sensitivity of case contents, Saak identifies five “rules of the road” for specifying medical cases.

• Choose appropriate case materials:
Typically, the choice is between metal, plastic, or aluminum. Each offer benefits, however each have limitations. It is important to realize the demands you plan to place on your case before deciding on a material.

• Consider short-term and future costs:
While the choice of case materials has a definite impact on cost, the true economics depend primarily on the manufacturing process involved. This amplifies the importance of choosing the appropriate materials for your case. Factor in such details as mode of transport and climate exposure.

• Look for a turnkey solution:
There are responsibility and quality issues when a company chooses to outsource secondary operations, and it creates extra work that will likely affect costs.

• Appearance matters:
Specific colors, logos, warnings, and other body graphics may be required on the case exterior, and specific case handles, feet, and other attachments may require aesthetic, as well as functional consideration.

• Weigh postsale support needs:
Medical instruments and other devices change over time, as do kits and systems that are transported or stored in cases. It is often beneficial to have a supplier who can reconfigure or even re-engineer your case without going back to square one.

Contact: Zero Manufacturing (801) 298-5900

 SurgiLance One-Step Ruled a Patent Infringement

The federal court in Atlanta has entered an order in a patent infringement suit brought by Owen Mumford USA against SurgiLance Inc and SurgiLance PTE Ltd. The court held that the SurgiLance One-Step blood-sampling device infringes an Owen Mumford patent covering a design for blood-sampling devices.

The court concluded in September that SurgiLance’s One-Step blood-sampling device contains each element found in Owen Mumford’s US Patent No. 4,869,249. Following this decision, the only issue remaining for further proceedings in the district court is a determination, based on whether the infringement was willful, of the amount of damages Owen Mumford USA will be awarded. The decision will influence the entry of an injunction to stop SurgiLance Inc, the domestic distributor of the One-Step, and its Singapore-based parent corporation, SurgiLance PTE Ltd, from importing, selling, and offering to sell One-Step in the United States.

According to Owen Mumford President Robert Shaw, SurgiLance was asked by Owen Mumford to stop selling the licensed product; however, SurgiLance would not do so voluntarily.

Contact: Owen Mumford USA (800) 421-6936

Beckman Coulter Signs Agreement With Clinton Foundation to Offer AIDS Testing
During a press conference at the William J. Clinton Presidential Foundation in New York City, Beckman Coulter Inc signed an agreement to participate in a program to supply HIV and AIDS-related products to certain developing countries. Through this agreement, Beckman Coulter will provide a package specifically designed for use in resource-poor areas. The package includes COULTER® EPICS™ XL flow cytometer and an AIDS test. The company expects to begin delivering instruments and tests as early as April of this year.

“We were pleased when the Clinton Foundation approached us to participate in this HIV and AIDS prevention and treatment program. They have made tremendous progress in their effort to assist the developing world in combating the AIDS crisis,” says Bonnie Anderson, vice president of Beckman Coulter’s Translational Solutions Business Center. “This opportunity has expedited our plans to take the AIDS test we licensed from the National Health Laboratory Service (NHLS) in South Africa and deliver it to millions of individuals whose conditions might not otherwise be monitored.”

In addition to the traditional fees and royalties Beckman Coulter agreed to with the NHLS, the company will pay a royalty to the NHLS Research Trust Fund for AIDS Research.

Contact: Beckman Coulter Inc (714) 773-7655

BDS International Signs Agreement With i-Stat Corp
BDS International Diagnostics GmbH and i-Stat Corp have signed an agreement under which BDS will support i-Stat Corp’s current drive to establish its own sales organizations and distributor network.

i-Stat Corp manufactures point-of-care diagnostic systems for blood analysis. The i-Stat® System offers a comprehensive suite of tests, including blood gas analysis, hematocrit, electrolytes, chemistry, ACT, and Troponin I.

BDS International’s “Bridgehead” services help IVD and medical device suppliers establish a foothold in international markets. Services include searching, screening, selecting, training, and managing a network of distributors throughout an agreed-upon territory.

Under the agreement with i-Stat Corp, BDS International will be responsible for identifying, establishing, and supporting new i-Stat distributors in certain countries of Europe, the Middle East, and Africa.

According to Bruce Basarab, executive vice president of Commercial Operations at i-Stat Corp. “i-Stat is currently establishing its own global sales and marketing presence, including an i-Stat Europe office, to ensure that in 2004 and beyond we can professionally support our customer base in that part of the world and continue to expand our sales and distribution network. Our product offering is already well accepted in the European and Middle Eastern markets, and in BDS we have a team of professionals who share our philosophy of quality and service.”

Contact: BDS International Diagnostics GmbH (011) 49-6202-9377-0