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Lankenau Institute for Medical Research innovation will be used to assist global efforts to further eradicate polio

January 22, 2020 Research News

Antibodies cloned by a team at the Lankenau Institute for Medical Research (LIMR), the research division of Main Line Health, and colleagues recently were adopted globally as the standard batch quality-control test for Sabin polio vaccines.

This means that, in the future, everyone around the world who gets a polio vaccine will receive doses whose quality and potency has been assured by the work done by LIMR Professor Scott Dessain, MD, PhD, his lab team, and colleagues from the U.S. Food and Drug Administration (FDA) and the Global Virus Network Center of Excellence in Baltimore.

“This important achievement by LIMR’s Dr. Dessain and his colleagues significantly advances worldwide polio-eradication efforts,” said George Prendergast, PhD, president and CEO of LIMR. “Dr. Dessain’s accomplishments in this effort attest to his many years studying methods to clone human monoclonal antibodies for medicinal purposes.”

Following worldwide vaccination efforts in recent decades, the annual number of polio cases has decreased markedly, from about 350,000 in 1988 to only 138 in 2018, according to the World Health Organization. The decrease has been attributed to the widespread administration of inactivated poliovirus vaccines (IPVs).

To meet the world’s ongoing demand for vaccines and minimize risks of reintroduction of wild strains of the poliovirus into circulation, several manufacturers began making IPVs from attenuated (or reduced) Sabin strains of the virus.

“That raised several new challenges,” said Dr. Dessain who serves as director of the Center for Human Antibody Technology at LIMR and holds the Joseph and Ray Gordon Chair in Clinical Oncology and Research. “Immunological differences exist between wild type and attenuated Sabin strains, leading to important questions about how to determine the potency of the new vaccines.”

One complication entails variability among the labs that are testing for vaccine potency, because not all labs use the exact same assay. To solve this challenge, Dr. Dessain and his team set out to select antibodies that would react equally with wild and Sabin strains, so the resulting protocol would be suitable for measuring potency of both conventional IPVs and Sabin IPVs.

Instead of using antibodies derived from mice, as other researchers had done, the Dessain team used human monoclonal antibodies cloned from volunteers who had received polio vaccination and who consented to the study. The antibodies were isolated by Rama Devudu Puligedda, PhD, who works in Dr. Dessain’s LIMR lab.

“Our assay is suitable for use to measure potency of conventional IPVs and Sabin IPVs, each against its own international standard,” explained Dr. Puligedda. “We’re pleased that the monoclonal antibodies we developed can be used to create a sustainable supply of reagents for determining potency of both types of IPV. These reagents harmonize the assay globally and make it unnecessary for every manufacturer to go through the tedious assay development and validation process.”

After identifying a panel of specific antibodies, the Dessain team shared those with Drs. Konstantin Chumakov and Diana Kouiavskaia at the FDA’s Center for Biologics Evaluation and Research, Silver Spring, Md. Dr. Chumakov is an internationally known poliovirus researcher and a member of the Global Virus Network Center of Excellence. Drs. Chumakov and Kouiavskaia have collaborated with the Dessain lab on four published manuscripts in the past six years, and they performed the antibody validation studies reported in the manuscript “Universal ELISA for quantification of D-antigen in inactivated poliovirus vaccines,” published recently in the Journal of Virological Methods.

The antibodies used in the test were cloned at LIMR and will be stored and distributed by the National Institute for Biological Standards and Control (NIBSC) in the United Kingdom. NIBSC plays a leading role in preparing, evaluating and distributing international biological standards and other reference materials, supplying more than 90 percent of these for the World Health Organization. The team’s work was funded by the PATH Foundation, a nonprofit global health organization based in Seattle.

About Main Line Health

Founded in 1985,Main Line Health is a not-for-profit health system serving portions of Philadelphia and its western suburbs. Main Line Health’s commitment—to deliver advanced medicine to treat and cure disease while also playing an important role in prevention and disease management as well as training physicians and other health care providers—reflects our intent to keep our community and ourselves well ahead. A team of more than 10,000 employees and 2,000 physicians care for patients throughout the Main Line Health system.

At Main Line Health’s core are four of the region’s most respected acute care hospitals—Lankenau Medical Center, Bryn Mawr Hospital, Paoli Hospital and Riddle Hospital—as well as one of the nation’s recognized facilities for rehabilitative medicine, Bryn Mawr Rehabilitation Hospital.

Main Line Health also includes Mirmont Treatment Center for drug and alcohol recovery; Main Line Health HomeCare & Hospice, which includes skilled home health care, hospice and home infusion services; Main Line Health Centers, primary and specialty care, lab and radiology, and other outpatient services located in Broomall, Collegeville, Concordville, Exton, King of Prussia and Newtown Square; Lankenau Institute for Medical Research, a biomedical research organization; and Main Line HealthCare,one of the region’s largest multispecialty physician networks.

Main Line Health is the recipient of numerous awards for quality care and service, including System Magnet® designation, the nation’s highest distinction for nursing excellence and the Mid-Atlantic Alliance for Performance Excellence (MAAPE) Excellence Award. Main Line Health is committed to creating an environment of diversity, respect and inclusion and has proudly embraced the American Hospital Association’s #123forEquity Pledge to Act to eliminate disparities in care. We are dedicated to advancing patient-centered care, education and research to help our community stay healthy.

About Lankenau Institute for Medical Research

Lankenau Institute for Medical Research (LIMR) is a nonprofit biomedical research institute located on the campus of Lankenau Medical Center and is part of Main Line Health. Founded in 1927, LIMR’s mission is to improve human health and well-being. Faculty and staff are devoted to advancing innovative new approaches to formidable medical challenges, including cancer, cardiovascular disease, gastrointestinal disorders and autoimmune diseases, such as diabetes and arthritis. LIMR’s principal investigators conduct basic, preclinical and translational research, using their findings to explore ways to improve disease detection, diagnosis, treatment and prevention. They are committed to extending the boundaries of human health through technology transfer and training of the next generation of scientists and physicians.