Lankenau Institute for Medical Research innovation will be used to assist global efforts to further eradicate polio
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
Main Line Health® is a not-for-profit health system serving the greater Philadelphia region. The System comprises five hospitals, seven health centers, more than 160 outpatient and physician practice locations, over 14,500 employees and more than 2,200 employed and independent physicians and advanced practice providers.
Founded in 1985, Main Line Health includes four of the region’s most respected acute care hospitals — Lankenau Medical Center, Bryn Mawr Hospital, Paoli Hospital and Riddle Hospital — as well as Bryn Mawr Rehab Hospital, one of the nation’s premier facilities for rehabilitative medicine. The System also includes Mirmont Treatment Center, which provides treatment and support for substance use disorders; Main Line Health HomeCare & Hospice; Main Line HealthCare, its employed multispecialty physician network; Lankenau Institute for Medical Research, a leading biomedical research organization; and Main Line Health Centers offering primary and specialty care, lab, radiology and other outpatient services in Broomall, Collegeville, Concordville, Devon, Exton, King of Prussia and Newtown Square.
Main Line Health brings together physicians, advanced practice providers, nurses, researchers and other healthcare professionals across a broad network of inpatient, outpatient, home-based and community-based services. Through this integrated approach, the System delivers high-quality, comprehensive care across the continuum — from primary care and preventive services to complex specialty, surgical, trauma, emergency, rehabilitative, behavioral health, home care and hospice services — with a focus on making care accessible in the communities where people live and work.
Main Line Health also collaborates with leading clinical partners to expand access to specialized care. Through its affiliation with Children's Hospital of Philadelphia, pediatric care is provided at select Main Line Health locations, including neonatal intensive care units at its acute care hospitals and Bryn Mawr Hospital’s Inpatient Pediatric Unit and Emergency Department. Jefferson Health neurosurgeons and neurointerventionalists also provide 24/7 specialized care, including neurointervention and lifesaving stroke care.
About Lankenau Institute for Medical Research
Lankenau Institute for Medical Research (LIMR), part of Main Line Health, is a nonprofit biomedical research institute on the campus of Lankenau Medical Center celebrating its landmark 100th anniversary of scientific accomplishment in Fall 1927. LIMR's mission is to improve human health and well-being. Through its ACAPRENEURIAL™ organizational model, which integrates academic and entrepreneurial approaches, LIMR faculty and staff advance innovative strategies to address formidable medical challenges including cancer, cardiovascular disease, tissue regeneration, gastrointestinal disorders and autoimmune diseases such as rheumatoid arthritis. LIMR's principal investigators conduct basic, preclinical and clinical research, using their findings to improve disease detection, diagnosis, treatment and prevention. They are committed to extending the boundaries of human health through technology transfer and training the next generation of scientists and physicians.