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Global Health Fund Workshop on Alternatives to Animal-based Release Testing

NEWARK, Del., April 2, 2019 — The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) will host a Global Health Fund Workshop titled Replacing Animal-based Release Testing for Vaccines on Thursday, April 18, 2019 in Arlington, VA. The workshop is open to NIIMBL members, non-members and federal scientists with knowledge of in vitro vaccine potency and toxicity tests.


This workshop will explore the current state of animal-based release testing and discuss alternative approaches. Featured speakers include Barry Buckland and Ruben Carbonell (NIIMBL); Ray Prasad (Bill & Melinda Gates Foundation); Kathy Remington (BioReliance – EMD Millipore); Bob Sitrin (PATH Center for Vaccine Innovation and Access); Robin Levis (FDA, CBER); Nicholas Mantis (Wadsworth Center); Tim Schofield (CMC Sciences); and Rebecca Sheets (Grimalkin Partners); and Ivana Knezevic (WHO). Breakout sessions will provide an opportunity for in-depth discussions focused on the following topics:



·        Vaccine potency assays

·        In vitro adventitious agent testing for vaccine release

·        Regulatory considerations for non-animal based release testing

·        Advances made by biopharmaceutical industry in non-animal based release testing



In January 2019, NIIMBL announced a $1.5M grant from the Bill & Melinda Gates Foundation to establish a Global Health Fund. The Global Health Fund supports the development of innovative technologies to reduce the cost of manufacturing biopharmaceuticals. This grant provides a valuable resource for leading scientists and subject matter experts from the NIIMBL community to develop manufacturing technology solutions that increase speed to market and lower costs for biopharmaceuticals to improve healthcare outcomes for all patients, including those in underserved markets and developing nations.

The registration fee is $150. There is no charge for federal employees. Additional details including the agenda, venue, hotel and transportation information can be found on the registration website. Those interested in attending should at

by April 12, 2019. For questions, please contact Arpan Mukherjee at

For more information on NIIMBL membership, please visit





NIIMBL is a public-private partnership with the goal of advancing innovation in biopharmaceutical manufacturing. NIIMBL is part of Manufacturing USA®, a network of 14 manufacturing institutes across the country that brings together industry, academia, and the public sector to propel promising research developments, accelerate new products to market, and train tomorrow’s workforce in order to secure America’s future. NIIMBL is funded through a cooperative agreement with the National Institute of Standards and Technology (NIST) in the U.S. Department of Commerce and leverages additional support from industry, academic institutions, non-profit organizations, and the states of Delaware, Maryland, North Carolina, and the Commonwealth of Massachusetts. The NIIMBL mission is to accelerate biopharmaceutical innovation, support the development of standards that enable more efficient and rapid manufacturing capabilities, and educate and train a world-leading biopharmaceutical manufacturing workforce, fundamentally advancing U.S. competitiveness in this industry.


Contact: Daniel Maiese, Communications Manager 302-831-3824


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