Characterization of Materials for Regulatory Submissions

Timeslot: Friday, April 29, 2022 - 1:30pm to 3:30pm
Room: Laurel A-B, 4th Floor

About

As the need for commercially-viable biomaterials grow so does an emphasis on characterization, evaluation, and commercial-scale manufacturing. Designing and developing novel biomaterials with commercial viability in mind from the beginning is key in successfully bringing materials to market. This session will highlight novel characterization approaches as well as discuss current practices in biomaterial evaluations. Presentations will also focus on material evaluation for regulatory submissions and methods of commercial-scale manufacturing. This topic would be helpful for researchers who are interested in developing their materials/devices for translational applications. We will discuss how to translate innovative research into commercial viability with a focus on: • Characterization methods for novel materials • Discussion of current regulatory approaches • Designing materials with the end goal of commercialization

Abstracts

Abstracts will be available for download on April 27, 2022.

  • 1:30:00 293. Development of Bone Slice Model to Screen Particulate Implant Materials for Osteolytic Potential, Nicholas A. Hodges(1)*, Jan P. Stege- mann(2), Eric M. Sussman(1); (1) Center for Devices and Radiological Health, FDA, Silver Spring, MD, USA, (2)University of Michigan, Department of Biomedical Engineering, Ann Arbor, MI, USA

  • 1:45:00 PM 294. SIG-005: Demonstrating Comparability between Fresh and Cryopreserved Drug Substance, Lauren Jansen, PhD(1), Janet Huang, M.S.(1), Marissa Donovan, PhD(1), Michele McAuliffe(1), Mark Lalli, PhD(1), Drew Tietz, PhD(1), Lauren Wolf, PhD(1), Martha Rook, PhD(1), Susan Drapeau, PhD(1), Kayla Klein, Chris Sparages*, Roger Harrington; (1)Sigilon Therapeutics, Inc.,Cambridge, MA, USA

  • 2:00:00 PM 295. Potency Tests, Potency and Clinical Efficacy, Carl Simon, PhD*, National Institute of Standards & Technology, Gaithersburg, MD, USA

  • 2:15:00 PM 296. Quantitative, traceable determination of cell viability using absorbance microscopy, Greta Babakhanova(1), Stephen Zimmerman(1), Laura Pierce(1), Sumona Sarkar(1), Nicholas Schaub(2), Carl Simon, Jr., PhD(1)*; (1)National Institute of Standards & Technology, Gaithersburg, MD, USA, (2)National Institutes of Health, Bethesda, MD, USA

  • 2:30:00 PM 297. In vitro Characterization of Biodegradable Photopolymerizable Polymers for Biomedical Applications, Hafiz Busari, MS*, Mathew Stanford, MS, Debra Tindall, PhD, Michael Vaughn, PhD, Poly-Med, Inc., Greenville, SC, USA

  • 2:45:00 PM 298. Assessment of Factors Impacting Material-mediated Hemolysis Results in the ASTM F756-17 Testing Standard, Cindy Liu, Qijin Lu*, Shelby Skoog, Nidhi Kalaria, Richard Malinauskas, US Food and Drug Administration

  • 3:00:00 PM 299. In-vitro test methods to screen materials for susceptibility to third body wear and quantification of metal ions and particulate debris for implanted metal devices, Arindam Paul(1), Lauren Ickes(1,2), Alexander Nguyen(1), Paul Turner(1), Diane Smith(1), Eric M. Sussman(1), Sherrill Lathrop Blitzer(1)*; (1)US Food and Drug Administration, Center for Devices and Radiological Health, Silver Spring, MD, (2)The Department of Biomedical Engineering, University of Akron, OH, USA

  • 3:15:00 PM 300. Evaluation of Alternative Materials for Personal Respirators Using a Novel Low-Cost Evaluation Device, Quinton Burke, B.S.*, Kevin Aroom, M.S., P.E., Martha Wang, Ph.D., Robert E. Fishchell Institute for Biomedical Devices, University of Maryland, College Park, MD, USA