Nexight Group and SCB Hold Second Webinar on Regenerative Medicine Standards

Washington, DC (March 13, 2018) — Nexight Group and SCB today held their second webinar aimed at increasing the awareness of available and potential standards and the benefits they can bring to the regenerative medicine community. As part of the FDA-funded project to identify process recommendations and criteria to identify and prioritize standards needs and advance standards for regenerative medicine therapies, the Overview Of Standards For The Regenerative Medicine Landscape webinar featured an overview of the landscape of available standards and a case study on sterility testing requirements.

SCB’s Technical Program Manager Dawn Henke began the webinar by offering highlights from the report, The Regenerative Medicine Standards Landscape. Published in late February by Nexight Group and SCB, the report was developed with input from more than 30 academic institutions, standards development organizations, and other industry experts. Henke reviewed the types of standards relevant to regenerative medicine and shared the consensus input from the interviewed and surveyed regenerative medicine experts, including an overview of the existing standards in the field and current gaps and needs for standards development across the community.

Jacqueline Wolfrum, Assistant Director of the MIT Center for Biomedical Innovation’s BioMANufacturing (BIOMAN) Program, followed Henke’s presentation with a case study outlining lessons learned from the 2012 revisions of 21 CFR 610.12 sterility test requirements. When these requirements were revised in 2012, references to specific test methods were removed—instead, general guidelines were put in place that encouraged the use of the most appropriate and state-of-the-art test methods. Wolfrum emphasized that this choice effectively enhanced sterility testing while promoting innovation. It is now enabling the development of new standards and best practices as rapid microbial test methods advance.

Nexight Group and SCB will be holding a third webinar on regenerative medicine standards development on June 26, 2018 at 12 pm ET. To attend future webinars or to learn more about how you can get involved in regenerative medicine standards development, contact SCB or sign up for our monthly e-newsletter (below).