Standards Advancement Continues During the Pandemic

While the COVID-19 pandemic has brought unprecedented changes to the way we live and work, the need for standards to help accelerate regenerative medicine therapy innovation is still urgent—perhaps more than ever before. SCB has modified our operating procedures to put safety first during the pandemic, and remains committed to our mission of coordinating the advancement and awareness of standards in the regenerative medicine community. As we all continue to adapt to a new way of collaborating, we wanted to highlight some of the ways standards advancement is continuing during the pandemic.

Recent and Upcoming Virtual Events

Collaborative discussions are critical to the standards advancement ecosystem. Standards developing organization (SDO) technical committee and working group meetings enable experts to build consensus regarding in-development standards, and industry events allow stakeholders to share ideas on how to meet common challenges.

Although networking and collaboration are most effective in in-person settings, virtual meetings can allow groups to safely share information and continue critical work while following social distancing practices. While some events have been cancelled or postponed during the pandemic, many have transitioned to virtual formats, including the following:

• MAY 5, 12, 19, AND JUNE 1: The ARMI | BioFabUSA Spring Summit was offered as a series of webinars featuring various speakers who had been scheduled to present at the in-person summit. Recordings of prior sessions are available to those who sign up for the event.

• MAY 28–29: ISCT 2020 Paris was held as a virtual event. Recordings will be available until May 26, 2021.

• JUNE 8–19: The ISO/TC 276 Working Group (WG) Meetings will be held as a teleconference series. WG 1 and WG3 will meet June 8–9, WG 4 will meet June 15–16, and WG 2 will meet June 18–19.

• JUNE 23–JUNE 25: The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) 2020 National Meeting will be held as a teleconference.

• COMING SOON: SCB is planning a webinar focused on ancillary materials used in regenerative medicine therapeutic manufacturing. The webinar will be facilitated by Claudia Zylberberg, CEO of Akron Biotech, among other experts.

Our events calendar provides a more comprehensive list of events of interest to the community.

Opportunities to Provide Input

SCB is continuing to coordinate standards advancement efforts via teleconferences, virtual meetings, and other electronic means. Standards need the input of experts in the community to ensure they meet the needs of everyone who they will impact. Below are some current opportunities to participate:

• Join the working group for Evaluating Pre-existing Immunity to Adeno-Associated Viruses: SCB is seeking experts on pre-existing immunity to help define the focus area for a potential standard.

• Help draft a standard on Bioprinter Software/Data Governance: SCB is looking for experts to join their Institute of Electrical and Electronics Engineers (IEEE) standard project.

• Weigh in on Tissue Engineering Terminology: SCB is coordinating multiple efforts to help standardize tissue engineering terms. We are seeking input from experts on how you use these terms in your work to help develop consensus definitions.

  • ASTM F2312, Standard Terminology Related to Tissue Engineered Medical Products (revision)

  • American Society of Mechanical Engineers (ASME) Thermal Medicine Lexicon

  • ASME Thermal Medicine Tissue Material Properties

Recent Standards Updates

As SDOs move to virtual formats for their meetings, standards efforts continue to move forward. Some recent key updates include:

• ISO/DIS 23033, General guide for the characterization and testing of cellular therapeutic products: This standard project has moved to final voting. (SCB Characterization of Human Cells for Therapeutic Use project)

• Standard Labeling for Apheresis Collection Products for Sponsor Cellular Therapy Manufacturing: This effort to update the ICCBBA ISBT 128 labeling standard has begun the review and comment phase. (SCB Base Labeling Requirements for Apheresis Products for Regenerative Medicine Manufacturing project)

• Cell Collection Standards for Cell Therapies: SCB will soon be distributing surveys for apheresis centers and industry groups on their cell collection protocols and processes to help assess aspects of the collection process that can be standardized. (SCB-coordinated project)

Get Involved

To join any of these efforts or learn about other ways you can contribute to regenerative medicine standards development, contact SCB or join the sector working group for your sector.