Experts Needed for Three SCB Working Groups
SCB seeks experts to join three of its working groups developing standards targeted at high-priority needs identified by the community.
Join the Working Groups
Each of the three SCB working groups described below is at a critical juncture where participation by additional experts will help ensure advancement to the next stage of development, ultimately leading to publication and application.
1) Cardiac and Cardiovascular Microphysiological Systems (MPS)
Purpose: Focuses on defining minimum requirements and recommendations for best practices in cardiac MPS performance, components, and documentation
Why it matters: Will help users understand what functional parameters (e.g., activity measurements, biomarkers) contribute to an MPS that accurately mimics the target tissue, allowing them to develop more effective MPS products
Expertise needed: Cardiac and cardiovascular MPS experts who have experience with the validation of MPS systems and their manufacture, use, quality, or regulatory affairs
2) Bioreactors for Regenerative Medicine Manufacturing
Purpose: Provides minimum requirements and general considerations for suppliers and users of bioreactor equipment used in the development of regenerative medicine products, including hardware, software, and connectors
Why it matters: Will promote an ecosystem of increased interoperability for bioreactor components that will make it easier for manufacturers to make changes to components as needs evolve and enable greater flexibility, efficiency, and cost-effectiveness of product development
Expertise needed: Bioreactor equipment manufacturers, cell culture experts with experience in using bioreactors, quality, or regulatory affairs
3) Development and Manufacturing of DNA and RNA Templates for Regenerative Medicine Therapies
Purpose: Will offer a flexible framework to ensure appropriate quality criteria for the manufacture of DNA and RNA templates used in regenerative medicine products, dependent on their intended use, including as starting materials or ancillary materials in the manufacturing of regenerative medicine products
Why it matters: Because there are a wide range of possible interpretations of the term “template,” it is currently unclear what set of regulatory expectations apply to the development of DNA and RNA templates. The standard will clarify applicable requirements to help manufacturers achieve optimal product quality.
Expertise needed: Template, plasmid, or oligosaccharide manufacturers; experts in molecular biology, gene synthesis or synthetic biology, DNA and RNA quantification and qualification strategies
About SCB Working Groups
SCB’s standard project working groups are collaborative forums in which technical experts and relevant stakeholders discuss and address standards needs identified by the regenerative medicine community. Working groups outline and draft standards for submission to a standards developing organization (SDO) that gathers input from the broader community and publishes the standard.
Working group membership is open to anyone who may be impacted by the standard or who has relevant technical knowledge
Participation is voluntary and has no associated fees, but may require SDO membership to view in-progress standards drafts
The level of commitment is flexible and typically involves a teleconference every 2-4 weeks with optional volunteer tasks outside of meeting times (e.g., standards drafting and revisions in response to comments)
For more information about SCB’s working groups, see the Working Groups FAQ.
Get Involved
Joining a working group has several key benefits, including:
Giving you a voice in the standards that will impact you
Helping you build relationships and increase collaboration with other regenerative medicine organizations
To join one or more of SCB’s working groups, complete this short form.