Project Working Groups

SCB’s project working groups are collaborative forums where technical experts and relevant stakeholders discuss and address standards needs identified by the regenerative medicine community. Members work together to develop outputs such as feasibility studies, standards drafts, and white papers, or coordinate data generation activities such as round robin testing.

Learn more about participating in an SCB project working group:

Working Group Opportunities

Bold status indicates input/participation is needed

PROJECT TITLE CURRENT STATUS
Chain of Custody/Chain of Identity Accepting new working group members
Determining and Interpreting Cell Viability Accepting new working group members
Evaluating Pre-existing Immunity to Adeno-Associated Viruses Accepting new working group members
Methods and Processes for Assessing Cell Identity Accepting new working group members
Off-Target Effect Analyses for Gene Editing Products Accepting new working group members
Rapid Microbial Testing Methods Accepting new working group members
Specifications for Bioinks and Bioprinters Accepting new working group members
Tissue Engineering Lexicon Accepting new working group members
Treatment Center Data Management Standards Accepting new working group members
Cell Collection Standards for Cell and Gene Therapies In progress: additional input TBD
Viral Vector Functional Titer Assessment and Quantification In progress: additional input TBD
Ancillary Materials Used in Cellular Therapy Production Publication pending: additional needs TBD
Base Labeling Requirements for Apheresis Products for Regenerative Medicine Manufacturing Standard published: additional needs TBD
Characterization of Fiber-Based Scaffolds Standard published: additional needs TBD
Characterization of Human Cells for Therapeutic Use Standard published: additional needs TBD
Cryopreservation of Cells (PDA-led project) Standard published: additional needs TBD
General Guidance on Cell Counting Standard published: additional needs TBD
Microphysiological Systems Standard published: additional needs TBD
Requirements for Cell Therapy Manufacturing Equipment Standard published: additional needs TBD
Transportation Requirements of Cells for Therapeutic Use Standard published: additional needs TBD

PROJECT PROPOSAL PROCESS

SCB reviews and accepts projects that span the priorities of the SCB consortium under the four working groups: cell-based drug discovery, cell therapy, gene therapy, and tissue engineering. Each working group seeks to identify and assess needs for standards or best practices that can support advances in enabling technologies and infrastructure, clinical development, and commercialization. Learn more:

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