Sector Call Summaries: Tissue Engineering (2020)
1) SCB Updates
Staff shared key SCB accomplishments from the past year
2) Landscape and Needed Standards Report feedback
Landscape Report feedback:
Add information on which standards are formally/informally FDA-recognized
Include more about framework of how SDOs are involved with SCB
Add more about implementation—how to do so, include links to relevant publications beyond the standards themselves
Add new sorting methods: types of products, processes, materials, equipment, quality/testing issues, supply chain
Capture search results for a pull-down menu of common terms
Include links to relevant documents, places standards can be purchased
Needed Standards Report feedback:
The tissue engineering sector working group identified several ways to revise this report to make it more user-friendly and valuable, including adding standards needs related to:
Lexicon/terminology for tissue engineering terms to have a common language
Equipment monitoring for industrial equipment used in tissue engineering
Standards for correlation of decellularization measurements and clinical outcomes
3) SCB Project Updates
Shared project updates specific to the tissue engineering sector
4) Communications Feedback
Invited feedback on ways to improve communication with stakeholders
5) Workshop/Courses
SCB is planning future workshop opportunities focused around standards for tissue engineering. Possible topics include:
Characterization and testing of cellularized/deceullurized products and how to implement standards around this process.
Validation, fit-for-purpose for RMTM and incorporating these methods into the manufacturing process
Measurement and product performance: how to incorporate standards to measure real-world scenarios.
Lexicon/terminology workshop
The new open ballots page was also shared.
6) Other Business
1) COVID-19 UPDATES
Staff provided an update on plans to reschedule in-person SCB-hosted events from summer/fall to later in winter/spring
Shared updates from major standards developing organizations (SDOs), including virtual events and free access to standards relevant to COVID-19
2) SCB UPDATES
Shared key SCB accomplishments from the past year
3) PROJECT UPDATES
Shared project updates specific to the tissue engineering sector
4) IN-DEVELOPMENT STANDARDS
Provided updates on current in-development standards in need of expert input
5) TISSUE ENGINEERING LEXICON
Staff asked participants for input on an SCB and BioFabUSA-led revision of a tissue engineering lexicon (ASTM 2312).
Participant feedback on tissue engineering terms in need of consensus:
Terms to Define
Accessories for vat polymerization and other non-extrusion methods
Biomodels
Biopolymer
Cell analysis and cell counting terms (e.g., viability)
Continuous manufacturing
Decellularization
Organoids
Tissue
Commonly Confused Terms to Distinguish
Biofabrication/bioprinting/bioink
Closed operations/open operations
Embedded/imbedded
Gel/hydrogel/cryogel
Repeatability/reproducibility
Ruggedness/robustness
Scale up/scale out
Scaffolds/constructs
Small batch/large batch
Upstream manufacturing/downstream manufacturing
1) SCB News
Staff shared news about upcoming offerings, including standards implementation courses, planned feasibility reports, planned updates to the Regenerative Medicine Standards Landscape report, and a rapid microbial testing article that will be published in Cytotherapy journal.
2) Tissue Engineering Standards Updates
Shared project updates specific to the tissue engineering sector
3) Identification and Prioritization of Needed Standards
Participants looked at Impact/Urgency ratings of standards from the Community Perspectives: Needed Standards in Regenerative Medicine report and provided suggested changes.
Participants also suggested additional standards needs to add to the report.
SCB will distribute a survey to gather additional feedback on these topics.
4) Upcoming Annual Meeting and SDO Forum
SCB is planning an annual meeting for January 2021 to inform the public about published and in-development standards, increase engagement with standards, and solicit input on standards needs.
There will be a meeting among SDO representatives in November to discuss current standards efforts under way and harmonize efforts, as well as focus on next steps for addressing community-identified needs.
1) SCB UPdates
Staff shared recent updates, including:
Upcoming projects including feasibility assessments, training for regenerative medicine standards implementation, and updating the Regenerative Medicine Standards Landscape report to be an interactive, searchable portal
Plans to hire additional staff to help with upcoming initiatives
2) Cell Therapy Standards Updates
Shared project updates specific to the tissue engineering therapy sector
3) Identification and Prioritization of Needed Standards
Participants provided feedback on:
The functional areas with the greatest impact and urgency in the field
The standards areas with the greatest impact and urgency in the field
Which standards areas have the greatest community support
Which standards areas have the greatest scientific consensus
Participants also suggested additional standards needs to add to the report.
SCB will distribute a survey to gather additional feedback on these topics.
4) Upcoming Annual Meeting and SDO Forum
SCB is planning an annual meeting for January 2021 to:
Inform the public about published and in-development standards
Identify and prioritize needed standards
Increase engagement with standards
Answer questions on standards implementation