Standards Coordinating Body
Standards Coordinating Body is a non-profit that coordinates regenerative medicine standards development across industry, academia, and regulators, operating the Regenerative Medicine Standards Portal (covering 25+ organizations) and convening working groups and educational programs.
- Company typePrivate
- Founded2016
- HeadquartersGaithersburg, United States
- Headcount1–10
- GTM typeB2B
- OfferingServices
What Standards Coordinating Body does
Standards Coordinating Body (SCB) is a non-profit organization founded in 2016 and headquartered in Gaithersburg, Maryland, that serves as the primary coordinating body for regenerative medicine standards development. Its mission is to connect the regenerative medicine community—encompassing cell therapy, gene therapy, and tissue engineering stakeholders—to the standards development process, reducing fragmentation and accelerating the availability of consensus standards needed for product development and regulatory submissions.
SCB's core product is the Regenerative Medicine Standards Portal, a free, interactive database covering hundreds of standards across 25+ standards-developing organizations, including ASTM International, ISO, PDA, ASME, NIST, and ATCC. The portal allows customizable searches by keyword, sector, functional area, organization, and special designation such as FDA recognition. Beyond the portal, SCB operates Project and Sector Working Groups (convening up to 70+ experts per project), the Standards Education Institute (offering on-demand and hands-on ISO cell counting courses), Feasibility Assessments, Curated Standards Packages, and Community Publications. The organization also administers a 9-step standards development process framework and coordinates directly with the FDA and NIST to ensure its outputs are recognized in regulatory pathways such as the SRP-RMT program.
The business model is donation-based: SCB is funded through contributions accepted in any amount, with larger donations earmarked for specific Focus Areas. There is no commercial pricing for the Standards Portal (which is free to access), and course fees, if any, are not publicly disclosed. SCB is led by Executive Director Justin Barch, with co-founder Michael Mendicino serving on the board, and operates with a lean team of 1–10 employees. The organization derives its strategic value from the breadth of its community ecosystem and its neutral convener status, rather than from a commercial product surface.
Standards Coordinating Body firmographics
Firmographics- Name
- Standards Coordinating Body
- Legal name
- Standards Coordinating Body
- Website
- https://standardscoordinatingbody.org
- Company type
- Private
- Founded year
- 2016
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- Standards Coordinating Body is a non-profit that coordinates regenerative medicine standards development across industry, academia, and regulators, operating the Regenerative Medicine Standards Portal (covering 25+ organizations) and convening working groups and educational programs.
- Ownership category
- akta.pro rank
Standards Coordinating Body industry classification
Industry- Product category
- Regenerative Medicine Standards Coordination
- NAICS
- Research and Development in the Physical, Engineering, and Life Sciences (54171)
- SIC
- Services-Commercial Physical & Biological Research (8731)
- akta.pro primary industry
- Standards Development & Publishing (SDOs, Technical Standards) (MPAJACAB)
- akta.pro secondary industries
- International Standards Development & Standardization Bodies (BPADANAA), International Standards, Norms & Technical Regulatory Bodies (BPADAAAJ)
Keywords
Where Standards Coordinating Body is headquartered
LocationHeadquarters
- HQ city
- Gaithersburg
- HQ country
- United States
- HQ region
- North America
Markets served
Standards Coordinating Body business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Technology or R&D, Marketing or Sales, Others
Revenue model
- Donations and Contributions: SCB is funded through donations and contributions from supporters. The organization accepts contributions in any amount to support standards advancement efforts, with larger donations able to support specific Focus Areas.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Pay-as-you-go | Donation-based support |
Go-to-market motion2 records
Distribution channels3 records
Marketing channels7 records
Standards Coordinating Body product offering
Product offeringCore offering
Standards Coordinating Body (SCB) coordinates and accelerates the development of regenerative medicine standards across cell therapy, gene therapy, and tissue engineering. It does not publish standards itself, but operates the Regenerative Medicine Standards Portal (a searchable database covering 25+ standards bodies), convenes Project and Sector Working Groups, conducts Feasibility Assessments, curates Standards Packages, and runs the Standards Education Institute for ISO cell counting training.
Product overview
Standards Coordinating Body (SCB) operates as a coordinating body for regenerative medicine standards, offering a portfolio of interconnected products and services. The core offering is the Regenerative Medicine Standards Portal—a searchable database of standards across 25+ organizations—which serves as the central resource for the community. Complementing the portal are Standards Education Institute courses (including ISO cell counting training), Project Working Groups and Sector Working Groups that facilitate collaborative standards development, Feasibility Assessments to evaluate new standards initiatives, Curated Standards Packages for targeted access, and Community Publications aggregating industry research. SCB functions as a convener and coordinator rather than a standards developer itself, with its products designed to accelerate standards advancement and community engagement in the regenerative medicine field.
Differentiator
Problem solved
Functional benefit
Brands
- Regenerative Medicine Standards Portal: A unique, interactive database of the current regenerative medicine standards landscape offering customizable searches, at-a-glance summaries, one-click standard access, and the ability to provide feedback on areas of standards need.
Products and services
- Regenerative Medicine Standards Portal A free, interactive, searchable database of the regenerative medicine standards landscape covering hundreds of standards across 25+ standards organizations, with customizable searches by keyword, sector, functional area, standard organization, and special designation (e.g., FDA recognized, ANSI package). Designed for product developers, CDMOs, researchers, and regulators in regenerative medicine.
- Standards Education Institute (ISO Cell Counting Courses) Educational arm of SCB delivering on-demand and hands-on courses focused on ISO cell counting standards implementation for regenerative medicine professionals, including the on-demand 'Implementation of Cell Counting Standards' course, the hands-on 'iso cell counting' course, and a bundled option.
- Project Working Groups Collaborative multi-stakeholder forums where volunteers from the regenerative medicine community discuss and address specific standards needs, advancing the development of needed standards through working group participation.
- Sector Working Groups Ongoing collaborative groups organized by sector (e.g., cell therapy, gene therapy, tissue engineering) that bring together stakeholders to address sector-specific standards needs and advance coordinated standards development, supported by quarterly sector calls.
- Feasibility Assessments Expert-led assessments that evaluate the feasibility of developing new regenerative medicine standards, confirming whether proposed standards have the necessary technical foundation and community support to move forward.
- Curated Standards Packages Pre-packaged collections of regenerative medicine standards organized by topic or need, providing targeted access to relevant standards for specific regenerative medicine applications such as cryopreservation, CFU assays, or osteoinductivity measurement.
Quantifiable outcome
- Standards can reduce time to market for new therapies by providing regulators with assurance that fundamental operations are sound
- +2 more outcomes
Companies that use Standards Coordinating Body
Customer profileNamed customers6 records
Segments6 records
Ideal customer profiles5 records
Standards Coordinating Body technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature3 records
Standards Coordinating Body partnerships and signals
Strategic signalPartnerships
13 partnerships are on record, tiered core and supporting.
- ISBiotechcoreISBiotech, a professional society dedicated to the advancement of biotechnology, helped lead a working group of more than 30 experts in rapidly developing a viral gene vector reference material for Human Adenovirus 5. The group included stakeholders from industry, academia, and non-voting members from FDA.
- ASTM InternationalcoreSCB coordinates standards development projects with ASTM International, a leading international developer of codes and standards. SCB supports ASTM technical committees and helps streamline the standards advancement process.
- International Organization for Standardization (ISO)coreSCB coordinates ISO standard development efforts, including projects like ISO 24190 on risk-based framework for validation of microbial testing methods and ISO 20391 cell counting standards.
- Parenteral Drug Association (PDA)coreSCB supports PDA standards development efforts in regenerative medicine, including cryopreservation standards. PDA carries out standards development through technical committees of volunteers.
- American Society of Mechanical Engineers (ASME)coreSCB coordinates with ASME on standards development, particularly their Bioprinters Standards Committee that develops guidelines for bioprinter hardware requirements.
- U.S. Food and Drug Administration (FDA)coreFDA participates as non-voting members in working groups and as liaisons to SDOs. CBER launched the Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies (SRP-RMT) to recognize appropriate standards for facilitating product development.
- National Institute of Standards and Technology (NIST)coreNIST participates in standards development projects and research that lead to the development of standards in partnership with FDA. NIST also leads development of standards like ISO 20391 cell counting standards.
- American Type Culture Collection (ATCC)supportingATCC supplies reference materials for regenerative medicine standards, including the ATCC RSM VR-1516 Human Adenovirus 5 reference material used for characterizing adenoviral gene therapy products.
- iVexSolcoreCEO Dr. Rodney Rietze of iVexSol (vector manufacturing company) spearheads a project to develop an ISO standard for rapid microbial testing methods validation framework.
- CCRMcoreDirector Dr. Spencer Hoover of CCRM (a non-profit consortium dedicated to commercializing regenerative medicine) co-leads the RMTM standards development project.
- Cleveland CliniccoreCleveland Clinic developed an automated colony forming unit counting technique and worked with ASTM to develop a standard for automated CFU assays.
- LifeNet HealthcoreLifeNet Health, a provider of allograft bio-implants and organs for transplantation, helped develop an ASTM standard for measuring osteoinductivity of demineralized bone matrices.
- PluristyxcorePluristyx, a biotechnology company manufacturing stem cells for regenerative medicine therapies, initiated a cryopreservation standard development effort through PDA with SCB support.
Scale indicators4 records
Recent moves6 records
Expansion highlights4 records
Standards Coordinating Body competitors and assessment
Company assessmentEmerging players
- ATCC (American Type Culture Collection): Biological reference materials provider that supplied the Human Adenovirus 5 reference material (VR-1516) developed through an SCB-coordinated working group. ATCC supports standards through physical materials where SCB supports them through coordination.
- Alliance for Regenerative Medicine (ARM): Advocacy and industry group for the cell and gene therapy sector. While ARM focuses on policy and advocacy rather than standards coordination, it represents an alternative convening body for the same regenerative medicine community SCB serves.
- BioPhorum: Consortium that develops industry consensus standards and best practices for biopharmaceutical manufacturing. Comparable to SCB in its industry-coordination model but focused on broader biopharma manufacturing rather than regenerative medicine specifically.
- CCRM (Centre for Commercialization of Regenerative Medicine): Non-profit consortium dedicated to commercializing regenerative medicine that co-leads the RMTM standards development project with SCB. CCRM is a broader development/incubation entity; SCB focuses exclusively on standards coordination.
- International Society for Cell & Gene Therapy (ISCT): Professional society in cell and gene therapy that partners with SCB to deliver Standards Education Institute courses. Both engage the regenerative medicine community through education, but ISCT is membership-based while SCB is donation-funded.
Broad incumbents
- International Organization for Standardization (ISO): Global standards body with which SCB coordinates regenerative medicine projects including ISO 20391 (cell counting) and ISO 24190 (microbial testing validation). ISO is a much larger incumbent across all industries; SCB focuses narrowly on regenerative medicine coordination.
- National Institute of Standards and Technology (NIST): U.S. federal agency participating in regenerative medicine standards projects and co-developing ISO standards with FDA. NIST is a government-led R&D and standards organization with vastly larger resources than SCB.
Direct peers
- ASTM International: Leading international standards developer with which SCB directly coordinates multiple regenerative medicine projects (e.g., automated CFU assays, osteoinductivity measurement). Both operate in technical standards development, but ASTM is the publisher while SCB is the coordinator.
- American Society of Mechanical Engineers (ASME): Engineering standards body whose Bioprinters Standards Committee SCB coordinates with. Both convene volunteer technical committees to publish consensus standards, though ASME's scope is much broader across mechanical engineering.
- Parenteral Drug Association (PDA): Standards and education organization for pharmaceutical manufacturing. SCB supports PDA's regenerative medicine standards efforts (e.g., cryopreservation) and shares a similar volunteer-technical-committee model in adjacent therapeutic areas.
Market position
Strengths4 records
Weaknesses4 records
Competitive moat5 records
Key risks6 records
Key highlights6 records
Customer concentration
Standards Coordinating Body social profiles
Digital presenceStandards Coordinating Body financial estimates
Financial estimateRevenue estimate
Valuation estimate
Standards Coordinating Body leadership team
Management profileNumber of profiles
Profiles2 records
Standards Coordinating Body funding detail
Funding detailFunding overview
Funding rounds
Investors
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Standards Coordinating Body M&A and investment
M&A and investmentM&A
Investments
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Frequently asked questions about Standards Coordinating Body
What does Standards Coordinating Body do?
Standards Coordinating Body (SCB) coordinates and accelerates the development of regenerative medicine standards across cell therapy, gene therapy, and tissue engineering. It does not publish standards itself, but operates the Regenerative Medicine Standards Portal (a searchable database covering 25+ standards bodies), convenes Project and Sector Working Groups, conducts Feasibility Assessments, curates Standards Packages, and runs the Standards Education Institute for ISO cell counting training.
When was Standards Coordinating Body founded?
Standards Coordinating Body was founded in 2016. It employs 1 to 10 people.
Where is Standards Coordinating Body based?
Standards Coordinating Body is headquartered in Gaithersburg, United States, in the North America region.
How does Standards Coordinating Body make money?
One revenue line is on record: donations and Contributions.
Who are Standards Coordinating Body's main competitors?
Emerging players on record are ATCC (American Type Culture Collection), Alliance for Regenerative Medicine (ARM), BioPhorum, CCRM (Centre for Commercialization of Regenerative Medicine) and International Society for Cell & Gene Therapy (ISCT). Broad incumbents are International Organization for Standardization (ISO) and National Institute of Standards and Technology (NIST). Direct peers are ASTM International, American Society of Mechanical Engineers (ASME) and Parenteral Drug Association (PDA).
Does Standards Coordinating Body have an API?
No public API is recorded for Standards Coordinating Body.
What industry is Standards Coordinating Body in?
Standards Coordinating Body's product category is Regenerative Medicine Standards Coordination. Its primary akta.pro industry code is MPAJACAB, Standards Development & Publishing (SDOs, Technical Standards), with a secondary code of BPADANAA, International Standards Development & Standardization Bodies. Its NAICS code is 54171 and its SIC code is 8731.