October 24, 2023

Discussion with VCAT on CETs: 

Biotechnology

Dr. Christopher Szakal

Acting Director

NIST Program Coordination 

Office

Dr. Sheng Lin-Gibson

Chief

NIST Biosystems and 

Biomaterials Division
Recent USG Biotechnology 

Policy and Actions

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Why Now? What’s Driving the Bioeconomy?

Recognition that biotechnology and 

biomanufacturing provide solutions 

to pressing societal issues related to 

human health, climate, food security, 

and others.

Biotechnology*: technology that 

applies to and/or is enabled by life 

sciences innovation or product 

development

Biomanufacturing*: the use of 

biological systems to produce goods 

and services at commercial scale

*https://www.nist.gov/bioscience/nist- bioeconomy-lexicon

https://ebrc.org/focus-areas/roadmapping/engineering-biology-2019/
Executive Order 14081 Signed Sept. 12, 2022

National Security Council (NSC)-led effort 

across two Administrations intended to 

launch major National Biotechnology 

and Biomanufacturing Initiative

Whole-of-government approach to 

advance biotechnology and 

biomanufacturing towards innovative 

solutions 

NIST “at the table” from the beginning, 

played a key role in its development, and 

continues to support its implementation 

https://www.whitehouse.gov/briefing-room/presidentialactions/2022/09/12/executive-order-on-advancing-biotechnology-andbiomanufacturing-innovation-for-a-sustainable-safe-and-secure-american-bioeconomy/

Advancing Biotechnology and 

Biomanufacturing Innovation for a 

Sustainable, Safe, and Secure American 

Bioeconomy
“Harness the power of biology to create services and products, provide opportunities to 

grow the U.S. economy/workforce, and improve the quality of our lives/environment.”

NIST technical strengths align with E.O. R&D focus

Enable unprecedented innovation 

through predictive engineering of 

biological systems and parts

Unlock the power of biological data 

through innovation; enhance data 

privacy and security

Advance technologies to enable at 

scale production of bioproducts

Engineering Biology Biomanufacturing Biological data + AI
E.O. 14081: Key Sections

• Harnessing Biotech. & Biomfg. R&D 

• Data for the Bioeconomy

• Build Domestic Biomanufacturing

• Encourage Biobased Products

• Strengthen Biotech. Workforce

• Clarify Biotech. Regulation

• Advance Biosafety/Biosecurity

• Measure the Bioeconomy

• Assess Threats to Bioeconomy

• International Engagement

Areas with NIST involvement in bold
NIST Lead Role: Develop a Bioeconomy Lexicon

Developed a process for delivering 

a lexicon within the interagency 

group

Conducted an inventory of existing 

terms and definitions; identified 

additional needed terms 

Terms and definitions reviewed and 

harmonized through discussions 

with D/As to be broadly applicable 

List of terms and definition 

released to the public within 90 

days (Sept to Dec 2022) 
E.O. 14081 R&D Bold Goals 

Multiple Departments:

• Medical breakthroughs (HHS)

• Mitigating effects of climate Change 

(DOE)

• Supply chain resilience (DOC)

• Food and ag. innovation (USDA)

• Crosscutting science (NSF)

Feedback from industry and private 

sector entities, WH roundtables, RFI
NIST and DOC/OPSP Lead Role for Supply Chain 

Resilience, with Inputs from ITA, BIS, EDA, BEA

• Alternative supply chain pathways

o Critical drug supply

o Sustainable chemical production

o Accelerating development of biomanufactured

products

• Supply chain resilience

o Predictive capabilities

o Real-time biomanufacturing adjustments

o Adaptive supply chains

o Supply chain flexibility

• Standards and data infrastructure
Example Bold Goals and NIST Equities
Promoting and Protecting the U.S. Bioeconomy

Two sides of the same coin: platform 

measurements and technologies; 

standards

NIST plays key role within the USG 

to address diagnostics, testing, 

among other needs

Sequence screening -- NIST asked 

to develop standards, databases, 

and tools to help implementation 

of new guidance 
NIST Biotechnology and 

Biomanufacturing Research 

and Outreach

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• Biomolecular measurements

• Genomics and multi-omics 

measurements

• Cell measurements

• Viral and non-viral vectors

• Multiple cellular systems

Example Capabilities and Platform Technologies 

Biometrology

• Genome engineering & 

editing

• Protein engineering

• Cell line engineering 

• Cell free systems 

engineering

• Microbial engineering

• Biofabrication

Engineering Biology

• Single cell engineering & 

msmts. 

• Automation: P-CAMP, LMSF, 

library prep, microbial, Flow 

Prep

• End-to-end bioprocessing, NIST 

strain biorepository & cell lines

• Advanced data analytics, 

ML/AI, NASA/JPL IAA

Core Platforms

Engineering/Synthetic Biology via Microbial Systems

Data integration for 

modeling and prediction

Abstraction for design

Integration of parts and 

systems

Measurements and 

standards to 

understand controlled 

evolution

Synthetic biology for tissues, 

consortia, and multicellular organisms

Dynamic, programmable 

whole genome remodeling

Synthetic and minimal 

cells The 

Bioeconomy
Engineering/Synthetic Biology via Mammalian Systems

Data integration for 

modeling and prediction

Predictive on target 

genome engineering

Fit for purpose 

application via 

engineered systems

Genome Editing

Engineering of 

multicellular systems 

and tissues

The 

Bioeconomy

Engineering of cells and 

producer cells

Engineering of viral and 

nonviral gene delivery 

systems
Building a Measurement Infrastructure

Reference 

Materials

Reference 

Data

Documentary 

Standards

Calibration 

Services

Measurement 

science & 

technology 

development 
Advanced Biological Reference Materials (& More)

Genome in a 

Bottle (GIAB) 

Human DNA, 

cells, 

engineering cells

Microbial whole 

cell RMs & 

mixed DNA RMs

Fully consented 

matched cancer/ 

normal cells/DNA; 

engineered cell 

lines

Genetically 

tagged strain 

of yeast

Viruses, Viral 

vectors & 

Jurkat cells with 

different VCNs

NIST mAb & 

NIST CHO
From Laboratory Programs to Standards

Laboratory 

programs

Stakeholder 

engagement

Global 

Standards 

Leadership 

SDO: ISO, IEC, OECD, 

WHO, ASTM, PDA, etc.

SCB*: engage, coordinate, 

educate

*NIST and FDA funds SCB to jointly advance standards per 21st Century Cures Act

https://www.nist.gov/mml/bbd/standards-and-tools

NIST Core Laboratory 

Capabilities 

NIST Consortia, 

Interagency coordination, 

NMIs, NGOs & other 

strategic partnerships

In house capabilities & expertise to 

support the rapidly evolving 

biotechnology 

• Pre-competitive technology, 

measurement solutions, reference 

materials and ref. data, etc.

• Ongoing bilateral collaborations with 

LGC, NRC, INMETRO, AIST, KRISS, etc. 

• Supports innovation and commerce 

• Supports FDA’s upcoming std 

recognition program

• Supports ICH, WHO, & global regulatory 

convergence
Coordinated Standards Leadership in Biotechnologies

Catapulted NIST leadership in global 

biotechnology standards development, 

well recognized WH NSTC/OSTP, other 

agencies, and U.S. industry 

Supported all sectors of bioeconomy via 

the creation of an inclusive and 

collaborative environment for consensus 

building and standards development

Exceptional productivity and impact (40+ 

ISO stds); numerous NIST-led standards 

underpinned by the biotechnology & 

biometrology laboratory programs
Global Standards for the Bioeconomy

• Supported by Schmidt Futures and coorganized by the Engineering Biology 

Research Consortium (EBRC), Imperial 

College London, NIST, and National 

University of Singapore

• Brought together global experts to 

produce community-driven standards 

and metrics to advanced global 

bioeconomy 

• Findings will lay the groundwork for 

the establishment of open voluntary 

standards for engineering biology
NIST Consortia: Public-Private Partnerships to Address Precompetitive Challenges

NIST GENOME IN A BOTTLE 

(GIAB) CONSORTIUM 

NIST GENOME EDITING 

CONSORTIUM* 

NIST FLOW CYTOMETRY 

STANDARDS CONSORTIUM*

NIST RAPID MICROBIAL 

TESTING METHODS 

CONSORTIUM

Accelerates the adoption of 

quantitative flow cytometry 

in biomanufacturing

Formal members: 29

Develops measurement 

solutions and standards 

needed to increase 

confidence and reduce risk

Formal members: 40

Provides authoritative 

characterization of 

benchmark human 

genomes

Addresses measurements 

and standards needed to 

increase confidence in 

the use of rapid testing

Formal members: 35

https://www.nist.gov/mml/bbd

Working to expand and integrate into an Alliance 
NIST Gene Delivery 

Systems Public 

Workshop

NIST-FDA Workshops on Measurements and Standards 

for Advanced Therapy

November 1, 2023

NIST Genome Editing 

Consortium Public 

Workshop

November 2, 2023

NIST Flow Cytometry 

Standards Consortium 

Public Workshop

November 3, 2023

https://www.nist.gov/news-events/events/2023/11/nist-workshops-measurements-and-standards-advanced-therapy
Research Data Management 

(RDM) vision and goals

• Optimize outputs by 

integrating RDM across 

measurement space

• Strengthen data reuse and 

interoperability

• Enable data driven discovery 

and access

• Enable custom and/or shared 

laboratory workflows towards 

end-to-end automation

• Enable the development and 

realization of digital twin

Data for the Bioeconomy

Biotech &

Biomfg. R&D

Stakeholders

Industry – Academia – Government – Others

Domain 

Expertise & 

Partnership 

Projects,

Validation,

Benchmarks

National & 

International

Standards

Discovery Portal - Repository - Services

LIMS

HPC

Metadata

Integrated 

Architecture

Processing/Compute AI/ML

Metrology

Orchestration

Controlled Access

Data Infrastructure Data/metadata

Standards

Data software & 

tools 

Data & data 

Products

Research Data 

Management
Digital Twins for Biomanufacturing 

Derived from NIST contributions to 

ISO 23247 series of standards on ‘Digital Twin Framework for Manufacturing’

Industrial Ontologies Foundry specification from Open Applications Group Inc

• Two-way synchronization is a 

key feature in digital twins, 

compared to conventional 

modeling and simulation

• Synchronization can be eventbased or time-based

• Event-based: updates occur 

in response to an event 

• Time-based: updates occur 

from a time-stamped data 

stream

Observable Manufacturing Elements (OMEs)

Digital Twins of OMEs

Sense Actuate/

Control

Process

Analytic

Technologies

(PAT)

Emphasis on synchronization between physical and digital entities Measurements

Digital

Entities

Physical

Entities
Oligonucleotide Sequence Screening: A New Pilot

• Expand its work to develop global standards 

requiring & supporting screening practices.

• Engage with industry to identify appropriate 

features of Sequence of Concern (SOC) databases 

and engage with industry to develop clear 

expectations for screening tools

• Demonstrate performance of screening tools

• Develop enduring capabilities to evolving 

screening; support HHS Guidance and NBS Goals
NIST Laboratory 

Programs:

Measurement 

Science

Standards

Extramural 

Programs:

NIIMBL and 

Manufacturing 

USA

NIST-led 

NIST-funded 

Additional Biomanufacturing Partnerships 

• NIST and UMD partnership 

through the Institute for 

Bioscience & Biotechnology 

Research (IBBR)

• Manufacturing USA

o Sponsorship of NIIMBL

o Engagement with BioFabUSA

and BioMADE (DoD-funded)
Labs/MFG USA Biomanufacturing Collaborations

https://www.manufacturingusa.com/institutes

Manufacturing USA: Each institute is a public-private partnership that focuses on promoting robust and 

sustainable advanced manufacturing R&D; providing workforce training and education; each has a standards 

emphasis 

DOC-funded Institute: accelerate biopharmaceutical manufacturing innovation

Technical Scope: Product focus areas include cell and gene therapy as well as 

existing biopharmaceutical products

DoD-funded Institute: make practical the large-scale manufacturing of 

engineered tissues and tissue-related technologies

Technical Scope: engineered tissue-based products

DoD-funded Institute: build a sustainable, domestic end-to-end bioindustrial

manufacturing ecosystem

Technical Scope: enable domestic bioindustrial manufacturing at all scales
Big Data Project with NIIMBL

Standards to address data interoperability problems in biomanufacturing industry

NIIMBL Ontology Provides:

• A core modeling framework

• Initial terms for end-to-end 

processes

• A framework for future use 

case extensions

The NIIMBL Biopharma Ontology Architecture
 NIST continuing to play a key role in E.O. 14081 and NBS 

implementation now and in the future

Maintain focus on measurement science and standards including emerging 

biomanufacturing technologies and convergence with AI/data security

Expand NIST biotechnology and biomanufacturing programs to advance key societal 

goals outlined by the E.O. (health + climate, food/ag, energy, supply chains)

 Biotechnology will be a key growth area across NIST and DOC

Balance of U.S. economic opportunities and risks similar to CETs, semiconductors

Future of NIST Biotechnology/Biomanufacturing

https://www.whitehouse.gov/briefing-room/statements-releases/2022/09/14/fact-sheet-the-united-states-announces-new-investments-andresources-to-advance-president-bidens-national-biotechnology-and-biomanufacturing-initiative/
Proposed New Center for Biomeasurement and Biomanufacturing 

Innovation at the Institute for Bioscience and Biotechnology Research

Positions NIST and IBBR to respond to E.O. 14081 by:

Vision: 

To become a nationally recognized research center for advancing measurements, standards, 

and data to accelerate development and biomanufacturing of biotechnology products

• Leveraging Federal and State investment in state-of-the-art 

biological measurement science and standards to stimulate 

advances in biotechnology and biomanufacturing

• Actively engaging the local and national biotechnology 

ecosystem to catalyze innovation and promote the growth of 

the National bioeconomy

• Educating & training a skilled workforce and next-gen 

biotech leaders from underrepresented and diverse groups
Thank you

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