Closed-loop systems for plants expressing animal proteins: a modernized framework to safeguard the future of agricultural innovation

Escalating population growth and climate change pressures on crop production necessitate agricultural innovation to ensure food security and sustainability. Plant molecular farming (PMF), which uses genetically modified (GM) plants to produce high-value proteins for food products, offers a promising...

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Main Authors: Kristin A. Bresnahan, Justin M. Ferber, J. Thomas Carrato, Thomas J. Stoddard, Patrick V. Palad, Magi Richani
Format: Article
Language:English
Published: Frontiers Media S.A. 2025-01-01
Series:Frontiers in Plant Science
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Online Access:https://www.frontiersin.org/articles/10.3389/fpls.2025.1426290/full
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author Kristin A. Bresnahan
Justin M. Ferber
J. Thomas Carrato
Thomas J. Stoddard
Patrick V. Palad
Magi Richani
author_facet Kristin A. Bresnahan
Justin M. Ferber
J. Thomas Carrato
Thomas J. Stoddard
Patrick V. Palad
Magi Richani
author_sort Kristin A. Bresnahan
collection DOAJ
description Escalating population growth and climate change pressures on crop production necessitate agricultural innovation to ensure food security and sustainability. Plant molecular farming (PMF), which uses genetically modified (GM) plants to produce high-value proteins for food products, offers a promising solution. PMF products, particularly those that express an animal protein in seed and grain crops, have the potential to substantially benefit U.S. and global agriculture, food systems, economies, and the environment. Farmers can diversify and generate increased revenue streams, while consumers gain access to affordable proteins beyond those currently available. However, the development and commercialization of PMF products, especially those expressing allergenic animal proteins, require careful consideration of existing stewardship guidelines and best practices. Current GM plant stewardship practices must be thoroughly assessed to identify and address any gaps, ensuring that PMF products maintain identity preservation and containment throughout their lifecycle. Implementing a fit-for-purpose closed-loop system (CLS) is crucial for effectively identifying, managing, and mitigating the potential risks and liabilities associated with PMF product development, production, and processing. A CLS framework for PMF products expressing animal proteins should integrate existing best practices from Excellence Through Stewardship and applicable third-party guidelines, including by way of example ISO standards, Good Manufacturing Practices, Hazard Analysis and Risk-Based Preventive Controls, Hazard Analysis and Critical Control Points, and Safe Quality Food, as well as newly designed controls to address potential PMF-specific risks. This comprehensive approach maximizes containment, identity preservation, regulatory compliance, traceability, incident response capabilities, and continuous improvement across the product lifecycle. While customization is required based on each PMF product developer’s specific product and operations, this paper examines industry best practices and describes CLS components that a PMF developer should consider in designing a robust, bespoke CLS to maintain identity preservation and product containment. Such a system will optimize for product quality and integrity while preventing commingling with commodity supplies and any associated market disruption while also addressing food safety. By implementing these rigorous systems, the PMF industry can realize its potential to contribute significantly to sustainable agriculture and food security.
format Article
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language English
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spelling doaj-art-7f74c89b4bca4fb591dd29794c9287642025-01-30T06:22:17ZengFrontiers Media S.A.Frontiers in Plant Science1664-462X2025-01-011610.3389/fpls.2025.14262901426290Closed-loop systems for plants expressing animal proteins: a modernized framework to safeguard the future of agricultural innovationKristin A. Bresnahan0Justin M. Ferber1J. Thomas Carrato2Thomas J. Stoddard3Patrick V. Palad4Magi Richani5Alpine Bio, South San Francisco, CA, United StatesAlpine Bio, South San Francisco, CA, United StatesCreative Biotech Solutions Limited Liability Corporation (LLC), Monterey, CA, United StatesAlpine Bio, South San Francisco, CA, United StatesAlpine Bio, South San Francisco, CA, United StatesAlpine Bio, South San Francisco, CA, United StatesEscalating population growth and climate change pressures on crop production necessitate agricultural innovation to ensure food security and sustainability. Plant molecular farming (PMF), which uses genetically modified (GM) plants to produce high-value proteins for food products, offers a promising solution. PMF products, particularly those that express an animal protein in seed and grain crops, have the potential to substantially benefit U.S. and global agriculture, food systems, economies, and the environment. Farmers can diversify and generate increased revenue streams, while consumers gain access to affordable proteins beyond those currently available. However, the development and commercialization of PMF products, especially those expressing allergenic animal proteins, require careful consideration of existing stewardship guidelines and best practices. Current GM plant stewardship practices must be thoroughly assessed to identify and address any gaps, ensuring that PMF products maintain identity preservation and containment throughout their lifecycle. Implementing a fit-for-purpose closed-loop system (CLS) is crucial for effectively identifying, managing, and mitigating the potential risks and liabilities associated with PMF product development, production, and processing. A CLS framework for PMF products expressing animal proteins should integrate existing best practices from Excellence Through Stewardship and applicable third-party guidelines, including by way of example ISO standards, Good Manufacturing Practices, Hazard Analysis and Risk-Based Preventive Controls, Hazard Analysis and Critical Control Points, and Safe Quality Food, as well as newly designed controls to address potential PMF-specific risks. This comprehensive approach maximizes containment, identity preservation, regulatory compliance, traceability, incident response capabilities, and continuous improvement across the product lifecycle. While customization is required based on each PMF product developer’s specific product and operations, this paper examines industry best practices and describes CLS components that a PMF developer should consider in designing a robust, bespoke CLS to maintain identity preservation and product containment. Such a system will optimize for product quality and integrity while preventing commingling with commodity supplies and any associated market disruption while also addressing food safety. By implementing these rigorous systems, the PMF industry can realize its potential to contribute significantly to sustainable agriculture and food security.https://www.frontiersin.org/articles/10.3389/fpls.2025.1426290/fullclosed-loop systemsplant molecular farmingbiotechnologystewardshipfood allergenalternative proteins
spellingShingle Kristin A. Bresnahan
Justin M. Ferber
J. Thomas Carrato
Thomas J. Stoddard
Patrick V. Palad
Magi Richani
Closed-loop systems for plants expressing animal proteins: a modernized framework to safeguard the future of agricultural innovation
Frontiers in Plant Science
closed-loop systems
plant molecular farming
biotechnology
stewardship
food allergen
alternative proteins
title Closed-loop systems for plants expressing animal proteins: a modernized framework to safeguard the future of agricultural innovation
title_full Closed-loop systems for plants expressing animal proteins: a modernized framework to safeguard the future of agricultural innovation
title_fullStr Closed-loop systems for plants expressing animal proteins: a modernized framework to safeguard the future of agricultural innovation
title_full_unstemmed Closed-loop systems for plants expressing animal proteins: a modernized framework to safeguard the future of agricultural innovation
title_short Closed-loop systems for plants expressing animal proteins: a modernized framework to safeguard the future of agricultural innovation
title_sort closed loop systems for plants expressing animal proteins a modernized framework to safeguard the future of agricultural innovation
topic closed-loop systems
plant molecular farming
biotechnology
stewardship
food allergen
alternative proteins
url https://www.frontiersin.org/articles/10.3389/fpls.2025.1426290/full
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