生物合成科技与应用的监管

Regulation and regulatory science for biosynthetic science,technology and applications

以生物体系为工具合成物质的生物合成技术,既是生物技术的重要组成,经历了从传统向现代的跨越;也是生物技术的重要出口,在食品、医药、化工等产业领域发挥着重要作用.合成生物学的兴起促进了生物合成技术及相关产业的变革.与基因工程技术相比,合成生物学技术会聚程度更高、赋能能力更强、产品类型更多,给现有监管体系带来的挑战也更大.如何科学有效地监管生物合成技术的研发与应用,使之在保障人民健康、保护环境、维护社会稳定的前提下,加速赋能技术研发和产业转化,已成为不可回避的紧迫问题.本文回顾了传统生物技术到近代生物技术,再到现代生物技术的三个阶段中生物合成监管的发展历史,系统梳理了生物合成监管的内涵;选取医药、传染病防控、食品和环境四个典型应用场景中的案例,就新技术、新产品带来的监管挑战进行了分析.最后,提出了明确监管政策衔接、调整、突破或创新的重点,开发科学评估的工具、标准和方法,建立综合治理与科学传播体系等针对性建议.

Biosynthesis,as one of the major connotations of biotechnology,is the process of producing chemicals from feedstocks through enzymatic reactions either in vitro as cell-free systems or in vivo employing living organisms carrying corresponding enzymes.Biosynthesis is featured with its high transformation efficiency under normal temperature and pressure,and that has been continuously enhanced ever since the transition of biotechnology from traditional to modern,directory revolutionized the food,medicine,chemical and ecological industries.Synthetic Biology was emerged in the 2000s,integrating engineering,physics,chemistry,computer science and other disciplines into biology.Its multi-dimensional convergence character and groundbreaking“bottom-up”engineering concept revolutionized the biological science with the Design-Build-Test-Learn Paradigm.It also accelerates the“disruptive”innovation not only in biosynthesis technology but also in the development of an enabling chain for the related industries and diverse products.Due to the disruptive and complex nature of biosynthesis enabled by synthetic biology,significant challenges have arisen for the current regulatory system,especially concerning human health and societal safety.Establishing scientific and effective regulations has become an unavoidable and urgent issue.This will enable the establishment of an innovative ecosystem that ensures timely technological advancements and industrial transformation,benefiting people’s health,protecting the environment,and maintaining social stability.In this paper,we firstly reviewed the regulatory history of biosynthesis.In the traditional stage,the so-called regulation was primitive,empirical-based and mainly focused on discerning false/fake from genuine.When biotechnology entered its science and technology(S&T)-based modern stage started in the 19th century,regulations upon biosynthesis were truly established mainly focusing on food and drug R&D and commercialization.Since the molecular biology era of middle 20th century,development of genetic manipulation,molecular cloning,genome editing and synthetic biology has been quickly bringing biosynthesis into today’s contemporary stage.During this period,lessons learned from a series of biosafety and/or biosecurity incidents attributed to the evolving of the biosynthetic governance system and the emergence and development of Regulatory Science of biotechnology.Next,we analyzed several cases in four typical scenarios of biosynthesis R&D and applications to reveal the regulatory challenges brought by the emergence of new technologies and the experiences in answering questions of‘why’,‘what’,‘how’and‘who’for the corresponding regulatory systems.It is obvious,as the vital part of the technology R&D and application ecosystem,regulatory science has to be developed alongside or even ahead of the corresponding technology to ensure the regulations may comprehensively coordinates with S&T and ethical,legal and social issues(ELSI).Thus,several applicable strategies are proposed.Firstly,effective connection of currently implemented policies under the principle of prudential supervision can be applied widely for the R&D and manufacturing/application of majority of the pure chemical-based products,including pharmaceuticals;and even for proper and necessary research practice employing human embryo.Secondly,adaptive adjustment of some imperfect regulations in China taking international practices as reference such as in case of dual-use research or of some missing connections in regulations for Chinese herbal medicine versus biological products/chemical drugs employing the newly developed technology for natural product production.Finally,breakthrough change of some currently applied regulations that apparently hindered the transformation of some technology critical for social development,such as GMO,or innovative reestablishment of some unavailable regulations to smoothen the transformation of novo products,such as cell and gene therapy,need to be seriously concerned.To prioritize regulatory policies categorized into connection,adjustment,breakthrough,or innovation,the corresponding regulatory technologies,evaluation standards and methods,and regulatory systems have to be developed or improved accordingly to meet the needs of expanding fields and scenarios of supervision.Meanwhile,the regulatory concept of combining industry,academia,research,application,and public participation has to be strengthened to establish a scientific,effective and safe ecosystem.