Future-proofing regulation for rapidly changing biotechnologies.

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ID: 52737
2019
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Abstract
Our understanding of DNA structure and how it interacts with the environment to give form and function at the organism level is growing at an unprecedented pace which shows no sign of slowing. These developments have already led to many new products and will continue to underpin as yet unpredicted future developments in biotechnology. However, this potential will not be realised unless the mechanisms for risk assessment, regulatory approval, product claims and labelling etc. are fit for purpose, have the confidence of all stakeholders and are sufficiently agile to support this rapidly changing field. The sectors that are making particular advances in biotechnological processes include agriculture, pharmaceuticals, food, chemical and human diagnostics and therapeutics. In many of these areas the research, investment and innovation pipeline is operating well as evidenced by the many marketed products. However, developments in plant breeding methods have posed particular challenges for regulators which in turn is stifling R&D and innovation, particularly in the EU. In rapidly moving areas of research and development, it is imperative that regulatory frameworks are future-proofed by design.
Reference Key
jones2019futureproofingtransgenic Use this key to autocite in the manuscript while using SciMatic Manuscript Manager or Thesis Manager
Authors Jones, Huw D;
Journal transgenic research
Year 2019
DOI
10.1007/s11248-019-00143-4
URL
Keywords
Mass spectrometry post-translational modification hydroxyproline ptm biotherapeutics maldi-isd ft-icr fab purification sulfotyrosine

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