Portal de Periódicos da CAPES

Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation

2018; European Food Safety Authority; Volume: 15; Issue: 8 Linguagem: Inglês

10.2903/sp.efsa.2018.en-1466

2397-8325

Konstantinos Paraskevopoulos, Matthew Ramon, Tamás Dalmay, Patrick du Jardin, Josep Casacuberta, Philippe Guerche, Huw Jones, Fabien Nogué, Christophe Robaglia, Nils Rostoks,

Transgenic Plants and Applications

EFSA Supporting PublicationsVolume 15, Issue 8 1466E Technical reportOpen Access Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation European Food Safety Authority (EFSA), European Food Safety Authority (EFSA)Search for more papers by this authorKonstantinos Paraskevopoulos, Konstantinos ParaskevopoulosSearch for more papers by this authorMatthew Ramon, Matthew RamonSearch for more papers by this authorTamas Dalmay, Tamas DalmaySearch for more papers by this authorPatrick du Jardin, Patrick du JardinSearch for more papers by this authorJosep Casacuberta, Josep CasacubertaSearch for more papers by this authorPhilippe Guerche, Philippe GuercheSearch for more papers by this authorHuw Jones, Huw JonesSearch for more papers by this authorFabien Nogué, Fabien NoguéSearch for more papers by this authorChristophe Robaglia, Christophe RobagliaSearch for more papers by this authorNils Rostoks, Nils RostoksSearch for more papers by this author European Food Safety Authority (EFSA), European Food Safety Authority (EFSA)Search for more papers by this authorKonstantinos Paraskevopoulos, Konstantinos ParaskevopoulosSearch for more papers by this authorMatthew Ramon, Matthew RamonSearch for more papers by this authorTamas Dalmay, Tamas DalmaySearch for more papers by this authorPatrick du Jardin, Patrick du JardinSearch for more papers by this authorJosep Casacuberta, Josep CasacubertaSearch for more papers by this authorPhilippe Guerche, Philippe GuercheSearch for more papers by this authorHuw Jones, Huw JonesSearch for more papers by this authorFabien Nogué, Fabien NoguéSearch for more papers by this authorChristophe Robaglia, Christophe RobagliaSearch for more papers by this authorNils Rostoks, Nils RostoksSearch for more papers by this author First published: 20 August 2018 https://doi.org/10.2903/sp.efsa.2018.EN-1466Citations: 8 Requestor: EFSA Question number: EFSA-Q-2016-00231 AboutPDF ToolsExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat Abstract Genetically modified organisms are subject to a risk assessment and regulatory approval before entering the European market. According to legislation (Directive 2001/18/EC, Regulation (EC) No 1829/2003 and Regulation (EU) No 503/2013) and the EFSA guidance documents on the risk assessment of food and feed from genetically modified (GM) plants and on the environmental risk assessment of GM plants, applicants need to perform a molecular characterisation of any DNA sequence inserted in the GM plant genome. When a GM plant is designed to produce one or more newly expressed proteins, an aspect of the risk assessment process is to characterise these proteins and to reliably determine their levels in the GM plant tissues. A number of methods to measure protein expression levels are used and several experimental factors within these methods are of critical importance in order to obtain reliable results. This explanatory note provides details on key methodological aspects for the determination of newly expressed protein levels that should be considered and reported by applicants in order to harmonise the information in GM plant applications submitted to EFSA. References Andreasson U, Perret-Liaudet A, van Waalwijk van Doorn LJ, Blennow K, Chiasserini D, Engelborghs S, Fladby T, Genc S, Kruse N, Kuiperij HB, Kulic L, Lewczuk P, Mollenhauer B, Mroczko B, Parnetti L, Vanmechelen E, Verbeek MM, Winblad B, Zetterberg H, Koel-Simmelink M and Teunissen CE, 2015. A Practical Guide to Immunoassay Method Validation. Frontiers in neurology, 19(6), 179. doi: 10.3389/fneur.2015.00179. Armbruster DA and Pry T, 2008. Limit of Blank, Limit of Detection and Limit of Quantitation. The Clinical Biochemist. Reviews. 29(Suppl 1), S49- S52. Crespo AL, Spencer TA, Nekl E, Pusztai-Carey M, Moar WJ and Siegfried BD, 2008. Comparison and validation of methods to quantify Cry1Ab toxin from Bacillus thuringiensis for standardization of insect bioassays. Applied and Environmental Microbiology, 74(1), 130- 5. EFSA (European Food Safety Authority), 2014. Indicative timelines for submitting additional or supplementary information to EFSA during the risk assessment process of regulated products. EFSA Journal 2014; 12(1):3553, 37 pp. doi:10.2903/j.efsa.2010.3553. EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), 2010. Guidance on the environmental risk assessment of genetically modified plants. EFSA Journal 2010; 8(11):1879. 111 pp. doi:10.2903/j.efsa.2010.1879. EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), 2011. Guidance for risk assessment of food and feed from genetically modified plants. EFSA Journal 2011; 9(5):2150, 37 pp. doi:10.2903/j.efsa.2011.2150. EMA (European Medicines Agency), 2011. Guideline on bioanalytical method validation. EMA, London. Available online: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/08/WC500109686.pdf. FAO (Food and Agriculture Organization of the United Nations), 2010. Codex CAC/GL 74-2010. Guidelines on performance criteria and validation of methods for detection, identification and quantification of specific DNA sequences and specific proteins in foods. FAO, Rome. Available online: http://www.fao.org/fao-who-codexalimentarius/codex-texts/guidelines/en/ FDA (Food and Drug Administration), 2018. Bioanalytical method validation. Guidance for industry. FDA, Silver Spring, MD. Available online: https://www.fda.gov/downloads/Drugs/Guidance/ucm070107.pdf. Gatto L, Hansen KD, Hoopmann MR, Hermjakob H, Kohlbacher O and Beyer A, 2016. Testing and Validation of Computational Methods for Mass Spectrometry. Journal of Proteome Research, 15(3), 809- 14. Grothaus GD, Bandla M, Currier T, Giroux R, Jenkins GR, Lipp M, Shan G, Stave JW and Pantellam V, 2006. Immunoassay as an analytical tool in agricultural biotechnology. Journal of AOAC International, 89(4), 913- 928. Herman R-A and Shan G, 2011. Chapter 9: Data interpretation and sources of error validation. In: Shan G (Ed.). Immunoassays in Agricultural Biotechnology. John Wiley & Sons, Inc., Hoboken, NJ. ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use), 2005. ICH Harmonized Tripartite Guideline. Validation of analytical procedures: text and methodology Q2(R1). ICH, Geneva. Available online: https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q2_R1/Step4/Q2_R1__Guideline.pdf. ISO (International Organization for Standardization), 2013. ISO 21572 Food stuffs–molecular biomarker analysis–protein-based methods. 2nd edition. ISO, Geneva. Jenkins R, Duggan JX, Aubry AF, Zeng J, Lee JW, Cojocaru L, Dufield D, Garofolo F, Kaur S, Schultz GA, Xu K, Yang Z, Yu J, Zhang YJ and Vazvaei F, 2015. Recommendations for validation of LC-MS/MS bioanalytical methods for protein biotherapeutics. AAPS Journal, 17(1), 1- 16. Kruve A, Rebane R, Kipper K, Oldekop ML, Evard H, Herodes K, Ravio P and Leito I, 2015a. Tutorial review on validation of liquid chromatography-mass spectrometry methods: Part I. Analytica Chimica Acta, 870, 29- 44. Kruve A, Rebane R, Kipper K, Oldekop ML, Evard H, Herodes K, Ravio P and Leito I, 2015b. Tutorial review on validation of liquid chromatography-mass spectrometry methods: Part II. Analytica Chimica Acta, 870, 8- 28. Laing W and Christeller J, 2004. Extraction of Proteins from Plant Tissues. Current Protocols in Protein Science, 38, 4.7.1- 4.7.7. Liebler DC and Zimmerman LJ, 2013. Targeted quantitation of proteins by mass spectrometry. Biochemistry, 52(22), 3797- 3806. Lipton CR, Dautlick JX, Grothaus GD, Hunst PL, Magin KM, Mihaliak CA, Rubio FM and Stave JW, 2000. Guidelines for the validation and use of immunoassays for determination of introduced proteins in biotechnology enhanced crops and derived food ingredients. Food and Agricultural Immunology, 12(2), 153- 164. Martínez-García JF, Monte E and Quail PH, 1999. A simple, rapid and quantitative method for preparing Arabidopsis protein extracts for immunoblot analysis. The Plant Journal, 20(2), 251- 257. Matsuo Y, Asakawa K, Toda T, Katayama S, 2006. A rapid method for protein extraction from fission yeast. Bioscience, Biotechnology and Biochemistry, 70(8), 1992- 4. Noble JE and Bailey MJA, 2009. Chapter 8: Quantitation of Protein. In: RR Burgess and MP Deutscher (Eds.). Guide to Protein purification in Methods in Enzymology. 2nd Ed. Volume 463, 73- 95. Academic Press, Cambridge, MA. Pan S, Aebersold R, Chen R, Rush J, Goodlett DR, McIntosh M-W, Zhang J and Brentnall TA, 2009. Mass spectrometry based targeted protein quantification: methods and applications. Journal od Proteome Research, 8(2), 787- 797. Parker CE and Borchers CH, 2014. Mass spectrometry based biomarker discovery, verification, and validation-quality assurance and control of protein biomarker assays. Molecular Oncology, 8(4), 840- 58. Rauh M, 2012. LC-MS/MS for protein and peptide quantification in clinical chemistry. Journal of chromatography. B, Analytical technologies in the biomedical and life sciences, 883-884, 59- 67. Schmidt J and Alarcon C, 2011. Chapter 6: Immunoassay method validation. In: Shan G (Ed.). Immunoassays in Agricultural Biotechnology. John Wiley & Sons, Inc., Hoboken, NJ. Settlage SB, Eble JE, Bhanushali JK, Cheever ML, Gao AG, Goldstrohm DA, Hill R, Hu TX, Powley CR, Unger A and Shan G, 2017. Validation Parameters for Quantitating Specific Proteins Using ELISA or LC-MS/MS: Survey Results. Food Analytical Methods, 10(5), 1339- 1348. van den Broek I, Niessen WMA and van Dongen WD, 2013. Bioanalytical LC-MS/MS of protein-based biopharmaceuticals. Journal of chromatography. B, Analytical technologies in the biomedical and life sciences, 929, 161- 179. Citing Literature Volume15, Issue8August 20181466E ReferencesRelatedInformation