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Guideline on virus safety evaluation of biotechnological investigational medicinal products
https://www.ema.europa.eu/documents/scientific-guideline/guideline-virus-safety-evaluation-biotechnological-investigational-medicinal-products_en.pdf
Recommendations for the evaluation of animal cell cultures as substrates for the manufacture of biological medicinal products and for the characterization of cell banks, Annex 3, TRS No 978
https://cdn.who.int/media/docs/default-source/biologicals/documents/trs_978_annex_3.pdf?sfvrsn=fe61af77_3&download=true
Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products : Guidance for industry
https://www.fda.gov/media/156896/download
Questions and answers on comparability considerations for advanced therapy medicinal products (ATMP) – Scientific guideline
https://www.ema.europa.eu/documents/other/questions-answers-comparability-considerations-advanced-therapy-medicinal-products-atmp_en.pdf
Toolbox guidance on scientific elements and regulatory tools to support quality data packages for PRIME and certain marketing authorisation applications targeting an unmet medical need – Scientific guideline
https://www.ema.europa.eu/documents/scientific-guideline/toolbox-guidance-scientific-elements-regulatory-tools-support-quality-data-packages-prime-certain_en.pdf
WHO TRS 978_annex3 : Recommendations for the evaluation of animal cell cultures as substrates for the manufacture of biological medicinal products and for the characterization of cell banks
https://cdn.who.int/media/docs/default-source/biologicals/documents/trs_978_annex_3.pdf?sfvrsn=fe61af77_3&download=true
ICH considerations : Oncolytic Viruses
https://admin.ich.org/sites/default/files/2019-04/ICH_Considerations_Oncolytic_Viruses_rev_Sep_17_09.pdf
Guideline on quality, non-clinical and clinical aspects of live recombinant viral vectored vaccines (EMA/CHMP/VWP/141697/2009)
https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-quality-non-clinical-clinical-aspects-live-recombinant-viral-vectored-vaccines_en.pdf