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
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
Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products : Guidance for industry
https://www.fda.gov/media/156896/download
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
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
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 : General Principles to Address Virus and Vector Shedding
https://admin.ich.org/sites/default/files/2019-04/ICH_Considerations_Viral-Vector_Shedding_.pdf