1. EMA. Similar biological medicinal products containing monoclonal antibodies: non-clinical and clinical issues. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-containing-monoclonal-antibodies-non-clinical_en.pdf.
2. EMA. ICH Q11 Development and manufacture of drug substances (chemical entities and biotechnological/biological entities). https://www.ema.europa.eu/en/ich-q11-development-manufacture-drug-substances-chemical-entities-biotechnologicalbiological.
3. EMA. Development pharmaceutics for biotechnological and biological products (Annex to note for guidance on development pharmaceutics. https://www.ema.europa.eu/en/documents/ scientific-guideline/development-pharmaceutics-biotechnological-biological-products-cpmp/bwp/328/99-annex-note-guidance-development-pharmaceutics-cpmp/qwp/155/96_en.pdf.
4. EMA. Guideline on development, production, characterisation and specification for monoclonal antibodies and related products. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-development-production-characterisation-specification-monoclonal-antibodies-related_en.pdf.
5. EMA. Guideline on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-immunogenicity-assessment-monoclonal-antibodies-intended-vivo-clinical-use_en.pdf.