| Document Date: 2013-07-21 06:32:38
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City London / / Company IgG / Risk Management Systems / EPO / Immunogenicity / / Country United Kingdom / / / Event Product Issues / / Facility Canary Wharf / / IndustryTerm biotechnology-derived medicinal products / biological products / physico-chemical profile / biotechnology-derived proteins / mAb products / individual mAb products / biotechnology-derived pharmaceuticals / generation products / residual product / banking / automated sampling systems / expression systems / residual circulating product / biotechnology-derived therapeutic proteins / similar biological medicinal products / manufacturing process / / MedicalCondition disease / severe anaphylaxis / rheumatoid arthritis / tumour / anaphylaxis / juvenile arthritis / preliminary antigen-antibody dissociation / allergic reactions / allergic hypersensitivity / / Organization European Medicines Agency / .ema.europa.eu An / Committee for Medicinal Products for Human Use / European Union / / / Position Executive / contents Executive / / Product clinical responses / / Technology antibodies / biotechnology / coated chip / /
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Guideline on immunogenicity assessment of monoclonal antibodies intended for in-vivo clinical use