Impact of Post Manufacturing Handling of Protein-Based Biologic Drugs on Product Quality and User Centricity

Author:

Cappelletto EliaORCID,Kwok Stanley C.,Sorret LéaORCID,Fuentes NathalieORCID,Medina Annette M.,Burleigh StephenORCID,Fast JonasORCID,Mackenzie Isla S.ORCID,Fureby Anna Millqvist,Paulsson MattiasORCID,Wahlgren Marie,Elofsson UllaORCID,Flynn Angela,Miolo GiorgiaORCID,Nyström LinaORCID,De Laureto Patrizia PolverinoORCID,De Paoli GiorgiaORCID

Funder

European Commission

Innovative Medicines Initiative

Hospital Clínic de Barcelona

Reumatikerförbundet

European Federation of Pharmaceutical Industries and Associations

Publisher

Elsevier BV

Reference102 articles.

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3. FDA. Voluntary recall of certain over-the-counter drugs and medical devices. Available at:https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/voluntary-recall-certain-over-counter-drugs-and-medical-devices. Accessed February 8, 2024.

4. Antibody structure, instability, and formulation;Wang;J Pharm Sci,2007

5. ICH Q8 (R2) pharmaceutical development. Available at:https://www.ema.europa.eu/en/ich-q8-r2-pharmaceutical-development-scientific-guideline. Accessed February 8, 2024.

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