Development pathways for subcutaneous formulations of biologics versus biosimilar development
Author:
Affiliation:
1. Global Product Development Medical Affairs, F. Hoffmann-La Roche Ltd, Basel, Switzerland
2. Biostatistics, F. Hoffmann-La Roche Ltd, Basel, Switzerland
3. Department of Biomathematics, University of Thessaly School of Medicine, Larisa, Greece
Funder
F. Hoffmann-La Roche
Publisher
Informa UK Limited
Subject
Drug Discovery,Pharmacology,Genetics,Molecular Medicine
Link
https://tandfonline.com/doi/pdf/10.1080/23808993.2019.1585806
Reference36 articles.
1. Biosimilars: an overview
2. Recovery and purification process development for monoclonal antibody production
3. Immunogenicity of Biotherapeutics: Causes and Association with Posttranslational Modifications
4. The process defines the product: what really matters in biosimilar design and production?
5. Fc glycans of therapeutic antibodies as critical quality attributes
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