Evaluation of physicochemical and functional similarity of a new CHO derived anti-EGFR antibody P-mAb to its reference medicinal product
Author:
Affiliation:
1. Biochemical Engineering Research and Process Development Centre, CSIR-Institute of Microbial Technology, Chandigarh, India
2. GNR Advanced Protein Centre, CSIR-Institute of Microbial Technology, Chandigarh, India
Publisher
Informa UK Limited
Subject
Pharmaceutical Science,Biomedical Engineering,General Medicine,Medicine (miscellaneous),Biotechnology
Link
https://www.tandfonline.com/doi/pdf/10.1080/21691401.2022.2028284
Reference38 articles.
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3. CDER/CBER, FDA. Quality considerations in demonstrating biosimilarity of a therapeutic protein product to a reference product. Guid Ind. 2015. [cited 2021 Jan 26]. https://www.fda.gov/media/135612/download.
4. European Medicines Agency. Guideline on similar biological medicinal products containing monoclonal antibodies – non-clinical and clinical issues. 2014;44:1–16. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/01/WC500180219.pdf
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