Recent advancements, challenges, and practical considerations in the mass spectrometry-based analytics of protein biotherapeutics: A viewpoint from the biosimilar industry

Author:

Háda Viktor,Bagdi Attila,Bihari Zsolt,Timári Sarolta Baginé,Fizil Ádám,Szántay Csaba

Publisher

Elsevier BV

Subject

Clinical Biochemistry,Spectroscopy,Drug Discovery,Pharmaceutical Science,Analytical Chemistry

Reference283 articles.

1. World Preview 2017, Outlook to 2022;Evaluate Pharma,2017

2. European Public Assessment Reports;European Medicines Agency,2018

3. Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations;U.S. Food and Drug Administration,2018

4. Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product;CDER/CBER, FDA,2015

5. Biological Guidelines;European Medicines Agency,2018

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