Accelerated development of a SEC-HPLC procedure for purity analysis of monoclonal antibodies using design of experiments

Author:

Cernosek Terezie,Jain Nitin,Dalphin Matthew,Behrens SueORCID,Wunderli Peter

Publisher

Elsevier BV

Subject

Cell Biology,Clinical Biochemistry,Biochemistry,General Medicine,Analytical Chemistry

Reference43 articles.

1. Molecular and functional analysis of monoclonal antibodies in support of biologics development, Protein;Wang;Cell,2018

2. Identification of monoclonal antibody variants involved in aggregate formation – Part 1: Charge variants;Meyer;Eur. J. Pharm. Biopharm.,2021

3. WHO Guideline for the safe production and quality control of monoclonal antibpdies for use in humans, (n.d.). https://cdn.who.int/media/docs/default-source/biologicals/mabs-manufacture-guideline-draft-for-1st-public-comment.pdf (accessed March 28, 2022).

4. Characterizing biological products and assessing comparability following manufacturing changes;Chirino;Nat. Biotechnol.,2004

5. Analytical strategies for the characterization of therapeutic monoclonal antibodies, TrAC;Fekete;Trends Anal. Chem.,2013

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