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MAbs. 2019 Feb/Mar;11(2):239-264. doi: 10.1080/19420862.2018.1553476. Epub 2018 Dec 17.

Structure, heterogeneity and developability assessment of therapeutic antibodies.

Author information

1
a Protein Analytics , Adimab , Lebanon , NH , USA.
2
b Analytical Department , Bioanalytix, Inc ., Cambridge , MA , USA.
3
c Product Characterization , Alexion Pharmaceuticals, Inc ., New Haven , CT , USA.
4
d Analytical Chemistry , Regeneron Pharmaceuticals, Inc ., Tarrytown , NY , USA.
5
e Formulation Development , Regeneron Pharmaceuticals, Inc ., Tarrytown , NY , USA.
6
f Pharmaceutical Sciences , MRL, Merck & Co., Inc ., Kenilworth , NJ , USA.
7
g Analytical Method Development , MRL, Merck & Co., Inc ., Kenilworth , NJ , USA.
8
h Sterile Formulation Sciences , MRL, Merck & Co., Inc ., Kenilworth , NJ , USA.
9
i Analytical Development , Bristol-Myers Squibb , Pennington , NJ , USA.
10
j Manufacturing Sciences , Abbvie Bioresearch Center , Worcester , MA , USA.
11
k Product development , Innovent Biologics , Suzhou Industrial Park , China.
12
l Analytical chemistry , NBEs, Center d'immunologie Pierre Fabre , St Julien-en-Genevois Cedex , France.

Abstract

Increasing attention has been paid to developability assessment with the understanding that thorough evaluation of monoclonal antibody lead candidates at an early stage can avoid delays during late-stage development. The concept of developability is based on the knowledge gained from the successful development of approximately 80 marketed antibody and Fc-fusion protein drug products and from the lessons learned from many failed development programs over the last three decades. Here, we reviewed antibody quality attributes that are critical to development and traditional and state-of-the-art analytical methods to monitor those attributes. Based on our collective experiences, a practical workflow is proposed as a best practice for developability assessment including in silico evaluation, extended characterization and forced degradation using appropriate analytical methods that allow characterization with limited material consumption and fast turnaround time.

KEYWORDS:

Developability; monoclonal antibody; posttranslational modifications

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