TY - JOUR
T1 - Exploring the analytical power of the QTOF MS platform to assess monoclonal antibodies quality attributes
AU - Gomes, Ricardo A.
AU - Almeida, Maria Conceição
AU - Correia, Catarina
AU - Guerreiro, Ana
AU - Simplício, Ana Luísa
AU - Abreu, Isabel A.
AU - Alves, Patrícia Gomes
PY - 2019/1/1
Y1 - 2019/1/1
N2 - The biopharmaceutical industry is growing at a fast pace, making nowadays 20% of the pharma market. Within this market, therapeutic monoclonal antibodies (mAbs) are the dominant product class. With the patent expirations, biosimilars and, perhaps more relevant, bio-betters, are in fast development. Thus, a comprehensive characterization at the molecular level of antibodies heterogeneity such as glycoforms, post-translational modifications (PTMs) and sequence variations is of utmost importance. Mass spectrometry (MS)-based approaches are undoubtedly the most powerful analytical strategies to monitor and define an array of critical quality attributes on mAbs. In this work, we demonstrate the analytical power of the Q-TOF MS platform for comprehensive and detailed analysis at molecular levels of an in-house produced mAb. This methodology involves minimal sample preparation procedures and provides an extensive collection of valuable data in a short period of time.
AB - The biopharmaceutical industry is growing at a fast pace, making nowadays 20% of the pharma market. Within this market, therapeutic monoclonal antibodies (mAbs) are the dominant product class. With the patent expirations, biosimilars and, perhaps more relevant, bio-betters, are in fast development. Thus, a comprehensive characterization at the molecular level of antibodies heterogeneity such as glycoforms, post-translational modifications (PTMs) and sequence variations is of utmost importance. Mass spectrometry (MS)-based approaches are undoubtedly the most powerful analytical strategies to monitor and define an array of critical quality attributes on mAbs. In this work, we demonstrate the analytical power of the Q-TOF MS platform for comprehensive and detailed analysis at molecular levels of an in-house produced mAb. This methodology involves minimal sample preparation procedures and provides an extensive collection of valuable data in a short period of time.
UR - http://www.scopus.com/inward/record.url?scp=85069588077&partnerID=8YFLogxK
U2 - 10.1371/journal.pone.0219156
DO - 10.1371/journal.pone.0219156
M3 - Article
C2 - 31291294
AN - SCOPUS:85069588077
SN - 1932-6203
VL - 14
JO - PLoS ONE
JF - PLoS ONE
IS - 7
M1 - e0219156
ER -