Origene_Jan2021_ProperAntibodyDesignKeeps - 6

Antibody Characterization Keeps Pace with the Antibody Industry

Antibody Characterization
Keeps Pace with the
Antibody Industry
Biosimilar approvals, production upgrades, and regulatory demands are
being matched by advances in monoclonal antibody characterization
By Gareth John Macdonald

iologic monoclonal antibody (mAb) drugs
are not just more targeted than small-molecule drugs, they are also larger, more

mAb characteristics become significant.
Back when the U.S. Food and Drug Administration approved the first mAb drug, muromonab-CD3

complicated, and more variable. Consequently,

(Orthoclone OKT3), making mAbs was a complex

biologic mAb drugs, which generate sizable reve-

and cutting-edge undertaking. It involved fusing

nues, may enjoy some degree of protection from

cells-in the case of Orthoclone OKT3, one from

biosimilars, follow-on biologics that are similar

a mouse's spleen and one from a tumor-to

but not identical to their corresponding reference

create an expression cell line followed by multiple

biologics. To obtain the maximum degree of protec-

harvesting steps. Yields were low, and production

tion, biologic mAb drugs need to be intensively

was costly.

and comprehensively characterized. Differences

Today, mAb production is almost routine. Cell

between mAbs and biosimilars, it may be argued,

line development and manufacturing techniques

are not merely incidental, but crucial to biological

have advanced, and more efficient production

activity and therapeutic action.

and harvesting platforms have been developed.

Biologic/biosimilar differentiation is just one

Changes such as these mean that the mAb industry

reason to enhance mAb characterization. Other

faces more nuanced challenges in elucidating mAb

reasons-potentially more compelling reasons-

molecular structures and characteristics.

include the need to collect metrics that can be

Fortunately, industry can meet these challenges

used to screen mAb drug candidates, optimize

by deploying advanced characterization technol-

production processes, and satisfy increasingly

ogies. Such technologies can, for example, help

stringent regulations. Also, as mAb processes

industry find mAb candidates faster, says Anis H.

become more sophisticated, increasingly subtle

Khimani, PhD, portfolio marketing director, strategy

GENengnews.com

http://www.GENengnews.com

Origene_Jan2021_ProperAntibodyDesignKeeps

Table of Contents for the Digital Edition of Origene_Jan2021_ProperAntibodyDesignKeeps