Origene_Jan2021_ProperAntibodyDesignKeeps - 10

Antibody Characterization Keeps Pace with the Antibody Industry
characterization effort in demonstrating structural
similarity to the originator profile to benefit from
the simplified regulatory framework available. "
The biopharma industry also compares biologics
and biosimilars for competitive reasons. It is now
common for firms to try to develop as complete and

complex analytical techniques. "
The emergence of next-generation mAbs, antibody drug conjugates (ADCs), and fragment-based
drugs is also impacting how industry uses characterization technologies.
" Beyond conventional mAbs, related products

detailed a description of their product's molecular

such as Fc fusion proteins or bispecific antibodies

properties as possible to make it harder for biosim-

(bsAbs) and antibody-fusion proteins are in

ilar firms to create matching drugs.

development, " Walker details. " Each of these brings

Incorporating advanced
analytical technologies

specific characterization challenges that may
require new approaches and technologies.
" For example, Fc fusion proteins are susceptible

Technology advances support more detailed

to proteolytic cleavage. They also have the potential

analyses, which are, Walker points out, becoming

to form higher levels of high-molecular-weight

increasingly routine as biomanufacturers respond

aggregates as compared to conventional mAbs. This

to regulatory demands. " Data-rich techniques

drives the need for a definitive suite of approaches

like mass spectrometry allow more critical quality

to monitor stability and occurrence of aggregation.

attributes to be monitored in a single assay to

" If bispecific antibodies introduce a new prod-

improve process development, " he continues.

uct-related impurity, the potential for mismatching

" The increased throughput and data integrity that

of protein subunits needs to be controlled. This

technological improvements have allowed open

is analytically challenging as often there is a high

up new parts of the manufacturing pipeline for

degree of conservation between chains. These
types of molecules have led to an increased interest

Are monoclonal antibodies
mono-specific? Not Really!

in native mass spectrometry methods hyphenated

Learn from a 2-min video

and capillary electrophoresis. "

to methods such as size-exclusion chromatography

Consolidating characterization chores
Another dynamic impacting biopharma's
approach to mAb characterization in the drive for
efficiency. Every company wants to get product
to market as quickly as possible. In the mAb
space, the focus is on completing the necessary

10 |

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