Origene_Jan2021_ProperAntibodyDesignKeeps - 9

Proper Antibody Design Keeps Specificity In Mind

Laboratory techniques to characterize monoclonal antibodies are being developed to satisfy demands for increasingly
detailed information. According to Intertek Pharmaceutical Services, which provided this image, better characterization
techniques can help biopharmaceutical companies accomplish increasingly ambitious goals with respect to efficiency,
safety, and regulatory compliance.

reduce release time by ensuring quality targets are

biosimilars. Although biosimilars are not generics,

met during the manufacturing process.

they are conceptually similar.
Biosimilar requirements vary from market to

Comparing reference biologics
and follow-on biosimilars

market. In general, securing a biosimilar's approval

Biopharmaceuticals, as stated above, are less

properties are similar to those of a reference

likely to face competition than small-molecule

product that has already been cleared by regulators.

drugs. Primarily this is due to variability inherent

To date, many of the approved biosimilars are

in production, which makes it hard for a company

versions of mAb-based therapies.

to replicate another's product. That said, off-patent
biopharmaceuticals can still face competition from

is a matter of showing that the molecule's active

" The biosimilar manufacturer, " Malmquist says,
" will have to exert a substantial and increased
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Origene_Jan2021_ProperAntibodyDesignKeeps

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