Origene_Jan2021_ProperAntibodyDesignKeeps - 7

Proper Antibody Design Keeps Specificity In Mind

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leader and applications, for PerkinElmer's Discovery

process development and routine manufacturing. "

& Analytical Solutions organization. " Monoclonal

The former is used to determine that you have

antibody characterization is important for the

the correct mAb and to establish potential critical

biopharmaceutical industry, " he says, " because

quality attributes of the antibody. The latter

it enables selection of the therapeutic molecule

depends, to some extent, on these attributes. " They

representing greater specificity, efficacy, stability,

will identify which product-related impurities you

and functionality. "

will need to consider during process development
and subsequently during manufacturing, " Malm-

Characterization through
development and production

quist advises.

The rationale for characterizing a mAb differs at

development and routine manufacturing fall into

each stage of the development and production

three different categories: process control and lot

process. Understanding what you are looking for

release; stability indicators; and characterization,

and why is critical. " It is important, " says Gunnar

which is used to confirm that drug properties

Malmquist, PhD, principal scientist at GE Healthcare,

remain consistent and to confirm acceptable levels

" to distinguish between the mAb characterization

of product-related impurities.

that takes place during drug development and the
mAb characterization that is performed during

The analysis methods used during process

Properly executed, analytical methods help
manufacturers detect high-molecular-weight
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Origene_Jan2021_ProperAntibodyDesignKeeps

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