Origene_Jan2021_ProperAntibodyDesignKeeps - 8

Antibody Characterization Keeps Pace with the Antibody Industry
aggregates resulting from the mAbs sticking

the heterogeneous population is consequently not

together during production. Likewise, analytical

so much concerned with ensuring the correct mAb

techniques are used to identify other impurities like

is formed, although identity testing would always

host cell proteins or leached Protein A.

be included, but [with] developing safe, effective

To illustrate the importance of such steps,

therapies through identification of the critical

Maryann Shen, PhD, LCMS global marketing

quality attributes. Ideally, these attributes, which

program manager, Agilent Technologies, discusses

need to be controlled through production, should

how they relate to a representative characteri-

be continuously monitored to ensure the continued

zation activity, glycan profiling. " Many approved

efficacy and safety of the product. "

biopharmaceuticals are glycoproteins, " she says.

This assessment of modifications is an area of

" Glycans can play an important role in drug

active research for industry, says Malmquist. He told

efficacy and safety. Regulatory agencies demand

us, " The extent of post-translation modifications

detailed analysis of glycosylation. Glycan profiling

lead to a severe variability of the mAb structure and

is a very common step in the characterization of

therefore to a large number of potential product

the mAb. "

related impurities that need to be characterized.
" An emerging trend [to achieve this] is to look at

Characterization challenges
posed by heterogeneity

so-called multiattribute methods, which are based

Biomanufacturing always involves variability. While

spectroscopy. The goal is to assess multiple quality

production advances have brought greater consis-

attributes with one analytical method. "

tency, the use of living cells in the process makes it
impossible for all variables to be controlled.
For mAbs, this variability usually impacts the

on a combination of peptide mapping and mass

Characterization techniques common
to the lab and the factory floor

product's quality attributes more often than the

Another characterization trend has seen drug

molecule itself, suggests Michael Walker, PhD,

companies take analytical techniques usually

technical expert, LC-MS protein analysis, Intertek

carried out in the laboratory into the production

Pharmaceutical Services. " This route of manufac-

space. According to Malmquist, the approach,

ture, " he points out, " leads to heterogenicity in

which involves firms placing analytical instruments

production lots, specifically in relation to differences

near manufacturing lines, " will increase data

in post-translational modifications, which are

frequency, decrease response times, and improve

hugely significant as they can impact both the

process control. "

efficacy and safety of the final product.
" Understanding the structural characteristics of

8|

GENengnews.com

Eventually, real time release testing may even be
possible which, Malmquist says, would significantly
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