Growing Pains of
Single-Use Systems
Speeding Up the
Protein Assembly Line
This projection comes from a report produced
by MarketsandMarkets, which divides the
protein engineering market into three applica-
tion areas: biotherapeutics, diagnostics, and re-
search. Relevant technologies cited in the report
include sequence modifcation/glycosylation,
pegylation, display technologies, humaniza-
tion technologies, hybrid technologies, and
transgenic mice.
Similar issues were discussed at two recent
conferences, CHI's PepTalk (held in San Di-
ego) and GTCbio's Protein Discovery Summit
(held in Boston). These events featured cutting-
edge research and highlighted current challenges
and evolving solutions in the feld. Presentations
included novel ways of utilizing mass spectrom-
etry, new strategies to engineer and express pro-
teins in yeast and baculovirus systems, how to
better validate biosimilar drugs, and improved
instrumentation to assess protein aggregation.
The ability to characterize proteins from
i nitial sequence to fnal conformation is criti-
cally important for delineating the safety and
effcacy of protein drugs. "Biological mass
spectrometry (MS)
provides a variety of
see page 10
GE Healthcare Life Sciences' ReadyToProcess single-use platform for
biomanufacturing
Mass spectroscopy plays a critical
role in characterizing the higher order
structure of proteins. angelblue1 / iStock
"There are still limitations with single-use technolo-
gies," remarks Berthold Boedeker, Ph.D., chief sci-
entist, global biologics development, Bayer Pharma,
"particularly in the areas of pretesting and the quality
of disposables, standardization and qualifcation of
bags and connections, and validation of leachables
and extractables, as well as dependency on individual
solutions from different vendors."
To be fair, these limitations have not prevented
single-use processing from achieving success after
success. The successes, rather, are what make the limi-
tations stand out.
Dr. Boedeker attributes the growing popularity
of single-use bioprocessing to rising protein titers,
particularly for monoclonal anti-
bodies, which have led to smaller
Angelo DePalma, Ph.D.
Despite its growing popularity, single-use bioprocessing is not an
unadulterated joy. It is spotted with process quality concerns.
Kathy Liszewski
The feld of protein engineering is booming. It represents a
market that is projected to reach $168 billion by 2017.
see page 22
TO O L S T E C H N O LO G I E S T E C H N I Q U E S
February 15, 2015
www.GENengnews.com
Sticky Ends...
Tattoo Measures
Glucose Levels
4
6
microRNA Gems,
Transcriptional
Settings
Court's "Hard"
Stance Will
Hinder Innovators
16
GEN Roundup:
Researchers
Catch the Exosome
Express
30
Optimizing
Stem Cell
Culture
26