3M and Catalent Obtain Outstanding Results in Purification and Clarification with 3M™ Emphaze™ AEX Hybrid Purifier
August 19 2015 - 10:40AM
Business Wire
Catalent Pharma Solutions and 3M Purification Inc., recently
investigated a novel purification approach that significantly
increased the performance of the mAb purification process by
enhancing the efficiency of the Protein A column. The process
resulted in a substantially pharmaceutically pure product
immediately after Protein A elution.
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The global monoclonal antibody (mAb) market exceeded 80 Billion
USD in 2013, and is predicted to top 100 Billion USD in 2015. To
sustain this rapid market growth into the future, the
biopharmaceutical industry requires increasingly efficient mAb
purification processes from discovery to commercial
manufacturing.
To meet this increasing product demand, product titers are
increasing, pushing cell culture density and duration to increase.
These cell culture characteristics lead to higher contaminant
levels which, in turn, can affect the efficiency of Protein A
chromatography. Protein A will continue to be the primary capture
step of choice due to its specificity and ability to yield pure
product. However, the increased contaminant load can cause the
purity of the Protein A eluate to drop from 99.9% to the 98-99%
range. While the exact causes and mechanisms of the decrease in
Protein A column performance are still a very active topic of
research, high concentrations of chromatin in cell culture fluid
has been suggested to be a major agent that interferes with Protein
A chromatography, and acts as a precipitation catalyst at various
stages of the process.
3M™ Emphaze™ AEX Hybrid Purifier, the first single-use
chromatography purification product line introduced by 3M, is
designed to help biopharmaceutical manufacturers achieve high
product purity early in the manufacturing process because this can
markedly improve efficiency and process economics. Three 3M core
technologies — advanced polymeric materials, fine fiber nonwovens
and porous membranes — are uniquely integrated into the novel
purification media used in the 3M Emphaze AEX Hybrid Purifier. The
result is an all-synthetic clarifying product line containing both
a novel anion exchange functional nonwoven-supported hydrogel and a
fine particle, bioburden reduction membrane. The 3M™ Emphaze™ AEX
Hybrid Purifier utilizes the high capacity Q-functional hydrogel
and 0.2 µm polyamide membrane to provide a high degree of soluble
and insoluble contaminants reduction. When used at the
clarification stage, it is capable of providing greater than 4 log
reduction of DNA in the cell culture fluid often with throughputs
over 400 L/m2.
To decrease the chromatin content of the cell culture fluid,
Catalent incorporated a 3M Emphaze AEX Hybrid Purifier capsule in
the place of a fine grade depth filter in the primary recovery
process. In this process position, the results were outstanding,
including greater than 4 logs reduction in DNA and an increase in
the efficiency of the protein A eluate pool to nearly injectable
product purity.
Catalent perceives the consequences of this enhanced process
performance to be far reaching. Depending on the specific process,
it may enable:
- restructuring and simplification of the
downstream polishing train and;
- elimination of the polishing train in
the cases where product aggregate content is sufficiently low and
final viral clearance is not required.
The 3M Emphaze AEX Hybrid Purifier attributes of robustness,
scalability, and ease of deployment make this an excellent choice
for enhancing your mAb purification processes.
About 3MAt 3M, we apply science in collaborative ways to
improve lives daily. With $32 billion in sales, our 90,000
employees connect with customers all around the world. Learn more
about 3M’s creative solutions to the world’s problems at www.3M.com
or on Twitter @3M or @3MNewsroom.
About CatalentCatalent is the leading global provider of
advanced delivery technologies and development solutions for drugs,
biologics and consumer health products. With over 80 years serving
the industry, Catalent has proven expertise in bringing more
customer products to market faster, enhancing product performance
and ensuring reliable clinical and commercial product supply.
Catalent employs approximately 8,000 people, including over 1,000
scientists, at 30 facilities across 5 continents, and in fiscal
2014 generated more than $1.8 billion in annual revenue. Catalent
is headquartered in Somerset, N.J. For more information, visit
www.catalent.comMore products. Better treatments. Reliably
supplied.™
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version on businesswire.com: http://www.businesswire.com/news/home/20150819005826/en/
Karwoski & CourageKristin Merchant,
612-342-9721k.merchant@creativepr.comor3M Purification Inc.Ellen M.
McPartlan, 203-238-8760emmcpartlan@mmm.com
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