Antibody fragment production breakthrough with 2nd generation EBA
27 May 2009
Richter-Helm BioLogics GmbH & Co. KG has announced a technological
breakthrough in the purification of antibody fragments from an E.
coli expression system.
Richter-Helm BioLogics has finalized the downstream process for Phase
III clinical trial material using 2nd generation expanded bed adsorption
(EBA) technology developed by the Danish biotech company Upfront
Having conducted a series of tests, Richter-Helm has discovered
significant advantages of 2nd Generation EBA over the latest,
alternative chromatographic methods. A 60% increase in yield was
observed using direct capture.
The simplified process is less likely to cause processing problems.
The processing time to take product from homogenate to clarified,
partially purified material was reduced to one working day, decreasing
the possibility of product degradation. The volume of buffers required
to perform clarification and capture was reduced significantly,
effecting cost of manufacture.
Upfront’s innovation lay in the usage of higher density adsorbents
and the proprietary design of an operational system which provides
increased flow rates and is free from clogging and channel formation.
Rhobust has improved Richter-Helm’s offering to customers operating
with microbial derived products, providing a superior downstream process
for clinical manufacturing. Richter-Helm embraced this technology under
tight timelines and cost pressures and has been rewarded with a superior
downstream offering in the CMO market.
The Rhobust universal processing platform from Upfront Chromatography
enables customers to efficiently capture and purify monoclonal
antibodies, therapeutic proteins and other biomolecules directly from
blood plasma or bioreactors, without the need for prior filtration.
A selection of proprietary mixed mode ligand chemistry enables
efficient control of the capture and release of target molecules by
simple changes of pH, which can be readily implemented in large-scale
production facilities and maintain biological activity of the product.
Mixed mode ligands are selected for their suitability for industrial
processing, in particular their stability during high temperature
cleaning with 1M NaOH, low toxicity, and very low leakage from
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