Antibody Fragment Production Breakthrough with 2nd Generation EBA

05-18-2009: Richter-Helm BioLogics GmbH & Co. KG announced a technological breakthrough in the field of 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 Chromatography A/S.

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. According to the company, 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.

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 adsorbent.