Improved Downstream Processing at Richter-Helm with 2nd Generation Expanded Bed Adsorption Chromatography
News Oct 29, 2009
A Phase II manufacturing process that used a high titre antibody fragment secreting, high-cell-density E. coli expression system and Upfront’s 2nd Generation EBA chromatography resulted in a 60% improvement in product yield compared to conventional clarification processes. By implementing EBA chromatography a 56% reduction in processing time in the cGMP suites has been achieved, as filtration steps, especially Cross-Flow-Filtration, are not necessary. Product quality is not compromised by removing this step. Further detailed data from these studies were presented by Dr. Timo May, Head of Downstream Processing, Richter-Helm at the 2nd Biomanufacturing Symposium, Hanover, Germany, 7th October.
“The manufacturing process with EBA chromatography required less facility time, allowing us to either increase the batch number or be operationally more flexible. The flexibility is of particular importance for busy contract manufacturing sites,” says Dr Timo May, “It is a simple and robust technology with a high degree of capability. Companies can save significant costs if EBA chromatography is implemented into downstream processes at an early stage of a product’s clinical development.”