Development For Downstream Processing Units

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Development For Downstream Processing Units

 Development For Downstream Processing Units

Downstream processing refers to the processes that take place after fermentation to recover and purify the product. Following cell culture, recovery is carried out by centrifugation and filtration from which the resulting cell harvest is transferred to the low-productivity purification processes. Purification of biologics involves usually Protein-A affinity chromatography, ion exchange chromatography and further filtration. Protein-A affinity chromatography is the most widely used method for capturing immunoglobin when purifying antibodies. However, productivity using this method is limited by the slow flow rates of resin columns. The price of Protein A resins contributes to the high prices being paid for by patients for biologics as it can cost up to €14,000/L (Franzreb M et al. ,). In trying to match the productivity of the upstream processes, the resulting Protein-A resin columns are oversized to increase the volumetric flow rate. This requires large investment in larger columns, larger facilities and associated equipment.Development For Downstream Processing Units

Further polishing steps such as anion and cation exchange chromatography are also used to purify the antibodies. These long, complicated processes result in non-optimal yields and increased risk of lost batches due to contamination or operator error. Sophisticated SU technologies such as perfusion bioreactors are pushing productivities that are more than 25 × higher than batch culture (Wang L et al. ,). This has resulted in downstream processes struggling to keep up with the increased workload which has led the biopharmaceutical industry to seek new technologies to take advantage of the increased output in upstream processes.