Decreasing Therapeutic Protein Costs and Improving Process Safety
Chromatography is an essential part of the production of novel recombinant proteins, monoclonal and engineered antibodies, or viral vectors for gene therapy. Market pressure requires manufacturers to speed up development, simplify protein or viral vectors purification processes, and improve process economics. Consistent, scalable and validated purification platform solutions can fast track the purification process from R&D phases up to cGMP large-scale production.
There is a strong pressure to decrease therapeutic proteins market cost, and conventional capture chromatography, particularly Protein A chromatography media, can be a significant contributor to this cost. In addition, there is the cost and inconvenience of handling large buffer volumes and large processing hardware typically required for industrial scale protein production. Strategies to reduce cost and make more efficient use of the chromatography hardware and resin suggest running more but smaller batches ideally in a shorter timeframe. This can be achieved by using single-use chromatography equipment and resins, and/or processing chromatography in a continuous mode.
Continuous, multi-column chromatography allows the switch from large columns used in batch mode to smaller columns cycled and operated in series. Multi-column chromatography (MCC) offers important productivity benefits and economic gains by using significantly less use of expensive chromatography sorbents (i.e. ProteinA or other affinity) and buffers. MCC also results in smaller footprint for chromatography systems, while processing similar harvest volumes, with as result a significant decrease of protein drug production costs.
Pall has a commitment to the manufacturing of industrial chromatography resins that can be operated in conventional, continuous and/or single-use modes.
Chromatography performance can be dramatically increased and costs reduced with the right associated hardware and automation selected. Pall is a leading supplier of chromatography columns, packing skids, and batch and continuous chromatography control hardware.
Continuous and/or single-use operation can be restricted to only the chromatography step or extended to the full process, from cell culture to final product, using stainless steel or single-use technologies. Pall’s integrated solutions allow you to select the best pathway for your process needs.