With a significant impact on biopharmaceutical manufacturing, downstream processing continues to limit capacity within the industry. Working to reduce capacity constraints, new downstream technologies are continuously being introduced. Virus filtration, column packing and affinity resins are just a few of the downstream operations causing the greatest issues. Working to move past regulatory bodies, including the FDA and EMA, several new downstream processing solutions are under consideration for industry-wide release.
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AREAS OF CONCERN
Currently, there are several bottlenecks within the biopharma industry. Many of these bottlenecks are due to the increase in upstream fermentation and cell culture yields. Complex and costly, downstream processing benefits most from small, incremental changes. Working to keep operating costs low, downstream processing can be improved if bottlenecks surrounding efficiency, yield and quality of process flows are acknowledged and improved. Two prominent areas of downstream processing, harvesting and chromatography, are currently benefiting from a variety of new methods and procedural modifications.
A trusted method of sample separation during purification, chromatography requires effective resins. Biopharma experts stress the extensive amount of resins currently available and how similar they all are, while lacking differentiating features. Suggested chromatography, purification and overall biotechnology improvements include new affinity formats, chemistries, resins, ligands, Protein A alternatives, more and less expensive custom ligands and new Protein L/mAb fragment resins. End-users suggest that more Protein L and other resins are also needed.
An important aspect of downstream processing, membrane technology can limit or enhance production methods. A significant bottleneck, membrane capacity curbs functionality and choices among membranes. Industry experts have suggested more diverse membranes, multilayered or mixed-mode membranes and a better variety of beads, linkages, resins, ligand and formats. Binding-and-elute/capture membranes, especially Protein A, options should also be expanded.
Clarification and Harvesting
Several issues are arising from clarification and harvesting operations within the biopharma industry. Fouling, complexity, scaling, selection and over-extended variety are just a few biotechnology problems requiring improvement. Industry experts suggest flocculation and the introduction of scaled bioprocessing as necessary new technologies. The ability to develop processes at small and large scales, so the process is predictable at various scales, is also in-demand.
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Outdated filtration, purification and chromatography are creating significant bottlenecks in the biopharma industry. Both manufacturers and vendors are working to introduce new technologies to improve downstream systems. There’s a noticeable push to move away from traditional Protein A as an affinity chromatography ligand and find other solutions that are both cost-effective and available to regulatory authorities. In addition to the wealth of alternatives to Protein A, there are various other technologies that are seeking to improve the biotechnology sector.
Affinity Purification Methods
Often considered the most important biopharmaceutical, protein production methods are costly and difficult to scale up. New affinity purification methods are working to enhance the efficiency of protein purification. Based on the expression of proteins or MAbs as fusion proteins, new purification methods focus on scalability and automatable procedures. Commercial availability is dependent on regulatory approval.
Column-based fractionation methods, including size exclusion and chromatography, are the standard techniques for complex polymer analysis. However, certain polymers, for large aggregates or other entities, cannot be properly analyzed by current, column-based methods. New fractionation methods are set to enhance upon current methods. Field-flow fractionation (FFF) is an open-channel technique that does not use a stationary phase. Problems related to the stationary phase are avoided by this new approach. Offering immense potential, new fractionation methods ease complex polymer analysis.
One of the most important units in biopharma processing, membranes are used for filtration and harvesting. Significant developing technologies are focused on using composite membranes to create high permeability, high capacity sterile filters. Other development trends are investigating the possibility of applying membrane absorber to the capture and purification processes of large biomolecules. Further advancements are being made in membrane size distribution, flow distribution and thickness.
Actively looking for new and better technologies, the biopharma industry often suffers under strict regulations that slow the adoption of new downstream processing methods. With a conservative nature towards adopting new technologies, biotechnology continues to advance forward with strategic new approaches. Some popular recent advances include single-use downstream technologies and membrane-based filtration technologies. Once regulators are on board, further improvements are expected to be implemented throughout the industry.