Downstream bioprocessing is a crucial step in the production of biologics such as monoclonal antibodies, recombinant proteins, vaccines and gene therapies. Traditionally, downstream purification has relied on stainless steel processing equipment that requires cleaning between batches. However, single-use technologies using disposable components are increasingly being adopted to streamline purification workflows and improve flexibility.
Moving From Stainless Steel To Single-Use Systems
For decades, downstream operations were carried out in large, complex stainless steel equipment that dominated facility footprints. They required complex cleaning and sanitization between each batch run, consuming both time and resources. The fixed nature of the equipment also made it challenging to rapidly switch product lines or improve processes. Single-use systems address many of these limitations by utilizing pre-sterilized bags, filters, mixers and other components that can be discarded after each use. Without the need for cleaning, single-use setups dramatically reduce turnaround times between runs from weeks to just a few days. They also effectively eliminate the risk of cross-contamination between products.
Adoption of single-use technologies was initially driven by the biopharmaceutical need for rapid process development as it progressed novel molecular entities through clinical testing. By switching to flexible single-use systems, researchers could evaluate multiple processing conditions and formulations in parallel without the constraints of large-scale stainless steel equipment. As processes matured, some manufacturers have moved validated production runs to single-use manufacturing trains for commercial launch. For batch mammalian cell culture processes, it is now common to see single-use technologies applied throughout downstream purification from harvest to final filtration or chromatography steps prior to filling.
Commercial Benefits Of Single-Use Downstream Processing
Beyond technical advantages, Single Use Downstream Bioprocessing also deliver significant commercial benefits that are driving increased adoption across the . By eliminating cleaning and validation of reusable equipment, facilities enjoy reduced operational costs, footprint requirements and validation timelines to get new products to . Capital investment is lower as expensive stainless steel skids are replaced by pre-assembled single-use systems. Additionally, single-use processing trains are well-suited for continuous manufacturing where multiple steps are directly connected without intervening equipment washing. This could enable construction of future 'continuous bioprocessing plants' dedicated to a particular product.
Continuous Chromatography: A Key Enabler
A major advancement is the development of single-use continuous chromatography columns utilizing plastic housing and pre-packed resins. Continuous chromatography processes product continuously through connected single-use columns rather than in batch mode. For capture and polishing steps, this allows near-complete utilization of resins' binding capacities. Continuous column skids eliminate hold times between cycles and enable multi-column connections for increased throughput.
Emerging platforms utilize alternating tangential flow filtration and continuous chromatography in directly connected single-use systems. Products continuously circulate through subsequent unit operations without intermediate storage tanks or hold times. Such integrated continuous purification trains could someday process multiple fed-batch bioreactor harvests as a continuous stream. This would maximize capacity and flexibility of single-use based manufacturing footprints.
Challenges For Wider Implementation
While single-use technologies offer clear benefits, wider adoption of end-to-end continuous processing using single-use components still faces challenges. Integrating multiple single-use unit operations and maintaining sterility across directly connected plastic components is technically complex. Flexible plastic tubes suitable for continuous processes also introduce their own qualification and extractables/leachables considerations. On the process side, robust control strategies are required to maintain continuous purification performance over extended run times. Overall, substantial process development efforts are still needed to design, control and qualify fully continuous single-use manufacturing trains for commercial production of critical biopharmaceuticals.
As biomanufacturers progress towards fully continuous Single Use Downstream Bioprocessing technologies, current purification strategies are moving in this direction. Single-use systems are already transforming batch downstream operations by streamlining set-up and teardown while maintaining product quality. Continuous chromatography is a promising platform enabling high resin utilization. In the future, truly integrated continuous single-use purification trains could further improve capacity, flexibility and reduce facility footprints for biomanufacturing. With ongoing technological advancements and process understanding, single-use components may one day enable construction of standalone continuous bioprocessing plants.
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Author Bio:
Money Singh is a seasoned content writer with over four years of experience in the market research sector. Her expertise spans various industries, including food and beverages, biotechnology, chemical and materials, defense and aerospace, consumer goods, etc. (https://www.linkedin.com/in/money-singh-590844163 )
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1. Source: Coherent Market Insights, Public sources, Desk research
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