by Downstream processing refers to the recovery and purification of biologically active compounds or therapeutic proteins from fermentation or cell culture broth. It represents a critical stage of the overall biopharmaceutical manufacturing process. The goal of downstream processing is to isolate the therapeutic product in its purest form while removing impurities, contaminants, and cell debris. This purified drug substance must then meet stringent quality standards before it can be formulated into the final drug product.
Traditionally, downstream processing equipment for large-scale manufacturing has consisted of stainless steel components designed for multiple product campaigns and extensive cleaning between batches. However, these systems require expensive validation, cleaning, and maintenance costs. Additionally, changing product types often necessitates equipment modifications or replacement parts. Over time, single-use technologies have emerged as a more flexible alternative approach.
Advantages Of Single-Use Systems
Single-use downstream processing utilizes disposable plastic components and tubing instead of stainless steel vessels and piping. Major benefits of this single-use approach include:
Reduced costs – Single-use systems eliminate the need for capital-intensive stainless steel equipment, facilities for cleaning and storage, and validation documentation. They provide a lower overall equipment footprint.
Faster production timelines – Single-use technologies allow for faster process development timelines. Quick assembly and disposability remove equipment changeover, cleaning, and validation bottlenecks between product campaigns.
Increased flexibility – Flexible, disposable bags and tubing can be reconfigured easily for new product development or clinical trial processes. This adaptability reduces technology transfer challenges.
Minimized cross-contamination risks – Single components are discarded after each batch, removing risk of carryover contamination between products. This enables multifunctional facility usage.
Improved process effectiveness – Disposable elements eliminate leaching and extractables/leachables issues from reused equipment. Seals, gaskets and connectors maintain integrity for each batch.
Application In Purification Steps
Single Use Downstream Bioprocessing have found wide application across specific downstream unit operations:
Clarification/Depth Filtration – Parameters like filter area, pore size and depth media type can be tailored using disposable filter housings and cassettes.
Chromatography – Flexible chromatography columns in disposable plastic or stainless steel housings with pre-packed resins enable modular, scalable capture and purification.
Viral Inactivation/Removal – Single-use packed-bed chromatography and filtration are suitable for steps like low pH or solvent/detergent treatment.
Concentration/Diafiltration – Tangential flow cassettes or hollow fiber cartridges efficiently concentrate and buffer exchange in single-use assemblies.
Formulation/Fill-Finish – Formulation buffer addition, sterile filtration and filling can utilize disposable tubing and bags from small to commercial scale.
Quality Considerations
While single-use technologies provide clear advantages, their adoption requires consideration of unique quality factors:
Extractable/leachable testing – Materials must be qualified to ensure no extractables or leachables above safe thresholds are introduced.
Sterilization validation – Gamma, e-beam or autoclave sterilization of plastic films, seals and connectors needs validation.
Process characterization – Potential for material degradation or extractables with exposure to different solutions or temperatures needs evaluation.
Supply chain management – Reliance on consumables necessitates planning for raw material availability and forecasting of disposables usage.
Training and documentation – New skillsets and documentation procedures are required to implement and maintain single-use systems effectively over the product lifetime.
With appropriate controls and protocols established, Single Use Downstream Bioprocessing has gained widespread adoption in the for its total-cost benefits. As therapeutic protein demand grows, it represents a sustainable solution for flexible, efficient biomanufacturing.
*Note:
1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile it
About Author - Money Singh
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. LinkedIn Profile
