Downstream bioprocessing is an important part of biopharmaceutical manufacturing that helps in the isolation and purification of therapeutic biomolecules from biological sources. Single-use technologies have emerged as a practical alternative to conventional stainless steel-based equipment in downstream bioprocessing applications. Various advantages of single-use systems over conventional stainless steel such as reduced costs, improved process flexibility and scalability, and minimized contamination risks are driving their increased adoption across the biopharmaceutical industry.
Growing Demand for Monoclonal Antibodies
Monoclonal antibodies have emerged as one of the most important biotherapeutic modalities in recent years. The exponential rise in the development and commercialization of monoclonal antibody drugs is a major factor fueling the need for advanced and scalable downstream purification technologies. According to industry estimates, more than 70 monoclonal antibodies are currently approved for therapeutic use globally, with many more in pipeline and development. As monoclonal antibodies are complex biomolecules, their successful recovery and purification require sophisticated downstream processing solutions. Single-use solutions offer scalable and flexible platforms for monoclonal antibody purification from batch to commercial scale. This is expected to significantly increase their adoption for monoclonal antibody downstream processing applications over the forecast period.
Advantages of Single-Use Systems
There are several advantages of single-use systems compared to conventional stainless steel equipment that are driving their adoption in downstream bioprocessing applications:
- Reduced capital costs - Single-use solutions eliminate the need for expensive stainless steel skids and systems. This significantly reduces capital investment costs for setting up new purification facilities or expanding existing capacities.
- Improved flexibility and scalability - Single-use systems are highly customizable and allow for quick scale-up or scale-down operations. This provides improved flexibility to handle varying batch sizes.
- Minimized cross-contamination risks - Single-use systems are disposable after each run which eliminates cleaning, maintenance and contamination carryover issues associated with reusable equipment.
- Faster setup and changeover times - Single-use systems have a simplified design which requires lesser validation and cleaning efforts. This helps speed up equipment set-up between product changeovers.
- Improved process economics - Single-use technologies enable continuous processing which improves product yields. Overall, they provide better resource utilization through single-use operations.
Chromatography Dominates Single-Use Downstream Processing
Chromatography techniques such as affinity chromatography, ion exchange chromatography, and hydrophobic interaction chromatography continue to be widely used unit operations for purifying biomolecules in downstream bioprocessing. Among these, affinity chromatography enjoys an early lead as it allows highly selective capture of target biomolecules by exploiting their natural binding properties. The availability of single-use pre-packed chromatography columns has revolutionized affinity chromatography and other chromatography techniques by addressing scale-up needs as well as eliminating several operational challenges. This has resulted in chromatography emerging as the foremost application segment in the single-use downstream bioprocessing currently. Other key downstream unit operations leveraging single-use technologies include filtration, viral inactivation, and lyophilization.
Regional Insights
North America represents the largest region for single-use technologies in downstream bioprocessing, driven mainly by the large presence of biopharmaceutical CMOs and robust biologics drug pipeline in the region. According to industry estimates, North America accounted for over 40% of the global revenue in 2022. Availability of supportive regulatory guidelines as well as presence of leading global players in the US and Canada boosts the North America. Europe is also a major region attributed to ongoing expansion of biomanufacturing capacities across UK, Germany, France, and other countries. On the other hand, Asia Pacific is anticipated to witness highest growth during the forecast period supported by increasing government investments in healthcare sector, rising R&D activities by local pharmaceutical companies, and improving availability of single-use solutions. Countries such as China, India, Japan, and South Korea will be pivotal in shaping the future growth outlook of the Asia Pacific single-use downstream bioprocessing.
Conclusion
The biopharmaceutical industry is facing steady growth worldwide driven by increasing demand for monoclonal antibody therapies as well as cell and gene therapies. This is creating an upsurge in manufacturing capacities for biologics. Single-use technologies have emerged as a preferred solution in downstream bioprocessing to address flexibility, scalability and economic needs of growing biopharmaceutical sector. Single-use systems will increasingly replace conventional stainless steel equipment over the coming years. With their ability to handle future demands, single-use downstream bioprocessing solutions are positioned for continued strong growth through 2033.
Published Date: Oct 2024
