Sartorius - Simplifying Progress in Biopharmaceutical Manufacturing

Sartorius has evolved over 150 years from a precision mechanical workshop into a leading international life science group. Both then and today, our innovative tools have helped researchers make scientific discoveries and drive progress.

Life science markets and technologies are constantly evolving. Currently, our primary focus is serving the biopharmaceutical sector - an industry that did not even exist 150 years ago. However, our goal remains to support scientists and engineers with innovative tools to help them develop and manufacture biologics from drug discovery to commercial production, giving more people access to better medicine.

Here, we present excerpts from two recent Sartorius white papers dealing with key industry challenges: maximizing efficiency in downstream processes and navigating cell and gene therapy challenges.

Maximizing Productivity With Downstream Process Intensification Tools

One area in which we excel is offering our clients tools to implement process intensification strategies, which offer an excellent opportunity for improving overall efficiency within the biopharmaceutical industry.

Significant progress toward process intensification has been made for well-established modalities such as monoclonal antibodies (mAbs), fusion proteins, and bi- | multi-specifics. The industry is also beginning to explore process intensification in newer modalities such as adeno-associated viruses (AAVs).

Most of these advances and process adaptations have been applied upstream, where the industry has many options for adopting intensification, from simple (N-1) perfusion to a steady-state perfusion process in the production (N) bioreactor. However, downstream processes have not kept up with these advances, so while upstream process intensification strategies have greatly improved productivity, the industry faces bottlenecks when purifying the feeds with increased titers.

A recent industry survey reported that the top bottlenecks biomanufacturers encounter during downstream processing are clarification, lower productivity and high costs of Protein A resins for mAb capture, productivity and buffer requirement constraints posed by chromatography resins | columns, and lack of efficient equipment platforms that can be connected to upstream to maintain and improve productivity and footprint to process all the downstream steps [1]. In fact, when asked, “Which new downstream purification technologies are you actively considering to address bottlenecks and problems?” the top response (37.7% of respondents) was adopting continuous (or connected) purification systems.

Clearly, the industry is looking for solutions to connect upstream (whether intensified or fed-batch) and downstream process steps to leverage and maintain increased productivity while reducing cost and facility footprint. Though there have been efforts made in developing scaled-down models connecting upstream bioreactor with the capture and subsequent chromatography steps, scale-up | GMP-scale adoption has been hindered by the effort, cost, and time required to integrate and connect existing ‘islands’ of downstream systems to replicate the scale-down models.

Sartorius offers a range of solutions for downstream intensification, whether you want to boost the productivity of your capture step or intensify your entire downstream process. We recently worked with Enzene Biosciences to develop a simple, gradual approach for connecting downstream unit operations to demonstrate the potential ease of introducing process intensification into your process. The aim was to use the Resolute® BioSC to reduce overall downstream processing time, creating further opportunities for even higher productivity at a reduced footprint. Learn more about the collaboration in our white paper [2].

End-to-End Cell and Gene Therapy Solutions

While optimizing downstream processes is crucial for enhancing overall productivity in biopharmaceutical processes, the rapidly evolving field of cell and gene therapy presents its own set of unique challenges and opportunities. We share your mission to develop these life-changing next-generation biologics, which offer treatment and cures for diseases previously thought to be incurable and, as such, are addressing critical, unmet clinical needs.

The demand for these innovations is on the rise, with the potential of cell and gene therapies now extending far beyond the treatment of rare and ultra-rare diseases. The increased attention has also highlighted the need for manufacturers to develop tools that expedite the commercialization of their products, thereby increasing patient access to effective therapies.

However, the rapid evolution of the field brings challenges, including navigating regulatory hurdles, developing and scaling complex manufacturing processes, and overcoming logistical challenges related to specialized handling. These are associated with long timelines and high costs, but neglecting to take the appropriate measures increases the risk of trial failures.

The rapid advancements in cell and gene therapies are revolutionizing the treatment landscape for previously incurable or untreatable diseases. However, the journey from development to commercialization is paved with hurdles, including achieving reproducible performance, streamlining scalability, and navigating complex regulatory landscapes. These challenges must be overcome to provide patients with a reliable supply of high-quality treatments.

Sartorius is committed to partnering with you to overcome these obstacles. By leveraging our end-to-end solutions, you can ensure high-quality, scalable, and compliant processes that meet the stringent demands of the industry. By prioritizing quality from the start, you can adopt scalable, compliant tools and take advantage of regulatory expertise to accelerate time to market. Together, we are setting the standard in cell and gene therapy. To learn more about how we are helping you solve cell and gene therapy manufacturing challenges, read our recent white paper [3]. 

Browse our end-to-end bioprocessing solutions

References

[1] BioPlan Associates. (2023). Twentieth Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production. A Study of Biotherapeutic Developers and Contract Manufacturing Organizations
[2] Gupta, P., McLaughlin, K., Kumar, G., & Jadhav, S. (2023). Re-imagining chromatography: Building efficient, connected downstream processes [White paper]. Sartorius
[3] Ladi, R., Ede, D., & McLaughlin, K. (2024, September). Setting the standard in cell and gene therapy: Perspectives on performance, scalability, and regulatory compliance [White paper]. Sartorius