The biopharmaceutical industry is entering an exciting and transformative phase. Increasing demand for treatments that address unmet medical needs while remaining affordable is driving significant changes. This is reflected in rising numbers of US Food and Drug Administration (FDA) approvals for biologics each year. Biomanufacturers are expanding beyond monoclonal antibodies (mAbs) into new modalities such as cell and gene therapies (CGTs), without losing focus on the substantial market potential of mAbs.

Biopharmaceutical companies are tasked with balancing the development of new therapeutic modalities and reducing manufacturing costs while maintaining environmental responsibility. Efforts are underway for improving process robustness and efficiency and creating more flexible manufacturing facilities that can accommodate diverse biological products. Key strategies include adopting single-use technologies, implementing process-intensification and continuous-manufacturing strategies, enhancing process analytics, and developing digital capabilities to leverage artificial intelligence (AI) in development and manufacturing while aiming for sustainable operations.

At Tosoh Bioscience, we are committed to supporting biomanufacturers toward achieving their goals of producing affordable, high-quality medicines. In addition, sustainability is a core value that is integrated into every facet of our business. We are dedicated to implementing robust sustainability measures at the corporate level and incorporating ecologically friendly practices into our product development to enable sustainable production processes for the biopharmaceutical industry. Industry can pursue sustainability through process intensification and continuous manufacturing. Continuous manufacturing not only increases manufacturing sustainability, but also streamlines production and enhances the flexibility and scalability of biopharmaceutical operations, enabling rapid responses to market demands and regulatory changes.

Tosoh has developed multicolumn chromatography (MCC) skids and specialized columns to tackle those evolutions:

• Octave BIO process development system

• Octave PRO large-scale production system for good manufacturing practice (GMP) operations

• SkillPak prepacked chromatography columns.

Working Together

Through collaboration with Catalent Pharma, one of the largest global contract development and manufacturing organizations (CDMOs), Tosoh has optimized both the hardware and software for the Octave PRO skid to facilitate GMP operations. This partnership is meant to accelerate the implementation of MCC in the highly regulated production stage for clinical materials.

To develop MCC instruments further in anticipation of future industry activities, we joined the ECOnti project for developing innovative technologies that require relatively small production facilities, reduce water and energy consumption, and help users limit their carbon dioxide (CO₂) emissions. Led by enGenes Biotech GmbH and supported by the Austrian Research Promotion Agency (FFG), the ECOnti project is meant to develop a fully integrated and automated continuous upstream and downstream process at up to 10-L batch size, featuring the Octave BIO MCC skid for downstream processing. Technology developed within this initiative will offer several key advantages, including reducing the necessary size of production facilities, lowering water and energy consumption, and limiting CO₂ emissions — while providing end-to-end process control, full digitization and automation, increased product yields, and enhanced process stability.

Additionally, Tosoh Bioscience has announced a pioneering partnership with Dr. Michael Wolff, a professor at the University of Applied Sciences Mittelhessen (THM) in Gießen, Germany. This collaboration focuses on developing continuous purification processes for viral vectors and other viruses. By financing a research position and supplying essential equipment, including an Octave BIO MCC system, Tosoh Bioscience is dedicated to advancing solutions that meet the critical needs of the CGT industry. This partnership exemplifies our company’s commitment to innovation and industry–academic collaborations, with the goal of making future CGT manufacturing processes more cost-effective and accessible than current technologies allow.

That commitment extends to the design of single-use consumables. A first example is our SkillPak prepacked chromatography columns. By 2025, we will introduce columns for GMP production, with dedicated product lines for both batch and MCC applications. The columns will use significantly less plastic than traditional options and incorporate recycled glass fibers, further supporting sustainable practices. Another option will cater to the mAb market.

To enhance process robustness and flexibility, our new Toyopearl Super A resin offers significant advantages for mAb manufacturers looking to implement a capturing platform to reduce their time to market. This resin provides high binding capacity at shorter retention times, robust alkaline stability, reduced pressure loss, and minimized aggregation with elution at pH 4.0. Those attributes bring more process flexibility and robustness to antibody manufacturing, improving overall efficiency and product quality.

Following the COVID-19 pandemic, industries have emphasized business continuity, with many biomanufacturers forging closer collaborations with the suppliers of their critical consumables to ensure supply-chain resilience. To bolster business continuity, Tosoh is expanding its manufacturing capacities.

That includes constructing its fifth manufacturing facility in Japan, this one located at the Yokkaichi Complex in Yokkaichi City, Mie Prefecture. The facility complements the company’s fourth plant, which is under construction in Nanyo, Shunan, Yamaguchi Prefecture and will open in 2025. The fifth site for chromatography media production is expected to be operational by the middle of 2027. These expansions will ensure that our customers can plan confidently for business continuity and expect an assured supply for their own future expansion needs.

R&D for the Future

The biopharmaceutical industry is navigating a period of rapid change and growth during which a drive to address unmet medical needs with new and affordable treatments pushes biomanufacturers to innovate and adapt. Tosoh Bioscience is committed to supporting those efforts through capacity expansions, process-intensification initiatives, and unwavering commitment to sustainability. We also are engaged in numerous promising research and development (R&D) projects at different stages for supporting customers in their own process-development efforts for novel modalities such as oligonucleotides, adenoassociated viruses (AAVs), and others. Tosoh’s continuous focus on innovation and improvement ensures that we remain at the forefront of biopharmaceutical manufacturing, helping our customers meet the growing demands for effective and affordable treatments.

We are proud of our achievements so far and view innovation and sustainability as an ongoing journey. Our approach includes continuous improvement, investment in R&D for improving the efficiency and sustainability of our products, and partnering with stakeholders. By working closely with our partners and continually investing in R&D, we strive to help the biopharmaceutical industry meet its ambitious goals and improve patient outcomes worldwide.

Balu Guduri is global product manager for process consumables at Tosoh Bioscience GmbH in Griesheim, Germany; [email protected]; https://www.tosohbioscience.com.

Octave, SkillPak, and Toyopearl are registered trademarks of Tosoh Bioscience.