From Concept to Cleanroom: Case Studies in Single-Use Fluid Management Collaboration (Webcast Recap)

Single-use (SU) bioprocessing has enabled optimization and innovation for many biomanufacturing processes. Specific facilities have particular needs, and by collaborating with suppliers that have expertise in design, extrusion, molding, fabrication, and assembly, biomanufacturers can leverage vendor knowledge to enhance bioprocess development. Collaborative relationships between suppliers and end users are vital for the success of SU solutions. Three Repligen team members — Gregory Verni (vice president of fluid management), Derek Masser (director of business and market development), and Scott Bendon (senior director of research and development, R&D) — presented three case studies to demonstrate the importance of such collaborative relationships in a September 2024 Ask the Expert webinar.

The Presentation

Keep an Open Mind: One company planned to use an automated filling machine to aliquot buffers into 125-mL preparations several thousand times annually and needed a SU supplier to create a compatible flow path. The company was hesitant to invest in expensive equipment but knew of no alternative. Through open collaboration, Repligen suggested an alternative approach: Instead of recommending an expensive, complex system, the team developed a straightforward filling manifold that met all customer requirements. The solution involved minimal setup, required only a peristaltic pump, and eliminated the need for more costly equipment such as load cells and weigh scales. This case demonstrates how a collaborative approach can provide efficient and cost-effective solutions.

Don’t Design in the Dark: The growing use of hybrid systems, which combine multiuse stainless-steel equipment with SU technologies, presents challenges in ensuring smooth transitions between the two equipment formats. Another company needed a solution that would allow for increased flow rates in a bulk transfer system while reducing downtime between process runs. Conventional diaphragm-valve (DV) technology required labor-intensive cleaning validation, which slowed down manufacturing. Repligen worked closely with the customer to design an optimized product, adapting an existing two-way pinch DV with SU injection-molded liners. The result met the company’s needs by providing a sterile connection between stainless-steel and SU systems, increasing flow rates, simplifying cleaning processes, and improving overall production capacity.

Prepare for Supply-Chain Risks: Another company sought secondary and tertiary sources for its SU flow paths to reduce supply-chain disruptions. The challenge was finding alternate suppliers whose flow paths could fit existing equipment. Bag geometries from different suppliers can vary significantly, making it difficult to design a system that could accommodate different formats. Through close collaboration with the customer, Repligen designed totes and racks capable of holding bags from three different suppliers. That design required adjusting for different bag geometries and port configurations. Using polypropylene as a material of construction provided the flexibility needed to accommodate such variations. The success of this project relied on transparent communication and a willingness from the supplier to work with other vendors, ensuring that the customer had multiple options for sourcing their SU flow paths.

Key Lessons: The three case studies illustrated important lessons for biomanufacturers that want to optimize their processes through SU technologies. Being open to new ideas and collaborating with suppliers can bring more innovative and cost-effective solutions than are anticipated initially. Transparency between suppliers and users is essential in ensuring that products will be designed correctly from the start. Preparation is key to minimizing supply-chain risks.

SU technologies offer several advantages across bioprocessing. Suppliers with broad portfolios of SU solutions and vertically integrated capabilities can help to innovate solutions that address unique process challenges. The ability to customize solutions based on specific needs while maintaining an open dialogue ensures that end-user processes will be optimized for efficiency, safety, and scalability.

Questions and Answers

What film options does Repligen offer for bulk-hold bags? We offer Renolit 9101 and our proprietary five-layer ProConnex RG-V films. Our films are made up of ultra low-density polyethylene layers and durable structures to work with many types of bulk-hold bags.

Can valve inserts be added to the end of an SU assembly? Yes, the valve’s outlet side is configurable to many applications.

Visit https://repligen.com/products/fluid-management for more information.

Find the full webinar online at www.bioprocessintl.com/category/webinars.