By Jay Collins, MBA, CAPM®, Product Manager, Charter Medical
As bioprocessing companies and advanced therapy manufacturers work to strengthen sterility assurance, streamline operations, and accelerate time to market, building closed-system fluid management workflows with custom single-use solutions has emerged as a key strategy for achieving these objectives.
Custom single-use solutions are critical to the success of both upstream and downstream operations, providing sterile, integrated fluid management pathways throughout the manufacturing process. From media and buffer preparation to cell processing, harvest, and final fill operations, custom single-use assemblies enhance process flexibility and efficiency, simplify scale-up, reduce contamination risk, and enable faster implementation of manufacturing workflows while safeguarding product quality and integrity.
Specifically, single-use technologies can support numerous bioprocessing steps, including:
- Aseptic connections between seed trains, bioreactors, and process equipment
- Buffer preparation and storage using customized bag and tubing assemblies
- Cell culture media preparation and storage in ready-to-use sterile containers
- Drug product formulation, containment, and storage prior to filling and packaging
- Drug substance containment, freezing, and storage for intermediate and bulk biologics
- Pre-Use Post-Sterilization Integrity Testing (PUPSIT) assemblies that allow manufacturers to verify filter integrity before processing product while maintaining a closed, sterile fluid pathway
- Sampling operations that enable safe, sterile process monitoring without exposing product
By enabling closed fluid pathways throughout these operations, single-use solutions help manufacturers improve sterility while reducing facility complexity and cleaning requirements often associated with traditional stainless steel-based processes.
Closed-System Upstream Bioprocessing With Custom Single-Use Solutions
Upstream bioprocessing encompasses all activities associated with cell line expansion, media preparation, seed train development, and bioreactor cultivation. The objective is to create optimal conditions for cells to grow and generate the desired therapeutic product.
Custom single-use solutions can support a wide range of upstream applications, including:
- Cell culture media preparation and storage
- Buffer preparation and hold operations
- Seed train transfer assemblies
- Bioreactor feed systems
- Harvest transfer systems
- Sampling systems
- Manifold assemblies
Custom solutions are particularly valuable because they can be designed around specific process requirements, equipment interfaces, facility layouts, and scalability objectives. Integrated tubing, connectors, filters, sensors, and containers (featuring different geometries, if required) can be configured into a single, ready-to-use closed-system assembly that reduces operator intervention and streamlines workflow execution.
The benefits of custom single-use technologies in upstream processing include:
- Reduced risk of contamination through closed-system design
- Elimination of cleaning and cleaning validation requirements
- Faster changeovers between batches
- Greater manufacturing flexibility
- Simplified scale-up and technology transfer designed to specific workflow processes
- Lower capital equipment investment
- Reduced facility footprint and utility consumption
For emerging therapies and multiproduct facilities, these advantages can significantly accelerate development timelines while improving manufacturing efficiency.
Closed-System Downstream Bioprocessing With Single-Use Solutions
Downstream bioprocessing includes all steps required to recover, purify, concentrate, formulate, and store the therapeutic product after cell culture production. Product quality, yield, and process consistency are key priorities during this phase.
Single-use systems support numerous downstream applications, including:
- Chromatography feed, collection, and buffer management assemblies
- Filtration and tangential flow filtration (TFF) operations
- Viral filtration and PUPSIT processes
- Product pooling and intermediate storage
- Bulk drug substance freezing, storage, and cold-chain transfer
- Final formulation preparation
- Bulk drug product containment and transfer
Custom downstream solutions provide manufacturers with tailored fluid paths that can integrate filters, tubing, connectors, sampling ports, manifolds, and storage containers into a single sterile system. These solutions minimize manual connections and help maintain closed processing conditions throughout purification and formulation workflows.
Benefits of single-use technologies in downstream operations include:
- Enhanced sterility assurance
- Reduced cross-contamination risk
- Improved process consistency
- Quicker implementation and validation
- Increased operational flexibility
- Lower maintenance requirements
- Reduced downtime and manufacturing costs
As biologic pipelines become increasingly diverse, customized single-use solutions enable manufacturers to adapt equipment and processes without extensive facility modifications.
Choosing the Right Single-Use Solutions Partner
The success of a closed-system bioprocessing strategy depends heavily on selecting the right single-use solutions partner. An ideal supplier should possess deep expertise in both upstream and downstream fluid management workflows, from prototyping to scale-up for commercialization. This includes understanding which fluid containment bags, filters, tubing, connectors, manifolds, and materials of construction are most appropriate for each application and manufacturing process.
Key partner attributes of the ideal single-use solutions partner include:
- Robust custom design and engineering capabilities, supported by strong partnerships that align with customer preferences and application requirements
- Proven quality systems and regulatory support, including validation documentation, extractables and leachables (E&L) support, and change-control management
- Proven manufacturing experience and scalable production capacity
- Extensive material science expertise
- Strong supply chain security and continuity planning
- Collaborative project management and technical support
- Validation support
Custom capabilities are particularly important because every manufacturing process presents unique technical, operational, and regulatory challenges. An experienced supplier can design assemblies tailored to specific workflows, equipment interfaces, and scalability requirements. In many bioprocessing and advanced therapy development applications, the product being manufactured is both highly valuable and vital to patient care. As a result, manufacturers require robust, customized single-use solutions that support process reliability, product protection, and uninterrupted manufacturing performance.
Equally important is a supplier’s ability to ensure long-term supply continuity. Manufacturers increasingly seek partners with diversified supply networks, proactive change-control programs, robust business continuity planning, and reliable access to critical materials. These capabilities help minimize supply disruptions while maintaining consistency throughout the product lifecycle.
Charter Medical is well positioned to support these requirements through comprehensive custom single-use assembly capabilities and decades of fluid management workflow expertise. Combined with parent company Solesis’ advanced polymer and film development capabilities, Charter can provide integrated solutions that address demanding bioprocessing applications while supporting quality, performance, and supply continuity objectives.
Building a Closed-System Bioprocessing Strategy With Charter Medical
Closed-system bioprocessing has become a cornerstone of modern biomanufacturing, helping organizations improve sterility, flexibility, and operational efficiency.
As bioprocessing companies and therapy manufacturers continue to demand flexible solutions that support sterility, scalability, and efficiency, single-use technologies have become an ideal option for implementing closed-system processing to reduce complexity and accelerate implementation. By partnering with Charter Medical, manufacturers gain access to customizable fluid management solutions, engineering and materials expertise, and dependable supply chain support to bring life-changing therapies to patients faster.
About the Author
Jay Collins, MBA, CAPM®, is the Product Manager at Charter Medical in Winston-Salem, North Carolina. Jay is responsible for managing Charter’s single-use portfolio, introducing new products and providing cross-functional project leadership. Jay leverages his experience in market research, product operations, and product management in the medical device and single-use industry to drive growth in global markets. Jay has a B.S.B.A. from the University of North Carolina at Charlotte and an MBA from Appalachian State University in Boone, NC.