Bioprocessing Liquid Cell Culture Media & Buffers

Ready-to-use Solutions that Optimize Production

Process steps such as media and buffer preparation or hydration of bulk powders can consume precious time, labor, and manufacturing floor space. Our ready-to-use sterile filtered liquid solutions eliminate the extra tasks, workforce and space associated with hydrating bulk powders, such as tubing and refilling, sample taking, and additional quality control testing streamline your processes while providing advantages such as:

• Fewer operational and contamination risks
• Reduced process footprint, freeing more floor space
• Elimination of tasks associated with hydrating bulk powders, including extra filtration steps, tubing and refilling, sample taking, and additional quality control testing
• More resources available for value-added tasks and core activities
• Right-sized buffer delivery, reducing chemical waste and WFI use for improved sustainability

Your sterile filtered liquid arrives ready-to-use in the quantities you need, with no waste and no excess to inventory. Our manufacturing facilities are specifically designed to provide sterile filtered products in a wide range of final vessel formats, from standard PET bottles to standard or custom bags, as well as custom volumes and formats. Our products are sterile filtered liquids which are supporting your research and further manufacturing processes. To ensure safe delivery of your sterile filtered liquids, our packaging and transport options include:

• Mobius^® or equivalent standard single-use bags, as well as the Mobius^® MyWay Portfolio of customizable single-use packaging solutions ranging from one-way shipping drums to recyclable and reusable bulk liquid containers with individual bar coding and tracking for complete control
• Mobius^® or equivalent 3D large liquid transportation systems for shipment of bulk sterile filtered liquid product (media, buffers, in-process intermediates, and final bulk drug product) in working volumes of 100, 200, 500, or 1,000 liters, with a user-friendly design and your choice of sterile or non-aseptic connectors for reliable fluid management and secure, sterile disconnection
• Mobius^® MyWay or equivalent Portfolio of single-use assembly options, ranging from one-way shipping drums to recyclable and reusable bulk liquid containers that meet your sustainability requirements – all individually bar coded and tracked for complete flexibility and control

Quality Ingredients and Transparent Supply

Water for injection is the key starting ingredient for all our liquid products. We ensure consistency, security, and EP and USP compliance by establishing redundant water for injection (WFI) supplies at all our facilities. This bulk-packaged water is suitable for the preparation of both upstream and downstream process solutions in industrial and regulated bioprocessing applications.

• Upstream applications: cell culture media, cell suspension and wash solutions, and reconstitution of products
• Downstream applications: process and biological buffers, cleaning and rinsing agents, diafiltration and purification buffers

All our liquid media facilities worldwide are part of our comprehensive Global Quality Management System, assuring the highest product consistency, reproducibility, performance, and expertise. We are committed to meeting or exceeding all relevant international guidelines and regulations, and we maintain quality certification programs at all facilities with on-site quality control testing. Our Global Quality Management System is certified as ISO 9001:2015, and all sites voluntarily comply with the Joint IPEC-PQG Guide on Good Manufacturing Practices (GMP) for Excipients and applicable sections of Annex 1 of the EU Guidelines to Good Manufacturing Practice for Medicinal Products.

To provide a consistent supply of material for your business continuity, our Global Raw Material Management Program is robust, controlled, and coordinated to ensure that our incoming supply is safe and secure. We also:

• Qualify, monitor materials and audit manufacturers and suppliers constantly for quality, qualification, and management
• Reduce variability by identifying and mitigating risks in the supply chain
• Work with subject matter experts to establish appropriate release criteria and specifications
• Maintain comprehensive change control and change notification procedures from our suppliers through to our customers

Streamlining your Qualification and Drug Filing

To help you stay on top of regulatory changes and simplify your processes, our manufacturing sites have 100% access to our industry-leading Emprove^® Program. This powerful, always up-to-date repository of current and anticipated regulatory data supports our high-quality pharmaceutical and biopharmaceutical raw materials and consumables, providing you with comprehensive documentation that can:

• Speed approval preparation and extend compliance
• Facilitate the qualification process
• Support risk assessment
• Increase supply chain transparency