Sterile Liquids
Our global sterile liquid capabilities are designed to enhance and streamline your process, from clinical-phase trials all the way through to commercial production:
- Cell culture media – standard or custom formulation
- Downstream buffers
- Cleaning-in-place (CIP) and Sterilization-in-place (SIP) solutions
As a trusted partner, we bring together products and services from across our company to offer the industry’s highest quality sterile liquid capabilities. All manufacturing locations operate according to ISO 9001/2015 and GMP principles, so we can address your global needs and provide faster turnaround for your order.
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 liquid solutions eliminate the extra tasks 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
- Right-sized buffer delivery, reducing chemical waste and WFI use for improved sustainability
Your sterile 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 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. To ensure safe delivery of your sterile liquids, our packaging and transport options include:
- Mobius® 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® 3D large liquid transportation systems for shipment of bulk sterile 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 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
- Liquid Solutions MyWay, offering the fastest way to receive commonly used sterile liquids in ready-to-use bags of 1 L, 20 L, 50 L and 190 L/200 L, with convenient online ordering for streamlined global sourcing, less risk, and reduced stock footprint
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 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, and 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.
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:
- 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 notification 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
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