Single-Use And Ready-To-Use Products

Biopharmaceutical development and manufacturing demands scalable processes that can be quickly developed and smoothly transferred to production. GE Healthcare Life Sciences’ single-use and ready-to-use technologies, ReadyToProcess™ and Xcellerex™, play a crucial role in providing the flexibility to support multi-product facilities. They deliver process time savings by removing steps such as cleaning, cleaning-validation, filter prewashing and column packing, allowing faster start-up and easier changeover between products.

WAVE Bioreactor™

WAVE Bioreactor™ 200 and 500/1000 systems are ready-to-use products. The system is a cell culture device for the production of recombinant proteins in mammalian and insect cell lines in batch, fed-batch, and perfusion culture.

WAVE Bioreactor 200 and 500/1000 systems deliver:

• Presterilized, single-use Cellbag bioreactors, require no cleaning, minimal validation
• Cellbag bioreactors are supplied sterile and ready for use and suitable for cGMP commercial production
• Multiple instrument configurations for suspension, microcarrier, batch, fed-batch, or perfusion culture
• Capable of handling culture volumes from 500 mL to 500 L

XDR Bioreactor

The design of XDR single-use bioreactor systems is grounded on the same principles as conventional stainless steel bioreactors, and use the same traditional scaling methodology based on measures such as shear, tip speed, power, and fluid velocity.

• Robust automation for advanced process control
• Designed for GMP clinical and commercial production
• Available in six different volumes, from 10 L to 2000 L

ReadyMate Disposable Aseptic Connector (DAC) 

The ReadyMate DAC provides secure connections for high-fluid throughput and offers a simple and economical connection for upstream and downstream applications.

• Secure, single-use connections
• Genderless design with cross-size connectivity reduces inventory
• Large inner diameter for high throughput
• TC, Mini-TC, and standard hose barb sizes
• Secure closure mechanism make a tamper-proof, lightweight connection

ÄKTA™ Ready & ReadyToProcess Columns

ÄKTA ready and ReadyToProcess columns are part of the ReadyToProcess platform, consisting of plug-and-play, ready-to-use solutions for entire chromatography processes. ÄKTA ready is a fully automated liquid chromatography system for process scale-up and production of materials for clinical trials. The system operates with ready-to-use, disposable flow paths that are available in High and Low Flow Kits. The ReadyToProcess columns are delivered prepacked, prequalified and presanitized.

XDM Quad & XDUO Quad Single-Use Mixing Systems

Xcellerex XDM Quad and XDU Quad single-use mixing systems are designed for convenient and efficient mixing of buffer, media, product, and other process fluids.

XDM Quad Key features and benefits:

• Square configuration offers enhanced mixing efficiency through natural baffling effect
• Workable heights and low center of gravity increase level of safety
• Real-time sensing and sampling capability via mixer window and bag probe ports, sampling port and thermowell for non-invasive temperature sensing
• GMP compliant

XDUO Quad key features and benefits:

• Onboard instrument panel allows immediate initiation of unit operations and mixing processes upon start-up
• Eliminates need for time-consuming charging of superconducting magnets, complicated mating of motor and drive systems to storage tanks, and many manual steps
• Titration processes can be automated to deliver greater accuracy and significant time saving over manual methods
• Data capture for batch record requirements in GMP manufacturing suites eliminates the need for paper logging

ReadyToProcess Filters & Fluid Management

Preconditioned ReadyToProcess filters for cross flow (CFF/TFF) and normal flow filtrations (NFF) cut unnecessary downtime and eliminate time-consuming cleaning and cleaning validation. Fluid management is seamless with ReadyCircuit bags and tubing assemblies that form sterile, self-contained modules in minutes. ReadyKart mobile processing station simplifies ergonomic placement of bags, tube sets, filters, and other related equipment. For biopharmaceutical companies, CMOs, and startups, this enables accelerated development and reduced up-front investment – manufacturing agility increases, opening doors to new business opportunities.

Applications:

• Aseptic processing
• Clarification
• Ultrafiltration
• Diafiltration in vaccine and MAb
• Media filtration
• Normal flow prefiltration for bioreactors and columns