GE Healthcare - Upstream and Downstream Solutions for Bioprocessing

BioProcess™ media are designed to meet manufacturing needs for security of supply, robust performance, and regulatory support. BioProcess media are available in a range of convenient formats from development to manufacturing.

MABSELECT FOR ANTIBODY PURIFICATION

MabSelect™ is the shared name for protein A capture media optimised to give high productivity of monoclonal antibodies. There are three MabSelect products: MabSelect for high purity and throughput at production scale; MabSelect SuRe™ that withstands rigorous and cost-effective CIP protocols using 0.1-0.5 M NaOH; and MabSelect Xtra™ for capturing high-titer antibody feedstocks and reducing processing costs.

CAPTO FOR FLEXIBLE PROCESS DESIGN AND ENHANCED PRODUCTIVITY

Capto™ media combine high binding capacity with high flow velocity and low back pressure which enables high bed-heights and purification at high flow rates. There are five available Capto products are, Capto MMC – Multimodal cation exchanger, Capto S & Capto DEAE– cation exchangers, Capto adhere – Multimodal anion exchanger and Capto Q – Strong anion exchanger.

PREDICTOR 96-WELL PLATES FOR HIGH-THORUGHPUT PROCESS DEVELOPMENT

PreDictor™ plates are 96-well filter plates pre-filled with Capto or MabSelect media. PreDictor plates allow parallel screening of chromatographic conditions in manual and automated mode. Evaluation of parameters for binding/wash/elution conditions as well as media benchmarking is fast and efficient. Data generated by using PreDictor plates show good correlation with data obtained in chromatography columns.

AXICHROM COLUMNS WITH INTELLIGENT PACKING

Preprogrammed, verified packing methods simplify the packing and achieve optimal bed compressions. A distribution system ensures uniform flow through the bed, producing reproducible results over a range of scales. AxiChrom™ 50 & 70 with two different tube lengths allow bed volumes between 0.2L to 2L.

MEDIA WAND FOR SIMPLIFIED MEDIA HANDLING

The Media Wand™ is designed for simplified removal of supernatant, addition of water or buffer, creation of homogenous media slurries in shipping containers, and transfer of media to slurry tanks. Media Wand eliminates the need for cumbersome and time-consuming tasks that frequently arise when handling large volumes of media.

READYTOPROCESS AN INTEGRATED PLATFORM FOR BIOPROCESSING

The ReadyToProcess™ portfolio comprises ready-to-use products across bioprocessing.

READYTOPROCRESS WAVE BIOREACTOR

The WAVE Bioreactor™ comprises a rocking platform and a disposable cell culture bag. The state of the art design offers considerable advantages such as scalability, rapid installation and significantly lower costs by eliminating the need for cleaning and validating between batches.

READYTOPROCESS CHROMATOGRAPHY COLUMNS

ReadyToProcess pre-packed columns are expertly packed in a clean room class ISO 8, testing of HETP and asymmetry is then performed as part of the acceptance criteria for release. After qualification, the columns are sanitized and shipped in 20% ethanol. They are plug-and-play solutions that require no preparation time.

READYTOPROCESS FILTERS

ReadyToProcess ULTA™ Normal Flow Capsule Filters are:

• Available in Sterilizing Grade and High Capacity versions
• Processed for minimized endotoxin levels (0.125Eu/mL)
• Provided Sterile by exposure to gamma irradiation
• Fully validated and integrity tested membrane for assurance of sterility

FULLY AUTOMATED PURIFICATION SYSTEMS

ÄKTAdesign™ is a platform that utilises UNICORN™ software.

ÄKTAexplorer™ is the industry standard for fast method and process development. The optimized methods can easily be scaled up and transferred to ÄKTApilot™ for small scale production.

ÄKTAcrossflow™ is a fully automated cross flow filtration system designed for use with either cassettes or hollow-fibres. Sample volumes from litres down to 25ml.

UniFlux™ is a range of automated cross flow filtration system used for pilot and manufacturing scale. The systems can be operated with cassettes or hollow fibers and are capable of processing batches of <5L to 10,000L of feed material.

FAST TRAK BIOPHARMA SERVICES

Fast Trak BioPharma services provide consulting, validation and education support in planning, implementing and documenting downstream processes - from start-up to routine production.