Monitoring and control for cell culture from lab bench to manufacturing

Simultaneous monitoring of up to four different instrument configurations either directly connected, or via a network, enables faster data acquisition. A common control platform and dynamic graphical user interface for all culture volumes simplifies scale up, whilst the automatic storage of all run data in a secure and unalterable result file provides added security

GE Healthcare has extended its WAVE Bioreactor platform with the launch of the WAVEPOD II Integrated Controller, the pHOPT optical pH sensor, and UNICORN DAQ 1.0 software.

All specifically designed to improve monitoring and control of cell culture conditions in WAVE Bioreactor Systems, and forming part of GE Healthcare’s ReadyToProcess platform of ready-to-use products for upstream and downstream processing of biologicals.

The WAVEPOD II Integrated Controller supports the set up, control and monitoring of cell culture parameters in Cellbag bioreactors.

Available with a choice of control modules to meet individual needs and a large colour touchscreen providing easy access to all operations, data, and alarm conditions from the connected control modules. 

 

By coordinating the functions of individual control modules, it is possible to develop complex schemes for the precise measurement and control of culture conditions including pH, dissolved oxygen, CO2, and O2 gas mixing.

pHOPT is an optical single-use sensor which is preinstalled on the underside of the Cellbag bioreactor. Designed for use with the pH controller of WAVEPOD II, it enables continuous pH monitoring in the crucial pH range, 6 to 8. 

 

The UNICORN DAQ 1.0 software’s real time data acquisition allows the user to monitor the run status of any connected WAVE Bioreactor instrument. 

GE Healthcare

Predictive accuracy of Cytiva hESC-derived Cardiomyocytes in toxicity testing

GE Healthcare will announce preliminary data from its ongoing structural cardiomyocyte biomarker collaboration with Genentech, a member of the Roche Group. The preliminary data will be presented at the 50th Annual Meeting of The Society of Toxicology (SOT) in Washington DC, 6-10 March 2011.

GE Healthcare and Genentech have been working together since September 2010 to assess and further explore the functional properties of GE Healthcare’s newly-launched Cytiva hESC-derived Cardiomyocyte toxicity assays and to identify novel cellular biomarkers for cardiotoxicity.

The collaboration combines Genentech’s toxicology expertise, experience with primary cardiomyocytes, and a library of reference compounds, with GE Healthcare’s Cytiva Cardiomyocytes and its IN Cell Analyzer high-content analysis (HCA)imaging system. GE Healthcare’s Cytiva Cardiomyocytes have so far been evaluated through blind testing against 26 known compounds with preclinical and clinical cardiac discordances.

Stephen Minger, Global Head of R&D, Cell Technologies, GE Healthcare, said: “The data we will be presenting far exceed our expectations and show that using Cytiva cardiomyocytes and the IN Cell HCA platform, we can probe deeply into cells to identify cardiotoxicity and how it is manifested. This will give our customers the confidence that our Cytiva Cardiomyocytes offer a far more effective alternative to current cell-based and animal models used in toxicology testing.”

Drug-treated Cytiva cardiomyocytes were analysed using GE Healthcare’s IN Cell Analyzer 2000 HCA system using a panel of fluorescent markers to report on drug effects on a wide range of cellular parameters. Multi-parameter analysis and data profile clustering revealed a wealth of information on drug toxicity and mode of action and showed good correlation with previously reported clinical cardiotoxicity.

The collaboration will be discussed at SOT by Genentech on March 6 and the preliminary data will be presented in depth by GE Healthcare on March 9.

GE Healthcare

GE Healthcare appoints Kieran Murphy as Life Sciences CEO

GE Healthcare announced today that on 1st April 2011, Kieran Murphy will be promoted to succeed current Life Sciences President and CEO Peter Ehrenheim who will retire from GE after a transition period on July 31 2011. Kieran is currently GE Healthcare’s Head of Global Commercial Operations, Life Sciences.

GE Healthcare launches MabSelect SuRe LX affinity chromatography medium

GE Healthcare has extended the MabSelect family with MabSelect SuRe LX, a protein A-derived affinity medium designed to promote efficient processing of high-titer bioreactor feeds.

MabSelect SuRe LX has enhanced alkaline stability and exceptional dynamic binding capacity that exceeds similar high-flow agarose media such as MabSelect SuRe. The highly-rigid base matrix facilitates the use of higher bed heights and high flow rates, which reduces cycle time and provides flexibility in process design. Additionally, higher dynamic binding capacity and bed heights enable the use of small-diameter columns, thus reducing equipment footprint.

Enabling equipment qualification and GMP compliance

GE Healthcare is launching Installation Qualification (IQ) and Operational Qualification (OQ) protocols for ImageQuant LAS 4000 mini, 4000 and 4010 biomolecular imagers. Required for controlled environments, the protocols enable ImageQuant systems to comply with regulatory and Good Manufacturing Processing standards (GMP). The protocols have been developed in accordance with recent guidelines, including GAMP5 and ASTME2500, and highlight data integrity and product quality.

The IQ protocol is carried out during installation of the ImageQuant system and demonstrates that the device has been set up correctly and adheres to regulatory guidelines. The subsequent OQ protocol is performed to ensure that the instrument functions as intended.

Both qualification protocols must be performed by a certified GE Healthcare Service Specialist. The resulting validation documents are uniform, simplifying document handling for all stakeholders. As required by current regulatory guidelines, the protocols have been reviewed by Subject Matter Experts to ensure compliance.

The ImageQuant IQ/OQ document package includes:

* Protocols describing the objective and acceptance criteria of the different tests included in the IQ/OQ.
* Record sheets for each test module with descriptions of the qualification criteria.
* Reports summarizing the IQ/OQ results.

GE Healthcare

Ion exchangers for high-throughput purification of recombinant proteins

GE Healthcare has announced that the capabilities of the Capto platform are now extended to include Capto ImpRes ion exchange chromatography media for late-stage purification of a wide range of biomolecules. The first Capto ImpRes products to be launched are Capto SP ImpRes and Capto Q ImpRes, strong cation and strong anion exchangers, respectively, that enable high throughput, high resolution polishing, and flexibility in process design.

Capto ImpRes media are based on a rigid high-flow agarose matrix that allows the use of high flow rates and higher bed heights, providing biopharmaceutical manufacturers with the possibility to reduce cycle times and maintain or reduce column equipment footprint, thus contributing to driving improvements in process economics.

“The extension of the Capto platform with Capto ImpRes ion exchangers demonstrates our commitment to supporting biopharmaceutical manufacturers with the most modern tools to improve their processes in terms of throughput, productivity, and economy,” said Dr Nigel Darby, Vice President, Biotechnologies, GE Healthcare. “Capto ImpRes media have been designed to meet the throughput and high resolution needs of intermediate purification and polishing.”

Capto ImpRes media are available in several convenient formats, including Predictor 96-well filter plates and prepacked HiTrap and HiScreen columns to support all stages of biopharmaceutical development and manufacture. As part of the GE Healthcare BioProcess media platform, Capto ImpRes ion exchangers are manufactured under validated production methods, backed up with Regulatory Support Files, and have Secure Supply routines in place.

GE Healthcare

Quick design of sterile and disposable fluid processing systems

GE Healthcare’s on-line ReadyToProcess Konfigurator is a product selection and quotation tool that enables quick and easy selection and order of standard off-the-shelf, as well as custom designed, ReadyCircuit assemblies.

ReadyToProcess equipment provides ready-to-use tools for all process stages in the manufacture of biopharmaceuticals, including cell culture and fermentation, chromatography, and filtration.

Customers can design their fluid management circuits and systems in minutes by entering the parameters of their process, from which the Konfigurator will generate the preferred design.

The Konfigurator’s rapid and convenient output includes Piping and Instrumentation Diagram (P&ID) drawings and a Bill of Materials (BOM) to enable product ordering. The self-designed ReadyCircuit assemblies can include normal flow and cross flow filtration capabilities, sensor technology and can be designed to suit up to 200L liquid volumes. The Konfigurator removes labour intensive manual design, helps in selecting and ordering the right single-use equipment, and provides related budgetary quotations.

GE Healthcare

GE Healthcare extends HiScreen prepacked column range

GE Healthcare has extended its range of HiScreen prepacked chromatography columns, taking the total number of media now available in this format to 23. The four new columns are packed with a range of BioProcess chromatography media.

HiScreen columns provide a solution for fast, easy separations in a convenient format. The columns are packed with robust media, allowing repeated use with reproducible results. The 10 cm bed height is suitable for method optimization and parameter screening (e.g. for selectivity and capacity), and the columns are easily connected in series to give a 20 cm bed height.

HiScreen columns have a small bed volume (4.7 ml), reducing the cost of sample and buffer consumption. In addition, the columns are made of biocompatible polypropylene that does not interact with biomolecules.

Membrane protein purification kit for detergent screening of His-tagged membrane proteins

GE Healthcare’s Membrane Protein Purification Kit is designed for rapid and easy detergent screening of histidine-tagged membrane proteins, enabling simultaneous evaluation of solubilization and purification efficiency. Analysis and evaluation can be performed by a number of methods such as Western blot, gel filtration, or light scattering.

The Kit contains seven detergents in ready-to-use solution (purity ≥ 99% by HPLC analysis), His Mag Sepharose Ni, buffer stock solutions, and an easy-to-follow protocol, and is sufficient for two complete screening experiments.

High-content analysis achieves 20-fold increase in throughput

GE Healthcare has announced the winner of the first GE Healthcare HCA Award. Supported by BioTechniques, the Award recognizes the outstanding contribution of HCA to scientific understanding and celebrates its positive impact on data quality and quantity, resulting in increased productivity, deeper insights and better decisions.

The winner of the first HCA Award is Dr Michael Freeley from the Institute of Molecular Medicine, Trinity College Dublin (TCD), who investigates how white blood cells (T lymphocytes) move in the body during an immune response. Movement of T lymphocytes from the blood stream into target tissues is crucial in an effective immune response against disease-causing organisms, but unregulated migration of T lymphocytes is also a major contributor to auto-immune diseases such as multiple sclerosis, Crohn’s disease and rheumatoid arthritis. A better understanding of this process could ultimately lead to treatments that selectively block this migration in these diseases.

Reagent offers highly sensitive, stable detection of small protein quantities

GE Healthcare has introduced Amersham ECL Prime, a highly sensitive reagent characterized by stable signal emission up to three hours after addition of the reagent, allowing for the possibility of repeated exposures and making it easier to process several blots in the same experimental run.

High signal intensity means that proteins may be detected using more dilute primary and secondary antibodies, which reduces background noise and reagent consumption.

Licensing and collaboration agreement to automate sample analysis for forensics and drug discovery

GE Healthcare and Hamilton Robotics have entered into a licensing and collaboration agreement to develop a fully automated workflow for sample handling and processing from FTA substrates. Financial terms are not being disclosed.

Human cardiomyocytes for predictive toxicity testing

GE Healthcare announces the availability of human cardiomyocytes, or heart muscle cells, that provide a more readily available and biologically-relevant alternative to current cell models and primary cells used in drug discovery and predictive toxicity testing.

Cardiotoxicity is one of the most common causes of drug safety liabilities, withdrawal of in-market drugs, and late-stage failure during drug development. Early detection, or prediction, of cardiotoxicity could significantly reduce overall drug development costs, and help minimize patient exposure to potentially harmful compounds.

Easy-to-use empty columns for process development and preparative chromatography

GE Healthcare HiScale pressure-stable columns are optimized for process development and preparative chromatography. The empty columns are available in inner diameters of 16, 26 and 50 mm and in lengths of 20 and 40 cm. The columns offer an easy-to-use design, providing reproducibility, robustness and process control.

GE Healthcare launches new Mag Sepharose beads

GE Healthcare has launched His Mag Sepharose Ni, Protein A Mag Sepharose Xtra, and Protein G Mag Sepharose Xtra magnetic beads. The new magnetic beads provide high binding capacity, for fast separation and high quality results.

The highly visible, dense beads provide superior purity and yield, with easy parallel screening and high repeatability. Handling is simplified as rapid capture is facilitated by magnetic devices, and visibility ensures reliable collection of the bound proteins/antibodies. The process is easily scalable, enabling simple capture of target protein or antibody from low microliter to high-milliliter scale.