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Developing biomanufacturing processes is a complex task of balancing the quality (purity) of the product with process robustness and a minimum of unit operations to improve economy.
At the earliest stage of development, laboratory-scale purification is required to obtain material for discovery and development. Even at this stage, future process development must be considered to avoid the use of methods that cannot be efficiently scaled up and use of materials that are too expensive or hazardous to use in manufacturing processes. Requirements also change when moving a purification process from an explorative environment to a highly regulated production environment.
The challenge of the process developer is to shorten development time, and increase process knowledge to design a robust, scalable process. Development of downstream chromatography processes has become faster and simpler due to technology platforms and high throughput process development (HTPD) tools. High throughput tools allow developers to save time by parallel screening of chromatography media and conditions.
Once a suitable process has been identified by empirical experimentation, the next step is to check its robustness (i.e., whether it is a well-controlled process) by performing cause–effect studies of critical parameters. UNICORN 6 Control Software for ÄKTA avant has an integrated Design of Experiments (DoE) tool that speeds up process development. DoE is a powerful tool for predicting relationships between critical parameters, and can eliminate a substantial amount of work compared to testing parameters individually against one another.
We offer a range of filter plates and columns prepacked with BioProcess chromatography media to facilitate process development and method optimization. PreDictor 96-well Filter Plates for HTPD allow you to screen several different chromatography media in parallel, shortening development time. PreDictor RoboColumn miniaturized columns also support HTPD by allowing parallel screening of chromatographic conditions using a robotic workstation.
HiScreen prepacked columns have a small column volume (4.7 ml) that saves on sample and buffer consumption, while the height (10 cm) serves as a good basis for optimizing chromatography conditions and for linear process scale-up.
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UNICORN 6 Control Software for ÄKTA avant has an integrated Design of Experiments (DoE) tool that speeds up process development.
PreDictor plates and PreDictor RoboColumn™ miniaturized columns support HTPD by allowing parallel screening of chromatography conditions for binding, wash, and elution.
HiScreen columns, prepacked with a range of BioProcess chromatography media (resins), are designed for method optimization and parameter screening.
© 2012 General Electric Company doing business as GE Healthcare
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