2022 - A Strain Development Strategy to Enhance Screening, Process Development and Scale-Up

Any current Good Manufacturing Practice (cGMP) E. coli program must be based on a solid strain development strategy. This thought led to the development of Cytovance’s Keystone Expression System® to provide a robust, high-yield E. coli strain to support cGMP manufacturing of a biologic. Cytovance’s elaborate toolbox enables creation and evaluation of multiple strains simultaneously. Although the workflow is standardized, it is versatile and flexible enough to accommodate unique requirements from companies, with cutting-edge technology. All of the offering is based on peer-reviewed literature published by leaders in the industry, which provides an intellectual property (IP)-free platform that is comprised of elements that are familiar to regulatory agencies. All of the strains are also created to fit into a robust, platform high-cell density fermentation process, that is designed for efficient scale-up into a Single-Use (SUF) or Stainless (SIP) fermenter.
NODATA
Through this webinar, the speaker wishes to highlight the importance of an efficient strain development strategy in order to reduce the timelines and the costs associated with product development. The Keystone Expression system® and the toolbox generated in-house allows for simultaneous strain construction and screening. Through the course of the screening process, the simple but powerful SDS-PAGE is used for evaluating the expression levels of the strains, which negates the need for other sophisticated methods in earlier stages of the project. Once the top strains have been evaluated, in-house liquid chromatography–mass spectrometry (LC-MS) is used onsite to confirm the identity of the biologic prior to scale-up of the fermentation process.
Register for this webinar to learn more about protein expression and strain development strategies for effective product development.