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.
Since all of the strain construction, screening, fermentation and analysis occur in-house at Cytovance, it allows for an overall reduction in the timeline for the molecule to proceed from a gene sequence to the high-yield fed-batch fermentation, thereby reducing the costs associated with the project.
In this webinar, the featured speaker will cover the basics of strain development, which includes the screening strategy, fermentation, analysis and robust scale-up, with the emphasis on the Keystone Expression System®. The talk will also use real examples of biologics developed in-house with a comparison to other expression strategies.
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.
Hari Priya Parameshwaran, PhD, Scientist, PD Upstream/Strain Development, R&D Services, Cytovance Biologics
Dr. Hari Priya Parameshwaran is a Scientist leading the Strain Development team at Cytovance Biologics. She earned her Doctorate in Biochemistry from the University of Oklahoma during which she extensively worked on elucidating the functional aspects of proteins using structural biology. Her experience with different proteins and their expression strategies makes her a subject matter expert for this process. She also works with the Business Management team to help onboarding of new clients and familiarizing them to the strain development strategy at Cytovance.
Who Should Attend?
- Process development scientists
- Analytical development scientists
- Business development professionals from biotech companies
- Managers and directors from biotech companies
What You Will Learn
Attendees will learn about:
- The importance of a platform strain development strategy
- Cytovance’s in-house Keystone Expression System®
- Real examples of biologics developed using this strategy
- Cost effectiveness of in-house development
Cytovance® Biologics is a leading biopharmaceutical Contract Development and Manufacturing Organization (CDMO) that excels in the rapid and cost-effective development and manufacture of large molecule APIs from both mammalian cell culture and microbial fermentation, such as monoclonal antibodies, fragment antibodies, bispecifics, enzymes, fusion proteins, vaccines and other biological products including plasmid DNA and cell-based therapeutics. In addition to our clinical and commercial cGMP API manufacturing services, Cytovance offers well integrated development services supporting the entire product lifecycle, including cell line development, cell banking, microbial strain development, process and analytical development, and process characterization. A centralized, responsive program management team coordinates all critical CMC activities for each client program around raw materials management, QC testing, ICH stability studies, and regulatory support. Our 140,000 sq. ft. state-of-the-art facilities in Oklahoma City are designed to meet U.S., EU, and other global regulatory standards.