Course Description:
USP and ATCC are collaborating to present the webinar “Residual DNA Testing” focused on Residual DNA detection in biologics for therapeutic use. This webinar will introduce USP General Chapter <509> Residual DNA Testing, outlining validated extraction and qPCR method for the measurement of E. coli and Chinese hamster ovary (CHO) genomic DNA within these biologics. Highlighting the use of USP Reference Standards catering to these substrates, the webinar provides the application examples of these RSs used for the determination of residual genomic DNA content in samples and for the crucial demonstration of system suitability for analytical procedures.
Additionally, the session will showcase the pioneering products jointly launched by ATCC and USP, specifically designed to elevate quality standards and minimize risks during the development of biological therapeutics and vaccines. These products facilitate the assessment of residual gDNA clearance using analytical reference materials derived from authenticated cell lines commonly employed in vaccine and biologic manufacturing. Attendees of this course will gain expertise in residual DNA monitoring and control, accessing and implementing General Chapter <509>, and effectively utilizing USP Reference Standards and ATCC-USP joint gDNA reference materials to determine the residual DNA in samples and assess analytical procedure performance.
Who should participate:
- QA and QC specialists and auditors
- Lab personnel in research and development
- Manufacturing and production
- Manufacturing scientists and managers
- Contract research/manufacturing organization personnel
- Scientists and researchers
- Batch record reviewers
- Validation specialists