Course Description
Residual DNA testing is required for demonstrating clearance of DNA from the cell substrate used to manufacture biologics for therapeutic purposes. This webinar presents an overview of USP General Chapter <509> Residual DNA Testing, which contains validated measurement methods for E. coli and Chinese hamster ovary genomic DNA in such biologics. Two USP Reference Standards for the genomic DNA of these substrates have been developed to determine the residual genomic DNA content in a sample and to demonstrate system suitability for these analytical procedures. This course will also discuss best practices for other residual DNA methods that are found in USP General Chapter <1130> Nucleic-Acid Based Techniques—Approaches for Detecting Trace Nucleic Acids (Residual DNA Testing).
The live version of this recording took place on September 28, 2021.
Upon completion of this course, you will be able to:
- Identify common procedures (hybridization based, DNA-binding protein based and PCR based) for testing residual DNA.
- Identify which assay format may be best for your application, taking into consideration the advantages and disadvantages of each assay.
- Describe the basis of a qPCR-based residual DNA method.
- Access and use General Chapter <509>.
- Illustrate how to use the appropriate Reference Standard to assess system performance for the analytical procedures.
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
Access Duration:Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.
USP Approved Instructor
Ying Han
Senior Scientist II
Ph.D. in biochemistry,
University of New Mexico