Recombinant Adeno-associated virus (rAAV) vectors are increasingly utilized in in vivo gene therapy. However, the complexity of rAAV manufacturing introduces various process-related impurities. These impurities can pose considerable risks to patient safety if not adequately addressed.
This webinar discusses the common process-related impurities encountered in rAAV vector production and outlines the analytical methodologies used to detect and quantify these residuals in the drug substance. This information is particularly valuable for rAAV sponsors seeking to mitigate risks associated with process-related impurities and to comply with regulatory expectations.
In this webinar, you will learn:
- Typical process-related impurities in rAAV vectors
- Analytical methodologies used to test the process-related impurities
- Pros and cons of different analytical methodologies
Speaker
Judy Cao, Ph.D.
Merck
Senior Strategic Business Development Specialist
Zhiyun (Judy) Cao, Ph.D., is a senior strategic business development specialist. Judy joined Merck as a senior scientist in 2015, supporting the development of certified reference materials, later working as an account manager at Waters Corporation before returning to our company for her current role. She earned her Ph.D. from the University of Pittsburgh, specializing in LC-MS biomarker identification for aging-related diseases like Alzheimer’s disease.
Pharma and biopharma manufacturing
- Pharma and biopharma manufacturing
Duration:1h
語言:English
會話 1:提出 November 7, 2024
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