BIO Professional Development
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AAV Gene Therapy Manufacturing
AAV Gene Therapy Manufacturing describes the properties of the naturally occurring Adeno-associated virus, discusses the use of this virus as a viral vector, and explains the manufacturing and control process including manufacturing platforms, vector characterization, and regulatory considerations.
Takeaways
- Describe the characteristics of the naturally occurring Adeno-associated virus (AAV)
- Discuss the features of a mature AAV vectors
- Describe the four primary platforms used to create AAV vectors
- Explain how each of the following are characterized with respect to viral vectors: Safety, Identity, Potency, Quality, and Purity
- Explain key regulatory considerations for AAV manufacturing
Download Course Syllabus
Explore cGMP benefits & challenges. Learn about pillar requirements: QMS, Premises, Personnel, Materials, Documents, Validation. Understand audits & remediations with case studies.
Learn about AAV viral vector platforms, Triple Transient Transfection, upstream & downstream bioprocessing, packaging, & CMC regulatory aspects.
Explore AAV viral vector platforms, manufacturing processes, regulatory aspects, facility workflows. Requires strong molecular biology knowledge.
Discover best practices for integrating biosafety protocols into lab operations, ensuring safety & security.