BIO Professional Development
Through a curated network of education alliance partners, BIO offers industry professionals executive training and development resources for accelerating career growth
Gene Therapy Manufacturing Primer 201
Gene Therapy Manufacturing Primer 201 is a deep dive into cGMP manufacturing processes for AAVs. This class explores in detail the science and regulatory controls of AAV gene therapy manufacturing. It begins by elucidating the critical steps in upstream vector cGMP production platforms, including Transient Transformation (TT), Baculovirus Expression (rBV/Sf9), Herpes Simplex Expression (HSV/BHK), and Producer Cell Lines (PCL). It continues by focusing on CMC strategies and precursor materials for each production platform. Purification strategies, AAV vector product characterization, analytical testing for safety and quality, viral vector manufacturing facility design, and regulatory considerations for AAV vectors are considered in detail. Take the next step and learn the highly technical aspects of AAV gene therapy manufacturing. Enroll today!
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Takeaways
- Explain how the structure and functions of the AAV virus influence its tissue tropisms.
- Analyze the challenges faced in manufacturing recombinant AAV gene therapy vectors
- Identify the strengths and weaknesses of the different AAV vector production platforms Transient Transformation (TT), Baculovirus Expression (rBV/Sf9), Herpes Simplex Expression (HSV/BHK), and Producer Cell Lines (PCL).
- Examine downstream bioprocessing strategies, including CMC strategies and precursor materials, for each production platform (TT, rBV/Sf9, HSV/BHK, PCL).
- Assess the key considerations in viral vector manufacturing facility design and regulatory requirements for AAV vectors, ensuring compliance with safety, identity, potency, quality, and purity testing.
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Certificate Requirements
Complete the course quiz with a passing score of 75% or higher