BIO Professional Development
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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!
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.
Certificate Requirements
Complete the course quiz with a passing score of 75% or higher
Gain foundational knowledge on gene therapy: vectors, disease targeting, FDA approval process, safety, and efficacy assessment.
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.
Discover best practices for integrating biosafety protocols into lab operations, ensuring safety & security.
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