BIO Professional Development
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Gene Therapy Manufacturing Primer 101
Gene Therapy Manufacturing Primer 101 is a foundational class that ventures into the essential AAV production platforms, comparing four different approaches and dissecting the key elements of the AAV cassette. This class illustrates the basic upstream/downstream bioprocessing stages, contrasting suspension and adherent cell lines. Bioreactors, such as hyperstacks and iCellis, are examined for their role in this cutting-edge process. This primer ends by summarizing the role of CMC in AAV development, giving an overview of identity, potency, purity, and sterility testing required by the regulatory authorities. Grab your seat today for this introductory course and become conversant in gene therapy manufacturing!
Takeaways
- Gain mastery in the structure and function of AAV.
- Describe how AAV types affect tissue targeting and give examples.
- Compare and contrast common AAV vector systems.
- List in order the general steps of AAV gene therapy production.
- Investigate the main regulatory guidelines for conducting CMC evaluations of AAV viral vectors.
Certificate Requirements
Complete the course quiz with a passing score of 75% or higher
Gain a comprehensive understanding of DNA, proteins, and cells, explaining how they are manipulated to create innovative therapies and diagnostic tools.
Explore foundational science of genetic modification -- the impetus for the creation of the biotechnology industry in the 1980s.
Explore challenges in biologics manufacturing. Learn about production differences from small molecule drugs.
Explore cGMP benefits & challenges. Learn about pillar requirements: QMS, Premises, Personnel, Materials, Documents, Validation. Understand audits & remediations with case studies.
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.
A digital strategy can no longer lie within a siloed digital or innovation team. It’s critical to integrate digital across the enterprise to maintain a competitive edge.