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!Â
Section 1: AAV Properties
Explore the structures, functions, and tissue tropism of popular AAV serotypes, gaining a deep understanding of AAV characteristics.
Section 2: AAV Production Platforms
Compare four AAV production platforms, delve into key features of AAV vector DNA, understand the AAV cassette, and explore the production of cell banks, including master and working cell banks, as well as AAV double-stranded and single-stranded DNA.
Section 3: AAV Upstream Bioprocessing
Explore the stages of AAV manufacturing, including the use of suspension and adherent cell lines, learn about upstream bioprocessing steps, small and large batch production, and discover various bioreactors such as hyperstacks and iCellis.
Section 4: AAV Downstream Bioprocessing
Learn more about cell harvesting, downstream bioprocessing, and purification platforms, including chromatography, filters, and centrifugation. Explore fill and finish processes, packaging, and gain an overview of the AAV viral vector manufacturing workflow.
Section 5: AAV CMC
Explore the critical role of Chemistry, Manufacturing, and Controls (CMC) in AAV manufacturing, covering ICH guidelines, identity, potency, quality, purity, and sterility testing. Gain insights into CMC regulatory considerations and the unique challenges in AAV manufacturing.
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Five 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./li>
- List in order the general steps of AAV gene therapy production.
- Investigate the main regulatory guidelines for conducting CMC evaluations of AAV viral vectors.
Features
- Closed Captioning in English, Spanish, French, French Canadian, Hindi, Japanese, Korean, Mandarin, Russian, Standard Arabic
- Transcripts in English, Spanish, French, French Canadian, Hindi, Japanese, Korean, Mandarin, Russian, Standard Arabic
- Course materials
- Real-time tracking
- Progress reporting
- Accessibility features
- Corporate account upgrades
- LinkedIn certificate attachment
- Verified certificates
FAQ
- How long do I have to complete an on-demand course? You have one year from the date of purchase to complete the course. During that year, you may watch the class an unlimited number of times.
- What happens if I don’t complete the course in one year? There are no time extensions. If you want to complete the course, you must purchase it again.
- How long are the on-demand classes? Our longest course has a running time of 90 minutes. However, most have a running time of 45 minutes. The running time is listed for each class on its registration page. The assessment at the end of each course takes between 10-20 minutes to complete.
- Are there any downloadable class materials? No. All course slides and transcripts remain on your Biotech Primer dashboard, but they are always available for review.
- What is the format of the on-demand classes? The online class begins with the class objectives and the course itself and ends with a summary of what you learned. The course is a series of images and text accompanied by a professional voice-over and subtitles. Subtitles are available in 9 languages. The course ends with a quiz to assess your understanding.
- Can I repeat the course? You can repeat the course as often as you like within your one-year access.
- How many times can I take the course quiz? You have three chances to pass the quiz. A passing score is 75% or higher. You must pass the quiz to receive the class certificate. Your quiz score will be shown on your class certificate.
- May I share a course I purchased with others? Each course is to be taken by one individual. If you want to learn as a group, please contact us at training@biotechprimer.com for group pricing.
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