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!
Section 1: AAV Overview
Provides an overview of the properties of the naturally occurring Adeno-associated virus including its origin and characteristics.
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Section 2: AAV Vectors
Describes how the adeno-associated virus is utilized as an AAV vector. Includes a discussion of the general characteristics and composition of AAV viral vectors. Ends with a survey of genes that can be transfected using these vectors.
Section 3: AAV Manufacturing and Controls
Discusses AAV Manufacturing and control including an introduction to manufacturing, the four primary platforms for AAV production, the characterization of AAV manufacturing products, and the regulation of AAV production.
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Five 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.
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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