SMART AAV Analytical Method Toolbox - Live Online Training

Thursday, 25 April 2024 11.00 - 18.00 h

Course No. 21276

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Speakers

Dr. Sabine Hauck

Dr. Sabine Hauck

dequra pharma consult hauck, Chair of ECA ATMP Interest Group

Dr. Ulrike Herbrand

Dr. Ulrike Herbrand

Charles River Laboratories Germany

All times mentioned are CEST.

Objectives

This course focuses on optimization possibilities of methods in the formulation, production and analysis of AAVs. Speakers from manufacturing, laboratory and authority will show their expectations as well as their experiences in GMP-compliant work.

Background

Gene therapies are becoming increasingly popular and offer great potential for treating diseases ranging from degenerations to congenital neurological disorders. Many DNA-based gene therapies use viral vectors to transfer the genetic material. The most common viral vector is the adeno-associated virus (AAV). Historically, this is not a new invention, it was already discovered in 1965.

With AAV, as with other products, it is always a challenge to define appropriate CQAs. But what is the best way to do this without wasting time and money? This question and how to make optimizations in analytics and manufacturing will be answered in this Course.

Target Group

This course is addressed to all people involved in the day-to-day work of AAV with manufacturing, method development and optimisation and Analysis.

Technical Requirements

We use WebEx for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programme

SMART AAV Analytical Method Toolbox - Live Online Training

Seminar Programme as PDF

AAV Analytical Toolbox for Stability Assessment
  • Selection of suitable Methods
  • Analysis of the stability indicating power
  • Learnings for formulation development
Bioactivity for AAV Therapeutic
  • Matrix Approach
  • MoA reflection
  • Challenges related to references and control items
Development of USP Standards to Support AAV Therapeutics
  • USP development of documentary Standards
  • USP development of physical standards
  • Future direction of USP standard development for AAV
Building and Breaking AAV Processes
  • How is development representative of future manufacturing scale?
  • What data can we collect/analyze?
  • How do we scale up?
  • What tools do we have for making quick decisions?
  • Are they worth the potential tradeoffs?
  • What happens when something goes wrong?
  • How can we be good stewards of time/resources?
Chemistry, Manufacturing and Control (CMC) Testing for AAV Therapeutics
  • Identity testing
  • Purity testing
  • Safety testing

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To find alternative dates for this training/webinar or similar events please see the complete list of all events.

For many training courses and webinars, there are also recordings you can order and watch any time. Just take a look at the complete list of all recordings.

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Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org

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