Dr. Sabine Hauck
dequra pharma consult hauck, Chair of ECA ATMP Interest Group
Referent:innen
Dr. Ulrike Herbrand
Charles River Laboratories Germany
All times mentioned are CEST.
Zielsetzung
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.
Hintergrund
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.
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.
Zielgruppe
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.
Programm
Gesamtes Programm als PDF herunterladen
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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Tel.: +49 6221 84 44 0
E-Mail: info@concept-heidelberg.de
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