Zielgruppe
Zielsetzung
By the end of the course, participants will have a robust understanding of both the scientific principles and practical applications of RNA and non-viral technologies, enabling them to contribute to the development of innovative and patient-centric therapies.
Background
At the forefront of these innovations is the use of RNA, a versatile biomolecule that has transformed therapeutic approaches in various domains. The success of mRNA-based vaccines, exemplified by the BioNTech COVID-19 vaccine, has demonstrated the molecule's potential to drive rapid and targeted therapeutic development. Beyond vaccines, RNA is increasingly utilized in personalized medicine, particularly in cancer therapies, where patient-specific RNA-based treatments are being explored.
Non-viral delivery platforms, including lipid nanoparticles (LNPs), electroporation, and cell squeeze technologies, have emerged as game-changing tools in cell therapy. These systems offer distinct advantages, such as reduced toxicity, enhanced delivery efficiency, and streamlined manufacturing processes. By eliminating the risks associated with viral vectors, these technologies pave the way for more accessible and patient-friendly therapies.
Despite these advancements, the regulatory and manufacturing landscapes for virus-free transduction methods remain complex. Developing robust quality control measures and adhering to stringent GMP requirements are critical for ensuring the safety and efficacy of these therapies. Furthermore, understanding the comparative strengths and weaknesses of viral and non-viral systems is essential for informed decision-making in therapeutic development.
This course is designed to address the knowledge gaps in this rapidly evolving field, offering professionals a unique opportunity to engage with experts and gain practical insights into the future of RNA and non-viral cell therapy platforms.
With a focus on real-world applications, cutting-edge research, and regulatory considerations, the program equips participants with the tools to drive innovation in their respective fields.
Programm
- The biology, mode of action and current formulations of RNA
- RNA-based medicinal products: Overview over current clinical trials and approved products
- The current regulatory landscape for RNA-based products
- Introduction to cell therapy across different disease Areas
- Different non-viral platforms and their applications
- Outlook and future directions
- Introduction to cell therapy across different disease areas
- Challenges of viral delivery: manufacturing, transduction efficiency, toxicities
- How can non-viral delivery systems solve These challenges
- Summary overview of viral vs non-viral delivery systems
- Introduction to LNPs: Structure and function
- Use of LNPs in cell Manipulation
- Comparison of LNP technologies with alternative systems
- Future prospects for LNPs in research and clinical applications
- Overview of mRNA technologies in cell therapy
- Optimizing mRNA transfection for CAR-T cells
- Challenges and advances in mRNA delivery
- Applications beyond CAR-T: next generation mRNA-based cell therapies
- Introduction to GMP-compliant cell therapy manufacturing
- Process control and quality assurance
- Scalability challenges and new emerging technologies
- Standards and quality control strategies for engineered cells
- Characterization techniques for engineered cells
- Defining appropriate release criteria for virus-free cells
- Outline key endpoints and safety monitoring specific to viral-free engineered cells
- Discuss manufacturing challenges and solutions during clinical development
- Address patient stratification and dosing strategies
- Present strategies for demonstrating comparability to viral vector-based approaches
- Principles and mechanisms of electroporation and cell squeeze
- Advantages and limitations of the two methods
- Comparison with other cell-manipulating technologies
- Application examples and future developments
- The development of the BioNTech Covid-19 vaccine
- Current developments in RNA-based vaccines
- Development of a patient individualized RNA-based cancer vaccine
Weitere Informationen
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 events 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.
Fees (per delegate plus VAT)
ECA Members € 1,890
APIC Members € 1,990
Non-ECA Members € 2,090
EU GMP Inspectorates € 1,045
The fee is payable in advance after receipt of invoice.
Presentations/Certificate
The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Conference language
The official conference language will be English.
Contacts:
Questions regarding content:
Mr Clemens Mundo (Operations Director) +49(0)62 21/84 44 42, mundo@concept-heidelberg.de
Questions regarding organisation:
Mr Ronny Strohwald (Organisation Manager), +49(0)62 21/84 44 51, strohwald@concept-heidelberg.de
Datum & Uhrzeiten
Wednesday, 20 May 2026, 09:00 – 15:00 h
Teilnahmegebühr
| ECA-Member*: | € 1890,- |
| Non ECA Member*: | € 2090,- |
| EU/GMP Inspectorates*: | € 1045,- |
| APIC Member Discount*: | € 1990,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
This course is part of the GMP Certification Programme "ECA Certified Biotech Manager"
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E-Mail: info@concept-heidelberg.de
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