Referent:innen

Dr Christoph Peter

Dr Christoph Peter

Peter Auditing

Dr Mohamad Toutounji

Dr Mohamad Toutounji

Molgenium

Dr Julia Schüler

Dr Julia Schüler

Charles River Laboratories Germany

Selina Roth

Selina Roth

Lonza

All  times mentioned are CEST.

Zielsetzung

The primary objective of this two-day course, is to provide participants with a comprehensive understanding of the latest breakthroughs in non-viral transduction methods for cell therapy. Designed for professionals in the pharmaceutical and biotechnology sectors, the course aims to foster a deeper appreciation of RNA-based medicinal products, non-viral delivery systems, and their transformative potential in advancing cell therapies.

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.

Hintergrund

Innovations in cell therapies have revolutionized the pharmaceutical and biotech industries, unlocking unprecedented possibilities for treating previously incurable diseases. Traditional viral transduction methods, while effective, face significant challenges, including scalability, high production costs, and potential immunogenicity. To address these limitations, virus-free transduction technologies have emerged as promising alternatives, enabling safer, more efficient, and scalable cell engineering solutions.

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.

Zielgruppe

This training is tailored for professionals in the pharmaceutical, biotechnology, and life sciences sectors who are actively involved in the development, manufacturing, or regulation of advanced therapies. It is designed for individuals seeking to expand their knowledge of RNA-based products and non-viral transduction technologies, particularly as they pertain to cell therapy and precision medicine. Whether you are an academic, an industry professional, or a regulatory expert, this course provides valuable knowledge to enhance your expertise and contribute to advancing the field of cell therapies.

Date / Technical Requirements / Presentations / Certificate

Date of the Live Online Training
Tuesday, 06 May 2025, 09.00 h – 15.30 h CEST
Wednesday, 07 May 2025, 09.00 h – 15.00 h CEST

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.

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.

Programm

Virus-free Transduction in Cell Therapies - Live Online Training

Gesamtes Programm als PDF herunterladen

Introduction to RNA as an API
  • 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
Advances in Virus-free Transduction for Cell Therapies
  • Introduction to cell therapy across different disease Areas
  • Different non-viral platforms and their applications
  • Outlook and future directions
Comparison of Viral vs. Non-viral Delivery in Cell Engineering
  •  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
Lipid Nanoparticles (LNPs) for Cell Engineering
  • 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
mRNA Delivery Systems in CAR-T and other Cell Therapies
  • 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
GMP-Compliant Manufacturing of Virus-free engineered Cells
  • Introduction to GMP-compliant cell therapy manufacturing
  • Process control and quality assurance
  • Scalability challenges and new emerging technologies
Ensuring the Safety and Functionality of engineered Cells: Quality Control and Characterization
  • Standards and quality control strategies for engineered cells
  • Characterization techniques for engineered cells
  • Defining appropriate release criteria for virus-free cells
Clinical Trial Design Considerations
  • 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
Emerging Technologies: Electroporation and Cell Squeeze
  • 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
In Vivo Use of RNAs – a closer Look
  • The development of the BioNTech Covid-19 vaccine
  • Current developments in RNA-based vaccines
  • Development of a patient individualized RNA-based cancer vaccine

ECA-Member*: € 1890,-
Non ECA Member*: € 2090,-
EU/GMP Inspectorates*: € 1045,-
APIC Member Discount*: € 1990,-

Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.

* auch unkompliziert per Kreditkarte bezahlbar
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