mRNA & Non-viral Delivery - Online Training Recording

Course No. 23046

header-image

Speakers

Dr Mohamad Toutounji

Dr Mohamad Toutounji

Molgenium

Dr Christoph Peter

Dr Christoph Peter

Peter Auditing

Selina Roth

Selina Roth

Lonza

Dr Julia Schüler

Dr Julia Schüler

Charles River Laboratories Germany



Target Group

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.

Objectives

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.

Background
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.


Programme

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


Further Information

Technical Details
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.

Timing and Duration
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.

In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.

Please be aware: The recording does not include the Q & A sessions.

Training Course Documentation and Certificate
The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.

Contacts
Questions regarding content:
Mr Clemens Mundo, +49 6221 84 44-42, mundo@concept-heidelberg.de
Questions regarding organisation:
Mr Ronny Strohwald, +49 6221 84 44-51, strohwald@concept-heidelberg.de

Recording from 19-20 May 2026
Duration of recording: 7h 45m
 

Costs

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

(All prices excl. VAT). Important notes on sales tax.

* also payable by credit card
American Express Visa Mastercard

icon
Recording/ Additional dates on-site
not available
Recording/ Additional dates on-site
not available
stop

This course is part of the GMP Certification Programme "ECA Certified Biotech Manager"

Do you have any questions?

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

Woman with headset

Go back

Testimonials about our courses and conferences

"Great material and speakers" and "Great speakers a lot of experience and sharing"

Felipe Gonzalez, Mucos Emulsionsgesellschaft mbH
Live Online Training - Granulation & Tableting, September 2024

“I found the course eye opening and very well organized.”

Jozsef Maklary, Veolia Industries Austria GmbH
The GMP-Compliance Manager, October 2025

"I am so grateful for having attended this course. Great job from all, and very profitable. Thanks!”

Alba Aranda Cuesta, Kern Pharma
KPIs and Quality Metrics, Berlin, Germany, April 2025

"The lectures were very informative, interesting and entertaining."

Albert Godoy Hernández, Company synaffix
Live Online Training - GMP Auditor Practice, October 2024

"Really useful training which I will use in my daily work."

Regina Mommaerts, Galapagos NV
Live Online Training - GMP Auditor Practice, October 2024

"Wonderful format of the sessions: Good range of participations and experience in the team. Would love to attend another one soon."

Roopasi Mathi, Wacker Biotech B.V.
Live Online Training - GMP Auditor Practice, October 2024

"Very good balance between general and detailed information"

Dr Ralf Albrecht, Tillotts Pharma AG
Live Online Training - Granulation & Tableting
September 2024

"Nice presentations: easy understanding, quite visual"

Susana Manrique, Boehringer Ingelheim España, S.A,
Live Online Training - Granulation & Tableting, September 2024

“Fantastic course – I really enjoyed the interactive structure & greatly appreciate social activity.”

Anthony Cummins, Sebela Pharmaceuticals, Ireland
GMP Auditor Practice, September 2023

 

“Very well organized, information on point without being overwhelming.”

Eleni Kallinikou, Pharmathen
Live Online Trainng - Pharmaceutical Contracts - Febuary 2024

 

“Good overview of different types of agreements, good to see both the GMP and the legal angle”

Ann Michiels, Johnson&Johnson
Live Online Trainng - Pharmaceutical Contracts, Febuary 2024

 

 

“Both, organizers and lecturers were very friendly, open for discussions and extremely constructive. The course was a valuable experience for me.”

Maria Dimitrova, NKN Law Firm
Pharmaceutical Contracts: GMP and Legal Compliance, March 2025

10% Early-Bird Discount until 30 June 2026

Book by 30 June 2026 and get 10% early-bird discount

Here’s how it works:

  • Select the event of interest
  • Book by 30 June 2026
  • Enter the code “SAVE10” during the booking process

The discount will be automatically deducted from the event fee.

*This offer does not apply to recordings and conferences with their own early bird discount (PharmaLab, QP Forum, API Conference).