header-image

mRNA & Non-viral Delivery - Online Training Recording

Seminar-Nr. 23046

Referierende

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


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.

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.

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.


Programm

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


Weitere Informationen

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
 

Teilnahmegebühr

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

Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.

* auch unkompliziert per Kreditkarte bezahlbar
American Express Visa Mastercard

icon
Aufzeichnung/weitere Termine nicht verfügbar
Aufzeichnung/weitere Termine nicht verfügbar

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

Haben Sie noch Fragen?

Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.

Frau mit Headset
Tel.: +49 6221 8444-0
E-Mail: info@concept-heidelberg.de

Zurück

Teilnehmerstimmen - das sagen andere über unsere Seminare:

"Die Umsetzung mit Memberspot ist wirklich ausgezeichnet gelungen.
Es unterstützt die Wissensvermittlung und gewährleistet auch die richtige Durchführung des Kurses.”
Christian Wagener, WAGENER & CO. GmbH
GMP Basis-Einstiegsschulung (B 1) - Aufzeichnung Online Seminar, April 2024

"Die Rollenspiele haben interessante Situationen beschrieben und gute Lösungsmöglichkeiten aufgezeigt.”
Dr. Daniel Weicherding, KRAIBURG TPE GmbH & Co. KG
GMP-Auditor/in (FA 1) - Live Online Seminar, November 2025

„Kurzweilig, informativ“
Behrendt, Christian, IOI Oleo GmbH

„Austausch zwischen Teilnehmern & Vortragenden sorgt für Anstöße & Optimierungsmöglichkeiten im eigenen Unternehmen! Praxisnahe Beispiele veranschaulichen und vertiefen die Theorie sehr gut“
Marina Maier, CHEPLAPHARM Arzneimittel GmbH

Abweichungen und CAPA (QS 12)
November 2024

„Danke für das tolle und interessante Seminar! Ich nehme mir fachlich total viel mit und habe viele tolle Menschen kennengelernt.“
Melanie Schifferer, DAIICHI SANKYO EUROPE GmbH
Batch Record Review (QS 23)
September 2024

Guter, breit gefächerter Überblick mit interessanten Verknüpfungen zur Praxis,
welche die Theorie super veranschaulicht.”
Marina Kicoranovic, Labor Hartmann GmbH
GMP/Basis-Einstiegsschulung (B 14), September 2023

Die Referenten waren sehr gut! Sie haben sehr klar gesprochen, nur sehr wenige englische Begriffe
verwendet (super) und waren sehr praxisbezogen.”
Astrid Gießler, Regierungspräsidium Karlsruhe
Live Online Seminar - Basiskurs Computervalidierung & Datenintegrität im GxP Umfeld (B 3), Juni 2023

Sehr guter Bezug zur Schulung für einen GMP-Anfänger. Habe mich sehr gut abgeholt gefühlt.”
Dr. Harald Werner, Infraserv GmbH & Co. Höchst KG
GMP-Basisschulung (B 1), Juni 2023

„Interessante Themen, gut vorgetragen, die eigenen Erfahrungen der Vortragenden helfen, dies noch besser nachzuvollziehen.“ „Gute Gestaltung der Workshops, das Zusammenarbeiten in Gruppen und der Austausch mit anderen hilft sehr.“
Manuela Seibert, Merck, GMP-Leadauditor/in (FA 2), April 2024

NEWSLETTER

Bleiben Sie informiert mit dem GMP Newsletter von Concept Heidelberg!

GMP Newsletter

Concept Heidelberg bietet verschieden GMP Newsletter die Sie auf Ihren Bedarf hin zusammenstellen können.

Hier können Sie sich kostenfrei registrieren.

Kontakt

Kontaktieren Sie uns

Haben Sie Fragen?

Concept Heidelberg GmbH
Rischerstraße 8
69123 Heidelberg

Tel. :+49622184440
Fax : +49 6221 84 44 84
E-Mail: info@concept-heidelberg.de

zum Kontaktformular

Sparen SIe 10% bis zum 31.07.2026

Buchen Sie bis zum 31.07.2026 und sichern Sie sich 10% Frühbucherrabatt auf alle Veranstaltungen*, die ab dem 25.08.2026 beginnen.

So funktioniert es:

  •   Wunschveranstaltung auswählen
  •   Bis zum 31.07.2026 buchen
  •   Im Bestellprozess den Code „SAVE10“ eingeben

Der Rabatt wird automatisch vom Veranstaltungspreis abgezogen.

*Die Aktion gilt nicht für Aufzeichnungen und Konferenzen mit eigenem Frühbucherrabatt (aseptikon, PharmaLab, QP Forum, GAMP, API Conference).