Fraunhofer Institute for Cell Therapy and Immunology IZI
Fraunhofer Institute for Cell Therapy and Immunology IZI

Automated production technologies for mRNA-based drugs

Production plant for the automated formulation of mRNA

Flexible, scalable and digital production

Screening system for the automated formulation of mRNA
© Fraunhofer IPT

Production plant with digital process control and data-driven inline quality control – the solution for automated mRNA nanotransporter production up to 20 ml. 

Designed as a flexible test system, it enables the screening of customer-specific formulation and process parameters – without any limitations such as flow rate, pressure, and temperature. Scalable, flexibly combinable, and manufacturer-independent production modules are interchangeable via plug-and-play, even in the event of a fault.

Digital quality control is performed via inline analytics – without product loss. A digital batch record summarizes all measured production and product parameters in a compact form and forms the basis for the targeted optimization of your process parameters.

Highlights

Production plant

  • Modular design made up of individual components
  • Scalable and flexibly expandable
  • Microfluidic mixing technology with high throughput
  • Plug-and-play functionality

Process control

  • Automated process control
  • Digital twins of all individual components
  • Recording of all production parameters

Analysis technology

  • Inline dynamic light scattering
  • pH value
  • Viscosity
  • Temperature
  • UV/Vis absorption

Inline quality assurance

  • Digital twin of product quality
  • Quality control without product loss
  • Monitoring of all quality parameters
  • Digital product passport
  • Optimization of production parameters
© Fraunhofer IMM
Manufacturing of the micromixer structures.
© Fraunhofer IMM
Inline particle size measurement using DLS.

Literature

  • Biermann F, Mathews J, Nießing B, König N, Schmitt RH. 2021. Automating Laboratory Processes by Connecting Biotech and Robotic Devices – An Overview of the Current Challenges, Existing Solutions and Ongoing Developments. Processes 9: 966. 
  • Schmidt A, Frey J, Hillen D, Horbelt J, Schandar M, Schneider D, Sorokos I. A Frame-work for Automated Quality Assurance and Documentation for Pharma 4.0. Lecture Notes in Computer Science (LNPSE, volume 12852), Springer, 2021.
  • Fischer RP, Freundel M, Graf P, Luetjohann D, Mavreas C, Trapl J, Volckmann J, Wolf A. Simplified integration of qualified laboratory devices with the Asset Administration Shell as the Digital Twin. IPSE Concept Paper (2023). 
  • Fischer RP. 2023. ISPE Baseline Guide: Volume 8 – Pharma 4.0. Guidance Document, Tempa: International Society for Pharmaceutical Engineering (ISPE). 
  • Hort S, Herbst L, Bäckel N, Erkens F, Niessing B, Frye M, König N, Papantoniou I, Hudecek M et al. 2022. Toward Rapid, Widely Available Autologous CAR-T Cell Therapy - Artificial Intelligence and Automation Enabling the Smart Manufacturing Hospital. Frontiers in Medicine 9: 913287. 
  • Schmidt A, van Lengen RH, Horbelt J, Gebken N, König N, Biermann F, Blache U et al. 2021. Skalierbare Herstellung von ATMPs - Notwendige Kernbausteine für die standardi­sierte automatische Produktion von neuartigen Zell- und Gentherapeutika. München: Fraunhofer-Gesellschaft. 
  • IESE BaSyx. https://eclipse.dev/basyx IPT 
  • Cope. https://copesoftware.de