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Cell Labeling and Targeting with Superparamagnetic Iron Oxide Nanoparticles

Cell Labeling and Targeting with Superparamagnetic Iron Oxide Nanoparticles

Published on: October 19, 2015

GMP-compliant batch manufacturing of dextran-coated iron oxide nanoparticles: A process development case study.

Helmut Spielvogel¹, Eveline Schreiber¹, Teresa Siegert¹

¹ENT-Department, Section for Experimental Oncology and Nanomedicine (SEON), Else Kröner-Fresenius-endowed Professorship for Nanomedicine, Universitätsklinikum Erlangen, Erlangen, Germany.

Biochemical and Biophysical Research Communications

|February 6, 2026

Summary

Superparamagnetic iron oxide nanoparticles (SPIONs) like SEON^Dex30 offer advanced MRI contrast imaging. Manufacturing these investigational medicinal products requires strict Good Manufacturing Practice (GMP) guidelines for clinical trials.

Area of Science:

Nanomedicine and Materials Science
Biotechnology and Pharmaceutical Manufacturing

Background:

Superparamagnetic iron oxide nanoparticles (SPIONs) are valuable for magnetic accumulation and MRI visualization.
SEON^Dex30, developed by SEON, features an iron oxide core with a dextran coating, designed for enhanced liver imaging in clinical trials.
Current iron oxide nanoparticle contrast agents face limitations in application safety, long-term tolerance, and imaging quality.

Purpose of the Study:

To detail the Good Manufacturing Practice (GMP)-compliant development and manufacturing process for SEON^Dex30 SPIONs.
To establish SEON^Dex30 as an Investigational Medicinal Product (IMP) for human clinical trials.
To demonstrate the potential superiority of SEON^Dex30 over existing MRI contrast agents for liver imaging.

Main Methods:

Fabrication of SEON^Dex30 nanoparticles with an iron oxide core (magnetite/maghemite) and a cross-linked dextran shell.
Adherence to Good Manufacturing Practice (GMP) guidelines for nanomedicine production, including quality control and regulatory compliance.
Exploration of alternative biocompatible coating materials (proteins, lipids, polymers) and functionalization with active pharmaceutical ingredients (APIs).

Main Results:

The report illustrates a process-oriented technical case study of GMP-compliant nanoparticle manufacturing.
Requirements for starting materials, technology, production processes, and quality inspections for SEON^Dex30 are outlined.
The described manufacturing standards are representative for future iron oxide-based nanoparticle medicinal products.

Conclusions:

GMP-compliant manufacturing is essential for the clinical translation of nanomedicines like SEON^Dex30.
Specialized pharmaceutical companies can provide necessary resources for institutions lacking in-house production capabilities.
Further applications for functionalized SPIONs include targeted cancer therapies and controlled drug delivery.

Keywords:

Good manufacturing practice (GMP)Investigational medicinal product (IMP)Nanotechnology-based medicinal products Superparamagnetic nanoparticles

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