Development of a novel disposable flowcell for spectroscopic bioprocess monitoring

authored by: Phil Thiel, Tobias Steinwedel, Philipp Raithel, Mathias Belz, Dörte Solle
Abstract: Regulatory authorities require product control for market release, especially for medical products due to legal regulations. Thus, end product control is conducted before drug market release. For real-time release in terms of Process Analytical Technology (PAT), product quality must be designed into the process. Process sensors are needed to monitor critical process parameters (CPP) for immediate control. Conventional sensors lack interfaces for disposable bioreactors, but new flow cell systems enable spectroscopic bioprocess monitoring via a bypass system. The flow cell is gamma-sterilized and clamped into a reusable holder, allowing spectroscopic techniques like turbidity, UV/VIS spectroscopy, and fluorescence. The cell setup and biocompatibility are presented, with in-vitro toxicity of various 3D printable materials evaluated per ISO 10993 to find suitable materials. Polyamide (PA), Acrylonitrile Butadiene Styrene (ABS) and Polymethyl Methacrylate (PMMA) were used for manufacturing flow cells and tested for in vitro biocompatibility. Results confirm the suitability of these materials and processes, with UV–VIS spectroscopy providing key insights. Selectivity and sensitivity for three different important bioprocess variables were evaluated and enables precise sensor system characterization across various analytes, advancing flow cell and sensor technology in biosensing and analytical chemistry.
Organisation(s): Institute of Technical Chemistry
External Organisation(s): Lytegate GmbH
Type: Article
Journal: Measurement: Sensors
Volume: 38
Publication date: 04.2025
Publication status: Published
Peer reviewed: Yes
ASJC Scopus subject areas: Electronic, Optical and Magnetic Materials, Mechanics of Materials, Industrial and Manufacturing Engineering, Electrical and Electronic Engineering
Electronic version(s): https://doi.org/10.1016/j.measen.2025.101862 (Access: Open)

BibTeX

@article{d1ed457cdc3a486e8312ebbce9b08f7b,
title = "Development of a novel disposable flowcell for spectroscopic bioprocess monitoring",
abstract = "Regulatory authorities require product control for market release, especially for medical products due to legal regulations. Thus, end product control is conducted before drug market release. For real-time release in terms of Process Analytical Technology (PAT), product quality must be designed into the process. Process sensors are needed to monitor critical process parameters (CPP) for immediate control. Conventional sensors lack interfaces for disposable bioreactors, but new flow cell systems enable spectroscopic bioprocess monitoring via a bypass system. The flow cell is gamma-sterilized and clamped into a reusable holder, allowing spectroscopic techniques like turbidity, UV/VIS spectroscopy, and fluorescence. The cell setup and biocompatibility are presented, with in-vitro toxicity of various 3D printable materials evaluated per ISO 10993 to find suitable materials. Polyamide (PA), Acrylonitrile Butadiene Styrene (ABS) and Polymethyl Methacrylate (PMMA) were used for manufacturing flow cells and tested for in vitro biocompatibility. Results confirm the suitability of these materials and processes, with UV–VIS spectroscopy providing key insights. Selectivity and sensitivity for three different important bioprocess variables were evaluated and enables precise sensor system characterization across various analytes, advancing flow cell and sensor technology in biosensing and analytical chemistry.",
keywords = "3D printing, Biocompatibility, Bioprocess monitoring, In-vitro, Process Analytical Technology (PAT), Spectroscopic techniques",
author = "Phil Thiel and Tobias Steinwedel and Philipp Raithel and Mathias Belz and D{\"o}rte Solle",
note = "Publisher Copyright: {\textcopyright} 2025 The Authors",
year = "2025",
month = apr,
doi = "10.1016/j.measen.2025.101862",
language = "English",
volume = "38",
journal = "Measurement: Sensors",
issn = "2665-9174",
publisher = "Elsevier Ltd.",
}