Details
| Original language | English |
|---|---|
| Article number | 101862 |
| Journal | Measurement: Sensors |
| Volume | 38 |
| Early online date | 24 Feb 2025 |
| Publication status | E-pub ahead of print - 24 Feb 2025 |
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
ASJC Scopus subject areas
- Materials Science(all)
- Electronic, Optical and Magnetic Materials
- Engineering(all)
- Mechanics of Materials
- Engineering(all)
- Industrial and Manufacturing Engineering
- Engineering(all)
- Electrical and Electronic Engineering
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In: Measurement: Sensors, Vol. 38, 101862, 04.2025.
Research output: Contribution to journal › Article › Research › peer review
}
TY - JOUR
T1 - Development of a novel disposable flowcell for spectroscopic bioprocess monitoring
AU - Thiel, Phil
AU - Steinwedel, Tobias
AU - Raithel, Philipp
AU - Belz, Mathias
AU - Solle, Dörte
N1 - Publisher Copyright: © 2025 The Authors
PY - 2025/2/24
Y1 - 2025/2/24
N2 - 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.
AB - 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.
KW - 3D printing
KW - Biocompatibility
KW - Bioprocess monitoring
KW - In-vitro
KW - Process Analytical Technology (PAT)
KW - Spectroscopic techniques
UR - http://www.scopus.com/inward/record.url?scp=85218907485&partnerID=8YFLogxK
U2 - 10.1016/j.measen.2025.101862
DO - 10.1016/j.measen.2025.101862
M3 - Article
AN - SCOPUS:85218907485
VL - 38
JO - Measurement: Sensors
JF - Measurement: Sensors
M1 - 101862
ER -