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RAAV Manufacturing: The Challenges of Soft Sensing during Upstream Processing.

ABSTRACT: Recombinant adeno-associated virus (rAAV) is the most effective viral vector technology for directly translating the genomic revolution into medicinal therapies. However, the manufacturing of rAAV viral vectors remains challenging in the upstream processing with low rAAV yield in large-scale production and high cost, limiting the generalization of rAAV-based treatments. This situation can be improved by real-time monitoring of critical process parameters (CPP) that affect critical quality attributes (CQA). To achieve this aim, soft sensing combined with predictive modeling is an important strategy that can be used for optimizing the upstream process of rAAV production by monitoring critical process variables in real time. However, the development of soft sensors for rAAV production as a fast and low-cost monitoring approach is not an easy task. This review article describes four challenges and critically discusses the possible solutions that can enable the application of soft sensors for rAAV production monitoring. The challenges from a data scientist's perspective are (i) a predictor variable (soft-sensor inputs) set without AAV viral titer, (ii) multi-step forecasting, (iii) multiple process phases, and (iv) soft-sensor development composed of the mechanistic model.

SUBMITTER: Iglesias CF

PROVIDER: S-EPMC9951952 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature

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rAAV Manufacturing: The Challenges of Soft Sensing during Upstream Processing.

Iglesias Cristovão Freitas CF Ristovski Milica M Bolic Miodrag M Cuperlovic-Culf Miroslava M

Bioengineering (Basel, Switzerland) 20230208 2

Recombinant adeno-associated virus (rAAV) is the most effective viral vector technology for directly translating the genomic revolution into medicinal therapies. However, the manufacturing of rAAV viral vectors remains challenging in the upstream processing with low rAAV yield in large-scale production and high cost, limiting the generalization of rAAV-based treatments. This situation can be improved by real-time monitoring of critical process parameters (CPP) that affect critical quality attrib ...[more]

PMID: 36829723

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Project description:With the purpose of making soft robotic structures with embedded sensors, additive manufacturing techniques like fused deposition modeling (FDM) are popular. Thermoplastic polyurethane (TPU) filaments, with and without conductive fillers, are now commercially available. However, conventional FDM still has some limitations because of the marginal compatibility with soft materials. Material selection criteria for the available material options for FDM have not been established. In this study, an open-source soft robotic gripper design has been used to evaluate the FDM printing of TPU structures with integrated strain sensing elements in order to provide some guidelines for the material selection when an elastomer and a soft piezoresistive sensor are combined. Such soft grippers, with integrated strain sensing elements, were successfully printed using a multi-material FDM 3D printer. Characterization of the integrated piezoresistive sensor function, using dynamic tensile testing, revealed that the sensors exhibited good linearity up to 30% strain, which was sufficient for the deformation range of the selected gripper structure. Grippers produced using four different TPU materials were used to investigate the effect of the Shore hardness of the TPU on the piezoresistive sensor properties. The results indicated that the in situ printed strain sensing elements on the soft gripper were able to detect the deformation of the structure when the tentacles of the gripper were open or closed. The sensor signal could differentiate between the picking of small or big objects and when an obstacle prevented the tentacles from opening. Interestingly, the sensors embedded in the tentacles exhibited good reproducibility and linearity, and the sensitivity of the sensor response changed with the Shore hardness of the gripper. Correlation between TPU Shore hardness, used for the gripper body and sensitivity of the integrated in situ strain sensing elements, showed that material selection affects the sensor signal significantly.

Dataset Information

RAAV Manufacturing: The Challenges of Soft Sensing during Upstream Processing.

Publications

rAAV Manufacturing: The Challenges of Soft Sensing during Upstream Processing.

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