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Integrated control and sensing platform for biopharmaceutical cultivation process high-throughput development and production

Deliverables

Transferrable and generic chemometric model procedures are ready for application (models obtained by MBR can be used in STR)

The results of the transferability of models developed using MBR to apply in STR are obtained. The conditions and procedures how to transfer are determined. Under which conditions and how models obtained by MBR can be used in STR.

Off-line glycosylation/titre assays after sample purification/preparation on fluidic platform

Different glycan assay formats will be tested for integration into microfluidic platform.

Data-driven models with different complexity levels related to their use (description/soft sensor/control)

Data-driven models will be derived by applying MLPCA to the datasets to determine the data-driven required number of pseudo-bioreactions. In a second step, a decision on the kinetic structure (grey-box vs black-box) will be taken with respect to the data content. Eventually, an adapted identification procedure will be applied and validated with the datasets.

Software sensors using the previously obtained models

A general observability mapping will be determined based on the previously obtained models from D8.1 and D8.2. Necessary on-line measurements will be selected and software sensors will be derived from the models and these measurements. First off-line validations of the resulting software sensors will be achieved and used as basis for further on-line validations using closed-loop controllers.

Chemometric models methodology is fixed and can be utilized by partners

The best modeling methodology is determined (such as PCR, PLS or neural network, support vector regression) and can be applied by the partners

Spectral pre-processing procedures (such as outlier detection, noise reduction and smoothing) are implemented

The algorithms of outlier detection, noise reduction and smoothing are implemented and validated. Furthermore preprocessing procedures like deviation-, distance- and density-based approaches are implemented in the evaluation program.

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Publications

Analysis of amino acids in cell culture supernatant using capillary electrophoresis with contactless conductivity detection

Author(s): Saara Mikkonen, Åsa Emmer
Published in: ELECTROPHORESIS, 2021, ISSN 0173-0835
Publisher: John Wiley & Sons Ltd.
DOI: 10.1002/elps.202100122

Knowing more from less: miniaturization of ligand-binding assays and electrophoresis as new paradigms for at-line monitoring and control of mammalian cell bioprocesses

Author(s): Inês F Pinto, Saara Mikkonen, Leila Josefsson, Meeri E-L Mäkinen, Ruben RG Soares, Aman Russom, Åsa Emmer, Veronique Chotteau
Published in: Current Opinion in Biotechnology, 71, 2021, Page(s) 55-64, ISSN 0958-1669
Publisher: Elsevier BV
DOI: 10.1016/j.copbio.2021.06.018

Multiplexed Microfluidic Cartridge for At-Line Protein Monitoring in Mammalian Cell Culture Processes for Biopharmaceutical Production

Author(s): Inês F. Pinto, Ruben R. G. Soares, Meeri E.-L. Mäkinen, Veronique Chotteau, Aman Russom
Published in: ACS Sensors, 6/3, 2021, Page(s) 842-851, ISSN 2379-3694
Publisher: ACS Publications
DOI: 10.1021/acssensors.0c01884

High-Throughput Quantification and Glycosylation Analysis of Antibodies Using Bead-Based Assays

Author(s): Sebastian Giehring
Published in: Animal Cell Biotechnology - Methods and Protocols, 2095, 2020, Page(s) 271-284, ISBN 978-1-0716-0190-7
Publisher: Springer US
DOI: 10.1007/978-1-0716-0191-4_15