Integration and digitalization in the manufacturing of therapeutic proteins

Spectroscopic models for real‐time monitoring of cell culture processes using spatiotemporal just‐in‐time Gaussian processes

(2021) Aditya Tulsyan et al.   AICHE JOURNAL

Analysis and optimal design of batch and two‐column continuous chromatographic frontal processes for monoclonal antibody purification

(2021) Ce Shi et al.   BIOTECHNOLOGY AND BIOENGINEERING

Process Intensification for the Purification of Peptidomimetics: The Case of Icatibant through Multicolumn Countercurrent Solvent Gradient Purification (MCSGP)

(2021) Chiara De Luca et al.   INDUSTRIAL & ENGINEERING CHEMISTRY RESEARCH

Hybrid Models for the simulation and prediction of chromatographic processes for protein capture

(2021) Harini Narayanan et al.   JOURNAL OF CHROMATOGRAPHY A

Hybrid Models Based on Machine Learning and an Increasing Degree of Process Knowledge: Application to Capture Chromatographic Step

(2021) Harini Narayanan et al.   INDUSTRIAL & ENGINEERING CHEMISTRY RESEARCH

A hybrid mechanistic-empirical model for in silico mammalian cell bioprocess simulation

(2021) Conor M. O'Brien et al.   METABOLIC ENGINEERING

Hybrid modeling — a key enabler towards realizing digital twins in biopharma?

(2021) Michael Sokolov et al.   Current Opinion in Chemical Engineering

Multi-attribute PAT for UF/DF of Proteins—Monitoring Concentration, particle sizes, and Buffer Exchange

(2020) Laura Rolinger et al.   ANALYTICAL AND BIOANALYTICAL CHEMISTRY

Process‐wide control and automation of an integrated continuous manufacturing platform for antibodies

(2020) Fabian Feidl et al.   BIOTECHNOLOGY AND BIOENGINEERING

Design space and robustness analysis of batch and counter-current frontal chromatography processes for the removal of antibody aggregates

(2020) Sebastian Vogg et al.   JOURNAL OF CHROMATOGRAPHY A

Oligonucleotides: Current Trends and Innovative Applications in the Synthesis, Characterization, and Purification

(2020) Martina Catani et al.   Biotechnology Journal

Model based strategies towards protein A resin lifetime optimization and supervision

(2020) Fabian Feidl et al.   JOURNAL OF CHROMATOGRAPHY A

Bioprocess intensification: aspirations and achievements

(2020) Bill Whitford   BIOTECHNIQUES

Towards a Digital Bioprocess Replica: Computational Approaches in Biopharmaceutical Development and Manufacturing

(2020) Jens Smiatek et al.   TRENDS IN BIOTECHNOLOGY

Decision Making and Risk Management in Biopharmaceutical Engineering—Opportunities in the Age of Covid-19 and Digitalization

(2020) Michael Sokolov   INDUSTRIAL & ENGINEERING CHEMISTRY RESEARCH

Chromatography bioseparation technologies and in-silico modelings for continuous production of biotherapeutics

(2020) Ketki Behere et al.   JOURNAL OF CHROMATOGRAPHY A

A multisensor approach for improved protein A load phase monitoring by conductivity‐based background subtraction of UV spectra

(2020) Laura Rolinger et al.   BIOTECHNOLOGY AND BIOENGINEERING

Optimal loading flow rate trajectory in monoclonal antibody capture chromatography

(2020) Joaquín Gomis-Fons et al.   JOURNAL OF CHROMATOGRAPHY A

Reinforcement learning based optimization of process chromatography for continuous processing of biopharmaceuticals

(2020) Saxena Nikita et al.   CHEMICAL ENGINEERING SCIENCE

Prediction of the Quantity and Purity of an Antibody Capture Process in Real Time

(2019) Nicole Walch et al.   Biotechnology Journal

A new flow cell and chemometric protocol for implementing in‐line Raman spectroscopy in chromatography

(2019) Fabian Feidl et al.   BIOTECHNOLOGY PROGRESS

An overview of mechanistic modeling of liquid chromatography

(2019) Lalita K. Shekhawat et al.   PREPARATIVE BIOCHEMISTRY & BIOTECHNOLOGY

A two-step procedure for the design of perfusion bioreactors

(2019) Moritz K.F. Wolf et al.   BIOCHEMICAL ENGINEERING JOURNAL

A machine‐learning approach to calibrate generic Raman models for real‐time monitoring of cell culture processes

(2019) Aditya Tulsyan et al.   BIOTECHNOLOGY AND BIOENGINEERING

A new generation of predictive models: The added value of hybrid models for manufacturing processes of therapeutic proteins

(2019) Harini Narayanan et al.   BIOTECHNOLOGY AND BIOENGINEERING

Optimization of integrated chromatography sequences for purification of biopharmaceuticals

(2019) Anton Löfgren et al.   BIOTECHNOLOGY PROGRESS

Perfusion cell culture for the production of conjugated recombinant fusion proteins reduces clipping and quality heterogeneity compared to batch-mode processes

(2019) Jean-Marc Bielser et al.   JOURNAL OF BIOTECHNOLOGY

Monitoring of antibody glycosylation pattern based on microarray MALDI-TOF mass spectrometry

(2019) Joanna Hajduk et al.   JOURNAL OF BIOTECHNOLOGY

Combining Mechanistic Modeling and Raman Spectroscopy for Monitoring Antibody Chromatographic Purification

(2019) Feidl et al.   Processes

Impact of micro and macroporous TFF membranes on product sieving and chromatography loading for perfusion cell culture

(2019) Nuno D. S. Pinto et al.   BIOTECHNOLOGY AND BIOENGINEERING

Optimal Antibody Purification Strategies Using Data-Driven Models

(2019) Songsong Liu et al.   Engineering

Antibodies to watch in 2020

(2019) Hélène Kaplon et al.   mAbs

Digital Twin-driven smart manufacturing: Connotation, reference model, applications and research issues

(2019) Yuqian Lu et al.   ROBOTICS AND COMPUTER-INTEGRATED MANUFACTURING

Regulatory challenges of nanomedicines and their follow-on versions: A generic or similar approach?

(2018) Stefan Mühlebach   ADVANCED DRUG DELIVERY REVIEWS

Perfusion mammalian cell culture for recombinant protein manufacturing – A critical review

(2018) Jean-Marc Bielser et al.   BIOTECHNOLOGY ADVANCES

Industrial bioprocessing perspectives on managing therapeutic protein charge variant profiles

(2018) Stanley Chung et al.   BIOTECHNOLOGY AND BIOENGINEERING

Multi-criterion control of a bioprocess in fed-batch reactor using EKF based economic model predictive control

(2018) Anilkumar Markana et al.   CHEMICAL ENGINEERING RESEARCH & DESIGN

Model predictive control in comparison to elemental balance control in an E. coli fed-batch

(2018) Sophia Ulonska et al.   CHEMICAL ENGINEERING SCIENCE

Selective protein quantification for preparative chromatography using variable pathlength UV/Vis spectroscopy and partial least squares regression

(2018) Nina Brestrich et al.   CHEMICAL ENGINEERING SCIENCE

Digital twin driven prognostics and health management for complex equipment

(2018) Fei Tao et al.   CIRP ANNALS-MANUFACTURING TECHNOLOGY

On the glycosylation aspects of biosimilarity

(2018) László Hajba et al.   DRUG DISCOVERY TODAY

Progression of continuous downstream processing of monoclonal antibodies: current trends and challenges

(2018) Balaji Somasundaram et al.   BIOTECHNOLOGY AND BIOENGINEERING

Model-assisted process characterization and validation for a continuous two-column protein A capture process

(2018) Daniel Baur et al.   BIOTECHNOLOGY AND BIOENGINEERING

Mechanistic modeling and applications for CHO cell culture development and production

(2018) Sha Sha et al.   Current Opinion in Chemical Engineering

Upstream process intensification and continuous manufacturing

(2018) Chun Chen et al.   Current Opinion in Chemical Engineering

Advanced monitoring and control of pharmaceutical production processes with Pichia pastoris by using Raman spectroscopy and multivariate calibration methods

(2017) Jan-Patrick Voss et al.   ENGINEERING IN LIFE SCIENCES

In-line monitoring of amino acids in mammalian cell cultures using raman spectroscopy and multivariate chemometrics models

(2017) Hemlata Bhatia et al.   ENGINEERING IN LIFE SCIENCES

The sweet spot for biologics: recent advances in characterization of biotherapeutic glycoproteins

(2017) Róisín O’Flaherty et al.   Expert Review of Proteomics

Root cause investigation of deviations in protein chromatography based on mechanistic models and artificial neural networks

(2017) Gang Wang et al.   JOURNAL OF CHROMATOGRAPHY A

Designing affinity chromatographic processes for the capture of antibodies. Part I: A simplified approach

(2017) D. Pfister et al.   JOURNAL OF CHROMATOGRAPHY A

Glycosylation flux analysis reveals dynamic changes of intracellular glycosylation flux distribution in Chinese hamster ovary fed-batch cultures

(2017) Sandro Hutter et al.   METABOLIC ENGINEERING

Next generation antibody drugs: pursuit of the 'high-hanging fruit'

(2017) Paul J. Carter et al.   NATURE REVIEWS DRUG DISCOVERY

Workflow for Target-Oriented Parametrization of an Enhanced Mechanistic Cell Culture Model

(2017) Sophia Ulonska et al.   Biotechnology Journal

Quality by control: Towards model predictive control of mammalian cell culture bioprocesses

(2017) Wolfgang Sommeregger et al.   Biotechnology Journal

Advanced control strategies for the multicolumn countercurrent solvent gradient purification process

(2016) Maria M. Papathanasiou et al.   AICHE JOURNAL

Rapid and improved characterization of therapeutic antibodies and antibody related products using IdeS digestion and subunit analysis

(2016) Jonathan Sjögren et al.   ANALYST

Characterization and comparison of ATF and TFF in stirred bioreactors for continuous mammalian cell culture processes

(2016) Daniel J. Karst et al.   BIOCHEMICAL ENGINEERING JOURNAL

Hybrid modeling as a QbD/PAT tool in process development: an industrial E. coli case study

(2016) Moritz von Stosch et al.   BIOPROCESS AND BIOSYSTEMS ENGINEERING

Process performance and product quality in an integrated continuous antibody production process

(2016) Daniel J. Karst et al.   BIOTECHNOLOGY AND BIOENGINEERING

Real-time monitoring and control of the load phase of a protein A capture step

(2016) Matthias Rüdt et al.   BIOTECHNOLOGY AND BIOENGINEERING

Comparison of batch and continuous multi-column protein A capture processes by optimal design

(2016) Daniel Baur et al.   Biotechnology Journal

Continuous counter-current chromatography for capture and polishing steps in biopharmaceutical production

(2016) Fabian Steinebach et al.   Biotechnology Journal

Controlling the time evolution of mAb N-linked glycosylation - Part II: Model-based predictions

(2016) Thomas K. Villiger et al.   BIOTECHNOLOGY PROGRESS

Model based adaptive control of a continuous capture process for monoclonal antibodies production

(2016) Fabian Steinebach et al.   JOURNAL OF CHROMATOGRAPHY A

Comparison of batch and continuous multi-column protein A capture processes by optimal design

(2016) Daniel Baur et al.   Biotechnology Journal

Continuous counter-current chromatography for capture and polishing steps in biopharmaceutical production

(2016) Fabian Steinebach et al.   Biotechnology Journal

Artificial neural network associated to UV/Vis spectroscopy for monitoring bioreactions in biopharmaceutical processes

(2015) Maria Beatriz Takahashi et al.   BIOPROCESS AND BIOSYSTEMS ENGINEERING

The future of industrial bioprocessing: Batch or continuous?

(2015) Matthew S. Croughan et al.   BIOTECHNOLOGY AND BIOENGINEERING

Advances in inline quantification of co-eluting proteins in chromatography: Process-data-based model calibration and application towards real-life separation issues

(2015) Nina Brestrich et al.   BIOTECHNOLOGY AND BIOENGINEERING

Optimal model-based design of the twin-column CaptureSMB process improves capacity utilization and productivity in protein A affinity capture

(2015) Daniel Baur et al.   Biotechnology Journal

Systematic interpolation method predicts protein chromatographic elution from batch isotherm data without a detailed mechanistic isotherm model

(2015) Arch Creasy et al.   Biotechnology Journal

Fingerprint detection and process prediction by multivariate analysis of fed-batch monoclonal antibody cell culture data

(2015) Michael Sokolov et al.   BIOTECHNOLOGY PROGRESS

Generic Raman-based calibration models enabling real-time monitoring of cell culture bioreactors

(2015) Hamidreza Mehdizadeh et al.   BIOTECHNOLOGY PROGRESS

End-to-end integrated fully continuous production of recombinant monoclonal antibodies

(2015) Rahul Godawat et al.   JOURNAL OF BIOTECHNOLOGY

Twin-column CaptureSMB: A novel cyclic process for protein A affinity chromatography

(2015) Monica Angarita et al.   JOURNAL OF CHROMATOGRAPHY A

Developability Assessment During the Selection of Novel Therapeutic Antibodies

(2015) Alexander Jarasch et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Optimal model-based design of the twin-column CaptureSMB process improves capacity utilization and productivity in protein A affinity capture

(2015) Daniel Baur et al.   Biotechnology Journal

Systematic interpolation method predicts protein chromatographic elution from batch isotherm data without a detailed mechanistic isotherm model

(2015) Arch Creasy et al.   Biotechnology Journal

Development of a soft-sensor based on multi-wavelength fluorescence spectroscopy and a dynamic metabolic model for monitoring mammalian cell cultures

(2014) Kaveh Ohadi et al.   BIOTECHNOLOGY AND BIOENGINEERING

Hybrid modeling for quality by design and PAT-benefits and challenges of applications in biopharmaceutical industry

(2014) Moritz von Stosch et al.   Biotechnology Journal

Cross-scale predictive modeling of CHO cell culture growth and metabolites using Raman spectroscopy and multivariate analysis

(2014) Brandon Berry et al.   BIOTECHNOLOGY PROGRESS

Mini-review: soft sensors as means for PAT in the manufacture of bio-therapeutics

(2014) Carl-Fredrik Mandenius et al.   JOURNAL OF CHEMICAL TECHNOLOGY AND BIOTECHNOLOGY

Process for protein PEGylation

(2014) David Pfister et al.   JOURNAL OF CONTROLLED RELEASE

Glucose concentration control of a fed-batch mammalian cell bioprocess using a nonlinear model predictive controller

(2014) Stephen Craven et al.   JOURNAL OF PROCESS CONTROL

Performance monitoring of a mammalian cell based bioprocess using Raman spectroscopy

(2013) Boyan Li et al.   ANALYTICA CHIMICA ACTA

Very high density of CHO cells in perfusion by ATF or TFF in WAVE bioreactor™. Part I. Effect of the cell density on the process

(2013) Marie-Françoise Clincke et al.   BIOTECHNOLOGY PROGRESS

Chemometrics and in-line near infrared spectroscopic monitoring of a biopharmaceutical Chinese hamster ovary cell culture: Prediction of multiple cultivation variables

(2013) Matthieu Clavaud et al.   TALANTA

Enabling global access to high-quality biopharmaceuticals

(2013) J Christopher Love et al.   Current Opinion in Chemical Engineering

Integrated continuous production of recombinant therapeutic proteins

(2012) Veena Warikoo et al.   BIOTECHNOLOGY AND BIOENGINEERING

Process model comparison and transferability across bioreactor scales and modes of operation for a mammalian cell bioprocess

(2012) Stephen Craven et al.   BIOTECHNOLOGY PROGRESS

Optimizing capacity utilization by large scale 3000 L perfusion in seed train bioreactors

(2012) Michael Pohlscheidt et al.   BIOTECHNOLOGY PROGRESS

Design of high productivity antibody capture by protein A chromatography using an integrated experimental and modeling approach

(2012) Candy K.S. Ng et al.   JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES

A general hybrid semi-parametric process control framework

(2012) Moritz von Stosch et al.   JOURNAL OF PROCESS CONTROL

Experimental validation of an Extended Kalman Filter estimating acetate concentration in E. coli cultures

(2012) L. Dewasme et al.   JOURNAL OF PROCESS CONTROL

Hybrid modeling framework for process analytical technology: Application to Bordetella pertussis cultures

(2011) M. von Stosch et al.   BIOTECHNOLOGY PROGRESS

Two step capture and purification of IgG2 using multicolumn countercurrent solvent gradient purification (MCSGP)

(2010) T. Müller-Späth et al.   BIOTECHNOLOGY AND BIOENGINEERING

Towards the implementation of quality by design to the production of therapeutic monoclonal antibodies with desired glycosylation patterns

(2010) Ioscani Jimenez del Val et al.   BIOTECHNOLOGY PROGRESS

On-line Estimation in Fed-batch Fermentation Process Using State Space Model and Unscented Kalman Filter

(2010) Jianlin WANG et al.   CHINESE JOURNAL OF CHEMICAL ENGINEERING

Optimizing model predictive control of the chromatographic multi-column solvent gradient purification (MCSGP) process

(2010) Cristian Grossmann et al.   JOURNAL OF PROCESS CONTROL

Modeling kinetics of a large-scale fed-batch CHO cell culture by Markov chain Monte Carlo method

(2009) Zizhuo Xing et al.   BIOTECHNOLOGY PROGRESS

Simulated moving bed chromatography for the separation of enantiomers

(2008) Arvind Rajendran et al.   JOURNAL OF CHROMATOGRAPHY A

Limited Use of Centritech Lab II Centrifuge in Perfusion Culture of rCHO Cells for the Production of Recombinant Antibody

(2007) B.J. Kim et al.   BIOTECHNOLOGY PROGRESS

A Hybrid Model Framework for the Optimization of Preparative Chromatographic Processes

(2004) Deepak Nagrath et al.   BIOTECHNOLOGY PROGRESS