Process Analytical Technology for Precipitation Process Integration into Biologics Manufacturing towards Autonomous Operation—mAb Case Study

Towards Autonomous Operation by Advanced Process Control—Process Analytical Technology for Continuous Biologics Antibody Manufacturing

(2021) Heribert Helgers et al.   Processes

Truly continuous low pH viral inactivation for biopharmaceutical process integration

(2020) Duarte L. Martins et al.   BIOTECHNOLOGY AND BIOENGINEERING

Accelerating Biologics Manufacturing by Modeling: Process Integration of Precipitation in mAb Downstream Processing

(2020) Lara Julia Lohmann et al.   Processes

Continuous capture of recombinant antibodies by ZnCl 2 precipitation without polyethylene glycol

(2020) Gregory Dutra et al.   ENGINEERING IN LIFE SCIENCES

High throughput solubility and redissolution screening for antibody purification via combined PEG and zinc chloride precipitation

(2020) Qin Gu et al.   BIOTECHNOLOGY PROGRESS

Automation of Dead End Filtration: An Enabler for Continuous Processing of Biotherapeutics

(2020) Garima Thakur et al.   Frontiers in Bioengineering and Biotechnology

Enhanced filtration performance using feed‐and‐bleed configuration for purification of antibody precipitates

(2020) Zhao Li et al.   BIOTECHNOLOGY PROGRESS

Process analytical technology application for protein PEGylation using near infrared spectroscopy: G-CSF as a case study

(2020) Vishwanath Hebbi et al.   JOURNAL OF BIOTECHNOLOGY

Continuous integrated antibody precipitation with two-stage tangential flow microfiltration enables constant mass flow

(2019) Daniel Burgstaller et al.   BIOTECHNOLOGY AND BIOENGINEERING

Accelerating Biologics Manufacturing by Upstream Process Modelling

(2019) Martin Kornecki et al.   Processes

Accelerating Biologics Manufacturing by Modeling or: Is Approval under the QbD and PAT Approaches Demanded by Authorities Acceptable Without a Digital-Twin?

(2019) Steffen Zobel-Roos et al.   Processes

Real‐time monitoring and model‐based prediction of purity and quantity during a chromatographic capture of fibroblast growth factor 2

(2019) Dominik Georg Sauer et al.   BIOTECHNOLOGY AND BIOENGINEERING

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

(2019) Fabian Feidl et al.   BIOTECHNOLOGY PROGRESS

Continuous Precipitation for Monoclonal Antibody Capture Using Countercurrent Washing by Microfiltration

(2019) Zhao Li et al.   BIOTECHNOLOGY PROGRESS

Accelerating Biomanufacturing by Modeling of Continuous Bioprocessing—Piloting Case Study of Monoclonal Antibody Manufacturing

(2019) Kornecki et al.   Processes

Fractal dimension of antibody‐PEG precipitate: Light microscopy for the reconstruction of 3D precipitate structures

(2019) Peter Satzer et al.   ENGINEERING IN LIFE SCIENCES

Assessment of the human albumin in acid precipitation process using NIRS and multi-variable selection methods combined with SPA

(2019) Zhongyu Sun et al.   JOURNAL OF MOLECULAR STRUCTURE

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

An integrated precipitation and ion-exchange chromatography process for antibody manufacturing: Process development strategy and continuous chromatography exploration

(2018) Steffen Großhans et al.   JOURNAL OF CHROMATOGRAPHY A

In-line Fourier-transform infrared spectroscopy as a versatile process analytical technology for preparative protein chromatography

(2018) Steffen Großhans et al.   JOURNAL OF CHROMATOGRAPHY A

In-situ monitoring of saccharides removal of alcohol precipitation using near-infrared spectroscopy

(2018) Hongxia Huang et al.   Journal of Innovative Optical Health Sciences

Calibration transfer of near infrared spectrometers for the assessment of plasma ethanol precipitation process

(2018) Zhongyu Sun et al.   CHEMOMETRICS AND INTELLIGENT LABORATORY SYSTEMS

Predicting performance of constant flow depth filtration using constant pressure filtration data

(2017) Stephen Goldrick et al.   JOURNAL OF MEMBRANE SCIENCE

In-line Monitoring of Monomer and Polymer Content During Microgel Synthesis Using Precipitation Polymerization via Raman Spectroscopy and Indirect Hard Modeling

(2016) Julian Meyer-Kirschner et al.   APPLIED SPECTROSCOPY

Developments of Blocking Filtration Model in Membrane Filtration

(2016) Eiji Iritani et al.   KONA Powder and Particle Journal

Continuous polyethylene glycol precipitation of recombinant antibodies: Sequential precipitation and resolubilization

(2016) Nikolaus Hammerschmidt et al.   PROCESS BIOCHEMISTRY

In-column ATR-FTIR spectroscopy to monitor affinity chromatography purification of monoclonal antibodies

(2016) Maxime Boulet-Audet et al.   Scientific Reports

Fractal aggregation and disaggregation of newly formed iron(iii) (hydr)oxide nanoparticles in the presence of natural organic matter and arsenic

(2016) Chelsea W. Neil et al.   Environmental Science-Nano

Continuous precipitation of IgG from CHO cell culture supernatant in a tubular reactor

(2015) Nikolaus Hammerschmidt et al.   Biotechnology Journal

Continuous precipitation of IgG from CHO cell culture supernatant in a tubular reactor

(2015) Nikolaus Hammerschmidt et al.   Biotechnology Journal

A tool for selective inline quantification of co-eluting proteins in chromatography using spectral analysis and partial least squares regression

(2014) Nina Brestrich et al.   BIOTECHNOLOGY AND BIOENGINEERING

Ethanol precipitation for purification of recombinant antibodies

(2014) Anne Tscheliessnig et al.   JOURNAL OF BIOTECHNOLOGY

Getting ready for PAT: Scale up and inline monitoring of protein refolding of Npro fusion proteins

(2014) Cornelia Walther et al.   PROCESS BIOCHEMISTRY

Alternative separation steps for monoclonal antibody purification: Combination of centrifugal partitioning chromatography and precipitation

(2013) Stefan A. Oelmeier et al.   JOURNAL OF CHROMATOGRAPHY A

Near infrared spectroscopy in combination with chemometrics as a process analytical technology (PAT) tool for on-line quantitative monitoring of alcohol precipitation

(2013) Ye Jin et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

The relevance study of effective information between near infrared spectroscopy and chondroitin sulfate in ethanol precipitation process

(2013) Lian Li et al.   Journal of Innovative Optical Health Sciences

NIR analysis for batch process of ethanol precipitation coupled with a new calibration model updating strategy

(2012) Bing Xu et al.   ANALYTICA CHIMICA ACTA

In-line monitoring of alcohol precipitation by near-infrared spectroscopy in conjunction with multivariate batch modeling

(2011) Hongxia Huang et al.   ANALYTICA CHIMICA ACTA

Protein precipitation by polyethylene glycol: A generalized model based on hydrodynamic radius

(2011) Siow-Leng Sim et al.   JOURNAL OF BIOTECHNOLOGY

Validation of a NIR quantification method for the determination of chlorogenic acid in Lonicera japonica solution in ethanol precipitation process

(2011) Zhisheng Wu et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Quality-by-Design (QbD): An integrated process analytical technology (PAT) approach for a dynamic pharmaceutical co-precipitation process characterization and process design space development☆

(2010) Huiquan Wu et al.   INTERNATIONAL JOURNAL OF PHARMACEUTICS

Quality by design for biopharmaceuticals

(2009) Anurag S Rathore et al.   NATURE BIOTECHNOLOGY

Determination of the secondary structure of proteins in different environments by FTIR-ATR spectroscopy and PLS regression

(2008) Yeqiu Wang et al.   BIOPOLYMERS

Liquid high concentration IgG1 antibody formulations by precipitation

(2008) Susanne Matheus et al.   JOURNAL OF PHARMACEUTICAL SCIENCES