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

Cost-effective bioprocess design for the manufacture of allogeneic CAR-T cell therapies using a decisional tool with multi-attribute decision-making analysis

(2018) Michael J. Jenkins et al.   BIOCHEMICAL ENGINEERING JOURNAL

Impact of allogeneic stem cell manufacturing decisions on cost of goods, process robustness and reimbursement

(2018) Tania D. Pereira Chilima et al.   BIOCHEMICAL ENGINEERING JOURNAL

Current state of the art in continuous bioprocessing

(2018) Mark Schofield   BIOTECHNOLOGY LETTERS

Integrating crystallization with experimental model parameter determination and modeling into conceptual process design for the purification of complex feed mixtures

(2018) Martin Lucke et al.   CHEMICAL ENGINEERING RESEARCH & DESIGN

In-line Raman spectroscopy and advanced process control for the extraction of anethole and fenchone from fennel ( Foeniculum vulgare L. MILL.)

(2018) Maximilian Sixt et al.   COMPTES RENDUS CHIMIE

Continuous integrated manufacturing of therapeutic proteins

(2018) Daniel Johannes Karst et al.   CURRENT OPINION IN BIOTECHNOLOGY

Exosomes derived from human adipose tissue-derived mesenchymal stem cells alleviate atopic dermatitis

(2018) Byong Seung Cho et al.   Stem Cell Research & Therapy

Toward a Distinct and Quantitative Validation Method for Predictive Process Modelling—On the Example of Solid-Liquid Extraction Processes of Complex Plant Extracts

(2018) Maximilian Sixt et al.   Processes

Process analytical technology mechanisms in biologics manufacturing

(2018) M. Kornecki et al.   CHEMIE INGENIEUR TECHNIK

Digitale Transformation bei BASF - Fallstricke und Erfolgsbeispiele aus der Umsetzungspraxis

(2018) F. Netzer   CHEMIE INGENIEUR TECHNIK

Rigorous modeling of lyophilization for botanicals and biologics process integration

(2018) L. Klepzig et al.   CHEMIE INGENIEUR TECHNIK

Model-Based Optimization of SPTFF Ultrafiltration for Integration in Continuous Biopharmaceutical Processing

(2018) M. Huter et al.   CHEMIE INGENIEUR TECHNIK

Systematic and Model-Assisted Process Design for the Extraction and Purification of Artemisinin from Artemisia annua L.—Part I: Conceptual Process Design and Cost Estimation

(2018) Maximilian Sixt et al.   Processes

Process intensification in biologics manufacturing

(2018) J. Strube et al.   CHEMICAL ENGINEERING AND PROCESSING

Systematic and Model-Assisted Process Design for the Extraction and Purification of Artemisinin from Artemisia annua L.—Part III: Chromatographic Purification

(2018) Fabian Mestmäcker et al.   Processes

Systematic and Model-Assisted Process Design for the Extraction and Purification of Artemisinin from Artemisia annua L.—Part IV: Crystallization

(2018) Maximilian Huter et al.   Processes

Systematic and Model-Assisted Process Design for the Extraction and Purification of Artemisinin from Artemisia annua L.—Part II: Model-Based Design of Agitated and Packed Columns for Multistage Extraction and Scrubbing

(2018) Axel Schmidt et al.   Processes

Module design for ultrafiltration in biotechnology: Hydraulic analysis and statistical modeling

(2017) Holger Thiess et al.   JOURNAL OF MEMBRANE SCIENCE

Production of virus-like particles for vaccines

(2017) J. Fuenmayor et al.   New Biotechnology

Model-Based Methods in the Biopharmaceutical Process Lifecycle

(2017) Paul Kroll et al.   PHARMACEUTICAL RESEARCH

Systematic and Model-Assisted Evaluation of Solvent Based- or Pressurized Hot Water Extraction for the Extraction of Artemisinin from Artemisia annua L.

(2017) Maximilian Sixt et al.   Processes

DoE based integration approach of upstream and downstream processing regarding HCP and ATPE as harvest operation

(2016) Petra Gronemeyer et al.   BIOCHEMICAL ENGINEERING JOURNAL

Efficient production and enhanced tumor delivery of engineered extracellular vesicles

(2016) Dionysios C. Watson et al.   BIOMATERIALS

Exosomes as therapeutic drug carriers and delivery vehicles across biological membranes: current perspectives and future challenges

(2016) Dinh Ha et al.   Acta Pharmaceutica Sinica B

Macroscopic modeling of mammalian cell growth and metabolism

(2015) Bassem Ben Yahia et al.   APPLIED MICROBIOLOGY AND BIOTECHNOLOGY

Infrared and Raman spectroscopic methods for characterization of Taxus baccata L. – Improved taxane isolation by accelerated quality control and process surveillance

(2015) Gennadi Gudi et al.   TALANTA

Biosimilars: The Need, The Challenge, The Future: The FDA Perspective

(2014) Michael S Epstein et al.   AMERICAN JOURNAL OF GASTROENTEROLOGY

Design and Operation of Continuous Countercurrent Chromatography in Biotechnological Production

(2014) Steffen Zobel et al.   INDUSTRIAL & ENGINEERING CHEMISTRY RESEARCH

Towards an advanced therapy medicinal product based on mesenchymal stromal cells isolated from the umbilical cord tissue: quality and safety data

(2014) José Paulo Martins et al.   Stem Cell Research & Therapy

Enabling multiscale modeling in systems medicine

(2014) Olaf Wolkenhauer et al.   Genome Medicine

Prädiktive Modellierung von Trennverfahren

(2012) Jochen Strube   CHEMIE INGENIEUR TECHNIK

Virus-like particles as a highly efficient vaccine platform: Diversity of targets and production systems and advances in clinical development

(2012) Natasha Kushnir et al.   VACCINE

Omics and Drug Response

(2011) Urs A. Meyer et al.   Annual Review of Pharmacology and Toxicology

Therapeutic antibodies: Market considerations, disease targets and bioprocessing

(2011) John G. Elvin et al.   INTERNATIONAL JOURNAL OF PHARMACEUTICS

Technology trends in antibody purification

(2011) Pete Gagnon   JOURNAL OF CHROMATOGRAPHY A

Large-scale production and purification of VLP-based vaccines

(2011) Tiago Vicente et al.   JOURNAL OF INVERTEBRATE PATHOLOGY

The characterization of macroporous solids: An overview of the methodology

(2011) Jean Rouquerol et al.   MICROPOROUS AND MESOPOROUS MATERIALS

Few inputs can reprogram biological networks

(2011) Franz-Josef Müller et al.   NATURE

Virus-like particles in vaccine development

(2010) António Roldão et al.   Expert Review of Vaccines

Recovery and purification process development for monoclonal antibody production

(2010) Hui F. Liu et al.   mAbs

Cell culture processes for monoclonal antibody production

(2010) Feng Li et al.   mAbs

Recent advances in large-scale production of monoclonal antibodies and related proteins

(2010) Abhinav A. Shukla et al.   TRENDS IN BIOTECHNOLOGY

CHO gene expression profiling in biopharmaceutical process analysis and design

(2009) Jochen Schaub et al.   BIOTECHNOLOGY AND BIOENGINEERING

Rational and systematic protein purification process development: the next generation

(2009) Beckley K. Nfor et al.   TRENDS IN BIOTECHNOLOGY

Mining bioprocess data: opportunities and challenges

(2008) Salim Charaniya et al.   TRENDS IN BIOTECHNOLOGY

Upstream processes in antibody production: Evaluation of critical parameters

(2007) Era Jain et al.   BIOTECHNOLOGY ADVANCES