Accelerating Biologics Manufacturing by Modeling or: Is Approval under the QbD and PAT Approaches Demanded by Authorities Acceptable Without a Digital-Twin?
出版年份 2019 全文链接
标题
Accelerating Biologics Manufacturing by Modeling or: Is Approval under the QbD and PAT Approaches Demanded by Authorities Acceptable Without a Digital-Twin?
作者
关键词
-
出版物
Processes
Volume 7, Issue 2, Pages 94
出版商
MDPI AG
发表日期
2019-02-14
DOI
10.3390/pr7020094
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注意：仅列出部分参考文献，下载原文获取全部文献信息。- 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
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