Cargando…

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

Process understanding is emphasized in the process analytical technology initiative and the quality by design paradigm to be essential for manufacturing of biopharmaceutical products with consistent high quality. A typical approach to developing a process understanding is applying a combination of d...

Descripción completa

Detalles Bibliográficos
Autores principales:	von Stosch, Moritz, Hamelink, Jan-Martijn, Oliveira, Rui
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	Springer Berlin Heidelberg 2016
Materias:	Original Paper
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4839057/ https://www.ncbi.nlm.nih.gov/pubmed/26879643 http://dx.doi.org/10.1007/s00449-016-1557-1

Ejemplares similares

QbD Based Media Development for the Production of Fab Fragments in E. coli
por: Kumar, Deepak, et al.
Publicado: (2019)

Industrial application of QbD and NIR chemometric models in quality improvement of immediate release tablets
por: Ramadan, Ahmed, et al.
Publicado: (2021)

Satisfying QTPP of Erythropoietin Biosimilar by QbD through DoE-Derived Downstream Process Engineering
por: Nag, Kakon, et al.
Publicado: (2023)

Implementation of QbD strategies in the inoculum expansion of a mAb production process
por: Böhl, Ole Jacob, et al.
Publicado: (2020)

Toward QbD Process Understanding on DNA Vaccine Purification Using Design of Experiment
por: Hocharoen, Lalintip, et al.
Publicado: (2021)

Investigation of Silicone-Containing Semisolid in Situ Film-Forming Systems Using QbD Tools
por: Kis, Nikolett, et al.
Publicado: (2019)

Early Implementation of QbD in Biopharmaceutical Development: A Practical Example
por: Zurdo, Jesús, et al.
Publicado: (2015)

Pharmaceutical Development and Design of Thermosensitive Liposomes Based on the QbD Approach
por: Dobó, Dorina Gabriella, et al.
Publicado: (2022)

Novel NIR modeling design and assignment in process quality control of Honeysuckle flower by QbD
por: Ma, Lijuan, et al.
Publicado: (2020)

QbD Enabled Azacitidine Loaded Liposomal Nanoformulation and Its In Vitro Evaluation
por: Kesharwani, Prashant, et al.
Publicado: (2021)

An Updated Risk Assessment as Part of the QbD-Based Liposome Design and Development
por: Németh, Zsófia, et al.
Publicado: (2021)

Compression-coated pulsatile chronomodulated therapeutic system: QbD assisted optimization
por: Aldawsari, Hibah M., et al.
Publicado: (2022)

The way to a design space for an animal cell culture process according to Quality by Design (QbD)
por: Puskeiler, Robert, et al.
Publicado: (2011)

Design and Optimization of Lornoxicam Dispersible Tablets Using Quality by Design (QbD) Approach
por: Almotairi, Nawaf, et al.
Publicado: (2022)

Quality by design (QbD) approach in processing polymeric nanoparticles loading anticancer drugs by high pressure homogenizer
por: Soni, Govind, et al.
Publicado: (2020)

Design Space and QbD Approach for Production of Drug Nanocrystals by Wet Media Milling Techniques
por: Peltonen, Leena
Publicado: (2018)

QbD-Based Investigation of Dermal Semisolid in situ Film-Forming Systems for Local Anaesthesia
por: Kovács, Anita, et al.
Publicado: (2020)

Quality by Design (QbD) Approach for a Nanoparticulate Imiquimod Formulation as an Investigational Medicinal Product
por: Pielenhofer, Jonas, et al.
Publicado: (2023)

Application of the Quality by Design Concept (QbD) in the Development of Hydrogel-Based Drug Delivery Systems
por: Mohseni-Motlagh, S. Farid, et al.
Publicado: (2023)

Application of QbD Principles for the Evaluation of Empty Hard Capsules as an Input Parameter in Formulation Development and Manufacturing
por: Stegemann, Sven, et al.
Publicado: (2014)

Development and Validation of a UPLC Method by the QbD-Approach for the Estimation of Rabeprazole and Levosulpiride from Capsules
por: Thummala, Veera Raghava Raju, et al.
Publicado: (2014)

Novel Phenobarbital-Loaded Nanostructured Lipid Carriers for Epilepsy Treatment: From QbD to In Vivo Evaluation
por: Scioli-Montoto, Sebastian, et al.
Publicado: (2022)

Employing QbD strategies to assess the impact of cell viability and density on the primary recovery of monoclonal antibodies
por: Wohlenberg, Ole Jacob, et al.
Publicado: (2022)

QbD driven targeted pulmonary delivery of dexamethasone-loaded chitosan microspheres: Biodistribution and pharmacokinetic study
por: Asha, B.R., et al.
Publicado: (2023)

Quality by Design (QbD) Based Method for Estimation of Xanthohumol in Bulk and Solid Lipid Nanoparticles and Validation
por: Harish, Vancha, et al.
Publicado: (2023)

Process optimization for the synthesis of functionalized Au@AgNPs for specific detection of Hg(2+) based on quality by design (QbD)
por: Zhang, Hui, et al.
Publicado: (2022)

QbD based approach for optimization of Tenofovir disoproxil fumarate loaded liquid crystal precursor with improved permeability
por: Patil, Sharvil, et al.
Publicado: (2017)

Development of Metronidazole Loaded Chitosan Nanoparticles Using QbD Approach—A Novel and Potential Antibacterial Formulation
por: Sreeharsha, Nagaraja, et al.
Publicado: (2020)

Fluidised bed granulation of two APIs: QbD approach and development of a NIR in-line monitoring method
por: Gavan, Alexandru, et al.
Publicado: (2020)

QbD based development of HPLC method for simultaneous quantification of Telmisartan and Hydrochlorothiazide impurities in tablets dosage form
por: Palakurthi, Ashok K., et al.
Publicado: (2020)

QbD Consideration for Developing a Double-Layered Tablet into a Single-Layered Tablet with Telmisartan and Amlodipine
por: Kim, Joo-Eun, et al.
Publicado: (2022)

Augmentation of Antidiabetic Activity of Glibenclamide Microspheres Using S-Protected Okra Powered by QbD: Scintigraphy and In Vivo Studies
por: Rizg, Waleed Y., et al.
Publicado: (2022)

The Use of the QbD Approach to Optimize the Co-Loading of Simvastatin and Doxorubicin in Liposomes for a Synergistic Anticancer Effect
por: Barbalata, Cristina-Ioana, et al.
Publicado: (2022)

Evaluations of Quality by Design (QbD) Elements Impact for Developing Niosomes as a Promising Topical Drug Delivery Platform
por: Shah, Parinbhai, et al.
Publicado: (2020)

A QbD Approach for Evaluating the Effect of Selective Laser Sintering Parameters on Printability and Properties of Solid Oral Forms
por: Gueche, Yanis A., et al.
Publicado: (2021)

Optimization of the Micellar-Based In Situ Gelling Systems Posaconazole with Quality by Design (QbD) Approach and Characterization by In Vitro Studies
por: Durgun, Meltem Ezgi, et al.
Publicado: (2022)

QbD Supported Optimization of the Alginate-Chitosan Nanoparticles of Simvastatin in Enhancing the Anti-Proliferative Activity against Tongue Carcinoma
por: Rizg, Waleed Y., et al.
Publicado: (2022)

QbD-based rivastigmine tartrate-loaded solid lipid nanoparticles for enhanced intranasal delivery to the brain for Alzheimer's therapeutics
por: Arora, Deepshi, et al.
Publicado: (2022)

Implementation of QbD Approach to the Analytical Method Development and Validation for the Estimation of Metformin Hydrochloride in Tablet Dosage Forms by HPLC
por: Sha’at, Mousa, et al.
Publicado: (2022)

Quality by Design (QbD) and Design of Experiments (DOE) as a Strategy for Tuning Lipid Nanoparticle Formulations for RNA Delivery
por: Gurba-Bryśkiewicz, Lidia, et al.
Publicado: (2023)

Cannot write session to /tmp/vufind_sessions/sess_ss0b1mtpbrc4vholfo5riejf10