Literature DB >> 19418475

Quality-by-design for biotechnology-related pharmaceuticals.

Carl-Fredrik Mandenius1, Klaus Graumann, Torsten W Schultz, Andreas Premstaller, Ing-Marie Olsson, Emma Petiot, Christoph Clemens, Mats Welin.   

Abstract

The following article is a report from a workshop on Quality-by-Design (QbD) held at the 7th European Symposium on Biochemical Engineering Science (7 September 2008, Faro, Portugal).The aim of the workshop was to provide an update on the present status of using QbD in biotechnology-related applications in the pharmaceutical industry. The report summarizes the essential parts of the presentations and covers the industrial, academic, and regulatory aspects of QbD. It concludes with recommendations for further work and development.

Mesh：

Year:  2009        PMID： 19418475     DOI： 10.1002/biot.200800333

Source DB:  PubMed          Journal:  Biotechnol J        ISSN： 1860-6768            Impact factor:   4.677


  7 in total

1.  Real-time monitoring of adherent Vero cell density and apoptosis in bioreactor processes.

Authors:  Emma Petiot; Amal El-Wajgali; Geoffrey Esteban; Cécile Gény; Hervé Pinton; Annie Marc
Journal:  Cytotechnology       Date:  2012-02-25       Impact factor: 2.058

2.  Efficient feeding profile optimization for recombinant protein production using physiological information.

Authors:  Patrick Wechselberger; Patrick Sagmeister; Helge Engelking; Torsten Schmidt; Jana Wenger; Christoph Herwig
Journal:  Bioprocess Biosyst Eng       Date:  2012-06-28       Impact factor: 3.210

3.  Digital Twins and Their Role in Model-Assisted Design of Experiments.

Authors:  Kim B Kuchemüller; Ralf Pörtner; Johannes Möller
Journal:  Adv Biochem Eng Biotechnol       Date:  2021       Impact factor: 2.635

4.  A dynamic method for the investigation of induced state metabolic capacities as a function of temperature.

Authors:  Patrick Sagmeister; Timo Langemann; Patrick Wechselberger; Andrea Meitz; Christoph Herwig
Journal:  Microb Cell Fact       Date:  2013-10-15       Impact factor: 5.328

5.  Development of an optical system for the non-invasive tracking of stem cell growth on microcarriers.

Authors:  Akinlolu Oyekunle Oluseun Odeleye; Sara Castillo-Avila; Mathew Boon; Haydn Martin; Karen Coopman
Journal:  Biotechnol Bioeng       Date:  2017-05-23       Impact factor: 4.530

Review 6.  Development of L-Asparaginase Biobetters: Current Research Status and Review of the Desirable Quality Profiles.

Authors:  Larissa Pereira Brumano; Francisco Vitor Santos da Silva; Tales Alexandre Costa-Silva; Alexsandra Conceição Apolinário; João Henrique Picado Madalena Santos; Eduardo Krebs Kleingesinds; Gisele Monteiro; Carlota de Oliveira Rangel-Yagui; Brahim Benyahia; Adalberto Pessoa Junior
Journal:  Front Bioeng Biotechnol       Date:  2019-01-10

7.  Model-assisted DoE software: optimization of growth and biocatalysis in Saccharomyces cerevisiae bioprocesses.

Authors:  André Moser; Kim B Kuchemüller; Sahar Deppe; Tanja Hernández Rodríguez; Björn Frahm; Ralf Pörtner; Volker C Hass; Johannes Möller
Journal:  Bioprocess Biosyst Eng       Date:  2021-01-20       Impact factor: 3.210
  7 in total

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