Traceability of products and guide for batch definition in integrated continuous biomanufacturing

[1]  A. Jungbauer,et al.  Impact of failure rates, lot definitions and scheduling of upstream processes on the productivity of continuous integrated bioprocesses , 2021 .

[2]  Frank Riske,et al.  Periodic counter-current chromatography -- design and operational considerations for integrated and continuous purification of proteins. , 2012, Biotechnology journal.

[3]  William Engisch,et al.  Using Residence Time Distributions (RTDs) to Address the Traceability of Raw Materials in Continuous Pharmaceutical Manufacturing , 2015, Journal of Pharmaceutical Innovation.

[4]  Alois Jungbauer,et al.  Modeling the Residence Time Distribution of Integrated Continuous Bioprocesses. , 2020, Biotechnology journal.

[5]  Suzanne S Farid,et al.  Integrated continuous bioprocessing: Economic, operational, and environmental feasibility for clinical and commercial antibody manufacture , 2017, Biotechnology progress.

[6]  A. Jungbauer,et al.  Continuous Solvent/Detergent Virus Inactivation Using a Packed-Bed Reactor. , 2019, Biotechnology journal.

[7]  A. Jungbauer,et al.  Truly continuous low pH viral inactivation for biopharmaceutical process integration , 2020, Biotechnology and bioengineering.

[8]  Jason Walther,et al.  The business impact of an integrated continuous biomanufacturing platform for recombinant protein production. , 2015, Journal of biotechnology.

[9]  A. Jungbauer,et al.  Economics and ecology: Modelling of continuous primary recovery and capture scenarios for recombinant antibody production. , 2019, Journal of biotechnology.

[10]  Gordon Munro ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (APIs) , 2017 .

[11]  A. Jungbauer,et al.  A narrow residence time incubation reactor for continuous virus inactivation based on packed beds. , 2020, New biotechnology.

[12]  RTD modeling of a continuous dry granulation process for process control and materials diversion. , 2017, International journal of pharmaceutics.

[13]  S. G. Desai Continuous and semi-continuous cell culture for production of blood clotting factors. , 2015, Journal of biotechnology.

[14]  D. Bracewell,et al.  The effect of feed quality due to clarification strategy on the design and performance of protein A periodic counter‐current chromatography , 2018, Biotechnology progress.

[15]  Alois Jungbauer,et al.  Continuous downstream processing of biopharmaceuticals. , 2013, Trends in biotechnology.

[16]  Brian Hubbard,et al.  Downstream processing of monoclonal antibodies--application of platform approaches. , 2007, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.

[17]  Konstantin B Konstantinov,et al.  White paper on continuous bioprocessing. May 20-21, 2014 Continuous Manufacturing Symposium. , 2015, Journal of pharmaceutical sciences.

[18]  Duncan Low,et al.  Future of antibody purification. , 2007, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.