Dr.-Ing. Laura David
Curriculum Vitae
Born | September 8th, 1989 in Dortmund, Germany |
2000 - 2009 | Mallinckrodt Gymnasium Dortmund, Germany |
2009 - 2013 | B.Sc. Biochemical Engineering studies at TU Dortmund University Bachelor thesis: Process development for the production of trans-4-hydroxy-L-proline using growing cells of E. coli BL21 (DE3) ΔputA |
2013 - 2014 | M.Sc. Biochemical Engineering studies at TU Dortmund University Master thesis: Cost evaluation of monoclonal antibody production processes in different operation modes |
2015 - 2020 | PhD thesis at INVITE GmbH in Leverkusen, Germany Field of research: Viral clearance for continuous, pharmaceutical processes |
Field of Research
The market for monoclonal antibodies (mAb) changes drastically due to different reasons. The trend to a more personalized medicine and niche products, an increased cost pressure and large market growth rates make production adjustments unavoidable. Therefore, the existing batch-wise operated large-scale stainless steel plants are questioned. Continuous processing of mAb within single use plants seems to be a promising alternative to meet the future demands.
Within the continuous manufacturing of biopharmaceutical products, especially mAb, the continuous viral clearance plays an important role. In order to ensure the product safety, already applied fed-batch strategies have to be adapted into the continuous process mode
Publications
Dissertation
- L. David
Viral clearance for continuous biopharmaceutical processes
TU Dortmund, 2020, Verlag Dr. Hut, München ISBN 978-3-8439-4471-7
Patents
- B. Maiser, P. Schwan, L. Holtmann, M. Lobedann
Validation of continuous viral clearance
EP3141611A2, 15.3.2017
Paper
- David, L., Bayer, M.P., Lobedann, M., Schembecker, G.
Simulation of continuous low pH viral inactivation inside a coiled flow inverter
Biotechnology and Bioengineering117(4) ( 2020) 1048-1062, doi.org/10.1002/bit.27255
- David, L., Schwan, P., Lobedann, M., ...Oehme, F., Schembecker, G.
Side-by-side comparability of batch and continuous downstream for the production of monoclonal antibodies
Biotechnology and Bioengineering 117(4) (2020) 1024-1036, doi.org/10.1002/bit.27267
- David, L., Waldschmidt, L.M., Lobedann, M., Schembecker, G.
Simulation of pH level distribution inside a coiled flow inverter for continuous low pH viral inactivation
Biotechnology and Bioengineering 117(2) ( 2020) 429-437, doi.org/10.1002/bit.27201
- L.Holtmann, S.Klutz, M.Lobedann, G.Schembecker
mAbs: hybrid style
The Medicine Maker; 0816-304; September 2016, (Article)
- L. Holtmann, M. Lobedann, J. Magnus, G. Schembecker
Disposables for continuous viral clearance for the production of monoclonal antibodies
European Pharmaceutical Review 21(2) 2016 22-27. (Article)
- Klutz, S., Holtmann, L., Lobedann, M., Schembecker, G.
Cost evaluation of antibody production processes in different operation modes
Chemical Engineering Science 141 (2016), 63–74, (doi.org/10.1016/j.ces.2015.10.029)
Oral presentations
- L. David, B. Maiser, P. Schwan, M. Lobedann, L. M. Waldschmidt, M. Bayer, M. Lasse, H. Ruppach, G. Schembecker
Continuous Low pH Viral Inactivation for mAb Production Processes
2018 PDA Virus Forum, Florence, Italy (2018)
- L. David, B. Maiser, P. Schwan, M. Lobedann, L. M. Waldschmidt, M. Bayer, M. Lasse, H. Ruppach, G. Schembecker
Continuous Low pH Viral Inactivation for mAb Production Processes
Bioprocess International European Summit, Amsterdam, Netherlands (2018)
- L. David, S. Klutz, M. Lobedann, B. Maiser, J. Niklas, P. Schwan, G. Schembecker
Continuous Processing of Biopharmaceuticals: Virus Clearance
2017 PDA Modern Biopharmaceutical Processing Conference, Singapore (2017)
- L. David, B. Maiser, M. Lobedann, P. Schwan, M. Fröhlich, H. Ruppach, L. M. Waldschmidt, G. Schembecker
Low pH viral inactivation for continuous, biopharmaceutical processes
Charles River 2017 Viral Safety and Viral Clearance Summit, San Mateo, CA, USA ( 2017)
- L. Holtmann, S. Klutz, B. Maiser, J. Niklas, P. Schwan, M. Lobedann, G. Schembecker
Continuous viral clearance for the production of mAbs
Virus & TSE Safety Forum, Dubrovnik, Croatia (2017)
- L. Holtmann, S. Klutz, M. Lobedann, B. Maiser, J. Niklas, G. Schembecker
Continuous and disposable production of mAb
Continuously improving bioprocesses workshop, Pall Life Sciences, Tokyo, Japan (2016)
- L. Holtmann, S. Klutz, M. Lobedann, B. Maiser, J. Niklas, G. Schembecker
Continuous processing of mAb - achievements, benefits and remaining challenges
Lilly continuous processing workshop, Eli Lilly and Company, Indianapolis, USA (2016)
- L. Holtmann, S. Klutz, M. Lobedann, B. Maiser, J. Niklas, G. Schembecker
Viral clearance for continuous processes
8th Workshop on Monoclonal Antibodies, Berlin, Germany (2015)