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Specification-driven acceptance criteria for validation of biopharmaceutical processes.
Front Bioeng Biotechnol. 2022 Sep 23;10:1010583. doi: 10.3389/fbioe.2022.1010583. eCollection 2022.
Front Bioeng Biotechnol. 2022.
PMID: 36213075
Free PMC article.
Functional design of experiment for potency assay optimization and in-silico simulation.
Kunzelmann M, Wittmann A, Nold V, Presser B, Schreiber J, Gehrig T, Sadlers S, Scholz R, Solzin J, Berger A, Eppler K.
Kunzelmann M, et al.
J Pharm Biomed Anal. 2023 Sep 20;234:115584. doi: 10.1016/j.jpba.2023.115584. Epub 2023 Jul 16.
J Pharm Biomed Anal. 2023.
PMID: 37481901
Free article.
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Non-targeted analysis of unexpected food contaminants using LC-HRMS.
Kunzelmann M, Winter M, Åberg M, Hellenäs KE, Rosén J.
Kunzelmann M, et al.
Anal Bioanal Chem. 2018 Sep;410(22):5593-5602. doi: 10.1007/s00216-018-1028-4. Epub 2018 Mar 29.
Anal Bioanal Chem. 2018.
PMID: 29594430
Free PMC article.
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Integrated Process Model Applications Linking Bioprocess Development to Quality by Design Milestones.
Taylor C, Marschall L, Kunzelmann M, Richter M, Rudolph F, Vajda J, Presser B, Zahel T, Studts J, Herwig C.
Taylor C, et al. Among authors: kunzelmann m.
Bioengineering (Basel). 2021 Oct 24;8(11):156. doi: 10.3390/bioengineering8110156.
Bioengineering (Basel). 2021.
PMID: 34821722
Free PMC article.
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Towards robust cell culture processes - Unraveling the impact of media preparation by spectroscopic online monitoring.
Brunner M, Brosig P, Losing M, Kunzelmann M, Calvet A, Stiefel F, Bechmann J, Unsoeld A, Schaub J.
Brunner M, et al. Among authors: kunzelmann m.
Eng Life Sci. 2019 Aug 22;19(10):666-680. doi: 10.1002/elsc.201900050. eCollection 2019 Oct.
Eng Life Sci. 2019.
PMID: 32624960
Free PMC article.
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