Bechtold-Peters K - Search Results

1

CMC Regulatory Considerations for Antibody-Drug Conjugates.

Bechtold-Peters K, Ruggiero A, Vriezen N, Ihle N, Klein A, Morgan C, Schweizer D, Liu D, Jacobson F, Buecheler J, Panek M, Duggan N, Malyala P, Dupraz P, Desai P, Niu S, Feng Y, Wang X. Bechtold-Peters K, et al. J Pharm Sci. 2023 Dec;112(12):2965-2980. doi: 10.1016/j.xphs.2023.09.007. Epub 2023 Sep 21. J Pharm Sci. 2023. PMID: 37741455 Review.

2

Conformational analysis of protein secondary structure during spray-drying of antibody/mannitol formulations.

Schüle S, Friess W, Bechtold-Peters K, Garidel P. Schüle S, et al. Eur J Pharm Biopharm. 2007 Jan;65(1):1-9. doi: 10.1016/j.ejpb.2006.08.014. Epub 2006 Sep 1. Eur J Pharm Biopharm. 2007. PMID: 17034996

3

Development of a pilot-scale manufacturing process for protein-coated microcrystals (PCMC): mixing and precipitation - part I.

König C, Bechtold-Peters K, Baum V, Schultz-Fademrecht T, Bassarab S, Steffens KJ. König C, et al. Eur J Pharm Biopharm. 2012 Apr;80(3):490-8. doi: 10.1016/j.ejpb.2011.11.012. Epub 2011 Nov 26. Eur J Pharm Biopharm. 2012. PMID: 22137999

4

Cryoconcentration and 3D Temperature Profiles During Freezing of mAb Solutions in Large-Scale PET Bottles and a Novel Scale-Down Device.

Bluemel O, Buecheler JW, Rodrigues MA, Geraldes V, Hoelzl G, Bechtold-Peters K, Friess W. Bluemel O, et al. Pharm Res. 2020 Aug 30;37(9):179. doi: 10.1007/s11095-020-02886-w. Pharm Res. 2020. PMID: 32864719

5

Scaling Down Large-Scale Thawing of Monoclonal Antibody Solutions: 3D Temperature Profiles, Changes in Concentration, and Density Gradients.

Bluemel O, Buecheler JW, Hauptmann A, Hoelzl G, Bechtold-Peters K, Friess W. Bluemel O, et al. Pharm Res. 2021 Nov;38(11):1977-1989. doi: 10.1007/s11095-021-03117-6. Epub 2021 Nov 2. Pharm Res. 2021. PMID: 34729702 Free PMC article.

6

Evaluation of Two Novel Scale-Down Devices for Testing Monoclonal Antibody Aggregation During Large-Scale Freezing.

Bluemel O, Rodrigues MA, Buecheler JW, Geraldes V, Hoelzl G, Hauptmann A, Bechtold-Peters K, Friess W. Bluemel O, et al. J Pharm Sci. 2022 Jul;111(7):1973-1983. doi: 10.1016/j.xphs.2022.01.003. Epub 2022 Jan 8. J Pharm Sci. 2022. PMID: 35007568

7

The effect of mAb and excipient cryoconcentration on long-term frozen storage stability - Part 1: Higher molecular weight species and subvisible particle formation.

Bluemel O, Anuschek M, Buecheler JW, Hoelzl G, Bechtold-Peters K, Friess W. Bluemel O, et al. Int J Pharm X. 2021 Dec 25;4:100108. doi: 10.1016/j.ijpx.2021.100108. eCollection 2022 Dec. Int J Pharm X. 2021. PMID: 35024603 Free PMC article.

8

The effect of mAb and excipient cryoconcentration on long-term frozen storage stability - part 2: Aggregate formation and oxidation.

Bluemel O, Buecheler JW, Hauptmann A, Hoelzl G, Bechtold-Peters K, Friess W. Bluemel O, et al. Int J Pharm X. 2021 Dec 25;4:100109. doi: 10.1016/j.ijpx.2021.100109. eCollection 2022 Dec. Int J Pharm X. 2021. PMID: 35024604 Free PMC article.

9

Industry Perspective on the use and Characterization of Polysorbates for Biopharmaceutical Products Part 1: Survey Report on Current State and Common Practices for Handling and Control of Polysorbates.

Wuchner K, Yi L, Chery C, Nikels F, Junge F, Crotts G, Rinaldi G, Starkey JA, Bechtold-Peters K, Shuman M, Leiss M, Jahn M, Garidel P, de Ruiter R, Richer SM, Cao S, Peuker S, Huille S, Wang T, Le Brun V. Wuchner K, et al. J Pharm Sci. 2022 May;111(5):1280-1291. doi: 10.1016/j.xphs.2022.02.009. Epub 2022 Feb 22. J Pharm Sci. 2022. PMID: 35192858 Review.

10

Raman Marker Bands for Secondary Structure Changes of Frozen Therapeutic Monoclonal Antibody Formulations During Thawing.

Hauptmann A, Hoelzl G, Mueller M, Bechtold-Peters K, Loerting T. Hauptmann A, et al. Among authors: bechtold peters k. J Pharm Sci. 2023 Jan;112(1):51-60. doi: 10.1016/j.xphs.2022.10.015. Epub 2022 Oct 22. J Pharm Sci. 2023. PMID: 36279956 Free article.

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