Buecheler J - 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. Among authors: buecheler j. 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

Oxidation-Induced Destabilization of Model Antibody-Drug Conjugates.

Buecheler JW, Winzer M, Weber C, Gieseler H. Buecheler JW, et al. J Pharm Sci. 2019 Mar;108(3):1236-1245. doi: 10.1016/j.xphs.2018.10.039. Epub 2018 Oct 30. J Pharm Sci. 2019. PMID: 30389566

3

Alteration of Physicochemical Properties for Antibody-Drug Conjugates and Their Impact on Stability.

Buecheler JW, Winzer M, Weber C, Gieseler H. Buecheler JW, et al. J Pharm Sci. 2020 Jan;109(1):161-168. doi: 10.1016/j.xphs.2019.08.006. Epub 2019 Aug 10. J Pharm Sci. 2020. PMID: 31408634 Review.

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. Among authors: buecheler jw. 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. Among authors: buecheler jw. 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. Among authors: buecheler jw. 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. Among authors: buecheler jw. 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. Among authors: buecheler jw. 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

Evaluating Clinical Safety and Analytical Impact of Subvisible Silicone Oil Particles in Biopharmaceutical Products.

Saggu M, Bou-Assaf GM, Bucher R, Budyak IL, Buecheler J, Cao S, Groenning M, Khan E, Kwok SC, Minocha S, Pisupati K, Radhakrishnan V, Videbæk N, Yang DT, Zhang B, Narhi LO. Saggu M, et al. Among authors: buecheler j. J Pharm Sci. 2024 May;113(5):1401-1414. doi: 10.1016/j.xphs.2024.01.002. Epub 2024 Jan 12. J Pharm Sci. 2024. PMID: 38220088

10

High-throughput oxidation screen of antibody-drug conjugates by analytical protein A chromatography following IdeS digest.

Buecheler JW, Winzer M, Weber C, Gieseler H. Buecheler JW, et al. J Pharm Pharmacol. 2018 May;70(5):625-635. doi: 10.1111/jphp.12873. Epub 2018 Jan 30. J Pharm Pharmacol. 2018. PMID: 29380379

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