Searles J - Search Results

1

Stress Factors in Protein Drug Product Manufacturing and Their Impact on Product Quality.

Das TK, Sreedhara A, Colandene JD, Chou DK, Filipe V, Grapentin C, Searles J, Christian TR, Narhi LO, Jiskoot W. Das TK, et al. Among authors: searles j. J Pharm Sci. 2022 Apr;111(4):868-886. doi: 10.1016/j.xphs.2021.09.030. Epub 2021 Sep 24. J Pharm Sci. 2022. PMID: 34563537

2

Strategies for Implementing New Drying & Packaging Technology for Sterile Injectable Drug Products.

Searles J, Ohtake S. Searles J, et al. J Pharm Sci. 2021 May;110(5):1931-1934. doi: 10.1016/j.xphs.2021.01.019. Epub 2021 Jan 23. J Pharm Sci. 2021. PMID: 33493478 No abstract available.

3

Impact of Annealing and Controlled Ice Nucleation on Properties of A Lyophilized 50 mg/ml MAB Formulation.

Wang J, Searles JA, Torres E, Tchessalov SA, Young AL. Wang J, et al. Among authors: searles ja. J Pharm Sci. 2022 Sep;111(9):2639-2644. doi: 10.1016/j.xphs.2022.05.016. Epub 2022 May 22. J Pharm Sci. 2022. PMID: 35613684 Free article.

4

Accelerated Storage for Shelf-Life Prediction of Lyophiles: Temperature Dependence of Degradation of Amorphous Small Molecular Weight Drugs and Proteins.

Shalaev E, Ohtake S, Moussa EM, Searles J, Nail S, Roberts CJ. Shalaev E, et al. Among authors: searles j. J Pharm Sci. 2023 Jun;112(6):1509-1522. doi: 10.1016/j.xphs.2023.02.008. Epub 2023 Feb 15. J Pharm Sci. 2023. PMID: 36796635 Review.

5

Vial Breakage in Lyophilization- Case Studies from Commercial Manufacturing and Laboratory Studies.

Sahni EK, Searles JA, Nachtigall M, Owen E, Lyne D. Sahni EK, et al. Among authors: searles ja. J Pharm Sci. 2023 Apr;112(4):1151-1159. doi: 10.1016/j.xphs.2022.11.007. Epub 2022 Nov 11. J Pharm Sci. 2023. PMID: 36372227

6

The ice nucleation temperature determines the primary drying rate of lyophilization for samples frozen on a temperature-controlled shelf.

Searles JA, Carpenter JF, Randolph TW. Searles JA, et al. J Pharm Sci. 2001 Jul;90(7):860-71. doi: 10.1002/jps.1039. J Pharm Sci. 2001. PMID: 11458335

7

Annealing to optimize the primary drying rate, reduce freezing-induced drying rate heterogeneity, and determine T(g)' in pharmaceutical lyophilization.

Searles JA, Carpenter JF, Randolph TW. Searles JA, et al. J Pharm Sci. 2001 Jul;90(7):872-87. doi: 10.1002/jps.1040. J Pharm Sci. 2001. PMID: 11458336

8

Recommended Best Practices for Process Monitoring Instrumentation in Pharmaceutical Freeze Drying-2017.

Nail S, Tchessalov S, Shalaev E, Ganguly A, Renzi E, Dimarco F, Wegiel L, Ferris S, Kessler W, Pikal M, Sacha G, Alexeenko A, Thompson TN, Reiter C, Searles J, Coiteux P. Nail S, et al. Among authors: searles j. AAPS PharmSciTech. 2017 Oct;18(7):2379-2393. doi: 10.1208/s12249-017-0733-1. Epub 2017 Feb 15. AAPS PharmSciTech. 2017. PMID: 28205144 Review.

9

Effects of Chamber Pressure and Partial Pressure of Water Vapor on Secondary Drying in Lyophilization.

Searles JA, Aravapalli S, Hodge C. Searles JA, et al. AAPS PharmSciTech. 2017 Oct;18(7):2808-2813. doi: 10.1208/s12249-017-0768-3. Epub 2017 Apr 5. AAPS PharmSciTech. 2017. PMID: 28382602

10

Viable cell recycle with an inclined settler in the perfusion culture of suspended recombinant Chinese hamster ovary cells.

Searles JA, Todd P, Kompala DS. Searles JA, et al. Biotechnol Prog. 1994 Mar-Apr;10(2):198-206. doi: 10.1021/bp00026a600. Biotechnol Prog. 1994. PMID: 7764677

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