Shankar G - Search Results

1

A generic method for the detection of polyethylene glycol specific IgG and IgM antibodies in human serum.

Ehlinger C, Spear N, Doddareddy R, Shankar G, Schantz A. Ehlinger C, et al. Among authors: shankar g. J Immunol Methods. 2019 Nov;474:112669. doi: 10.1016/j.jim.2019.112669. Epub 2019 Oct 12. J Immunol Methods. 2019. PMID: 31614128

2

Detection of low-affinity anti-drug antibodies and improved drug tolerance in immunogenicity testing by Octet(®) biolayer interferometry.

Li J, Schantz A, Schwegler M, Shankar G. Li J, et al. Among authors: shankar g. J Pharm Biomed Anal. 2011 Jan 25;54(2):286-94. doi: 10.1016/j.jpba.2010.08.022. Epub 2010 Sep 24. J Pharm Biomed Anal. 2011. PMID: 20869832

3

Analysis of regulatory guidance on antidrug antibody testing for therapeutic protein products.

Bano N, McKelvey T, Spear N, Yang TY, Shankar G, Schantz A. Bano N, et al. Among authors: shankar g. Bioanalysis. 2019 Dec;11(24):2283-2296. doi: 10.4155/bio-2019-0241. Bioanalysis. 2019. PMID: 31845602

4

Development of a method that eliminates false-positive results due to nerve growth factor interference in the assessment of fulranumab immunogenicity.

Dai S, Schantz A, Clements-Egan A, Cannon M, Shankar G. Dai S, et al. Among authors: shankar g. AAPS J. 2014 May;16(3):464-77. doi: 10.1208/s12248-014-9581-z. Epub 2014 Mar 5. AAPS J. 2014. PMID: 24590506 Free PMC article. Clinical Trial.

5

Implementing a tiered approach to bioanalytical method validation for large-molecule ligand-binding assay methods in pharmacokinetic assessments.

Watson RG, Clements-Egan A, Schantz A, Ware M, Wu B, Yang TY, Shankar G, Marini JC. Watson RG, et al. Among authors: shankar g. Bioanalysis. 2017 Sep;9(18):1407-1422. doi: 10.4155/bio-2017-0044. Epub 2017 Sep 18. Bioanalysis. 2017. PMID: 28920457

6

Validation of immunoassays used to assess immunogenicity to therapeutic monoclonal antibodies.

Geng D, Shankar G, Schantz A, Rajadhyaksha M, Davis H, Wagner C. Geng D, et al. Among authors: shankar g. J Pharm Biomed Anal. 2005 Sep 15;39(3-4):364-75. doi: 10.1016/j.jpba.2005.04.045. J Pharm Biomed Anal. 2005. PMID: 15963677 Review.

7

The COSTIM bioassay: a novel potency test for dendritic cells.

Shankar G, Bader R, Lodge PA. Shankar G, et al. J Immunol Methods. 2004 Feb 15;285(2):293-9. doi: 10.1016/j.jim.2003.12.008. J Immunol Methods. 2004. PMID: 14980442

8

Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products.

Koren E, Smith HW, Shores E, Shankar G, Finco-Kent D, Rup B, Barrett YC, Devanarayan V, Gorovits B, Gupta S, Parish T, Quarmby V, Moxness M, Swanson SJ, Taniguchi G, Zuckerman LA, Stebbins CC, Mire-Sluis A. Koren E, et al. Among authors: shankar g. J Immunol Methods. 2008 Apr 20;333(1-2):1-9. doi: 10.1016/j.jim.2008.01.001. Epub 2008 Jan 29. J Immunol Methods. 2008. PMID: 18275969 Review.

9

Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products.

Mire-Sluis AR, Barrett YC, Devanarayan V, Koren E, Liu H, Maia M, Parish T, Scott G, Shankar G, Shores E, Swanson SJ, Taniguchi G, Wierda D, Zuckerman LA. Mire-Sluis AR, et al. Among authors: shankar g. J Immunol Methods. 2004 Jun;289(1-2):1-16. doi: 10.1016/j.jim.2004.06.002. J Immunol Methods. 2004. PMID: 15251407

10

Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products.

Shankar G, Devanarayan V, Amaravadi L, Barrett YC, Bowsher R, Finco-Kent D, Fiscella M, Gorovits B, Kirschner S, Moxness M, Parish T, Quarmby V, Smith H, Smith W, Zuckerman LA, Koren E. Shankar G, et al. J Pharm Biomed Anal. 2008 Dec 15;48(5):1267-81. doi: 10.1016/j.jpba.2008.09.020. Epub 2008 Sep 19. J Pharm Biomed Anal. 2008. PMID: 18993008 Review.

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