Michael E Hodsdon
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Explore the profile of Michael E Hodsdon including associated specialties, affiliations and a list of published articles.
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48
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933
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Recent Articles
1.
Pack B, Siegel R, Cornwell P, Ferrante A, Roepke D, Hodsdon M, et al.
AAPS J
. 2025 Mar;
27(2):56.
PMID: 40050561
There is limited regulatory guidance that outlines the globally acceptable level of individual and total impurities present in peptide and oligonucleotide drug substances that can be supported and accepted during...
2.
Abel A, Chambers A, Fill J, Reiske H, Lu M, Morris A, et al.
J Appl Lab Med
. 2025 Jan;
PMID: 39836199
Background: Blood-based biomarkers, especially P-tau217, have been gaining interest as diagnostic tools to measure Alzheimer disease (AD) pathology. Methods: We developed a plasma P-tau217 chemiluminescent immunoassay using 4G10E2 and IBA493...
3.
Zhang L, Hodsdon M, Pottanat T, Wang S, Konrad R, Seta N, et al.
J Immunol Methods
. 2023 Sep;
522:113569.
PMID: 37748729
Biologic drugs (therapeutic proteins or peptides) have become one of the most important therapeutic modalities over the past few decades. Drug-induced immunogenicity is a significant concern as it may affect...
4.
Mullins G, Hodsdon M, Li Y, Anglin G, Urva S, Schneck K, et al.
J Clin Endocrinol Metab
. 2023 Sep;
109(2):361-369.
PMID: 37700637
Context: Antidrug antibodies (ADA) can potentially affect drug pharmacokinetics, safety, and efficacy. Objective: This work aimed to evaluate treatment-emergent (TE) ADA in tirzepatide (TZP)-treated participants across 7 phase 3 trials...
5.
Jani D, Marsden R, Gunsior M, Hay L, Ward B, Cowan K, et al.
AAPS J
. 2022 Oct;
24(6):113.
PMID: 36307592
A clear scientific and operational need exists for harmonized bioanalytical immunogenicity study reporting to facilitate communication of immunogenicity findings and expedient review by industry and health authorities. To address these...
6.
Vang J, Pustovalova Y, Korzhnev D, Gorbatyuk O, Keeler C, Hodsdon M, et al.
Biophys J
. 2022 Feb;
121(7):1312-1321.
PMID: 35192840
Metal binding by members of the growth hormone (GH) family of hematopoietic cytokines has been a subject of considerable interest. However, beyond appreciation of its role in reversible packing of...
7.
Myler H, Pedras-Vasconcelos J, Phillips K, Hottenstein C, Chamberlain P, Devanaryan V, et al.
AAPS J
. 2021 Dec;
24(1):4.
PMID: 34853961
Evolving immunogenicity assay performance expectations and a lack of harmonized anti-drug antibody validation testing and reporting tools have resulted in significant time spent by health authorities and sponsors on resolving...
8.
Peterson D, Pottanat T, Denning H, Bivi N, Sloan J, Nguyen H, et al.
Bioanalysis
. 2021 Jul;
PMID: 34289719
We present a novel methodology to compare results between distinct immunogenicity assays, performed by two laboratories, for the same biotherapeutic. Human serum pools from clinical trials were generated to provide...
9.
Hollister K, Nguyen H, Bishop J, Cramer J, Bivi N, Gardner M, et al.
Bioanalysis
. 2020 Nov;
12(22):1597-1605.
PMID: 33156693
Over the developmental lifetime of a therapeutic protein, the immunogenicity assay validation history can become substantial, frustrating review of clinical immunogenicity within the biologics license application. In our experience, this...
10.
Bivi N, Swearingen C, Shockley T, Sloan J, Pottanat T, Carter Q, et al.
J Immunol Methods
. 2020 Sep;
486:112856.
PMID: 32916164
Polyethylene glycol (PEG) represents an effective strategy to improve the pharmacokinetic profile of a molecule as it extends the biotherapeutic's half-life, masks immunogenic epitopes or modifies its distribution. The addition...