Marta Starcevic Manning
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Explore the profile of Marta Starcevic Manning including associated specialties, affiliations and a list of published articles.
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10
Citations
81
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Recent Articles
1.
Kroenke M, Manning M, Zuch de Zafra C, Zhang X, Cook K, Archer M, et al.
Front Immunol
. 2024 Jul;
15:1441999.
PMID: 38966638
[This corrects the article DOI: 10.3389/fimmu.2024.1345473.].
2.
Kroenke M, Manning M, Zuch de Zafra C, Zhang X, Cook K, Archer M, et al.
Front Immunol
. 2024 Feb;
15:1345473.
PMID: 38343535
AMG 256 is a bi-specific, heteroimmunoglobulin molecule with an anti-PD-1 antibody domain and a single IL-21 mutein domain on the C-terminus. Nonclinical studies in cynomolgus monkeys revealed that AMG 256...
3.
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...
4.
Manning M, Hassanein M, Partridge M, Jawa V, Mora J, Ryman J, et al.
AAPS J
. 2022 Jul;
24(4):81.
PMID: 35821280
During biotherapeutic drug development, immunogenicity is evaluated by measuring anti-drug antibodies (ADAs). The presence and magnitude of ADA responses is assessed using a multi-tier workflow where samples are screened, confirmed,...
5.
Zhou Y, Zhang F, Manning M, Hu Z, Hsu C, Chen P, et al.
Cephalalgia
. 2022 Mar;
42(8):749-760.
PMID: 35272533
Background: Immunogenicity of erenumab, a human anti-calcitonin gene-related peptide receptor monoclonal antibody developed for migraine prevention, has been evaluated throughout clinical development. Methods: Integrated post hoc analysis assessing immunogenicity of...
6.
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...
7.
Xue L, Clements-Egan A, Amaravadi L, Birchler M, Gorovits B, Liang M, et al.
AAPS J
. 2017 Nov;
19(6):1576-1586.
PMID: 29110222
Anti-drug antibodies (ADA) pose a potential risk to patient safety and efficacy and are routinely monitored during clinical trials. Pre-existing drug-reactive antibodies are present in patients without prior drug exposure...
8.
Assay signal as an alternative to titer for assessment of magnitude of an antidrug antibody response
Manning M, Kroenke M, Lee S, Harrison S, Hoofring S, Mytych D, et al.
Bioanalysis
. 2017 Oct;
9(23):1849-1858.
PMID: 29020795
Background: Titer methods are commonly used to characterize the magnitude of an antidrug antibody response. Assay S/N is an appealing alternative, but the circumstances under which use of signal-to-noise (S/N)...
9.
Tatarewicz S, Mytych D, Manning M, Swanson S, Moxness M, Chirmule N
Bioanalysis
. 2014 Jul;
6(11):1509-23.
PMID: 25046051
All therapeutic proteins have the potential to induce anti-drug antibodies (ADA). Clinically relevant ADA can impact efficacy and/or safety of a biological therapeutic. Immunogenicity assessment strategy evaluates binding and neutralizing...
10.
Gorovits B, Wakshull E, Pillutla R, Xu Y, Manning M, Goyal J
J Immunol Methods
. 2014 May;
408:1-12.
PMID: 24861938
Many biotherapeutics currently in development have complex mechanisms of action and contain more than one domain, each with a specific role or function. Examples include antibody-drug conjugates (ADC), PEGylated, fusion...