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1 . Academic Journal
AAV9-NGLY1 gene replacement therapy improves phenotypic and biomarker endpoints in a rat model of NGLY1 Deficiency
저자
by
Lei Zhu
;
Brandon Tan
;
Selina S. Dwight
;
Brendan Beahm
;
Matt Wilsey
, et al.
소스
Molecular Therapy: Methods & Clinical Development, Vol 27, Iss , Pp 259-271 (2022)
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7 . Academic Journal
Pharmacokinetic, pharmacodynamic, and immunogenic rationale for optimal dosing of pegvaliase, a PEGylated bacterial enzyme, in adult patients with phenylketonuria
저자
by
Yulan Qi
;
Gina Patel
;
Joshua Henshaw
;
Soumi Gupta
;
Joy Olbertz
, et al.
소스
Clinical and Translational Science, Vol 14, Iss 5, Pp 1894-1905 (2021)
Open Access (Wiley)
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7 . Academic Journal
The Impact of Pre-existing Immunity on the Non-clinical Pharmacodynamics of AAV5-Based Gene Therapy
저자
by
Brian R. Long
;
Krystal Sandza
;
Jennifer Holcomb
;
Lucy Crockett
;
Gregory M. Hayes
, et al.
소스
Molecular Therapy: Methods & Clinical Development, Vol 13, Iss , Pp 440-452 (2019)
Full Text (ScienceDirect)
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7 . Academic Journal
Association of immune response with efficacy and safety outcomes in adults with phenylketonuria administered pegvaliase in phase 3 clinical trialsResearch in context
저자
by
Soumi Gupta
;
Kelly Lau
;
Cary O. Harding
;
Gillian Shepherd
;
Ryan Boyer
, et al.
소스
EBioMedicine, Vol 37, Iss , Pp 366-373 (2018)
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7 .
2020 White Paper on Recent Issues in Bioanalysis: Vaccine Assay Validation, qPCR Assay Validation, QC for CAR-T Flow Cytometry, NAb Assay Harmonization and ELISpot Validation (
Part 3
– Recommendations on Immunogenicity Assay Strategies, NAb Assays, Biosimilars and FDA/EMA Immunogenicity Guidance/Guideline, Gene & Cell Therapy and Vaccine Assays)
저자
by
Swati Gupta
;
Sylvie Bertholet
;
Daniela Verthelyi
;
Jason Delcarpini
;
George R Gunn
, et al.
소스
Bioanalysis
. 13:415-463
Web of Science
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7 .
Early Phase Clinical Immunogenicity of Valoctocogene Roxaparvovec, an AAV5-Mediated Gene Therapy for Hemophilia A
저자
by
Nina Mitchell
;
Wing Yen Wong
;
Federico Mingozzi
;
M. Benjamin Hock
;
Kelly Lau
, et al.
소스
Molecular Therapy
Molecular Therapy, Cell Press, 2021, 29 (2), pp.597-610. ⟨10.1016/j.ymthe.2020.12.008⟩
Molecular Therapy, 2021, 29 (2), pp.597-610. ⟨10.1016/j.ymthe.2020.12.008⟩
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7 .
2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3 – Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62)
저자
by
Steven Piccoli
;
Devangi Mehta
;
Alessandra Vitaliti
;
John Allinson
;
Shashi Amur
, et al.
소스
Bioanalysis
. 11:2207-2244
Open Access (OpenAIRE)
Web of Science
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7 .
The Impact of Pre-existing Immunity on the Non-clinical Pharmacodynamics of AAV5-Based Gene Therapy
저자
by
Jennifer Holcomb
;
Christian Vettermann
;
Charles A. O'Neill
;
Krystal Sandza
;
Carlos Fonck
, et al.
소스
Molecular Therapy: Methods & Clinical Development, Vol 13, Iss, Pp 440-452 (2019)
Molecular Therapy. Methods & Clinical Development
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7 .
Immunogenicity to cerliponase alfa intracerebroventricular enzyme replacement therapy for CLN2 disease: Results from a Phase 1/2 study
저자
by
Becky Schweighardt
;
Temitayo Ajayi
;
Charles A. O'Neill
;
Joshua Henshaw
;
Greg de Hart
, et al.
소스
Clinical Immunology
. 197:68-76
Full Text (Clinical Key)
Web of Science
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7 .
Pharmacokinetic, pharmacodynamic, and immunogenic rationale for optimal dosing of pegvaliase, a PEGylated bacterial enzyme, in adult patients with phenylketonuria
저자
by
Cary O. Harding
;
Stephen J. Zoog
;
Roberto T. Zori
;
Markus Merilainen
;
Joy Olbertz
, et al.
소스
Clinical and Translational Science
Clinical and Translational Science, Vol 14, Iss 5, Pp 1894-1905 (2021)
Open Access (Wiley)
Open Access (OpenAIRE)
Scopus
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