Becky Schweighardt

Grace (United States) — United States

Immunology and Microbiology · Life Sciences

25h-index1.9kcitations45works0.52yr avg
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Research Topics

HIV Research and Treatment(21), HIV/AIDS drug development and treatment(10), HIV/AIDS Research and Interventions(9), Lysosomal Storage Disorders Research(7), Trypanosoma species research and implications(6)

Publications45 total

Progressive Neurodegeneration, Motor Decline, and Premature Mortality in Aging Ngly1 Deficient Rats
2025Open Access
Preclinical pharmacology and safety studies to support an AAV9 NGLY1 gene therapy clinical trial for the treatment of NGLY1 deficiency
Molecular Therapy — Methods & Clinical Development·2025· 1 citedOpen Access
AAV9-NGLY1 gene replacement therapy improves phenotypic and biomarker endpoints in a rat model of NGLY1 Deficiency
Molecular Therapy — Methods & Clinical Development·2022· 22 citedOpen Access
Pharmacokinetic, pharmacodynamic, and immunogenic rationale for optimal dosing of pegvaliase, a PEGylated bacterial enzyme, in adult patients with phenylketonuria
Clinical and Translational Science·2021· 17 citedOpen Access
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 ( <u>Part 3</u> –Recommendations on Immunogenicity Assay Strategies, NAb Assays, Biosimilars and FDA/EMA Immunogenicity Guidance/Guideline, Gene &amp; Cell Therapy and Vaccine Assays)
Bioanalysis·2021· 60 cited
Early Phase Clinical Immunogenicity of Valoctocogene Roxaparvovec, an AAV5-Mediated Gene Therapy for Hemophilia A
Molecular Therapy·2020· 71 citedOpen Access
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 &amp; CLSI H62)
Bioanalysis·2019· 92 citedOpen Access
The Impact of Pre-existing Immunity on the Non-clinical Pharmacodynamics of AAV5-Based Gene Therapy
Molecular Therapy — Methods & Clinical Development·2019· 75 citedOpen Access
2018 White Paper on Recent Issues in Bioanalysis: Focus on Flow Cytometry, Gene Therapy, Cut Points and Key Clarifications on Bav (Part 3 – Lba/Cell-Based Assays: Immunogenicity, Biomarkers and Pk Assays)
Bioanalysis·2018· 53 citedOpen Access
Association of immune response with efficacy and safety outcomes in adults with phenylketonuria administered pegvaliase in phase 3 clinical trials
EBioMedicine·2018· 69 citedOpen Access
Immunogenicity to cerliponase alfa intracerebroventricular enzyme replacement therapy for CLN2 disease: Results from a Phase 1/2 study
Clinical Immunology·2018· 34 cited
Induction, titration, and maintenance dosing regimen in a phase 2 study of pegvaliase for control of blood phenylalanine in adults with phenylketonuria
Molecular Genetics and Metabolism·2018· 31 cited
Interim Analysis of Immunogenicity to the Vector Capsid and Transgene-Expressed Human FVIII in a Phase-1/2 Clinical Study of Bmn 270, an AAV5-Mediated Gene Therapy for Hemophilia a
Blood·2017· 1 cited
Immunogenicity to cerliponase alfa, an enzyme replacement therapy for patients with CLN2 disease: results from a phase 1/2 study
Molecular Genetics and Metabolism·2017
Long-term Immunogenicity of Elosulfase Alfa in the Treatment of Morquio A Syndrome: Results From MOR-005, a Phase III Extension Study
Clinical Therapeutics·2016· 34 citedOpen Access
Antibodies that neutralize cellular uptake of elosulfase alfa are not associated with reduced efficacy or pharmacodynamic effect in individuals with Morquio A syndrome
Journal of Immunological Methods·2016· 17 citedOpen Access
PEGylated Biopharmaceuticals
Toxicologic Pathology·2015· 158 citedOpen Access
Table of Contents
Clinical Therapeutics·2015Open Access
Immunogenicity of elosulfase alfa, an enzyme replacement therapy in patients with Morquio syndrome type A: Results from MOR-004, a phase 3 trial
Molecular Genetics and Metabolism·2015· 2 cited
Immunogenicity of Elosulfase Alfa, an Enzyme Replacement Therapy in Patients With Morquio A Syndrome: Results From MOR-004, a Phase III Trial
Clinical Therapeutics·2014· 55 cited
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Frequent Co-authors

Terri Wrin(14), Charles O’Neill(8), Brian Long(6), Lynne Jesaitis(6), Troy Tompkins(6), Stephen J. Zoog(5), Kelly Lau(5), Douglas F. Nixon(5), Yulan Qi(5), Marit J. van Gils(4), Hanneke Schuitemaker(4), Mingjin Li(4), Donald G. Musson(4), Adam J. Shaywitz(4), Faruk Sinangil(4), Zelda Euler(3), Pham Phung(3), Christos J. Petropoulos(3), Fabio Garofolo(3), Yuanxin Xu(3)