Publications by authors named "Therese Solstad"

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Harmonization of Vaccine Ligand Binding Assays Validation.
Francis Dessy, Ivo Sonderegger, Leslie Wagner, Alessandra Buoninfante, Meenu Wadhwa, Therese Solstad

Bioanalysis· November 2024

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2022 White Paper on Recent Issues in Bioanalysis: Enzyme Assay Validation, BAV for Primary End Points, Vaccine Functional Assays, Cytometry in Tissue, LBA in Rare Matrices, Complex NAb Assays, Spectral Cytometry, Endogenous Analytes, Extracellular Vesicles - Recommendations on Biomarkers/CDx, Flow Cytometry, Ligand-Binding Assays Development & Validation; Emerging Technologies; Critical Reagents Deep Characterization.
Giane Sumner, Steve Keller, James Huleatt, Roland F Staack, Leslie Wagner, Therese Solstad

Bioanalysis· August 2023

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2022 White Paper on Recent Issues in Bioanalysis: ICH M10 BMV Guideline & Global Harmonization; Hybrid Assays; Oligonucleotides & ADC; Non-Liquid & Rare Matrices; Regulatory Inputs ( - Recommendations on Mass Spectrometry, Chromatography and Sample Preparation, Novel Technologies, Novel Modalities, and Novel Challenges, ICH M10 BMV Guideline & Global Harmonization - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/CDx/BAV, Immunogenicity, Gene & Cell Therapy and Vaccine).
Matt Szapacs, Wenying Jian, Daniel Spellman, Jennifer Cunliffe, Elizabeth Verburg, Therese Solstad

Bioanalysis· August 2023

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2022 White Paper on Recent Issues in Bioanalysis: FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, ADA Affinity, Risk-based Approaches, NGS, qPCR, ddPCR Assays ( - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Immunogenicity & Risk Assessment of Biotherapeutics and Novel Modalities; NAb Assays Integrated Approach).
Luying Pan, Johanna Mora, Karl Walravens, Leslie Wagner, Shirley Hopper, Therese Solstad

Bioanalysis· July 2023

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2021 White Paper on Recent Issues in Bioanalysis: TAb/NAb, Viral Vector CDx, Shedding Assays; CRISPR/Cas9 & CAR-T Immunogenicity; PCR & Vaccine Assay Performance; ADA Assay Comparability & Cut Point Appropriateness ( - Recommendations on Gene Therapy, Cell Therapy, Vaccine Assays; Immunogenicity of Biotherapeutics and Novel Modalities; Integrated Summary of Immunogenicity Harmonization).
Lina Loo, Shannon Harris, Mark Milton, Meena, Wibke Lembke, Therese Solstad

Bioanalysis· June 2022

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2021 White Paper on Recent Issues in Bioanalysis: Mass Spec of Proteins, Extracellular Vesicles, CRISPR, Chiral Assays, Oligos; Nanomedicines Bioanalysis; ICH M10 Section 7.1; Non-Liquid & Rare Matrices; Regulatory Inputs ( - Recommendations on Endogenous Compounds, Small Molecules, Complex Methods, Regulated Mass Spec of Large Molecules, Small Molecule, PoC &  - Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine).
Surinder Kaur, Stephen C Alley, Matt Szapacs, Amanda Wilson, Eugene Ciccimaro, Therese Solstad

Bioanalysis· May 2022

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2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback ( - Recommendations on Biotherapeutics Stability, PK LBA Regulated Bioanalysis, Biomarkers Assays, Cytometry Validation & Innovation - Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine).
Susan Spitz, Yan Zhang, Sally Fischer, Kristina McGuire, Ulrike Sommer, Therese Solstad

Bioanalysis· March 2021

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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 ( - Recommendations on Immunogenicity Assay Strategies, NAb Assays, Biosimilars and FDA/EMA Immunogenicity Guidance/Guideline, Gene & Cell Therapy and Vaccine Assays).
Bart Corsaro, Tong-Yuan Yang, Rocio Murphy, Ivo Sonderegger, Andrew Exley, Therese Solstad

Bioanalysis· March 2021

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A PKA-ezrin-Cx43 signaling complex controls gap junction communication and thereby trophoblast cell fusion.
Guillaume Pidoux, Pascale Gerbaud, Jim Dompierre, Birgitte Lygren, Therese Solstad

J Cell Sci· October 2014

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Identification of dynamic changes in proteins associated with the cellular cytoskeleton after exposure to okadaic acid.
Jill A Opsahl, Sonja Ljostveit, Therese Solstad, Kristin Risa, Peter Roepstorff

Mar Drugs· May 2013

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Nodularin exposure induces SOD1 phosphorylation and disrupts SOD1 co-localization with actin filaments.
Linda V Hjørnevik, Lise Fismen, Fiona M Young, Therese Solstad, Kari E Fladmark

Toxins (Basel)· December 2012

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CD147 (Basigin/Emmprin) identifies FoxP3+CD45RO+CTLA4+-activated human regulatory T cells.
Therese Solstad, Simer Jit Bains, Johannes Landskron, Einar Martin Aandahl, Bernd Thiede

Blood· November 2011

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Quantitative proteome analysis of detergent-resistant membranes identifies the differential regulation of protein kinase C isoforms in apoptotic T cells.
Therese Solstad, Elisa Bjørgo, Christian J Koehler, Margarita Strozynski, Knut Martin Torgersen

Proteomics· August 2010

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Increased interaction between DJ-1 and the Mi-2/ nucleosome remodelling and deacetylase complex during cellular stress.
Jill A Opsahl, Linda V Hjørnevik, Vibeke H Bull, Lise Fismen, Ann K Frøyset, Therese Solstad

Proteomics· April 2010

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Identification of a novel phosphorylation site of acyl-CoA binding protein (ACBP) in nodularin-induced apoptotic hepatocytes.
Therese Solstad, Lise Fismen, Hilde Garberg, Kari E Fladmark

Exp Cell Res· June 2008

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Deamidations in recombinant human phenylalanine hydroxylase. Identification of labile asparagine residues and functional characterization of Asn --> Asp mutant forms.
Raquel Negrão Carvalho, Therese Solstad, Elisa Bjørgo, João Filipe Barroso, Torgeir Flatmark

J Biol Chem· April 2003

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Deamidation of labile asparagine residues in the autoregulatory sequence of human phenylalanine hydroxylase.
Therese Solstad, Raquel N Carvalho, Ole A Andersen, Dietmar Waidelich, Torgeir Flatmark

Eur J Biochem· March 2003

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Studies on the regulatory properties of the pterin cofactor and dopamine bound at the active site of human phenylalanine hydroxylase.
Therese Solstad, Anne J Stokka, Ole A Andersen, Torgeir Flatmark

Eur J Biochem· March 2003

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