Manuela Braun

Pharmaceuticals R&D
Berlin, BE 13342, Germany

Last Updated: 09/26/2026

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Found 12 publications

A Review of the Challenge of Pre-Existing Humoral Immunity in Adeno-Associated Virus Gene Therapy and Potential Solutions.

A Review of the Challenge of Pre-Existing Humoral Immunity in Adeno-Associated Virus Gene Therapy and Potential Solutions.

Journal: Human gene therapy
Published: March 18, 2026

Immunogenicity Risk Assessment for Nucleic Acid Therapeutics: A Comprehensive Evaluation for ASO, siRNA, and Nonvaccine mRNA/LNP Therapies by the IQ Consortium.

Immunogenicity Risk Assessment for Nucleic Acid Therapeutics: A Comprehensive Evaluation for ASO, siRNA, and Nonvaccine mRNA/LNP Therapies by the IQ Consortium.

Journal: Nucleic acid therapeutics
Published: November 08, 2025

Nonclinical toxicity study duration in AAV gene therapy development: Evidence from industry survey supports adequacy of short-term assessments.

Nonclinical toxicity study duration in AAV gene therapy development: Evidence from industry survey supports adequacy of short-term assessments.

Journal: Molecular therapy. Methods & clinical development
Published: August 14, 2025

Current regulatory requirements for assessment of immunogenicity for gene therapy medicinal products.

Current regulatory requirements for assessment of immunogenicity for gene therapy medicinal products.

Journal: Cell reports. Medicine
Published: February 17, 2025

Preexisting antibody assays for gene therapy: Considerations on patient selection cutoffs and companion diagnostic requirements.

Preexisting antibody assays for gene therapy: Considerations on patient selection cutoffs and companion diagnostic requirements.

Journal: Molecular therapy. Methods & clinical development
Published: March 18, 2024

PK/PD and Bioanalytical Considerations of AAV-Based Gene Therapies: an IQ Consortium Industry Position Paper.

PK/PD and Bioanalytical Considerations of AAV-Based Gene Therapies: an IQ Consortium Industry Position Paper.

Journal: The AAPS journal
Published: March 20, 2023

Quantitative polymerase chain reaction in the bioanalytical laboratory and technical and scientific considerations for nonclinical and clinical assay characterization, validation and sample analysis.

Quantitative polymerase chain reaction in the bioanalytical laboratory and technical and scientific considerations for nonclinical and clinical assay characterization, validation and sample analysis.

Journal: Bioanalysis
Published: September 20, 2022

Immunogenicity assessment of AAV-based gene therapies: An IQ consortium industry white paper.

Immunogenicity assessment of AAV-based gene therapies: An IQ consortium industry white paper.

Journal: Molecular therapy. Methods & clinical development
Published: September 12, 2022

Applying context of use to quantitative polymerase chain reaction method validation and analysis: a recommendation from the European Bioanalysis Forum.

Applying context of use to quantitative polymerase chain reaction method validation and analysis: a recommendation from the European Bioanalysis Forum.

Journal: Bioanalysis
Published: October 28, 2021

Recommendations for singlet-based approach in ligand binding assays: an IQ Consortium perspective.

Recommendations for singlet-based approach in ligand binding assays: an IQ Consortium perspective.

Journal: Bioanalysis
Published: June 20, 2020

Bypassing nonparallelism of a monoclonal antibody ligand-binding assay by employment of alternative assay formats.

Bypassing nonparallelism of a monoclonal antibody ligand-binding assay by employment of alternative assay formats.

Journal: Bioanalysis
Published: November 26, 2016

Preclinical Efficacy of the Auristatin-Based Antibody-Drug Conjugate BAY 1187982 for the Treatment of FGFR2-Positive Solid Tumors.

Preclinical Efficacy of the Auristatin-Based Antibody-Drug Conjugate BAY 1187982 for the Treatment of FGFR2-Positive Solid Tumors.

Journal: Cancer research
Published: January 18, 2016
Showing 1-12 of 12

Last Updated: 09/26/2026