Immunogenicity of CRISPR therapeutics—Critical considerations for clinical translation
R Ewaisha, KS Anderson - Frontiers in Bioengineering and …, 2023 - frontiersin.org
CRISPR offers new hope for many patients and promises to transform the way we think of
future therapies. Ensuring safety of CRISPR therapeutics is a top priority for clinical …
future therapies. Ensuring safety of CRISPR therapeutics is a top priority for clinical …
The perspective of DMPK on recombinant adeno-associated virus-based gene therapy: past learning, current support, and future contribution
N Chen, K Sun, NV Chemuturi, H Cho, CQ Xia - The AAPS Journal, 2022 - Springer
Given the recent success of gene therapy modalities and the growing number of cell and
gene-based therapies in clinical development across many different therapeutic areas, it is …
gene-based therapies in clinical development across many different therapeutic areas, it is …
2020 White paper on recent issues in bioanalysis: Vaccine assay validation, qPCR assay validation, QC for CAR-T flow cytometry, NAb assay harmonization and …
B Corsaro, T Yang, R Murphy, I Sonderegger, A Exley… - Bioanalysis, 2021 - Taylor & Francis
The 14th edition of the Workshop on Recent Issues in Bioanalysis (14th WRIB) was held
virtually on June 15-29, 2020 with an attendance of over 1000 representatives from …
virtually on June 15-29, 2020 with an attendance of over 1000 representatives from …
2021 White Paper on Recent Issues in Bioanalysis: Mass Spec of Proteins, Extracellular Vesicles, CRISPR, Chiral Assays, Oligos; Nanomedicines Bioanalysis; ICH …
S Kaur, SC Alley, M Szapacs, A Wilson, E Ciccimaro… - Bioanalysis, 2022 - Taylor & Francis
The 15th edition of the Workshop on Recent Issues in Bioanalysis (15th WRIB) was held on
27 September to 1 October 2021. Even with a last-minute move from in-person to virtual, an …
27 September to 1 October 2021. Even with a last-minute move from in-person to virtual, an …
2021 White paper on recent issues in bioanalysis: TAb/NAb, viral vector CDx, shedding assays; CRISPR/Cas9 & CAR-T immunogenicity; PCR & vaccine assay …
L Loo, S Harris, M Milton, Meena, W Lembke… - Bioanalysis, 2022 - Taylor & Francis
The 15th edition of the Workshop on Recent Issues in Bioanalysis (15th WRIB) was held on
27 September to 1 October 2021. Even with a last-minute move from in-person to virtual, an …
27 September to 1 October 2021. Even with a last-minute move from in-person to virtual, an …
Recommendations on qPCR/ddPCR assay validation by GCC
M Wissel, M Poirier, C Satterwhite, J Lin, R Islam… - Bioanalysis, 2022 - Taylor & Francis
Gene therapy, cell therapy and vaccine research have led to an increased use of
qPCR/ddPCR in bioanalytical laboratories. CROs are progressively undertaking the …
qPCR/ddPCR in bioanalytical laboratories. CROs are progressively undertaking the …
Validation of a 12‐color flow cytometry assay for acute myeloid leukemia minimal/measurable residual disease detection
SA Wang, JL Jorgensen, S Hu, F Jia… - Cytometry Part B …, 2023 - Wiley Online Library
Background Acute myeloid leukemia (AML) minimal/measurable residual disease (MRD) by
multicolor flow cytometry is a complex laboratory developed test (LDT), challenging for …
multicolor flow cytometry is a complex laboratory developed test (LDT), challenging for …
2022 White Paper on Recent Issues in Bioanalysis: FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors …
L Pan, J Mora, K Walravens, L Wagner, S Hopper… - Bioanalysis, 2023 - Taylor & Francis
Abstract The 2022 16th Workshop on Recent Issues in Bioanalysis (WRIB) took place in
Atlanta, GA, USA on September 26–30, 2022. Over 1000 professionals representing …
Atlanta, GA, USA on September 26–30, 2022. Over 1000 professionals representing …
2022 White Paper on Recent Issues in Bioanalysis: ICH M10 BMV Guideline & Global Harmonization; Hybrid Assays; Oligonucleotides & ADC; Non-Liquid & Rare …
M Szapacs, W Jian, D Spellman, J Cunliffe… - Bioanalysis, 2023 - Taylor & Francis
Abstract The 16th Workshop on Recent Issues in Bioanalysis (16th WRIB) took place in
Atlanta, GA, USA on September 26–30, 2022. Over 1000 professionals representing …
Atlanta, GA, USA on September 26–30, 2022. Over 1000 professionals representing …
Dystrophin and mini-dystrophin quantification by mass spectrometry in skeletal muscle for gene therapy development in Duchenne muscular dystrophy
V Farrokhi, J Walsh, J Palandra, J Brodfuehrer… - Gene therapy, 2022 - nature.com
Duchenne muscular dystrophy (DMD) is a lethal, degenerative muscle disorder caused by
mutations in the DMD gene, leading to severe reduction or absence of the protein …
mutations in the DMD gene, leading to severe reduction or absence of the protein …