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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)

Bioanalysis, 2019-12, Vol.11 (24), p.2207-2244

2019

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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

Bioanalysis, 2021-03, Vol.13 (6), p.415-463

2021

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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

Bioanalysis, 2022-06, Vol.14 (11), p.737-793

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

Bioanalysis, 2022-05, Vol.14 (9), p.505-580

2022

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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, 2018-12, Vol.10 (24), p.1973-2001

2018

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2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback

Bioanalysis, 2021-03, Vol.13 (5), p.295-361

2021

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The Human Immunodeficiency Virus: Biology, Immunology, and Therapy

Emilio Emini, Emilio Emini

2021

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2018 White Paper on Recent Issues in Bioanalysis: 'A global bioanalytical community perspective on last decade of incurred samples reanalysis (ISR)' (Part 1 - small molecule regulated bioanalysis, small molecule biomarkers, peptides & oligonucleotide bioanalysis)

Bioanalysis, 2018-11, Vol.10 (22), p.1781-1801

2018

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2019 White Paper On Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs

Bioanalysis, 2019-12, Vol.11 (23), p.2099-2132

2019

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2018 White Paper on Recent Issues in Bioanalysis: focus on immunogenicity assays by hybrid LBA/LCMS and regulatory feedback (Part 2 - PK, PD & ADA assays by hybrid LBA/LCMS & regulatory agencies' inputs on bioanalysis, biomarkers and immunogenicity)

Bioanalysis, 2018-12, Vol.10 (23), p.1897-1917

2018

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Deletion Mutagenesis within the Dimerization Initiation Site of Human Immunodeficiency Virus Type 1 Results in Delayed Processing of the p2 Peptide from Precursor Proteins

Journal of Virology, 1999-07, Vol.73 (7), p.6147-6151

1999

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2018 White Paper on Recent Issues in Bioanalysis

Bioanalysis, 2018-11, Vol.10 (22), p.1781-1801

2018

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Effect of HIV constructs containing protease-reverse transcriptase fusion proteins on viral replication

AIDS (London), 1998-06, Vol.12 (9), p.967-975

1998

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The Structure and Biology of HIV-l: Introduction

The Human Immunodeficiency Virus, 2022, p.1-43

2022

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Characterization of human immunodeficiency virus type-1 (HIV-1) particles that express protease-reverse transcriptase fusion proteins

Journal of molecular biology, 1998-11, Vol.284 (1), p.43-56

1998

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Trans -dominant negative inhibition of human immunodeficiency virus type 1 replication by expression of protease -reverse transcriptase fusion proteins

Cherry, Elana

1999

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Mutations at codon 184 in simian immunodeficiency virus reverse transcriptase confer resistance to the (-) enantiomer of 2',3'-dideoxy-3'-thiacytidine

Antimicrobial Agents and Chemotherapy, 1997-12, Vol.41 (12), p.2763-2765

1997

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Characterization of human immunodeficiency virus type-1 (HIV-1) particles that express protease-reverse transcriptase fusion proteins 1 1Edited by J. Karn

Journal of molecular biology, 1998-11, Vol.284 (1), p.43-56

1998

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Neutralizing antibodies directed against the V3 loop select for different escape variants in a virus with mutated reverse transcriptase (M184V) than in wild-type human immunodeficiency virus type 1

AIDS research and human retroviruses, 1998-06, Vol.14 (9), p.735-740

1998

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Cotransfection of mutated forms of human immunodeficiency virus type 1 Gag-Pol with wild-type constructs can interfere with processing and viral replication

Journal of human virology, 1998-03, Vol.1 (3), p.240

1998

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Computational reconstruction of the signalling networks surrounding implanted biomaterials from single-cell transcriptomics

Nature biomedical engineering, 2021-10, Vol.5 (10), p.1228-1238

2021

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Age‐associated Senescent – T Cell Signaling Promotes Type 3 Immunity that Inhibits the Biomaterial Regenerative Response

Advanced materials (Weinheim), 2024-10, Vol.36 (43), p.e2310476-n/a

2024

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Transfer Learning Reveals Cancer-Associated Fibroblasts Are Associated with Epithelial-Mesenchymal Transition and Inflammation in Cancer Cells in Pancreatic Ductal Adenocarcinoma

Cancer research (Chicago, Ill.), 2024-05, Vol.84 (9), p.1517-1533

2024

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Abstract 6212: A differential ligand-receptor network inference method to identify alterations in communication between myeloid cells and CD8 T cells in response to PancVAX neo-epitope peptide vaccine, anti-CTLA-4 and anti-PD-1 antibodies in a murine model of pancreatic ductal adenocarcinoma

Cancer research (Chicago, Ill.), 2024-03, Vol.84 (6_Supplement), p.6212-6212

2024

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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

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

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

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)

2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback

The Human Immunodeficiency Virus: Biology, Immunology, and Therapy

2018 White Paper on Recent Issues in Bioanalysis: 'A global bioanalytical community perspective on last decade of incurred samples reanalysis (ISR)' (Part 1 - small molecule regulated bioanalysis, small molecule biomarkers, peptides & oligonucleotide bioanalysis)

2019 White Paper On Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs

2018 White Paper on Recent Issues in Bioanalysis: focus on immunogenicity assays by hybrid LBA/LCMS and regulatory feedback (Part 2 - PK, PD & ADA assays by hybrid LBA/LCMS & regulatory agencies' inputs on bioanalysis, biomarkers and immunogenicity)

Deletion Mutagenesis within the Dimerization Initiation Site of Human Immunodeficiency Virus Type 1 Results in Delayed Processing of the p2 Peptide from Precursor Proteins

2018 White Paper on Recent Issues in Bioanalysis

Effect of HIV constructs containing protease-reverse transcriptase fusion proteins on viral replication

The Structure and Biology of HIV-l: Introduction

Characterization of human immunodeficiency virus type-1 (HIV-1) particles that express protease-reverse transcriptase fusion proteins

Trans -dominant negative inhibition of human immunodeficiency virus type 1 replication by expression of protease -reverse transcriptase fusion proteins

Mutations at codon 184 in simian immunodeficiency virus reverse transcriptase confer resistance to the (-) enantiomer of 2',3'-dideoxy-3'-thiacytidine

Characterization of human immunodeficiency virus type-1 (HIV-1) particles that express protease-reverse transcriptase fusion proteins 1 1Edited by J. Karn

Neutralizing antibodies directed against the V3 loop select for different escape variants in a virus with mutated reverse transcriptase (M184V) than in wild-type human immunodeficiency virus type 1

Cotransfection of mutated forms of human immunodeficiency virus type 1 Gag-Pol with wild-type constructs can interfere with processing and viral replication

Computational reconstruction of the signalling networks surrounding implanted biomaterials from single-cell transcriptomics

Age‐associated Senescent – T Cell Signaling Promotes Type 3 Immunity that Inhibits the Biomaterial Regenerative Response

Transfer Learning Reveals Cancer-Associated Fibroblasts Are Associated with Epithelial-Mesenchymal Transition and Inflammation in Cancer Cells in Pancreatic Ductal Adenocarcinoma

Transfer learning in a biomaterial fibrosis model identifies in vivo senescence heterogeneity and contributions to vascularization and matrix production across species and diverse pathologies

Abstract 6212: A differential ligand-receptor network inference method to identify alterations in communication between myeloid cells and CD8 T cells in response to PancVAX neo-epitope peptide vaccine, anti-CTLA-4 and anti-PD-1 antibodies in a murine model of pancreatic ductal adenocarcinoma

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