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1.
"High-risk" host cell proteins (HCPs): A multi-company collaborative view.
Biotechnol Bioeng
; 118(8): 2870-2885, 2021 08.
Artículo
en Inglés
| MEDLINE | ID: mdl-33930190
2.
A simple and sensitive differential digestion method to analyze adeno-associated virus residual host cell proteins by LC-MS.
J Pharm Biomed Anal
; 242: 116009, 2024 May 15.
Artículo
en Inglés
| MEDLINE | ID: mdl-38354541
3.
Comprehensive chromatographic assessment of forced degraded in vitro transcribed mRNA.
J Chromatogr A
; 1722: 464885, 2024 May 10.
Artículo
en Inglés
| MEDLINE | ID: mdl-38631223
4.
Comprehensive biophysical characterization of AAV-AAVR interaction uncovers serotype- and pH-dependent interaction.
J Pharm Biomed Anal
; 234: 115562, 2023 Sep 20.
Artículo
en Inglés
| MEDLINE | ID: mdl-37441888
5.
A single-nucleotide resolution capillary gel electrophoresis workflow for poly(A) tail characterization in the development of mRNA therapeutics and vaccines.
J Pharm Biomed Anal
; 236: 115692, 2023 Nov 30.
Artículo
en Inglés
| MEDLINE | ID: mdl-37696189
6.
2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback (Part 2A - Recommendations on Biotherapeutics Stability, PK LBA Regulated Bioanalysis, Biomarkers Assays, Cytometry Validation & Innovation Part 2B - Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine).
Bioanalysis
; 13(5): 295-361, 2021 Mar.
Artículo
en Inglés
| MEDLINE | ID: mdl-33511867
7.
Mitigating target interference in bridging immunogenicity assay with target-blocking reagents and mild basic pH.
Bioanalysis
; 11(17): 1569-1580, 2019 Sep.
Artículo
en Inglés
| MEDLINE | ID: mdl-31208197
8.
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
; 11(24): 2207-2244, 2019 Dec.
Artículo
en Inglés
| MEDLINE | ID: mdl-31820675
9.
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
; 10(24): 1973-2001, 2018 Dec.
Artículo
en Inglés
| MEDLINE | ID: mdl-30488726
10.
Current and effective strategies for critical reagent characterization, storage, stability, retesting and life cycle management for ligand-binding assays and flow cytometry.
Bioanalysis
; 13(10): 737-740, 2021 May.
Artículo
en Inglés
| MEDLINE | ID: mdl-34037426
11.
An evolutionary route to xylanase process fitness.
Protein Sci
; 13(2): 494-503, 2004 Feb.
Artículo
en Inglés
| MEDLINE | ID: mdl-14718652
12.
Fjord-region benzo[g]chrysene-11,12-dihydrodiol and benzo[c]phenanthrene-3,4-dihydrodiol as substrates for rat liver dihydrodiol dehydrogenase (AKR1C9): structural basis for stereochemical preference.
Chem Res Toxicol
; 21(3): 668-77, 2008 Mar.
Artículo
en Inglés
| MEDLINE | ID: mdl-18251511
13.
A multifunctional hybrid glycosyl hydrolase discovered in an uncultured microbial consortium from ruminant gut.
Appl Microbiol Biotechnol
; 74(1): 113-24, 2007 Feb.
Artículo
en Inglés
| MEDLINE | ID: mdl-17103163
14.
Activation of polycyclic aromatic hydrocarbon trans-dihydrodiol proximate carcinogens by human aldo-keto reductase (AKR1C) enzymes and their functional overexpression in human lung carcinoma (A549) cells.
J Biol Chem
; 277(27): 24799-808, 2002 Jul 05.
Artículo
en Inglés
| MEDLINE | ID: mdl-11978787
15.
Unusual microbial xylanases from insect guts.
Appl Environ Microbiol
; 70(6): 3609-17, 2004 Jun.
Artículo
en Inglés
| MEDLINE | ID: mdl-15184164
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