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1.
Maintaining the quality of vaccines through the use of standards: Current challenges and future opportunities.
Biologicals
; 86: 101756, 2024 May.
Artículo
en Inglés
| MEDLINE | ID: mdl-38479213
2.
A next-generation sequencing based method for determining genetic stability in Clostridium tetani vaccine strains.
Biologicals
; 64: 10-14, 2020 Mar.
Artículo
en Inglés
| MEDLINE | ID: mdl-32057566
3.
Animal testing for vaccines. Implementing replacement, reduction and refinement: challenges and priorities.
Biologicals
; 68: 92-107, 2020 Nov.
Artículo
en Inglés
| MEDLINE | ID: mdl-33041187
4.
A single immunogenicity assay for testing potency of combination DTaP vaccines: Simultaneous quantitation of anti-DT, anti-TT, anti-PTxd and anti-FHA antibodies in Guinea-pig serum with a Luminex®-xMAP® bead-based serological assay.
Biologicals
; 61: 15-21, 2019 Sep.
Artículo
en Inglés
| MEDLINE | ID: mdl-31451353
5.
Host cell protein testing strategy for hepatitis B antigen in Hexavalent vaccine - Towards a general testing strategy for recombinant vaccines.
Biologicals
; 54: 1-7, 2018 Jul.
Artículo
en Inglés
| MEDLINE | ID: mdl-29861269
6.
One science-driven approach for the regulatory implementation of alternative methods: A multi-sector perspective.
Regul Toxicol Pharmacol
; 99: 33-49, 2018 Nov.
Artículo
en Inglés
| MEDLINE | ID: mdl-30098372
7.
Modern science for better quality control of medicinal products "Towards global harmonization of 3Rs in biologicals": The report of an EPAA workshop.
Biologicals
; 48: 55-65, 2017 Jul.
Artículo
en Inglés
| MEDLINE | ID: mdl-28596049
8.
Development and validation of high-performance size exclusion chromatography methods to determine molecular size parameters of Haemophilus influenzae type b polysaccharides and conjugates.
Anal Biochem
; 453: 22-8, 2014 May 15.
Artículo
en Inglés
| MEDLINE | ID: mdl-24608090
9.
Regulation of Clostridium tetani Neurotoxin Expression by Culture Conditions.
Toxins (Basel)
; 14(1)2022 01 02.
Artículo
en Inglés
| MEDLINE | ID: mdl-35051008
10.
The consistency approach for the substitution of in vivo testing for the quality control of established vaccines: practical considerations and progressive vision.
Open Res Eur
; 2: 116, 2022.
Artículo
en Inglés
| MEDLINE | ID: mdl-37645306
11.
Development and validation of a targeted LC-MS/MS quantitation method to monitor cell culture expression of tetanus neurotoxin during vaccine production.
Talanta
; 236: 122883, 2022 Jan 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-34635263
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