Detalhe da pesquisa
1.
Regulatory workshop on challenge strain development and GMP manufacture - A stakeholder meeting report.
Biologicals
; 85: 101746, 2024 Feb.
Artigo
em Inglês
| MEDLINE | ID: mdl-38309984
2.
Estimation of manufacturing development costs of cell-based therapies: a feasibility study.
Cytotherapy
; 23(8): 730-739, 2021 08.
Artigo
em Inglês
| MEDLINE | ID: mdl-33593688
3.
What does cell therapy manufacturing cost? A framework and methodology to facilitate academic and other small-scale cell therapy manufacturing costings.
Cytotherapy
; 22(7): 388-397, 2020 07.
Artigo
em Inglês
| MEDLINE | ID: mdl-32414635
4.
Pragmatic rules for comparability of biological medicinal products.
Biologicals
; 63: 97-100, 2020 Jan.
Artigo
em Inglês
| MEDLINE | ID: mdl-31836276
5.
Regulatory perspective on in vitro potency assays for human dendritic cells used in anti-tumor immunotherapy.
Cytotherapy
; 20(11): 1289-1308, 2018 11.
Artigo
em Inglês
| MEDLINE | ID: mdl-30327247
6.
Regulatory perspective on in vitro potency assays for human T cells used in anti-tumor immunotherapy.
Cytotherapy
; 20(5): 601-622, 2018 05.
Artigo
em Inglês
| MEDLINE | ID: mdl-29598903
7.
Regulatory perspective on in vitro potency assays for human mesenchymal stromal cells used in immunotherapy.
Cytotherapy
; 19(7): 784-797, 2017 07.
Artigo
em Inglês
| MEDLINE | ID: mdl-28457740
8.
Report of the European Medicines Agency Conference on RNA-Based Medicines.
Nucleic Acid Ther
; 34(1): 4-11, 2024 Feb.
Artigo
em Inglês
| MEDLINE | ID: mdl-38174996
9.
Rational arguments for regulatory acceptance of consistency testing: benefits of non-animal testing over in vivo release testing of vaccines.
Expert Rev Vaccines
; 22(1): 369-377, 2023.
Artigo
em Inglês
| MEDLINE | ID: mdl-37010241
10.
Variability of in vivo potency assays of whole-cell pertussis, inactivated polio, and meningococcal B vaccines.
Vaccine
; 41(38): 5603-5613, 2023 08 31.
Artigo
em Inglês
| MEDLINE | ID: mdl-37527955
11.
Development of a cell line-based in vitro assay for assessment of Diphtheria, Tetanus and acellular Pertussis (DTaP)-induced inflammasome activation.
Vaccine
; 40(38): 5601-5607, 2022 09 09.
Artigo
em Inglês
| MEDLINE | ID: mdl-35999078
12.
Overcoming scientific barriers in the transition from in vivo to non-animal batch testing of human and veterinary vaccines.
Expert Rev Vaccines
; 20(10): 1221-1233, 2021 Oct.
Artigo
em Inglês
| MEDLINE | ID: mdl-34550041
13.
Variability of in vivo potency tests of Diphtheria, Tetanus and acellular Pertussis (DTaP) vaccines.
Vaccine
; 39(18): 2506-2516, 2021 04 28.
Artigo
em Inglês
| MEDLINE | ID: mdl-33824038
14.
Dawn of Monitoring Regulatory T Cells in (Pre-)clinical Studies: Their Relevance Is Slowly Recognised.
Front Med (Lausanne)
; 7: 91, 2020.
Artigo
em Inglês
| MEDLINE | ID: mdl-32300597
15.
Corrigendum to "Variability of in vivo potency tests of Diphtheria, Tetanus and acellular Pertussis (DTaP) vaccines" [Vaccine 39(18) (2021) 2506-2516].
Vaccine
; 40(23): 3272-3273, 2022 May 20.
Artigo
em Inglês
| MEDLINE | ID: mdl-35469695
16.
Characteristics of product recalls of biopharmaceuticals and small-molecule drugs in the USA.
Drug Discov Today
; 21(4): 536-9, 2016 Apr.
Artigo
em Inglês
| MEDLINE | ID: mdl-26552336
17.
Dendritic cell-based in vitro assays for vaccine immunogenicity.
Hum Vaccin Immunother
; 8(9): 1323-5, 2012 Sep.
Artigo
em Inglês
| MEDLINE | ID: mdl-22951585
18.
Response of MUTZ-3 dendritic cells to the different components of the Haemophilus influenzae type B conjugate vaccine: towards an in vitro assay for vaccine immunogenicity.
Vaccine
; 29(32): 5114-21, 2011 Jul 18.
Artigo
em Inglês
| MEDLINE | ID: mdl-21624423
19.
In support of the European Union biosimilar framework.
Nat Biotechnol
; 30(8): 745-8; author reply 748-9, 2012 Aug.
Artigo
em Inglês
| MEDLINE | ID: mdl-22871707
20.
High-level acetaldehyde production in Lactococcus lactis by metabolic engineering.
Appl Environ Microbiol
; 71(2): 1109-13, 2005 Feb.
Artigo
em Inglês
| MEDLINE | ID: mdl-15691976