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Regulatory workshop on challenge strain development and GMP manufacture - A stakeholder meeting report.
Corti N, Chiu C, Cox RJ, Demont C, Devaster JM, Engelhardt OG, Gorringe A, Hassan K, Hoefnagel M, Kamerling I, Krut O, Lane C, Liebers R, Luke C, Van Molle W, Morel S, Neels P, Roestenberg M, Rubbrecht M, Klaas Smits W, Stoughton D, Talaat K, Vehreschild MJGT, Wildfire A, Meln I, Olesen OF. Corti N, et al. Among authors: van molle w. Biologicals. 2024 Feb;85:101746. doi: 10.1016/j.biologicals.2024.101746. Epub 2024 Feb 3. Biologicals. 2024. PMID: 38309984 Free article.
Maintaining the quality of vaccines through the use of standards: Current challenges and future opportunities.
Sajjadi NC, Brady R, Jungbäck C, Mallet L, Milne C, Prior S, Pulle G, Rigsby P, Schofield T, Siggers R, Smith D, Stickings P, Uhlrich S, Van Molle W, Walker A, Wu T, Zhou T, Baca-Estrada M. Sajjadi NC, et al. Among authors: van molle w. Biologicals. 2024 Mar 12;86:101756. doi: 10.1016/j.biologicals.2024.101756. Online ahead of print. Biologicals. 2024. PMID: 38479213
The consistency approach for the substitution of in vivo testing for the quality control of established vaccines: practical considerations and progressive vision.
Dierick JF, Halder M, Jungbaeck C, Lorenz J, Préaud JM, Riou P, Tesolin L, Uhlrich S, Van Molle W, Vandeputte J. Dierick JF, et al. Among authors: van molle w. Open Res Eur. 2022 Dec 13;2:116. doi: 10.12688/openreseurope.15077.2. eCollection 2022. Open Res Eur. 2022. PMID: 37645306 Free PMC article.
Development of a multiplex-based immunoassay for the characterization of diphtheria, tetanus and acellular pertussis antigens in human combined DTaP vaccines.
Vermeulen M, Feck I, Francotte A, Hassall L, Tesolin L, Van Molle W, Pizzato R, Laurent T, Hoebreck C, Stickings P, Dobly A. Vermeulen M, et al. Among authors: van molle w. J Immunol Methods. 2023 Jun;517:113483. doi: 10.1016/j.jim.2023.113483. Epub 2023 Apr 24. J Immunol Methods. 2023. PMID: 37100343 Free article.
Controlled Human Infection Studies: Proposals for guidance on how to design, develop and produce a challenge strain.
Bekeredjian-Ding I, Trouvin JH, Depraetere H, La C, Suvarnapunya AE, Bell A, Mann A, Meij P, Bethony JM, Schellhaas L, Nazziwa WB, Karikari-Boateng E, Prachumsri JS, Salmikangas P, Smith D, Stjärnkvist P, Van Molle W, Baay M, Neels P. Bekeredjian-Ding I, et al. Among authors: van molle w. Biologicals. 2021 Nov;74:16-23. doi: 10.1016/j.biologicals.2021.09.002. Epub 2021 Oct 5. Biologicals. 2021. PMID: 34620540 Free article.
30 results