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Zoekresultaten - 12 results
Advanced GMP/CMC
Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle; Koen Brusselmans Source: Capacity Building for vaccine manufacturers in Iran, Issue European Centre for ...
Training on the assessment of quality part (M3) of the eCTD for the registration of vaccines for human use
Publication Type: Scientific poster, presentation or proceeding Authors: Koen Brusselmans; Wim Van Molle; L. Tesolin Source: Training on The assessment of quality part (M3) of the eCTD for the ...
The EMA PRIME procedure in an accelerated assessment environment for vaccine licensure: Experiences from quality (CMC) assessors. A case study for Ebola vaccine.
Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle; Koen Brusselmans Source: 2020 PDA EUROPE- Driving Biopharmaceutical Innovations & Sustainability ...
An application of mass spectrometry for quality control of biologicals: Highly sensitive profiling of plasma residuals in human plasma-derived immunoglobulin.
Publication Type: Peer reviewed scientific article Authors: Franck Limonier; Van Steendam, Katleen; Geneviève Waeterloos; Koen Brusselmans; Myriam Sneyers; Deforce, Dieter Source: J Proteomics, ...
Tetravac/Pentavac vaccines: follow-up on the aP immunogenicity assay situation
Publication Type: Scientific poster, presentation or proceeding Authors: C. Domicent; M. Lejeune; V. Stygelbout; Koen Brusselmans; Geneviève Waeterloos Source: OMCL ANNUAL MEETING 2016, NA, Issue ...
Batch release of vaccines in Europe: from method transfer to first commercial batch available on the market. Straightforward approach that requires a proactive mind-set of the manufacturer.
Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle; L. Tesolin; Koen Brusselmans; Geneviève Waeterloos Source: PDA Europe Conference Vaccines. Featuring WHO on ...
Expertise activities: participation in licensing procedures for vaccines and plasma-derived products
Publication Type: Scientific poster, presentation or proceeding Authors: Koen Brusselmans Source: Quality control and batch release of vaccines and blood products in Europe, NA, Issue WIV-ISP, NA ...
Les vaccins: contrôles approfondis
Publication Type: Non-peer reviewed scientific publication Authors: Alexandre Dobly; Koen Brusselmans; L. Tesolin; Geneviève Waeterloos Source: Vaxinfo, Volume 69, Number 10, p.7- 10 (2014) ...
Veiligheid vaccins- Verregaande controle
Publication Type: Non-peer reviewed scientific publication Authors: Alexandre Dobly; Koen Brusselmans; L. Tesolin; Geneviève Waeterloos Source: Vaxinfo, Volume 69, Number 10, p.7- 10 (2014) ...
Regulatory issues regarding manufacture and control of vaccine adjuvants. The EU situation.
Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle; Koen Brusselmans; L. Tesolin; Geneviève Waeterloos Source: Modern Vaccines/adjuvants Formulation: Impact On ...