Wim Van Molle

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2025

Advancing regulatory dialogue: In silico models for improved vaccine biomanufacturing - an expert meeting report., Irina, Meln, Van Molle Wim, Perea Vélez, Mónica, Greger Abrahamsen, Koen Brusselmans, Eric Calvosa, Gaetano Cardillo, Antonio, Didier Clénet, Caroline Forestieri, V Gernaey, Krist, et al. , Vaccine, 2025 May 22, Volume 56, (2025)

DNA templates for the preparation of mRNA substances (5.40), Van Molle, Wim , 1/07/2025, Volume European Pharmacopoeia (Ph. Eur.) 12.1, (2025)

mRNA Substances for the production of mRNA vaccines for human use (5.39), Van Molle, Wim , 1/07/2025, Volume European Pharmacopoeia (Ph. Eur.) 12.1, (2025)

mRNA vaccines for human use (5.36), Van Molle, Wim , 1/07/2025, Volume European Pharmacopoeia (Ph. Eur.) 12.1, (2025)

The Role of EDQM and OMCLs, Van Molle, Wim , Training "Responsable des affaires réglementaires", 14/03/2025, Issue Culture in vivo ASBL, (2025)

Session Chair: "Panel discussion: Feedback from regulators on Stability models", Van Molle, Wim , Second Regulatory Workshop on Utilizing In Silico Models to Expedite Vaccine Development, Testing, and Lifecycle Management, 27/05/2025, Brussels, Belgium, (2025)

2024

Accelerating vaccine manufacturing development through model-based approaches: current advances and future opportunities, Ramin, Elham, Cardillo Antonio Gaetano, Liebers Reinhard, Schmölder Johannes, von Lieres Eric, Van Molle Wim, Niebel Bastian, Natalis Laurent, Meln Irina, Perea-Vélez Mónica, et al. , Current Opinion in Chemical Engineering, Volume 43, (2024)

Advanced GMP/CMC, Van Molle, Wim, and Brusselmans Koen , Capacity Building for vaccine manufacturers in Iran, 29/10/2024, Issue European Centre for Clinical Research Training, (2024)

Communication on out of specification results for vaccine Drug Substances, Meunier, Karine, Maisonneuve Stéphane, Cano François, Van Molle Wim, Domicent C., and Masquelier F. , Annual OMCL Meeting, OCABR Vaccin Session, 16/05/2024, Issue EDQM, Ohrid, North Macedonia, (2024)

Ethical approval for controlled human infectious model clinical trial protocols - A workshop report., Euzebiusz, Jamrozik, Littler Katherine, Irina Meln, Van Molle Wim, Morel Sandra, Olesen Ole F., Rubbrecht Michelle, Balasingam Shobana, and Neels Pieter , Biologicals, 2024 Feb, Volume 85, (2024)

EU Annual report : batch release of human vaccines, Waeterloos, Geneviève, Van Molle Wim, Tesolin L., Ribaucour F, Florens Morgane, Masquelier F., Clouet S., Domicent C., Auquier J., Laurent F., et al. , 01/04/2024, Brussels, Belgium, p.261, (2024)

Maintaining the quality of vaccines through the use of standards: Current challenges and future opportunities., Sajjadi, Nancy C., Brady Ryan, Jungbäck Carmen, Mallet Laurent, Milne Catherine, Prior Sandra, Pulle Gayle, Rigsby Peter, Schofield Tim, Siggers Richard, et al. , Biologicals, 2024 Mar 12, Volume 86, (2024)

Regulatory workshop on challenge strain development and GMP manufacture - A stakeholder meeting report., Corti, Nicoletta, Chiu Christopher, Cox Rebecca J., Demont Clarisse, Devaster Jeanne-Marie, Engelhardt Othmar G., Gorringe Andrew, Khaole Hassan, Hoefnagel Marcel, Ingrid Kamerling, et al. , Biologicals, 2024 Feb, Volume 85, (2024)

The Role of EDQM and OMCLs, Van Molle, Wim , Training « Responsable des affaires réglementaires », 24/01/2024, Issue Culture in vivo ASBL, (2024)

2023

Closing Session: Health Emergencies Preparedness for the Future Panel Discussion, Van Molle, Wim , 2023 PDA BioManufacturing Conference Agility and Biomanufacturing Excellence to Meet Patients’ Needs, 13/09/2023, Issue PDA, (2023)

Development of a multiplex-based immunoassay for the characterization of diphtheria, tetanus and acellular pertussis antigens in human combined DTaP vaccines., Vermeulen, Maxime, Feck Isabelle, Francotte Antoine, Hassall Laura, Tesolin L., Van Molle Wim, Pizzato Romain, Laurent Thierry, Hoebreck Charline, Stickings Paul, et al. , J Immunol Methods, 2023 Jun, Volume 517, (2023)

EU batch release procedure: Annual Report 2 - Batch Release of Vaccines, Waeterloos, Geneviève, Auquier J., Domicent C., Cuignet L., Clouet S., Desmet N., Florens Morgane, Laurent F., Masquelier F., Ribaucour F, et al. , 2023 05 25, p.314, (2023)

The IMI Inno4Vac project: a public-private partnership focussing on Innovations to accelerate vaccine development and manufacture, Van Molle, Wim , 2023 PDA BioManufacturing Conference Agility and Biomanufacturing Excellence to Meet Patients’ Needs, 12/09/2023, Issue PDA, Seville, Spain, (2023)

Rational arguments for regulatory acceptance of consistency testing: benefits of non-animal testing over release testing of vaccines., Hoefnagel, Marcel H. N., Stickings Paul, Smith Dean, Jungbäck Carmen, Van Molle Wim, and Tesolin L. , Expert Rev Vaccines, 2023 Apr 03, Volume 22, Issue 1, Number 377, (2023)

Regulatory expectations on the use of vaccine reference standards for maintaining product quality., Van Molle, Wim , Maintaining the Quality of Vaccines through the Use of Standards: Current Challenges and Future Opportunities, 21/06/2023, Issue IABS, Ottawa, Canada, (2023)

Regulatory progress and future plans, Van Molle, Wim , Inno4Vac 2nd annual meeting 2023, 5/10/2023, Lyon, France, (2023)

The Role of EDQM and OMCLs, Van Molle, Wim , Responsable des affaires réglementaires, 26/01/2023, Issue Culture in vivo ASBL, (2023)

Round table discussion, Van Molle, Wim , Maintaining the Quality of Vaccines through the Use of Standards: Current Challenges and Future Opportunities, 22/06/2023, Issue IABS, Ottawa, Canada, (2023)

Training on the assessment of quality part (M3) of the eCTD for the registration of vaccines for human use, Brusselmans, Koen, Van Molle Wim, and Tesolin L. , Training on The assessment of quality part (M3) of the eCTD for the registration of vaccines for human use, 15/11/2023, Brussels, Belgium, (2023)

What do we request for production and quality control of CHIM strains.Should it be GMP or is adherence to GMP acceptable ?, Van Molle, Wim , Ethical Approval for CHIM Clinical Trial Protocols, 30/05/2023, Brussels, Belgium, (2023)