Application: Soutient la transition du développement de procédé en phase tardive vers la fabrication biotechnologique commerciale, aidant les produits à obtenir l'approbation réglementaire.
Pays d'origine: Autriche, Allemagne, Suisse
Norme de certification: Utilisé pour soutenir la documentation Chimie, Fabrication et Contrôles (CMC) et les activités de soumission réglementaire pour les produits biologiques.

Autres informations

Description supplémentaire:

VTU Engineering's Manufacturing Science & Technology group supports development and production teams through the later stages of biotech product development and commercialization, serving as an experienced partner to help products reach approval. The transition from late-phase process development to commercial manufacturing is a pivotal and often complex step toward a successful launch, and the group brings deep experience in process characterization, including risk assessment, study design, design of experiments, and Monte Carlo simulation, alongside technology transfer between labs, sites, or CMOs, and process validation, applying ICH Q8 and Q11 guidelines, Quality by Design principles, and effective risk management and control strategies to bring pipeline products to market promptly.