Pays d'origine: Fabriqué en/aux les États-Unis
Norme de certification: Fourni selon des systèmes qualité alignés sur les normes cGMP/ISO/GxP applicables aux services biopharmaceutiques
Application: Études de caractérisation et de validation de procédé à échelle réduite sur un modèle réduit qualifié, soutenant les demandes de licence de produits biologiques

Autres informations

Description supplémentaire:

Scale-down process characterization studies, run on a qualified scale-down model, are essential to biologics licensure applications; KBI brings deep expertise in designing and executing these studies to help define a process control strategy ahead of manufacturing conformance and validation lots. The resulting data can justify process ranges and their classification through a design space, in keeping with current post-QbD regulatory expectations, and scale-down validation studies further supplement manufacturing-scale conformance data by exploring parts of the process operating space not normally tested at large scale.