Application: Service de soutien au développement, à la fabrication ou à l'analyse biopharmaceutique
Norme de certification: Fabriqué selon les normes cGMP avec traçabilité complète des lots et essais de libération de lot
Statut réglementaire: Soutient les soumissions réglementaires (par ex. BLA/MAA/NDA) conformément aux directives ICH

Autres informations

Description supplémentaire:

Development laboratories are equipped to run a diverse range of experiments spanning formulation development, cycle design and process refinement, and finished product evaluation. Process development studies conducted within a pilot-scale manufacturing environment, including the use of ControLyo technology in process engineering studies, ease scale-up. Critical fill/finish areas operate within a certified HEPA environment that emulates aseptic operations for sterile products, and comprehensive development reports readily support regulatory submissions. Capabilities include low-temperature thermal analysis, product development, cycle design/refinement, vial and cartridge work, finished product testing, isolation/containment, and work with aqueous and organic solvents.