Application: Développement de HPAPI/ADC et fabrication à l'échelle commerciale, depuis la faisabilité jusqu'à la production en confinement
Norme de certification: Installations conformes aux BPF (cGMP) avec contrôles techniques pour le confinement des substances hautement actives (classification OEB/OEL)
Statut réglementaire: Fabriqué selon les cadres réglementaires applicables aux programmes de substances actives cytotoxiques/hautement actives et aux ADC

Autres informations

Description supplémentaire:

HPAPI handling spans everything from concept through commercial-scale manufacturing. Combining technology, infrastructure and expertise delivers flexible, seamless HPAPI development and manufacturing tailored to each program, cutting timelines, complexity and risk. Highly potent APIs are becoming more common in the development pipeline, driven by oncology research and more targeted therapies across many indications, representing a shift in how small molecules deliver new patient treatments. This move toward HPAPIs is producing more effective medicines with potentially lower doses and fewer side effects, but it also creates significant handling challenges for innovators and their partners.