High potency drug substance and drug product manufacturing
Available from Lonza Pharma & Biotech
The asset base at our Center of Excellence for HPAPI includes multiple lab-scale, pilot and clinical scale, launch and commercial scale production facilities, thereby providing for seamless development, clinical trial material manufacture and commercialization.
Specialized HPAPI R&D labs and small scale plants are in place support early phase clinical to low volume commercial production of potent compounds (to OEL ≥ 1ng/m3) and ADC payloads. Investment is ongoing to expand HPAPI capacity at all scales and to handle extremely high potent compounds to 1 microgram/m3.
R&D and Lab-Scale: 8 production lines (10-50L)
Small / Mid-Scale:15 production lines (160-2500L)
Commercial Scale: 3 production lines (4000-10000L)
This asset base is key for effective process implementation incorporating:
Chemical synthesis and advanced synthesis
Large range of different scales
Capacity for parallel work streams
And we have a track record you can trust. Our team at Visp has developed and is manufacturing dozens of HPAPI compounds. An extensive inspection record also exists with major regulatory agencies around the world, including FDA, ANVISA (Brazil), Swissmedic, KFDA (Korea), and Taiwan FDA.
We can also provide integrated services options for HPAPI drug programs inclusive of contained particle engineering and specialized drug product development and manufacturing (sterile fill-finish, liquid-filled hard capsules and soft gels).