Drug Substance Manufacturing
Cell banking
Pilot-scale manufacturing
Commercial manufacturing
TOT BIOPHARM has established a commercial GMP production base for biological drugs, which is equipped with a series of cell bank production lines (independent cell bank workshops) and several independent drug substance production lines. We provide cell bank production (MCB and WCB) and antibody DS manufacturing services in 200 L, 500 L and 2,000 L size, with total capacity over than 20,000 L.
– TOT BIOPHARM uses production equipment of international leading brand, including Cytiva’s single use bioreactors and chromatography systems, as well as Millipore and PALL’s ultrafiltration systems.
– With single use technology and highly flexible production strategy, stages for batches and specifications at the same time can be accommodated.
– With extensive experience, the team has completed dozens of drug substance production, including the successful completion of multiple batches of marketed products.
Demonstration Case
Project highlights
Validated scale-up process
Executable and successful scale up strategy from 3 L to 2,000 L commercial production.
Precise solutions
High efficient execution
The project has been completed ahead of schedule, which includes 18 batches for small-scale study, 9 method transfers, and 4 method development and validation works.
Key Figures Regarding Commercial Manufacturing
Workshop
Disposable dispensing system with weighing module
Automated TFF ultrafiltration system
Automated liquid chromatography systems with chromatography columns