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 workshops) and several independent drug substance production lines. we provide mcb/wcb production and antibody ds manufacturing services in various scales, from 200 l to 2,000 l, with total capacity >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