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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
20000l

manufacturing capacity

150batches

designed annual manufacturing capacity

>300,000l

designed annual manufacturing capacity

10

project > 500 l manufacturing scale

10 7

average service years of core team members

workshop
disposable bioreactor
disposable dispensing system with weighing module
automated tff ultrafiltration system
automated liquid chromatography systems with chromatography columns
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