TOT BIOPHARM has a commercial scale, cost-efficient and advanced production base in Suzhou, built and operated in accordance with international standards, covering a total area of about 50,000 square meters. ● plant no. 1 was completed and started operating in 2012, comprise biological drug pilot plant, oral small molecule drugs workshop and injection workshop meeting GMP standards.
● plant no. 2, completed in March 2018, is a commercial production base for biological drugs, with a designed capacity of 16,000 liters. It is an advanced base for high quality commercial production.
In order to enhance production safety and reduce production cost, single-use bioreactor system is used in pilot study and commercial production of biological drugs. Compared with traditional stainless steel bioreactors, disposable bioreactors have many advantages, including reduced downtime, reduced cleaning and disinfection, significantly reduced risk of cross-contamination, flexibility to adjust and easily change the product mix based on market demand. In addition, single-use technology can also save a lot of capital investment and production costs.
The company independently developed a new cell amplification technology, namely "perfusion - batch hybrid culture technology", suitable for commercial production of mAb drugs, the technology allows us to conduct seed expansion in 25L bioreactors, eliminating the need for 50, 200 and 500 liters bioreactor, and directly scale up to 2000L bioreactor, saving capital expenditure, facilities, production cost and production time.