TOT BIOPHARM Contract Manufacturing & Development (CDMO) Profile
TOT BIOPHARM is dedicated to becoming the industry leading and trusted biopharmaceutical best partner for global clients.
With extensive practical experience, mature technical platforms and robust quality system, TOT BIOPHARM has developed diversified strategic partnerships with domestic and international pharmaceutical companies to provide one-stop CDMO solutions for drug development and manufacturing, which help customers to accelerate the development and manufacturing of biologics, especially antibody-drug conjugates (ADCs), empowering to achieve high-quality development for the industry.
TOT BIOPHARM has established a large-scale commercial GMP production base for biological drugs which has equipped with multiple complete upstream and downstream production lines, with a total manufacturing capacity exceeding 20,000 L. The company has established an integrated platform for antibody-drug conjugates (ADCs), which can complete key production processes such as antibodies, linker and drug substance to be completed in one place, reducing transfer costs and regulatory risks. Currently, TOT BIOPHARM has established a quality management system in line with commercial manufacturing, which has successfully supported the commercial production of several marketed products. TOT BIOPHARM has a mature, stable core team and good reputation for professional, which can provide customers with excellent professional services.
CDMO Services:
Biologics; Packaging Liquids; Lyophilized amps/vials Analytical Development; Cell Line Development; Drug Delivery System; Formulation Development; ICH Stability Testing; Process Development; Protein Synthesis Antibodies; Antibody-drug conjugate (ADC); Fusion Proteins; Recombinants + other Proteins
Year Founded: 2009
Head Office: Suzhou Shi, China
Number of Facilities: 1-2
Facility locations: China
Website: Visit the TOT BIOPHARM website
Linkedin: Connect on Linkedin
Current Capacity: Antibody Drug Substance: >20,000L;Antibody Drug Product: 20 million vials/year
Antibody Drug Conjugates DS: 960 kg/year;Antibody Drug Conjugates DP: 5.3 million vials/year