TOT BIOPHARM established in 2010
Listed in Hong Kong Stock Exchange (HKEX)
in November, 2019
Approaching TOT BIOPHARM
With extensive practical experience, mature technical platforms and robust quality system, TOT BIOPHARM has ...
ADC Integrated Platform

R&D, process development, and commercial manufacturing platform including mAb, DS and DP for ADC.

Services

ADC Integrated Platform

Process and Analytical
Method Development

Based on the QbD concept, TOT BIOPHARM provides process development and analytical services for mAb, ADC, and fusion proteins…,etc.

Services

Process and Analytical
Method Development

GMP Manufacturing

TOT BIOPHARM has established a large-scale commercial GMP production base for biological drugs, which equipped with multiple complete upstream and downstream production lines, and the total manufacturing capacity has exceeded 20,000 L.

Services

GMP Manufacturing

Technology Transfer

In principle of mutual trust and reasonable control strategies, to achieve efficient technology transfer and smooth project implementation.

Services

Technology Transfer

Quality

A GMP quality management system conforms to commercial manufacturing standards
Running through from R&D to commercialization
Several marketed products online production

Services

Quality

Regulatory affairs

TOT BIOPHARM provides comprehensive regulatory support services throughout the entire lifecycle of products from R&D to marketing application.

Services

Regulatory affairs

Manufacturing Base
TOT BIOPHARM is based in Suzhou Industrial Park, with a large-scale commercial production base which is in compliance with GMP standards.
20000 L

Monoclonal antibody drug substance capacity

100 +

CDMO projects collaboration

50 +

ADC drug development

600 kg

ADC drug substance manufacturing capacity

20 +

ADC commercial scale batch manufacture

20 +

Commercial production of listed products