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company overview

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.


corporate culture

vision
empowering pharmaceutical innovation to improve the quality of life and safeguard human health
mission
to be the industry-leading and customer-trusted best partner in biopharmaceuticals
strive for better life
values

manufacturing base

headquartered in suzhou industrial park, tot biopharm provides end-to-end cdmo services to the customers leveraging established technology platforms and production capabilities.

tot biopharm possesses a “one-site ∙ end-to-end” commercial manufacturing platform integrating the manufacturing of monoclonal antibody and adc, which can fulfill the manufacturing capacity demands of different scales including lab-, pilot- and commercial scales

  • building 1

    adc manufacturing base:

    adc drug substance production lines

    adc drug product production line


    small molecule oral drug production base
  • building 3

    global r&d center

    innovative technology development

    process development

    quality control

    administration center

  • building 2

    adc manufacturing base:

    adc drug substance production lines

    adc drug product production lines (lyophilized formulate/injectable solution)


    antibody drugs manufacturing base (ds > 20,000 l; drug product preparation):

    antibody drug substance production lines (equipped with 200 l, 500 l and 2,000 l bioreactors)

    production lines for mab drug products (lyophilized formulate/injectable solution)

  • building 4 (planning)

    biopharmaceutical production base
  • building 5 (planning)

    biopharmaceutical production base

mah

tot biopharm has successfully developed a diverse range of high-quality anti-tumor drugs across multiple series and varieties, owing to its outstanding research and development and production capabilities. additionally, tot biopharm actively engages in diversified strategic collaborations with domestic and foreign pharmaceutical companies to further enhance its r&d and production capabilities, as well as to expand its product portfolio and market competitiveness.

drug development to commercialization

tot biopharm has established an integrated platform with independent analytical capabilities, spanning across the stages of r&d, clinical development, gmp manufacturing, and commercial production. tot biopharm provides efficient services as a one-stop cdmo from drug development to successful commercialization.

milestones

2010
tot biopharm was established with its headquarter located in suzhou industrial park, covering an area of approximately 50,000 ㎡
2012

completed the construction of a manufacturing base spanning 10,000 ㎡

2016

awarded as the third mah cooperation pilot unit in china and the first in jiangsu province

2017
the pilot-scale biomanufacturing workshop has successfully passed the ind registration inspection
2018
the 13,000 square meter commercial-scale biopharmaceutical production facility has been constructed and activated
2019
tot biopharm was listed on the hong kong stock exchange in november (1875.hk)
2020

the adc commercial production workshop has been constructed and activated

2021
pusintin®, tazian®, and megaxia® has received marketing approval from nmpa, and have established territory-based commercialization collaborations
2022

commercial manufacturing base for antibody and adc passed gmp compliance audit by eu qp

2023

global r&d service center is in operation

new adc commercial ds and dp production line is active

new antibody commercial ds and dp (lyophilized) production line is active

code of business ethics

tot biopharm believes that compliance with the laws and regulations and adherence to business ethics is the obligation and responsibility of any enterprise to the public and its shareholders
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