antibody drug conjugates (adc), known as the “magic
bullet”, has been developing rapidly through continuous technological
iterations, and especially in the past three to four years, the explosion of
adc has been achieved, with several adc drugs approved one after another. in
the wave of biopharmaceutical r&d, adc has ushered in its golden age.
founded in 2010, tot biopharm has witnessed the
booming development of biopharmaceutical industry and is fully aware that
differentiated innovation is the key to development. unlike many pharmaceutical
companies, tot biopharm has been targeting adc, which is more difficult to
develop, and has been working in adc fields for many years. whether in product
development or commercial production capacity layout, tot biopharm is at the
forefront in china in adc fields. leveraging its rich practical experience and
sophisticated platform system, tot biopharm provides one-stop cdmo solutions
for adc development and manufacture.
adc drugs are a combination of large-molecule
antibody drug and small-molecule chemical drug, with the complexity and
diversity of both, and there are many challenges in the manufacture and quality
control related to cmc; at the same time, the complexity of the mechanism of
action and metabolic processes in vivo also pose challenges to
non-clinical and clinical studies.
with years of experience in adc development,
tot biopharm has built a complete industrial platform covering the full links
of drug development, pilot process, clinical manufacture and commercial
manufacture. meanwhile, tot biopharm has actively made deployment in the
construction of adc commercialization capacity and has a gmp-compliant adc pilot
and commercialization manufacture workshop with a designed annual capacity of
60,000g, allowing the manufacture of adc drugs to be completed at the park
base.
adc
one-stop industrial platform
resources brought together and manufacture completed at one site
tot biopharm has a gmp-compliant complete adc
commercial manufacture plant integrating antibody intermediate, adc ds and adc dp, which is rarely seen in china, and it is equipped with obe-5
level isolators, so that key adc manufacture processes can be completed
centrally in the same plant. in addition to consistent quality management
system, it can also reduce the difficulty of supply chain management and risk
control to achieve better control in time, cost and risk.
quality development realized by complete capabilities
tot biopharm boasts an adc team which is
experienced in project development and has the technical advantages of core
conjugation process and scale-up. it has established a complete adc analysis
technology platform with independent analysis capability regarding adc key
quality attributes and comprehensive quality control capability to meet the
requirements of nmpa, fda and ema regulations to ensure high quality product
development.
meanwhile, all aspects of adc monoclonal and
conjugation process development are under the same quality system, and all
functional teams are seamlessly connected and coordinated, so that the cost,
risk and quality of the project are under control.
experienced full- process team
tot biopharm has a complete team from process
development, clinical manufacturing, registration and approval to commercial
manufacture, as well as a team of experts in adc conjugation technology
development and complex molecular structure analysis of adc.
up to now, the company has completed a number
of drug process development projects involving different adc technologies and
clinical manufacture projects at different stages, including pre-marketing
process validation, and have accumulated rich practical experience.
based on the rare domestic r&d and
industrialization platform integrating monoclonal antibodies and
antibody-conjugated drugs (adc), tot biopharm provides reliable one-stop cdmo
services to its partners with its advanced core conjugate technology and adc
analysis technology, as well as its high-quality management system and
gmp-compliant commercialization capability, thus empowering adc drug
development and providing high-quality and cost-effective system solutions for
innovative drug development and manufacture, helping partners accelerate drug
development for the benefit of patients.