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.