• Antibody discovery platform HitmAb®
  • Cell line building platform
  • Process development platform
  • Non-clinical research platform
  • GMP production platform

Fully native human mAbs R&D technology Platform (HitmAb®)

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Technology features of platform
Trinomab has developed world-class fourth-generation of monoclonal antibody (mAb) technology platform (HitmAb®), a proprietary high throughput comprehensive technology platform that integrates the various modern technologies to discover fully native human mAbs through the process of identifying human individuals with desired antibodies for specific application targets, single-cell isolation, single-cell antibody gene amplification, antibody gene sequencing, high throughput antibody gene expression and functional evaluation, with great competitive edge over the other mAb technologies.
Most of currently approved mAbs are derived from mouse-human chimeric or humanized mouse antibodies, or the so-called “fully” human antibodies. Chimeric and humanized antibodies have un-predictable fate in long-time development processes because of high risk of immunogenicity and cross-reactivity that can only be truly assessed in large-scale human clinical trials. The so-called “fully” human antibodies derived from human-Ig gene transgenic mice and/or phage display are misleading in its name and are NOT truly human because these antibodies were not selected through human immune tolerance mechanism and they are likely immunogenic in human.
In comparison, native human mAbs developed by HitmAb faithfully represent in vivo human antibodies that have undergone through selection processes by human immune tolerance mechanism. Therefore, native human mAbs have no or minimal immunogenicity in human and have no or minimal risk to induce anti-drug antibody (ADA) response or off target to cross react with human host antigens. Furthermore, some of the better antibodies can only be developed in and isolated from humans. Thus, native human mAb theapeutics should exhibit better safety and efficacy.

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Technology features of platform
1. HD-BIOP3 metrocyte platform based on CHO K1 suspension-cultured cell.
2. The adoption of antibody light-and heavy-chain single-plasmid expression and GS screening system eliminates the risk of antibiotic residue in the past antibiotic screening system.
3. The targeted expression antibody is genetically stable with a high protein yield(4-7g/L).
4. Flexible, stable and cost-saving in terms of culture medium choosing.

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Technology features of platform
Trinomab's process development platform consists of four parts: cell culture, protein purification, formulation prescription, and analytical science. The platform follows the internationally accepted "Quality by Design" (QbD) concept and the rigorous DoE test design method for process development, which can quickly complete the process development from monoclonal cell lines to 200L pilot scale, and obtain efficient, stable, and scalable production process.

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Technology features of platform
The main study includes pharmacokinetic evaluation, pharmacodynamic evaluation, toxicological evaluation and biological sample analysis. The characteristics and advantages of this platform are to carry out anti-infection-based neutralizing antibody evaluation at molecular level, cellular level, tissue level and animal level to initially verify drug safety and efficacy.

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Technology features of platform
Located in Zhuhai International Health Park, the production site has a designed area of about 24,000 square meters. It includes several 1000L bioreactor scale FlexFactory™ production lines and one clinical sample production line with a scale of 200L bioreactor, which can meet the pre-clinical development, clinical sample production and product commercialization of the company’s key project, the fully native human antibody drugs at this stage.
The production site adopts a new generation of innovative technologies fusing information technology and smart manufacturing technology, and cooperates with Cytiva, SIEMENS and other companies to make the production plant fully automated and intelligent on the basis of GMP compliance, which can realize the digitalization, transparency, informatization and standardization during the monoclonal antibody production process, thus laying the technical foundation for drug quality assurance.