Bi-multispecific antibody (Bi (multi)-specific Antiboby) refers to an antibody molecule that can bind to two (or) multiple different antigens or two (or) multiple different epitopes of the same antigen.Different targets are combined on the diversified dual polyclonal antibody platform of ViliZhibo to obtain unique MOA or molecules with synergistic effects:

Based on the understanding of the target and the mechanism of action of the drug, Weilizhibo has established a variety of Biomarker detection platforms, which have the ability of forward transformation and reverse transformation, and provide strong support for the development of clinical projects.

The evaluation of in vivo and in vitro activity and pharmacodynamics is a very important part of the early discovery of macromolecular biopharmaceuticals.The pharmacology team has rich R&D experience in the development of target activity and cell function methods. At present, a variety of stable cell lines for assays have been established, and a series of in vitro cell activity evaluation methods have been developed and optimized. At the same time, based on the mechanism of action of each target A method for the study of activity of primary immune cells was developed.And independently established a variety of humanized mouse models for animal pharmacodynamics, MoA mechanism and translational medicine research and evaluation, and preliminary toxicology and pharmacokinetic analysis.

Combining software analysis, physical and chemical detection, immune detection, accelerated experiment, PK experiment (pharmaceutics detection platform passed the 2019 annual blood sample analysis capability verification of China National Inspection Institute), process developability, etc. to evaluate candidate molecules from multiple angles, and finally select a suitable drug Molecules of sexual demands.

Monoclonal cells were obtained 4 months from the plasmid and entered for stability assessment.The obtained monoclonal cell line has good stability, and after 60 passages of continuous subculture, the change of expression yield is still maintained within ±30%.The self-developed cell lines have obtained high-yield clones in different types of projects such as monoclonal antibodies, double antibodies, and fusion proteins, and have passed FDA/NMPA IND applications.

Vilizhibo has established a complete and efficient antibody drug development platform in Nanjing Biomedical Valley, including process (cell culture, protein purification and preparation process) development, analytical method development, quality control and pilot liquid production.
The pilot liquid production platform conforms to GMP and cGMP, equipped with Cytiva's 50L/200L/500L disposable bioreactor and purification equipment, which can flexibly adjust the production scale to meet preclinical pharmacology and toxicology tests, IND declaration and phase I/II clinical trials Requirements for the test article used in the test.
The CMC team can support and undertake preclinical CMC development, pilot GMP production (200L or 500L), technology transfer, preparation of global IND registration application materials, process characterization, process validation, and BLA registration application.

Velizhibo has established a full life cycle quality management system covering drug discovery, development, production and delivery.We adopt an integrated corporate quality management system that complies with all applicable standards and regulations of the China National Medical Products Administration and the U.S. Food and Drug Administration.
We advocate and practice that everyone is responsible for quality, so that we can continue to provide safe, effective and accessible innovative drugs.