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Overview
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Antibody drugs, which are a category of therapeutic macromolecular agents engineered via bioengineering techniques, are capable of specifically identifying and binding to disease - related targets, such as cell surface receptors and pathogenic proteins. They achieve precise therapeutic effects through mechanisms like blocking pathological signaling pathways, activating immune effector functions (e.g., antibody dependent cell mediated cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC)), or delivering therapeutic molecule in a targeted fashion (for instance, the payloads in antibody drug conjugates (ADCs)).

In contrast to traditional pharmaceuticals, the core advantages of antibody drugs are manifested in their high target specificity, low off target toxicity, and the capacity for engineered functional expansion (such as bispecific antibodies and nanobodies). Currently, they have emerged as the central therapeutic modalities in the realms of oncology, autoimmune disorders, and infectious diseases.

During the early - stage research and development and process development phases of antibody drugs, it is often imperative to conduct comprehensive evaluations on various aspects, including the content of drug components, antibody affinity, binding specificity, and the results of antibody screening. This is to ensure the quality of products in the final large - scale manufacturing. As such, accurate, rapid, and high - throughput assay methods are of utmost significance for the R & D of antibody drugs during this period. Biological activity represents a critical quality - control parameter for guaranteeing the efficacy of antibodies.

Vazyme offers a comprehensive process and multi dimensional innovative solution for the research phase of antibody drugs, spanning all aspects from early stage R&D to process development. By leveraging cutting-edge technology platforms and providing customized services, we assists pharmaceutical enterprises in surmounting key bottlenecks.


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Workflow

Early-stage Drug Research and Development

(1) Target Discovery & Validation: Discover and confirm safe, effective, and druggable targets.

(2) Antibody Discovery: Screen the antibody that can bind or block the targets.

Antibody discovery stages: Antigen Preparation and Immunization → Antibody Screening → Antibody Optimization → Druggability Assessment.

(3) Pre-clinical Studies: Select appropriate test substances and animal models to conduct in vitro and in vivo pharmacodynamic studies, pharmacokinetic studies, and safety studies, providing supportive evidence for subsequent clinical trials.


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Clinical Trials & Commercialization

(1) Clinical Research: Conduct experimental research in accordance with the design and objectives of the clinical trial protocol to provide a basis for market launch.

(2) NDA Application: New Drug Application for the marketing of new drugs

(3) Commercialization: Launch the new drug on the market, carry out batch production, and implement quality control. 


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Resources

Learn more about our technologies to support antilbody drug discovery.Find the information you need in our educational materials database.

Publications
  1. Niu M, Yi M, Wu Y, et al. Synergistic efficacy of simultaneous anti-TGF-β/VEGF bispecific antibody and PD-1 blockade in cancer therapy. J Hematol Oncol. 2023;16(1):94. Published 2023 Aug 12. doi:10.1186/s13045-023-01487-5

  2. Liu Y, Zhou YQ, Nie L, et al. BR109, a Novel Fully Humanized T-Cell-Engaging Bispecific Antibody with GPRC5D Binding, Has Potent Antitumor Activities in Multiple Myeloma. Cancers (Basel). 2023;15(24):5774. Published 2023 Dec 9. doi:10.3390/cancers15245774

  3. Wang R, Zhang C, Cao Y, et al. Blockade of dual immune checkpoint inhibitory signals with a CD47/PD-L1 bispecific antibody for cancer treatment. Theranostics. 2023;13(1):148-160. Published 2023 Jan 1. doi:10.7150/thno.79367

  4. Chen J, Shen Z, Jiang X, et al. Preclinical evaluation of IAP0971, a novel immunocytokine that binds specifically to PD1 and fuses IL15/IL15Rα complex. Antib Ther. 2022;6(1):38-48. Published 2022 Nov 17. doi:10.1093/abt/tbac031

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