Biological Activity Characterization
About Biological Activity Characterization Program
In addition to physicochemical properties, biological activity characterization is an indispensable part of the biosimilars quality evaluation system. Biological activity characterization is the determination of the content and titer of active ingredients of antibody drugs, which is an important quality control index to ensure the effectiveness of antibody drugs, so it is necessary to establish a complete system for characterization. In general, it includes biological activity assays and binding activity assays. Commonly biological activity assays include: ADCC, CDC, inhibition of cell proliferation, cytotoxicity, cytokine secretion capacity, internalization, etc. Creative Biolabs leverages years of experience in biosimilars to provide customers with a range of bioactivity assay services and consulting. At the same time, we are happy to work with scientists and platforms with rich experience in the field of biosimilars to create higher value together!
Biological Activity Characterization
Target and Receptor Binding Assay
Bioactivity Assay
Fig.1 Our biological activity characterization program. (Creative Biolabs)
Target and Receptor Binding Assay
| What We Can Do | Related Methods |
| Soluble Antigen Binding |
|
| Cell-surface Antigen Binding | |
| FcRn Binding | |
| C1q Binding |
- Published Data
Here are some typical figures about target and receptor binding assay.
Analysis of ELISA
Fig.2 ELISA analysis of the binding to sTNFα.1
Analysis of SPR
Fig.3 Similarity assessment of biosimilars by SPR.1
Analysis of Cell-based Binding Assay
Fig.4 Functional assessment of binding to mbTNFα on CHO MT-3 cells by imaging cytometry.1
Analysis of FcRn Binding
Fig.5 FcRn/FcγRI binding analysis of biosimilars.2
Analysis of C1q Binding
Fig.6 C1q binding assessment of biosimilar ABP 798.3
Bioactivity Assay
| What We Can Do | Related Methods |
| Cell-based Neutralization Assay |
|
| Cell-based Apoptosis Assay | |
| Cell-based CDC Assay | |
| Cell-based ADCC Assay |
- Published Data
Here are some typical figures about bioactivity assay:
Analysis of Cell-based Neutralization Assay
Fig.7 Neutralisation assay of freeze-dried infliximab in the SS-571 and SS-575.4
Analysis of Cell-based Apoptosis Assay
Fig.8 Representative figures of apoptosis assay.5
Analysis of Cell-based CDC Assay
Fig.9 CDC assay of CD20 mAb.6
Analysis of Cell-based ADCC Assay
Fig.10 ADCC bioassay of rituximab innovator and biosimilar to V variant.7
Do It Better Together
Creative Biolabs has a professional R&D team in biosimilar, which has strong professional knowledge and skills. We are aim to help you with customized services and comprehensive analysis of your biosimilar project. We are looking for outstanding scientists and professional technology platforms to collaborate. Through close collaboration, our partners can identify promising biosimilar drug candidates and determine accurate preclinical results. Creative Biolabs is committed to helping everyone from discovery to preclinical research and even IND applications. If you are interested in our Biological Activity Characterization program, contact us today to learn more!
References
- Saleem, Ramsey.; et al. "Analytical and Functional Similarity Assessment of ABP 710, a Biosimilar to Infliximab Reference Product." Pharmaceutical research (2020) 37,6 114.
- Kapelski, Stephanie.; et al. "Influence of the bispecific antibody IgG subclass on T cell redirection." mAbs 6 (2019): 1012-1024.
- Seo, Neungseon.; et al. "Analytical and functional similarity of biosimilar ABP 798 with rituximab reference product." Biologicals (2020): 79-91.
- Metcalfe, Clive.; et al. "The first world health organization international standard for infliximab products: A step towards maintaining harmonized biological activity." mAbs 1 (2019): 13-25.
- Rao, Hua-Chun.; et al. "MiR-25-3p serves as an oncogenic microRNA by downregulating the expression of merlin in osteosarcoma." Cancer management and research (2020) 12 8989-9001.
- Van den Bremer.; et al. "Human IgG is produced in a pro-form that requires clipping of C-terminal lysines for maximal complement activation." mAbs 4 (2015): 672-80.
- Kang, Jukyung.; et al. "Multifaceted assessment of rituximab biosimilarity: The impact of glycan microheterogeneity on Fc function." European journal of pharmaceutics and biopharmaceutics (2020): 111-124.
For research use only. Not intended for any clinical use.
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