Hu-Mouse SingleB® mAb Discovery Service
As "non-self" substances, antibody drugs generated from non-human animals usually trigger human immune responses when administered to human, and produce anti-drug antibodies (ADAs) that in many cases seriously affect the safety and effectiveness of drugs, limiting their clinical outcomes and, in the worst cases, leading to project termination or marketed drug withdrawal.
Therefore, it is urgent to reduce the immunogenicity of therapeutic antibodies, which has been achieved to some degree through either antibody humanization or antibody generation from transgenic mice or fully human libraries. As of February, 2021, FDA has approved 39 fully human mAb, of which most are from transgenic mice. However, the abovementioned approaches each have drawbacks, such as residual immunogenicity, impaired affinity and develop ability, or insufficient efficacy.
DetaiBio integrated its proprietary SingleB® mAb discovery technology with an up-to-date fully-humanized transgenic mice model to fulfill fast, fully human antibody discovery. By directly screening primary memory B cells and plasma cells harvested from immunized, fully-humanized transgenic mice, we deliver FACS-validated, fully-humanized mAbs that areofcomparable affinity with its wild type counterparts for you to minimize the immunogenicity risk of antibody drug.
CAMouseHG: Fully-humanized Transgenic Mouse
CAMouseHG was generated by in situ replacing murine antibody-coding gene fragments with 70 human Ig V-region genes for expressing human antibody molecules in mice. The random recombination of separate V, D, and J gene segments and human/mouse Ig temporal and spatial expression technology enable the formation of mouse IgM BCR structure in the early stage of B cell development, and ensure the normal maturation of mouse B cells thereafter.
Service Features
“1+1” Double Guarantee
- PBC&MBC double screening, double guarantee
Natural Maturation
- In-vivo natural maturation
- Natural pairing of heavy and light chains
High Probability
- High antibody diversity
- Higher probability of discovery of unique epitopes
High Delivery
- At least 50 FACS binders
- Reserve hundreds of clones
Procedure
Workflow
| Stage | Service | Timeline | Deliverables |
|---|
| Stage Ⅰ Animal Immunization | - Antigen preparation (optional)
- Animal immunization
- Serum titer test
| 2-4 weeks | Premium Package- FACs binders ＞50
- Ensure sequence diversity
- Antibody sequence and expression plasmid
- CoA
Economic Package - 5-10 ELISA positive clones
- Antibody sequence and expression plasmid
- Select one strain purified 1 mg antibody
- CoA
|
| Stage Ⅱ “1+1”Double Screening | - MBC screening
- PBC screening
| 1 day |
| Stage Ⅲ BGE® HTP Expression & Functional Test | | 1-2 weeks |
| Stage Ⅳ Monoclonal Antibody Gene Sequencing | | 1 week |
| Stage Ⅴ Expression and Purification of Recombinant Antibody (optional) | - Transfection level plasmid preparation
- Transient transfection expression
- HTP purification
- Endotoxin control
| For enquiry |
Advantages of Human Antibody
| Chimeric
antibody | Humanized
antibody | Human
antibody |
|---|
| Position of Humanization | C-region | Region except CDR or SDR | All regions |
| Degree of Humanization | 60%-70% | 90%-95% | 100% |
| Immunogenicity | High | Medium | Low |
Advantages of SingleB®
| DetaiBio SingleB® | Phage Library | Beacon |
|---|
| Limitation | High technical threshold | Limited by natural library capacity | High price & Low throughput |
| Source of Antibody | MBC & PBC | MBC & PBC | PBC |
| Heavy & Light Chain Pairing | Natural pairing | Unnatural pairing | Natural pairing |
| Throughput x Diversity | High | Medium | Low |
| Timeline | 1.5 months | 1-2 weeks | 1-2 months |
| Price | Low | High | High |
| Deliverables | Full length antibody sequence & Recombinant plasmid | scFv、Fab、VHH sequence & Recombinant plasmid (additional affinity maturation needed) | Antibody sequence & Recombinant plasmid |
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