As a foreign substance, antibody drugs will trigger human immune response, produce drug-resistant antibodies, and be quickly cleared. This immunogen reaction seriously affects the safety and effectiveness of drugs and limits the diagnostic or therapeutic effect. Therefore, it is very important to improve the humanization of antibody, reduce immunogenicity and improve the tolerance in vivo. As of 2019, FDA has approved 30 fully human mAb, accounting for 40% of fully human mAb, of which 70% are from transgenic mice.
DetaiBio uses fully-humanized transgenic mice through self-developed SingleB® rapid mAb discovery platform, directly against antigen-specific memory B cells and plasma cells for double line screening. The delivered fully-humanized mAb is naturally mature in-vivo, and the heavy and light chains are naturally paired, and has been verified by FACS binding function.
CAMouseHG was transferred into 70 human Ig V-region genes, which could directly express human IgG. The rearrangement is rich in diversity，which ensures the normal development of B cells. Human/mice Ig temporal and spatial expression technology enables the formation of mouse IgM BCR structure in the early stage of B cell development, ensuring the normal development of mouse B cells. When B cells develop to the plasma cell stage, human IgG antibodies are directly produced through class switch.
“1+1” Double Guarantee
|Stage Ⅰ Animal Immunization||2-4 weeks|| Premium Package|
|Stage Ⅱ “1+1”Double 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)||For enquiry|
|Position of Humanization||C-region||Region except CDR or SDR||All regions|
|Degree of Humanization||60%-70%||90%-95%||100%|
|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|
|Deliverables||Full length antibody sequence & Recombinant plasmid||scFv、Fab、VHH sequence & Recombinant plasmid (additional affinity maturation needed)||Antibody sequence & Recombinant plasmid|