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Antibody humanization

In antibody drug development, minimizing immunogenicity while preserving target specificity remains a central challenge for clinical translation. Leveraging its CDR‑grafting–based humanization technology, Xichang Bio provides scientifically sound solutions to clients worldwide, driving dual breakthroughs in both the safety and efficacy of antibody therapeutics.

Xichang Bio—A Pioneer in CDR Grafting Technology for Antibody Humanization

Technological Advantages

Accurate Design: By precisely grafting the complementarity-determining regions (CDRs) of murine or rabbit antibodies onto human antibody framework regions (FRs), this approach largely preserves the original antibody’s high affinity and specificity while eliminating heterologous immunogenicity risks.

Intelligent Optimization: Leveraging structural biology and AI algorithms, we perform rational design of key FR residues to enhance antibody stability and developability, thereby mitigating the loss of activity often associated with conventional humanization.

Efficiency validation: By integrating surface plasmon resonance (SPR), immunogenicity prediction software, and in vitro/in vivo functional assays, the binding affinity and clinical safety of the humanized antibody are comprehensively evaluated.

Service Highlights

Full‑cycle coverage: From sequence analysis and CDR grafting to affinity maturation and stable cell line development, we offer end‑to‑end humanization services.

High success rate: Leveraging experience from over 50 successful cases, humanized antibodies exhibit a >90% reduction in immunogenicity and maintain an affinity retention rate of >85%.

Flexible Adaptability: Supports multiple formats, including monoclonal antibodies, bispecific antibodies, scFvs, and nanobodies, and is applicable across diverse therapeutic areas such as oncology, autoimmune diseases, and infectious diseases.

Specific content

Humanization of antibodies derived from mice or other species is achieved through CDR grafting.

Taking mice as an example, this method primarily comprises the following key steps:

Mouse antibody sequence analysis and CDR region sequencing: A comprehensive analysis of the mouse antibody sequence was performed to identify the CDR regions and predict potential post-translational modification sites.

Human framework region selection: Based on the results of homology alignment, identify the most suitable human-derived framework regions.

Reversion mutation sites: Identified based on antibody light- and heavy-chain pairing and their impact on the CDR loops.

Gene synthesis and eukaryotic expression plasmid construction: The humanized antibody amino acid sequence is reverse-translated into nucleotides, subjected to codon optimization, and then cloned into a eukaryotic expression plasmid.

Expression and purification: Transiently expressed in CHO or HEK293 cells, followed by purification.

Affinity Assay: The affinity of the post‑transplant humanized antibody was assessed using Biacore.

The advantage of the CDR grafting approach is that it preserves the antigen-binding capacity of the original murine antibody while reducing its immunogenicity and the potential for adverse reactions.

Service Process

Service Items	Specific content	Time	Result
Humanization design of antibodies	Mouse Anti-Sequence Analysis Germline Alignment and Selection CDR grafting Sequence Optimization Confirm the mutation site of the response	2-3 days	Multiple humanized sequences
Recombinant expression of humanized antibodies	Codon Optimization and Gene Synthesis Construction of Eukaryotic Expression Plasmids Transient expression Purification and QC	2 weeks	Purified humanized antibody
Activity Assay of Humanized Antibodies	Antigen-binding activity and affinity assay	1 week	Confirmed humanized sequences and reports

Service Cases

Whether it’s early‑stage antibody humanization or preclinical candidate optimization, Xichang Bio leverages cutting‑edge technologies and extensive expertise to propel antibody therapeutics from the laboratory all the way to market. Contact us today to usher in a new chapter of low immunogenicity and high efficacy in antibody development!

Documentary materials