Antibody Humanization
Antibody Humanization is about ensuring safety first and foremost.
Antibody Humanization Service
We offer a dedicated team at Fusion Antibodies to deliver your humanized monoclonal antibody. We guarantee that the function of your molecule will be maintained and a good developability profile achieved.
Our expert team have been engineering antibodies for more than 20 years and we know what it takes to progress a biologic into the clinic. We have successfully humanized antibodies against more than 200 targets so you can trust us to deliver the results you need. Most importantly, a number of antibodies that we have humanized, have reached the clinic, with the most advanced in Phase II development.
We perform a ‘modernized’ approach to CDR grafting using our CDRx™ platform. Guaranteeing success in delivering a humanized sequence that is safe, effective and will help accelerate your journey to the clinic.
CDRx™ : Diversity is key
CDRx is a flexible platform for humanization of your antibody sequence, no matter from which species or format it originates. For the success of a therapeutic antibody, diversity is key. We don’t restrict your humanized monoclonal antibody construct to a limited set of human germline sequences – our platform is built around diversity. We select suitable donor framework sequences from a database of mature human sequences.
By utilising a greater diversity of framework sequences, we increase the chances of successfully maintaining the binding function in the humanized format and also the chances of developing stable and robust antibodies that express well downstream. By creating a diverse pool of mature human frameworks we often improve the affinity or even specificity of the parental antibody.
Furthermore, by triaging frameworks for removal of those with sequence liabilities (incl. predicted T cell epitopes), we ensure that framework sequences are the best possible carriers for your CDRs.
Antibody Humanization process
Design
As part of a full humanization program, or as a stand-alone service, we will perform design of 25 humanized variant sequences (as standard) for your parental antibody.
Suitable mature human donor frameworks are selected based on homology and positioning of key residues important for structure and conformation. Donor sequences are triaged for sequence liabilities.
Full Package
We offer humanization design followed by in vitro expression, in CHO and affinity ranking of all variants as a combined package.
High-throughput
We have adapted humanization algorithms to enable a high throughput humanization process for clients wishing to humanize a high number of hit molecules in parallel.
Follow on steps
If further polishing is required to address manufacturing liabilities in the CDRs, or if further affinity improvements are needed we offer platforms for Developability and Affinity Maturation.
Advantages of CDRx™ Platform
- Next generation in silico CDR grafting platform
- We predict and avoid T-cell epitopes using the same prediction tools as the FDA
- We predict and avoid sequence liabilities for deamidation, glycosylation, oxidation, cleavage
- We will model each variant using molecular dynamics and rank the variants by RMSD from the parental antibody
- 2-fold affinity guarantee
- Antibody humanization from a broad range of parental species including mouse, rat, rabbit, chicken, llama and avian
- scFvs, Fabs and other antibodies humanized
- 20+ years’ experience of antibody drug development
- Flexible payment terms and business models