Mouse DimAb Development
Our team has decades of experience on high quality monoclonal antibody development services. DIMA’s DimAb® development platform is a revolutionary technology platform for monoclonal antibody development. Different from hybridoma fusion platform, we can directly isolate IgG genes from B cells of immunized animals. At present, we have successfully completed a number of custom development projects with high satisfaction (Please see our customer testimonials).
Mouse is the best animal model system to study human diseases. Before clinical trial, mouse disease model is commonly used to simulate the pathogenesis of human diseases and test the drug responses. Till today, more than 90% of the therapeutic antibody drugs were developed from mouse or humanized mouse. There are well-established systems to humanize mouse monoclonal antibodies. Therefore, mouse is still the first choice when coming for a therapeutic antibody drug developmental program.
Although mouse hybridoma technology was developed several decades ago, it is still the major working horse people commonly using for monoclonal antibody development. However, there are limitations in the preparation of monoclonal antibodies by traditional hybridoma methods, such as low fusion efficiency of hybridoma, long preparation process, unstable hybridoma cells, etc. DIMA’s DimAb® technology platform for mouse monoclonal antibody development is a total revolution, which has a number of advantages.
|Mouse DimAb®||Hybridoma mouse monoclonal antibody|
|Short development process (4-5 months)||Long development process (8-10 months)|
|High project success rate（80-90%）||Low project success rate（50%）|
|High cloning efficiency (thousands of clones from one immunized animal)||Low cloning efficiency|
|Direct acquisition of antibody IgG gene sequence, easy to maintain and transmit information||High cost of hybridoma cell preservation, Need separate cloning step to clone IgG gene|
|High quality consistency between batches, and possible to automate the process||Hybridoma cells are unstable and might loss during passage|
|No need to kill animals (PBMCs are good enough)||Animals need to be killed to separate the splenocytes|
Therapeutic antibody drug development Since the first mouse monoclonal antibody drug muromonab OKT3 was developed in 1986, now close to 100 monoclonal antibody drugs have been approved by FDA and it is a multi-hundred billion dollars market. Monoclonal antibodies have been used to treat different diseases, including cancer, infectious diseases, immunological disorders, etc. Many therapeutic antibody drugs become multi-billion dollar blockbuster, such as Humira (anti-tumor necrosis factor (TNF), Keytruda (anti-Pd-1), Praluent (anti-PCSK9), etc. In the future, the research and development trend of mouse monoclonal antibody will focus on new targets, new indications, new combinatorial treatment and so on.
|Rank||Drug name (trade name)||Company||Billion dollars|
|Cancer||blocking ligand binding||cetuximab|
|Block cell signal||Pertuzumab|
|Inhibition of angiogenesis||Bevacizumab|
|Immunosuppressant||PD-1/L1 Monoclonal Antibody|
|Immunological Disorders||Receptor blocking and regulation||Omalizumab|
|Depletion antigen producing cell||Rituximab|
Application in clinical diagnosis Since the approval of Herceptin and HER2 IHC detection reagents by FDA in 1998, mouse monoclonal antibodies have played an important role in clinical diagnosis. As of 2018, FDA has approved 35 companion diagnostic products and quite a number of immunological assaysuse mouse monoclonal antibodies. In addition, mouse monoclonal antibodies have also been widely used in the field of in vitro diagnosis.
Application in scientific research In the past 30 years, mouse monoclonal antibodies have played an important role in scientific research and are the basic reagents for a lot of immunological assays.
|Comparison items||Rabbit monoclonal antibody||Mouse monoclonal antibody|
|New IHC clones||+++++||+++|
|Oldand Common IHC clones||+++||++++|
|Maturity for antibody drug development||++||+++++|
|Common IVD clones||++||++++|
|Step||Service details||Deliverables||Estimated production cycle (week)|
|Immunogen preparation||Plasmid construction, mammalian cell produced immunogens or supplied by customer||7-10 weeks|
|Animal immunization||Immunize two animals (mice) against the same antigen||Crude sera and ELISA data on anti-serum titer test||8-12 weeks|
|Collect mouse splenocytes||Dissect animal and cryopreservation; target positive B cell enrichment and single B cell expansion||100ul B cell supernatant;B cell supernatant ELISA test data||4 weeks|
|DimAb® cDNA cloning, sequencing and storage||IgG gene cloning, Expression vector construction; small-scale antibody production and validation; select 1-2 positive clones for full-length IgG sequencing and sequence analysis||Sequencing report of one clone; ELISA data||2 weeks|
|DimAb® production and validation||Antibody production and identification antibody mass production and purification; antibody function identification||Antibody production, purification and QC validation||4 weeks|
coming soon ...