Human monoclonal antibody development


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Human monoclonal antibody development

  1. 1. Janos Luka, Ph.D. Scientific DirectorBioworld Consulting Laboratories, LLC 1
  2. 2.  The current methods of antibody development are mainly hybridoma based method using mice, and phage display method Some companies also use the EBV transformation method which have several disadvantages including loss of specific B-cells and IgM type of antibody response 2
  3. 3. Unique proprietary method to capture andimmortalize natural human antibody producing cellsfor in vitro production of antigen specific humanantibodies.  it does not require isolation and purification of B-cells therefore no loss of antigen specific B-cells occurs, which is generally associated with other methods.  it produces natural human antibodies, which has been innately produced by the immune system. It can be easily characterized for specific therapies and epitope mapped without recombinant technology. 3
  4. 4.  antibodies against multiple epitopes can be isolated, and combined as multiclonal or polyclonal mixture which might be more effective than a single monoclonal antibody for clinical use once the donor blood has been obtained, it will take only 6-8 weeks to obtain the monoclonal antibody producing clones compared to traditional methods which might take up to several years. if blood donors with previous exposure to antigen of the interest cannot be found, in vitro immunization can be done to produce human antibodies 4
  5. 5.  The technology uses a proprietary method to generate an antigen presentation system, which emulates the natural presentation of antigens by the immune system. BCL has initiated proof of principle studies to generate antibodies against specific tumor associated antigens by means of in vitro immunization using on purified antigens and peptides. 5
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  7. 7.  For generating specific antibody producing cells, first we examine by ELISA whether aimed antibodies are present in the serum of the donors. this screening is completed in one day, and reveals which donors are suitable for human antibody development. In the next step, the antibody producing cells are immortalized from the donors where the antibodies have been confirmed to be present. 7
  8. 8.  Transformed lymphocytes are dropped on 50,000 wells micro-array (coated with specific antigen) and incubated for several hours. The specific antibody producing single cells are identified by fluorescence. The cells that are secreting antibodies to the antigen are isolated with a micro- manipulator, then expanded. The expanded cells, which now produce specific antibodies can be further characterized before transferring the IgG genes for other cells (CHO) for large scale production 8
  9. 9.  Not affected by patents associated with other technologies Rapid progress from target identification to clinical development using epitope specific antibodies Clones can be selected targeting different epitopes on the same antigen Native human antibodies, therefore unlikely to be immunogenic or induce adverse effects in patients, which generally a problem with humanized antibodies. 9
  10. 10.  Bioworld Consulting Laboratories antibodies are fully human antibodies, and of high affinity. Due to the high affinity and selectivity, it is expected that our antibodies will be effective at lower dosages, resulting in reduction of cost during large scale production. Each antibody developed has unique amino- acid sequence therefore substance patent can be approved. 10