The document describes a proprietary method from Bioworld Consulting Laboratories for generating human antibodies. It captures and immortalizes natural human antibody producing cells to produce antigen-specific human antibodies in vitro. This avoids losing antigen-specific B-cells associated with other methods. It produces natural human antibodies characterized without recombinant technology. Within 6-8 weeks it can obtain monoclonal antibody producing clones, compared to years for traditional methods.
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
http://www.bioworldantibodies.com 2
3. Unique proprietary method to capture and
immortalize natural human antibody producing cells
for in vitro production of antigen specific human
antibodies.
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.
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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
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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.
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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.
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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
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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.
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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.
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