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.

1. Janos Luka, Ph.D.
Scientific Director
Bioworld Consulting Laboratories, LLC
http://www.bioworldantibodies.com 1

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.
http://www.bioworldantibodies.com 3

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
http://www.bioworldantibodies.com 4

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.
http://www.bioworldantibodies.com 5

6. http://www.bioworldantibodies.com 6

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.
http://www.bioworldantibodies.com 7

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
http://www.bioworldantibodies.com 8

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.
http://www.bioworldantibodies.com 9

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.
http://www.bioworldantibodies.com 10