Custom antibody production 2015

Posted by antibodyman on April 1st, 2015

Current Demand for Monoclonal
Antibodies
The applications of mAbs are numerous and
diverse. They are extensively used in fundamental
research, medicine and biotechnology.
At present, four user groups can be
identified, according to the amount of antibody
required. These are summarised in Figure
1.
User group A: < 0.1g
Approximately 60% of the mAb users in
Europe fall within this group, as do many of
the current users of the in vivo (ascites)
method. Small amounts of antibodies are
produced for use in fundamental and applied
research, the commercial production of special
diagnostic kits for research, and for analytical
purposes.
User group B: 0.1ñ0.5g
This group accounts for approximately 30%
of mAb users and encompasses a significant
number of people still using the in vivo
method. Antibodies in these amounts are
required for the development and production
of a wide range of in vitro diagnostic kits and
reagents, as well as for evaluating the usefulness
of novel therapeutic mAbs in animal
experiments.
User group C: 0.5ñ10g
In this group, which accounts for approximately
10% of mAb users, adoption of the in
vivo method is comparatively rare. The
mAbs produced are used in routine diagnostic
procedures and in preclinical evaluation
studies. They are usually produced by large
biotechnology companies but, during the last
few years, the production of these mAbs has
increasingly been contracted out to smaller
facilities.
User group D: > 10g
Users in this group, who require mAbs for
prophylactic and therapeutic purposes in
vivo, make up less than 1% of all mAb users
in Europe. The mAb production processes
they use are first developed and validated by
the pharmaceutical industry, and are then
submitted to a regulatory body for approval.
The extensive use of the ascites method by
groups A and B can be attributed to its supposed
economic advantage as well as to a
lack of inclination to adopt the new techniques.
Most of the mAbs produced by
these groups are not used in clinical studies
and therefore do not have to comply with
the standard requirements for pharmaceutical
products. This has led to a lack of
awareness in these user groups of the disadvantages
of ascites production, such as
the potential for infection by animal
viruses, and the reduced immunoreactivity
of the mAb due to contamination with nonspecific
animal immunoglobulins.

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