Therapeutic treatment of human diseases using human monoclonal
antibodies (mAbs) has proven to be effective, with few side
effects. The development of mAb drugs has become a major
priority within the biotech and pharmaceutical industries. MAb
drug development activity has experienced explosive growth in
the past 30 years since the process for creating mAbs was introduced
[1-4]. Twenty - five therapeutic mAbs and 4 Fc-fusion proteins
have been approved by the Food and Drug Administration
(FDA), nine of which have exceeded annual sales of $1 billion.
Numerous new technologies to perfect the design and production
of mAbs for therapeutic, diagnostic, and other purposes
have been developed within industry and by academics. Over
the past two decades, technologies have emerged for generating
mAbs derived from human immunoglobulin gene sequences
by phage display and transgenic mice, human B cells directly by
Human-Human Hybridoma, Hybrid hybridoma, B cell immortalization
and cloning or Single-cell RT–PCR. These human mAbs
provide an alternative to re-engineered, or de-immunized, rodent
mAbs as a source of low immunogenicity therapeutic antibodies.
There are now three marketed fully human therapeutic mAbs,
adalimumab, panitumumab and Golimumab, and several dozen
more in various stages of human clinical testing. In this review,
I describe briefly the new technologies for the generation of human
mAbs. I also discuss the trend of antibody therapies in the
treatment of various human diseases and new technologies that
drive the fast growth of the industry.