A Renaissance for Mab Therapeutics
This chapter discusses the emergence of engineered monoclonal antibodies (Mabs) in the 1990s. The failure of Centoxin to gain FDA approval prompted many in the biotechnology and pharmaceutical industry as well as the financial world to view Mab drugs as a lost cause. However, things began to change in 1994 with the approval of ReoPro. The drug signified a major engineering revolution in Mabs after the 1980s, when various competitive and complementary engineering methods began to be developed in the academic and corporate worlds. The first Mabs—known as murine Mabs—were produced by fusing myeloma tumor cells taken from mice with spleen cells derived from other mice or rats previously immunized with an antigen. While these could be made to target almost any antigen and in vast quantities, they were considered foreign by the human body, causing patients treated with murine Mabs to experience immune reactions. This also led to the rapid destruction and clearance of the Mab from the body before it could have its full therapeutic effect. Faced with these obstacles, scientists turned to genetic engineering to transform animal antibodies into human ones.
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