INTRODUCTION
The era of the medical application of proteins started at the end of the
19th century when animal sera were introduced for the treatment of serious
complications of infections such as diphtheria and tetanus. The high doses
used, the general lack of quality controls and a regulatory system, and the
impurity of the prepara-tions led to many serious and sometimes even fatal side
effects. Many of the problems were caused by the strong immune response these
foreign proteins induced, especially when readministered. People who had been
treated in general had a warning in their passports or identification cards to
alert physi-cians for a possible anaphylactic reaction after rechallenge with
an antiserum. Also serum sickness caused by deposits of antigen–antibody
complexes was a common complication of the serum therapy.
Also the porcine and bovine insulins introduced after 1922 induced
antibodies in many patients. This was also explained by the animal origin of
the products, although over the years the immunogeni-city became less because
of improvements in the production methods andincreasing purity.
In the second half of the 20th century a number of human proteins from
natural sources have introduced such as plasma-derived clotting factors and
growth hormone produced from pituitary glands of cadavers. These products were
given mainly to children with an innate deficiency who therefore lacked the
natural immune tolerance. Therefore, their immune response was also interpreted
as a response to foreign proteins. The correlation between the factor VIII gene
defect and level of deficiency with the immune response in hemophilia patients
confirmed this explanation.
Thus, until the advent of recombinant DNA technology, the immunological
response to therapeu-tic proteins could be explained as a classical immune
response comparable to that of a vaccine.
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