John P. McCue, PhD, MPH
Commercial development of therapeutic proteins ("biologicals"), such as human immunoglobulins, interferons, and interleukins, as therapeutic agents has increased in recent years as advances in biotechnology, expansion of the biotechnology industry, and interest in immune deficiencies has increased. Despite the common sense dictum that replacement and augmentation therapy with these naturally occurring substances should be free from problems, the opposite has been true. Adverse clinical reactions have been reported (1-3), and variation in clinical efficacy has been observed (2, 4).
Two assignable causes of these problems can be envisioned: patient idiosyncrasy and product variability. The first is familiar from clinical experience
McCue JP. Changes in Therapeutic Proteins Caused by Preparation Techniques. Ann Intern Med. ;111:271–272. doi: 10.7326/0003-4819-111-4-271
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Published: Ann Intern Med. 1989;111(4):271-272.
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