Changes in Therapeutic Proteins Caused by Preparation Techniques (1989)

Editorials15 August 1989Changes in Therapeutic Proteins Caused by Preparation TechniquesJohn P. McCue, PhD, MPHJohn P. McCue, PhD, MPHSearch for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-111-4-271 SectionsAboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail ExcerptCommercial 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...References1. Pirofsky B. Intravenous immune globulin therapy in hypogammaglobulinemia: A review. Am JMed. 1984;76(3A):53-60. Google Scholar2. CameCarter PW. Clinical use of interferon in the treatment of viral infections. In: Pfeffer LM, ed. Mechanism of Interferon Actions, v 2. Boca Raton, Florida: CRC Press; 1987:129-41. Google Scholar3. IsnerDeitz JW. Cardiovascular consequences of recombinant DNA technology: interleukin-2. Ann Intern Med. 1988;109:933-5. LinkGoogle Scholar4. FrankFriedman IH. Progress in the treatment of cytomegalovirius pneumonia. Ann Intern Med. 1988;109:769-71. LinkGoogle Scholar5. HeinMcCueHink RJJ. Non-A, non-B hepatitis and intravenous immunoglobulin [Letter]. Lancet. 1985;1:404-5. MedlineGoogle Scholar6. McCueJohnson JA. Noncomparability among IgG products [Letter]. Transfusion. 1986;26:489. CrossrefMedlineGoogle Scholar7. McCueHeinTenold JRR. Three generations of immunoglobulin G preparations for clinical use. Rev Infect Dis. 1986;8(Suppl4):S374-81. CrossrefMedlineGoogle Scholar8. McCueSasagawaHein JPR. Changes induced in antibodies by isolation methods. Biotechnol Appl Biochem. 1988;10:63-71. MedlineGoogle Scholar9. HillAugustineShigeoka HNA. Comparative opsonic activity of intravenous gamma globulin preparations for common bacterial pathogens. Am J Med. 1984;76(3A):61-6. CrossrefMedlineGoogle Scholar10. HillBathras HJ. Protective and opsonic activities of a native, pH 4.25 intravenous immunoglobulin G preparation against common bacterial pathogens. Rev Infect Dis. 1986;8(Suppl 4):S396-400. CrossrefMedlineGoogle Scholar11. CohnStrongHughes ELW. Preparation and properties of serum and plasma proteins. IV. A system for the separation into fractions of the protein and lipoprotein components of biological tissues and fluids. Journal of the American Chemistry Society. 1946;68:459-75. CrossrefMedlineGoogle Scholar12. OncleyMelinRichertCameronGross JMDJP. The separation of the antibodies, isoagglutinins, prothrombin, plasminogen and beta-1 -lipoprotein into subfractions of human plasma. Journal of the American Chemistry Society. 1949;71:541-50. CrossrefMedlineGoogle Scholar13. JanewayRosen CF. The gammaglobulins. IV. Therapeutic uses of gamma globulin. N Engl J Med. 1966;275:826-31. CrossrefMedlineGoogle Scholar14. BarandunKistlerJennet SPF. Intravenous administration of human γ-globulin. Vox Sang. 1962;7:157-74. CrossrefMedlineGoogle Scholar15. Tenold R. Intravenously injectable immune Serumglobulin. US Patent. 1983;4:396, 608. Google Scholar16. Pirofsky B. Safety and toxicity of a new serum immunoglobulin G intravenous preparation, IGIV pH 4.25. Rev Infect Dis. 1986;8(Suppl4):S457-63. CrossrefMedlineGoogle Scholar17. PappenhagenLundbladSchroeder AJD. Pharmaceutical compositions comprising intravenously injectable modified serum globulin, its production and use. US Patent. 1975;3:262, 903. Google Scholar18. JacksonPerkinsRubenis GJM. Passive immunoneutralization of human immune deficiency virus in patients with advanced AIDS. Lancet. 1988;2:647-52. CrossrefMedlineGoogle Scholar This content is PDF only. To continue reading please click on the PDF icon. Author, Article, and Disclosure InformationAffiliations: Salem State College Salem, Massachusetts PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetails Metrics Cited byConcluding remarks. Current trends and future directionsRational Principles for Immunoglobulin Prophylaxis and Therapy of Neonatal Infections 15 August 1989Volume 111, Issue 4Page: 271-272KeywordsAdverse reactionsBiotechnologyImmune deficiencyInterferonsInterleukins Issue Published: 15 August 1989 PDF downloadLoading ...