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Review

Safety of L-proline as a stabilizer for immunoglobulin products

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Pages 169-178 | Published online: 10 Jan 2014

References

  • Rezaei N, Abolhassani H, Aghamohammadi A, Ochs HD. Indications and safety of intravenous and subcutaneous immunoglobulin therapy. Expert Rev. Clin. Immunol.7(3), 301–316 (2011).
  • Cunningham-Rundles C. Key aspects for successful immunoglobulin therapy of primary immunodeficiencies. Clin. Exp. Immunol.164(Suppl. 2), 16–19 (2011).
  • Krane SM. The importance of proline residues in the structure, stability and susceptibility to proteolytic degradation of collagens. Amino Acids35(4), 703–710 (2008).
  • Wu G. Amino acids: metabolism, functions, and nutrition. Amino Acids37(1), 1–17 (2009).
  • Tomlinson C, Rafii M, Sgro M, Ball RO, Pencharz P. Arginine is synthesized from proline, not glutamate, in enterally fed human preterm neonates. Pediatr. Res.69(1), 46–50 (2011).
  • Wu A. Tietz Clinical Guide to Laboratory Tests (4th Edition). Saunders, PA, USA (2006).
  • Voet D, Voet JG. Biochemistry (2nd Edition). John Wiley & Sons, Inc., NJ, USA (1995).
  • Cohen SM, Nadler JV. Proline-induced potentiation of glutamate transmission. Brain Res.761(2), 271–282 (1997).
  • Krishnan N, Dickman MB, Becker DF. Proline modulates the intracellular redox environment and protects mammalian cells against oxidative stress. Free Radic. Biol. Med.44(4), 671–681 (2008).
  • Washington JM, Rathjen J, Felquer F et al.L-proline induces differentiation of ES cells: a novel role for an amino acid in the regulation of pluripotent cells in culture. Am. J. Physiol. Cell Physiol.298(5), C982–C992 (2010).
  • Gelfand EW. Critical decisions in selecting an intravenous immunoglobulin product. J. Infus. Nurs.28(6), 366–374 (2005).
  • Daugherty AL, Mrsny RJ. Formulation and delivery issues for monoclonal antibody therapeutics. Adv. Drug Deliv. Rev.58(5–6), 686–706 (2006).
  • Kroez M, Kanzy EJ, Gronski P, Dickneite G. Hypotension with intravenous immunoglobulin therapy: importance of pH and dimer formation. Biologicals31(4), 277–286 (2003).
  • Berger M. L-proline-stabilized human IgG: Privigen® 10% for intravenous use and Hizentra® 20% for subcutaneous use. Immunotherapy3(2), 163–176 (2011).
  • Barandun S, Kistler P, Jeunet F, Isliker H. Intravenous administration of human γ-globulin. Vox Sang.7, 157–174 (1962).
  • Bleeker WK, Agterberg J, Rigter G, van Rooijen N, Bakker JC. Key role of macrophages in hypotensive side effects of immunoglobulin preparations. Studies in an animal model. Clin. Exp. Immunol.77(3), 338–344 (1989).
  • Andresen I, Kovarik JM, Spycher M, Bolli R. Product equivalence study comparing the tolerability, pharmacokinetics, and pharmacodynamics of various human immunoglobulin-G formulations. J. Clin. Pharmacol.40(7), 722–730 (2000).
  • Szenczi A, Kardos J, Medgyesi GA, Zavodszky P. The effect of solvent environment on the conformation and stability of human polyclonal IgG in solution. Biologicals34(1), 5–14 (2006).
  • Bolli R, Woodtli K, Bartschi M, Hofferer L, Lerch P. L-proline reduces IgG dimer content and enhances the stability of intravenous immunoglobulin (IVIG) solutions. Biologicals38(1), 150–157 (2010).
  • Maeder W, Lieby P, Sebald A, Spycher M, Pedrussio R, Bolli R. Local tolerance and stability up to 24 months of a new 20% proline-stabilized polyclonal immunoglobulin for subcutaneous administration. Biologicals39(1), 43–49 (2011).
  • Cramer M, Frei R, Sebald A, Mazzoletti P, Maeder W. Stability over 36 months of a new liquid 10% polyclonal immunoglobulin product (IgPro10, Privigen) stabilized with L-proline. Vox Sang.96(3), 219–225 (2009).
  • Cramer M, Frei R, Sebald A, Mazzoletti P, Maeder W. Stability over 36 months of a new liquid 10% polyclonal immunoglobulin product (IgPro10, Privigen) stabilized with L-proline. Vox Sang.96(3), 219–225 (2009).
  • Hizentra (Immune Globulin Subcutaneous (Human), 20% Liquid). Full prescribing information, CSL Behring, LLC, IL, USA (2011).
  • Privigen (Immune Globulin Intravenous (Human), 10% Liquid). Full prescribing information, CSL Behring, LLC, IL, USA (2011).
  • Privigen (human normal immunoglobulin). EPAR-product information, CSL Behring GmbH, Marburg, Germany (2011).
  • Hizentra (human normal immunoglobulin [SCIg]). EPAR-Product Information, CSL Behring GmbH, Marburg, Germany (2011).
  • Phang J, Chien-an A, Valle D. Disorders of proline and hydroxyproline metabolism. In: Disorders of Proline and Hydroxyproline Metabolism (7th Edition). Valle D, Beaudet A, Vogelstein B, Kinzler K, Antonarakis S, Ballabio A (Eds). McGraw-Hill, NY, USA (2007).
  • Goodman BK, Rutberg J, Lin WW, Pulver AE, Thomas GH. Hyperprolinaemia in patients with deletion (22)(q11.2) syndrome. J. Inherit. Metab. Dis.23(8), 847–848 (2000).
  • Kobrynski LJ, Sullivan KE. Velocardiofacial syndrome, DiGeorge syndrome: the chromosome 22q11.2 deletion syndromes. Lancet370(9596), 1443–1452 (2007).
  • McDonald-McGinn DM, Sullivan KE. Chromosome 22q11.2 deletion syndrome (DiGeorge syndrome/velocardiofacial syndrome). Medicine (Baltimore).90(1), 1–18 (2011).
  • Shprintzen RJ. Velo-cardio-facial syndrome: 30 years of study. Dev. Disabil. Res. Rev.14(1), 3–10 (2008).
  • Botto LD, May K, Fernhoff PM et al. A population-based study of the 22q11.2 deletion: phenotype, incidence, and contribution to major birth defects in the population. Pediatrics112(1 Pt 1), 101–107 (2003).
  • Veerapandiyan A, Abdul-Rahman OA, Adam MP et al. Chromosome 22q11.2 deletion syndrome in African-American patients: a diagnostic challenge. Am. J. Med. Genet. A.155(9), 2186–2195 (2011).
  • Raux G, Bumsel E, Hecketsweiler B et al. Involvement of hyperprolinemia in cognitive and psychiatric features of the 22q11 deletion syndrome. Hum. Mol. Genet.16(1), 83–91 (2007).
  • Lewandowski KE, Shashi V, Berry PM, Kwapil TR. Schizophrenic-like neurocognitive deficits in children and adolescents with 22q11 deletion syndrome. Am. J. Med. Genet. B Neuropsychiatr. Genet.144B(1), 27–36 (2007).
  • McDonald-McGinn DM, LaRossa D, Goldmuntz E et al. The 22q11.2 deletion: screening, diagnostic workup, and outcome of results; report on 181 patients. Genet. Test.1(2), 99–108 (1997).
  • International Schizophrenia Consortium. Rare chromosomal deletions and duplications increase risk of schizophrenia. Nature455(7210), 237–241 (2008).
  • Sullivan KE, Jawad AF, Randall P et al. Lack of correlation between impaired T cell production, immunodeficiency, and other phenotypic features in chromosome 22q11.2 deletion syndromes. Clin. Immunol. Immunopathol.86(2), 141–146 (1998).
  • Sullivan KE, McDonald-McGinn D, Driscoll DA, Emanuel BS, Zackai EH, Jawad AF. Longitudinal analysis of lymphocyte function and numbers in the first year of life in chromosome 22q11.2 deletion syndrome (DiGeorge syndrome/velocardiofacial syndrome). Clin. Diagn. Lab. Immunol.6(6), 906–911 (1999).
  • Ballow M, Notarangelo L, Grimbacher B et al. Immunodeficiencies. Clin. Exp. Immunol.158(Suppl. 1), 14–22 (2009).
  • Sullivan K. Hypogammaglobulinemia in DiGeorge syndrome: a registry approach. Presented at: Clinical Immunology Society. Chicago, IL, USA, 19–22 May 2011.
  • Campbell HD, Webb GC, Young IG. A human homologue of the Drosophila melanogaster sluggish-A (proline oxidase) gene maps to 22q11.2, and is a candidate gene for Type-1 hyperprolinaemia. Hum. Genet.101(1), 69–74 (1997).
  • Delwing D, Bavaresco CS, Wannmacher CM, Wajner M, Dutra-Filho CS, Wyse AT. Proline induces oxidative stress in cerebral cortex of rats. Int. J. Dev. Neurosci.21(2), 105–110 (2003).
  • Ferreira AG, Lima DD, Delwing D et al. Proline impairs energy metabolism in cerebral cortex of young rats. Metab. Brain Dis.25(2), 161–168 (2010).
  • Bavaresco CS, Streck EL, Netto CA, Wyse AT. Chronic hyperprolinemia provokes a memory deficit in the Morris water maze task. Metab. Brain Dis.20(1), 73–80 (2005).
  • Moreira JC, Wannmacher CM, Costa SM, Wajner M. Effect of proline administration on rat behavior in aversive and nonaversive tasks. Pharmacol. Biochem. Behav.32(4), 885–890 (1989).
  • Shanti ND, Shashikumar KC, Desai PV. Influence of proline on rat brain activities of alanine aminotransferase, aspartate aminotransferase and acid phosphatase. Neurochem. Res.29(12), 2197–2206 (2004).
  • Delwing D, Bavaresco CS, Chiarani F et al.In vivo and in vitro effects of proline on some parameters of oxidative stress in rat brain. Brain Res.991(1–2), 180–186 (2003).
  • Delwing D, Chiarani F, Bavaresco CS et al. Protective effect of antioxidants on brain oxidative damage caused by proline administration. Neurosci. Res.52(1), 69–74 (2005).
  • Adibi SA, Gray SJ, Menden E. The kinetics of amino acid absorption and alteration of plasma composition of free amino acids after intestinal perfusion of amino acid mixtures. Am. J. Clin. Nutr.20(1), 24–33 (1967).
  • Jaksic T, Wagner DA, Burke JF, Young VR. Plasma proline kinetics and the regulation of proline synthesis in man. Metabolism36(11), 1040–1046 (1987).
  • Maher TJ, Glaeser BS, Wurtman RJ. Diurnal variations in plasma concentrations of basic and neutral amino acids and in red cell concentrations of aspartate and glutamate: effects of dietary protein intake. Am. J. Clin. Nutr.39(5), 722–729 (1984).
  • Stein MR, Nelson RP, Church JA et al. Safety and efficacy of Privigen, a novel 10% liquid immunoglobulin preparation for intravenous use, in patients with primary immunodeficiencies. J. Clin. Immunol.29(1), 137–144 (2009).
  • Hayasaka S, Saito T, Nakajima H, Takahashi O, Mizuno K, Tada K. Clinical trials of vitamin B6 and proline supplementation for gyrate atrophy of the choroid and retina. Br. J. Ophthalmol.69(4), 283–290 (1985).
  • Scriver CR, Efron ML, Schafer IA. Renal tubular transport of proline, hydroxyproline, and glycine in health and in familial hyperprolinemia. J. Clin. Invest.43, 374–385 (1964).
  • Robak T, Salama A, Kovaleva L et al. Efficacy and safety of Privigen, a novel liquid intravenous immunoglobulin formulation, in adolescent and adult patients with chronic immune thrombocytopenic purpura. Hematology14(4), 227–236 (2009).
  • Hagan JB, Fasano MB, Spector S et al. Efficacy and safety of a new 20% immunoglobulin preparation for subcutaneous administration, IgPro20, in patients with primary immunodeficiency. J. Clin. Immunol.30(5), 734–745 (2010).
  • Jacquet H, Berthelot J, Bonnemains C et al. The severe form of Type 1 hyperprolinaemia results from homozygous inactivation of the PRODH gene. J. Med. Genet.40(1), e7 (2003).
  • Afenjar A, Moutard ML, Doummar D et al. Early neurological phenotype in 4 children with biallelic PRODH mutations. Brain Dev.29(9), 547–552 (2007).
  • Bender HU, Almashanu S, Steel G et al. Functional consequences of PRODH missense mutations. Am. J. Hum. Genet.76(3), 409–420 (2005).
  • Clelland CL, Read LL, Baraldi AN et al. Evidence for association of hyperprolinemia with schizophrenia and a measure of clinical outcome. Schizophr. Res.131(1–3), 139–145 (2011).
  • Jacquet H, Demily C, Houy E et al. Hyperprolinemia is a risk factor for schizoaffective disorder. Mol. Psychiatr.10(5), 479–485 (2005).
  • Jacquet H, Rapoport JL, Hecketsweiler B et al. Hyperprolinemia is not associated with childhood onset schizophrenia. Am. J. Med. Genet. B Neuropsychiatr. Genet.141B(2), 192 (2006).
  • Williams HJ, Williams N, Spurlock G et al. Detailed analysis of PRODH and PsPRODH reveals no association with schizophrenia. Am. J. Med. Genet. B Neuropsychiatr. Genet.120B(1), 42–46 (2003).
  • Oldendorf WH. Brain uptake of radiolabeled amino acids, amines, and hexoses after arterial injection. Am. J. Physiol.221(6), 1629–1639 (1971).
  • Takanaga H, Tokuda N, Ohtsuki S, Hosoya K, Terasaki T. ATA2 is predominantly expressed as system A at the blood–brain barrier and acts as brain-to-blood efflux transport for L-proline. Mol. Pharmacol.61(6), 1289–1296 (2002).
  • Humbertclaude V, Rivier F, Roubertie A et al. Is hyperprolinemia Type 1 actually a benign trait? Report of a case with severe neurologic involvement and vigabatrin intolerance. J. Child Neurol.16(8), 622–623 (2001).
  • Boyle JM, Buckley RH. Population prevalence of diagnosed primary immunodeficiency diseases in the United States. J. Clin. Immunol.27(5), 497–502 (2007).

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