Survival and digestibility of orally-administered immunoglobulin preparations containing IgG through the gastrointestinal tract in humans

Nutrition Journal

Volumn 14, Issue 1, 2015, Pages

  Jasion, Victoria S ^a   Burnett, Bruce P ^a  

^a Department of Medical Affairs Entera Health ^*  (United States)

Author keywords

Bovine colostrum; Immunoglobulin digestion; Oral immunoglobulin; Serum derived bovine immunoglobulin; Serum derived human immunoglobulin

Indexed keywords

ANTACID AGENT; BOVINE IMMUNOGLOBULIN; HUMAN IMMUNOGLOBULIN; IMMUNOGLOBULIN; IMMUNOGLOBULIN F(AB) FRAGMENT; IMMUNOGLOBULIN G; OMEPRAZOLE; PLACEBO;

BREAST FEEDING; CHEMICAL ANALYSIS; CLINICAL STUDY; COLOSTRUM; CONTROLLED CLINICAL TRIAL (TOPIC); CONVALESCENCE; DIGESTION; DRUG FORMULATION; DRUG METABOLISM; DRUG STABILITY; ENCAPSULATION; FECES; GASTROINTESTINAL TRACT; HUMAN; ILEOSTOMY; IMMUNOGLOBULIN STRUCTURE; IN VITRO STUDY; MICROCAPSULE; MILK; PH; POWDER; PROTEIN DEGRADATION; PROTEIN PURIFICATION; REACTION TIME; REVIEW; SURVIVAL RATE; TEMPERATURE; THERMOSTABILITY; ANIMAL; BOVINE; CHEMISTRY; DIET THERAPY; DRUG EFFECTS; IMMUNOLOGY; IMMUNOTHERAPY; INFLAMMATION; ORAL DRUG ADMINISTRATION; PASSIVE IMMUNIZATION; PROCEDURES;

ANIMALIA; BOVINAE;

ADMINISTRATION, ORAL; ANIMALS; CATTLE; GASTROINTESTINAL TRACT; HUMANS; IMMUNIZATION, PASSIVE; IMMUNOGLOBULIN G; IMMUNOGLOBULINS; IMMUNOTHERAPY; INFLAMMATION;

EID: 84924977745     PISSN: None     EISSN: 14752891     Source Type: Journal    
DOI: 10.1186/s12937-015-0010-7     Document Type: Review

References (61)

1. Weiner C, Pan Q, Hurtig M, Boren T, Bostwick E, Hammarstrom L. Passive immunity against human pathogens using bovine antibodies. Clin Exp Immunol. 1999;116:193-205.
2. Hurley WL, Theil PK. Perspectives on immunoglobulins in colostrum and milk. Nutrients. 2011;3:442-74.
3. Godden SM, Smith S, Feirtag JM, Green LR, Wells SJ, Fetrow JP. Effect of on-farm commercial batch pasteurization of colostrum on colostrum and serum immunoglobulin concentrations in dairy calves. J Dairy Sci. 2003;86:1503-12.
4. Roos N, Mahe S, Benamouzig R, Sick H, Rautureau J, Tome D. 15 N-labeled immunoglobulins from bovine colostrum are partially resistant to digestion in human intestine. J Nutr. 1995;125:1238-44.
5. Kelly CP, Chetham S, Keates S, Bostwick EF, Roush AM, Castagliuolo I, et al. Survival of anti-Clostridium difficile bovine immunoglobulin concentrate in the human gastrointestinal tract. Antimicrob Agents Chemother. 1997;41:236-41.
6. Warny M, Fatimi A, Bostwick EF, Laine DC, Lebel F, LaMont JT, et al. Bovine immunoglobulin concentrate-clostridium difficile retains C difficile toxin neutralising activity after passage through the human stomach and small intestine. Gut. 1999;44:212-7.
7. Bhol KC, Tracey DE, Lemos BR, Lyng GD, Erlich EC, Keane DM, et al. AVX-470: a novel oral anti-TNF antibody with therapeutic potential in inflammatory bowel disease. Inflamm Bowel Dis. 2013;19:2273-81.
8. Petschow BW, Burnett BP, Shaw AL, Weaver EM, Klein GL. Dietary Requirement for Serum-Derived Bovine Immunoglobulins in the Clinical Management of Patients with Enteropathy. Dig Dis Sci. 2015;60:13-23.
9. Zinkernagel RM, Hilpert H, Gerber H. The digestion of colostral bovine immunoglobulins in infants. Experientia. 1972;28:741.
10. Blum PM, Phelps DL, Ank BJ, Krantman HJ, Stiehm ER. Survival of oral human immune serum globulin in the gastrointestinal tract of low birth weight infants. Pediatr Res. 1981;15:1256-60.
11. Eibl MM, Wolf HM, Furnkranz H, Rosenkranz A. Prevention of necrotizing enterocolitis in low-birth-weight infants by IgA-IgG feeding. N Engl J Med. 1988;319:1-7.
12. Hilpert H, Brussow H, Mietens C, Sidoti J, Lerner L, Werchau H. Use of bovine milk concentrate containing antibody to rotavirus to treat rotavirus gastroenteritis in infants. J Infect Dis. 1987;156:158-66.
13. Losonsky GA, Johnson JP, Winkelstein JA, Yolken RH. Oral administration of human serum immunoglobulin in immunodeficient patients with viral gastroenteritis. A pharmacokinetic and functional analysis. J Clin Invest. 1985;76:2362-7.
14. Pacyna J, Siwek K, Terry SJ, Roberton ES, Johnson RB, Davidson GP. Survival of rotavirus antibody activity derived from bovine colostrum after passage through the human gastrointestinal tract. J Pediatr Gastroenterol Nutr. 2001;32:162-7.
15. Turner MW, Bennich HH, Natvig JB. Pepsin digestion of human G-myeloma proteins of different subclasses. II. Immunochemical investigations of the products of peptic digestion. Clin Exp Immunol. 1970;7:627-40.
16. Tacket CO, Binion SB, Bostwick E, Losonsky G, Roy MJ, Edelman R. Efficacy of bovine milk immunoglobulin concentrate in preventing illness after Shigella flexneri challenge. Am J Trop Med Hyg. 1992;47:276-83.
17. McClead Jr RE, Butler T, Rabbani GH. Orally administered bovine colostral anti-cholera toxin antibodies: results of two clinical trials. Am J Med. 1988;85:811-6.
18. Copelan EA, Bechtel TP, Klein JP, Klein JL, Tutschka P, Kapoor N, et al. Controlled trial of orally administered immunoglobulin following bone marrow transplantation. Bone Marrow Transplant. 1994;13:87-91.
19. Bogstedt AK, Hammarstrom L, Robertson AK. Survival of immunoglobulins from different species through the gastrointestinal tract in healthy adult volunteers: implications for human therapy. Antimicrob Agents Chemother. 1997;41:2320.
20. Lissner R, Thurmann PA, Merz G, Karch H. Antibody reactivity and fecal recovery of bovine immunoglobulins following oral administration of a colostrum concentrate from cows (Lactobin) to healthy volunteers. Int J Clin Pharmacol Ther. 1998;36:239-45.
21. Moughan P: Dietary protein quality evaluation in human nutrition: Report of an FAO Expert Consultation. http://www.fao.org/ag/humannutrition/nutrition/63158/en/: FAO; Accessed 5 January 2015.
22. Moughan P, Gilani S, Rutherfurd S, Tome D: The assessment of amino acid digestibility in foods for humans and including a collation of published ileal amino acid digestibility for human foods. http://www.fao.org/ag/humannutrition/nutrition/63158/en/: FAO; Accessed 5 January 2015.
23. Goto Y, Hamaguchi K. The role of the intrachain disulfide bond in the conformation and stability of the constant fragment of the immunoglobulin light chain. J Biochem. 1979;86:1433-41.
24. Goto Y, Hamaguchi K. Unfolding and refolding of the reduced constant fragment of the immunoglobulin light chain. Kinetic role of the intrachain disulfide bond. J Mol Biol. 1982;156:911-26.
25. Ashikari Y, Arata Y, Hamaguchi K. pH-induced unfolding of the constant fragment of the immunoglobulin light chain: effect of reduction of the intrachain disulfide bond. J Biochem. 1985;97:517-28.
26. Thies MJ, Talamo F, Mayer M, Bell S, Ruoppolo M, Marino G, et al. Folding and oxidation of the antibody domain C(H) 3. J Mol Biol. 2002;319:1267-77.
27. Pace CN, Grimsley GR, Thomson JA, Barnett BJ. Conformational stability and activity of ribonuclease T1 with zero, one, and two intact disulfide bonds. J Biol Chem. 1988;263:11820-5.
28. 1 antibody CH3 domain. Protein Sci. 2008;17:95-106.
29. Payne RB. The controlling effect of carbohydrate in human, rabbit and bovine immunoglobulin G on proteolysis by papin. Biochem J. 1969;111:473-8.
30. Youings A, Chang SC, Dwek RA, Scragg IG. Site-specific glycosylation of human immunoglobulin G is altered in four rheumatoid arthritis patients. Biochem J. 1996;314(Pt 2):621-30.
31. Krapp S, Mimura Y, Jefferis R, Huber R, Sondermann P. Structural analysis of human IgG-Fc glycoforms reveals a correlation between glycosylation and structural integrity. J Mol Biol. 2003;325:979-89.
32. Zheng K, Bantog C, Bayer R. The impact of glycosylation on monoclonal antibody conformation and stability. MAb. 2011;3:568-76.
33. Welfle K, Misselwitz R, Hausdorf G, Hohne W, Welfle H. Conformation, pH-induced conformational changes, and thermal unfolding of anti-p24 (HIV-1) monoclonal antibody CB4-1 and its Fab and Fc fragments. Biochim Biophys Acta. 1999;1431:120-31.
34. Sathya Devi V, Coleman DR, Truntzer J. Thermal unfolding curves of high concentration bovine IgG measured by FTIR spectroscopy. Protein J. 2011;30:395-403.
35. Li Y, Mach H, Blue JT. High throughput formulation screening for global aggregation behaviors of three monoclonal antibodies. J Pharm Sci. 2011;100:2120-35.
36. Martsev SP, Kravchuk ZI, Vlasov AP. Large increase in thermal stability of the CH2 domain of rabbit IgG after acid treatment as evidenced by differential scanning calorimetry. Immunol Lett. 1994;43:149-52.
37. Buchner J, Renner M, Lilie H, Hinz HJ, Jaenicke R, Kiefhabel T, et al. Alternatively folded states of an immunoglobulin. Biochemistry. 1991;30:6922-9.
38. Vlasov AP, Kravchuk ZI, Martsev SP. [Non-native conformational states of immunoglobulins: thermodynamic and functional analysis of rabbit IgG]. Biokhimiia. 1996;61:212-35.
39. Kats M, Richberg PC, Hughes DE. pH-dependent isoform transitions of a monoclonal antibody monitored by micellar electrokinetic capillary chromatography. Anal Chem. 1997;69:338-43.
40. Andrew SM, Titus JA: Purification of immunoglobulin G. Curr Protoc Cell Biol 2000, Chapter 16:Unit 16.13 (16.13.1 - 16.13.12).
41. Djoumerska I, Tchorbanov A, Pashov A, Vassilev T. The autoreactivity of therapeutic intravenous immunoglobulin (IVIG) preparations depends on the fractionation methods used. Scand J Immunol. 2005;61:357-63.
42. Djoumerska-Alexieva IK, Dimitrov JD, Voynova EN, Lacroix-Desmazes S, Kaveri SV, Vassilev TL. Exposure of IgG to an acidic environment results in molecular modifications and in enhanced protective activity in sepsis. Febs J. 2010;277:3039-50.
43. McMahon MJ, O'Kennedy R. Polyreactivity as an acquired artefact, rather than a physiologic property, of antibodies: evidence that monoreactive antibodies may gain the ability to bind to multiple antigens after exposure to low pH. J Immunol Methods. 2000;241:1-10.
44. Porter RR. The hydrolysis of rabbit y-globulin and antibodies with crystalline papain. Biochem J. 1959;73:119-26.
45. Porter RR. Chemical structure of gamma-globulin and antibodies. Br Med Bull. 1963;19:197-201.
46. Edelman GM, Benacerraf B, Ovary Z, Poulik MD. Structural differences among antibodies of different specificities. Proc Natl Acad Sci U S A. 1961;47:1751-8.
47. Edelman GM, Poulik MD. Studies on structural units of the gamma-globulins. J Exp Med. 1961;113:861-84.
48. Utsumi S. Stepwise cleavage of rabbit immunoglobulin G by papain and isolation of four types of biologically active Fc fragments. Biochem J. 1969;112:343-55.
49. Whitcomb DC, Lowe ME. Human pancreatic digestive enzymes. Dig Dis Sci. 2007;52:1-17.
50. Butler JE, Kennedy N. The differential enzyme susceptibility of bovine immunoglobulin G1 and immunoglobulin G2 to pepsin and papain. Biochim Biophys Acta. 1978;535:125-37.
51. 1). Biochem J. 1976;155:25-30.
52. 1. J Immunol. 1978;121:98-104.
53. de Rham O, Isliker H. Proteolysis of bovine immunoglobulins. Int Arch Allergy Appl Immunol. 1977;55:61-9.
54. Reilly RM, Domingo R, Sandhu J. Oral delivery of antibodies. Future pharmacokinetic trends. Clin Pharmacokinet. 1997;32:313-23.
55. Petschow BW, Burnett B, Shaw AL, Weaver EM, Klein GL. Serum-derived bovine immunoglobulin/protein isolate: postulated mechanism of action for management of enteropathy. Clin Exp Gastroenterol. 2014;7:181-90.
56. Bosi P, Casini L, Finamore A, Cremokolini C, Merialdi G, Trevisi P, et al. Spray-dried plasma improves growth performance and reduces inflammatory status of weaned pigs challenged with enterotoxigenic Escherichia coli K88. J Anim Sci. 2004;82:1764-72.
57. Perez-Bosque A, Miro L, Polo J, Russell L, Campbell J, Weaver E, et al. Dietary plasma protein supplements prevent the release of mucosal proinflammatory mediators in intestinal inflammation in rats. J Nutr. 2010;140:25-30.
58. Perez-Bosque A, Amat C, Polo J, Campbell JM, Crenshaw J, Russell L, et al. Spray-dried animal plasma prevents the effects of Staphylococcus aureus enterotoxin B on intestinal barrier function in weaned rats. J Nutr. 2006;136:2838-43.
59. Asmuth DM, Ma ZM, Albanese A, Sandler NG, Devaraj S, Knight TH, et al. Oral serum-derived bovine immunoglobulin improves duodenal immune reconstitution and absorption function in patients with HIV enteropathy. AIDS. 2013;27:2207-17.
60. Torrallardona D. Spray dried animal plasma as an alternative to antibiotics in weanling pigs - a review -. Asian-Aust J Anim Sci. 2010;23:131-48.
61. Wilson D, Evans M, Weaver E, Shaw AL, Klein GL. Evaluation of serum-derived bovine immunoglobulin protein isolate in subjects with diarrhea-predominant irritable bowel syndrome. Clin Med Insights Gastroenterol. 2013;6:49-60.