A Non-radiometric Approach to Determine Tissue Vascular Blood Volume in Biodistribution Studies.
Biodistribution
Pharmacokinetics (PK)
Residual blood
Tissue blood content
Vascular blood volume
Journal
The AAPS journal
ISSN: 1550-7416
Titre abrégé: AAPS J
Pays: United States
ID NLM: 101223209
Informations de publication
Date de publication:
14 11 2022
14 11 2022
Historique:
received:
08
08
2022
accepted:
28
10
2022
entrez:
14
11
2022
pubmed:
15
11
2022
medline:
18
11
2022
Statut:
epublish
Résumé
The aim of this research was to develop a reliable non-radiometric method to measure the residual blood in tissue without the need for perfusion or radiometric measurements in biodistribution studies. It was found that the perfusion method not only was ineffective in removing blood from tissue, but also introduced additional variability in the determination of tissue drug exposure and was not reproducible across studies. In addition, the use of hemoglobin as an endogenous protein and biomarker for tissue blood content was studied and it was found that hemoglobin measurement in tissue was not a reliable and effective approach for determination of residual blood level in tissue. To evaluate an alternative method for addressing the tissue blood level in biodistribution studies, animals were dosed with a Residual Blood Determinant Reagent (RBDR) 5 min prior to tissue harvesting. The level of RBDR, an exogenous protein, was measured in whole blood homogenate and in tissue lysate. Based on the level of the RBDR, the vascular blood volume (VBV) in tissue was calculated and then the tissue exposures were corrected based on the blood volumes. The tissue VBVs measured by the RBDR method were comparable with the literature values obtained by radiometric measurements.
Identifiants
pubmed: 36376552
doi: 10.1208/s12248-022-00770-6
pii: 10.1208/s12248-022-00770-6
doi:
Substances chimiques
Hemoglobins
0
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
116Informations de copyright
© 2022. The Author(s), under exclusive licence to American Association of Pharmaceutical Scientists.
Références
Wang W, Wang EQ, Balthasar JP. Monoclonal antibody pharmacokinetics and pharmacodynamics. Clinc Pharmaco Therap. 2008;84(5):548–58.
doi: 10.1038/clpt.2008.170
Vugmeyster Y, Xu X, Theil FP, Khawli LA, Leach MW. Pharmacokinetics and toxicology of therapeutic protein: advance and challenges. World J Biol Chem. 2012;3(4):73–92.
doi: 10.4331/wjbc.v3.i4.73
pubmed: 22558487
pmcid: 3342576
Tabrizi MA, Tseng CML, Roskos LK. Elimination mechanism of therapeutic monoclonal antibodies. Drug Discov Today. 2006;11(1/2):81–8.
doi: 10.1016/S1359-6446(05)03638-X
pubmed: 16478695
Tabrizi MA, Bornstein GG, Klakamp SL, Drake A, Knight R. Roskos L. Translational strategies for development of monoclonal antibodies from discovery to clinic. Drug Discov Today. 2009;14(5/6): 298–30.
Mould DR, Sweeney KRD. The pharmacokinetics and pharmacodynamics of monoclonal antibodies-mechanistic modeling applied to drug development. Drug Discov Dev. 2007;10(1):84–96.
Tabrizi M, Funelas C, Suria H. Application of quantitative pharmacology in development of therapeutic monoclonal antibodies. AAPS J. 2010;12(4):592–601.
doi: 10.1208/s12248-010-9220-2
pubmed: 20652780
pmcid: 2977000
Walker, KW, Salimi-Moosavi H, Arnold GE, Chen Q, Soto M, Jacobsen FW, Hui J. Pharmacokinetic comparison of a diverse panel of non-targeting human antibodies as matched IgG1 and IgG2 isotypes in rodents and non-human primates. PLoS ONE 14(5):e0217061. https://doi.org/10.1371/journal.pone.021706 .
Tabrizi MA, Bornstein GG, Suria H. Biodistribution mechanism of therapeutic monoclonal antibodies in health and disease. AAPS J. 2010;12(1):33–43.
doi: 10.1208/s12248-009-9157-5
pubmed: 19924542
Lee JW, Kelley M, King LE, Yang J, Salimi-Moosavi H, Tang MT, Lu J-F, Kamerud J, Ahene A, Myler H, Rogers C. Bioanalytical approaches to quantify “total” and “free” therapeutic antibodies and their targets: technical challenges and PK/PD applications over the course of drug development. AAPS J. 2011;13(1):99–110.
doi: 10.1208/s12248-011-9251-3
pubmed: 21240643
pmcid: 3032085
LeBlanc PP. Drug distribution in the body. Gen Pharmac. 1988;19(3):357–60.
doi: 10.1016/0306-3623(88)90028-6
Shah DK, Bets AM. Antibody biodistribution coefficients. mAbs. 2013;5(2):297–305.
doi: 10.4161/mabs.23684
pubmed: 23406896
pmcid: 3893240
Baxter LT, Zu H, Mackensen DG, Jain RH. Physiologically based pharmacokinetic model for specific and nonspecific monoclonal antibodies and fragments in normal tissues and human tumor xenografts in nude mice. Cancer Res. 1994;54(6):1517–1528.
Richter WF, Bhansali SG, Morris ME. Mechanistic determination of biotherapeutics absorption following SC administration. AAPS J. 2012;14(3):559–70.
doi: 10.1208/s12248-012-9367-0
pubmed: 22619041
pmcid: 3385825
Gill KL, Gardner I, Li L, Jamei M. A bottom-up whole-body physiologically based pharmacokinetic model to mechanistically predict tissue distribution and the rate of subcutaneous absorption of therapeutic proteins. AAPS J. 2016;18(1):156–70.
doi: 10.1208/s12248-015-9819-4
pubmed: 26408308
Yip V, Palma E, Tesar DB, Mundo EE, Bumbaca D, Torres EK, Reyes NA, Shen BQ, Fielder PJ, Pebhu S, Khawli LA, Boswell CA. Quantitative cumulative biodistribution of antibodies in mice. mAbs. 2014;6(3):689–96.
doi: 10.4161/mabs.28254
pubmed: 24572100
pmcid: 4011913
Abuqayyas L, Balthasar J. Pharmacokinetic mAb-mAb interaction: anti-VEGF mAb decreases the distribution of anti-CEA mAb into colorectal xenografts. AAPS J. 2012;14(3):445–55.
doi: 10.1208/s12248-012-9357-2
pubmed: 22528507
pmcid: 3385816
Vugmeyster Y, Defranco D, Szklut P, Wang Q, Xu X. Biodistribution of [
doi: 10.1002/jps.21855
Kamth AV, Williams SP, Bullens S, Cowan KJ, Stenberg Y, Chery SR, Rending S, Lukis DL, Griesmer C, Damico-Beyer LA, Bunting S. Pharmacokinetics and biodistribution of human monoclonal antibody to oxidized LDL in cynomolgus monkey using PET imaging. PLOS One. 2012;7(9):1–8.
Bernareggi A, Rowlan M. Physiologic of cyclosporin kinetics in rat and man. J Pharmaco Biopharm. 1991;19(1):21–50.
doi: 10.1007/BF01062191
Boswell CA, Ferl GZ, Mundo EE, Schweiger MG, Marik J, Reich MP, Theil FP, Fielder PJ, Khawli LA. Development and evaluation of a novel method for preclinical measurement of tissue vascular volume. Mol Pharm. 2010;7(5):1848–57.
doi: 10.1021/mp100183k
pubmed: 20704296
Boswell CA, Mundo EE, Ulufatu S, Bumbaca D, Cahaya HS, Majidy N, Hoy MV, Schweiger MG, Fielder PJ, Prabhu S, Khawli LA. Comparative physiology of mice and rats: radiometric measurement of vascular parameters in rodent tissues. Mol Pharm. 2014;11:1591–8.
doi: 10.1021/mp400748t
pubmed: 24702191
Brown RP, Delp MD, Lindstedt SL, Rhoberg LR, Beliles RP. Physiological parameter values for physiological based pharmacokinetic models. Toxicol Ind Health. 1997;13(4):407–84.
doi: 10.1177/074823379701300401
pubmed: 9249929
Vlot AHC, Witte WEA, Dahof M, Graaf PH, Westen GJP, Lange ECM. Target and tissue selectivity prediction by integrated mechanistic pharmacokinetic-target binding and quantitative structure activity modeling. AAPS J. 2018;20(1):11. https://doi.org/10.1208/s12248-017-0172-7 .
doi: 10.1208/s12248-017-0172-7
Deng R, Iyer S, Theil FP, Mortensen DL, Fielder PJ, Prabhu S. Projecting human pharmacokinetics of therapeutic antibodies from nonclinical data. mAbs. 2011;3(1):61–6.
doi: 10.4161/mabs.3.1.13799
pubmed: 20962582
pmcid: 3038012
Smith AD, Beaumont K, Maurer TS, Di L. Volume of distribution in drug design. J Med Chem. 2015;58(15):5691–8.
doi: 10.1021/acs.jmedchem.5b00201
pubmed: 25799158
Wan H. An overall comparison of small molecules and large biologics in ADME testing. ADMET& DMPK. 2016;4(1):1–22. https://doi.org/10.5599/admet.4.1.276 .
Roopenian DC, Akilesh S. FcRn: the neonatal Fc receptor comes of age. Nature Rev Immuno. 2007;7(9):715–25.
doi: 10.1038/nri2155
Datta-Mannan A, Witcher DR, Tang Y, Watkins J, Wroblewski VJ. Monoclonal antibody clearance-impact of modulating the interaction of IgG with neonatal Fc receptor. J Biol Chem. 2007;282(3):1709–17.
doi: 10.1074/jbc.M607161200
pubmed: 17135257
Chen N, Wang W, Fauty S, Fang Y, Hamuro L, Hussain A, Prueksartanont T. The effect of the neonatal fc receptor on human IgG biodistribution in mice. Mabs. 2014;6(2):502–8.
doi: 10.4161/mabs.27765
pubmed: 24492305
pmcid: 3984338
Wang W, Lu P, Hamuro L, Pittman T, Carr B, Hochman J, Prueksartanont T. Monoclonal antibodies with identical Fc sequence can bind to FcRn differently with pharmacokinetic consequence. Drug Met Disp. 2011;39(9):1469–77.
doi: 10.1124/dmd.111.039453
Leabman MK, Meng YG, Kelly RF, DeForge L, Cowan KJ, Iyer S. Effect of altered FcγR binding on antibody pharmacokinetics in cynomolgus monkeys. mAbs. 2013;5(6):896–903.
doi: 10.4161/mabs.26436
pubmed: 24492343
pmcid: 3896603
Kim J, Hayton WL, Robinson JM, Anderson CL. Kinetics of FcRn-mediated recycling of IgG and albumin in human: pathophysiology and therapeutic implications using a simplified mechanism-based model. Clinc Immun. 2007;122(2):146–55.
doi: 10.1016/j.clim.2006.09.001
Leelawattanachai J, Kwon KW, Michael P, Ting R, Kim JY, Jin MM. Side-by side comparison of commonly used biomolecules that differs in size and affinity on tumor uptake and internalization. PLoS ONE 10(4):e0124440. https://doi.org/10.1371/Journal.pone.0124440 .
Li Z, Krippendorff B-F, Sharma S, Walz AC, Lave T, Shah DK. Influence of molecular size on tissue distribution of antibody fragments. mAbs. 2016;8(1):113–9.
doi: 10.1080/19420862.2015.1111497
pubmed: 26496429
Heerington-Symes AP, Farys M, Khalili H, Brocchini S. Antibody fragments: prolonging circulating half-life special issue-antibody research. Advance Biosci Biotec. 2013;4:689–98.
doi: 10.4236/abb.2013.45090
Scita G, DiFore PP. The endocytic matrix. Nature. 2010;463:464–73.
doi: 10.1038/nature08910
pubmed: 20110990
Steinman RM, Mellman IS, Muller WA, Cohn ZA. Endocytosis and the recycling of plasma membrane. J Cell Biol. 1983;96:1–27.
doi: 10.1083/jcb.96.1.1
pubmed: 6298247
Chang H-P, Kim SJ, Shah DK. Whole-body pharmacokinetics of antibody in mice determined using enzyme-linked immunosorbent assay and derivation of tissue interstitial concentrations. J Pharmaco Sci. 2021;110:446–55.
doi: 10.1016/j.xphs.2020.05.025
Patrick ST, Glowniak JV, Turner FE, Robbins MS, Wolfangel RG. Comparison of in vitro RBC labeling with the UltraTag RBC kit versus in vivo labeling. J Nucl Med. 1991;32(2):242–4.
pubmed: 1992026
Wiig H, Kolmannskog O, Tenstad O, Bert JL. Effect of charge on interstitial distribution of albumin in rat dermis in vitro. J Physiol. 2003;550(2):505–14.
doi: 10.1113/jphysiol.2003.042713
pubmed: 12766239
pmcid: 2343033
Salimi-Moosavi H, Soto M, Salyers K. The use of biotin-drug-conjugates in an in-vivo PK study for investigating the impact of anti-drug antibody on the exposures. National Biotechnology Conference 2012, NBC-12–00440, Poster # W3083.
Mandikian D, Figueroa I, Oldendorp A, Rafidi H, Ulufatu S, Schweiger MG, Couch JA, Dybdal N, Joseph SB, Prabhu S, Ferl GZ, Boswell CA. Tissue physiology of cynomolgus monkeys: cross species comparison and implications for translational pharmacology. AAPS J. 2018;20(6):107.
doi: 10.1208/s12248-018-0264-z
pubmed: 30298434
Garg A, Balthasar JP. Physiologically-based pharmacokinetic (PBPK) model to predict IgG tissue kinetics in wild-type and FcRn-knockout mice. J Pharmacokinet Pharmacodyn. 2007;34(5):687–709.
doi: 10.1007/s10928-007-9065-1
pubmed: 17636457