Progress on pharmacokinetics of biotechnology drugs

HE Xiaobo; ZHU Jiahui; GAO Fangyuan

doi:10.3969/j.issn.1006-0111.2019.05.003

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Article Navigation > Journal of Pharmaceutical Practice and Service > 2019 > 37(5): 394-399

HE Xiaobo, ZHU Jiahui, GAO Fangyuan. Progress on pharmacokinetics of biotechnology drugs[J]. Journal of Pharmaceutical Practice and Service, 2019, 37(5): 394-399. doi: 10.3969/j.issn.1006-0111.2019.05.003

Citation:

HE Xiaobo, ZHU Jiahui, GAO Fangyuan. Progress on pharmacokinetics of biotechnology drugs[J]. Journal of Pharmaceutical Practice and Service, 2019, 37(5): 394-399. doi: 10.3969/j.issn.1006-0111.2019.05.003

Progress on pharmacokinetics of biotechnology drugs

doi: 10.3969/j.issn.1006-0111.2019.05.003

1.
Cadet Company 16th, School of Navy Medicine, Naval Medical University, Shanghai 200433, China
2.
Cadet Company 1st, School of Navy Medicine, Naval Medical University, Shanghai 200433, China
3.
Department of Health Toxicology, School of Navy Medicine, Naval Medical University, Shanghai 200433, China

Received Date: 2018-12-11
Rev Recd Date: 2019-03-22

Abstract

Biotechnology drugs have attracted increasing attention as a hot topic in research and development of new drugs.The pharmacokinetics of biotechnology drugs shows uniqueness and complexity due to the different physical and chemical properties from those of small molecule drugs.In this paper,the concept of biotechnology drugs was described and four main analytical methods for biotechnology drugs were summarized,the absorption,distribution,metabolism and excretion of biotechnology drugs in vivo were reviewed and the differences in pharmacokinetics between monoclonal antibody drugs,one of the mainstreams of biotechnology drugs,and small molecule drugs were compared.This review was intended to provides a deep and fully understanding for the pharmacokinetic characteristics and mechanisms of biotechnology drugs,which can serve as a supporting reference for the new biotechnology drug screening,R&D,safety evaluation and clinical use of drugs.
- biotechnology drugs,
- pharmacokinetics

References

[1]	韩迎.生物技术药物的优势与前景展望[J].中国医院药学杂志,2013,33(13):1083-1085.
[2]	KESIK-BRODACKA M.Progress in biopharmaceutical development[J].Biotechnol Appl Biochem,2018,65(3):306-322.
[3]	刘昌孝.我国药物代谢动力学研究的发展及其对创新药物研发的重要作用[J].中国药理学与毒理学杂志,2015,29(5):686-687.
[4]	张振清.我国药物代谢与药代动力学学科发展与展望[J].中国药理学与毒理学杂志,2015,29(5):752-754.
[5]	PARR M K,MONTACIR O,MONTACIR H.Physicochemical characterization of biopharmaceuticals[J].J Pharm Biomed Anal,2016,130:366-389.
[6]	斯琴朝克图,黄玲利,袁宗辉.放射性同位素标记药物在药物代谢与处置研究中的应用[J].中国新药杂志,2016,25(13):1475-1484.
[7]	林立红,余洋,李晓磊,等.放射性同位素示踪法研究2-氟-6-三氟甲基吡啶在大鼠体内的吸收、分布和排泄[J].中国药理学与毒理学杂志,2017,31(6):670-674.
[8]	赵小亮,刘曦,杨忆,等.利用活体成像技术研究海茸β-1,3/1,6-葡聚糖在小鼠体内的分布[J].高等学校化学学报,2017,38(8):1368-1374.
[9]	MU LL,LI SW,ZHOU R,et al. The application of immunoassay in bioanalysis[J].中国药学(英文版),2015,24(4):205-216.
[10]	LIU C C,FANG G Z,DENG Q L,et al. Determination of metolcarb in food by capillary electrophoresis immunoassay with a laser-induced fluorescence detector[J].Electrophoresis,2012,33(9-10):1471-1476.
[11]	WANG J,ZHU X H,KOLLI S,et al. Plasma pharmacokinetics and bioavailability of verticillin A following different routes of administration in mice using liquid chromatography tandem mass spectrometry[J].J Pharm Biomed Anal,2017,139:187-192.
[12]	FRANZONI S,VEZZELLI A,TURTORO A,et al. Development and validation of a bioanalytical method for quantification of LNA-i-miR-221,a 13-mer oligonucleotide,in rat plasma using LC-MS/MS[J].J Pharm Biomed Anal,2018,150:300-307.
[13]	LIAN D S,ZHAO S J.Highly sensitive analysis of nucleic acids using capillary gel electrophoresis with ultraviolet detection based on the combination of matrix field-amplified and head-column field-amplified stacking injection[J].J Chromatogr B,2015,978-979:29-42.
[14]	YU R Z,GRUNDY J S,GEARY R S.Clinical pharmacokinetics of second generation antisense oligonucleotides[J].Expert Opin Drug Metab Toxicol,2013,9(2):169-182.
[15]	BURKI U,KEANE J,BLAIN A,et al. Development and application of an ultrasensitive hybridization-based ELISA method for the determination of peptide-conjugated phosphorodiamidate morpholino oligonucleotides[J].Nucleic Acid Ther,2015,25(5):275-284.
[16]	THWALA L N,PRÉAT V,CSABA N S.Emerging delivery platforms for mucosal administration of biopharmaceuticals:A critical update on nasal,pulmonary and oral routes[J].Expert Opin Drug Deliv,2017,14(1):23-36.
[17]	WALLIS L,KLEYNHANS E,TOIT T,et al. Novel non-invasive protein and peptide drug delivery approaches[J].PPL,2014,21(11):1087-1101.
[18]	UENO H,MIZUTA M,SHⅡYA T,et al. Exploratory trial of intranasal administration of glucagon-like peptide-1 in japanese patients with type 2 diabetes:figure 1[J].Dia Care,2014,37(7):2024-2027.
[19]	RICHTER W F,JACOBSEN B.Subcutaneous absorption of biotherapeutics:knowns and unknowns[J].Drug Metab Dispos,2014,42(11):1881-1889.
[20]	VUGMEYSTER Y.Pharmacokinetics and toxicology of therapeutic proteins:advances and challenges[J].World J Biol Chem,2012,3(4):73.
[21]	ZHAO L,REN T H,WANG D D.Clinical pharmacology considerations in biologics development[J].Acta Pharmacol Sin,2012,33(11):1339-1347.
[22]	LENE H S,PETERSEN L C,LAURITZEN B,et al. Target-mediated clearance and bio-distribution of a monoclonal antibody against the Kunitz-type protease inhibitor 2 domain of Tissue Factor Pathway Inhibitor[J].Thromb Res,2014,133(3):464-471.
[23]	XIAO G Q,GAN L S.Receptor-mediated endocytosis and brain delivery of therapeutic biologics[J].Int J Cell Biol,2013,2013:1-14.
[24]	DENG R,JIN F,PRABHU S,et al. Monoclonal antibodies:what are the pharmacokinetic and pharmacodynamic considerations for drug development[J].Expert Opin Drug Metab Toxicol,2012,8(2):141-160.
[25]	SHI S J.Biologics:an update and challenge of their pharmacokinetics[J].Curr Drug Metab,2014,15(3):271-290.
[26]	BAUMANN A.Early development of therapeutic biologicspharmacokinetics[J].Curr Drug Metab,2006,7(1):15-21.
[27]	PYZIK M,RATH T,LENCER W I,et al. FcRn:the architect behind the immune and nonimmune functions of IgG and albumin[J].J Immunol,2015,194(10):4595-4603.
[28]	WILCOX C R,HOLDER B,JONES C E.Factors affecting the FcRn-mediated transplacental transfer of antibodies and implications for vaccination in pregnancy[J].Front Immunol,2017,8:1294.
[29]	ROBBIE G J,CRISTE R,DALL'ACQUA W F,et al. A novel investigational fc-modified humanized monoclonal antibody,motavizumab-YTE,has an extended half-life in healthy adults[J].Antimicrob Agents Chemother,2013,57(12):6147-6153.
[30]	EZAN E,BECHER F,FENAILLE F.Assessment of the metabolism of therapeutic proteins and antibodies[J].Expert Opin Drug Metab Toxicol,2014,10(8):1079-1091.
[31]	KAPLON H,REICHERT J M.Antibodies to watch in 2018[J].mAbs,2018,10(2):183-203.
[32]	KAPLON H,REICHERT J M.Antibodies to watch in 2019[J].mAbs,2019,11(2):219-238.
[33]	DOSTALEK M,GARDNER I,GURBAXANI B M,et al. Pharmacokinetics,pharmacodynamics and physiologically-based pharmacokinetic modelling of monoclonal antibodies[J].Clin Pharmacokinet,2013,52(2):83-124.
[34]	KAMATH A V.Translational pharmacokinetics and pharmacodynamics of monoclonal antibodies[J].Drug Discov Today Technol,2016,21-22:75-83.
[35]	LIN J.Pharmacokinetics of biotech drugs:peptides,proteins and monoclonal antibodies[J].Curr Drug Metab,2009,10(7):661-691.
[36]	MOULD D R,GREEN B.Pharmacokinetics and pharmacodynamics of monoclonal antibodies[J].BioDrugs,2010,24(1):23-39.

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通讯作者: 陈斌, bchen63@163.com

1.
沈阳化工大学材料科学与工程学院沈阳 110142

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Progress on pharmacokinetics of biotechnology drugs

1. Cadet Company 16th, School of Navy Medicine, Naval Medical University, Shanghai 200433, China

2. Cadet Company 1st, School of Navy Medicine, Naval Medical University, Shanghai 200433, China

3. Department of Health Toxicology, School of Navy Medicine, Naval Medical University, Shanghai 200433, China

Received Date: 2018-12-11

Rev Recd Date: 2019-03-22

Key words:

biotechnology drugs /
pharmacokinetics

Abstract: Biotechnology drugs have attracted increasing attention as a hot topic in research and development of new drugs.The pharmacokinetics of biotechnology drugs shows uniqueness and complexity due to the different physical and chemical properties from those of small molecule drugs.In this paper,the concept of biotechnology drugs was described and four main analytical methods for biotechnology drugs were summarized,the absorption,distribution,metabolism and excretion of biotechnology drugs in vivo were reviewed and the differences in pharmacokinetics between monoclonal antibody drugs,one of the mainstreams of biotechnology drugs,and small molecule drugs were compared.This review was intended to provides a deep and fully understanding for the pharmacokinetic characteristics and mechanisms of biotechnology drugs,which can serve as a supporting reference for the new biotechnology drug screening,R&D,safety evaluation and clinical use of drugs.

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Reference (36)

[1]	韩迎.生物技术药物的优势与前景展望[J].中国医院药学杂志,2013,33(13):1083-1085.
[2]	KESIK-BRODACKA M.Progress in biopharmaceutical development[J].Biotechnol Appl Biochem,2018,65(3):306-322.
[3]	刘昌孝.我国药物代谢动力学研究的发展及其对创新药物研发的重要作用[J].中国药理学与毒理学杂志,2015,29(5):686-687.
[4]	张振清.我国药物代谢与药代动力学学科发展与展望[J].中国药理学与毒理学杂志,2015,29(5):752-754.
[5]	PARR M K,MONTACIR O,MONTACIR H.Physicochemical characterization of biopharmaceuticals[J].J Pharm Biomed Anal,2016,130:366-389.
[6]	斯琴朝克图,黄玲利,袁宗辉.放射性同位素标记药物在药物代谢与处置研究中的应用[J].中国新药杂志,2016,25(13):1475-1484.
[7]	林立红,余洋,李晓磊,等.放射性同位素示踪法研究2-氟-6-三氟甲基吡啶在大鼠体内的吸收、分布和排泄[J].中国药理学与毒理学杂志,2017,31(6):670-674.
[8]	赵小亮,刘曦,杨忆,等.利用活体成像技术研究海茸β-1,3/1,6-葡聚糖在小鼠体内的分布[J].高等学校化学学报,2017,38(8):1368-1374.
[9]	MU LL,LI SW,ZHOU R,et al. The application of immunoassay in bioanalysis[J].中国药学(英文版),2015,24(4):205-216.
[10]	LIU C C,FANG G Z,DENG Q L,et al. Determination of metolcarb in food by capillary electrophoresis immunoassay with a laser-induced fluorescence detector[J].Electrophoresis,2012,33(9-10):1471-1476.
[11]	WANG J,ZHU X H,KOLLI S,et al. Plasma pharmacokinetics and bioavailability of verticillin A following different routes of administration in mice using liquid chromatography tandem mass spectrometry[J].J Pharm Biomed Anal,2017,139:187-192.
[12]	FRANZONI S,VEZZELLI A,TURTORO A,et al. Development and validation of a bioanalytical method for quantification of LNA-i-miR-221,a 13-mer oligonucleotide,in rat plasma using LC-MS/MS[J].J Pharm Biomed Anal,2018,150:300-307.
[13]	LIAN D S,ZHAO S J.Highly sensitive analysis of nucleic acids using capillary gel electrophoresis with ultraviolet detection based on the combination of matrix field-amplified and head-column field-amplified stacking injection[J].J Chromatogr B,2015,978-979:29-42.
[14]	YU R Z,GRUNDY J S,GEARY R S.Clinical pharmacokinetics of second generation antisense oligonucleotides[J].Expert Opin Drug Metab Toxicol,2013,9(2):169-182.
[15]	BURKI U,KEANE J,BLAIN A,et al. Development and application of an ultrasensitive hybridization-based ELISA method for the determination of peptide-conjugated phosphorodiamidate morpholino oligonucleotides[J].Nucleic Acid Ther,2015,25(5):275-284.
[16]	THWALA L N,PRÉAT V,CSABA N S.Emerging delivery platforms for mucosal administration of biopharmaceuticals:A critical update on nasal,pulmonary and oral routes[J].Expert Opin Drug Deliv,2017,14(1):23-36.
[17]	WALLIS L,KLEYNHANS E,TOIT T,et al. Novel non-invasive protein and peptide drug delivery approaches[J].PPL,2014,21(11):1087-1101.
[18]	UENO H,MIZUTA M,SHⅡYA T,et al. Exploratory trial of intranasal administration of glucagon-like peptide-1 in japanese patients with type 2 diabetes:figure 1[J].Dia Care,2014,37(7):2024-2027.
[19]	RICHTER W F,JACOBSEN B.Subcutaneous absorption of biotherapeutics:knowns and unknowns[J].Drug Metab Dispos,2014,42(11):1881-1889.
[20]	VUGMEYSTER Y.Pharmacokinetics and toxicology of therapeutic proteins:advances and challenges[J].World J Biol Chem,2012,3(4):73.
[21]	ZHAO L,REN T H,WANG D D.Clinical pharmacology considerations in biologics development[J].Acta Pharmacol Sin,2012,33(11):1339-1347.
[22]	LENE H S,PETERSEN L C,LAURITZEN B,et al. Target-mediated clearance and bio-distribution of a monoclonal antibody against the Kunitz-type protease inhibitor 2 domain of Tissue Factor Pathway Inhibitor[J].Thromb Res,2014,133(3):464-471.
[23]	XIAO G Q,GAN L S.Receptor-mediated endocytosis and brain delivery of therapeutic biologics[J].Int J Cell Biol,2013,2013:1-14.
[24]	DENG R,JIN F,PRABHU S,et al. Monoclonal antibodies:what are the pharmacokinetic and pharmacodynamic considerations for drug development[J].Expert Opin Drug Metab Toxicol,2012,8(2):141-160.
[25]	SHI S J.Biologics:an update and challenge of their pharmacokinetics[J].Curr Drug Metab,2014,15(3):271-290.
[26]	BAUMANN A.Early development of therapeutic biologicspharmacokinetics[J].Curr Drug Metab,2006,7(1):15-21.
[27]	PYZIK M,RATH T,LENCER W I,et al. FcRn:the architect behind the immune and nonimmune functions of IgG and albumin[J].J Immunol,2015,194(10):4595-4603.
[28]	WILCOX C R,HOLDER B,JONES C E.Factors affecting the FcRn-mediated transplacental transfer of antibodies and implications for vaccination in pregnancy[J].Front Immunol,2017,8:1294.
[29]	ROBBIE G J,CRISTE R,DALL'ACQUA W F,et al. A novel investigational fc-modified humanized monoclonal antibody,motavizumab-YTE,has an extended half-life in healthy adults[J].Antimicrob Agents Chemother,2013,57(12):6147-6153.
[30]	EZAN E,BECHER F,FENAILLE F.Assessment of the metabolism of therapeutic proteins and antibodies[J].Expert Opin Drug Metab Toxicol,2014,10(8):1079-1091.
[31]	KAPLON H,REICHERT J M.Antibodies to watch in 2018[J].mAbs,2018,10(2):183-203.
[32]	KAPLON H,REICHERT J M.Antibodies to watch in 2019[J].mAbs,2019,11(2):219-238.
[33]	DOSTALEK M,GARDNER I,GURBAXANI B M,et al. Pharmacokinetics,pharmacodynamics and physiologically-based pharmacokinetic modelling of monoclonal antibodies[J].Clin Pharmacokinet,2013,52(2):83-124.
[34]	KAMATH A V.Translational pharmacokinetics and pharmacodynamics of monoclonal antibodies[J].Drug Discov Today Technol,2016,21-22:75-83.
[35]	LIN J.Pharmacokinetics of biotech drugs:peptides,proteins and monoclonal antibodies[J].Curr Drug Metab,2009,10(7):661-691.
[36]	MOULD D R,GREEN B.Pharmacokinetics and pharmacodynamics of monoclonal antibodies[J].BioDrugs,2010,24(1):23-39.

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Progress on pharmacokinetics of biotechnology drugs

doi: 10.3969/j.issn.1006-0111.2019.05.003

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References

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通讯作者: 陈斌, bchen63@163.com

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