Bioanalytical Challenge Kumar, King, Clark & Gorovits
Financial & competing interests disclosure All authors (S Kumar, LE King, TH Clark and B Gorovits) are employees of Pfizer, Inc. (MA, USA), which is involved in the development of compounds relevant to those discussed in this article, and receive salary- and equity-based remunera- tion. The authors have no other relevant affiliations or finan-
References Papers of special note have been highlighted as: • of interest; •• of considerable interest
1 Hamblett KJ, Senter PD, Chace DF et al. Effects of drug loading on the antitumor activity of a monoclonal antibody drug conjugate. Clin. Cancer Res. 10(20), 7063–7070 (2004).
2 Xie H, Audette C, Hoffee M et al. Pharmacokinetics and biodistribution of the antitumor immunoconjugate, cantuzumab mertansine (huC242-DM1), and its two components in mice. J. Pharmacol. Exp. Ther. 308(3), 1073–1082 (2004).
3
Junutula JR, Raab H, Clark S et al. Site-specific conjugation of a cytotoxic drug to an antibody improves the therapeutic index. Nat. Biotechnol. 26(8), 925–932 (2008).
4 Baldwin AD, Kiick KL. Tunable degradation of maleimide- thiol adducts in reducing environments. Bioconjug. Chem. 22(10), 1946–1953 (2011).
5
Shen BQ, Bumbaca D, Saad O et al. Catabolic fate and pharmacokinetic characterization of trastuzumab emtansine (T-DM1): an emphasis on preclinical and clinical catabolism. Curr. Drug Metab. 13, 901–910 (2012).
6 7
Shen BQ, Xu K, Liu L et al. Conjugation site modulates the in vivo stability and therapeutic activity of antibody–drug conjugates. Nat. Biotechnol. 30(2), 184–189 (2012).
Strop P, Shu-Hui L et al. Location matters: site of conjugation modulates stability and pharmacokinetics of antibody drug conjugates. Chem. Biol. 20(2), 161–167 (2013).
8 Gorovits B, Alley S, Bilic S et al. Bioanalysis of antibody– drug conjugates. AAPS ADC working group position paper. Bioanalysis 5(9), 997–1006 (2013).
•• Antibody–drug conjugate (ADC) working group position paper that provides a comprehensive review of ADC bioanalysis.
9 Kaur S, Xu K, Saad OM et al. Bioanalytical assay strategies for the development of antibody drug conjugate biotherapeutics. Bioanalysis 5(2), 201–226 (2013).
• Describes different bioanalytical methods required during different stages of ADC development.
10 Dufield D, Neubert H, Garofolo F et al. 2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 2 – hybrid LBA/LCMS, ELN & regulatory agencies’ input). Bioanalysis 6(23), 3237–3249 (2014).
11 Keyang Xu, Luna Liu, Randall Dere et al. Characterization of the drug-to-antibody ratio distribution for antibody–drug conjugates in plasma/serum. Bioanalysis 5(9), 1057–1071 (2013).
12 Lin K, Tibbitts J. Pharmacokinetic considerations for antibody drug conjugates. Pharm. Res. 29(9), 2354–2366 (2012).
cial involvement with any organization or entity with a finan- cial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this
manuscript.
13 Sauerborn M, van Dongen W. Practical considerations for the pharmacokinetic and immunogenic assessment of antibody–drug conjugates. BioDrugs 28(4), 383–391 (2014).
14 King LE, Leung S, Ray C. Discovery fit-for-purpose ligand- binding PK assays: what’s really important? Bioanalysis 5(12), 1463–1466 (2013).
15 Stephan JP, Chan P, Lee C et al. Anti-CD22-MCC-DM1 and MC-MMAF conjugates: impact of assay format on pharmacokinetic parameters determination. Bioconjug. Chem. 19(8), 1673–1683 (2008).
• Compares assay formats for conjugated antibody assay formats and their impact on PK parameter determinations.
16 Stephan JP, Kozak KR, Wong WLT. Challenges in developing bioanalytical assays for characterization of antibody–drug conjugates. Bioanalysis 3(6), 677–700 (2011).
17 Kozak KR, Tsai SP, Fourie-O’Donohue A et al. Total antibody quantification for MMAE-conjugated antibody–drug conjugates: impact of assay format and reagents. Bioconjug. Chem. 24(5), 772–779 (2013).
18 Dowell JA, Korth-Bradley J, Liu H et al. Pharmacokinetics of gemtuzumab ozogamicin, an antibody-targeted chemotherapy agent for the treatment of patients with acute myeloid leukemia in first relapse. J. Clin. Pharmacol. 41, 1206–1214 (2001).
19 Dijoseph JF, Armellino DC, Boghaert ER et al. Antibody- targeted chemotherapy with CMC-544: a CD22-targeted immunoconjugate of calicheamicin for the treatment of B-lymphoid malignancies. Blood 103(5), 1807–1814 (2004).
20 Dere R, Yi JH, Lei C et al. PK assays for antibody–drug conjugates: case study with ado-trastuzumab emtansine. Bioanalysis 5, 1025–1040 (2013).
21 Hussain A, Gorovits B, Leal M et al. PK of immunoconjugate anticancer agent CMD-193 in rats: ligand-binding assay approach to determine in vivo immunoconjugate stability. Bioanalysis 6(1), 21–32 (2014).
22 Tuck MK, Chan DW, Chia D et al. Standard operating procedures for serum and plasma collection: early detection research network consensus statement standard operating procedure integration working group. J. Proteome Res. 8(1), 113–117 (2009).
23 Mitchell BL, Yasui Y, Li CI et al. Impact of freeze-thaw cycles and storage time on plasma samples used in mass spectrometry based biomarker discovery projects. Cancer Inform. 1, 98–104 (2005).
24 Kelley M, Ahene AB, Gorovits B. Theoretical considerations and practical approaches to address the effect of anti-drug antibody (ADA) on quantification of biotherapeutics in circulation. AAPS J. 3, 646–658 (2013).
25 Stevenson L, Amaravadi L, Myler H et al. White Paper on recent issues in bioanalysis: a full immersion in bioanalysis
1616 Bioanalysis (2015) 7(13)
future science group
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76 |
Page 77 |
Page 78 |
Page 79 |
Page 80 |
Page 81 |
Page 82 |
Page 83 |
Page 84 |
Page 85 |
Page 86 |
Page 87 |
Page 88 |
Page 89 |
Page 90 |
Page 91 |
Page 92 |
Page 93 |
Page 94 |
Page 95 |
Page 96 |
Page 97 |
Page 98 |
Page 99 |
Page 100 |
Page 101 |
Page 102 |
Page 103 |
Page 104 |
Page 105 |
Page 106 |
Page 107 |
Page 108 |
Page 109 |
Page 110 |
Page 111 |
Page 112 |
Page 113 |
Page 114 |
Page 115 |
Page 116 |
Page 117 |
Page 118 |
Page 119 |
Page 120 |
Page 121 |
Page 122 |
Page 123 |
Page 124 |
Page 125 |
Page 126 |
Page 127 |
Page 128 |
Page 129 |
Page 130 |
Page 131 |
Page 132 |
Page 133 |
Page 134 |
Page 135 |
Page 136 |
Page 137 |
Page 138 |
Page 139 |
Page 140 |
Page 141 |
Page 142 |
Page 143 |
Page 144 |
Page 145 |
Page 146 |
Page 147 |
Page 148 |
Page 149 |
Page 150 |
Page 151 |
Page 152 |
Page 153 |
Page 154