PMID- 35183952
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231020
IS  - 1873-376X (Electronic)
IS  - 1570-0232 (Linking)
VI  - 1193
DP  - 2022 Mar 15
TI  - Development of a retention prediction model in ion-pair reversed-phase HPLC for 
      nucleoside triphosphates used as mRNA vaccine raw materials.
PG  - 123168
LID - S1570-0232(22)00072-1 [pii]
LID - 10.1016/j.jchromb.2022.123168 [doi]
AB  - The International Conference on Harmonization guidelines for quality on 
      pharmaceutical development recommends a systematic development approach including 
      robustness studies which assure performance of manufacturing and analytical 
      method development of drug product. It was demonstrated that the retention 
      prediction model for nucleoside triphosphates (NTPs) on ion-pair reversed-phase 
      HPLC was developed by a highly accurate Kawabe's model which supports the 
      development of robust HPLC methods. As NTPs and its derivatives are typically 
      used for Messenger ribonucleic acid (mRNA) vaccine production, 
      adenosine-5'-triphosphate (ATP), guanosine-5'-triphosphate (GTP), 
      cytidine-5'-triphosphate (CTP), 5-methylcytidine-5'-triphosphate (m(5)-CTP), 
      uridine-5'-triphosphate (UTP), 5-methyluridine-5'-triphosphate (m(5)-UTP), 
      pseudouridine-5'-triphosphate (Psi-UTP) and N1-methylpseudouridine-5'-triphosphate 
      (m(1)Psi-UTP) were applied for prediction model development. By a comparison of the 
      predicted retention factor in eight studied samples with the retention factor 
      measured under six isocratic conditions, the absolute prediction error was 0.075 
      and also the prediction error (%) was 2.70%. In practical examples, analytical 
      method for residual ATP, GTP, CTP, and m(1)Psi-UTP in the commercial mRNA-based 
      drugs and purity method for UTP derivatives were optimized by QbD approach. The 
      design space for the minimum resolution between adjacent peaks was simulated with 
      the models developed to evaluate the robustness of peak separation, and the 
      optimal mobile phase condition was also simulated. As a conclusion, the desired 
      peak was successfully separated under the optimized condition, and we thought 
      that these retention models could optimize the mobile phase condition of the NTP 
      analysis method for applying to various quality tests, such as quantity, purity 
      and identity test for NTPs and its derivates in the mRNA-based drugs.
CI  - Copyright (c) 2022 Elsevier B.V. All rights reserved.
FAU - Kitamura, Ryunosuke
AU  - Kitamura R
AD  - Biologics Technology Research Laboratories, Daiichi Sankyo Co., Ltd, 2716-1 
      Akaiwa, Kurakake, Chiyoda-cho, Ora-gun, Gunma 370-0503, Japan.
FAU - Kawabe, Takefumi
AU  - Kawabe T
AD  - Analytical & Quality Evaluation Research Laboratories, Pharmaceutical Technology 
      Division, DAIICHI SANKYO Co., LTD, 1-12-1, Shinomiya, Hiratsuka-shi, Kanagawa 
      254-0014, Japan.
FAU - Masuda, Yumiko
AU  - Masuda Y
AD  - Biologics Technology Research Laboratories, Daiichi Sankyo Co., Ltd, 2716-1 
      Akaiwa, Kurakake, Chiyoda-cho, Ora-gun, Gunma 370-0503, Japan.
FAU - Kajiro, Toshi
AU  - Kajiro T
AD  - Analytical & Quality Evaluation Research Laboratories, Pharmaceutical Technology 
      Division, DAIICHI SANKYO Co., LTD, 1-12-1, Shinomiya, Hiratsuka-shi, Kanagawa 
      254-0014, Japan.
FAU - Nonaka, Koichi
AU  - Nonaka K
AD  - Biologics Technology Research Laboratories, Daiichi Sankyo Co., Ltd, 2716-1 
      Akaiwa, Kurakake, Chiyoda-cho, Ora-gun, Gunma 370-0503, Japan.
FAU - Yonemochi, Etsuo
AU  - Yonemochi E
AD  - Graduate School of Pharmaceutical Sciences, Hoshi University, 2-4-41 Ebara, 
      Shinagawa-ku, Tokyo 142-8501, Japan. Electronic address: e-yonemochi@hoshi.ac.jp.
LA  - eng
PT  - Journal Article
DEP - 20220215
PL  - Netherlands
TA  - J Chromatogr B Analyt Technol Biomed Life Sci
JT  - Journal of chromatography. B, Analytical technologies in the biomedical and life 
      sciences
JID - 101139554
SB  - IM
OTO - NOTNLM
OT  - Ion-pair reversed-phase HPLC
OT  - Nucleoside triphosphates
OT  - Prediction model
OT  - Retention factor
OT  - mRNA vaccine raw material
EDAT- 2022/02/21 06:00
MHDA- 2022/02/21 06:01
CRDT- 2022/02/20 20:35
PHST- 2021/11/24 00:00 [received]
PHST- 2022/02/09 00:00 [revised]
PHST- 2022/02/10 00:00 [accepted]
PHST- 2022/02/21 06:01 [medline]
PHST- 2022/02/21 06:00 [pubmed]
PHST- 2022/02/20 20:35 [entrez]
AID - S1570-0232(22)00072-1 [pii]
AID - 10.1016/j.jchromb.2022.123168 [doi]
PST - ppublish
SO  - J Chromatogr B Analyt Technol Biomed Life Sci. 2022 Mar 15;1193:123168. doi: 
      10.1016/j.jchromb.2022.123168. Epub 2022 Feb 15.