| Title: |
An Innovative Standard for LC-MS-based HCP-profiling and Accurate Quantity Assessment: Application to Batch Consistency in Viral Vaccine Samples |
| Authors: |
Trauchessec, Mathieu; Hesse, Anne Marie; Kraut, Alexandra; Berard, Yves; Herment, Laura; Fortin, Tanguy; Bruley, Christophe; Ferro, Myriam; Manin, Catherine |
| Contributors: |
Sanofi Pasteur Marcy-l'Étoile, France; Etude de la dynamique des protéomes (EDyP); BioSanté (UMR BioSanté); Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut de Recherche Interdisciplinaire de Grenoble (IRIG); Direction de Recherche Fondamentale (CEA) (DRF (CEA)); Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Direction de Recherche Fondamentale (CEA) (DRF (CEA)); Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Université Grenoble Alpes (UGA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut de Recherche Interdisciplinaire de Grenoble (IRIG); Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Université Grenoble Alpes (UGA); Anaquant; ANR-10-INBS-0008,ProFI,Infrastructure Française de Protéomique(2010) |
| Source: |
ISSN: 1615-9853. |
| Publisher Information: |
CCSD; Wiley-VCH Verlag |
| Publication Year: |
2021 |
| Collection: |
Université Grenoble Alpes: HAL |
| Subject Terms: |
viral vaccine; quantification; mass spectrometry; integrated solution; host cell proteins; HCP-PROFILER; [SDV]Life Sciences [q-bio] |
| Description: |
International audience ; Biotherapeutics, molecules produced from biological systems, require rigorous purification steps to remove impurities including host cell proteins (HCPs). Regulatory guidelines require manufacturers to monitor process-related impurities along the purification workflow. Mass spectrometry (MS) has recently been considered as a complementary method to the well-established ELISA for HCPs quantification, since it has the advantage of unambiguously identifying individual HCP. In this study, we developed an innovative standard dedicated to MS-based HCP-profiling analysis in order to monitor the consistency of viral vaccine intermediate purification samples. This standard, termed the HCP-PROFILER standard, is composed of a water-soluble bead (READYBEADSTM technology) which, after being added into the sample, releases unlabeled peptides in controlled amounts. The standard meets three desired criteria: (1) it is composed of multiple peptides, at different concentration levels, allowing construction of a calibration curve covering the dynamic range of HCPs present in the target sample, ensuring quantification accuracy; (2) it demonstrates high batch-to-batch reproducibility, ensuring quantification robustness and consistency over time; and (3) it is easy to use and avoids user-induced analytical biases. In this study, we present the use of the HCP-PROFILER standard for vaccine batches comparison and downstream process performance studies. This article is protected by copyright. All rights reserved. |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| Relation: |
info:eu-repo/semantics/altIdentifier/pmid/33459490; PUBMED: 33459490 |
| DOI: |
10.1002/pmic.202000152 |
| Availability: |
https://hal.science/hal-03605374; https://doi.org/10.1002/pmic.202000152 |
| Accession Number: |
edsbas.E5AA5ADE |
| Database: |
BASE |