PXD018427

PXD018427 is an original dataset announced via ProteomeXchange.

Title	A Sensitive, Rapid, Robust and Reproducible Workflow for Host Cell Protein Profiling in Biopharmaceutical Process Development
Description	There is a growing industry and regulatory need to detect host cell protein (HCP) impurities in the production of protein biopharmaceuticals, as certain HCPs can impact product stability, safety, and efficacy, even at low levels.1-6 In some cases, regulatory agencies require the identification as well as the quantification of HCPs in drug products for risk assessment, and this is an active and growing topic of conversation in industry and amongst regulators. In this study, we developed a sensitive, robust, and reproducible workflow for HCP detection and quantification in the significantly shorter turnaround time than previously reported using an Evosep ONE LC system coupled to an Orbitrap Fusion Lumos mass spectrometer. Due to its fast turnaround time, this HCP workflow can be integrated into process development for the high-throughput (60 samples analyzed per day) identification of HCPs. The ability to rapidly measure HCPs and follow their clearance throughout the downstream process can be used to pinpoint sources of HCP contamination, which can be used to optimize biopharmaceutical production to minimize HCP levels. Analysis of the NIST monoclonal antibody (mAb) reference material using the rapid HCP profiling workflow detected the largest number of HCPs reported to date, underscoring an improvement in performance along with an increased throughput. The HCP workflow can be readily implemented and adapted for different purposes to guide biopharmaceutical process development and enable better risk assessment of HCPs in drug substances (DS) and drug products (DP).
HostingRepository	PRIDE
AnnounceDate	2024-10-22
AnnouncementXML	Submission_2024-10-22_05:06:42.128.xml
DigitalObjectIdentifier
ReviewLevel	Peer-reviewed dataset
DatasetOrigin	Original dataset
RepositorySupport	Unsupported dataset by repository
PrimarySubmitter	Jiao Ma
SpeciesList	scientific name: Mus musculus (Mouse); NCBI TaxID: 10090;
ModificationList	No PTMs are included in the dataset
Instrument	Orbitrap Fusion Lumos

Revision	Datetime	Status	ChangeLog Entry
0	2020-04-08 02:27:18	ID requested
1	2020-06-02 08:59:12	announced
⏵ 2	2024-10-22 05:06:44	announced	2024-10-22: Updated project metadata.

10.1021/acs.jproteome.0c00252;

Ma J, Kilby GW, Sensitive, Rapid, Robust, and Reproducible Workflow for Host Cell Protein Profiling in Biopharmaceutical Process Development. J Proteome Res, 19(8):3396-3404(2020) [pubmed]

submitter keyword: monoclonal antibody (mAb), drug product (DP), EvosepONE, drug substance (DS),host cell proteins (HCPs), LC-MS/MS

Greg Kilby
contact affiliation	GlaxoSmithKline CMC Analytical
contact email	greg.w.kilby@gsk.com
lab head
Jiao Ma
contact affiliation	GSK
contact email	jiao.8.ma@gsk.com
dataset submitter

Dataset FTP location NOTE: Most web browsers have now discontinued native support for FTP access within the browser window. But you can usually install another FTP app (we recommend FileZilla) and configure your browser to launch the external application when you click on this FTP link. Or otherwise, launch an app that supports FTP (like FileZilla) and use this address: ftp://ftp.pride.ebi.ac.uk/pride/data/archive/2020/06/PXD018427

PRIDE project URI

• PRIDE
  1. PXD018427
     1. Label: PRIDE project
     2. Name: A Sensitive, Rapid, Robust and Reproducible Workflow for Host Cell Protein Profiling in Biopharmaceutical Process Development