WO2026110108 - METHODS OF DETECTING HOST CELL PROTEINS

National phase entry is expected:
Publication Number WO/2026/110108
Publication Date 28.05.2026
International Application No. PCT/IB2025/061973
International Filing Date 21.11.2025
Title **
[English] METHODS OF DETECTING HOST CELL PROTEINS
[French] PROCÉDÉS DE DÉTECTION DE PROTÉINES DE CELLULES HÔTES
Applicants **
SUN PHARMACEUTICAL INDUSTRIES LIMITED
Inventors
MODY, Rustom
NAGE, Nitin
LAYEK, Sourav
Priority Data
202421090896   22.11.2024   IN
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Quotation for National Phase entry

Country StagesTotal
China Filing, Examination, Granting2401
EPO Filing, Examination, Granting14806
Japan Filing, Examination, Granting2578
South Korea Filing, Examination, Granting2853
USA Filing, Examination, Granting6340
MasterCard Visa
Total: 28,978
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Abstract[English] The disclosure relates to methods of detecting Host Cell Proteins (HCPs) in biopharmaceutical samples containing a drug product. More specifically, the disclosure relates to methods of assaying HCPs in biopharmaceutical samples using enzymatic digestion protocols, liquid chromatography (LC) gradients, immunoaffinity capture protocols, and High-Resolution Mass Spectrometry (HRMS) to enhance the recovery, detection, and profiling of HCPs, which can impact the efficacy, shelf-life, and therapeutic response of drug products.[French] La présente divulgation concerne des procédés de détection de protéines de cellules hôtes (HCP) dans des échantillons biopharmaceutiques contenant un produit médicamenteux. Plus spécifiquement, l'invention concerne des procédés de dosage de HCP dans des échantillons biopharmaceutiques à l'aide de protocoles de digestion enzymatique, de gradients de chromatographie en phase liquide (LC), de protocoles de capture par immunoaffinité, et de spectrométrie de masse à haute résolution (HRMS) pour améliorer la récupération, la détection et le profilage de HCP, qui peuvent impacter l'efficacité, la durée de conservation et la réponse thérapeutique de produits médicamenteux.

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