HCP Absolute Quantification Analysis

Host Cell Proteins (HCP) are a very important type of impurity in the biopharmaceutical process. When host cells (such as E. coli, yeast, mammalian cells, etc.) are used to produce recombinant proteins or other biological products, these cells' own proteins may mix with the target product. These residual HCPs may not only affect the safety and efficacy of the drug but also trigger adverse reactions or immune responses. Therefore, accurate quantitative analysis of HCPs is a crucial part of biopharmaceutical development and production. Mass spectrometry-basedabsolute quantification of HCP involves mixing a sample with known concentrations of standard HCP proteins, and then comparing their responses through mass spectrometry to calculate the absolute concentration of HCP in the sample,assessing their potential impact on the drug,is an important step in quality control of biopharmaceuticals.

E, S. Y. J Pharm Sci. 2022.

BTP BioScienceAbsolute Quantification of HCPProcess

Unlike traditional relative quantification methods, absolute quantification provides more accurate and specific HCPcontentinformation,providing a key quality control tool for the biopharmaceutical industry.BTP BioScience(BTP)has been certified byCNAS/ISO9001 dual quality systems; the companyusesthe latestObitrap Fusion Lumosmass spectrometer from Thermocombined withNano-LCnano chromatography technology,to develop an efficient HCP absolute quantification platform,including a high-sensitivity ELISA technology platform and an LC-MS/MS platform, providing you withHCP absolute quantificationservices, regardless of whether HCP antibodies are present, allowing for absolute quantification of total HCP in biological products. For specific HCPs (from a few to several dozen), absolute quantification can be achieved by synthesizing heavy-labeled fingerprint peptides and using PRM data acquisition. We provide you with a complete solution to monitor changes in HCP content during production, thereby ensuring drug quality and efficacy.

Bilingual Project Report

In the technical report, BTP BioScience will provide you with a detailed bilingual (Chinese and English) technical report, including:

1. Experimental steps (in Chinese and English)
2. Related mass spectrometry parameters (in Chinese and English)
3. Detailed information on HCP absolute quantification analysis
4. Mass spectrometry images
5. Raw data

HCP Absolute QuantificationOne-stop Service

You only need to place an order and send the sample
BTP BioScience's one-stop service completes: sample processing, machine analysis, data analysis, project report

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