Host Cell Protein Detection Service

Host cell protein detection is a critical analytical process in biopharmaceutical manufacturing, designed to identify and quantify residual host cell proteins (HCPs) in the final product. These process-related impurities originate from host cells used during the production of therapeutic proteins and may remain in trace amounts even after purification, potentially causing immunogenic reactions, reduced stability, or interference with therapeutic efficacy. By employing advanced techniques such as ELISA, 2D gel electrophoresis, and mass spectrometry, host cell protein detection ensures comprehensive identification and quantification of HCPs, meeting regulatory standards and ensuring product safety. This process addresses challenges such as detecting low-abundance HCPs, characterizing their modifications, and identifying immunogenic proteins. Additionally, it helps manufacturers optimize purification strategies, improve process consistency, and ensure batch-to-batch uniformity.

 



Figure 1. The Workflow of Host Cell Protein Detection by LC-MS/MS

 

Services at MtoZ Biolabs

MtoZ Biolabs offers professional host cell protein detection service that helps biopharmaceutical companies ensure product quality and safety. By combining advanced ELISA, 2D gel electrophoresis (2D-Gel), and high-resolution mass spectrometry technologies, we provide comprehensive identification and quantification of residual HCPs, including low-abundance and modified proteins. Our services cover all stages, from early process development to final batch release, delivering high-sensitivity and high-precision HCP analysis. Backed by an experienced technical team and state-of-the-art equipment, MtoZ Biolabs' HCP detection services optimize purification processes, enhance process consistency, and ensure compliance with regulatory requirements while minimizing potential immunogenic risks. We empower clients to accelerate biopharmaceutical development with reliable and comprehensive host cell protein detection solutions. If you are interested in our service, please contact us freely.

 

Service Advantages

1. Precise Detection and Monitoring: MtoZ Biolabs offers high-sensitivity host cell protein detection technologies, enabling efficient monitoring at all stages of drug development and production to ensure product safety.

 

2. Advanced Mass Spectrometry Technology: Leveraging high-resolution mass spectrometry, MtoZ Biolabs provides comprehensive residual host cell protein detection, ensuring the accuracy and reliability of results.

 

3. Flexible Risk Assessment and Management: Incorporating risk assessment methodologies, MtoZ Biolabs customizes HCP control strategies to meet the needs of different production stages, helping clients optimize product quality and safety.

 

Case Study

Case 1: A study presents a simple, fast method for host cell protein detection in biotherapeutics using sodium deoxycholate (SDC) as a denaturant, eliminating the need for sample fractionation or enrichment, and enabling effective HCP quantification without complex procedures.

 



Li, D. et al. Anal Chem. 2020.

Figure 2. Host Cell Protein Detection After Sodium Deoxycholate-Assisted Digestion

 

Case 2: This article presents a simple and sensitive differential digestion method for host cell protein detection in adeno-associated virus samples using LC-MS. 

 



Hu, Y. et al. J Pharm Biomed Anal. 2024.

Figure 3. Concentration Detection of Virus Residual Host Cell Protein

 

FAQ

Q1: How many samples can be analyzed in one test using 2D WB for host cell protein detection?

Answer: Using 2D WB for host cell protein detection, one test can analyze up to 3 HCP samples. The test report provides individual HCP images and overlay images of different HCP samples, offering direct visualization and comparison of HCP composition, modifications, and fragments, which cannot be achieved on other platforms. Additionally, quantitative analysis includes spot counting, similarity analysis, and the total HCP and DS quantification.

 

Q2: What is the development process for host cell potein detection?

Answer: The overall process for developing host cell protein detection begins with defining/selecting a suitable antigen, which is characterized and prepared before being injected into animal models (e.g., rabbits, goats, or chickens). During the immunization process, the titer and specific immune response of the animals are thoroughly examined. Specific anti-HCP antibodies are purified from the antiserum and characterized using two-dimensional gel electrophoresis (2D-Gel)/Western Blot (WB) for linear coverage, ideally supplemented with pull-down experiments and mass spectrometry readings. The characterized antibody library is then used for assay setup and optimization, which can be validated and applied in routine batch release testing.

 

Deliverables

1. Comprehensive Experimental Details

2. Materials, Instruments, and Methods

3. Relevant Liquid Chromatography and Mass Spectrometry Parameters

4. The Detailed Information of Host Cell Protein

5. Mass Spectrometry Image

6. Raw Data