HCP (Host Cell Protein) Identification and Quantification Service Based on LC-MS/MS

STEMart offers advanced Host Cell Protein (HCP) Identification and Quantification Services using LC-MS/MS (Liquid Chromatography-Tandem Mass Spectrometry), a cutting-edge technology essential for detecting and quantifying residual host cell proteins in biopharmaceutical products. In our laboratory, LC-MS/MS provides the sensitivity and specificity needed to ensure the purity and safety of biologics. This technology is crucial for meeting regulatory requirements and ensuring the consistent quality of drug products during the development and manufacturing process.

LC-MS/MS operates by first separating protein mixtures using liquid chromatography, followed by mass spectrometric analysis to identify and quantify specific host cell proteins present in the sample. The tandem mass spectrometry stage allows for precise detection of even low-abundance proteins, making it ideal for HCP monitoring in complex biopharmaceutical samples. LC-MS/MS is widely applied in biopharmaceutical development, where controlling and minimizing HCP levels is critical for product safety and efficacy.

Leveraging our expertise in protein analysis and the capabilities of LC-MS/MS, STEMart offers a comprehensive range of HCP identification and quantification services. Whether you are conducting early-stage research or routine quality control, our services provide accurate and reliable data to support your biopharmaceutical development efforts.

What We Offer

• Comprehensive HCP Identification

We provide detailed identification of host cell proteins in biopharmaceutical products using LC-MS/MS, ensuring that all potential contaminants are detected.

• Quantification of Low-Abundance HCPs

Our service includes the quantification of low-abundance HCPs, helping to ensure that residual protein levels are within acceptable regulatory limits.

• Process Development Support

We offer HCP monitoring throughout the biopharmaceutical development process, supporting process optimization and ensuring product consistency.

• Lot-to-Lot Consistency Testing

Using LC-MS/MS, we perform lot-to-lot consistency testing to confirm that HCP levels remain controlled across different production batches.

Why Choose Us

• High Sensitivity and Specificity

Our LC-MS/MS system delivers high sensitivity and specificity, allowing for the accurate detection and quantification of even trace levels of host cell proteins in complex samples.

• Comprehensive Protein Coverage

We offer thorough coverage of HCPs, ensuring that no potential contaminants are missed in your biopharmaceutical product testing.

• Regulatory Compliance

Our HCP identification and quantification services meet stringent regulatory requirements, ensuring that your data supports compliance with industry standards.

Our Equipment

LC-MS/MS

This system combines liquid chromatography with tandem mass spectrometry, providing precise separation and identification of host cell proteins in biopharmaceutical products with high sensitivity.

Triple Quadrupole MS

Complementing our LC-MS/MS capabilities, this instrument delivers targeted quantification of specific HCPs, ensuring accurate monitoring of residual proteins in complex mixtures.

Nano-LC-MS/MS

This nano-scale liquid chromatography system offers enhanced sensitivity for low-abundance proteins, making it ideal for detecting trace levels of HCPs in biopharmaceutical samples.

STEMart provides high-quality mass spectrometry services tailored to meet the specific needs of our clients. Our experienced specialists use advanced equipment and follow strict quality control measures to ensure accurate and reliable results. Contact us to learn more about our mass spectrometry services and how we can help you achieve your research goals.