Host Cell Protein (HCP) Analysis
Host cell proteins (HCPs) are host cell-derived proteins introduced during the manufacturing process of recombinant therapeutic products. These residual HCPs could affect the efficacy, safety and product quality.
Applied Biomics’ HCP analysis complies with U.S. Pharmacopeia general chapter 1132.1 regarding accuracy, sensitivity, dynamic range and specificity. We offer both Gel (1D and 2D) and Mass spectrometry-based analysis to detect, identify and quantify HCPs for samples at different stages of process. Our services offer orthogonal methods to compliment your in-house tests and facilitate regulatory filing.
To better serve our customers, we now offer Anti-HCP Antibodies (CHO, HEK, E. coli) with over 95% HCP coverage.
Please use the table below to guide you in choosing the right service:
|Process Optimization & HCP Characterization 1
|1D HCP Profiling
|Quick comparison of HCPs by Mw
|2D HCP Profiling
|In-depth comparison of HCPs
by Mw and pI
|Evaluate HCP Antibody Coverage 2
|2D HCP Antibody Coverage
|Assess/compare commercial vs. process specific HCP Ab
|HCP Impurity Characterization 3
|HCP Identification and Quantitation by LCMSMS
|Identify and quantify all HCPs in a sample
1. Process Optimization & HCP Characterization:
For in-depth analysis of HCP clearance during the process development, our 2D HCP profiling can test up to 3 samples in each run and generates comprehensive HCP 2D image and quantitation of each sample as well as comparisons between the samples. Our 1D HCP profiling offers a rapid detection and quantitation of up to 10 process samples in each test.
2. HCP Antibody Coverage:
Most comprehensive platform to evaluate and compare process specific vs. commercial HCP antibody. Using high resolution, large format 2D fluorescent Western Blot, our HCP Antibody Coverage platform offers high sensitivity detection and accurate quantitation.
3. HCP Impurity Characterization:
Identify and quantify trace amount of HCPs in final product or any step during the process development. By incorporating fractionation at protein level and/or deep scan with AcquireX work flow, we can reliably detect, identify and quantify HCPs at 1-10 ppm level.