HCW Biologics is a clinical-stage company advancing the development of novel immunotherapeutics designed to disrupt the link between chronic, low-grade inflammation and age-related disorders. This field, known as inflammaging, targets the unresolved inflammatory responses and chronic, low-grade inflammation associated with advancing age and believed to be a significant contributing factor to cancer and other chronic conditions.
HCW Biologics requested characterization of a fusion protein complex containing 4 different subunits. The characterization study included:
- liquid chromatography pattern
- higher order structure analysis
- thermal stability
- protein oligomer analysis (aggregation)
BioPharmaSpec scientists successfully coordinated development and qualification (for liquid chromatography methods) of these methods to properly characterize the product and provide comparability data between different manufacturing lots.
Technical Consideration- Othogonality in Protein Characterization
HCW Biologics already had some characterization data for this molecule, however data from additional assays was needed to fill in gaps in their data package and satisfy the regulator’s recommendations and expectations. Although always important to consider, applying orthogonal approaches to these characterization techniques was especially important in the case of assessing this unique fusion protein.
- Liquid chromatography patterns were assessed by both IEX and HIC, which included method development and qualification as qualitative tests per ICH Q2(R1) guidelines.
- HOS was assessed using three techniques, CD, FTIR and Intrinsic Fluorescence, to provide a comprehensive data package.
- Aggregation was assessed using both chromatography (SEC-MALS) and a column-free method (SV-AUC).
“BioPharmaSpec provided an excellent service for us. They followed the project timeline without any delay and thanks to their great work, we were able to characterize the molecular weight of our product accurately.
Our product is a fusion protein complex. Initially our product molecular weight (MW) was estimated by SEC-HPLC in our laboratory. Considering the measuring principles of different analytical methods, we asked BioPharmaSpec to analyze our product MW with SEC-MALS and SV-AUC in order to determine a more accurate MW. In addition, BioPharmaSpec successfully conducted higher order structure analysis on our product. The results demonstrated that our product is not a typical globular protein, which accounted for the discrepancy of MW results between SEC-HPLC, SEC-MALS and SV-AUC.
As stated above, BioPharmaSpec performed with great professionalism and expertise in analyzing our product. We will definitely consider working with BiopharmaSpec again when we need to characterize our future products." – Scientist/Manager of DSPD – HCW Biologics
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