High Risk HCP ELISA

BioGenes has long been known for its generic ELISA kits, which provide broad coverage for detecting Host Cell Proteins (HCPs) across various production processes. Some of these HCPs are considered high-risk proteins due to their potential to cause immunogenic responses, adjuvant effects, or unintended biological activity in patients. Additionally, certain HCPs have been linked to the degradation of therapeutic products or excipients during storage, posing risks to both efficacy and shelf life of the drug. 

Below is a list of some Host Cell Proteins (HCPs) that are of particular concern due to their potential impact on product quality and patient safety:

1. Phospholipase B-Like 2 (PLBL2) binds to humanized monoclonal antibodies, particularly those of the IgG4 isotype, which impactes the drug formulation and causes an immune response.
2. Glutathione S-transferase (GSTp) is a metabolic enzyme that facilitates metabolite detoxification and antioxidation. GSTp reduces efficacy of chemotherapy drugs and inhibits tumor-cell apoptosis.
3. Clusterin (CLU) plays key roles in protein homeostasis/proteostasis, and the modulation of pro-survival signaling networks. It has been detected post protein A purification in multiple mAB products.
4. Peroxiredoxin-1 (PRDX1), crucial for regulating oxidative stress by reactive oxygen species (ROS), is particularly immunogenic due to its potential to cause oxidative cell damage and has been detected to persist through polishing steps.
5. Cathepsin B, D, L and Z have been identified as a source of active protein therapeutic fragmentation, thus classified as a high-risk protein.

These are just a few examples of high-risk proteins. For more detailed information, please refer to the BioPhorum website: BioPhorum

As a result, regulatory authorities advise to get a deeper understanding of individual HCPs and their potential risks. To address this need, BioGenes now offers protein-specific ELISA kits, complementing its established line of generic kits. These specialized assays enable targeted monitoring of individual HCPs, providing the detailed data necessary to enhance product safety, meet regulatory expectations, and ensure process robustness.

Customized Protein-specific ELISA Development 

If you’ve identified a protein in your process that poses a high risk or is particularly abundant, BioGenes can support you in addressing these challenges. We provide HCP coverage analyses on late-stage process samples to identify potential high-risk proteins that might impact product quality or safety.

Once identified, we can develop a customized ELISA tailored to detect and monitor the specific protein, ensuring precise quantification and robust quality control throughout your bioprocess.