Host Cell Protein Products from ICL
Targeted detection assays for high-risk residual host cell proteins
Host cell proteins (HCP) can cause unwanted side effects in any biological agent, which is of particular concern for biotherapeutic manufacturing. Proteases can degrade the therapeutic, and some proteins can cause unwanted immune responses.
Separation challenges can be down to a lack of information on protein variants or proteoforms that can be endogenously expressed and in-advertently co-precipitated with the desired therapeutic. 1
Mass Spectrophotometry can be a complementary method to assess results, but ELISA can be a more cost-effective long term solution.
Not all HCP impact therapeutics, so specific HCP ELISA kits can enable quantitative measurement of specific undesirable. This provides a simple read out of if the protein purification has been adequate. HCP ELISAS can support the initial phases of process and analytical development through manufacturing, to final product QC.
Chinese Hamster Ovary (CHO) cells are one of the main cell types used for biotherapeutic production; their mammalian heritage helps to produce proteins with appropriate folding and post-translational modifications, such as glycosylation and phosphorylation, not replicated in insect or yeast/ bacterial expression systems. CHO are also one of the most engineered host cell systems, making
Immunology Consultants Laboratory are developing a range of HCP ELISA kits to CHO HCP to assist efficient biomanufacturing.
Key Benefits:
- Detect residual CHO -contaminants with high sensitivity
- Enables targeted monitoring of high-risk contaminants
- Downstream purification optimization
- Can help streamline regulatory submissions
Key CHO HCP
Annexin A5
Beta 2-Microglobulin
CXC-Motif Chemokine 3
Cathepsin B
Cathepsin L
Cathepsin Z
Clusterin
GTB-Binding Nuclear Protein (RAN)
Glutathionine S-Transferase P
Legumain
Lysosomal Acid Lipase
Lysosomal phospholipase A2
Lysosomal Protective Protein
Matrix Metalloprotease-19
Nucleobindin-2
Peroxiredoxin-1
Phospholipase B-Like 2 Protein ( PLBL2)
ICL was among the first to commercialize ELISA kits that use highly specific and sensitive antibodies developed in our lab to detect specific CHO host cell proteins (HCP) like PLBL2 and NUCB2. HCP may co-purify and contaminate monoclonal antibodies cultured in CHO cells, but ELISA kits make it fast and simple to identify these variables before they affect your research. Reducing or minimizing HCP impurities is mandated by federal guidelines and is crucial in the development and manufacturing of recombinant biotherapeutics, which are key treatment options for a wide range of illnesses.
