Product Overview
HCP (Host Cell Proteins) are biological agent impurities released during cell growth and subsequent processing. They can adversely affect the safety and efficacy of the final drug, leading to adverse immune responses and hypersensitivity reactions in patients. They can also cause degradation of product proteins, impacting product safety and efficacy, making them a critical quality control indicator. Traditional enzyme-linked immunosorbent assays (ELISA) have become the gold standard for monitoring HCPs due to their inherent advantages of high sensitivity, high throughput, ease of operation, and high automation. However, this method lacks qualitative and quantitative information on the protein composition of individual HCPs, potentially missing or underestimating non-immunogenic HCPs. Therefore, LC-MS/MS-based HCP analysis has emerged as an orthogonal method, capable of qualitative and semi-quantitative analysis of the protein components of each HCP, independent of its immunogenicity. Establishing spectral libraries to identify HCP types can more effectively aid in the development of product-related HCP ELISA detection methods, promoting process optimization and facilitating product approval and market launch.
Analysis Process
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Instrumental Platform
- tims-tof HT
- Astral Zoom
- LC-MS
Key Deliverables
- protein description
- 78 kDa glucose-regulated protein (GRP 78,BiP)
- uniprot accession no.
- G3I8R9
- HCP quantity based on the protein standard [ng/mg product]
- 28524
- MW [kDa]
- 72.4
- pI
- 5.1
- protein description
- C-X-C motif chemokine 3 (CXCL3)
- uniprot accession no.
- A4URF0
- HCP quantity based on the protein standard [ng/mg product]
- 1776
- MW [kDa]
- 11
- pI
- 9.1
- protein description
- carboxylesterase 1-like protein,liver (CES1)
- uniprot accession no.
- G3I7X9
- HCP quantity based on the protein standard [ng/mg product]
- 464
- MW [kDa]
- 97.5
- pI
- 5.9
- protein description
- carboxypeptidase D (Cpd)
- uniprot accession no.
- G3HR95
- HCP quantity based on the protein standard [ng/mg product]
- 425
- MW [kDa]
- 123.4
- pI
- 5.8
- protein description
- cathepsin B (CatB)
- uniprot accession no.
- G3H0L9
- HCP quantity based on the protein standard [ng/mg product]
- 793
- MW [kDa]
- 37.5
- pI
- 5.7
- protein description
- cathepsin L (CatL)
- uniprot accession no.
- G3INC5
- HCP quantity based on the protein standard [ng/mg product]
- 1208
- MW [kDa]
- 37.3
- pI
- 6.8
- protein description
- cathepsin Z (CatZ)
- uniprot accession no.
- Q9EPP7
- HCP quantity based on the protein standard [ng/mg product]
- 2538
- MW [kDa]
- 34
- pI
- 7.5
- protein description
- clusterin (CLU)
- uniprot accession no.
- G3HNJ3
- HCP quantity based on the protein standard [ng/mg product]
- 23735
- MW [kDa]
- 51.8
- pI
- 5.5
- protein description
- glutathione S-transferase P 1 (GSTP1)
- uniprot accession no.
- G3I3Y6
- HCP quantity based on the protein standard [ng/mg product]
- 3138
- MW [kDa]
- 25
- pI
- 8.2
- protein description
- lipoprotein lipase (LPL)
- uniprot accession no.
- G3H6 V7
- HCP quantity based on the protein standard [ng/mg product]
- 3092
- MW [kDa]
- 50.5
- pI
- 8
- protein description
- lysosomal acid lipase (LAL)
- uniprot accession no.
- G3HQY6
- HCP quantity based on the protein standard [ng/mg product]
- 385
- MW [kDa]
- 45.6
- pI
- 7.3
- protein description
- matrix metalloproteinase-19 (MMP-19)
- uniprot accession no.
- G3HRK9
- HCP quantity based on the protein standard [ng/mg product]
- 1787
- MW [kDa]
- 58.9
- pI
- 7.7
- protein description
- monocyte chemoattractant protein-1 (MCP-1)
- uniprot accession no.
- G3GTT2
- HCP quantity based on the protein standard [ng/mg product]
- 11498
- MW [kDa]
- 15.9
- pI
- 9.3
- protein description
- peroxiredoxin-1 (PRDX1)
- uniprot accession no.
- G3GYP9
- HCP quantity based on the protein standard [ng/mg product]
- 15512
- MW [kDa]
- 22.3
- pI
- 8.2
- protein description
- phospholipase B-like 2 (PLBL2)
- uniprot accession no.
- G3I6T1
- HCP quantity based on the protein standard [ng/mg product]
- 4563
- MW [kDa]
- 65.5
- pI
- 5.9
- protein description
- procollagen-lysine 2-oxoglutarate 5-dehydrogenase 1 (PLOD1)
- uniprot accession no.
- G3IIE7
- HCP quantity based on the protein standard [ng/mg product]
- 3075
- MW [kDa]
- 76
- pI
- 5.8
- protein description
- protein S100-A6 (S10A6)
- uniprot accession no.
- G3HC31
- HCP quantity based on the protein standard [ng/mg product]
- 197
- MW [kDa]
- 10
- pI
- 5.3
- protein description
- pyruvate kinase (PK)
- uniprot accession no.
- G3H3Q1
- HCP quantity based on the protein standard [ng/mg product]
- 23758
- MW [kDa]
- 51.6
- pI
- 7.6
- protein description
- serine protease (HTRA1)
- uniprot accession no.
- G3IBF4
- HCP quantity based on the protein standard [ng/mg product]
- 3689
- MW [kDa]
- 28.7
- pI
- 6.5
- protein description
- sialate o-acetyltransferase (SIAE)
- uniprot accession no.
- G3IIB1
- HCP quantity based on the protein standard [ng/mg product]
- 1108
- MW [kDa]
- 59.3
- pI
- 8.6
| protein description | uniprot accession no. | HCP quantity based on the protein standard [ng/mg product] | MW [kDa] | pI |
|---|---|---|---|---|
| 78 kDa glucose-regulated protein (GRP 78,BiP) | G3I8R9 | 28524 | 72.4 | 5.1 |
| C-X-C motif chemokine 3 (CXCL3) | A4URF0 | 1776 | 11 | 9.1 |
| carboxylesterase 1-like protein,liver (CES1) | G3I7X9 | 464 | 97.5 | 5.9 |
| carboxypeptidase D (Cpd) | G3HR95 | 425 | 123.4 | 5.8 |
| cathepsin B (CatB) | G3H0L9 | 793 | 37.5 | 5.7 |
| cathepsin L (CatL) | G3INC5 | 1208 | 37.3 | 6.8 |
| cathepsin Z (CatZ) | Q9EPP7 | 2538 | 34 | 7.5 |
| clusterin (CLU) | G3HNJ3 | 23735 | 51.8 | 5.5 |
| glutathione S-transferase P 1 (GSTP1) | G3I3Y6 | 3138 | 25 | 8.2 |
| lipoprotein lipase (LPL) | G3H6 V7 | 3092 | 50.5 | 8 |
| lysosomal acid lipase (LAL) | G3HQY6 | 385 | 45.6 | 7.3 |
| matrix metalloproteinase-19 (MMP-19) | G3HRK9 | 1787 | 58.9 | 7.7 |
| monocyte chemoattractant protein-1 (MCP-1) | G3GTT2 | 11498 | 15.9 | 9.3 |
| peroxiredoxin-1 (PRDX1) | G3GYP9 | 15512 | 22.3 | 8.2 |
| phospholipase B-like 2 (PLBL2) | G3I6T1 | 4563 | 65.5 | 5.9 |
| procollagen-lysine 2-oxoglutarate 5-dehydrogenase 1 (PLOD1) | G3IIE7 | 3075 | 76 | 5.8 |
| protein S100-A6 (S10A6) | G3HC31 | 197 | 10 | 5.3 |
| pyruvate kinase (PK) | G3H3Q1 | 23758 | 51.6 | 7.6 |
| serine protease (HTRA1) | G3IBF4 | 3689 | 28.7 | 6.5 |
| sialate o-acetyltransferase (SIAE) | G3IIB1 | 1108 | 59.3 | 8.6 |
Shenzhen Wininnovate Bio Co., Ltd.
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