产品简介
宿主细胞蛋白(HCP)是在细胞生长和后续加工过程中释放的生物制剂杂质，会对最终药品的安全性和有效性产生不利影响，可导致患者不良的免疫反应、超敏反应，另外也存在导致产品蛋白的降解等问题，影响产品的安全性和有效性，是一项关键质控指标。传统的酶联免疫吸附试验（ELISA）由于其固有的高灵敏度、高通量、易于操作和高自动化等优点，成为了监测HCP的金标准，然而，这种方法缺乏个体HCP的蛋白定性和定量信息，可能会遗漏或低估非免疫原性HCPs；因此，基于LC-MS/MS的HCP分析已经成为一种正交的方法，它可以定性和半定量分析每个HCPs蛋白成分，独立于其免疫原性。通过建立谱库鉴定HCP的种类，可以更有效地帮助开发产品相关的HCP ELISA检测方法，推进工艺优化，促进产品获批上市进程。
分析流程
@2x.jpg)
宿主残留蛋白 (HCP) 分析流程
仪器平台
- tims-tof HT
- Astral Zoom LC-MS
主要交付结果
- 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 |
深圳市微纳菲生物技术有限公司
创新质谱与人工智能技术，为生命科学研究提供蛋白代谢质谱多组学解决方案，赋能生物与医药大健康产业发展。
