
腺相關病毒(Adeno-Associated Virus)
腺相關病毒用來傳遞較短的DNA,腺相關病毒不會將攜帶的DNA嵌入宿主細胞的染色體中,因此常用於感染不分裂的細胞,對於體內治療相對安全及有效。
上游生產平台
藉由高產量的293T細胞株建立獨家可客製化的上游平台,TFBS已開發出優化的貼壁/懸浮培養轉染方法,正常產量可大於1E+14 GC/L。
下游純化平台
我們根據客戶的需求、產品特性及專案開發,提供碘克沙醇梯度超速離心(iodixanol gradient ultracentrifugation)和層析純化服務。TFBS具有多位純化專家,為客戶提供最佳產量和純度的產[品。
品質測試
TFBS專業團隊可協助QC檢驗方法開發
Attributes of virus | Characteristics | Methodology | Research grade | High-quality | cGMP grade |
Identity | Apperarance | Visual inspection | ○ | ● | ● |
pH | pH Meter | ○ | ● | ● | |
Osmolality | Osmometry | ○ | ● | ● | |
Genetic composition/ integrity | NGS/DNA sequencing | ○ | ● | ||
Purity | Residual host cell proteins | ELISA | ○ | ● | |
Residual bovine plasma proteins | ELISA | ○ | ● | ||
Residual host cell DNA | q-PCR | ○ | ● | ||
Residual DNA size | DNA gel electrophoresis | ○ | ● | ||
Empty:full particles ratio | TEM | ○ | ● | ||
Residual plasmid DNA | q-PCR | ○ | ● | ||
Process derived impurities | Depends | ○ | ● | ||
Quantity | Viral genomes titer | q-PCR | ● | ● | ● |
AAV infectivity titer | Cell-based q-PCR | ○ | ● | ● | |
AAV capsid titer | ELISA | ○ | ● | ● | |
Safety | Endotoxin | Kinetic Chromogent LAL assay | ○ | ● | ● |
Sterility | 21 CFR | ● | ● | ● | |
Mycoplasma | 21 CFR or NAT | ● | ● | ● | |
Replication-competent virus (RCV) | Cell-based q-PCR or PERT | ○ | ● | ||
Testing for adventitious viruses | In vitro or in vivo test | ○ | ● | ||
Potency | Potency | Customized Bioassay Method: Cell-based or Virus-based assay | ○ | ● | ● |