CDMO
 

CDMO

About AAV

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