CDMO-Content | 啟弘生物科技股份有限公司

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。

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。

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。

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	○	●	●