CDMO-Content | TFBS Bioscience, Inc.

AAV Manufacturing

Adeno-Associated Viral Vectors, or AAVs, are used to deliver small genetic material packages. They are safe and efficient for in vivo treatment. AAVs are non-integrating, meaning the genetic materials they carry aren’t injected into the cell’s genome. Therefore, they are a preferred method for non-dividing target cells.

Upstream production platforms

With exclusive and customizable upstream platforms based on high producing 293T cell lines, TFBS Bioscience has developed an optimized adherent/suspension culture transfection methods for AAV production ( normal production >1E+14 GC/L)

Downstream purification platforms

We provide services, such as iodixanol gradient ultracentrifugation and chromatography purification, based on the preferences, product performance, and project development needs of our clients. Our team of specialists are experts in operating controlled processes in order to deliver optimal yield and purity of products to our clients.

QC Testing

Adeno-Associated Viral Vectors QC testing assay development

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	○	●	●