Lentivirus

Lentivirus can carry larger genetic material packages of RNA, which is then converted to DNA. During this process, the vectors are integrated into the genome of the target cell. This makes lentivirus best suited for ex vivo treatment of dividing cells, such as T cells, and stem cells. The treated cells will begin to divide and generate new cells once they are returned to the body, and the genetic material is copied into all the newly produced cells.

The GMP compliance production of clinical grade lentivirus for CAR-T and other gene-editing cellular product requires knowledge of the complex methods to generate, purify, and characterize lentivirus vectors in a well-established, proven GMP quality system. As a leader of lentivirus vector production, TFBS Bioscience combines the leading lentivirus production technology with comprehensive GMP procedural controls that have been developed to ensure clinical product quality, safety, and consistency for CAR-T and gene therapy clinical trials.

Lentivirus Production

With well-knowledge of comprehensive methods to generate, purify, and characterize lentivirus vectors in a well-established, proven GMP quality system, TFBS provides GMP compliance or high-quality (clinical) grade lentivirus production for CAR-T other gene-editing cellular product. As a leader of lentivirus production, TFBS Bioscience integrates the leading lentivirus production technology with comprehensive GMP procedural monitors, which have been developed to secure GMP/ High-quality (clinical) product quality, safety, and consistency for gene-editing cellular product clinical trials.

QC Testing

Lentiviral vectors QC testing assay development

Attributes of virus	Characteristics	Methodology	Research grade	High-quality	cGMP grade
Identity	Apperarance	Visual inspection	○	●	●
	pH	pH Meter	○	●	●
	VSV-G protein	Western Blot			●
	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	●	●	●
	LV physical titer (p24)	ELISA	○	●	●
	Transducing titer	Cell-based q-PCR	○	●	●
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	○	●	●

CDMO

Lentivirus

Lentivirus Production

QC Testing