In early development of gene and cell therapy products, in vitro and in vivo assays will be needed to verify the preliminary efficacy of the products. For the usage in this stage, GenScript ProBio’s Research Grade Viral Vector Packaging Services are appropriate to produce viral vectors for the transduction of cells, or directly for injection, for the preclinical research projects.
|Standard||1x10^8 TU/mL||1x10^8 TU/mL||1 mL||1 week|
|2x10^8 TU||2 mL||1 week|
|Ultra-purified (High titer)||1x10^9 TU/mL||1x10^9 TU||1 mL||2 weeks|
|1x10^10 TU||10mL||3 week|
Packaging of 3rd generation lentiviral vector, clients’ transfer plasmid is co-transfected with GenScript ProBio’s 3 LentiHelper™ plasmids in HEK293T cells. The LVV is then purified by ultracentrifugation, or ultrafiltration for in vivo application.
Manufacturing process of research grade LVV
After obtaining the final product, the viral titer is then measured by P24 ELISA. Other quality control includes appearance and bioburden.
|Service||Application||Minimum Titer (vg/ml)||Quantity (VG)||Deliverable||Timeline|
|Standard||in vitro assay||≥1 × 10^12||1 × 10^12||1 ml, 10 × 100 μl||3~4 weeks|
|Ultra-purified (High titer)||in vivo assay||≥1 × 10^13||5 × 10^12||500 μl, 5 × 100 μl|
|1 × 10^13||1 ml, 10 × 100 μl|
GenScript ProBio uses triple transfection system in HEK 293/293T cells for the packaging of AAV. Viral particles are harvested from cell lysate or supernatant, and then purified by PEG precipitation. For ultra-purified product for in vivo application, the viral particles will be further purified with gradient centrifugation.
Manufacturing process of research grade AAV
The quality control of research grade AAV includes titer measurement by qPCR and sterility test, and mycoplasma test and virus purity are also detected for ultra-purified products.
GenScript ProBio always guarantees the quality of product, no matter which stage your project is at, and which degree of the products are provided. And GenScript ProBio offers One-stop Solution from cell banking, process development, to analytical development and GMP manufacturing, to bring your projects to next milestones seamlessly.