Services
Solutions
About Us
Resources
tLVV IND-Enabling CMC Services – Targeted Lentiviral Vector for In Vivo CAR-T Therapies – ProBio

tLVV IND-Enabling CMC

An integrated CDMO service designed to accelerate the development and GMP manufacturing of lentiviral vector drug products from preclinical development through clinical and commercial stages.

From Sequence to tLVV in as Little as 9 Months

In Vivo Lentiviral Vector Workflow Workflow from cell thawing through lentiviral vector drug product, with plasmid packaging system development milestones. In Vivo Lentiviral Vector Workflow Cell Thawing CellExpansion Transfection NucleaseTreatment Clarification Purification &Concentration Formulation SterileFiltration Fill & Finish LVV DrugProduct Plasmid Packaging System TransferPlasmid LentiHelper™VSV-G LentiHelper™Rev LentiHelper™GagPol 0.5 – 1 months2 months8 months Gene Synthesis Transfer and EnvelopePlasmid IND CMC Helper Plasmids Cell Banking In Vivo Lentiviral VectorIND CMC • FDA/EMA ready CMC• Licensed strain withsublicensed authority• LentiBone™ III–TCSbackbone for In-vivoLVV transfer plasmid • Ready-to-useLentiHelper™ Rev &GagPol plasmids withFDA DMF • Ready-to-usesuspension cell line• ProprietaryPowerS™–293Tsuspension cell linewith FDA DMFregistration • Higher crude titer: 1E+7 ~1E+8 TU/ml• Stable process from 2L to200L• Upstream and downstreamprocess development toimprove yield and productpurity• In-house and comprehensiveDP testing and analyticalplatform

Phase-Appropriate Consistency from IND-Enabling CMC to GMP

 

Clinical Stage Grade Mapping
Clinical Stage Grade Mapping Chevron stages IND Filing, Clinical Stage I II III, BLA/NDA, Commercial mapped to grade bars: In-Vivo LVV, Packaging Test/Pro, CMC, Clinical GMP Lentiviral Vector, GMP, PC/PV, GMP. IND Filing Clinical Stage (I, II, III) BLA/NDA Commercial In-Vivo LVV Packaging Test/Pro CMC Clinical GMPLentiviral Vector GMP PC/PV GMP
Case Study: Increasing LVV Recovery and Manufacturing Performance Through Process Optimization
Flyer: Viral Vector Packaging for tLVV, LVV, and AAV – IND-Ready Manufacturing Solutions
Flyer: IND-Enabling tLVV for In Vivo CAR-T – Advanced Targeted Lentiviral Vector Solutions
Flyer: Cell Therapy – Integrated Plasmid and Lentiviral Vector Solutions for High Quality and Speed
White Paper: Design of Targeting Lentiviral Vectors and Their Producer Cells for In Vivo CAR-T
Request a Quote

Request a Quote

We’re here to help you accelerate your tLVV project.

Frequently Asked Questions