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.
Overview
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End-to-End Lentiviral Vector CDMO Services for Cell Therapy
Comprehensive Platform
Our tLVV platform covers packaging evaluation, process development, GMP manufacturing, and regulatory readiness, enabling faster transitions from preclinical research to IND‑enabling studies.
Streamlined Development
Robust suspension manufacturing platform scalable to 200L, comprehensive in-house analytical capabilities, and an integrated development strategy, enables efficient scale-up, rigorous product characterization, and a seamless path.
Proven Experience
Proven experience supporting more than 10 in vivo LVV and VLP programs, including clinical-stage projects, with a successful track record of FDA and NMPA IND clearances and regulatory filing support.
From Sequence to tLVV in as Little as 9 Months
Phase-Appropriate Consistency from IND-Enabling CMC to GMP
Clinical Stage Grade Mapping
Clinical Stage Grade MappingChevron 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 FilingClinical Stage (I, II, III)BLA/NDACommercialIn-Vivo LVVPackaging Test/ProCMCClinical GMPLentiviral VectorGMPPC/PVGMP
Case Study
Increasing LVV Recovery and Manufacturing Performance Through Process Optimization
Resources
FLYER
Viral Vector Packaging for tLVV, LVV, and AAV
Explore IND‑ready manufacturing, combining targeted vector design, robust process development, and streamlined timelines for various viral vectors.
FLYER
IND-Enabling tLVV for In Vivo CAR-T
Read about advanced targeted lentiviral vector solutions for In vivo CAR-T, and how phase-appropriate support is provided.
FLYER
Cell Therapy: Plasmid and Lentiviral Vector
Discover an integrated solution from plasmid to LVV, at high quality and speed.
WHITE
PAPER
Design of Targeting Lentiviral Vectors and Their Producer Cells for in Vivo CAR-T
Learn about successful tLVV design, manufacturing, and downstream application for in vivo CAR-T.
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