GMP LVV Manufacturing Service

Proprietary Suspension Cell Line PowerSTM-293T

Comprehensive Quality Assurance

GMP LVV Manufacturing Service

With the rapid development in cell therapy, LVV production a large amount of programs entered into clinical phases, and the manufacturing of lentiviral vectors are in urgent demand. GenScript ProBio has worked with global customers and is experienced in manufacturing GMP lentiviral vector for clinical phases. We are flexible to provide GMP lentiviral vector either with adherent culture or suspension culture, starting from MCB or WCB establishment, or even starting with GMP plasmid manufacturing.

Overview of GMP LVV Manufacturing Workflow

GenScript ProBio is experienced in manufacturing lentiviral vectors adopting both adherent production system and suspension production system. We use HEK293T cell lines, and developed our proprietary suspension cell line PowerSTM-293T, with the production capacity from 2L to 200L.

Our experts will discuss your project with you in detail and propose a best solution to accelerate your project.

Manufacturing Characteristics

  • Facilities compliant to FDA/NMPA GMP standards for investigational (clinical usage) medicinal products
  • Environment monitoring
  • QA controlled documentation
  • Personnel training and qualification
  • Facility and equipment qualification
  • Raw materials/excipients management and control
  • Vendor management
  • Change control/Deviation/CAPA/OOS handling
  • QA controlled Product release

Suspension Culture System

  • Proprietary cell line PowerSTM-293T
  • Stable and scalable suspension manufacturing process
  • up to 200L manufacturing scale
  • 4~5 times final yield improvement comparing with adherent culture system
  • ~50% cost reduction
  • High T cell transduction efficiency

PowerSTM-293T

  • Proprietary Suspension cell line
  • License for IND, clinical and commercial
  • Royalty free, maintenance free
  • Excellent performance in producing lentiviral vector

LVV Production: PowerSTM-293T with Different GOI

Titer over 107 TU/ml

Adherent Culture System

  • The largest manufacturing scales is 75CF10
  • Closed culture system reduces contamination and improves stability
  • Full-automatic operation improves reproducibility and stability
  • High final product titer of 5E7 TU/ml

Accumulated Experience

GenScript ProBio has accumulated rich experience in manufacturing lentiviral vector, which guaranteed a dedicated and professional service for customers.

  • Worked with global clients for their cell therapy projects
  • Provided GMP lentiviral vector for CAR-T, TCR-T projects
  • Over 30 GMP manufacturing batches experience

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