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Stable Cell Line Platform Advances Gene Therapy Manufacturing

A 3D render of a DNA double helix made of blue, white, and silver textured spheres against a white background.
Credit: Ashraful Islam / Unsplash.
Read time: 2 minutes

VIVEbiotech, announced the addition of EvoLVcell to its catalogue of LVV-manufacturing products, representing a cost-effective, transfection-free alternative to its existing transient transfection process. The thoroughly characterized, inducible, monoclonal lentiviral packaging cell line (PCL) derisks stable producer cell line (SCL) generation by incorporating the therapeutic transgene that typically would be transfected together with the helper plasmids. This SCL platform generation enables VIVEbiotech to get a prototype cell line in three months.

 

EvoLVcell is a SCL generation platform designed to reduce batchtobatch variability, improve vector quality, and provide a more predictable longterm production strategy for LVVs. The fully integrated platform requires only the addition of a developer’s transgenic element to the fully characterized monoclonal PCL, avoiding transfection – simplifying the manufacturing workflow, improving long-term predictability, and reducing reliance on plasmid and transfection reagent supply chains.

 

EvoLVcell reduces variability and produces fewer impurities, of particular importance to gene therapeutics1. At the same time, the platform's extensive characterization enables rapid yield assessment through a rapid proof-of-concept, allowing developers to reach a clear a go/no-go inflection point in just three months. High throughput clone screening lets VIVEbiotech to pick the best performance clone in terms of viral titer, stability, and transgene integrity. Also, the resulting clone can be adapted from adherent to suspension. 

 

“Achieving cost efficiency and high reproducibility is essential for the scalable production of lentiviral vectors and for expanding patient access. Stable producer cell lines provide a reliable and scalable manufacturing platform to support this goal,” said Andrés Lamsfus-Calle, PhD, Product Development Manager at VIVEbiotech. “EvoLVcell provides a powerful alternative to transient transfection - one that derisks production, improves quality, and supports longterm scalability for our partners.”

 

The EvoLVcell platform is initially available for VSVG pseudotyped lentiviral vectors, the most widely used LVV envelope. EvoLVcell will complement VIVEbiotech’s established transient transfection, offering developers more flexibility depending on program needs.

 

Other features include:

  • Helper genes remain fully silent during cell expansion, limiting potential toxicity and cell instability.
  • Expression activated with low concentrations of doxycycline, minimizing risk of residual inducer in the final product.
  •  Demonstrates strong repression when off and high titers when on, important to maintain cell stability and transgene integrity.
  • No requirement of plasmids and transfection agents, reducing considerably COGs.
  • Manufacturing flexibility. Adaptable to adherent or suspension platforms.
  • Improvement in vector quality, decreasing total amount of contaminants associated with the manufacturing process.

 

“EvoLVcell reflects years of purpose-built LVV manufacturing development based on the unrivalled expertise of our team,” said Marie Fertin, Chief of Custom Solution and Process Development Officer of VIVEbiotech. “We are committed to providing the cost-effective and consistent options for our partners need in order to reliably reach commercial scale.”


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