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Dive into the Biopharma Space

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T-Cell Therapy Manufacturing Challenges Provide Opportunities for Vendors: Spotlight on IOVANCE (IOVA)

With an upcoming PDUFA date of February 24, 2024, we focus on Iovance (IOVA) in this post.

🧫 Tumor Infiltrating Lymphocytes (TILs) vs. chimeric antigen receptor technology (CAR-T) manufacturing

  • Share very similar ex-vivo T-cell manufacturing processes

    • One of the biggest disadvantages of these cell therapies

      • Complex process/logistics

        • See Steps 2-4 (FIG. 1) 📸

      • Drives up costs

      • Sick patients need to wait for weeks to receive therapy

🔬 IOVA is working on streamlining its TIL ex-vivo manufacturing process (FIG. 1) 📸

  • Ex-vivo cell expansion (similar to CAR-T)

  • Genetic modification is optional for TILs (CAR-T requires genetic modification)

  • IOVA Gen2: 22-day manufacturing process

    • Time from T-cell isolation from a patient to infusion back into a patient.

  • Upcoming IOVA TIL Gen3: 16-day manufacturing process

🌐 Cell therapy manufacturing challenges, provide opportunities for vendors

  • Products and services for ex-vivo T-cell culturing and freezing

    • Media, growth factors, equipment, cell marker assays

  • Products and services for improved safety

    • Cell and gene assays to ensure infused cells are safe.

  • Software for managing the complex logistics between hospitals and cell therapy providers

    • Product is patient-specific

      • Maintaining the chain of custody during sample processing is critical

        • Sample shipped from procurement site to cell culture manufacturing site then to the infusion site

        • Almost always different facilities across different business entities

          • e.g., IOVA cell therapy center (iCTC) - Philadelphia ^1

        • Sometimes, the manufacturing site is out of the country

          • iCTC will service patients/samples from the U.S. and Europe

FIG. 1. IOVANCE 22-day GMP Mfg. Process. Proprietary Gen 2 technology enhances TIL therapy manufacturing, achieving over 90% success in treating 500+ patients by optimizing production and distribution processes.

Our 16-day, Gen 3 process

In some of our clinical trials, we are also exploring a Gen 3 process which reduces manufacturing to 16 days. The third generation of our process is expected to reduce the wait time between initial tumor sample and infusion for patients.


📈Enhance your sales and business development strategies with our comprehensive report featuring hundreds of biopharma companies specializing in cell therapy products. Ideal for...

  • 🔬 Contract Research Organizations

  • 🧪 Contract Manufacturing Organizations

  • 🧬 Biopharma vendors looking to expand their horizons

Article History:

2/4/2024 - EJV

This article is not investment or legal advice.

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