Allogeneic cell therapy stands out in the field of cell and gene therapy for its scalability requirements with challenges similar to those of traditional biologics. A key challenge is the ability of the allogeneic manufacturing platforms to support growth of living cells for a large patient pool. The right partner can help you accomplish this and establish a robust, efficient and scalable process that meets commercial demand. As you navigate the evolving cell and gene environment, trust in your partner to deliver becomes critical. Flexible capacity to grow with your project will come into play and become an underlying key success factor for the long run.

Our approach to develop and manufacture your therapy from concept to commercialization and beyond

Our New Product Introduction (NPI) and Lifecycle program, maps out your entire journey to commercialization. It accounts for each key milestone with checkpoints, to ensure you meet all required quality standards as your therapy progresses towards commercialization. The NPI program leverages our heritage and longstanding experience in establishing cGMP manufacturing standards. It combines both corporate and local quality standards customized for cell and gene therapies, to de-risk your journey to commercialization.

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NPI graphic 

Why work with us?

Extensive experience and expertise in the development and manufacture of cell therapies to take your product to market.

  • Our dedicated process development teams will help you to de-risk your manufacturing process before transferring it to GMP manufacturing and scale-up as appropriate. We are equipped to support the full analytical development lifecycle from new assay development to assay validation to supporting late stage products.
  • 8+ years of clinical manufacturing expertise within a wide range of immunotherapy applications.
  • Extensive experience with 2D and 3D immunotherapy bioprocessing.
  • Proprietary non-viral 4D-Nucleofector™ transfection technology to enhance robustness.
  • Best practices in process development characterization to address some of the key challenges for cell & gene therapy manufacturing include: eliminate or minimize open / manual unit operations; optimize of sub-optimal unit operations; implement in-process control / decision points; scale-out / automation and process characterization.
  • An end-to-end service offering including:
    • Phase appropriate assay and process qualification
    • Full characterization
    • Tissue acquisition
    • Cell processing (isolation, activation, editing, expansion and purification)
    • Formulation and fill & finish
    • Supply chain orchestration
    • Lifecycle regulatory support
  • R&D team focused on further developing next generation scalable and closed GMP technologies
Our global network

Cell & Gene therapy manufacturing services

Cell and Gene

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By joining Lonza, you will get to work with some of the world’s top experts in the space, while developing advanced therapies with a potentially life-saving outcome.

Behnam Ahmadian - Global Head of Process Development 
Behnam Ahmadian Baghbaderani

Global Head of Process Development