The Evolution of Cell and Gene Therapy Processing Tools


Borrowed tools from other industries

Prior to the invention of gene therapy research, the removal, storage and reinsertion of human cell tissue was limited to blood. The logistical and technical challenges were minimal. However, scientists quickly discovered that maintaining the integrity and transparency of autologous and allogeneic cells throughout extraction, storage, transportation, delivery and administration presented a myriad of logistical challenges exceeding the capabilities of the current machines and materials available. If gene therapy was to succeed, a new generation of machines, processes and storage materials were needed. 

The first attempts at cell/gene therapies

  • Why were these therapies developed
  • What tools were used to create the therapy
  • What hurdles were identified during manufacturing
    • Cryopreservation
    • Fluid management
    • Cell growth – hpl product and its effect on cell growth


Cell and Gene Therapy (CGT)
Specific tools needed and implications of tool selection

The gene therapy supply chain requires specific tools for each stage of the journey. Additionally, each of these tools must adhere to the high clinical and difficult technological requirements necessary to support the precise needs of cell and gene therapy. Then we’ll go into each product category and discuss the gene therapy needs, shortcomings of the current technology (in the early days of gene therapy exploration) and then discuss the proper tools that were created. Where possible, we’ll link to Sexton products. 

Identifying the tools needed by this developing industry

  • What specific tools are needed
    • Vials (containers)
    • Filling Systems 
    • Storage Media
    • Freeze/Thaw Tools
    • Any other gaps filled


Automation is needed - for scale and safety

The unprecedented growth of the industry, alongside the need to develop scalable manufacturing strategies, has led to a number of challenges that need to be addressed urgently. Previously, patient numbers were so small that processes were highly manual and required numerous skilled operators. However, the recent success of early gene therapy trials means upscaling now needs to be considered right from the start. Safe and scalable gene therapies require access to manufacturing capacity that employs state-of-the-art technologies for efficient, robust and scalable production, which creates a series of questions and considerations that must be considered earlier, rather than later, in the therapy development process.

Identifying when to implement automation

  • History of automation within CGT
    • Define historical automation strategies
    • Early attempts at automation
  • Challenges
    • The importance of early-stage automation
    • Cost of therapy development
    • Safety
  • Key decision factors driving the answer to “when”
  • Introducing new products
    • AF-500
    • Non-Sexton automation products
    • Challenges of these large scale automation products
  • The solution – produce a small footprint, low cost, highly flexible automation platform
    • CT-5
    • Specific importance of the product
    • Aa a lynchpin of bridging industry solutions
  • Future direction
    • Lowering the barrier to entry – barrier to entry is typically cost and lock you into a certain consumable… so future is building devices like CT-5, our vials, etc., that work both within our product universe as well as plug and play in someone else’s product universe.


Future of flexibility and optimization -
How do we get more therapies approved and approved faster

Collaboration, especially at the interface between process development and manufacturing technology, will be essential if CGT developers hope to fully realize the extraordinary potential that these therapies carry for our collective future.

How do we achieve more downstream success – all boats rise approach

  • Flexibility
    • Integration of all products – not just Sexton but across all manufacturers
    • Shared manufacturing strategies
    • Open industry knowledge
    • Not follow computer universe Mac  VS IBM – you had to adopt one ecosystem or the other and the more invested you were in that ecosystem the harder, most expensive it was to switch
  • Optimization
    • Decrease costs – decrease AP risk which is key to getting more of these therapies into testing
    • Decrease safety risks
  • Sexton Biotechnologies
    • How are we leading the industry to a brighter future
    • Our manifesto for the future

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