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Automating cell and gene therapy manufacturing: challenges and approaches

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With commercial demand for cell and gene therapies now higher than ever, the pressure is on for companies to scale up manufacturing while minimizing cost of goods. Process automation offers many benefits, but not without challenges in areas such as cost and implementation.

Yet, with so many options for tech solutions out there, where to start? What steps can organizations take to decide what is best, not only for their business, but also for patients? We asked three industry experts for their advice:

  • Stefano Baila, Director of Operations, Anemocyte
  • Colby Colasanto, Director of Strategy, Cellogics
  • Katleen Verleysen, PhD, Strategic Partnerships Life Sciences, Imec

This is an extract taken from Using automation in cell and gene therapy manufacturing. Read the full article here.

What is the best approach to automating the manufacturing of cell therapeutic products?

Stefano Baila: You have to know your process and start to challenge it: moving away from exclusive operator’s skill-based steps and evolving them introducing closed and automated solution.

The ultimate goal of automation is to allow treating your target patient population in an affordable way (sustainability of your manufacturing paradigm), automation should as well guarantee identity, safety, purity and potency.

Automation should be considered in all steps of the vein-to-vein journey of your product including production, analytics and logistics.

Colby Colasanto: Automation should be considered as a progressive operation, and explored with stage by stage approach. Identify the most critical sets of operations to automate, optimize each one, then integrate them together to establish a new automation standard. It is important to remember that information management is also part of automation.

Katleen Verleysen: Ideally, you have an all integrated solution, whereby the target cells are purified, re-engineered and cultured, as well as all the necessary steps to quality control the process. The number of manual handling steps and interventions are to be avoided at all cost, certainly because purity is of utmost importance and a minor contamination could have a severe adverse effect. The future of cell manufacturing is an all-in-one disposable chip/cartridge per patient, whereby the vein-to-vein time and overall cost is significantly reduced. Due to the complexity of the process, we firmly believe the solution will contain a few silicon-based sensor chips, because of its versatility towards high throughput and multiparameter sensing, system integration and read out, commingling the different processes of the manufacturing process.

What are the current limitations in implementing automation in cell and gene therapy manufacturing?

Colby Colasanto: For CGT there are multiple automation implementation limitations facing manufacturers, e.g. controls of cell seeding, monitoring of cells in situ, monitoring of potency of cells, monitoring of key nutrients, feeding them progressively, harvesting efficiently, cell preservation, etc.

Stefano Baila: In the early phases of development, the cost of automation might not be balanced by the advantages that come with it. On the other end in a more mature phase, time might become the limiting factor as you may not have the necessary time to adapt your process to an automated one.

Automation is not always an easy step as it rarely comes custom made for a specific process; therefore, a proper process development is necessary and the industry is still lacking of experienced process developer to lead this change.

Last, I think it is important to mentioned that different devices don’t necessarily “talk” well to each other, meaning it is not straight forward how to transfer material and related information from one tool to another (e.g. between a bioreactor and a washing device, tubing and software might not be compatible).

Katleen Verleysen: Automation through miniaturization is advisable, but has the challenge of processing a rather large amount of patient sample (ie. 300-500mL), so key will be to find ways of processing these large volumes in a timeline manner without the loss of cell viability. Automation will be crucial otherwise these therapies will be hard to scale up.

This is an extract taken from Using automation in cell and gene therapy manufacturing. Read the full article here.

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