Industrialisation

Industrialisation is one of our core capabilities and spans the whole cell and gene therapy development cycle.

Industrialisation is one of the biggest challenges for cell and gene therapies. Developing reliable and robust manufacturing processes that ensure adequate product safety, potency, and consistency at an economically viable cost for cell and gene therapies is very different from all other existing therapies, including biopharmaceuticals. Cell and gene therapy manufacturing processes can range from very short ex vivo processes to a simple expansion of autologous cells for administration back to a patient — to long cycles of culture, expansion, stimulation or treatment with external factors, or genetic manipulation of allogeneic cells that are banked for treating multiple patients.

We can help make your therapy safe, effective, scalable and affordable by:

  • Identifying the best ways to lower the costs of manufacturing your product
  • Finding innovative ways to make your process more efficient and robust
  • Scale up methods quickly to accelerate and support clinical trials
  • Ensure your process and product are in control and quality compliant
  • Established methods to transfer seamlessly to GMP

Read about how we put our novel process technology, assay and Quality by Design thinking to good use for UK based ReNeuron.

Industrialisation infrastructure: 

Schematic of our industrialisation group's capabilities

Click here to learn more about our infrastructure

Our team is made up of early adopters of cell and gene therapy with a diverse range of skills across the whole industrialisation spectrum. We are technology agnostic and can provide customised, integrated solutions for any cell and gene therapy development or quality challenge including:

  • Applying the technology step changes from our platform projects to give you the latest efficiencies in industrialisation
  • Our world-class analytical platform for proprietary product characterisation and production control
  • Our cost and risk based development approach to reduce cost of goods and maximise process automation and control within a Quality by Design framework

 

Industrialisation case study: Introducing automation to lower cost of goods

The product – gene-modified immuno-oncology T cell. 

The problem – open process, labour intensive, 978 manipulations 72% needle-based. Contract Manufacturing Organisation (CMO) throughput restricted due to labour. 

The approach – incremental changes were submitted over two generations to facilitate ongoing clinical trials. 

Results – All changes driven by a Cost (and risk) Based Development – see citation for further information.

Manipulation type Manual process First improvements Second improvements
  Number % Number % Number %
Needle 705 72 109 21 69 37
Spikes and other 209 21 20 4 12 6
Tube weld and seal 64 7 399 75 107 57
             
Total 978   528   188  

 

Second generation process demonstrates 60% overall CoGs reduction. 

Throughput within a given facility has increased by 39%. Ongoing automation and optimisation for third generation product will further reduce failure rate and increase facility efficiency.

Contact us to find out more about our industrialisation capabilities.

Discover who we are