One of the biggest challenges for cell and gene therapies lies in developing a reliable and robust manufacturing process.
Working with our industrialisation team
Our Industrialisation team can work with you throughout the whole cell and gene therapy development cycle, helping your therapies to be safer, more effective, scalable and affordable.
Our team is made up of early adopters of cell and gene therapies, who offer a diverse range of skills for you to draw on, across the whole industrialisation spectrum.
We think it’s important to be technology agnostic, so can work with you to provide customised, integrated solutions for any cell and gene therapy development or quality challenge including:
- Sharing our learning, developed in-house, to give you the latest efficiencies in industrialisation.
- Applying our 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.
How we can help
- Identifying ways to lower the costs of manufacturing your product.
- Finding innovative ways to make your process more efficient and robust.
- Providing methods to accelerate and support clinical trials.
- Help ensure your process and product are in control and quality compliant.
- Tried and tested methods to transfer seamlessly to Good Manufacturing Practice (GMP).
Case study: Industrialisation of a research process
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|
|Spikes and other||209||21||20||4||12||6|
|Tube weld and seal||64||7||399||75||107||57|
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.