The growth in the clinical adoption of advanced cell therapies and gene therapies is one of many indicators showing an increased focus on personalised medicines. While cell therapy is the transplantation of human cells to replace or repair damaged tissue or cells, gene therapy is the modification of the genetic information in living cells to address any mutated genes. As anticipation builds around these new manufacturing methods and the promise they hold, more attention is being paid to the manufacturing execution systems that will allow it to benefit more patients, whilst creating less risk to the batch.
Cell therapy is now moving from a manual oriented lab environment, to identifying production scale principles from the larger scale bioprocess industry and applying some of these best practises with a goal of making the process as robust as possible, error free with reduced costs. The introduction of MES to the lab and automating the tracking of the patient’s cells or genetic make up through the system can offer significant value. Electronically verifying the process negates human error and can also improve throughput for a lab.
More importantly, MES offers a means of reducing risk by alerting operators to problems that could have catastrophic consequences. These alerts are then used to trigger a call out to the lab to investigate any problems. Cell & gene therapy is often a last resort for patients, a delay or failure to return their modified blood may lead to the worst possible outcome.
The rate and scale of cell and gene therapy growth will depend on the pharma industry’s ability to make cell therapy more affordable. Automation and MES are two vehicles that will play an important role in making labs more efficient and lower-risk which will lead to increased adoption, to the benefit of patients around the world.
Zenith has been delivering semi-automated end-to-end manufacturing platforms, to help scale up, digitise and accelerate manufacturing processes for their cell therapy clinical trials and future commercialisation.
- Cell and Gene therapy process and technology knowledge
- Automation and MES expertise in cell and gene therapy
- Custom automation and MES libraries for cell and gene therapy
- Semi-automated end to end manufacturing platform roll out
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