The impact of cell and gene therapies (CGTs) in the pharmaceutical market has grown significantly in recent years, with 10,000s of patients now benefitting from their efficacy. Many companies are developing their own pipelines in advanced disease indications such as cancer, autoimmune diseases and genetic disorders.
Although these medicines hold significant potential, there are many challenges associated with their development, manufacture and eventual commercialisation that must be overcome to reach the scale now needed.
One solution, according to Jason Jones, Global Business Development Lead of Cellular Origins, is the full automation of manufacturing processes utilising robotics and full digital control, which he believes can revolutionise the CGT development and manufacturing process.
Developers have to find a way to make lab-based manufacturing techniques commercially viable and fully automated
Overcoming the issue of scalability
One of the most challenging elements of successfully commercialising a CGT is scaling its associated production processes to meet the indicated patient populations, explains Jason. “CGT is currently a victim of its own success. A cell and gene therapy manufacturer could be making more than 100 doses in a year throughout pivotal trials because the response rates are often relatively high and trials can be powered favourably — meaning that, once approved, they will then need to take steps to make products for much larger patient populations.”
He continues: “This is a whole different scale of manufacturing that requires industrialisation, meaning that developers will have to find a way to make lab-based manufacturing techniques commercially viable and fully automated.”
Implementing CGT automation solution
To overcome the challenges of scaling within the cell and gene therapy production process, Jason believes that developers should consider a more industrial approach: “By incorporating robotics into CGT production, manufacturers can reduce the labour associated with steps that are currently performed by humans, such as connections, transfers, sample taking, consumable transport, installation, deinstallation and running processes on multiple devices from a range of providers.”
“Factory level automation and robotics have been changing the game in other industries for years; and, although it’s newer to the CGT space, these technologies are now being proven as effective via their regular use. Automating the use of different devices from different suppliers, such as ScaleReady, Fresenius Kabi and 3P innovation, under one software system and within one robotic platform has the potential to improve the process significantly.”
Optimising, space time and labour usage
Full automation can impact all the key areas that challenge CGT manufacturing at scale, which include
- labour efforts: according to Jason, Cellular Origin’s Constellation platform can reduce labour requirements by up to 16 times as many of the tasks previously done by a human will be performed by the machinery
- utilisation of manufacturing space: automation can allow for the better use of manufacturing space, with up to a 30-fold reduction in the footprint required for production (or 30 fold increase in output from current facilities)
- cost of goods: by automating key parts of the CGT manufacturing process, Jason states that businesses can save more than 51% on the cost of goods from efficiencies in labour and manufacturing space alone
- process standardisation and reproducibility: fully automated technologies such as Constellation can remove the variables and risks associated with human operators while simultaneously providing a full digital record of every step of the production journey.
Things to consider when implementing automation
According to Jason, there are a range of factors that must be considered when incorporating full automation into the CGT production process. “Flexibility is crucial when picking automation technology as you’ll want robots that are compatible with a range of processes and facilities. You’ll also want something that provides full and safe human access — which will be necessary on certain occasions — while being robust and reliable.”
He concludes: “Full robotic automation with a collaborative, ecosystem approach to industrialising and scaling CGT manufacturing will allow businesses to meet the needs of patients who could greatly benefit from these remarkable therapies.”
[Image credit: Nissim Benvenisty]
