Regenerative medicine is a risky business. The decades-long development pipeline and the expenditure of millions of dollars presents itself as an insurmountable mountain for many researchers. The regenerative medicine commercialisation roadmap is fraught with risks and with a notorious high cash burn rate, the prospect of realising a cure for an aggressive disease can be very daunting.
As an industry we must begin to address future challenges faced by cell therapies that will reach the market in the next five years and beyond. As an industry, we need to recognise that these challenges cannot be addressed using today’s technology. We must forecast and begin to develop the next generation of tools and protocols that are not therapy-specific but will be designed to benefit the industry as a whole or classes of therapies.
With the ingenious idea of harnessing the body’s cells to facilitate wound healing, the curative potential (and profits) of stem cell-based technologies and innovations are boundless. However, a lack of risk mitigation and quality control in the process of cell therapy development and manufacturing can constrict not only treatment outcomes and the bottom line but also the viability of the industry.
The sector has identified the development of cutting-edge sensor technology to be the next logical step in improving risk mitigation, quality control and operational efficiencies. Not only can novel sensors form the safety net for day-to-day function, but they also create a new stream of valuable, highly sensitive and high-resolution data that can inform future regenerative medicine research.
Research Professor Nicolas Voelcker, who works in Monash University’s Drug Delivery Disposition and Dynamics in the Faculty of Pharmacy and Pharmaceutical Sciences, knows this issue all too well.
“A key challenge in regenerative medicine is improving and transforming quality control,” commented Professor Voelcker. “This is particularly important in the production of cell batches to be delivered to patients.”
The Importance of Sensors in Regenerative Medicine
With in-reactor sensors providing real-time measurements of both cellular and environmental parameters, such as cellular composition, specific biomarkers in situ, and media conditions, the information they provide to researchers would significantly enhance the ability to evaluate mechanisms of function and lower the risk involved in the development pathway. For Dr Dawn Driscoll, CEO of Cell Therapies, a cell contract manufacturing company, sensors are critical in risk mitigating and ensuring the quality of cellular products.
Sensors are currently being used but their capabilities are in their infancy. “We have a large variety of sensors that we incorporate into our processes,” commented Dr Driscoll. “They serve a variety of functions to ensure that the cells we produce are of the highest quality, utility, and are as controlled as possible. For example, we have sensors that track temperature and pH levels for cultures.”
The data currently being captured is in essence low hanging fruit and does not represent the complexity of information that could be unlocked with more sophisticated sensor technology. It is these types of sensors that we see having an impact on the evolution of the industry. For example, Gerry McKiernan, Quality Manager from Cell Therapies explained, “the time from collection of cells to the administration of finished products is proving to be a key factor in both effective patient treatment and gaining market share for many current cell therapy products. In-process sensors that can provide release for supply assay results for cell count, cell viability, phenotype, transduction, endotoxin, mycoplasma and microbial contamination would greatly assist in reducing these timelines and would be a huge benefit to the industry as a whole.”
CCRM Australia would like to form a working group to identify the challenges faced in research and commercial activity that can’t be resolved with the implementation of the sensors of today. We see the opportunity to craft the specifications for the next generation of sensor technology. To date, only preliminary discussions between research and industry in the US have been held. There is a genuine opportunity for the local Australian innovation system to leverage this commercialisation opportunity to look beyond solving the issues of today, but in creating a globally exportable product (with relatively low freight costs).
To discuss the evolution of sensor technology and commercialisation opportunities, please contact CCRM Australia Chief Operating Officer Dr Chih Wei Teng via firstname.lastname@example.org.
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CCRM Australia is an Australian not-for-profit organisation supporting the development of foundational technologies to accelerate the commercialisation of regenerative medicine products and therapies. CCRM Australia’s focus is to bridge the commercialisation gap through a network of scientists, entrepreneurs, academic institutions and industry partners and address bottlenecks in the industry. CCRM Australia is modelled on the highly successful CCRM in Canada and is legally separate to CCRM. As a member of the Global CCRM network, CCRM Australia is a partner to a leading-edge industry consortium. CCRM Australia is supported by MTPConnect and the Victorian State Government.
Photo by Hans Reniers on Unsplash.