In a previous article, I noted that digitization is critical for many cell and gene therapy firms, but few have fully embraced the approach. That was the view of Ori Biotech chief data officer Kevin Gordon.
Other experts agree with Gordon, especially regarding the need for a flexible, digital manufacturing infrastructure, a must for advanced therapy firms looking to scale up production. Advanced therapies, roughly defined as medicines based on gene, tissues, or cells, are a major focus for the biopharmaceutical industry research spending.
In 2019, the FDA predicted it would be approving 10 to 20 cell and gene therapies a year by 2025, based on industry development pipelines. Similarly in the European Union, an earlier study revealed that roughly 1,000 candidate advanced therapies are in clinical trials.
And this growing interest is reflected in investment in manufacturing capacity. Analysis by software specialist Autolomous suggests over 7 million ft2 of cell and gene therapy (CGT) manufacturing capability has been announced between 2020–21. Much of this new manufacturing capacity will need to be digital, according to company COO and co-founder Kwok Pang.
“In order for those manufacturing facilities to reach design manufacturing capabilities of 100s, if not 1000s of CGT products, digitisation of paper-based manufacturing processes is a ‘must’ and not an option,” Pang says. “For the CGT industry to reach its ambitious targets of treating 1,000s of patients with CGT, digitization of manual paper based processes cannot be delayed.”
Luke Thorstenson, director of business development at cell and gene therapy and production technology firm Orgenesis, also says digitized manufacturing is key to production scaleup.
“A significant challenge in the production of pharma and biotech products is the automation and integration of individual manufacturing operations,” he tells GEN. “Transitioning from the current ‘analog’ labor-intensive manufacturing process to machine automated processes like those in our Orgenesis Mobile Processing Units and Labs (OMPULs) requires digitization and will allow for the same activities currently done manually by an operator to efficiently scale. We believe these steps are necessary to make life saving treatments like CAR-T available, accessible and affordable.”
Flexibility is the key factor
Flexibility is the most important factor in any digital manufacturing management system Pang points out because unlike the monoclonal antibody space where production methods are mature, the cell and gene therapy sector is still developing.
“In my opinion, the biggest technical challenge facing CGT developers considering digitization, is flexibility and agility of the chosen digital system, CGT and CGT manufacturing is an emerging modality and the only certainty is ‘change.’ Therefore, a digital system must provide flexibility and agility to react to changing needs coming from process optimization, unit operation advancements, and emerging manufacturing platforms,” he maintains.
Collaboration between cell and gene therapy firms, CDMOs and the technology supply sector will be needed, according to Pang, who says making digitization the default approach is also an important part of the advanced therapy sector’s development.
“To aid adoption, suppliers across the CGT value chain must collaborate to simplify/exemplify /de-risk the decision to digitize,” he continues.
Pang cites his own firm’s outreach efforts as an example, explaining that “Autolomous’ integration strategy is centered on building manufacturing verticals, working with CGT suppliers of a given manufacturing vertical to strengthen the overall value proposition to a CGT developer belonging to the segment.”
The cell and gene therapy sector should also make sure to learn from the wider biopharmaceutical industry’s approach to manufacturing digitation, strongly suggests Orgenesis’ Luke Thorstenson.
“In addition to automation, the other area being actively addressed by Orgenesis and other firms is the development and use of novel sensors and ‘smart’ feedback loops to control process conditions and perform quality control tests in real time allowing for ‘closed system’ solutions,” Thorstenson tells GEN.
“These types of advances are already being implemented in the area of small-molecule drugs and biologics, and we are working to bring similar advances into autologous cell therapy products through our Point-of-Care solutions.”