Last week, Akron participated in the Phacilitate Automation Special Interest Group, a gathering of key industry stakeholders aimed at fostering discussion around the main challenges associated with developing and implementing automation solutions in an industry characterized by process variety and complexity, as well as the need to ensure data integrity.
According to Dr. Rodney Rietze, Senior Investigator in the Exploratory Immuno-Oncology group at the Novartis Institutes for Biomedical Research, implementing automation throughout cell and gene therapy manufacturing processes can reduce variability (mitigating risk), increase success rate (decreasing cost), and provide due process insight (increasing degree of control).
While the industry is progressing from first generation manufacturing processes, which tend to be manual, centralized, and paper-based, there is still a great deal of work to be done in order to shift towards production systems that are automated, device-based, closer to the bedside, and managed by comprehensive and cloud-based data management solutions.
Progress has certainly been made as far as vein-to-vein data management is concerned. There are now a variety of solutions aimed at tracking patient materials throughout the complex and geographically fragmented manufacturing process. Nevertheless, there are still challenges associated with maintaining chain of custody, chain of identity, and chain of condition.
Heidi Hagen, Chief Scientific Officer and Co-Founder of Vineti, chaired the session on supply chain integration, addressing the question of how to connect various partners and sites at clinical and commercial scales by collecting data throughout the supply chain, the manufacturing process, and the clinical setting, eventually interfacing with electronic medical records (EMRs).
Akron has long focused on developing and producing ancillary materials compliant with good manufacturing practices (GMP) for clients in the regenerative medicine industry. Given the importance of our materials for clients’ manufacturing processes, we are implementing robust electronic data management solutions aimed at ensuring their integrity and traceability.
By providing interoperable data management solutions, we do our part to improve visibility throughout the cell and gene therapy manufacturing process, and ultimately, support the uptake of safe and efficacious treatments that save lives. Given the industry’s current level of maturity and future growth prospects – see the Alliance for Regenerative Medicine’s latest data report – now is the time to invest in robust and scalable data management systems.
It is important to note that automation is not a panacea. It can’t solve many of the complex problems associated with bringing therapies to market. Furthermore, the collection of patient data raises important questions that must be addressed by industry leaders and regulators. However, it is safe to say that at commercial scale, automation can reduce the cost of goods associated with cell and gene therapy production while improving process robustness and ensuring continued safety, potency, and efficacy of these life-saving treatments.
For more on last week’s successful meeting of the Automation Special Interest Group, check out the event summary produced by our colleagues at Phacilitate. Also, consider subscribing to Phacilitate:Exchange, where you can gain access to the rapporteur’s report summarizing the meeting’s outcomes, as well as receive regular updates and learn about upcoming events.