Brian Hampson, Vice President, Global Manufacturing Sciences and Technology, Hitachi Chemical Advanced Therapeutics Solutions | October 1, 2015
Automation is not just a buzzword. Automation—the act of taking laborious, manual steps of cell therapy manufacturing and making them more efficient through elimination of the human element—is what will make commercial cell therapy manufacturing (especially for patient-specific cell therapies) feasible and cost-effective. Efficiencies are captured through savings of cost and time and reductions in error and product quality risk. When done right and as part of a comprehensive strategy, introducing automation to your cell therapy manufacturing process should support the Development by Designvision for commercially viable manufacturing—creating products at a consistently high product quality, at reasonable cost of goods, that meet demand, over the commercial life of the product (quality, COGs, scalability, sustainability).
There are several types of automation that can be beneficial to cell therapy:
- Process Automation (e.g. closed loop process control) - Task Automation (e.g. selection process) - Test Automation (e.g. compendial method) - Information Automation (e.g. electronic batch record) - Operational Automation (e.g. Manufacturing Execution System/MES)
Like all stages of planning for cell therapy manufacturing, there are benefits to considering automation early on in clinical development, rather than in later phases. Automation can:
- Manage risks (product comparability, quality, regulatory) - Lead to a defendable commercial manufacturing strategy (COGs, capacity, robustness) - Inform business planning (and inform funding requirements) - Inform discussions with potential partners, investors - Inform shorter-term development programs - Inform the next steps for executing strategy - Provide an opportunity to build IP
AUTOMATION: PLANNED IN THE CONTEXT OF OPPORTUNITY AND VALUE:
The Cost Concern
Despite the clear benefits, it is no secret that automation can significantly escalate up front development time and expense. It is not uncommon, therefore, for a cell therapy developer to be frustrated by the idea that they cannot afford automation right now, and realize that by the time they will be able to afford to automate, it will be too late in development to adjust the process significantly without introducing significant comparability risk. That is why it is important to begin with a comparability risk assessment—consider what elements of your manufacturing process might lend themselves to automation (or any type of change or optimization down the line), and address first those elements that will pose the biggest comparability risk if they are changed later rather than sooner. Next, taking into account the comparability risk assessment you just performed, one option is to develop manual unit operations that are seamlessly automatable. Finally, do your research so that you know what automated technology solutions exist on the market and how they might be best applied to your particular cell therapy. Not all choices will require development of new solutions, as there are a growing number of systems currently available.
Balancing Risk and Reward
While automation often targets a reduction in product quality risk, clearly, automation can elevate risks to program success and must be undertaken with a certain level of caution and acumen. Automation can add complexity, increase supply chain risk and comparability risk, and can be a significant cash and timeline sink, particularly when needed before clinical efficacy is established. Certainly, unmitigated failure of automation can have significant consequences. However, successfully managing these risks will lead to the reward of a robust and cost-effective manufacturing process. The bottom line for patient-specific cell therapies is that automation is a tactical means to a strategic end; it must be planned and implemented carefully, but ultimately, automation will be critical for commercially viable manufacturing of virtually all patient-specific products.
To learn more, click the button below to request a complementary copy of the white paper, “Manufacturing Cell Therapies: Development Strategies for Commercial Vision.”
Brian Hampson, Vice President, Global Manufacturing Sciences and Technology, Hitachi Chemical Advanced Therapeutics SolutionsBrian Hampson is Vice President, Global Manufacturing Sciences and Technology, tasked with leading Hitachi Chemical Advanced Therapeutics Solutions ("HCATS") Center for Innovation and Engineering (I&E).
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