Under the agreement, Invetech will provide system design and engineering development and NeoStem will develop applications for performing closed cell processing manipulations such as separation. The agreement will make NeoStem the commercial supplier of the manufacturing system.
As far as when this new system will hit the market, Brian Hampson, VP of manufacturing development and engineering at NeoStem, told BioPharma-Reporter.com that the companies are “currently in the process of developing prototypes for application testing.”
The system will be applicable to a range of cell therapy processes in development and commercialization stages, and will consist of an instrumentation platform, disposable flow path, and operating and application software for automated execution of user-selected protocols.
“The system will provide an automation platform that will reduce labor, and ensure quality, reducing the associated risks of human variability,” Hampson told us. “The system will also allow for more efficient use of manufacturing facilities by offering closed- system design. Taking labor out of the equation and focusing on automation and integration of processing steps will increase efficiency.”
Hampson added that the new system will be equipped “to perform several steps of cell therapy process that may have required separate systems previously,” and unlike most other systems, will be specifically designed to meet the needs of cell therapies.
The system also will be able to handle small scale processes suitable for GMP manufacturing of autologous and other products where small scale is full scale.
“Enabling processing in closed disposables also offer the opportunity for this processing to occur in a lower grade clean space thereby reducing the production facility capital and operating costs,” Richard Grant, global VP, cell therapy division of Invetech, told us.
Challenges in Cell Therapy Manufacturing
Many in the cell therapy manufacturing sector find difficulties in keeping costs in check, as well as ensuring the feasibility of scaling up from clinical trials.
“The challenge here is to consistently provide a quality product as you scale up and make more product to meet demand, while driving cost down low enough to be reasonable,” Hampson added. “You need to make sure the value proposition is there as you move toward commercialization, and realize that the solution must be long-term, not just for trials but for commercialization. This means being able to scale up while maintaining quality and reasonable cost of goods.”
Grant added that one of the biggest challenges is changing scale from smaller batch manual production methods to commercially feasible production methods and ensuring “that each processing step treats the cells in the same way so that their efficacy and mode of action is unchanged. Developing equipment that is scalable without changing the cell journey is paramount for every step in the manufacturing process.”
“Other challenges include, designing the production process to ensure that processing occurs in a functionally closed environment, bringing process steps together to perform them on single pieces of equipment, reducing manufacturing cost, eliminating human error, incorporating in-line, on-line QC testing and reducing equipment and facility cost in an immature field,” he added.