“However, there are limited automated solutions in this area, much less specific to formulation, fill, and finish, that genuinely address the market needs,” Kathie Schneider, director, global commercial lead, and Dalip Sethi, director, scientific affairs, Terumo BCT, told us.
Terumo Blood and Cell Technologies (BCT), a US-based medical technology firm and subsidiary of Tokyo-based Terumo Corporation, has been focusing on innovation in downstream technologies to automate the final steps involved in autologous cell therapy manufacturing.
Final formulation is considered one of the most critical steps in the autologous cell therapy manufacturing process but many developers are still performing this process manually, they said.
“To get drug products to scale in manufacturing, automation is required. Solutions must maintain the viability of the product as much as possible so that the cells are able to proliferate inside the body. This is further complicated with autologous products; one product is one batch. Therefore, finding automated solutions can be a challenge due to the smaller batch sizes.
“Uniquely maintaining drug products at ultralow temperatures, that can maintain the products viability from the fill/finish stage through infusion is also a challenge. The complex final formulation steps involve the addition of pre-cooled cryoprotectants and maintaining the cell product at low temperature for a short duration before freezing, which can limit the batch size of the drug product.”
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