OBJECTIVES:

Cell and gene therapy (CGT) is expanding its footprint and developing life-changing therapies. Companies are seeking out cost-efficient opportunities, standardization, and scalability. CGT manufacturing can be split into multiple components, one of which is the cell expansion process (CEP). This research focused on CEP, which is a critical stage which if insufficiently performed can impact product quality, cost and efficacy. The high-cost nature of CGT products makes CEP critical. Research on this stage could result in increased consistencies in product performance. This analysis compared manual cell handling with automated F&F from a risk perspective and cost perspective.

METHODS:

We used qualitative interviews and an Adelphi panel approach with 47 participants active in the CGT manufacturing process at different manufacturers. Respondents were prompted for their risk experience during the manual CEP and how they perceived automation could alter their experience.

RESULTS:

The most frequent risks that occurred ranked in order of importance included: process reproducibility (n =16), consistency in the final product (n = 14), exposure to additional man hours (n =14), low viability (n =7), contamination issues (n = 5), disposable stability and integrity (n =3), bag breakage (n =1). The main drivers to automate the CEP included: having a closed system (91%), reduce product variability (84%), comply with GMP for scaling up (84%) reduce human error (84%). From a cost perspective the following drivers of CEP were identified: labor (28%), facilities (25%), consumables (16%), batch contamination (13%), labor training (10%) quality control and traceability (8%). Automation of the CEP may result in 62% reduction of operator time and 58% of reduction of labor force cost.

CONCLUSIONS:

CGT manufacturers may benefit from automating the CEP thanks to the lower anticipated risks and costs versus manual cell handling upon the implementation of automation.