In autologous cell therapy, the patient’s own cells are cultured, genetically engineered and expanded outside the body in small, individual batches, bespoke to each patient, before being reintroduced into the body, for example to attack a tumour. This therapeutic approach places new demands on the manufacturing equipment needed to deliver this product. With traditional biologics, one scales up the liquid volume of the equipment to increase production capacity. Such systems are relatively simple to engineer for reliability and subsequently qualify through testing. With autologous cell products, production capacity is generally scaled up by increasing the number of manufacturing systems. This presents new challenges for manufacturing reliability because of the large number of systems, a high total part count and resulting challenges in system qualification. Given that reduced reliability and lost production runs are not an option in autologous cell therapy, what can therapy developers do to address this challenge?
Part 3: What is the yield of genetic transformation? Genetic engineering of CAR T-cells for therapeutic applications is going through
The benefits of preventive medicine and treating early are well known and a cornerstone of the current UK healthcare system¹.
Autologous cell therapies are unique because they are made in small, individual batches, bespoke to each patient. This places new
Part 2: To what extent can T cells expand in vitro? For cell sorter developers it is critical to specify
Part 1: How many cells are needed in the therapeutic dose? This is a hard question to answer, given the
The amazing results from CAR T-cell therapies for leukaemia in 2013 (Brentjens et al., 2013; Dudley et al., 2013; Grupp