The cell therapy industry (CTI) is emerging as a distinct and competitive component of global healthcare, creating value for investors and pro- viding life-changing therapies to patients [1,2]. Industry growth has necessitated an increased focus on large-scale manufacturing strategies to meet future demands [3,4].
One major challenge is the limited availability of some crucial raw materials used in cell therapy manufacturing – including bovine serum. Without a sus- tainable supply or viable alternatives to these components, the commercial-scale production of cell therapies will be impossible, halting the momentum of the industry. We propose that solutions to these challenges are achievable, and can be expedited by industry-wide collaboration.
Bovine serum is currently used in the majority of cell therapy manufacturing processes. Current stocks and production rates of serum suitable for GMP manufacture may only be sufficient to support the production of one blockbuster cell therapy. Limitations in the availability of bovine serum therefor act as a major cost driver and significant barrier to the commercial success of the industry as a whole.
Thus, without an increase in serum production, or at least a significant increase in the development and implementation of serum-free production strategies, the growth and sustainability of the CTI will be severely constrained.
Replacing FBS/FCS is common sence allready; also animal free (including human derived) is a station passed by. The last hurdle is to remove undefined components.
But al this is amplified by the strategic choise to avoid a-problem-in-the-making; the day you cannot buy FBS but still depend on it is coming, and it is coming sooner then you think. Today large batches of FBS are bought allready by large market parties for strategic reasons.