Rethinking CGT Manufacturing
To minimize the risk of contamination, the production of cell based therapies needs to be performed in a strictly controlled environment. GMP compliant sterile facilities are exepensive to run, take floor space, require expensive equipment and highly trained staff that generates detailed documentation procedures for each step. The cost to build, maintain and run such a high-tech facility represents a large portion of the costs of cell based treatments.
To deliver the promise of personalised medicine, CGT manufacturing requires a transition from a ‘make-to-stock’ to a ‘make-on-order’ strategy. The ‘one patient, one batch’ paradigm resists scale-up efforts, making current manufacturing practices and existing supply chain obsolete.
What Limula offers
Limula is building a system for automated manufacturing of CGT directly in the hospital environment. Our patented solution is a fully closed bioreactor embedded in a programmable platform that enables a range of applications. We remove superfluous human intervention during the multi-step procedure, keeping everything under sterile conditions while controlling cell culture parameters. The versatile setup will ultimately accommodate a variety cell types and multiple gene delivery systems.
CGT in numbers
With 17 cellular and gene therapy products approved for the US market (Source: FDA), and over 700 in development (of which 39 are projected to be approved by 2022), the number of patients who could benefit from these treatments is estimated to reach 50 000 per year by 2030.