Extract from Mesoblasts Breifing doc.9 CONCLUSIONSThe...

Extract from Mesoblasts Breifing doc.

9 CONCLUSIONS
The remestemcel-L manufacturing process has been developed to produce a safe, effective, and consistent product. Over development relevant quality attributes have been established that are representative of product characteristics for identity, purity, safety, and efficacy. The mechanism of action regarding the product’s immunomodulatory characteristics are well defined in vitro and in vivo. The relevancy of the product’s potency marker, TNFR1 expression levels, have been supported through in vitro data and correlation to clinical outcome measures in the clinical efficacy studies. Control of starting materials, raw materials, testing performed at multiple points of the manufacturing process through in-process testing and final release testing, use of sterile single use technology materials and a functionally closed manufacturing process, all provide assurance that the product is safe and manufactured consistently. The product has been well characterized through long-term stability studies demonstrating that it maintains a shelf-life of 48 months when stored at ≤ -135°C in LN2 vapor phase. Storage and distribution process and controls are in place to ensure product quality is maintained from the start of production through to receipt by the customer. In conclusion, remestemcel-L has a well-established and robust manufacturing process which produces a product that consistently meets product quality attributes.