From 2016 MSB AR......
".....to build up commercial scale-up and supply for our product candidates long-term, we are transitioning the manufacturing processes to three-dimensional, or 3D, bioreactors with greater capacity to improve efficiency and yields, with resulting lower-cost of goods.
Our manufacturing activities have met stringent criteria set by international regulatory agencies, including the FDA. By using well-characterized cell populations, our manufacturing processes promote reproducibility and batch-to-batch consistency for our allogeneic cell product candidates. We have developed robust quality assurance procedures and lot release assays to support this reproducibility and consistency.
Key Manufacturing Activities
The following represent current key manufacturing activities:
Introduction of defined FBS-free media: we have developed a proprietary FBS-free media that has the potential to greatly enhance the yields achieved in production. We have made substantial progress in this development effort, and once complete, we intend to conduct “comparability” studies to illustrate that products produced with this media are equivalent to those produced using FBS based media.
Establishment of
3D bioreactor production:
we have made significant advances in the development of 3D bioreactor processes. We have conducted
successful production runs in our facilities at a 50 liter scale, our targeted commercial volume for production. When finalized,
our proprietary 3D bioreactor process will be transferred to Lonza to be used
solely for our clinical and commercial production. We expect to evaluate products produced in 3D bioreactors in later stages of our Phase 3 clinical trials, which will serve as FDA required comparability studies to 2D if successful.
and still MORE to come......"Super Cells"......Google "Mesoblast Robert Sackstein, MD, PhD, Professor of Medicine at Harvard Medical School"
Mesoblast.....it's THE Cells that WILL Sell!
[I added the bold type for emphasis]
(20min delay)