John Farrell is a science and technology blogger for Forbes online. John was invited to cover proceedings at the 2015 Till & McCulloch Meetings and this is his third and final report. This blog also appears on Forbes and is reprinted here with permission.
One of the most time consuming and expensive steps in the whole stem cell and regenerative medicine field of discovery is the cell expansion process. Mundane, laborious … and absolutely necessary.
Pre-clinical development is usually done using traditional cell culture techniques, in simple culture flasks and with a lot of manual exercise from the bench-bound researcher.
“As long as you are working on your mouse or in vitro models,” writes stem cell consultant Reinout Hesselink, “that is no problem.” But this approach is not feasible to prep cells in clinically relevant quantities (millions and billions) that are necessary for patients when the time comes. “Once you go clinical, you need to make sure that the process you use to make the therapy guarantees you sufficient cells, of sufficient quality, in a way that will allow you to run processes for multiple patients in parallel.”
So, culture flasks aren’t going to cut it at this stage.
Enter RoosterBio, based in Frederick, Maryland, which is positioning itself to be a major player in the cell expansion market as more regenerative medicine and stem cell therapies prove effective and get approval to treat patients.
RoosterBio is a privately held corporation. Its name is a tip to the heralding of the dawn, and a new day in the regenerative medicine field.
The company specializes in the delivery and large scale production of human mesenchymal stem cells (MSCs), which it regards as the most robust and useful population of stem cells for a wide range of clinical indications.
According to the company web site, “New technologies such as bioprinting, cell and tissue engineering, synthetic biology/genetic manipulation, and of course, cell manufacturing sciences will continue to propel the field of Regenerative Medicine forward and further necessitate the need for the availability of large numbers (lot sizes in the billions) of clinically-translatable MSCs.”
As Keri Douglas writes in her profile of RoosterBio Chief Executive and Technical Offcier Jon A. Rowley, up until now regenerative medicine researchers requiring several millions of cells to start an experiment would spend five to six weeks to grow these cells, only to conduct a limited number of sequential experiments annually.
RoosterBio’s innovative product format–bioreactors and culture media–can cut the traditional time to cultivate and test from 5-6 weeks … to 5-10 days.
Rowley was among presenters at the Till-McCulloch conference which I attended in Toronto this past Fall, explaining the advantages of his company’s new platform for cheaper and more robust expansion of MSCs, which can be utilized for the treatment of multiple injuries and diseases.
In a recent post at his company blog, Rowley described RoosterBio’s latest product, a concentrated bioreactor feed (RoosterReplenish-MSC) that replaces nutrients and growth factors that have been depleted during the cell expansion process and obviates the need for the researcher to interrupt the system in order to replace the cell culture’s growth media, a laborious step which has hitherto been liable to introduce contamination into the cells.
An overiew of RoosterBio can be found here. For the time being, the company’s focus remains adult MSCs, rather than induced pluripotent stem cells (iPSCs). As the latter field shows more progress, however, I imagine RoosterBio will be well placed to expand into that market as well.