As a lead in to the upcoming Cell & Gene Therapy Bioprocessing & Commercialization event this coming October, we are able to provide our readers with exclusive insights from some of the brightest minds in the industry. Today, Dr. Mehendra Rao, Vice President of Regenerative Medicine at Q Therapeutic and The New York Stem Cell Foundation, discusses the biggest trends, innovations, and challenges that are currently present but also on the horizon for the industry.
Here is what Dr. Rao had to say…
“The biggest trends I see in Bioprocessing is the realization that we will need to scale-out and not necessarily scale-up and that the current focus on large scale bioreactors is probably not the way to go for cell based biomanufacture.
The biggest innovations that have an immediate impact have been the cGMP in a box approach and automation that allows for tissue printing. A large section of regenerative medicine is not simply injecting cells but making tissue mimetic or organdies or cell sheets
Another major change in thinking has been the realization that stem cells are essentially a cell line that is spontaneously immortal and as such the same starting material can be used to make multiple products. This is conceptually a different method of achieving cost-efficiencies and both manufacturing science and regulatory science have to deal with this.
CMO’s that have been able to adapt have had success but those that have not have suffered. Likewise companies that have tried to go it alone have underestimated the challenges and failed while those that have paid careful attention to COGS have succeeded.
Term-BCT is an example of a company that developed a closed manufacturing system that works well and has changed the COGS scenario for MSC manufacture. Another company at the forefront of this quest is Harvard Apparatus Regenerative Technology, Inc., headquartered in Holliston, MA. Harvard
Term in Japan Received Approval for the Manufacturer and Sale of its HeartSheet Autologous Skeletal Myoblast Sheets in Japan. Terumo Corporation (Headquarters: Shibuya-ku, Tokyo, Japan. President: Yutaro Shintaku) announced in mid June that it has received conditional approval for manufacturing and selling its HeartSheet autologous skeletal myoblast sheets as a cellular or tissue-based products in Japan.”
Interested in gaining more insights from Dr. Rao and other experts from the regenerative medicine industry? Join them this October in Boston at the Cell & Gene Therapy Bioprocessing & Commercialization event. Click here to learn more.