Jon A Rowley, Ph.D., Chief Executive and Technical Officer at RoosterBio Inc. will be joining the speaking faculty at the upcoming Cell & Gene Therapy Bioprocessing & Commercialization conference taking place October 5-7 in Boston, MA. Dr. Rowley was kind enough to sit down with the Cell & Gene Therapy Bioprocessing & Commercialization team to discuss the important trends that will be shaping the cell therapy industry in the coming years. In this exclusive Q&A, he addresses what he feels are the three major trends setting the stage for a new era of productivity in Cell Therapy.
What do you see as the important trends that will be shaping the cell therapy industry over the next several years?
JR: Many of the critical trends that are shaping the RegenMed Industry are on the manufacturing sciences side of the technology.
First – we are seeing an acknowledgement from all of the federal agencies that the Manufacturing Sciences aspect of Regenerative Medicine has been underappreciated and underfunded for the last decade. In order to maintain our innovation edge in this growing industry there has been an industry-academic consortium that laid out the technology roadmap for scalable and cost effective manufacturing of living cell-based products. This is laying the groundwork for several agencies to fund, to the tune of tens to hundreds of millions of dollars over the next several years, the technologies required for commercial manufacturing of therapeutic cells. This funding of manufacturing technology development will be critical for establishing a sustainable, profitable industry that is capable of supplying the world with safe and effective cell-based regenerative therapies.
Second – I see several innovations on the horizon that will be focused on dramatically simplifying product development and shortening development times for Regenerative Medicine products. This will have a major impact in accelerating the time it takes to go from discovery to first-in-man clinical studies, thereby resetting the ROI of many Regenerative Medicine programs. The products that will enable this will be off the shelf and standardized raw materials (vs home made) that cut across a variety of different products, as well as “plug-and-play” systems that enable simplified and rapid tech transfer of processes into manufacturing.
Thirdly – the therapeutic cell production world will continue to borrow best practices from the protein bioprocess industry and there will likely be a stronger focus on establishing production metrics. The main metric in the protein world is g/L, or grams of protein produced per liter consumed. An analogous metric in stem cell production that I really like is “Millions of Cells produced per Liter of media consumed” (or MCells/L). MCells/L as a metric fundamentally illustrates both technical aspects of the process, as well as economic parameters as media is always the major cost driver of manufacturing. As the industry adopts productivity metrics such as this, it will then be possible to make comparisons across platforms and provide fundamental goals for process development groups to strive for.
Taken together, I see these 3 trends setting the stage for a new era of productivity in Cell Therapy. I am more excited than ever for the advancements in this field.
To learn more from Dr. Rowley, join him this October at Cell & Gene Therapy Bioprocessing & Commercialization in Boston, MA. Click here for more information.