|Various cell manufacturing and processing devices seen throughout the exhibits at IBC’s
4th Annual Cell Therapy BioProcessing Conference – No BioPrinters (yet!)
Cell Therapy is most definitely standing on the shoulders of traditional biologics manufacturing. Our field is benefitting from many of the technologies that have been developed for the biologics production field, including sterile welding and sealing, single-use disposable bags and bagged reagents, single-use bioreactors and downstream processing equipment, and process analytical technologies. For today’s cell therapeutic manufacturing processes, these technologies are ready for implementation, since the lengthy technology development and commercialization stages happened over the last 10 years. This has effectively removed years off development timelines; thus, in many cases, we are seeing the manufacturing process and product development occurs quickly. This “technology acceleration”, based on benefitting from developments in preceding fields, is seen across technology disciplines and has been called the Law of Accelerating Returns by Ray Kurzweil.
One last component worth mentioning, which I feel is an under-appreciated aspect of Regenerative Medicine, is biopreservation and cold chain management. The advancements in off-the-shelf and ready-to-use cryopreservation and hypothermic storage solutions are simplifying the logistical challenges of shipping, inventory, and distribution of living cellular products. BioLife Solutions’** CSO Aby Mathews spoke on the impact of biopreservation on logistics and economics of living cellular products. BioLife has had a huge impact on the Cell Therapy field over the last 10 years, and their biopreservation products are now used in over 130 clinical studies and have full Master Files to reference for regulatory filings – making implementation simple and straight forward. While Akron Biotech (company blog) was not at the conference, they have a new line of cryopreservation products that is being targeted for cell therapy research, and it will be interesting to see how they move towards clinical implementation. Biocision** (who run the great Sampling Science blog) had Eric Kunkel on the podium to speak about standardization across the cold chain and how their products are designed to fit into the ecosystem. Biocision has been developing a range of devices targeted at Cell Therapy. Their innovative (and cool-looking) products include “ice-free” sample cooling and freezing devices, their CoolCell freezing containers, and validatable inventory transfer chests. Additionally, their newest product, the ThawStar, is focused on the “last mile” of product use, i.e. the controlled thawing of a cell product at the clinical site. It is these types of biopreservation and cold chain products that are making Cell Therapy products better, simpler to implement, and thus, will accelerate the time to market. The field still has the regulatory framework to navigate, but overall the path is much clearer today than it ever has been.
**Full disclosure – Jon Rowley, author of this post, is on the Scientific Advisory Boards of both BioLife and Biocision, but holds no stock in either company and was not compensated for this post.