A guest blog by William G. Whitford, Sr. Manager, HyClone Cell Culture, GE Healthcare
On a beautiful fall day within sight of the taller DC monuments, this years meeting kicked off with a rather encyclopedic overview of Cell Therapy from Lee Buckler, Founder of Cell Therapy Group. He noted the diversity of basic approaches and the number of therapy-specific products appearing over the past few years. A key component of his talk was a review of the status of some of the most successful products in development. The two exciting keynote lectures did not disappoint. Mahendra Rao, Chief, Stem Cell Biology, NIH opened with a review of their solutions to many challenges of transferring successful science into robust and economical commercial products. While using IPSC as a model, his insights into manufacturing process solutions and business economies apply to other platforms as well. Stefan Miltenyi began with a reviewed some of the recent science supporting currently successful therapeutic approaches. He continued with a description of valuable equipment being introduced to the field as well as identifying the most exciting clinical successes to-date.
The first day consisted of concurrent sessions on Autologous and Gene Therapies; Analytics and Metrology; QA/QC and Commercial Process Development. One interesting talk by Jon Rowley, CEO at RoosterBio, introduced how implementation of manufacturing strategies and technologies from the protein production field were accelerating technical milestones in Cell Therapy. One factor he noted as contributing to such a rapid advancement was “Cell Therapy processes are standing on the shoulders of bioprocessing”. Regarding the currently rapid evolution of these processes, he observed that “Scalable and efficient modes of manufacturing not only aid in cost effective manufacturing of existing product concepts, but will in fact open the door for innovative next generation products incorporating living cells.” Continuing on this theme, Phil Vanek, General Manager, Cell Therapy Technologies GE Healthcare, provided an excellent overview of some of the newer approaches to scalable implementations of some of the more popular platforms.
Lunches and breaks in the very pleasant exhibition hall were a comfortable mix of linened tables with plenty of seating amid a perimeter of 15 vendor booths of a diverse mix of contract service providers, biomanufactring reagents and equipment. Recent developments here include the acquisition of HyClone products by GE Healthcare and SoloHill and ATMI products by Pall Corporation. Fresenius Kabi was excited to be launching, at this meeting, their LOVO automated white blood cell washing/concentrating apparatus based upon a spinning membrane technology.
A featured presentation of note on the morning of day two was delivered by John Harrington, CSO at Athersys. He provided a detailed overview of the entire process they employ in manufacturing their MultiStem allogenic Cell Therapy product. John provided many specific details, up- and down-stream, on how to handle T-cell banking and expansion in microcarriers. He noted a paradigm on culture medium which he was echoed by others at the meeting. It is that, given some of the development scale requirements, there isn’t enough serum in the world to support some successful commercial products. Following this thought, he related that in microcarrier-based suspension culture they’ve observed that many commercial serum-free media work for well in small-scale 2D culture, but support very little cell-division in spinner or large-scale bioreactor culture. They suspect that sheer forces in suspension culture are the culprit and are beginning to see some success in their own suspension media formulations. Mark Szczypka Senior Director, Applications and New Product Development, Pall Life Sciences, in advocating consideration of microcarrier-based production noted “In order to generate 250B stromal cells, you need 1332 10-layer stack cell factories”.
An interesting and provocative presentation was delivered by Hemanthram Varadaraju, Process Engineer for Modern Meadow. He opened that door to there being dozens of distinct applications for stem cells in not only regenerative medicine, but other applications as well. His thesis was an overview of the manufacturing cultured leather through the in vitro culture of fibroblasts. He began with an outline the science and engineering of cell seeding and culture followed by the efficient progression to multilaminate sheets. Further developing the concept, he defending the basic virtues of such products as cultured leather as well as outlining many of the economic parameters. One challenge he presented here was the need to develop an extremely low cost, non-GMP culture media required for such an initiative.
The majority of Cell Therapy applications are based upon such primary steps as cell isolation, identification, cytokine stimulation and purification. Demonstrating that there are many other potent technologies available, Jeff Morgan, Professor, Medical Science and Engineering, presented his results in the generation of particular shapes of cell masses through the culture of cells in adherent-resistant molds. The basic shape he displayed was rods made by the culture of spheroid-generation cells in a long trough-shaped mold, but he went on to present work on such complex shapes as toroid and honeycombs.
Overall there seemed to be two takeaways from the meeting. One, the fact that there are a quite number of exciting technologies, product designs and scaled-up manufacturing approaches in operation today with a high degree of demonstrable success. The second is the rather surprising considering the there has yet to be a significant clinical approval in the field. But, the clear atmosphere and spirit of the participants last week was that with the hundreds of trials in progress right now, an exciting and auspicious product launch is certainly imminent.