ISCT 2018: MSC Biomanufacturing, Bioprocessing, Scale-Up, Analytics and Exosome Production Take Center Stage

Authored by Katrina Adlerz, Ph.D. Scientist, Analytical Development, RoosterBio Inc.

RoosterBio attended the International Society for Cell Therapy annual meeting, held May 2-5, 2018 in Montreal, which brought together leaders in the field including academic researchers, industry scientists, regulators, and clinicians. The society and conference focus on three key areas of translation: Academia, Regulatory, and Commercialization.

Six Roosters attended to hear the latest research and translational innovations at the scientific talks, present three different posters, and man the booth in the exhibit hall. Jon Rowley, founder and CTO of RoosterBio, also gave two talks discussing innovations to accelerate MSC Biomanufacturing, Bioprocessing and Scale-Up. He shared insights from RoosterBio’s path to GMP-manufactured cells and media as well as strategies for overcoming obstacles in his talk “Technologies for Radically Reducing Development Timelines of hMSC-based Therapeutic Products” during the Strategies for Commercialization Session. (New to MSCs? Read more about MSCs and biomanufacturing here, here, here and here.) For a copy of Jon's talk, email us.

RoosterBio Analytical, Process & Product Development efforts were well-represented with three posters.

- “A Xeno-Free Fed-Batch Microcarrier Suspension Bioreactor System for the Scalable and Economic Expansion of hBM-MSCs” showed that MSC critical quality attributes were maintained in 0.1L and 3L bioreactor culture. Poster.

- “Scalable Xeno-Free Manufacturing of Extracellular Vesicles Derived from Human Mesenchymal/Stromal Stem Cells” explained a process for generating a high yield of EVs/Exosomes from MSCs in a shortened time frame using RoosterNourish^TM-MSC-XF Media. Poster.

- “Development & Technology Transfer of a cGMP Potency Assay: Testing of an Ancillary Material for Stem Cell Manufacturing” outlined the steps in assay development, assay qualification/validation, and tech transfer for a custom potency assay based on cell expansion. Poster.

- In addition, the RoosterBio , BioLife Solutions and Brooks Life Science teams collaboratively presented a poster on MSC cryopreservation: "The Effect of Cryomedia Selection and Transient Warming Events on Post-Cryopreservation Human MSC Function". Poster. 

The posters gave presenting scientists the opportunity to talk with those doing similar work in process or assay development. It allowed us to learn from and share our expertise with the community.

The conference kicked off with a RoosterBio-sponsored workshop: Improving Mesenchymal Stem Cell Potency and Survival. Steven Bauer, Branch Chief of the Cellular and Tissue Therapy Branch  of the US FDA, and Head of the FDA's MSC Consortium, discussed his innovative work developing predictive assays for MSC potency by analyzing cell morphology in his talk “High Throughput Approaches to Assess MSC Function”.  You can find his blog here.  There were also a number of talks discussing clinical trials results. A common theme of the session was the need to develop analytical methods and assays that can predict MSC-based treatment efficacy in patients.
In addition to cell-based assays, predicting which patient populations will respond to treatment would be a big step forward and likely result in increased success with regards to patient outcomes. Eleuterio Lombardo of  TiGenix discussed the development of such a test during a clinical trial, where they found a group of 15 biomarkers that they could use to predict patient response to their MSC therapy.  There were also concurrent preconference workshops on Cord Blood, which featured several MSC talks, and Global Regulatory Perspectives and Standards. 

Another session that stood out was Progress in the World of Standards for Cell and Gene Therapies. We discussed the need for standards in an earlier blog post. Jiwen Zhang, president of the Standards Coordinating Body, presented the group’s efforts to support standards development, as well as training and educating the field on existing and upcoming standards. This is important work as the gene, cell, and regenerative medicine fields mature. RoosterBio looks forward to answering the SCB’s call for increased stakeholder participation in standards development.  You can download the Regenerative Medicine Standards Landscape State of the Industry Report from the SCB here.

There were several sessions on extracellular vesicles/exosomes that highlighted the growing excitement in the field for a so-called “cell-free therapy”. Sai King-Lim of A-Star gave a great talk summarizing the current landscape called “MSC Exosomes and Small EVs: A Comparative Review”. Additionally, the importance of a consistent manufacturing process was highlighted as numerous talks reported the impact of manufacturing on extracellular vesicle phenotype and function.

In addition to stem cells, the recent approvals of CAR-T immunotherapy drugs were much-discussed. One plenary session, Reimagining Cancer Care and Delivering on the Promise of CAR-T Therapies, featured a dynamic exchange between Carl June of the University of Pennsylvania, Pascal Touchon the of Novartis Oncology, and Diane Parks of Kite Pharma. The session discussed the development of CAR-T therapies in academia and the translation to industry. Kite Pharma was a particularly interesting case as a smaller, less well-known company that had to build trust with stakeholders like doctors and patients as well as build an infrastructure to accomplish the complicated logistics associated with autologous cell therapy before launching their product Yescarta.

Overall, the RoosterBio team had a great conference connecting with current and future collaborators and customers as well as other leaders in the field. The trip culminated with a Rooster Road Trip after some bad weather and cancelled flights, but the team stuck it out and ended up with a memorable drive back home to Frederick, Maryland.

Did you attend ISCT? What were some of your takeaways?