To deal with the challenges in regenerative medicine, in 2018, pioneer bioprinting expert Anthony Atala announced the foundation of an organization dedicated solely to advancing the field through manufacturing. Known as the Regenerative Medicine Manufacturing Society (RMMS), it is the first collaborative effort that aspires to help deliver regenerative medicine products to the marketplace. In particular, the RMMS recently announced that working groups of researchers – representing industry, government, academia, and non-profit organizations – will identify current gaps and solution spaces in regenerative medicine to improve patient outcomes; and among the four impact areas they will investigate, is 3D bioprinting.
RMMS members will share their knowledge and work together to create solutions to manufacturing challenges. The ultimate goal is to develop standardized manufacturing processes to facilitate the smooth and quick transition of new therapies to market, thereby ensuring patient access.
The four impact areas that the society’s leadership team has identified as critical in regenerative medicine are cell manufacturing; standards for regenerative medicine; 3D bioprinting; and artificial intelligence-enabled automation.
According to a paper published in Stem Cells Translational Medicine – the official journal of the RMMS – the working groups will help evaluate the current landscape of work already done in both regenerative medicine and related fields, including cell therapy manufacturing, as well as identify gaps, and propose solution spaces for the field to focus on. One of the targets of their upcoming work will be the development of safety and quality industry standards specifically for regenerative medicine manufacturing.
More precisely, and as far as 3D bioprinting is concerned, the RMMS working groups will look into the development of bioink standards and assist with understanding some of the regulatory hurdles of creating combination products, such as implants consisting of a scaffold and living cells.
Emerging as a powerful tool for building tissue and organ structures, the use of 3D bioprinting technology and the development of user-friendly software platforms have grown tremendously in the past five years. However, experts at the RMMS suggest that the advancement of out of the box customized bioinks that can be sold in tandem with this technology is lagging behind.
Furthermore, the RMMS paper hones in on some of the known materials that are being developed for use across different bioprinting platforms that have ultimately demonstrated a trade-off between printability and biological relevance, such as easier-to-print plant-based bioinks, or extracellular matrix (ECM) component bioinks that are more biologically relevant but more difficult to print.
To close this gap, the RMMS considers assisting organizations that are beginning to strategically circumvent these challenges, like ASTM International. Their work on bioink standards, including printability of bioinks and biomaterials, could be used in automated biofabrication technology, as well as guidance on the development of bioinks, including considerations such as material properties that assist with survival of cells within bioinks. All of this would ultimately lead to the development of new bioinks.
The second limiting factor that RMMS researchers wish to tackle is the regulatory hurdle of developing combination products. Using a 3D bioprinter to create implants consisting of a scaffold and living cells will need to go through review by both device and biologic regulatory agencies, which results in long and expensive regulatory approval pathways compared with the more traditional implants.
As many experts have suggested, regulation is a big issue in the bioprinting field. There are simply too many complex points to be considered with biomanufacturing and it appears that bioprinting research will always outpace the regulatory agencies’ ability to keep up; that is, unless the quality, risk and safety standards are clearly determined beforehand.
In that regard, the RMMS working groups will assist with understanding some of the regulatory challenges and technology gaps in this rapidly advancing area and highlight member-developed solutions.
RMMS researchers stated in the article that: “We envision assisting with the advancement of commercial products with industry partners in this space based on recommendations from our working groups.”
Moreover, some early clinical opportunities may include external regenerative medicine targets such as cell-based wound dressings.
Proposed as a collaborative work, the RMMS hopes to accelerate efforts in regenerative medicine manufacturing through partnerships with government, industry, and academia. The primary author of the paper and RMMS Executive Director, researcher Joshua Hunsberger, leads the group of researchers as they work with partners to identify areas where they can make an impact, as well as develop new education and training programs.
Education and training are critical to RMMS goals as they expect to accomplish their mission through outreach and education programs and securing grants for public-private collaborations in regenerative medicine manufacturing. From expanding the current talent pool to promoting careers in regenerative medicine, education and training is key to adapt to the growing demands of the workforce in this emerging sector.
RMMS hopes to collaborate in developing learning networks across all levels of education, and in tune with their mission, identify gaps where they could assist in developing new training programs or expanding current ones. The areas they are considering are hands-on cell culture techniques, the latest manufacturing technology, analytical methods, and regulatory requirements.
As the world’s first professional organization dedicated solely to advancing the field of regenerative medicine through manufacturing, RMMS also serves as an information clearinghouse, supports professional and workforce development, and promotes the infrastructure for the field’s success.
Back in 2018, during the RMMS inaugural meeting, founding member and director of the Wake Forest Institute for Regenerative Medicine (WFIRM), Atala, described how “regenerative medicine therapies are already benefiting small groups of patients through clinical trials.” Also revealing that “while there is still much to accomplish scientifically, the field is at a tipping point. If we are going to bring high-quality, cost-effective therapies to patients, now is the time to begin the important work of developing the manufacturing processes. Collaboration between stakeholders is vital to success.”
Certainly, RMMS is all about collaboration, focused on strengthening the framework of regenerative medicine by developing solutions to accelerate the commercialization of the latest technological advances and growing the workforce in a rapidly expanding sector. And with strong support from researchers coming together from the different branches that ultimately make up the field, it is difficult not to eagerly anticipate the results of this joint effort.