SBI Contributing Technology and Expertise to Advance RegenMed Development Organization’s (ReMDO’s) Mission
Scientific Bioprocessing, Inc. (SBI) is joining the advanced biomanufacturing initiative led by RegenMed Development Organization (ReMDO) by providing its cell culture and bioprocessing sensor technology and desktop products, as well as lending its bioprocessing expertise to several active projects and working groups.
“Regenerative medicine biomanufacturing can greatly benefit from real-time sensing, closed loop process control and automation that the bioprocessing industry has enjoyed for a while,” said John Moore, SBI’s President. “Our single use sensors pave the path for scale up, increased reproducibility and monitoring of critical process parameters,” added Moore.
ReMDO is a non-profit organization managing an industry-driven consortium (Regenerative Manufacturing Innovation Consortium, RegMIC) of more than 60 industry and academic partners working collaboratively to deliver on the promise of regenerative medicine by addressing manufacturing challenges. ReMDO was founded in 2014 to solve the biggest manufacturing challenges facing regenerative medicine, including manufacturing scale up, de-risking technology, speeding up the translation of technology into clinical practice and improving affordability. ReMDO manages an advanced biomanufacturing initiative aimed at bringing more regenerative medicine products out of the clinic and into the global market.
“SBI is an important industry collaborator that has a unique sensor technology and instruments that integrate and provide value across multiple ReMDO programs. SBI’s sensors provide a rich data source that can be used to optimize our project performance,” said Joshua G. Hunsberger, PhD, ReMDO’s Chief Technology Officer.
“Having this sensor data is really integral to each of these programs as we look to fine tune each platform technology. These sensors give our project partners real time data feedback. If you can look at pH, glucose, lactate and dissolved oxygen content data points in real time along your process, this helps our platforms produce healthy cells, which are the building blocks for regenerative medicine,” he added.
Dr. Hunsberger holds his PhD in Neuroscience from Yale and was instrumental in starting the ReMDO organization, developing its initial roadmap and helping to secure industry funding in key manufacturing impact areas to start some of its ongoing, signature projects.
“A colleague of mine has a great slide deck that shows different ways of making bread,” Dr. Hunsberger said. “One method is making it by hand slowly. The other is hundreds and hundreds of loaves coming off a conveyor belt. For regenerative medicine to be successful, we need option two. SBI and our partners are helping us get there.”
SBI is providing sensor technology and bioprocessing expertise for three active ReMDO projects —Universal Cell Media, Universal Bioink and a newly launched project focused on modular bioreactor scalability. These projects are part of the Advanced Biomanufacturing Initiative, which is supported by funding from the U.S. Army Medical Research & Materiel Command (USAMRMC) and the Medical Technology Enterprise Consortium (MTEC).
ReMDO’s Universal Cell Media collaboration, which began in 2016, is designed to reduce variability in cell media by improving media factor definition. ReMDO is striving to develop a defined, xeno-free (animal product free) universal media that works with most clinically-relevant cell types, which will improve FDA regulatory approval performance and potentially significantly reduce the cost of media. Better performance at lower development costs is not only critical for regenerative medicine developers and manufacturers, but also for patients who will pay less for the end products.
The Universal Bioink project is developing a tunable, universal bioink for the 3D bioprinting of implantable regenerative medicine clinical products, including tissue and organs. The goal is to create an out-of-the-box bioink that can be tuned to create different tissues using the same bioprinter. This bioink will also be able to be used across different 3D bioprinting modalities such as extrusion and ink jet based bioprinters.
ReMDO’s newest project is focused on bioreactor scalability for regenerative medicine. Being able to grow billions and billions of cells efficiently and effectively in 3D tissues and organs is currently a major challenge for regenerative medicine manufacturing.
In each case, SBI’s sensor technology and bioprocessing expertise is being deployed to monitor processes in real time, provide early warning signs of problems and generate the valuable and timely data sets that ReMDO and its partners need to achieve their respective goals. What’s more, SBI’s sensors are key tools in process and product validation.
“The SBI application scientist team is actively engaged with ReMDO and its members on all three projects on a regular basis. Current products for real-time sensing of pH and dissolved oxygen and products under development that expand the sensing platform and enhance sensing integration play a key role in biomanufacturing,” said Sandy Williams, PhD, SBI’s Marketing and Product Manager.
Ultimately, ReMDO and its industry and academic partners are seeking to augment standards development and codify standard operating procedures for regenerative medicine manufacturing; increase the utilization of process automation to reduce human error and accelerate the development process; and enhance the scalability of current regenerative medicine manufacturing processes.
All of the above will reduce research and development costs, streamline and accelerate regenerative medicine manufacturing, improve regulatory performance and help bring more affordable regenerative medicine therapies to patients in need.