RoosterBio has announced the launch of the Regenerative Medicine (RM) industry’s first xeno-free (XF) hMSC cell banks to advance and simplify stem cell biomanufacturing. By incorporating XF starting materials at early stages, RM scientists can perform more clinically relevant work, resulting in an expedited path towards clinical testing programs. Due of the importance of this announcement, I followed up with Dr. Priya Baraniak, Director of BD & Strategic Marketing at RoosterBio, to further explore details of the launch.
Cade Hildreth: What is the importance of RoosterBio’s recent launch of a Xeno-Free (XF) hMSC Cell Bank?
Dr. Priya Baraniak: RoosterBio’s mission is to accelerate Regenerative Medicine (“RM”), and we are doing so by simplifying stem cell biomanufacturing and clinical translation of stem cell based products. RoosterBio XF hMSC cell banks are a first-in-class critical cellular starting material for stem cell manufacturing and process and product development.
While bovine serum-containing medium is still widely used in industrial and clinical product development, the industry has been progressing technology towards the removal of xeno-containing components from RM cell and media systems. We are excited to bring to market not only XF cell culture media, but also the accompanying XF hMSC cell banks.
This cell and media system has the scalable and efficient manufacturing process and streamlined regulatory profile designed into it.
Cade Hildreth: What applications do you see for your XF hMSC Cell Bank?
Dr. Priya Baraniak: RoosterBio XF hMSC cell banks are used as starting materials in the manufacturing of hMSC-based products. These XF products are primarily utilized in product development and preclinical studies, across the vast array of Regenerative Medicine applications that depend upon highly functional hMSCs, or hMSC-derived products.
Applications include biofabricaton of living tissues and organs for transplantation, therapies where single cell suspensions are infused into patients (i.e. Stroke, GvHD, etc.), cell-based gene therapies, as well as hMSC-derived products like extracellular vesicles (or exosomes).
Now these transformational applications can shift to using cellular starting materials that lower regulatory burden/risk and elevate the level of clinical relevance.
Cade Hildreth: How are the RoosterVial™-XF line of products synergistic with RoosterBio’s existing products?
Dr. Priya Baraniak: RoosterBio is the first in the industry to introduce hMSC manufacturing solutions – cell banks paired with highly engineered bioprocess media systems.Now anyone with basic cell culture skills can readily become an expert hMSC manufacturer by using our products and following our protocols. We give our customers innovative products with best-in-class stem cell manufacturing processes. Our initial products do contain low levels of high quality bovine serum, which remains the industry gold standard for efficient cell culture. Last year, RoosterBio launched a XF bioprocess media system that is also highly productive, while lowering regulatory burden.
Now, we’ve released our companion XF cell banks. Our RoosterVial™-XF cell products, when coupled with our XF bioprocess media, enables anyone to produce their own manufacturing lots of completely XF hMSCs efficiently, economically and more simply than ever before.
Cade Hildreth: What future products does RoosterBio have in the pipeline?
Dr. Priya Baraniak: In the near future we will be launching our XF bioreactor media feed, which will enable fully XF fed-batch bioreactor expansion of hMSCs. We are thrilled about this product, as fed-batch bioreactor expansion is by far the most efficient processing method for scalable stem cell production for industrial applications.
In addition, all of these XF products can be manufactured in our single-use, closed system packaging which incorporates Allegro TK8 film technology. Our unique single-use packaging further enables scalable, cGMP-aligned hMSC manufacturing.
Our product pipeline is filled with additional systems and solutions that are designed to accelerate process development and commercial production workflows. Stay tuned for some very exciting announcements yet to come this year.