Sometimes a picture (or very quick video clip) can tell an entire story. If you click on the above video, you can see precisely what we mean by that. But this is a story years in the making. Before learning how Rooster’s high-performance media found its way into “Media,” here’s…
… A Little Bit of Background
RoosterBio began in 2013 with an observation. The founders realized that redundant efforts were impeding the regenerative medicine sector i.e., duplicated work to establish cell banks of mesenchymal stromal cells (MSCs). RoosterBio hypothesized that well-characterized, off-the-shelf MSCs would standardize the supply chain to accelerate cell therapies through preclinical and clinical studies. In turn, our customers’ success would unlock reliable patient care that delivers on the promises of regenerative medicine. By cooperating as a network of specialized experts, our community would thus de-risk the cellular therapy development pipeline.
Efficient collaboration to solve today’s problems in regenerative medicine requires the specialization of duties according to domain expertise. RoosterBio’s part is to provide solutions to these problems via best-in-class product materials, expertly developed bioprocesses for easy tech transfer and actionable information from its menu of analytical services. Its bulk quantities of high-performance MSCs and paired media propel projects from preclinical to clinical trials in full alignment with current Good Manufacturing Practice (cGMP) regulations. The customer determines RoosterBio’s involvement, which can conclude after order fulfillment—or build into a partnership. Products are available for direct purchase online or with a sales representative. The product portfolio includes MSC banks and process-specialized media for cell expansion, extracellular vesicle (EV) production, and genetic engineering.
Ongoing investments and grants enabled optimized protocols to reliably manufacture cells and efficiently harvest their secretomes. Here, RoosterBio’s technical support helps customers scale-up cell yields into the billions of MSCs for cell therapy doses or for EV/exosome preparation. The products and custom bioprocess protocols establish manufacturing. The level of detail and white glove technical support work for both customer-led in-house deployments and transfer to a contract development and manufacturing organization (CMDO). Development service contracts define a question asked by the customer that is to be answered experimentally by RoosterBio. Projects have included comparison of media performance, culture process parameter optimization, and a wide range of analytical services for thorough characterization of MSCs as well as EVs/exosomes. It is from our decades of person-years in servicing customers that we’re able to best understand their pain points. Few challenges come close to the issues posed by low-quality MSC media. Fortunately, our product developers were well-positioned to answer this unmet need from the earliest days of operation.
ImMEDIAte Application for Diverse MSC Uses
To be banked as RoosterBio cells, the parental MSCs must proliferate rapidly and with more than a 100x increase in cell number across 2 passages. For example, a single, one million-cell vial can multiply into 100 million cells in 7 to 14 days. How is this high level of performance possible? It is only guaranteed when these cells are prepared in concert with RoosterBio’s “traditional” (FBS-containing), Xeno-Free (XF), and cGMP grade media system and recommended bioprocess.
These media were formulated alongside the earliest cell banks to create a tailor-made, coactive system, which optimizes cell health, stabilizes phenotypic identity, and maximizes the speed of cell proliferation. The media formula contains a high density of growth-promoting ingredients. There are two benefits to this design choice:
(1) no media exchanges between passages and
(2) cell proliferation can be scaled from flaskware to bioreactors with the same media.
Without media exchanges, the flasks are handled and opened less, which reduces the risk for contamination to compromise the culture. Further, the system is ultimately less expensive in cells per unit of media—and more tractable for manufacturing thousands of doses.
RoosterBio’s Efficient Media System – “Crowing” Cells Without Morning Fuss
With an auditable process to supervise quality that’s running full steam, optimization of media system efficiency can stay at top priority. Our customers know that cell culture requires expensive “hands-on” time and consumables. Yet, media and simplified bioprocess for rapid cell expansion requires less of both. Here’s how. One cryovial of cells can become 5 billion ISCT-defined MSCs in 10 days with 32 L of media. During the process, RoosterBio makes manufacturing cells faster, more efficient and 60% less expensive.
A head-to-head comparison (see video, above) shows the RoosterBio XF cells and media outperform the industry competition by yielding more cells (150x compared to 40-60x expansion) in less time (8 compared to 14 days). The timelapse video follows two cell systems over 2 passages. Because of RoosterBio’s proliferation qualification and media formulation, the cells are expanded and ready in 8 days with 0 media exchanges. The competition takes 14 days and 4 media exchanges to do the same. The savings are 63% less media, 66% less days. The yield increased 2x cell number.
The RoosterBio system fuels the rapid commercialization of scalable regenerative cures. Regulatory expertise, cGMP manufacturing, and Type II MasterFile with the FDA save customers’ work. Those customers include 300+ government, academic, institutions, and industry partners across 25+ countries and 6 continents. RoosterBio technology has been cited in more than 200 peer-reviewed journals since 2015. However, the ultimate goal is approved, useful cell therapies that benefit patients. That is a team sport. Let’s each play to our strength and achieve the impossible!
For further reading, take a look at this article by David Alvaro, Ph.D., of Pharma’s Almanac: A Media Platform for Cost-Effective and Scalable 2D and 3D Bioreactor MSC Expansion.