Company FAQs - RoosterBio Inc

Company FAQs

RoosterBio was founded in 2012 with the intention to de-bottleneck and revolutionize the adult stem cell industry. RoosterBio launched manufacturing operations in October 2013 and started shipping cell and media products to customers in February 2014. We have 160+ customers Worldwide: from North America to Europe to Asia. We are passionate about advancing regenerative medicine applications and adult stem cell therapies to the clinic and will not back down from a challenge to do so.

Why the name RoosterBio?

Roosters proclaim the dawn of a new day, and RoosterBio is here to proudly proclaim the dawn of a new day in Biofabrication.

Why did you create RoosterBio?

Our goal is to accelerate the biologics and biofabrication revolution much in the same way we are seeing 3D printers drive the local-maker movement. We believe that, if we drive the cost of stem cells from $1000 to $10 per million cells, we will see a large expansion of living stem cells used into next generation therapeutics, medical devices, and even consumer products.

What is Biofabrication?

Biofabrication is the creation of advanced biological models, medical therapeutic products, and non-medical biological systems.

Why Mesenchymal Stem Cells (MSCs) and not Induced Pluripotent Stem Cells (iPSCs)?

Currently, the number and the growth of MSC trials are outpacing other cell sources. This is for several reasons.

  1. The safety profile of MSCs in early stage clinical trials has been very good.
  2. The accumulated data from these MSC trials has created a more straight-forward regulatory path MSCs when compared to many other less-proven cell types.
  3. Many MSC trials are performed with undifferentiated cells, and the manufacturing processes are simpler, more standardized, and more robust than many differentiated cell products. This leads to more straight forward filings with the FDA (specifically, CMC - Chemistry, Manufacturing and Controls filings) when compared to less-proven cell types that have complicated differentiation pathways and complicated, unscaled manufacturing processes.
  4. Due to their robust signaling activity, MSCs demonstrate usefulness in a wide range of clinical indications.

What is the relationship between MSCs and the field of Regenerative Medicine?

Due to their tremendous therapeutic potential, the trend of MSC technology being incorporated into regenerative therapies will continue, and there is a strong need for affordable, abundant, and extremely well characterized MSC products to enable product development and successful clinical translation. New technologies such as bioprinting, cell and tissue engineering, synthetic biology/genetic manipulation, and of course, cell manufacturing sciences will continue to propel the field of Regenerative Medicine forward and further necessitate the need for the availability of large numbers (lot sizes in the billions) of clinically-translatable MSCs.