RoosterBio was founded in 2013 to specifically address the industry-wide bottleneck that is the scarcity of high quality and scalable cellular starting materials for product development and clinical manufacturing, is a pioneer in Regenerative Medicine (RM) manufacturing, with a focus on human mesenchymal stem/stromal cells (hMSC) raw materials, bioprocess design, and production technologies.
We are pleased to announce the ARMI | BioFabUSA Spring 2019 Project Calls. We encourage you to read this blog and the project call documentation, which is available on our community portal.
The PMOA of a combination product is the action that is mainly responsible for how the product achieves its intended therapeutic effect (i.e., drug, device, or biologic). Thus, an understanding of the PMOA is directly linked to an understanding of the statutory definitions of a drug, device, and biologic.