To procure and optimize processing of human hepatocytes for research and clinical purposes.

Our goal is to develop a therapeutic product that can arrest or reverse the progress of osteoarthritis of the knee, delay or obviate the need for total knee preplacement, alleviate the debilitating pain associated with osteoarthritis, and improve the quality of life for millions of patients suffering from this condition. Our product will consist of nano-sized vesicles called exosomes that carry regenerative and anti-inflammatory cues to promote cartilage healing and also alleviate inflammation.

The central goal of this proposal is to conduct a viral clearance validation study. To meet the growing demand of pathogen reduced hPL used in clinical applications and remain competitive among other platelet lysate manufacturers, we need to adapt our production process to include a pathogen reduction step. The validation of this product is on its final stages. However, it is necessary to perform a viral clearance study to prove that the gamma irradiation applied to the hPL inactivates potential pathogens. The study will be outsourced to Charles River Laboratories, INC.

This proposal will expand Anatomic facilities through equipment purchases to establish an independent laboratory. This will create room for additional personnel, and allow Anatomic to conduct additional product development activities to keep pace with competitors.

The primary goal of the proposed work is to produce preclinical data to support the use of BIO 300 in patients with triple negative breast cancer receiving radiotherapy to improve patient survival by preventing metastasis to the lungs. The secondary goal is to further characterize the mechanism by which BIO 300 is able to protect normal tissues from the harmful side effects of radiotherapy.

Our goal is focused on developing the commercial pathway for two translational stem cell related projects in Minnesota, one creating Rapidly Endothelialized Vascular Bypass Grafts, a non-clotting blood vessel product for bypass surgeries and a second project, where TIF is the Managing Partner, building a novel low power, liquid nitrogen-free, cryogenic storage solution for the ultra-low temperature biologics in supply chain.

We are developing a one-time treatment for durable remission of HIV in the absence of antiretroviral treatment. This treatment is a regenerative medicine therapy of autologous HIV-specific chimeric antigen receptor (CAR)-T cells that target B cell follicles, an immune protected site that permits viral replication. Here, we propose to develop the infrastructure to produce GMP-ready plasmids, which will be used as starting materials for GMP manufacture of gammaretrovirus and CAR-T cells for the IND-enabling primate study and for the Phase 1 clinical trial.