At Regenerelle, we are experts in radically simplifying the use of adult human mesenchymal stem/stromal cells (hMSCs) to propel the commercialization of biologic technologies. By enabling living cells to become more affordable at the lowest cost per million cells with industry leading quality, we make MSCs easier to access and much simpler to incorporate into product development efforts, leading to rapid acceleration in products coming to market that incorporate these technologies.
Regenerelle hMSCs and Exosomes are the Gold Standard. We focus on Low Passage, High Potency, Purity and 3rd Party US CLIA Lab Testing (on Incoming Tissue and Final Product). High quality raw materials with built-in processes and protocols are integrated into our QMS. Our complete hMSC systems offer robust and affordable solutions that allow you to focus on your final development goals.
MSCs & EXOSOME FROM
THE NEW R&D
REGENERATIVE CELLULAR SOLUTIONS
THE THREE COMPONENTS OF OUR GUARANTEE:
VERSATILE & POTENT
Manufactured in ISO 7 3rd party Certified Clean Rooms. Maintains a QMS system compliant to FDA 21 CFR 1271, GLP, GTP, GMP & ISO 9001 via 1st party audits
MSCs from healthy Wharton’s Jelly donated after live healthy full term births.
Low passage MSCs process not to exceed 4 passages.
Mesenchymal Stem Cells derived from Wharton’s Jelly in human umbilical cords (UC) exhibit superior proliferation and differentiation potential compared to bone marrow MSCs
LEARN MORE BELOW:
Off-the-shelf product can be applied safely, immediately, and on demand
UC-MSC for Clinicl Trial and Expanded Access submissions are available in vials of 25 million & Exosomes for RUO are available in concentrations of 5, 10, 50 or 100 billion.
The path to Expanded Access IND approval for cell-based therapies can be challenging and time consuming with strict regulatory requirements. That is why Regenerelle provides Process Development Services to help you build clinical phase appropriate cGMP processes for your specific product needs. Right-sized to your current hMSC-based therapeutic research program, we take a customer centric approach - transferring the product and process knowledge back to you. We will help you build a cost-effective process to meet your future milestones.