©2020 BioProcess International All Rights reserved Mesoblast’s lead product candidate, RYONCIL (remestemcel-L), is an investigational therapy comprising culture- expanded mesenchymal stem cells derived from the bone marrow of an unrelated donor.

It is administered … According to Mesoblast, it counteracts the inflammatory processes responsible for steroid-refractory aGVHD in people who have received prior stem cell transplants. The trial completion is expected during the fourth quarter.“And we assume that we will be establishing a strategic partnership for manufacturing commercialization for this indication.”Bioprocessing begins upstream, most often with culturing of animal or microbial cells in a range of vessel types (such as bags or stirred tanks) using different controlled feeding, aerating, and process strategies.Beginning with harvest of material from a bioreactor, downstream processing removes or reduces contaminants to acceptable levels through several steps that typically include centrifugation, filtration, and/or chromatographic technologies.Drug products combine active pharmaceutical ingredients with excipients in a final formulation for delivery to patients in liquid or lyophilized (freeze-dried) packaged forms — with the latter requiring reconstitution in the clinical setting.Many technologies are used to characterize biological products, manufacturing processes, and raw materials. Ryoncil is made from mesenchymal stem cells from healthy donors. The Australian firm outlined its manufacturing plan for Ryoncil and other candidates Ryoncil (remestemcel-L) is a candidate cell therapy for children with steroid-refractory acute graft versus host disease (SR-aGVHD).The final decision is due in the next few weeks. This enables manufacturing at industrial scale for commercial purposes. Mesoblast’s Biologics License Application (BLA) for RYONCIL for the treatment of children with steroid-refractory acute GVHD has been accepted for priority review by the United States Food and Drug Administration (FDA). Mesoblast is committed to bringing to market innovative cellular medicines to treat serious and life-threatening diseases with significant, unmet medical needs.Mesoblast is using its proprietary mesenchymal lineage cell technology platform to develop and commercialize innovative allogeneic cellular medicines to treat complex inflammatory diseases resistant to conventional standard of care.The Company’s portfolio of Phase 3 product candidates are:Mesoblast’s Biologics License Application (BLA) for RYONCIL for the treatment of children with steroid-refractory acute GVHD has been accepted for priority review by the United States Food and Drug Administration (FDA). RYONCIL is an investigational therapy comprising culture-expanded mesenchymal stem cells derived from the bone marrow of an unrelated donor. Partnerships of many kinds — from outsourcing to licensing agreements to consultancies — help companies navigate this increasingly global business environment. Another key feature of Mesoblast’s cells is they can be administered to patients without the need for donor–recipient matching or recipient immune suppression. The Prescription Drug User Fee Act (PDUFA) action date is set at 9/30/2020, and if approved, Mesoblast is geared up to make RYONCIL available immediately in … Mesoblast Limited MESO announced that the FDA has accepted the biologics license application (BLA) for its lead product candidate Ryoncil (remestemcel-L), an allogeneic cell therapy. According to CEO Silviu Itescu, “if approved, the launch for this product [Ryoncil] is planned in 2020.“We have a PDUFA date for September 30, and we have industrial scale manufacturing in place to meet the commercial demand as we expect to move forward.”Itescu added: “We have sufficient capacity to meet our Ryoncil GVHD launch plans, and we have the ability to increase and plans underway to increase our capacity requirements.”The deal grants Mesoblast access to the Swiss CDMO’s cell therapy manufacturing facility in Singapore.The firm also has the option of asking Lonza to build a dedicated facility to meet its long-term commercial objectives.Ryoncil is made from mesenchymal stem cells from healthy donors.According to Mesoblast, it counteracts the inflammatory processes responsible for steroid-refractory aGVHD in people who have received prior stem cell transplants.The product’s mechanisms of action include “down-regulating the production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.”Ryoncil is also being tested as a therapy for children infected with COVID-19 who have acute respiratory distress syndrome, cardiovascular problems or other complications.Itescu said: “For acute respiratory distress syndrome, recruitment of Phase III trial of remestemcel is ongoing. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of September 30, 2020, and if approved, Mesoblast will make RYONCIL immediately available in the United States.The Company also has a promising emerging pipeline and next generation technologies.Mesoblast’s novel allogeneic product candidates are based on rare (approximately 1:100,000 in bone marrow) mesenchymal lineage cells that respond to tissue damage, secreting mediators that promote tissue repair and modulate immune responses.Mesenchymal lineage cells are collected from the bone marrow of healthy adult donors and proprietary processes are utilized to expand them to a uniform, well characterized, and highly reproducible cell population.

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