A unique, simultaneous manufacturing strategy of mesenchymal stem cell exosomes: significance for cost-effective treatments

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The high manufacturing costs of cell and gene therapy products are never missed in any commercialization discussions. Process automation and robust process development are several approaches to reduce the long-term pain of high cost of goods. In this webinar, Dr Westenfelder presents a novel strategy to simultaneously produce multiple therapeutic products, namely mesenchymal stem cells (MSCs) and their derived exosomes. Hear from Dr Westenfelder about how the hollow-fiber technology in Quantum Cell Expansion System has enabled him to produce high quality and cost-effective therapies for kidney infection and other diseases.

What will you learn?

  • MSCs and their derived exosomes for the treatment of acute kidney injury and microvascular/cardiovascular diseases
  • Programmed MSC-derived exosome production in a hollow fiber bioreactor (Quantum Cell Expansion System)
  • How hollow fiber bioreactors have a unique advantage for simultaneous manufacturing of at least two biotherapies
  • Cost–effectiveness of manufacturing in Quantum

Speaker:

Christof Westenfelder, MD

Founder and CEO of SymbioCellTech, Professor of Medicine and Physiology, Member of the Artificial Organ Institute at the University of Utah and Chief of Nephrology at the George E Wahlen VA Health Sciences Center

University of Utah, SymbioCellTech

Founder and CEO of SymbioCellTech, a regenerative medicine company in Salt Lake City (UT, USA), with a focus on the cure of Type I diabetes mellitus, Type II diabetes mellitus, a wide variety of microvascular and acute and chronic kidney diseases.

Dr Westenfelder is a Professor of Medicine and Physiology, and Member of the Artificial Organ Institute at the University of Utah, and served as Chief of Nephrology at the George E Wahlen VA Health Sciences Center for 36 years (all UT, USA).

He is experienced in clinical research in adult stem cell biology, stem cell translational research with an emphasis in the fields of regenerative medicine, and renal and critical care.

Dr Westenfelder’s expertise is in the biology and clinical uses of erythropoietin and treatment of acute kidney and multi-organ failure. He is also the founder of Nephrogen (MA, USA), Allocure (MA, USA) and Nephrocelltech (UT, USA), and holds numerous patents pertinent to SymbioCellTech’s technologies. He obtained an IND from the US FDA for the conduct of a successful Phase I trial in which the safety and kidney protective activity of allogeneic, bone marrow-derived multipotent stromal aka mesenchymal stem cells was demonstrated.

He is currently conducting an FDA guided (INAD) clinical pilot study in dogs with Type I diabetes mellitus. This study is based on the previous demonstration that mice with auto-immune Type I diabetes mellitus, analogous to human Type I diabetes mellitus, are permanently cured when treated with SymbioCellTech’s stem cell-based ‘Neo-Islets'”. So far, diabetic, insulin-dependent dogs responded favorably to this fundamentally new therapy as well.

Most recently, he had a successful pre-IND meeting for the conduct of a first-in-human clinical trial in patients with Type I diabetes mellitus, using SymbioCellTech’s stem cell-based technology. Currently, very promising preclinical studies have been conducted in which the treatment with stem cell-derived exosomes/nanovesicles was shown to rescue the kidney function in animal models with otherwise treatment resistant and often fatal acute kidney injury. Clinical translation will be undertaken.

 

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