Holistic Approach of Swiss Fetal Progenitor Cell Banking: Optimizing Safe and Sustainable Substrates for Regenerative Medicine and Biotechnology

Abstract

Swiss Fetal Progenitor Cell Banking is proposed, achieving sustained standards and potential production of billions of affordable and efficient therapeutic doses. Thereby, the aim is to validate the core therapeutic value proposition, to increase awareness and use of standardized protocols for translational regenerative medicine, potentially impacting millions of patients suffering from cutaneous and musculoskeletal diseases. Alternative applications of FPC banking include biopharmaceutical therapeutic product manufacturing, thereby indirectly and synergistically enhancing the power of modern therapeutic armamentariums. It is hypothesized that a single qualifying fetal organ donation is sufficient to sustain decades of scientific, medical, and industrial developments, as technological optimization and standardization enable high efficiency.

Industrial Development of Standardized Fetal Progenitor Cell Therapy for Tendon Regenerative Medicine: Preliminary Safety in Xenogeneic Transplantation

“…Overall, cultured hFPTs such as FE002-Ten cells are characterized by optimal stability, consistency, and traceability, which are prerequisites for all starting materials destined for allogeneic cell therapy applications [ 49 , 65 ]. Proposed bioprocessing methodologies and subsequent multi-tiered cell banking for clinical-grade progenitor cell sources (e.g., FE002-Ten cell type) are primordial for quality assurance and sustainability of the material source.…”

“…Therefore, as we had previously shown, properly sourced, isolated, and cultured hFPTs uphold the quality standards required from active pharmaceutical ingredients (API) for regenerative medicine product development and implementation [ 49 ]. Furthermore, integrative frameworks such as transplantation programs for FPC type establishment guarantee the highest level of quality and safety for subsequent clinical applications [ 60 , 61 , 62 , 63 , 64 , 65 ]. Indeed, thorough validation of identity, purity, sterility, stability, safety, and efficacy of biological raw and starting materials may be robustly performed within industrial multi-tiered cell banking of hFPTs following good manufacturing practices (GMP) [ 64 , 65 , 66 ].…”

“…Furthermore, integrative frameworks such as transplantation programs for FPC type establishment guarantee the highest level of quality and safety for subsequent clinical applications [ 60 , 61 , 62 , 63 , 64 , 65 ]. Indeed, thorough validation of identity, purity, sterility, stability, safety, and efficacy of biological raw and starting materials may be robustly performed within industrial multi-tiered cell banking of hFPTs following good manufacturing practices (GMP) [ 64 , 65 , 66 ]. Such approaches have been historically validated notably in the field of vaccine substrate development and use, wherein biotechnological process optimization has been a cornerstone in the industrial manufacture of many currently marketed biologicals and vaccines.…”

“…Such approaches have been historically validated notably in the field of vaccine substrate development and use, wherein biotechnological process optimization has been a cornerstone in the industrial manufacture of many currently marketed biologicals and vaccines. Adaptation of starting material sourcing and banking of isolated primary cell types therefore serve as thoroughly validated technical bases for exploitation of tissue-specific cell types within homologous therapeutic product development approaches [ 65 ].…”

Retrospective Evaluation of Progenitor Biological Bandage Use: A Complementary and Safe Therapeutic Management Option for Prevention of Hypertrophic Scarring in Pediatric Burn Care

“…Such bioengineered constructs may partly favor repair and regeneration of functional cutaneous tissues in burn victims by releasing cytokines and growth factors, potentially negating the need for subsequent skin grafting, while reducing the formation of hypertrophic scar tissues [4,6,9]. Inherently constituting a singularity, the Swiss FPC transplantation program, enabling the inception and continued clinical supply of PBBs, was devised for a holistic and sustainable control of therapeutic material generation and manufacturing under current Good Manufacturing Practices (cGMP) [11][12][13]. Therein, optimization and standardization of the successive steps necessary for implementation of FPC transplantation were undertaken, ranging from original primary FPC type establishment from a single organ donation, multi-tiered cell banking, to formulation of therapeutic biologicals for clinical delivery (Figure 1) [7,12,14].…”