SanBio, Inc.
SanBio is dedicated to developing regenerative medicine pharmaceuticals, including SB623, aiming to deliver innovative treatments to patients worldwide. Their mission is to provide value through regenerative medicine development, with a vision to become a global leader in the field. They focus on cell therapy medicines, advanced technology, and a top-level development team to support their goal of improving patient outcomes and expanding access to regenerative treatments.
Industries
Nr. of Employees
small (1-50)
SanBio, Inc.
8-1 Akashicho, Chuo City, Tokyo 104-0044, Japan
Patents
Medium, methods, cells and secreted factors for stem cell culture and therapy
US-12553033-B2
View DetailsMedium, methods, cells and secreted factors for stem cell culture and therapy
US-11946072-B2
View Details
Medium, methods, cells and secreted factors for stem cell culture and therapy
US-12553033-B2
View DetailsMedium, methods, cells and secreted factors for stem cell culture and therapy
US-11946072-B2
View DetailsProducts
Donor-derived MSC-based intracerebral cell therapy for chronic CNS injury
A cell therapy product class made from donor bone marrow-derived mesenchymal stromal cells that are transiently gene-modified, expanded at scale, cryopreserved and administered via intracerebral implantation to promote neuroregeneration in chronic CNS deficits.
Donor-derived MSC-based intracerebral cell therapy for chronic CNS injury
A cell therapy product class made from donor bone marrow-derived mesenchymal stromal cells that are transiently gene-modified, expanded at scale, cryopreserved and administered via intracerebral implantation to promote neuroregeneration in chronic CNS deficits.
Services
Design and conduct of multicenter clinical trials for regenerative cell therapy candidates, including randomized controlled study designs and safety monitoring.
Process development, GMP-aligned production, lot release testing and commercial production run execution for donor-derived live cell therapies.
Support for regulatory submissions, interactions with authorities, designation applications, and establishment of QA/QC frameworks for cell therapy products.
In vitro and in vivo model studies for CNS indications, including proteomic analysis, extracellular matrix characterization, and neuropoiesis assays.
Preparation for post-approval activities including manufacturing scale-up for commercial supply, distribution logistics, and hospital rollout for an approved cell therapy product.
Design and conduct of multicenter clinical trials for regenerative cell therapy candidates, including randomized controlled study designs and safety monitoring.
Process development, GMP-aligned production, lot release testing and commercial production run execution for donor-derived live cell therapies.
Support for regulatory submissions, interactions with authorities, designation applications, and establishment of QA/QC frameworks for cell therapy products.
In vitro and in vivo model studies for CNS indications, including proteomic analysis, extracellular matrix characterization, and neuropoiesis assays.
Preparation for post-approval activities including manufacturing scale-up for commercial supply, distribution logistics, and hospital rollout for an approved cell therapy product.
Expertise Areas
- Cell therapy development (allogeneic MSCs)
- Bioprocess scale-up and GMP manufacturing
- Regulatory strategy for regenerative medicine
- Clinical trial management for CNS indications
Key Technologies
- Allogeneic mesenchymal stromal cell therapy
- Transient gene modification of cells
- Large-scale cell culture and bioprocess scale-up
- GMP manufacturing for cell products
News & Updates
Announcement of Keita Mori, President and CEO of SanBio, being appointed as Chairman of the Samurai Biotech Association.
Announcement of the manufacturing results for the third production run of AKUUGO suspension for intracranial implantation.
Publication of the final analysis results of the Phase 2 STEMTRA trial for traumatic brain injury.
Various scientific papers and research articles related to SB623 and its effects on neural regeneration and recovery in CNS disorders.
Obtained IND approval from the US FDA for clinical trials of SB623 for chronic stroke and traumatic brain injury.
Announcement of Keita Mori, President and CEO of SanBio, being appointed as Chairman of the Samurai Biotech Association.
Announcement of the manufacturing results for the third production run of AKUUGO suspension for intracranial implantation.
Publication of the final analysis results of the Phase 2 STEMTRA trial for traumatic brain injury.
Various scientific papers and research articles related to SB623 and its effects on neural regeneration and recovery in CNS disorders.
Obtained IND approval from the US FDA for clinical trials of SB623 for chronic stroke and traumatic brain injury.