CellTrans
Developer and contract provider of cell-therapy manufacturing, preclinical testing, and in‑vitro assay services focused on pancreatic islets and related bioengineered therapeutics. Operates a current Good Manufacturing Practice (cGMP) cleanroom complex for clinical-grade islet manufacture, performs preclinical in vivo testing including non-human primate models, and develops microfluidic in‑vitro platforms and biomaterials for encapsulation and delivery.
Industries
Nr. of Employees
small (1-50)
Products
Allogeneic pancreatic islet cellular suspension for transplantation
Clinical-grade allogeneic pancreatic islet cellular suspension produced for transplantation to treat difficult-to-control type 1 diabetes.
Lantidra (donislecel-jujn) Allogeneic Pancreatic Islet Cellular Suspension
An FDA approved allogeneic pancreatic islet cellular suspension indicated for the treatment of hard to control type 1 diabetes in patients unable to approach target glycemia despite intensive insulin management.
cGMP Pancreatic Islet Manufacturing Facility
State-of-the-art cGMP facility featuring fully certified ISO 7 and ISO 5 processing areas dedicated to the manufacture of high-quality human islets for clinical use.
Autologous Islet Transplant
Isolated autologous islets for the treatment of chronic pancreatitis via partial resection or total pancreatectomy.
Consultation Services
Consultation services covering regulatory, statistical, and trial design for pre-clinical and clinical development of cellular products and biomaterial research.
Morphology Assessment with Islet Scoring
Evaluation of islet morphology based on five categories including size distribution, fragmentation, density, border, and shape using a maximum score of 10.
Allogeneic pancreatic islet cellular suspension for transplantation
Clinical-grade allogeneic pancreatic islet cellular suspension produced for transplantation to treat difficult-to-control type 1 diabetes.
Lantidra (donislecel-jujn) Allogeneic Pancreatic Islet Cellular Suspension
An FDA approved allogeneic pancreatic islet cellular suspension indicated for the treatment of hard to control type 1 diabetes in patients unable to approach target glycemia despite intensive insulin management.
cGMP Pancreatic Islet Manufacturing Facility
State-of-the-art cGMP facility featuring fully certified ISO 7 and ISO 5 processing areas dedicated to the manufacture of high-quality human islets for clinical use.
Autologous Islet Transplant
Isolated autologous islets for the treatment of chronic pancreatitis via partial resection or total pancreatectomy.
Consultation Services
Consultation services covering regulatory, statistical, and trial design for pre-clinical and clinical development of cellular products and biomaterial research.
Morphology Assessment with Islet Scoring
Evaluation of islet morphology based on five categories including size distribution, fragmentation, density, border, and shape using a maximum score of 10.
Services
Isolation, purification, and cGMP manufacture of clinical-grade human islets (autologous and allogeneic) with associated QC release testing and cleanroom operations.
Design and execution of in vivo efficacy, biocompatibility, and toxicology studies for islet and islet-like biologics across rodent, non-human primate, and xenogeneic models, including multiple implantation sites.
Multiparametric microfluidic assessments, oxygen consumption measurements, morphology scoring, viability and purity assays, and static GSIS testing to evaluate islet potency and viability.
Consulting on IND/IDE enabling experiments, regulatory document preparation, clinical study design, and statistical analysis planning.
Isolation, purification, and cGMP manufacture of clinical-grade human islets (autologous and allogeneic) with associated QC release testing and cleanroom operations.
Design and execution of in vivo efficacy, biocompatibility, and toxicology studies for islet and islet-like biologics across rodent, non-human primate, and xenogeneic models, including multiple implantation sites.
Multiparametric microfluidic assessments, oxygen consumption measurements, morphology scoring, viability and purity assays, and static GSIS testing to evaluate islet potency and viability.
Consulting on IND/IDE enabling experiments, regulatory document preparation, clinical study design, and statistical analysis planning.
Expertise Areas
- Islet isolation and transplantation
- cGMP cellular therapy manufacturing
- Biomaterials and microencapsulation
- Microfluidic assay development and live-cell imaging
Key Technologies
- Microfluidic biochips and perifusion devices
- Glucose-stimulated insulin secretion (GSIS) assays
- Insulin ELISA
- Viability staining (FDA/PI)
News & Updates
Publication describing alginate encapsulation to provide immune protection and improved islet graft survival in non-human primates.
Study of foreign body immune responses to implanted materials in rodent and primate models, relevant to biomaterial design for encapsulation.
Publication describing alginate encapsulation to provide immune protection and improved islet graft survival in non-human primates.
Study of foreign body immune responses to implanted materials in rodent and primate models, relevant to biomaterial design for encapsulation.