A Different Viewpoint.

About Us

ProCell Biotech has established relationships with world-class human islet isolation laboratories which meet cGMP and FDA regulations to isolate and distribute human islet cells. We provide human pancreatic islets and related tests at competitive prices on a regular or as needed basis. We provide services that use the islet platform to help Biotech/Pharmaceutical companies engaged in drug discovery and development to identify drugs to cure diabetes. We provide services to help our clients who would like to establish their own Autologous Islet Transplant Program at their facilities. We also provide services to help our clients in their IND and IDE applications with the FDA. ProCell Biotech, LLC is based in California, USA.

v Regulatory strategic planning and development

v cGMP enhancement Master Plan

v Manufacturing and scale-up management

v Process capabilities and controls

v Regulatory submission preparation - IND, IDE, NDA, PMA, BLA

v Due diligence audits

v Mock FDA inspections

v Pre-approval inspection readiness

v Equipment Qualification

· Design Qualification (DQ)

· Installation Qualification (IQ)

· Operational Qualification (OQ)

· Performance Qualification (PQ)

v Validation Master Plans

· Process Validation

· Cleaning Validation

v Facilities Qualification

v Procedure Development

v SOP Writing

Mission

Our mission is to provide human based solutions to research communities including academic and corporate entities engaged in drug discovery and development. We are committed to bridging the gap between the concepts in cell therapy industry and their therapeutic application in patient care by providing quality products and services for researchers to find new and innovative ways to treat and cure diseases.

Strategic Partners (IIAM)

ProCell has established an agreement with the International Institute for the Advancement of Medicine (IIAM). IIAM is one of the biggest recovery networks for procuring donated human tissues for research and education in the US. Our agreement with IIAM allows us to access donor organs that do not meet the criteria for transplantation to be used in research. We provide high quality human cells isolated from donated organs that do not meet the criteria for transplantation to research communities, including academic and corporate communities, to assist in their search for new and innovative ways to treat and cure diseases.

Discover More

Creating places that enhance the human experience.

ProCell Biotech has established relationships with world-class human islet isolation laboratories which meet cGMP and FDA regulations to isolate and distribute human islet cells. We provide human pancreatic islets and related tests at competitive prices on a regular or as needed basis. We provide services that use the islet platform to help Biotech/Pharmaceutical companies engaged in drug discovery and development to identify drugs to cure diabetes. We provide services to help our clients who would like to establish their own Autologous Islet Transplant Program at their facilities. We also provide services to help our clients in their IND and IDE applications with the FDA. ProCell Biotech, LLC is based in California, USA.

Mission

Our mission is to provide human based solutions to research communities including academic and corporate entities engaged in drug discovery and development. We are committed to bridging the gap between the concepts in cell therapy industry and their therapeutic application in patient care by providing quality products and services for researchers to find new and innovative ways to treat and cure diseases.

Strategic Partners (IIAM)

ProCell has established an agreement with the International Institute for the Advancement of Medicine (IIAM). IIAM is one of the biggest recovery networks for procuring donated human tissues for research and education in the US. Our agreement with IIAM allows us to access donor organs that do not meet the criteria for transplantation to be used in research. We provide high quality human cells isolated from donated organs that do not meet the criteria for transplantation to research communities, including academic and corporate communities, to assist in their search for new and innovative ways to treat and cure diseases.

Useful Pancreatic Product

Amazing cell enrichments

Building Castle in Cloud

Normal Human Pancreatic Products

High Purity Human Islets 100% – 75%
Medium Purity Human Islets 70% – 40%
Low Purity Human Islets 30 % - 20%
Fresh/Snap Frozen Exocrine or Ductal Tissue
Fresh/Snap Frozen Human Pancreas Biopsy (0.2x0.2x0.2 cm3)
Fresh/Snap Frozen Human Pancreas Biopsy (0.5x0.5x0.5 cm3)
Snap Frozen Human Islets

Type II Human Pancreatic Products

High Purity Human Islets 100% – 75%
Medium Purity Human Islets 70% – 40%
Low Purity Human Islets 30 % - 20%
Fresh/Snap Frozen Exocrine or Ductal Tissue

Fresh/Snap Frozen Human Pancreas Biopsy (0.2x0.2x0.2 cm3)
Fresh/Snap Frozen Human Pancreas Biopsy (0.5x0.5x0.5 cm3)
Snap Frozen Human Islets

Type I Human Pancreatic Products

Human Islets (Particle)
Fresh/Snap Frozen Exocrine or Ductal Tissue (ml)
Fresh/Snap Frozen Human Pancreas Biopsy (0.2x0.2x0.2 cm3)
Fresh/Snap Frozen Human Pancreas Biopsy (0.5x0.5x0.5 cm3)
Snap Frozen Human Islets

Cell Depletion and Cell Enrichment from Bone Marrow / Peripheral Blood / UCB

CD3 depletion
CD4 enrichment
CD34 selection
CD133 selection
CD34+/CD3- enrichment

CD56 selection

CD4+/CD25+ T regulatory cell enrichment

Drug Toxicity Screen with GSIS
Islet Enumeration Proficency Testing
Islets Enumeration and Purity Assessment
Islets Quality Assessment
Endotoxin Assessment
CFU Assay
CD34 Analysis