cell media

Regulatory strategic planning and developmentv  cGMP enhancement Master Planv  Manufacturing and scale-up managementv  Process capabilities and controlsv  Regulatory submission preparation - IND, IDE, NDA, PMA, BLAv  Due diligence auditsv  Mock FDA inspectionsv  Pre-approval inspection readinessv  Equipment Qualification·         Design Qualification (DQ)·         Installation Qualification (IQ)·         Operational Qualification (OQ)·         Performance Qualification (PQ)v  Validation Master Plans·         Process Validation·         Cleaning Validationv  Facilities Qualificationv  Procedure Developmentv  SOP Writing  Normal Human Pancreatic ProductsHigh Purity Human Islets 100% – 75%        Regulatory strategic planning and developmentv  cGMP enhancement Master Planv  Manufacturing and scale-up managementv  Process capabilities and controlsv  Regulatory submission preparation - IND, IDE, NDA, PMA, BLAv  Due diligence auditsv  Mock FDA inspectionsv  Pre-approval inspection readinessv  Equipment Qualification·         Design Qualification (DQ)·         Installation Qualification (IQ)·         Operational Qualification (OQ)·         Performance Qualification (PQ)v  Validation Master Plans·         Process Validation·         Cleaning Validationv  Facilities Qualificationv  Procedure Developmentv  SOP Writing                                   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 ProductsHigh 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 ProductsHuman 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 / UCBCD3 depletionCD4 enrichmentCD34 selectionCD133 selectionCD34+/CD3- enrichmentCD56 selectionCD4+/CD25+ T regulatory cell enrichment