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Induced Pluripotent Stem Cell (iPSC) Manufacturing Platform

·We offer a DMF-certified clinical-grade iPSC bank

·We offer iPSC line generation services

·We offer comprehensive solutions for the directed differentiation of over ten types of tissue-specific cells, including NK cells, pancreatic beta cells, neural stem cells, neurons, endothelial cells, liver cells, and cardiomyocytes.

·We offer iPSC lines for over twenty major and rare diseases

iPSCs Line Generation and Maintenance

  • Multiple reprogramming techniques

  • Footprint free

  • Safe & Highly Efficient

  • cGMP compliant

Manufacturing of iPSC-NK Cells

The iPSC-NK cell manufacturing process uses a feeder-free culture system and 3D expansion technology to enable large-scale production. This method enhances the safety of NK cell products while maintaining the high purity and potency of iPSC-NK cells.

Manufacturing of iPSC-derived β-Islets

Development of a Stable Differentiation Protocol for iPSC-Derived Islet β Cells

Offering Full Lifecycle Services for Induced Pluripotent Stem Cell (iPSC)-Based Drug Development

  • ·Pre-IND
  • ·Phase Ⅰ/Ⅱ
  • ·Phase Ⅲ/NDA
  • Process Development

    ·Process Research

    ·Process Optimization and Validation

    ·Formulation and Process Development, Research, and Validation

  • Quality Standard Research

    ·Research and Establishment of Quality Standards

    ·Development and Validation of Quality Analysis Methods

  • Stability Studies

    ·Accelerated Stability Study

    ·Storage Stability Study

    ·Transport Stability Study

    ·In-Use Stability Study

  • Clinical Trial Registration Batch Production and Testing

    ·Production of Seed Cell Bank for Clinical Trial Registration Batch

    ·Preparation of End-of-Production Cell Bank for Clinical Trial Registration Batch

    ·Batch Quality Inspection

  • Additional Services

    ·Mechanism of Action Research

    ·Storage of Seed Cell Bank and Working Cell Bank

    ·Preclinical Toxicology Study Consulting

    ·Preclinical Pharmacodynamics Study Consulting

    ·CTD Document Preparation Consulting

  • Continuous Process Optimization

    ·Process Optimization and Validation

    ·Formulation Process Optimization and Validation

  • Continuous Optimization of Quality Standards

    ·Optimization and Validation of Quality Standards

    ·Optimization and Validation of Quality Analysis Methods

  • Accumulation of Stability Data

    ·Storage Stability Studies

    ·In-Use Stability Studies

  • Small-scale Production and Verification

    ·Seed Cell Bank Production

    ·Working Cell Bank Production

    ·Batch Verification

  • Additional Services

    ·Clinical Trial Protocol Consulting

    ·Storage for Seed Cell Banks and Working Cell Banks

  • Large-scale Production and Quality Control System Validation

    ·Production Process Scale-up Research, Validation and Process Verification

    ·Validation and Verification of Quality Standards and Analytical Methods

  • Data Accumulation for Stability Studies

    ·Storage Stability

  • Large-Scale Production and Quality Control

    ·Production of Seed Cell Banks

    ·Production of Master Cell Banks

    ·Batch Quality Testing

  • Additional Services

    ·CTD Document Preparation Consulting

    ·Storage of Seed Cell Banks

    ·Storage of Master Cell Banks

Providing a Research-Grade iPSC Cell Line Repository

The repository consists of 130 iPSC lines derived from healthy controls and donors with 24 different diseases.
  • · Healthy Controls
  • · Alzheimer's Disease (AD)
  • · Parkinson's Disease (PD)
  • · Epilepsy
  • · Panic Disorder
  • · Obsessive-Compulsive Disorder
  • · Bipolar Disorder
  • · Depression
  • · Neural Tube Defects
  • · Central Retinal Vein Occlusion
  • · Retinitis Pigmentosa
  • · Liver Cancer
  • · Cirrhosis
  • · Fatty Liver Disease
  • · High Myopia (Genetic)
  • · Skeletal Diseases
  • · Brittle Bone Disease (Osteogenesis Imperfecta)
  • · Ciliary Dyskinesia
  • · Linear Nevus Sebaceous Syndrome (LNSS)
  • · Arrhythmia
  • · Hereditary Hyperexpansile Capillary Telangiectasia
  • · Thrombophilia
  • · MBD5 Gene Mutation
  • · STXBP1 Gene Mutation
  • · STXBP2 Gene Mutation

iPSCs cell lines

  • Phase Contrast

  • Karyotype analysis

  • Pluripotent marker immunofluorescence staining

  • Pluripotent marker flow cytometry analysis

  • In vitro EB differentiation

iPSC-Endothelial cells iPSC-Cardiomyocytes iPSC-Hepatocytes iPSC-Neural Stem Cells iPSC-Neurons

Techniques for Differentiating iPSCs and Their Applications

·IxCell NK Cells

·IxCell Pancreatic β cells

·IxCell Neural stem cells

·IxCell Endothelial cells

·IxCell Cardiomyocytes

·IxCell Hepatocytes

  • IxCell NK Cell

    Quality Indicators

    ·CD56+ Cells: ≥80%

    ·CD16+ Cells: ≥30%

    ·Percentage of Target Cell Lysis: ≥70%

    ·Cell Viability: ≥95%

    Indications

    Autoimmune Diseases

  • IxCell Pancreatic β cells

    Quality Indicators

    ·Glucagon+ cells: ≥95%

    ·Insulin Secretion: 8000 mU/L

    ·GSIS: Pass

    ·Cell Viability: ≥95%

    Indications

    Diabetes

  • IxCell Neural stem cells

    Quality Indicators

    ·Sox1+ cells: ≥99%

    ·Sox2+ cells: ≥99%

    ·Nestin+ cells: ≥99%

    ·Pax6+ cells: ≥56%

    ·Cell Viability: ≥95%

    Clinical Applications

    Neurodegenerative Diseases: Parkinson's Disease (PD), Senile Cognitive Impairment Syndrome, etc.

    National and Provincial Major R&D Grants Awarded to IxCell:

    ·Beijing Science and Technology Commission (Battlefield Trauma Repair) (Z181100004118004)

    ·National Key R&D Program (2016YFA0101300)

  • IxCell Endothelial cells

    Quality Indicators

    ·CD31+ cells: ≥98%

    ·CD144+ cells: ≥98%

    ·Cell Viability: ≥95%

    Indications

    Vascular Diseases

    National and Provincial Major R&D Grants Awarded to IxCell:

    ·National Key Research and Development Program (2018YFB1105600).

  • IxCell Cardiomyocytes

    Quality Indicators

    ·cTnT+ cells: ≥98%

    ·MLC-2a+ cells≥98%

    ·MLC-2v+ cells: ≥98%

    ·Cell Viability: ≥95%

    Indications

    Cardiac diseases; Myocardial drug screening and development

    National and Provincial Major R&D Grants Awarded to IxCell:

    ·National Key R&D Program (2016YFA0101300)

  • IxCell Hepatocytes

    Quality Indicators

    ·HNF+ cells: ≥98%

    ·Albumin+ cells: ≥98%

    ·PAS+ cells: ≥98%

    ·Cell Viability: ≥95%

    Indications

    Liver disease research and drug development

    National and Provincial major R&D Grants Awarded to IxCell:

    ·Major National Project for New Drug Creation, 2015ZX09501-009

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