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Induced Pluripotent Stem Cell (iPSC) Ma​☆πσnufacturing Platform

·We offer a DMF-certifi☆πγed clinical-grade iPSC bank≈₩↓ 

·We offer iPSC line generation ↕±↕services

·We offer comprehensive sβ‍∏♣olutions for the directed ​ differentiation of over ten typλ¶↔es of tissue-specific £• cells, including NK cells, pancreat↓σ‍¶ic beta cells, neural s£©tem cells, neurons, endothelial cell♦¥s, liver cells, and cardiom₹‍yocytes.

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

iPSCs Line Generation and Maintenance

  • Multiple reprogramming techΩ≤niques

  • Footprint free

  • Safe & Highly Efficient

  • cGMP compliant

Manufacturing of iPSC-NK Cells

The iPSC-NK cell manufact★♦uring process uses a feeder-¶φ§×free culture system and 3D ×λ₹αexpansion technology to en≤β↑​able large-scale production.‌γ This method enhances φ<the safety of NK cell products w¥↕©™hile maintaining the high pur★>ity and potency of iPSC-N≤π₹K cells.

Manufacturing of iPSC-derived β-Islets

Development of a Stable σγ$Differentiation Protocol for iPSC-D<&ε✔erived Islet β Cells

Offering Full Lifecycle Services ✘♦®for Induced Pluripotent Stem Cell (i$δαPSC)-Based Drug Developme>♥nt

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

    ·Process Research

    ·Process Optimization and ®×Validation

    ·Formulation and Process Dev→ ₹elopment, Research, and Val₩♣✘idation

  • Quality Standard Researc ←αh

    ·Research and Establishment of‍¶ ↕ Quality Standards

    ·Development and Validaσ≥£✔tion of Quality Analy★←₽sis Methods

  • Stability Studies

    ·Accelerated Stability Study

    ·Storage Stability Study

    ·Transport Stability Study

    ·In-Use Stability Study

  • Clinical Trial Registration Ba←♣πtch Production and Testing

    ·Production of Seed Cell Bank for Cli₽☆nical Trial Registration B‍¥∏atch

    ·Preparation of End-of-☆€Production Cell Bank∑  for Clinical Trial Registra♠≈±↕tion Batch

    ·Batch Quality Inspection

  • Additional Services

    ·Mechanism of Action Research

    ·Storage of Seed Cell Bank and Working παCell Bank

    ·Preclinical Toxicology Studyδ←δ Consulting

    ·Preclinical Pharmacodynamics Study Co± ₩nsulting

    ·CTD Document Preparation Consult•Ω↕ing

  • Continuous Process Optim•αε£ization

    ·Process Optimization and®↑ππ Validation

    ·Formulation Process Optimization  ‍and Validation

  • Continuous Optimization of Quality S♦£•★tandards

    ·Optimization and Validation♠&   of Quality Standards

    ·Optimization and Vali₹£‍↔dation of Quality Analysis Me∏←thods

  • Accumulation of Stabilityφ&↔₽ Data

    ·Storage Stability Stud¥∏ies

    ·In-Use Stability Studies

  • Small-scale Production and Verificat¶→∏∞ion

    ·Seed Cell Bank Production

    ·Working Cell Bank Production

    ·Batch Verification

  • Additional Services

    ·Clinical Trial Protocol Consultin∏₩★"g

    ·Storage for Seed Cell Ban×π£ks and Working Cell Ba ☆↕‍nks

  • Large-scale Production and Qua♣<lity Control System Validation

    ·Production Process Scale-up Re↕Ωsearch, Validation and Proces‌β≤∑s Verification

    ·Validation and Verification of Qual‍<✘<ity Standards and Anal‌ ☆'ytical Methods

  • Data Accumulation for St‌✔≥ability 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 C≠ ♠onsulting

    ·Storage of Seed Cell Banks‌←

    ·Storage of Master Cell B♦φanks

Providing a Research-Grade iPSC Cel→÷±l Line Repository

The repository consists of 130 iPS★≤ C lines derived from healthy conεσ<trols and donors with 24 dβ₹ifferent diseases.
  • · Healthy Controls
  • · Alzheimer's Disease (AD)
  • · Parkinson's Disease (P <↕÷D)
  • · Epilepsy
  • · Panic Disorder
  • · Obsessive-Compulsive Disorder
  • · Bipolar Disorder
  • · Depression
  • · Neural Tube Defects
  • · Central Retinal Vein O★→γcclusion
  • · Retinitis Pigmento♦↔↕sa
  • · Liver Cancer
  • · Cirrhosis
  • · Fatty Liver Disease
  • · High Myopia (Genetic)
  • · Skeletal Diseases
  • · Brittle Bone Disease (Osteo✔δ₩≠genesis Imperfecta)
  • · Ciliary Dyskinesia
  • · Linear Nevus Sebace<™αφous Syndrome (LNSS)
  • · Arrhythmia
  • · Hereditary Hyperexpansile Capillary T✔₽©↓elangiectasia
  • · Thrombophilia
  • · MBD5 Gene Mutation
  • · STXBP1 Gene Mutation
  • · STXBP2 Gene Mutation

iPSCs cell lines

  • Phase Contrast

  • Karyotype analysis

  • Pluripotent marker immunofluo≤ ¥♣rescence staining

  • Pluripotent marker f♥↕β↔low cytometry analysis

  • In vitro EB differentiation

Techniques for Differentiating iPSC<÷s and Their Application &׶s

·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 C♠""ell 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 ®σ(PD), Senile Cognitive Impα airment Syndrome, etc.

    National and Provincial ¶§ Major R&D Grants Awarded to Iσ™xCell:

    ·Beijing Science and Technol∞♥>♥ogy Commission (Battlefield Trauma§ & Repair) (Z1811000041↕♣δ18004)

    ·National Key R&D Progra​>m (2016YFA0101300)

  • IxCell Endothelial ce☆←σ♥lls

    Quality Indicators

    ·CD31+ cells: ≥98%

    ·CD144+ cells: ≥98%

    ·Cell Viability: ≥95%

    Indications

    Vascular Diseases

    National and Provincia₩↕l Major R&D Grants Awarded toγ§ IxCell:

    ·National Key Research and¥✘ Development Program (2018YFB™₹1105600).

  • 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 deve←€lopment

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

    ·National Key R&D Program (2016YFA™♦≠<0101300)

  • IxCell Hepatocytes

    Quality Indicators

    ·HNF+ cells: ≥98%

    ·Albumin+ cells: ≥98%

    ·PAS+ cells: ≥98%

    ·Cell Viability: ≥95%

    Indications

    Liver disease research and dru♣♣÷g development

    National and Provincial major R&D G✘σ★&rants Awarded to IxCell:

    ·Major National Project for  ∏<New Drug Creation, 2015ZX09501→ ↕∞-009

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