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weCANdev 
Cell Therapies Consulting
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weCANdev 
Cell Therapies Consulting
  • Home
  • Services
  • Our Team
  • Resources
  • Contact Us

Some of Our Services

Wet Lab Services

  • DoE-based CRISPR Gene Editing Optimization (iPSCs, HSCs, T-cells)
  • Bioreactor Process Development
  • Scale Down Models
  • Tech Transfers
  • Cell Processing Device Evaluation
  • Cell Culture Media Development
  • Cell Line Optimization

Process Development

  • DoE Training & Deployment
  • Process Gap Analysis
  • Process Development Strategy
  • Tech Transfers
  • CRISPR Gene Editing
  • Bioreactor Based Scale Up
  • Scale Down Models
  • SOP Templates
  • Critical Raw Materials Selection
  • Media Development
  • Automation
  • Process Characterization

Analytical Development

  • Assay Gap Analysis
  • Analytical Development Strategy
  • Assay Qualification
  • Assay Validation
  • Tech Transfer
  • Automation
  • Equipment Selection
  • Critical Raw Material Selection
  • Cell-based Assays
  • Genomic On/Off Target Assays
  • MS Metabolomics & Proteomics 

CMC Strategy

Technical Operations

  • QTPP Establishment
  • Product Development Stage Gates
  • Comparability Strategy
  • Genomic Integrity Strategy
  • Unit Operations Criticality Assessment
  • Phase Appropriate Development Strategy
  • Systems Cassette (Risk Assessment-Scale Down Model-DoE Based Process Understanding)

 

Technical Operations

Technical Operations

Technical Operations

  • Experiment Planning 
  • Experiment Execution Framework
  • Tech Transfer Framework
  • Root Cause Analysis
  • Process SOP Templates
  • Assay SOP Templates

GMP Vendor Selection

Technical Operations

Technical Operations

  • iPSC Lines
  • Donor Selection
  • CDMO Selection & Management
  • CRO Selection & Management 
  • GMP Critical Raw Materials


QbD Infrastructure & Advanced Analysis

  • Quality By Design Overview
  • Process Flow Diagrams
  • Risk Assessments
  • DoE Training
  • DoE Core Deployment
  • Comparability Demonstration
  • Software Assessment
  • Hypothesis Testing Statistics
  • Multivariate Statistics

Regulatory Guidance

  • Regulatory Strategy Seamlessly Coupled With Process & Analytical Development Through Our weCAN Network

weCANreg

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