Some of Our Services

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CMC Strategy

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)

Preclinical Strategy

IND-Enabling Study Design & Planning
Preclinical Development Strategy
In Vivo Model Selection & Study Design
Safety & Toxicology Strategy
Biodistribution & Persistence Studies
Dose Ranging & PK/PD Strategy
CRO Selection & Oversight for Preclinical Studies
Regulatory Submission Support (IND, CTA)

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Technical Operations

Technical Operations

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

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GMP Vendor Selection

Technical Operations

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

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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

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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

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

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