Assay and Protocol Development:

(Compendial & Non-Compendial)

• Development 
• Qualification 
• Validation 
• Tech Transfer & Method Lifecycle Management

Study Design and Execution

• Process Design, Scale-Up, and Performance Qualification

• Campaign

• Phase-Appropriate Sampling Plan

• Product Stability And Process Comparability Studies

• Continued Process Verification and Annual Product

• Quality Review

Analytics/Bioanalytical Testing

• Pharmacokinetics and Pharmacodynamics

GMP Product Release

• Product Purity
• Safety
• Identity
• Dose / Strength
• pH
• Potency
• Osmolality
• Appearance
• Particulate Detection

• Reagent Qualification

Characterization of:

• Plasmid
• sgRNA
• Vector
• Apheresis
• Process
• Drug Substance
• Product

• Comparability and Stability Studies